EN EN

EUROPEAN COMMISSION

Brussels, 9.9.2026 COM(2026) 568 final

2026/0267 (NLE)

Proposal for a

COUNCIL RECOMMENDATION

on common principles on regulatory sandboxes to support innovation and a future-

proof regulatory framework

EN 1 EN

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Across Europe, there is a strong political focus on competitiveness and innovation-friendly

regulation, while boosting global market access for businesses. The European Union wants to

remain a place where breakthrough innovation can emerge and scale, while maintaining high

standards for safety, trust and fairness. At the same time, innovative companies that want to

scale up in Europe may be hindered by regulations that are not sufficiently flexible1, posing

certain challenges for innovators. The fragmented landscape across Member States in areas

where no harmonised EU legislation exists also creates an uneven level playing field and

higher compliance costs for innovators to test solutions under real world conditions in

different Member States.

In response, the Commission adopted the EU Startup and Scaleup Strategy2 in May 2025,

outlining plans to enhance the Union’s regulatory agility. Among other measures, regulatory

sandboxes can provide businesses, including SMEs, startups, and other interested parties, with

testing environments and accelerate market entry. At the same time, regulators can better

understand the needs of emerging innovations and adjust rules to respond more effectively to

challenges they face. Regulatory sandboxes are usually set up on a case-by-case basis with a

clear scope. Importantly, this experimentation tool is not about deregulation. Rather, it is

about creating a safe space where innovation and regulatory learning can evolve together.

Regulatory sandboxes provide a practical way to learn by doing and offer firsthand insights

into emerging innovation – including their risks and impact. They may also reduce market

entry barriers for innovators and enhance communication and coordination between different

public authorities and innovators, especially in relation to cross-sectoral innovation.

In 2025, the Commission also conducted a survey of Member States on their national

experience with regulatory sandboxes3. The collective insights from the responding Member

States emphasised the need for political backing, open communication, adequate resource

allocation, and flexible, well-defined frameworks in achieving regulatory sandbox success.

Continuous collaboration, iterative adjustments, and close stakeholder engagement remain

vital to capitalise on regulatory sandboxes fully. Collectively, these insights point to the

necessity of clear procedural frameworks, strong stakeholder collaboration, flexible design,

effective communication, and strategic alignment with broader economic and social goals.

The objective of this proposal for a Council Recommendation is to contribute to an

environment where innovation and regulation drive growth, competitiveness, and resilience

across the EU. It sets out a common EU reference framework for regulatory sandboxes in

areas where there is no Union legislation, with a definition and principles for their

establishment, supervision and cross-border operation. This will provide a common

understanding of this regulatory experimentation tool across the Union, enabling its more

effective and efficient use that builds on existing experiences and best practices from the

Member States and existing initiatives. In practice, this also clarifies access to regulatory

1 The Draghi report: A competitiveness strategy for Europe, 2024, p. 6,

https://commission.europa.eu/topics/competitiveness/draghi-report_en#paragraph_47059. 2 COM/2025/270final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0270 3 European Commission: Directorate-General for Research and Innovation, Vuorinen, H., Isakovic, S. M.

and Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report, Publications Office of

the European Union, 2026, https://data.europa.eu/doi/10.2777/9535645

EN 2 EN

sandboxes and helps to reduce fragmentation between Member States. The Commission

proposal promotes regulatory learning and will further strengthen the dialogue with Member

States in the future. For innovators, well implemented regulatory sandboxes can improve

regulatory clarity and facilitate the development of innovative solutions, such as technologies,

products, services, and business models.

• Consistency with existing policy provisions in the policy area

The Council conclusions of 30 September 2025 on ‘The importance of research and

innovation for the EU Startup and Scaleup Strategy’4 recognised the importance of regulatory

sandboxes to facilitate market entry of innovations by supporting innovative startups and

innovative scaleups in developing and testing new ideas, assessing regulatory compliance of

new solutions, improving regulatory learning, and issuing recommendations for overcoming

regulatory hurdles. To ensure the rapid and effective implementation of regulatory sandboxes,

these Council conclusions encouraged the Union to develop clear and efficient rules in the for

regulatory sandboxes in the upcoming European Innovation Act, including for Union-wide

regulatory sandboxes.

This proposal for a Council Recommendation is adopted together with the proposal for

European Innovation Act5.

The proposal follows up on the 2020 Council Conclusions on the role of regulatory sandboxes

and experimentation clauses in an innovation-friendly, future-proof, sustainable and resilient

EU regulatory framework6. These conclusions called upon the Commission to organise, in

cooperation with Member States, an exchange of information and good practices regarding

regulatory sandboxes between Member States and itself in order to:

(a) establish an overview of the state of play regarding the use of regulatory sandboxes

in the EU;

(b) identify experiences regarding the legal basis, implementation and evaluation of

regulatory sandboxes;

(c) analyse how learning from regulatory sandboxes at national level can contribute to

evidence-based policy making at EU-level.

In response, the Commission has already adopted the 2023 staff working document on

regulatory learning in the EU7, one of the actions on the New European Innovation Agenda

(NEIA)8, and conducted a follow-up survey of Member States in 2025 on regulatory

sandboxes.

4 The importance of research and innovation for the EU Startup and Scaleup Strategy – Council

conclusions https://data.consilium.europa.eu/doc/document/ST-13357-2025-INIT/en/pdf 5 Commission proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL - European Innovation Act – COM(2026) 567 6 Council Conclusions on Regulatory sandboxes and experimentation clauses as tools for an innovation-

friendly, future-proof and resilient regulatory framework that masters disruptive challenges in the

digital age https://data.consilium.europa.eu/doc/document/ST-13026-2020-INIT/en/pdf 7 SWD(2023) 277/2 final, https://research-and-innovation.ec.europa.eu/document/download/fc6f35cd-

a8d6-4770-aefe-c09ca85cff8c_en?filename=swd_2023_277_f1.pdf 8 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions A New European Innovation

Agenda COM/2022/332 final, https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=CELEX:52022DC0332

EN 3 EN

• Consistency with other Union policies

This proposal recognises all policy areas where the Union and Member States have shared

competence. It takes into account that regulatory sandboxes have already been introduced in

legislation or form part of pending legal proposals, including:

• artificial intelligence, with Regulation (EU) 2024/1689 (‘AI Act’)9 requiring

Member States to establish at least one regulatory sandbox in this field providing

national coverage,

• biotechnology, following the Commission Proposal for the European Biotech Act10

in 2025 which outlined five regulatory sandbox frameworks and builds on the

Strategic Framework for a Competitive and Sustainable EU Bioeconomy11,

• cybersecurity, where the Cyber Resilience Act12, adopted in 2024 introduced

provisions on regulatory sandboxes for products with digital elements,

• public sector interoperability, where cross-border regulatory sandboxes were

introduced in the Interoperable Europe Act13, adopted in 2024,

• energy, climate and environmental transitions, following the adoption of the 2024

Net-Zero Industry Act14 which also includes provisions on regulatory sandboxes.

Contributing to Europe’s maritime technological leadership, industrial sovereignty

and twin transition objectives, the 2026 Industrial Maritime Strategy “encourages

Member States to further support the rapid uptake of innovation including tests beds

and regulatory experimentation”15. In the same vein, the 2026 Strategy for the

development and deployment of Small Modular Reactors (SMRs) in Europe

specifies that the Commission “will assist Member States in developing regulatory

9 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No

167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives

2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689,

12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj) 10 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on

establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing

sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No

1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech

Act) COM(2025) 1022 final, EUR-Lex - 52025PC1022(01) - EN - EUR-Lex 11 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions A Strategic Framework for a

Competitive and Sustainable EU Bioeconomy COM(2025) 960 final, https://eur-lex.europa.eu/legal-

content/EN/TXT/PDF/?uri=CELEX:52025DC0960 12 Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on

horizontal cybersecurity requirements for products with digital elements and amending Regulations

(EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (Text

with EEA relevance) https://eur-lex.europa.eu/eli/reg/2024/2847/oj/eng 13 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying

down measures for a high level of public sector interoperability across the Union (Interoperable Europe

Act), Regulation - EU - 2024/903 - EN - EUR-Lex 14 Regulation (EU) 2024/1735 of the European Parliament and of the Council of 13 June 2024 on

establishing a framework of measures for strengthening Europe’s net-zero technology manufacturing

ecosystem and amending Regulation (EU) 2018/1724 (Text with EEA relevance), Regulation - EU -

2024/1735 - EN - EUR-Lex 15 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions on the EU Industrial Maritime

Strategy COM(2026)111final, https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=celex:52026DC0111

EN 4 EN

sandboxes for SMRs”, building on the regulatory sandboxes provided for under the

Net-Zero Industry Act16,

• financial sector, where market infrastructures based on distributed ledger

technology benefitted from a pilot regime of Regulation (EU) 2022/858 (‘DLT Pilot

Regime Regulation’)17,

• mobility, as regulatory sandboxes are addressed in the Industrial Action Plan for the

European automotive sector, aiming to boost market readiness and

commercialisation of autonomous vehicles. Moreover, they are included in the

Commission proposal aiming to facilitate a more rapid and autonomous development

of innovative, dual-use transport solutions in cooperation between civil and military

authorities 18,

• life sciences and pharmaceutical sectors, with regulatory sandbox provisions

included in thepolitically agreed regulation laying down Union procedures for the

authorisation and supervision of medicinal products for human use and establishing

rules governing the European Medicines Agency19, as well as in the proposed

revision of the EU Regulations on medical devices and in vitro diagnostic medical

devices20 and in the proposal for a European Biotech act, which also addresses

regulatory sandboxes in the area of food chain.21The Commission’s Strategy to

position the Union as the world’s most attractive place for life sciences by 2030

indicated that “regulatory systems need to be responsive to emerging technologies

and keep pace with scientific progress. Future legislation should integrate

experimentation clauses, derogations and the use of test environments such as

regulatory sandboxes”22.

16 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, Strategy for the development and

deployment of Small Modular Reactors (SMRs) in Europe, COM(2026) 117 final, https://eur-

lex.europa.eu/legal-content/EN/TXT/?uri=celex:52026DC0117 17 Regulation (EU) 2022/858 of the European Parliament and of the Council of 30 May 2022 on a pilot

regime for market infrastructures based on distributed ledger technology, and amending Regulations

(EU) No 600/2014 and (EU) No 909/2014 and Directive 2014/65/EU (Text with EEA relevance)

Regulation - 2022/858 - EN - dlt - EUR-Lex 18 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on

establishing a framework of measures to facilitate the transport of military equipment, goods and

personnel across the Union COM(2025) 847 final, https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=celex:52025PC0847 19 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down Union procedures for the authorisation and supervision of medicinal products for human

use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No

1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation

(EC) No 141/2000 and Regulation (EC) No 1901/2006 EUR-Lex - 52023PC0193 - EN - EUR-Lex 20 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the

burden of the rules on medical devices and in vitro diagnostic medical devices, and amending

Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert

panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation

legislation referred to in its Annex I EUR-Lex - 52025PC1023 - EN - EUR-Lex 21 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on

establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing

sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No

1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 22 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, Choose Europe for life sciences A

EN 5 EN

This proposal focuses on national regulatory sandboxes set up by Member States and is

without prejudice to existing Union legislative provisions on regulatory sandboxes or

Commission proposals for new legislative initiatives. It encourages Member States to build on

the existing legislative framework for regulatory sandboxes made under Union law, when

relevant.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The legal bases for this initiative are Articles 173(3) and 292 of the Treaty on the Functioning

of the European Union (TFEU). In accordance with Article 292 TFEU, the Council can adopt

recommendations and acts on a proposal from the Commission in all cases where the Treaties

state that it must adopt acts on the basis of a proposal from the Commission.

In accordance with Article 173 TFEU, the Union and the Member States must ensure that the

necessary conditions for competitiveness of the Union’s industry exists. This includes

fostering better exploitation of the industrial potential of policies of innovation, research and

technological development. In particular, according to Article 173(3), the Union shall

contribute to the achievement of the objectives set out in Article 173(1) through the policies

and activities it pursues under other provisions of the Treaties.

The initiative does not propose any extension of Union regulatory power or binding

commitments on Member States. It is the Member States who will decide, based on their

national circumstances, how they implement this Council Recommendation, taking into

account relevant applicable Union legislation.

• Subsidiarity (for non-exclusive competence)

The present proposal is in conformity with the principle of subsidiarity as provided for in

Article 5(3) of the Treaty on the European Union (TEU).

The use of regulatory sandboxes, including cross-border regulatory sandboxes, is expected to

grow across the Union in the coming years. In this evolving context, different interpretations

and applications of the concept of a “regulatory sandbox” have started to emerge across

sectors and among Member States. Action by Member States alone, in non-harmonised areas,

is likely to result in divergent approaches, creating substantial coordination costs for Member

States seeking to cooperate or develop common practices. A coordinated approach is therefore

necessary to minimise transaction costs for European businesses and public authorities using

this tool.

The proposal provides an efficient means of establishing a common EU reference framework,

reducing fragmentation across Member States, and ultimately supporting the Single Market.

By promoting favourable framework conditions and a common approach to regulatory

experimentation, this proposal seeks to foster collective action. It aims to deliver more

targeted and effective results than isolated national initiatives. A common approach would

ease establishing regulatory sandboxes across borders by several Member States while

remaining flexible enough to accommodate the different degrees of experience and

strategy to position the EU as the world’s most attractive place for life sciences by 2030

COM/2025/525 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0525

EN 6 EN

preparedness among Member States in accelerating innovation and taking into account

relevant applicable Union legislation.

The proposed approach is consistent with the logic underpinning recent Union legislative

initiatives, notably the AI Act and the Interoperable Europe Act, both of which recognise that

purely national regulatory sandboxes cannot by themselves ensure cross-border regulatory

learning, mutual recognition of outcomes, or the scaling of innovative solutions across the

Single Market.

The proposal therefore generates Union added value by fostering joint regulatory

experimentation across jurisdictions and reducing the costs for innovators of engaging with

multiple national regimes, while leaving the design and operation of national regulatory

sandboxes to Member States.

• Proportionality

The present proposal is in conformity with the principle of proportionality as provided for in

Article 5(4) TEU. Neither the content nor the form of this proposed Council Recommendation

exceeds what is necessary to achieve the objective of achieving a minimum level of

consistency of approach across the Union.

The legal status of this initiative should ensure ownership of and endorsement by the Member

States.

The recommendation helps Member States and the Union to develop and implement

regulatory sandbox frameworks and to promote regulatory learning. A minimum level of

consistency of approach across the EU is essential. It underscores the importance of

transparency of establishment and implementation, following the principle ‘as open as

possible, as closed as necessary’. It also recommends considering risk management measures

for experimentation.

• Choice of the instrument

The proposed Council Recommendation provides guidance to Member States about how to

define regulatory sandboxes and agree on common principles for their establishment, design,

operation, including in cross-border context, and evaluation and regulatory learning. It

recommends that Member States support their innovation sector and public authorities, taking

appropriate steps to raise awareness.

The choice of a Council Recommendation ensures that all Member States are actively

involved and committed at political level, while at the same time it allows for sufficient

flexibility, considering that Member States may depart from different starting points in terms

of regulatory frameworks, availability of resources, and maturity of the innovation ecosystem.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

This is a new initiative so there was no preceding evaluation.

• Stakeholder consultations

The current initiative is covered by a comprehensive stakeholder consultation plan carried out

for the European Innovation Act.

EN 7 EN

Of the respondents to the stakeholder consultation that expressed an opinion23 on regulatory

sandboxes, a majority agreed that an EU-level definition of ‘regulatory sandbox’ would help

achieve a better common understanding across Europe, and that more possibilities for “cross-

border EU-level regulatory sandboxes” would facilitate their wider implementation, as well as

that there should be regulatory sandboxes for newly emerging technologies to facilitate their

wider adoption.

Respondents that have declared experience in participating in or setting up regulatory

sandboxes show higher agreement with the above statements than those that have not.

In the position papers submitted in response to the call for evidence on the European

Innovation Act, stakeholders highlighted the lack of sufficient opportunities to test innovative

solutions, identified regulatory sandboxes as essential for overcoming limited testing

opportunities in the Union and described Union funding and regulatory procedures as slow,

duplicative, and inaccessible. Other submissions argued that existing regulatory systems in

Member States are outdated and slow to keep pace with technological change, often applying

old rules to new technologies such as AI and biotechnology.

During stakeholder interviews, industry, SME, and startup associations discussed the idea of

harmonising regulatory sandboxes positively to allow innovative products to enter the market

under controlled conditions, reducing time-to-market. Financial-sector representatives

proposed a sandbox jurisdiction for start-ups with simplified incorporation, licensing and

harmonised business codes to enable easier cross-border operation.

In April 2025, the Commission survey of Member States on the national use of regulatory

sandboxes was launched at the Council Working Party on Competitiveness and Growth –

Better Regulation, under the Polish presidency for the Council of the European Union. It

builds on a similar survey conducted in 2021 by the Slovenian Council Presidency. In

September 2025, the latest data were presented at the same Working Party24 under the Danish

Council Presidency. During the discussion that followed the presentation, two Member States

provided additional data on regulatory sandbox practices in their national context and other

responses were accepted until January 2026. The final report published by the Commission in

March 2026 presents all the data received25.

• Collection and use of expertise

In addition to the input received during the consultation process, the proposal is underpinned

by extensive evidence, reports and studies collected over recent years. Key sources of

evidence include two surveys of Member States conducted by the Commission in 2021 and

2025, the 2026 Assessment of the state of play of the innovation principle in the preparation

of EU legislation, as well we the Commission’s biennial report on Science, Research and

Innovation Performance of the EU.

In 2025, the Commission conducted a survey of Member States on the use of regulatory

sandboxes at national level26. This second survey identified 132 regulatory sandboxes at

23 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14593-European-Innovation-

Act/public-consultation_en 24 https://data.consilium.europa.eu/doc/document/WK-12252-2025-INIT/en/pdf 25 European Commission: Directorate-General for Research and Innovation, Vuorinen, H., Isakovic, S. M.

and Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report, Publications Office of

the European Union, 2026, https://data.europa.eu/doi/10.2777/9535645 26 Ibid.

EN 8 EN

national level, across 15 Member States but primarily in Germany and France (up from 40

identified in the 2021 survey). This report shows the diversity of approaches in the Member

States, for example in terms of legal basis (horizontal or sector-specific), geographic

limitations of regulatory sandbox frameworks (i.e. in some cases enabling experimentation

only in some specific regions), openness to companies registered in other Member States,

monitoring and evaluation, as well as other aspects.

Looking at the inclusion of regulatory sandboxes and innovation more generally in the

preparation of EU legislation, a 2026 assessment27 found that experimentation clauses, pilot

schemes or regulatory sandboxes appear in approximately 10–15% of impact assessments

conducted in 2020-2025, primarily in digital, financial, and emerging technology policy areas.

According to the experts, regulatory sandboxes appear to have permeated the better regulation

agenda of the European Commission more than other tools.

In addition, the Commission’s biennial Science, Research and Innovation Performance of

the EU (SRIP) report highlighted the opportunities provided by regulatory sandboxes in the

most recent two editions. In 2024, the report underlined that “an adaptable regulatory

framework and a proactive standardisation strategy remain key to foster innovative

activities”28. The authors explain that the EU’s focus on regulatory sandboxes aims to

streamline the integration of research into the market, while ensuring the legislative agility

needed to keep pace with rapid technological advances. In 2022, the authors underlined that

the “emergence of new practices, technologies and business models, and the acceleration of

innovation call for more flexible and experimental approaches to regulation, such as

regulatory sandboxes”29.

• Impact assessment

The current proposal does not require an individual impact assessment given the non-binding

legal nature of the proposed instrument.

Nevertheless, each of the Union regulations and proposals that include regulatory sandbox

provisions as of July 2026 were accompanied by an impact assessment or analytical staff

working document.30

• Fundamental rights

One of the proposal’s main objectives is to support Member States and organisations

participating in regulatory sandboxes, ensuring that authorised experimentations support

innovation while preserving trust and protecting fundamental rights and values. Safeguards of

ethical and legal nature (e.g. data collection, transparency, protection of fundamental rights,

fair competition) need to be in place, and risks related to, for example health, safety or

fundamental rights, need to be managed properly. The proposal is based on a non-

discriminatory approach and promotes transparency of regulatory sandboxes.

27 European Commission: Directorate-General for Research and Innovation, Renda, A., Dell’'Aquila, M.,

Nyoka Rukudzo, I., Vu, H. et al., Assessment of the state of play of the innovation principle in the preparation of

EU legislation, Publications Office of the European Union, 2026, https://data.europa.eu/doi/10.2777/8779303 28 SRIP, 2024, p. 349, https://ec.europa.eu/assets/rtd/srip/2024/ec_rtd_srip-report-2024-chap-05.pdf 29 SRIP, 2022, p. 17, https://data.europa.eu/doi/10.2777/78826 30 SWD/2020/201 final; SWD/2020/201 final; SWD/2022/721 final; SWD(2023)219 final;

SWD/2022/282 final; SWD(2023) 192 final; SWD/2025/1050 final; SWD/2026/450 final.

EN 9 EN

4. BUDGETARY IMPLICATIONS

It is difficult to estimate cost changes brought by this Council Recommendation due to its

non-binding nature. Monitoring its application in Member States and evaluating its

implementation can provide cost estimates in the future.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

To support Member States and stakeholders as they implement the recommendation, full use

will be made of the existing governance structures, for example the Council Working Party on

Competitiveness and Growth.

The proposal underlines the importance of monitoring, evaluation and reporting on regulatory

learning that results from regulatory sandboxes and should be used to ensure legislation

remains fit for purpose.

• Explanatory documents (for directives)

Not applicable.

• Detailed explanation of the specific provisions of the proposal

The proposed Council Recommendation contains the following sections:

– After introducing the issue at stake and the political background of the proposal in

the recitals, its scope is explained. A definition of ‘regulatory sandbox’ is proposed,

which draws on the main elements of the various definitions in use internationally.

Other relevant terms are also defined, including experimentation, controlled

environment, competent authority and cross-border regulatory sandboxes.

– Then, principles for the establishment of regulatory sandboxes are proposed as a

recommendation to the Member States to agree on these minimum aspects for a

common framework in the Union. These principles are conceived in such a way that

they can be used to underpin the formulation and design of a regulatory sandbox at

any level and sector. These principles were formulated based on available best-

practice and taking into account results of the 2025 Survey of Member States31.

– A separate point outlines the minimum aspects that should be agreed related to any

cross-border regulatory sandbox to help innovative companies scale up across the

Union as it would enable larger scale testing in the different Member States.

Cooperation among competent authorities in cross-border regulatory sandboxes can

facilitate coordinated supervision, enhance regulatory coherence, and exploit cross-

border innovation synergies. They can also promote shared learning and sharing of

costs for the establishment, management and supervision of regulatory sandboxes for

innovations that are of relevance to multiple Member States.

– The duration and other conditions of experimentation and participation in regulatory

sandboxes that should be outlined are listed subsequently. To ensure regulatory

sandboxes to function effectively, the competent authorities should use transparent

31 European Commission: Directorate-General for Research and Innovation, Vuorinen, H., Isakovic, S. M.

and Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report, Publications Office of

the European Union, 2026, https://data.europa.eu/doi/10.2777/9535645

EN 10 EN

and objective processes governing participation including eligibility criteria,

application procedures, and clear terms and conditions for participation, as well as

conditions regarding the handling of intellectual property rights and liabilities to

ensure a predictable environment that supports the development of innovative

solutions. Any relevant support measures for participants, such as regulatory advice,

training and where appropriate funding, should be also clearly defined in advance in

the participation conditions. By doing so, it is ensured that innovation within the

regulatory sandboxes can be adequately nurtured and innovative solutions that

successfully complete experimentation in the regulatory sandbox can be guided

towards successful integration in the wider market. Dedicated points are then

provided on transparency and non-discriminatory access to regulatory sandboxes.

– The recommendation on regulatory learning and follow-up outlines that Member

States should require that after the completion of the regulatory sandbox, competent

authorities should analyse the available information and assess the need to amend the

regulatory framework. It also states that regulatory sandbox participants should be

able to obtain the exit report with the aim of accelerating the conformity assessment,

standardisation or national market approval of their innovations that were tested

within the regulatory sandbox.

– The final section specifies how the follow-up to the recommendation is facilitated

and monitored.

EN 11 EN

2026/0267 (NLE)

Proposal for a

COUNCIL RECOMMENDATION

on common principles on regulatory sandboxes to support innovation and a future-

proof regulatory framework

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 292, in conjunction with Article 173(3), thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) Innovation fuels the Union’s competitiveness and prosperity. However, existing legal

frameworks in certain areas do not stand the test of time in face of rapidly changing

and emerging technologies. Innovators face legal uncertainty when bringing new

products and services to the market which do not neatly fit into existing regulatory

frameworks.

(2) Innovation is built on experimentation and testing. Regulatory sandboxes are a

targeted form of experimentation which can help the Commission and Member States

assess whether existing legal requirements remain fit for purpose or need adaptation

due to rapidly evolving technology. They are usually set up on a case-by-case basis

with a clearly defined scope. They offer a practical way to learn by doing and provide

firsthand insights into emerging innovation – including their risks and impact. They

may also reduce market entry barriers and enhance communication and coordination

between different public authorities and innovators, especially in relation to cross-

sectoral innovation. Nevertheless, participation in regulatory sandboxes should not be

considered as a permanent exemption from regulatory requirements or an alternative

pathway to regulatory authorisations in the Union.

(3) In recent years, regulatory sandboxes have been increasingly promoted as a tool to

foster innovation throughout the Union, including by Council conclusions1

encouraging knowledge sharing of best practices, Member State initiatives and the

incorporation of regulatory sandbox provisions in key Union legislation2. Those

1 Council Conclusions on Regulatory sandboxes and experimentation clauses as tools for an innovation-

friendly, future-proof and resilient regulatory framework that masters disruptive challenges in the

digital age https://data.consilium.europa.eu/doc/document/ST-13026-2020-INIT/en/pdf 2 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying

down measures for a high level of public sector interoperability across the Union (Interoperable Europe

Act) (OJ L, 2024/903, 22.03.2024, ELI: http://data.europa.eu/eli/reg/2024/903/oj); Regulation (EU)

2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised

rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)

No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU)

2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.07.2024, ELI:

http://data.europa.eu/eli/reg/2024/1689/oj); Regulation (EU) 2024/1735 of the European Parliament and

of the Council of 13 June 2024 on establishing a framework of measures for strengthening Europe’s

net-zero technology manufacturing ecosystem and amending Regulation (EU) 2018/1724 (OJ L,

EN 12 EN

initiatives have underscored the value of regulatory sandboxes in supporting small and

medium-sized enterprises (SMEs), as defined in Commission Recommendation

2003/361/EC3, innovative startups and innovative scaleups, as defined in Commission

Recommendation (EU) 2026/7204 and informing evidence-based policymaking. The

Commission has reaffirmed its commitment to preparing legislative proposals

containing innovation-friendly, future-proof rules, balancing legal certainty with

adaptability to technological developments5, without compromising the high level of

protection of public interest objectives.

(4) As a result of the increasing focus on regulatory sandboxes, differing interpretations

on their purpose, scope and concept have become more visible. The definition of

regulatory sandboxes and the conditions for their establishment and operation vary

between Member States, an element which adds to the complexity faced by

innovators. A common understanding could facilitate the development of innovative

solutions across the internal market and reduce regulatory barriers resulting from

divergent national approaches to experimentation. At the same time, such an

understanding would allow sufficient flexibility while recognising Member States’

different starting points, capacities and sectoral differences, as well as the existence of

the Union legislation which defines regulatory sandboxes for specific sectors.

(5) To help innovators and other interested parties identify opportunities to participate in

regulatory sandboxes, it is necessary to lay down common and transparent principles

across the Union concerning the establishment of, conditions for participation in and

the outcomes of regulatory sandboxes. Such principles would contribute to building

public trust and facilitate knowledge-sharing between competent authorities across the

Union while preserving a level playing field. Participation criteria and operating

conditions should be transparent, objective and proportionate, ensuring that regulatory

sandboxes do not create unjustified competitive advantages or hinder the free

movement of goods in areas that have been subject to Union harmonisation.

(6) To ensure a predictable environment that supports the development of innovative

solutions in the internal market, the competent authorities in the Member States should

use transparent and objective processes governing regulatory sandboxes, including

eligibility criteria, application procedures, clear terms and conditions for participation

and operation, as well as regulatory learning. To ensure legal certainty, any possibility

of granting derogations from existing legal requirements should be explicit, clearly

defined and consistent with Union legislation.

2024/1735, 28.06.2024, ELI: http://data.europa.eu/eli/reg/2024/1735/oj); Regulation (EU) 2024/2847 of

the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity

requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU)

2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L, 2024/2847, 20.11.2024, ELI:

http://data.europa.eu/eli/reg/2024/2847/oj). See also Regulation (EU) 2022/858 of the European

Parliament and of the Council of 30 May 2022 on a pilot regime for market infrastructures based on

distributed ledger technology, and amending Regulations (EU) No 600/2014 and (EU) No 909/2014

and Directive 2014/65/EU (OJ L 151, 2.6.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/858/oj). 3 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small

and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI:

http://data.europa.eu/eli/reco/2003/361/oj). 4 Commission Recommendation (EU) 2026/720 of 18 March 2026 on the definition of innovative

enterprises, innovative startups and innovative scaleups (OJ L, 2026/720, 24.3.2026, ELI:

http://data.europa.eu/eli/reco/2026/720/oj). 5 Communication from the Commission to the European Parliament, the European Council, the Council,

the European Economic and Social Committee and the Committee of the Regions, A Simpler, Clearer

and Better Enforced EU Rulebook, COM/2026/380 final EUR-Lex - 52026DC0380 - EN - EUR-Lex

EN 13 EN

(7) With a view to enabling a common understanding of regulatory sandboxes, it is

necessary to raise further awareness, align communication and facilitate peer learning

between Member States and their competent authorities, as well as to contribute to a

learning approach that is both flexible and agile.

(8) Sharing information with conformity assessment bodies, standardisation organisations,

market surveillance authorities and other relevant actors about the outcomes of a

regulatory sandbox, for example in the form of an exit reports, could help accelerate

the conformity assessment, standardisation or national market approval of the

innovative solutions. As a result, innovation could be adequately supported and

innovative solutions that successfully complete experimentation in the regulatory

sandbox could be guided towards successful integration into the market.

(9) Non-discriminatory access to regulatory sandboxes throughout the Union would

promote fair competition and encourage broad participation by all relevant

stakeholders, including economic operators, which can provide useful input to

competent authorities for the purpose of regulatory learning. Regarding the possibility

to restrict access or grant priority access to regulatory sandboxes, which should be in

line with the obligations of the Union set out in applicable international agreements, it

is recommended to carefully consider the necessity for such restriction or priority

based on objective elements, such as the country of registration and size of

participating entities.

(10) Regulatory sandboxes and the evidence generated through the experimentation

performed therein should support the evolution of regulatory frameworks. Systematic

analyses of insights from experimentation activities should enhance the adaptability of

regulatory frameworks to changing circumstances and technological advancements.

Regulatory sandboxes should also provide an opportunity for advancing regulation in

the case of high uncertainty and disruptive challenges, as well as when preparing new

policies.

(11) In light of the experience gained from existing Union and national regulatory

sandboxes, the Council welcomes the Commission's intention to monitor relevant

developments and assess where appropriate whether further measures at Union level

may be necessary. Any such measures should be innovation-friendly and designed to

avoid unnecessary administrative burden or overly prescriptive requirements,

HEREBY RECOMMENDS:

1. For the purposes of this Recommendation, the following definitions should apply:

(1) ‘regulatory sandbox’ means a structured framework that allows regulatory

sandbox participants to experiment with innovative solutions for a limited time

in a controlled environment, under the supervision of one or several competent

authorities, and that results in evidence-based regulatory learning;

(2) ‘experimentation’ means any combination of development, testing, and

validation of innovative solutions in real-world conditions in a controlled

environment, prior to making them available or otherwise putting into service

or use;

(3) ‘controlled environment’ means a physical, digital or hybrid environment

inside or outside of a laboratory or an otherwise simulated environment in

which experimentation in regulatory sandboxes may take place under the

supervision of one or several competent authorities, subject to predefined

conditions, safeguards and measures to address and mitigate potential risks;

EN 14 EN

(4) ‘competent authority’ means any public sector body of a Member State at

national, regional or local level, which is entrusted under Union or national law

with responsibilities for the supervision or enforcement of legislation that is

related to or affects innovations that may be experimented or supervised within

a regulatory sandbox;

(5) ‘cross-border regulatory sandbox’ means a regulatory sandbox established,

operated or supervised jointly by competent authorities from more than one

Member State.

2. In developing national provisions on regulatory sandboxes, Member States should

consider the following:

(a) assess whether a regulatory sandbox is necessary in a particular sector;

(b) apply the Union legal provisions in force regarding the establishment and

operation of regulatory sandboxes where relevant;

(c) state the reasons for the necessity of including provisions on regulatory

sandboxes in the relevant national legal act and clearly define the regulatory

sandbox’s objectives within that act;

(d) where derogations from existing legal requirements are envisaged, ensure that

such derogations are explicit, clearly defined and duly justified;

(e) ensure that derogations from applicable Union secondary law are envisaged

only where the possibility for such derogations is provided for in applicable

Union acts;

(f) provide in the national legal act that regulatory sandboxes may be established

on the competent authority’s, or authorities’ initiative or at the request of an

applicant, subject to the competencies of that authority or those authorities

under Union and national law;

(g) check, where relevant, whether test facilities, including those accredited for

conformity assessments under Regulation (EC) No 765/2008 of the European

Parliament and of the Council6, could be made available for experimentation in

regulatory sandboxes;

(h) cooperate with research infrastructures and technology infrastructures7 to

provide participants in regulatory sandboxes with access to the facilities and

services of those infrastructures, where relevant.

3. Member States and their competent authorities should specify the conditions under

which experimentation is allowed, covering at least the following aspects:

(1) the objectives and scope of the experimentation, which should include

fostering innovative solutions that cannot be developed in accordance with the

currently applicable rules, and promoting regulatory learning;

(2) the types of experimentation that are authorised to be carried out;

6 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out

the requirements for accreditation and market surveillance relating to the marketing of products and

repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30, ELI:

http://data.europa.eu/eli/reg/2008/765/oj) 7 The European Strategy on Research and Technology Infrastructures, https://research-and-

innovation.ec.europa.eu/strategy/strategy-research-and-innovation/our-digital-future/european-strategy-

research-and-technology-infrastructures_en

EN 15 EN

(3) any restrictions on experimentation, including its maximum duration or any

geographical limitations;

(4) an assessment of potential risks, mitigation measures and the safeguards

necessary to ensure protection of the public interests, fundamental rights, the

rights guaranteed by national constitutions and rights guaranteed by the

Treaties, in particular those relating to protection of the safety of persons and

property, of consumers and of the environment, as well as to public health and

public order, also in accordance with international obligations and fair

competition;

(5) the terms of the evaluation of experimentation;

(6) the conditions of extension, renewal, suspension, modification, or termination

of experimentation, including the reporting of serious incidents;

(7) the conditions for applying any derogation from the legislation applicable to

the area in which the experimentation is proposed.

4. Member States should ensure that the duration of the experimentation in a regulatory

sandbox is proportionate to its objectives and allows for the achievement of the

intended purpose and the generation of sufficient regulatory learning.

5. Member States should ensure that participation in and the operation of regulatory

sandboxes are subject to clearly defined conditions covering, to the extent relevant,

the following aspects:

(a) eligibility criteria, the application procedure, selection criteria and procedures,

the conditions for participating in and exiting the regulatory sandbox, and,

where applicable, the conditions for access to a specific experimentation

environment, including any financial conditions for such access, as well as the

modalities governing the provision of the explicit and prior consent from

participating natural persons;

(b) the liability of participants and other parties involved in the regulatory

sandbox, in accordance with applicable Union and national law, for any

damage caused to third parties, including users, subjects of the testing and

consumers as a result of the experimentation;

(c) the management of intellectual property rights, data protection and measures

safeguarding the right to privacy, and the protection of confidential

information;

(d) any provisions specifying the materials and resources which participants or the

competent authority, or both, will make available to the regulatory sandbox

project;

(e) the arrangements for monitoring, reporting, evaluation and knowledge sharing;

as a minimum, the actors to be involved in the evaluation process should be

identified in the national provisions on regulatory sandbox, as well as, if

relevant, any reporting obligations;

(f) an exit strategy, including pathways for the deployment of the innovative

solutions that successfully complete the experimentation within the regulatory

sandbox, and a process for the orderly termination of experimentations that

produce unsuccessful or potentially harmful effects;

EN 16 EN

(g) any relevant support measures, including guidance and advice on regulatory

expectations, training, awareness-raising, and, where appropriate, funding,

tailored to the needs of innovative startups, innovative scaleups, small and

medium-sized enterprises (SMEs), potential public or private customers or

other end-users of the innovations.

6. Member States and their competent authorities are encouraged to establish and

facilitate participation in cross-border regulatory sandboxes. When setting up a cross-

border regulatory sandbox, competent authorities should conclude an agreement

setting out at least the following aspects:

(a) the conditions under which experimentation is allowed;

(b) the allocation of the respective roles and responsibilities of the competent

authorities from different Member States for the establishment, operation,

supervision, monitoring and termination of the regulatory sandbox;

(c) the legal provisions and administrative arrangements applicable to the cross-

border regulatory sandbox (including those listed in point 5), taking into

account the allocation of the respective roles and responsibilities among the

relevant competent authorities.

7. Member States should ensure that all requests to establish and to participate in

regulatory sandboxes are assessed on a transparent and non-discriminatory basis.

8. However, subject to the obligations of the Union set out in applicable international

agreements, Member States may, to the extent necessary and provided that objective

grounds are given:

(a) restrict the possibility of participating in regulatory sandboxes and provide that

possibility exclusively to Union citizens and to entities established in the

Union;

(b) give priority to SMEs, innovative startups, or innovative scaleups established

in the Union for participation in a regulatory sandbox; or

(c) require participants in a regulatory sandbox to carry out in the Union certain

research, development and innovation activities necessary for experimentation

within the regulatory sandbox.

9. With the support of the competent authorities, Member States should collect and

analyse the results of, and lessons learnt from, the experimentation within a

regulatory sandbox. Based on that analysis, Member States should assess the need to

integrate those learnings into the national regulatory framework applicable to the

innovation that was subject to the experimentation.

10. Member States should require competent authorities to issue, upon request from a

regulatory sandbox participant, an exit report detailing the activities carried out in the

regulatory sandbox, the results of the experimentation and the learning outcomes,

with the aim of accelerating the conformity assessment, standardisation or national

market approval of the innovations.

11. Member States should make available to the public any information related to the

establishment and outcomes of the experimentation, while fully protecting business

secrets or otherwise confidential information, including lessons learnt for the

purposes of regulatory learning, unless this would be contrary to national security

interests or the Union’s security interests.

EN 17 EN

12. It is recommended that Member States implement this Recommendation as soon as

practicable.

13. Member States are invited to monitor, with the support of the Commission, the

progress in the implementation of this Recommendation.

Done at Brussels,

For the Council

The President

EN EN

EUROPEAN COMMISSION

Brussels, 9.9.2026 COM(2026) 567 final

2026/0264 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a framework of measures for strengthening the Union innovation ecosystem

and amending Regulation (EU) 2017/1001 (European Innovation Act)

{SEC(2026) 567 final} - {SWD(2026) 567 final} - {SWD(2026) 568 final}

(Text with EEA relevance)

EN 1 EN

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

1.1. Reasons for and objectives of the proposal

The European Union (EU) is a global leader in scientific research, producing a significant

share of the world’s high-quality scientific output. However, this strength does not translate

into a commensurate level of innovation performance and commercial success within the

Single Market and worldwide. Innovative ideas developed in Europe too often fail to reach

the market, scale across borders, or generate new growth sectors. As a result, the Union

captures only a limited share of the economic and societal value generated by its scientific and

technological strengths, constraining the emergence of globally competitive firms, weakening

Europe’s capacity to secure critical technologies and value chains and long-term productivity

growth.

Enhancing the conditions for the development, commercialisation, and scale-up of

innovative solutions has become a central priority of the Commission’s policy agenda for

2024–2029, which places research and innovation at the core of Europe’s competitiveness and

sustainable prosperity. It is also essential for strengthening the Union’s resilience, economic

security, and strategic autonomy in an increasingly contested geopolitical environment. In this

context, the proposed Regulation contributes to the implementation of the EU Startup and

Scaleup Strategy1 and responds to the mandate set out in the Mission Letter of Commissioner

Zaharieva develop a framework facilitating the testing, financing and scaling of innovative

solutions in the EU.

Over the past two decades, the EU’s economic growth has lagged that of other major

economies, notably the United States (US) and China, with a widening difference in GDP

levels. A key driver of this divergence is weaker productivity growth in the EU. As research

and innovation account for a substantial share of productivity gains, the Union’s ability to

translate knowledge into marketable innovations is a critical determinant of its long-term

competitiveness and prosperity. It is equally a determinant of the Union’s ability to reduce

excessive strategic dependencies, preserve its freedom of action, and ensure secure access to

critical technologies, products and industrial capabilities.

The underlying challenge lies in structural barriers along the innovation lifecycle. While the

EU performs strongly in early-stage research, it faces persistent difficulties in the transition

from research results to market-ready products and scalable businesses. Innovative firms

encounter two critical bottlenecks: a pre-commercialisation gap, where projects remain too

risky or fragmented to attract private investment, and a scaling gap, where firms struggle to

expand due to financial, regulatory and market constraints. These bottlenecks reduce

incentives for investment and limit the emergence of new innovative firms and sectors.

Over the past years, the Union has taken significant steps to address these challenges. EU

funding programmes, such as Horizon Europe, the Recovery and Resilience Facility, the

Innovation Fund, the Digital Europe Programme, and InvestEU, as well as initiatives aimed at

deepening capital markets and strengthening the European Research Area, have contributed to

improving framework conditions for innovation. These efforts also support the Union’s

1 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, The EU Startup And Scaleup

Strategy Choose Europe To Start And Scale, COM/2025/270final, https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=celex:52025DC0270

EN 2 EN

broader objective of reinforcing resilience, preparedness and technological capacity in sectors

of strategic importance.

However, despite this progress, important barriers and disparities between Member

States persist, particularly in the transition from research to market deployment. These

barriers not only undermine innovation performance but also delay the deployment at scale of

technologies that are essential for Europe’s security, resilience and economic sovereignty.

First, markets for R&D procurement, including pre-commercial procurement, remain

underdeveloped because of the lack of a clear legal framework. The EU Public

Procurement Directives cover R&D services only where both of the following conditions are

met:

• the benefits accrue exclusively to the public buyer for use in its own affairs; and

• the public buyer wholly remunerates the service.

As a result, a substantial share of R&D procurement, including pre-commercial procurement,

falls outside their scope. Since the Commission clarified the concept of pre-commercial

procurement in 2007 in its Communication2, there has been an increase in these types of R&D

procurements and success cases show that strategic use of this instrument enables the EU to

regain leadership and strategic autonomy in high-tech markets. However, overall, across the

EU, the progress in raising investment levels is still too slow and fragmented. Key reasons are

that the absence of harmonised rules has contributed to divergent practices across Member

States, legal uncertainty, and limited use of joint cross-border R&D procurement, which is

often necessary to achieve the financial critical mass required for the development of

innovative technologies. This is particularly problematic in strategic sectors where fragmented

demand, duplicated national approaches, and dependence on non-EU suppliers can expose the

Union to vulnerabilities and supply risks. Moreover, the proposed revision of the EU public

procurement framework, the Public Procurement Act, proposes to exclude all forms of R&D

procurement.

Such public procurements of R&D are vital to create innovative solutions that can improve

the quality and efficiency of public services, address societal challenges and build sufficient

industrial capacity for innovative solutions and technologies in the EU to safeguard EU

economic security and strategic autonomy. They are also a key instrument for accelerating

market development in critical technologies, strengthening the European industrial and

technological base, improving security of supply, and ensuring that strategically relevant

capabilities are developed and deployed within the Union. Other leading economies in the

world are investing 5 to 8 times more in public procurement of R&D than the EU3. Raising

public investments in R&D procurement in the EU from 0,6% to 3% of total public

procurement or from €17,28Bn to €86,4Bn, would help the EU raise public R&D investments

with around 0,5% of GDP. Given that this could raise an equal additional amount of private

2 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, ‘Pre-commercial Procurement:

Driving innovation to ensure sustainable high quality public services in Europe’, 14.12.2007,

COM(2007) 799 final 3 The EU spends 0,6% of public procurement on R&D, the US 3,5% and South Korea 5%. Raising

investments in the EU to 3% of total public procurement on R&D would generate additional public

R&D investments equalling 0,5% of GDP - EU wide benchmarking of innovation procurement policy

frameworks and investments

EN 3 EN

investments in R&D, total investments in R&D in the EU could thus rise from 2,2% to 3% of

GDP4.

Second, insufficient clarity and comparability in the valuation and monetisation of

intellectual property (IP) continue to hinder the commercialisation of research and

innovation results. Innovation is now largely driven by intangible assets, with over 90% of

corporate value in certain leading firms coming from intellectual property. Yet in the EU,IP

is still rarely used as collateral in financing. Because financial institutions in the EU still focus

mostly on tangible assets and traditional accounting, IP-rich companies struggle to secure

financing. As a result, EU startups raise around 50% less capital than US peers by their tenth

year. This mismatch has created a major growth financing gap for asset-light, innovative

firms, estimated at up to EUR 18 billion per year.5 One of the key reasons explaining the lack

of IP-back financing in the EU is the absence of a harmonised methodology for valuing

intellectual property assets. This created divergent conditions across Member States for the

use of such assets in company financing, including as collateral for debt financing and for

their consideration in equity investment and other financing decisions. Other key reasons are

the lack of a mature EU-wide secondary market for intangible assets and a lack of skills

regarding IP-backed financing among financial institutions and innovative startups. This

undermines companies' access to capital within the Single Market, impeding their cross-

border growth and investment. This makes EU companies less successful at scaling and

commercialising innovation, especially in deep tech and breakthrough sectors than those from

other jurisdictions such as the US, China and South Korea.

Addressing these two barriers through this proposal could thus have a sizeable impact on

improving the functioning of the Single Market for R&D investments and commercialising IP

assets, thereby supporting Europe’s independence and competitiveness. It would also help

ensure that Europe retains finances and scales critical technologies and related IP assets in

line with its security, resilience and strategic autonomy objectives. Against this background,

this proposal delivers on President von der Leyen’s 2024-2027 Commission Political

Guidelines that set priorities to put research and innovation at the heart of our economy. The

European Innovation Act was announced in the EU Startup and Scaleup Strategy and in the

Competitiveness Compass for the EU as one of the key initiatives to strengthen the EU’s

innovation ecosystem and enhance its ability to compete globally.

The general objective of this initiative is to improve the functioning of the Single Market for

innovation by reducing structural barriers to bring innovative solutions to the market, thereby

speeding up their commercialisation in the EU. This objective contributes directly to the

Union’s broader priorities of strengthening competitiveness, fostering sustainable economic

growth, and enhancing technological sovereignty, while also reinforcing economic security,

resilience and the Union’s capacity to act autonomously in strategically important areas.

To achieve this, the proposal pursues a set of specific objectives. These include strengthening

the role of public procurement as a driver of innovation and enhancing the valuation,

commercialisation and use of IP.

The European Innovation Act aims to achieve these objectives by:

4 In 2023, public and private investments into R&D was 2,2% of GDP in the EU, compared to 3,3% in

Japan, 3,46% in the US, 4,93% in South Korea - Science, Research and Innovation Performance (SRIP)

report, 2024 edition, European Commission 5 European Investment Bank. (2025). Investment Report 2024/2025: Innovation, integration and simplification in

Europe

EN 4 EN

• creating a harmonised framework at Union level for R&D procurement, including

pre-commercial procurement; and

• mandating the creation of a competence centre on IP-backed finance at Union level

as part of the European Union Intellectual Property Office (EUIPO), an Union-wide

framework for IP valuation and a Union-wide IP marketplace for commercialising

IP.

By addressing these challenges in a coherent and targeted manner, the proposed Regulation

seeks to ensure that innovative ideas developed in Europe can more effectively progress from

research to market, scale across borders, and contribute to the Union’s long-term

competitiveness and prosperity, as well as to its resilience, economic security and strategic

autonomy.

1.2. Consistency with existing policy provisions in the policy area

There is currently no comprehensive Union legislative framework specifically addressing the

cross-cutting barriers affecting the development, testing and scale-up of innovative solutions

across the Single Market. Existing Union policies in the area of research and innovation

primarily focus on supporting knowledge creation, fostering collaboration and providing

funding for research and innovation activities, while only partially addressing the framework

conditions governing the transition from research to market.

The proposed Regulation complements these existing initiatives by targeting the remaining

bottlenecks along the innovation lifecycle, in particular those related to the use of R&D

procurement, and commercialisation and use of IP in financing of innovative companies.

In this context, the most relevant Union policy provisions in the field of research and

innovation include:

The European Research Area (ERA) incentivises and structurally support cross-border

research and development (R&D) collaboration and researcher mobility, primarily targeting

the early stages of the research and innovation lifecycle. It is implemented in part through

Union programmes such as Horizon Europe, which provide funding for collaborative

research, mobility schemes and research infrastructures. In parallel, the ERA Forum serves as

a soft coordination tool through which Member States align national research policies,

priorities and reforms.

Union funding programmes provide substantial financial support to research and innovation

activities across the different stages of the innovation lifecycle. In particular, programmes

such as Horizon Europe, including the European Innovation Council, as well as InvestEU,

Digital Europe Programme, the European Defence Fund, the Cohesion Policy Funds and the

Innovation Fund support the development, demonstration and, to some extent, the scale-up of

innovative solutions through grants, blended finance, risk-sharing mechanisms and via

support for R&D procurements. Without prejudging the next Multiannual Financial

Framework (MFF) and the implementation of future EU funding programmes, the next MFF

may strengthen this financial support by enhancing the Union’s capacity to mobilise public

and private investment in innovation and strategic technologies. The proposed Regulation is

consistent with these Union programmes as it does not propose any funding measures but will

reinforce the legal framework conditions for innovation across the Member States, which can

complement and contribute to improve the impact of these Union funding programmes in a

number of ways:

• Several of these Union funding programmes provide support to public buyers to

conduct R&D procurement. These experiences have also highlighted a remaining

EN 5 EN

lack of confidence of public buyers in starting pre-commercial procurements due to

the absence of a clear EU wide legal framework for pre-commercial procurements,

and they have also highlighted the extra effort and time it takes for public buyers to

setup joint cross-border pre-commercial procurements due to fragmentation of

national procurement rules across Member States. The proposed Regulation helps

address this issue by establishing common rules for implementing R&D

procurement, including pre-commercial procurement, and a harmonised framework

for joint cross-border R&D procurement, including pre-commercial procurement.

• Some of these Union funding programmes support innovators in trying to

commercialise their IP or to use their intellectual property rights as collateral to

obtain financial investments. These experiences have highlighted that innovators face

issues in finding the right parties that are interested in buying or licensing their IP

and getting good value out of their IP for obtaining financial investments due to a

knowledge gap and the lack of a Union-wide accepted valuation framework and the

lack of a Union-wide marketplace for IP rights. The proposed Regulation helps

address this issue by extending the mandate of the European Union Intellectual

Property Office to establish a competence centre for IP-backed finance, a common

framework for the valuation of IP and a Union-wide marketplace for the

commercialisation of IP rights.

It follows that the proposed Regulation is consistent with existing Union policy provisions in

the field of research and innovation by complementing existing funding programmes with a

coherent framework for R&D procurement and with new tasks for European Union

Intellectual Property Office that will help innovators obtain IP-backed finance.

1.3. Consistency with other Union policies

The proposed Regulation is a cross-sector initiative aiming to deliver a Union-wide level

playing field for innovators across all sectors, rather than focusing on specific application

sectors, technology fields or industries. Its measures are horizontal by design and address

structural barriers across Member States that affect innovation-intensive activities.

The proposed Regulation complements the forthcoming 28th Regime corporate legal

framework – EU Inc., which provides a optional harmonised corporateu framework for

companies operating across the Union. The proposal also complements the reforms under the

Savings and Investments Union, which aim to deepen the Union capital markets and channel

more private savings into equity, venture capital and scale-up financing, thereby improving

access to finance for innovative firms. Despite the expected progress in regulatory

harmonisation under the European Commission’s EU Inc. proposal, significant fragmentation

is expected to persist in how companies can navigate the innovation lifecycle. This

fragmentation risks hampering companies to bring innovative solutions to the market which

could limit the growth potential of innovative companies, including those that are set up under

the harmonised EU Inc. framework. In other words, while the EU Inc. proposal aims to

facilitate setting up and operating a business across the Union and help companies attract

investment, the proposed Regulation is designed to address further bottlenecks in the

innovation lifecycle, ensuring that companies can develop and market their innovations more

easily across the Single Market.

Similarly, despite the expected progress under the Savings and Investments Union in

deepening the Union capital markets and mobilising private investment, significant

constraints persist in other parts of the innovation lifecycle. In particular, barriers related to

EN 6 EN

the development, testing, valuation and early adoption of innovative solutions continue to

limit the pipeline of investment-ready projects. As a result, while the Savings and Investments

Union aims to improve access to finance and support the scale-up of innovative companies,

the proposed Regulation removes bottlenecks that hamper innovative ideas to attract IP-

backed finance and helps innovators fully benefit from improved capital market integration.

The proposed Regulation also builds on the forthcoming European Business Wallets, which

streamline cross-border procurement procedures and digital interactions between economic

operators and public sector bodies. The European Business Wallets will establish a digital

identity for economic operators and allow for secure data exchange in the form of electronic

attestations of attributes and by means of a secure communication channel. This will simplify

licencing, registrations, tax filings and procurement authorisations, and economic operators

will no longer need to duplicate information across portals, thereby reducing administrative

burden and compliance costs. Consequently, the proposed Regulation foresees that R&D

procurement procedures shall be carried out exclusively in digital form, and where possible

by means of the European Business Wallets or by alternative electronic means that that are

interoperable with the European Business Wallets.

The proposed Regulation also complements sectoral initiatives, such as the existing Critical

Medicines Act, the Cloud and AI Development Act, the Biotech I Act and the forthcoming

Advanced Materials Act, Biotech II Act and Ocean Act, targeting strategic sectors or

technologies and aim to strengthen the Union’s position as a high-tech powerhouse. While

these initiatives provide tailored, sector-specific approaches where needed, the European

Innovation Act addresses the cross-cutting gaps affecting innovation across sectors and across

different technology fields. It does so without prejudging or interfering with sector-specific

frameworks, thereby ensuring coherence across the overall Union innovation policy

landscape.

The proposed Regulation also complements the EU Public Procurement Directives and their

proposed revision through the Public Procurement Act (PPA). The EU Public Procurement

Directives exclude pre-commercial procurement, while certain R&D service procurements

still fall within their scope and the procurement of R&D is a mandatory element of the

innovation partnership procedure. By contrast, the PPA proposal excludes all forms of R&D

services procurement and removes also the procurement of R&D as a mandatory component

from the current innovation partnership procedure by replacing this with a new innovation

challenge procedure having as mandatory elements a testing phase and a phase for procuring

commercial deployment, which can include volumes of innovative solutions.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

2.1. Legal basis

The legal basis for the proposed Regulation is Article 114 of the Treaty on the Functioning of

the European Union, which allows the Union to adopt harmonisation measures to ensure the

proper functioning of the internal market. This is needed to remove cross-border regulatory

and structural barriers that hinder the proper functioning of the Single Market. Diverging

national rules on R&D procurement, including pre-commercial procurement, constitute

barriers that prevent companies from participating in and offering their services to public

buyers in different Member States. Similarly, different approaches to the valuation and

commercialisation of IP constitute barriers for innovators to attract IP-backed finance and

scaleup their businesses across the Union. These fragmented approaches to R&D procurement

and to the valuation and commercialisation of intellectual property impede cross-border

movement of goods, services and capital within the Single Market.

EN 7 EN

2.2. Subsidiarity (for non-exclusive competence)

The proposed Regulation is in conformity with the principle of subsidiarity as provided for in

Article 5(3) of the Treaty on the European Union.

Strengthening the Union’s capacity to develop, commercialise, and scale innovative solutions

is of high relevance for reinforcing the Union’s competitiveness and strategic autonomy.

Innovation ecosystems and markets for innovative companies are increasingly cross-border in

nature, while regulatory and framework conditions in the Union are fragmented along national

lines. In the absence of Union level measures, the competitiveness challenges currently facing

industry are likely to prompt Member States to implement even more unilateral measures.

While such efforts may be justified, leaving national measures uncoordinated and the cross-

border challenges that are not tackled in national measures unaddressed risks negatively

impacting the functioning and increasing the fragmentation of the Single Market, making the

Union more vulnerable and overdependent on innovative solutions and technologies from

third countries and unable to leverage the assets of the Single Market to deliver benefits to

national and European ecosystems.

In particular, the scale required to support the transition from research to market and to ensure

effective diffusion of innovation exceeds what individual Member States can achieve in

isolation. Divergent national approaches to the valuation and commercialisation of intellectual

property, to attract IP-backed finance, and to R&D procurement create legal uncertainty,

increase costs and limit cross-border activities for innovative firms. These divergencies have a

direct and demonstrable impact on the functioning of the Single Market, impeding cross-

border movement of goods, services and capital within the Union.

By contrast, action at Union level can establish common framework conditions and ensure

coordination across Member States, thereby enabling innovators to develop innovation, attract

IP-backed financing and scale across the Single Market. Union-level action allows for the

creation of a level playing field, reduces fragmentation and duplication, and facilitates

efficient allocation of resources across the Union.

No single Member State alone is capable of effectively addressing these issues due to the

integrated nature of the challenge and the need for proper functioning of the Internal market

for developing, testing, commercialising and scaling of innovative solutions across the Union.

A harmonised Union-level approach is therefore necessary to ensure the well-functioning of

the Single Market and to address the challenges of reinforcing the Union’s competitiveness

and strategic autonomy. The measures included in this initiative would not be as effective if

implemented by Member States acting alone, as the challenges they address concern the

Single Market. They are not limited to individual Member States or to a subset of Member

States, but they relate to the Union’s industrial base and Union-wide value chains. In addition,

measures implemented at Member States’ level are unlikely to adequately meet the needs of

closely interconnected supply chains within the Single Market and could lead to further

market fragmentation, innovation leakage and industrial relocation to other parts of the world

and overall weakening of the Union’s competitiveness and strategic autonomy.

Innovation is a trans-boundary challenge that requires Union-level action to effectively

complement and reinforce measures taken at regional, national and local levels. The cost of

inaction is pan-European. Without further Union action, the status quo is likely to persist,

increasing the risk of the Union losing strategic industrial capacities and capabilities, of the

Single Market to be further fragmented, and of the Union becoming critically dependent on

EN 8 EN

third countries for green, digital, defence, and economic security objectives. This in turn could

have negative implications on the Union’s economic security, defence, social and territorial

cohesion, primarily through impacts on employment, regional development, and equitable

access to industrial opportunities.

The proposed measures therefore focus on areas where there is clear added value in acting at

Union level due to the scale, speed and scope of the efforts needed. Actions aim at improving

the business case for innovators to bring innovations to the market by facilitating the

valuation, commercialisation and use of IP to obtain financing, and at making it easier to find

first customers through R&D procurement, including pre-commercial procurement. It

enhances efficiency by enabling better cross-border cooperation, ensures fairer access to

opportunities for innovative companies irrespective of their location, and strengthens the

Union’s capacity to compete globally. The proposed measures also enable to improve the

Union’s competitiveness and strategic autonomy, while respecting the Union’s international

commitments towards its trade partners.

2.3. Proportionality

The proposed Regulation is proportionate to its objective of improving the functioning of the

Single Market for innovation. Each of its components targets a specific objective and is

limited to what is appropriate and necessary to achieve that objective, without going beyond

what is required to address the identified barriers and without imposing disproportionate

burdens on Member States and affected entities in Member States that are excessive compared

to the benefits expected.

Firstly, common rules for R&D procurement, including pre-commercial procurement, will

create significant time and cost savings for public buyers to conduct such procedures,

enabling public buyers to modernise public services faster. and companies to accelerate

business growth across the Single Market. A harmonised framework for joint cross-border

R&D procurement enables public buyers to form the critical mass required to trigger industry

to develop better value for money solutions and to enable companies to grow their business

faster across the Single Market. The made in EU requirements for R&D procurement are

proportionate to the European R&D capacities and designed as to not place significant

financial burdens on administrative budgets. Establishing lead markets is pivotal to increasing

EU competitiveness of across sectors and technologies, thereby strengthening the Union’s

industrial base and ensuring the Union’s strategic autonomy. This combination of measures

on R&D procurement is necessary to provide legal certainty, reinforce the Union’s

competitiveness and ensure effective implementation of the Treaty principles and the Union’s

international public procurement commitments. They are proportionate as they are limited to

what is needed to achieve those objectives, designed not to place additional burden on

Member States and public buyers, build on existing and widely used practices, and allow

flexibility in their practical implementation.

Secondly, entrusting the European Union Intellectual Property Office with the establishment

of a competence centre for IP-backed finance, as well as the development of a Union-wide IP

valuation framework and a digital IP marketplace enables innovators, companies, universities

and financial investors to lower valuation costs and increase the licensing and transfer of

intellectual property rights in the Union. This is pivotal for increasing the commercialisation

of research and innovation results across the Union. Building on the European Union

Intellectual Property Office’s existing mandate, expertise and resources ensures efficient

implementation of these measures. Ensuring that the valuation framework is based on best

practices for different types of IP rights and that the digital IP marketplace is designed to

EN 9 EN

complement existing ones while offering the additional EU added value, ensures that these

measures are proportionate, as they leverage existing structures, thereby reducing additional

burden on Member States, and limit EU intervention to what is necessary to improve

transparency, comparability and access in IP-related transactions.

2.4. Choice of the instrument

Article 114 of the Treaty on the Functioning of the European Union gives the legislator the

possibility to adopt regulations and directives. For the present proposal, a regulation is

considered the most appropriate instrument as it is immediately applicable and makes it

possible to set requirements that apply directly to all the public and private actors targeted by

the proposed measures. This will help ensure that the requirements are implemented in a

timely and harmonised way, leading to greater legal certainty. It will ensure a consistent and

coherent framework across the Union and to prevent divergences between national rules that

hamper the development, testing and scale-up of innovation within the Single Market. A

regulation is necessary to establish uniform framework conditions, reduce legal uncertainty

and ensure a level playing field for innovators and innovative companies operating across

borders. A directive would not be sufficient to reach the envisaged objectives, as it would

require a time for transposition and may give rise to divergent transposition and

implementation across Member States, thereby perpetuating fragmentation in the framework

conditions for innovation.

A regulation is also a needed and appropriate legal instrument to amend Regulation (EU)

2017/1011 to enlarge the mandate of the European Union Intellectual Property Office and to

ensure the effective application of the Union’s exclusive competence in line with Article 207

of TFEU for those measures related to the access of economic operators from third countries

to R&D procurement procedures.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

3.1. Stakeholder consultations

This proposal is based on extensive stakeholder consultations carried out in line with the

Commission’s Better Regulation principles and minimum standards. The Commission started

consulting stakeholders on the barriers for innovation addressed by the European Innovation

Act already in the context of the EU Startup and Scaleup Strategy. The Call for Evidence on

the EU Startup and Scaleup Strategy was published on 17 February 2025 and closed on 17

March 2025. It gathered input from a broad range of stakeholders, including companies,

business associations, research organisations, public authorities and individual respondents.

The attracted 589 responses from stakeholders across 36 countries. The main barriers

identified by stakeholders included difficulties for innovative companies to access

procurements and underinvestment in innovation procurement in the EU, barriers to the

commercialisation of research and innovation results and to the valuation of intellectual

property, difficulties for innovative companies to access research and technology

infrastructures, lack of experimentation possibilities in legislation across the EU and

insufficient coordination between national and EU innovation policies and programmes. The

EU Startup and Scaleup Strategy that was adopted on 28 May 2025 set out a comprehensive

strategy to combine non-legislative as well as legislative measures to remove the identified

barriers to innovation, the latter to be addressed through the European Innovation Act.

In preparation of this proposal, the Commission then carried out a dedicated Call for

Evidence and Open Public Consultation to collect feedback on specific issues and to identify

possible solutions for the legal barriers that were previously identified in the EU Startup and

EN 10 EN

Scaleup Strategy. This Call for Evidence and Open Public Consultation were published on 8

July 2025 and closed on 3 October 2025. They gathered inputs from a broad range of

stakeholders, including companies, business associations, research organisations, public

authorities and individual respondents. In total, 336 responses were received to the Call for

Evidence, including 193 position papers. The Open Public Consultation received 202

responses, complemented by 54 additional supporting documents.

Responses to the public consultation on the European Innovation Act were well distributed

across stakeholder groups. Companies and businesses accounted for 27% of replies (55

responses), followed by business associations (23%, 47 responses) and academic and research

institutions (16%, 33 responses). Other contributions were received from EU citizens (8%, 17

responses), non-governmental organisations (8%, 17 responses), public authorities (4%, 8

responses), trade unions (2%, 4 responses), non-EU citizens (1%, 3 responses), and other

stakeholders (9%, 18 responses). Among participating companies, micro-enterprises (1-9

employees) represented the largest group (33%, 18 responses), followed by large companies

(29%, 16 responses), small companies (20%, 11 responses) and medium-sized companies

(18%, 10 responses).

The results of the Open Public Consultation and the corresponding synopsis report on the

European Innovation Act were published on 4 December 2025 and are available online.6

In addition, a targeted consultation on the European Innovation Act was carried out between

October and November 2025 to support the assessment of the expected costs and benefits of

the proposed measures. This consultation combined 18 semi-structured interviews with

selected stakeholders from the different sectors above, 55 responses to a targeted online

survey, and three online focus groups held on 24, 26 and 27 November 2025. The focus

groups were primarily aimed at validating the findings of the cost-benefit analysis.

Finally, a targeted consultation on the European Innovation Act was carried out with

representatives responsible for research and innovation policies and programmes in Member

States and Horizon Europe associate countries that participate in the EIC Forum. The EIC

Forum members adopted a joint Position paper and wish list for the European Innovation Act

in November 2025.7

In total, 1210 responses were collected across these different rounds and types of

consultations that helped prepare this proposal for the European Innovation Act. Overall,

stakeholders expressed broad support for EU action to address the identified barriers to

innovation. A large majority of respondents confirmed both the existence of the problems

identified and the relevance of the measures proposed for the European Innovation Act that

are aimed at improving the development, testing and scale-up of innovative solutions across

the Single Market.

3.2. Collection and use of expertise

The preparation of this proposal draws on a broad evidence base, including analytical work,

literature review, stakeholder input and expert advice.

6 Results of the Open Public Consultation and its Synopsis Report, 4 December 2025,

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14593-European-Innovation-

Act/public-consultation_en 7 Position paper and wishlist for the European Innovation Act, EIC Forum, November 2025,

https://op.europa.eu/en/publication-detail/-/publication/b690e2af-d0bd-11f0-8da2-

01aa75ed71a1/language-en

EN 11 EN

The Commission carried out desk research and reviewed relevant academic literature, policy

reports and data sources to support the analysis of the problems and policy options. This

included, among others, data from Eurostat, the European Innovation Scoreboard, the

Community Innovation Survey, the European benchmarking of national policy frameworks

and investments in innovation procurement and the World Intellectual Property Organization

(WIPO), as well as reports from international organisations such as the OECD and the

European Patent Office (EPO), and peer-reviewed academic literature.

Inputs from the EIC Forum working groups and expert inputs were also used, including the

report8 of group of experts from 33 countries appointed by the Commission that formulated

recommendations for the EU and EIC Forum member countries on how to overcome legal

barriers that hamper wider implementation of innovation procurement, including R&D

procurement, in the Union compared to other leading economies in the world.

An external contractor supported the Commission in carrying out additional desk research,

analysing the results of the open public consultation and targeted consultations, organising

focus groups and stakeholder interviews, and contributing to the cost-benefit assessment of

the proposed measures.

The Commission’s Joint Research Centre (JRC) provided further analytical support, including

the analysis of the Call for Evidence and macroeconomic modelling to assess the potential

impacts of the initiative.

3.3. Impact assessment

In line with the Better Regulation Guidelines, this regulatory proposal is supported by

an impact assessment analysing the need to accelerate the commercialisation and uptake of

innovative solutions and to create an innovation-friendly level playing field for innovative

companies to scale up across the EU Single Market, in a context of growing global

competitiveness challenges. The impact assessment identifies policy options to address the

underlying problem drivers and assesses their likely impacts. It was developed in close

consultation with the Commission’s Inter-Service Steering Group on the European Innovation

Act.

The draft impact assessment was submitted to the Regulatory Scrutiny Board (‘the

Board’) on 23 December 2025. A meeting with the Board took place on 28 January 2026 and

was followed by a negative opinion. Following a substantial revision to address the Board’s

comments, the impact assessment was resubmitted on 20 February 2026. In the second

submission the Board acknowledged significant improvements, in particular regarding the

reduced range of the proposed measures, the clarification of the context and scope of the

initiative, and the overall presentation of the report. However, some substantive comments, in

particular those related to the avoiding overlap with the upcoming revision of the EU Public

Procurement Directives remained difficult to address, as the public consultation on the

revision of these Directives had not completed yet and the planned measures and impact

assessment of the revision of these Directives were not available yet at that time. The Board

therefore maintained a negative opinion on 27 February 2026 and identified three main areas

requiring further improvement in the Impact Assessment report for the European Innovation

Act, namely to:

(1) Ensure better coherence of the European Innovation Act’s public procurement

measures with the upcoming revision of the EU Public Procurement Directives and

8 Independent expert report, ‘Overcoming legal barriers for the uptake of innovation procurement in the

EU’, May 2026, https://data.europa.eu/doi/10.2777/4586624

EN 12 EN

further assess the proportionality and subsidiarity of the procurement measures,

particularly regarding mandatory innovation procurement targets and the inclusion of

public procurement below the financial thresholds established under the EU

framework.

(29) Ensure a more complete impact analysis by extending the assessment of the

European Innovation Act measures beyond the estimated population of innovative

companies, as the proposed measures are not legally limited to a specific category of

firms. Also requesting to address the absence of a legal definition of innovative

companies within the European Innovation Act.

(30) Provide a more in-depth assessment of the costs and benefits of some European

Innovation Act measures, with particular emphasis on:

• stronger estimation of the economic costs associated with mandatory

innovation procurement targets and the introduction of an EU preference in

public procurement;

• assessing the risk that too narrow definitions and principles for regulatory

sandboxes could exclude potentially beneficial experimentation opportunities.

Following the Board’s second negative opinion, the Impact Assessment was further

substantially revised to address the identified shortcomings. The above-mentioned points

were fully considered through a strengthened analysis and, where necessary, by adjusting the

scope of the proposal. In particular, the comments of the Board were addressed in the

following way:

• The procurement measures on innovation-friendly procurement procedures and

EU preference were narrowed down to focus exclusively on R&D procurement

carried out by public buyers. The innovation-friendly procurement techniques

applicable to other forms of public procurement more broadly, were removed from

the scope of the European Innovation Act. In addition, an EU financial threshold of

EUR 216 000 (corresponding to the EU financial threshold used in the main public

procurement Directive for sub-central authorities) was introduced, ensuring

compliance with the principles of proportionality and subsidiarity.

• The mandatory target for Member States to increase overall innovation

procurement spending was removed from the scope of the European Innovation

Act.

• Explanation on definitions of innovative companies, startups and scaleups was

added. The Impact Assessment clarifies that, following the adoption of the EU

Recommendation on definitions of innovative companies, innovative startups and

innovative scaleups, the European Innovation Act no longer includes these

definitions as part of the proposal. At the same time, it explains that, in line with the

Better Regulation Guidelines, costs and benefits are estimated on the economically

affected population (in particular innovative enterprises) rather than on all legally

eligible entities. It clarified the difference between legally eligible and economically

affected firms and explains more in depth how the number of affected entities was

estimated.

• Quantitative estimates were added. The Impact Assessment provided additional

cost and benefit analysis so that all measures included both Standard Cost Model and

elasticity-based quantitative estimations of costs and benefits. In particular, it added

the economic risk-related costs of procurement measures, refined the estimations for

EN 13 EN

IP valuation and included dedicated sections explaining more in-depth the

assumptions underlying each estimation.

• The definitions and principles for regulatory sandboxes were removed from the

scope of the European Innovation Act and moved to a proposal for a Council

Recommendation on regulatory sandboxes.

The Board’s opinions as well as the final impact assessment and its executive summary are

published together with this proposal.

The Commission carried out the impact assessment at the level of individual measures, with

up to four variants considered for each measure as alternative policy options. This approach

allowed for the identification of the most appropriate intervention for each specific problem

area.

Finally, the preferred policy option for the European Innovation Act is defined as a composite

package, combining the most effective variants of each of the nine measures assessed. For

each measure, the selected variant is the one that performs best in terms of effectiveness,

efficiency, coherence and proportionality. The preferred option therefore reflects a coherent

combination of the strongest-performing elements across all measures, rather than a single

predefined policy package.

The preferred policy option consists of the following measures.

First measure: the establishment, through the European Union Intellectual Property Office

(EUIPO), of a competence centre for IP-backed finance, as well as the development of a

Union-wide IP valuation framework and a digital marketplace. This measure is expected to

increase IP transfer and licensing activity and the ability of innovators to attract IP-backed

financing. It would entail administrative costs for EUIPO estimated at approximately EUR

712 000 and adjustment costs for EUIPO of around EUR 2.5 million, which will be covered

by EUIPO’s own resources, with no contribution from the Union budget. At the same time,

this measure is expected to generate administrative cost savings for companies of

approximately EUR 35 million. It is also estimated that the measure will generate

additional IP-backed venture capital and debit of EUR 10.2 billion every year for

companies.

Second measure: the introduction of a harmonised procedure for R&D procurement and for

joint cross-border R&D procurement. This measure is expected to generate EUR 1 billion

per year in cost saving for affected public buyers, as well as additional EUR 25.92 bn in

firm profit every year.

Third measure: the establishment of the EU preference for R&D procurement with opt-out

clauses that allow procurement from non-covered suppliers where no suitable alternative from

covered suppliers exists or where there are disproportionate cost differences between covered

and non-covered suppliers9. This measure is expected to contribute to strengthening the

EU’s open strategic autonomy, in particular for critical technologies and strategic

infrastructures, by reducing dependency risks and supporting the development of EU-based

supply chains. The opt-out clauses are also estimated to minimise the negative macro-

economic effects of the EU preference, estimated to be around EUR 464 million.

9 Covered suppliers are here suppliers from EU Member States and third countries that have concluded

international agreements with the Union and in which the Union has commitments to open R&D services

procurements to those third countries.

EN 14 EN

The combination of measures ensures coherence across the innovation lifecycle, addressing

both supply- and demand-side barriers. By jointly improving framework conditions, access to

resources and market opportunities, the preferred option maximises the effectiveness of

individual measures and generates cumulative impacts beyond their standalone effects.

Overall, macroeconomic simulation using the mentioned input costs and benefits estimate

translated into an EU GDP increase of 0.25-0.42% over a ten-year horizon relative to a

baseline scenario without the European Innovation Act, corresponding to up to 507,000 new

jobs created across the EU over this ten-year horizon.

3.4. Regulatory fitness and simplification

The proposal is in line with the Commission’s simplification objectives. By establishing more

harmonised approaches across the Union for carrying out R&D procurement and tasking

European Union Intellectual Property Office to establish a common framework for IP

valuation, an EU wide marketplace for commercialising IP and a competence centre for IP-

backed finance, it reduces duplication of costs, information asymmetries, and search and

transaction costs for innovators.

Where new activities are introduced, the proposal builds on existing frameworks and

processes, thereby limiting additional administrative burden.

For public authorities limited additional adjustment costs (EUR 45 million) are expected due

to the need for increased training to implement R&D procurement techniques and EU

preference. With the EU public sector expected to face adjustment cost (EUR 2.4 million) to

develop the EU IP valuation framework, IP centre, and matchmaking platform. However,

these additional administrative costs are offset by significant net administrative cost savings.

For firms and public buyers no additional administrative costs are expected as the proposed

regulation does not impose additional obligations on them. On the contrary, additional

administrative cost savings are expected for companies:

• EUR 1 billion per year for public buyers that aim to conduct R&D procurements, due

to a harmonised framework for R&D procurement, including for joint cross-border

R&D procurements;

• EUR 35 million per year for IP-rich firms, due to more harmonised approaches to IP

valuation and easier IP licensing and transfer via the IP marketplace;

Overall, the preferred policy option is therefore expected to generate yearly net annual

cost savings (administrative and adjustment costs combined) of approximately EUR 1.1

billion from the first year onwards, compared to the baseline, across both public and private

stakeholders. Net savings are expected to increase further in subsequent years, as one-off

adjustment costs are phased out and only recurring administrative costs remain.

4. FUNDAMENTAL RIGHTS

The proposed Regulation is based on a non-discriminatory approach and promotes

transparency and equal treatment. It is not expected to significantly impact the fundamental

rights protected under the Union Treaties and the Charter on Fundamental Rights.

5. BUDGETARY IMPLICATIONS

The estimated impact on expenditure and staffing for 2028 and beyond is added for

illustrative purposes only and does not pre-judge the next Multiannual Financial Framework.

EN 15 EN

The source of financing and scope of Union financial commitment in the post-2027 period

remain subject to the outcome of interinstitutional negotiations on the MFF 2028-2034 and

thereafter shall be determined through the annual budgetary procedure. All appropriations and

staffing allocations as of 2028 are indicative. The proposal has budgetary implications for the

Commission. Specifically, it will require approximately 3 full-time equivalents per year to

implement. The budget implications are mainly to carry out the work foreseen to support and

monitor the implementation of the Regulation, including to prepare delegated and

implementing acts foreseen in the Regulation. The budget implications required for human

resources and other expenditure of an administrative nature will be met by appropriations

from the DG that are already assigned to management of the action and/or have been

redeployed within the DG, together, if necessary, with any additional allocation which may be

granted to the managing DG under the annual allocation procedure and in the light of

budgetary constraints.

6. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

Not Applicable

• Detailed explanation of the specific provisions of the proposal

The proposal consists of three Chapters. It is structured as follows:

Chapter I contains the general provisions setting out the subject matter and the scope of the

proposed Regulation, as well as lays down the definitions applicable to the proposed

Regulation. It clarifies that Chapter I of the Regulation only applies to R&D services

procurements that fall outside of the scope of Directive (EU) 2014/23, Directive (EU)

2014/24 and Directive (EU) 2014/25 and it clarifies that Chapter III of the Regulation only

applies to the European Union Intellectual Property Office.

Chapter II sets out common rules for implementing R&D procurement procedures, including

joint R&D procurement.

Chapter III sets out tasks entrusted by this Regulation to the European Union Intellectual

Property Office to establish a common framework for intellectual property (IP) valuation, an

EU wide marketplace for commercialising IP and a competence centre for helping innovators

access IP-backed finance.

EN 16 EN

2026/0264 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a framework of measures for strengthening the Union innovation ecosystem

and amending Regulation (EU) 2017/1001 (European Innovation Act)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(1),

Having regard to the opinion of the Committee of the Regions(2),

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Important barriers remain, hindering access of innovations to the market and scaling of

innovative enterprises in the Union. Innovators face lack of opportunities to bring

innovative ideas to the Union-wide public procurement market due to the lack of a

common legal framework for procurement of research and development services

(‘R&D procurement’) and an underdeveloped internal market for intellectual property

(IP) backed finance. National measures aimed at tackling such complex barriers that

transcend national borders are fragmented and risk undermining the functioning of the

internal market. This fragmentation creates obstacles to cross-border trade within the

Union and distortions in the internal market. It is therefore necessary to establish

harmonised measures to ensure the proper functioning of the internal market.

(2) The European Court of Auditors10 has called on the Commission to address the low

level of competition for public procurement in the Union. With the increasing

digitalisation of the Union economy and the growing demand from public buyers

across the Union for innovative solutions made in the Union, there is an increased

cross-border interest from economic operators to participate in R&D procurement

carried out by public buyers from other Member States. While Directives

(1) OJ C [...], [...], p. [...] (2) OJ C [...], [...], p. [...] 10 Special Report 28/2023: Public procurement in the EU, European Court of Auditors, December 2023,

https://www.eca.europa.eu/ECAPublications/SR-2023-28/SR-2023-28_EN.pdf

EN 17 EN

2014/23/EU11, 2014/24/EU12, and 2014/25/EU13 of the European Parliament and of the

Council harmonise procedures for public procurements falling within their scope,

procedures for procurements falling outside their scope are currently primarily

governed by fragmented national rules or are exempt from national public

procurement rules and are only subject to the fundamental principles under the

Treaties as interpreted by the Court of Justice of the European Union. This concerns

the majority of R&D procurements, in particular those that fall outside the scope of

those Directives because the benefits resulting from the R&D services procured do not

accrue exclusively to the public buyer for its use in the conduct of its own affairs, as is

the case in pre-commercial procurement, or because the R&D services procured are

not wholly remunerated by the public buyer14. However, the application of those

principles alone does not provide sufficient legal clarity to public buyers, address

cross-border fragmentation in the implementation of R&D procurement or address

structural barriers for public buyers to engage in joint cross-border R&D procurement.

For that reason, for R&D procurements above a certain value, common rules should be

adopted to ensure that those principles are given practical effect to ensure the proper

functioning of the internal market.

(3) For R&D procurement procedures to which Article 25 of Directive 2014/23/EU,

Article 14 of Directive 2014/24/EU and Article 32 of Directive 2014/25/EU do not

apply, public buyers should be required to apply the provisions of this Regulation.

However, the particular characteristics of defence procurement makes the procurement

of R&D in that field especially sensitive, often requiring a high level of confidentiality

and greater flexibility for Member States. Public buyers should therefore not be

required to apply the provisions of this Regulation to R&D procurement falling under

exemptions for R&D procurements laid down in Directive 2009/81/EC of the

European Parliament and of the Council15.

(4) The digitalisation of R&D procurement procedures is essential for the proper

functioning of the internal market, as it can significantly reduce administrative

burdens, increase efficiency, and enhance transparency. Therefore, all R&D

procurement procedures falling within the scope of this Regulation should be

conducted where possible through the European Business Wallets or by alternative

electronic means that that are interoperable with the European Business Wallets.

11 Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award

of concession contracts (OJ L 94, 28.3.2014, pp. 1, ELI: http://data.europa.eu/eli/dir/2014/23/oj). 12 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public

procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, pp. 65, ELI:

http://data.europa.eu/eli/dir/2014/24/oj). 13 Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on

procurement by entities operating in the water, energy, transport and postal services sectors and

repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, pp. 243, ELI:

http://data.europa.eu/eli/dir/2014/25/oj). 14 By virtue of Article 25 of Directive 2014/23/EU, Article 14 of Directive 2014/24/EU and Article 32 of

Directive 2014/25/EU, those Directives only apply to R&D services procurements when the benefits

accrue exclusively to the public buyer for its use in the conduct of its own affairs, and the service

provided is wholly remunerated by the public buyer, 15 Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the

coordination of procedures for the award of certain works contracts, supply contracts and service

contracts by contracting authorities or entities in the fields of defence and security, and amending

Directives 2004/17/EC and 2004/18/EC (Text with EEA relevance) (OJ L 216, 20.8.2009, pp. 76–136,,

ELI: http://data.europa.eu/eli/dir/2009/81/oj).

EN 18 EN

(5) To enhance access to business opportunities in R&D procurement and increase

competition for the award of R&D procurement contracts, the participation of groups

of economic operators should be further facilitated. This is of particular importance for

SMEs, innovative startups and innovative scaleup, which often face difficulties in

accessing larger R&D procurement opportunities. Therefore, the rules governing the

participation of groups of economic operators and the use of combined capacities

should be clarified and simplified, while ensuring that only requirements necessary for

the proper performance of the R&D procurement contract are imposed.

(6) Subcontracting parts of an R&D procurement contract remains a practical and

powerful tool of collaboration between economic operators. The rules for

subcontracting in this Regulation should preserve contractual freedom and facilitate

access for SMEs, innovative startups and innovative scaleup, enabling them to

participate effectively in R&D procurement and related supply chains. Subcontracting

the entirety of a R&D procurement contract should however not be allowed under this

Regulation, in particular in order to avoid that subcontracting is misused especially in

sectors which may be more vulnerable to labour exploitation owing to cost pressures

and complex subcontracting chains. Where a specific input, component or service that

is essential for the conduct of the R&D in the public interest is available only from an

economic operator established in country that does not have access to the R&D

procurement, the public buyer should be able to permit the use of that input,

component or service, including by way of subcontracting.

(7) Without consulting the market, public buyers risk launching R&D procurement

procedures on the basis of tender specifications that are insufficiently adapted to the

actual capabilities of market operators, that favour established solutions, or that do not

provide sufficient scope for innovative solutions. Common rules should therefore be

established to ensure that preliminary market consultations are conducted in a

transparent and publicly accessible manner in preparation for such procedures.

(8) Negotiations, with the possibility for negotiation in stages, can enable public buyers to

improve the quality, efficiency and overall value of the procured R&D services and

their intended results, especially where the subject matter requires adaptation of

procurement documents to operational and innovation needs or the balancing of other

strategic considerations. Such optional flexibility should be provided to public buyers

allowing them to decide to leave certain elements of the procurement documents open

for negotiation, including the payment schedule or the dispute resolution mechanism,

thereby lifting one of the major burdens for SME participation in public procurement.

(9) In accordance with the international and EU legal framework for public procurement,

R&D procurement, including pre-commercial procurement, may include limited

production and supply of prototypes or first products, services or works in order to

incorporate the results of field testing and to demonstrate that the product, service or

work is suitable for production or supply in quantity to acceptable quality standards,

and public buyers may obtain ownership of this limited set of prototypes or first

products, services or works that were developed at the public buyer’s request in the

course of and for that particular R&D services procurement contract. During an R&D

services procurement, public buyers cannot obtain ownership of prototypes of first

products, services or works that were not developed at their own request or that were

developed for other contracts. To ensure transparency to economic operators, common

rules shall ensure that public buyers specify in the procurement documents of an R&D

procurement whether they include the possibility to obtain the ownership of this

limited set of developed prototypes or first products, services or works.

EN 19 EN

(10) For certain products, services or works that need to be procured after an R&D

procurement for safeguarding security or public safety interests of the Union or its

Member States, including to avoid shortages of supply for critical technologies, public

buyers should be able to ensure when they start an R&D procurement that they will be

able to purchase, via a separate procurement procedure, the necessary amounts of

products, services or works resulting from the R&D procurement. Therefore, common

provisions should enable public buyers to include in the R&D procurement contracts

provisions providing them with a priority right to purchase a predefined volume or

value of such products, services or works, before these are offered to other potential

buyers. Including a priority right to purchase in R&D procurement contracts does not

give public buyers the right to favour contractors that participated in the R&D

procurement in later purchases of those products, services or works. Any such

purchases need to be conducted in accordance with applicable Union public

procurement rules.

(11) As clarified by the case law of the Court of Justice, the rights derived from Union

public procurement law do not extend to economic operators having their origin in

third countries with which the Union has not concluded trade agreements opening its

public procurement market. To ensure the effective application of this case law and

reinforce the Union’s strategic autonomy, common provisions should be adopted that

open the access to R&D procurements, generally, only to economic operators having

their origin in third countries with which the Union has concluded trade agreements

opening is R&D procurement market. Where this would result in a lack of tenders or

disproportionate costs, public buyers should be allowed to open R&D procurement

also to economic operators having their origin in third countries with which the Union

has concluded international agreements that open its public procurement market

without commitments for opening its R&D procurement market. Where candidate

countries have concluded an agreement with the Union providing for access to public

procurement, economic operators originating from those countries should be regarded

as economic operators falling under Article 11, paragraph 4 of this Regulation, in

accordance with the terms and conditions set out in the relevant agreement. This

approach reflects the perspective of enlargement and the gradual integration of

candidate countries into the Union's internal market, and is intended to support closer

economic integration, encourage regulatory alignment, and strengthen the application

of the Union's rules and standards in its immediate neighbourhood. Where justified by

security and public safety interests of the Union or its Member States, public buyers

should be able to further restrict access to R&D procurements only to economic

operators that have their origin in Member States and that are not subject to control of

a third country. Where an R&D procurement procedure is supported by the Union

under Union programmes and instruments, including pilot projects or preparatory

actions, it should be clarified that public buyers must ensure compliance with

conditions attached to the Union support also in cases where these conditions

complement or derogate from rules established under this Regulation

(12) Clear and uniform rules on the determination of origin are necessary to ensure the

effective and consistent application of international coverage and the access to R&D

procurement provisions across all R&D procurement procedures. This Regulation

should therefore establish rules of origin for the application of the rules on access to

R&D procurement procedures set out herein.

(13) Economic operators should be excluded from participation in R&D procurement

procedures where they have been convicted by final judgment for serious offences

EN 20 EN

defined in Union legislation. Self-cleaning measures should not be permitted for

mandatory exclusion grounds, while for optional exclusion grounds, which are related

to the reliability of the economic operators, those operators should be able to

demonstrate their reliability by means of self-cleaning measures. In that context, due

account should be taken of any cooperation with the investigating authorities aimed at

clarifying the relevant facts and circumstances. Member States should not add other

grounds for exclusion based on criteria relating to the professional situation of the

tenderer: however, this should not prevent Member States from adding other

legitimate grounds for exclusion, such as those aiming at preventing or addressing

threats to national security.

(14) To ensure equal opportunities for all economic operators across the Union, it is

necessary to lay down common rules which provide that public buyers do not use

exclusion grounds, selection criteria and financial guarantee requirements in R&D

procurement procedures that are disproportionate to the scope and nature of the R&D

procurement contract. Where the use of mandatory exclusion grounds is required, the

use of selection criteria and financial guarantee requirements should remain optional

and should not be used where not needed to ensure good outcomes for the R&D

procurement. Public buyers should not require prior experience in R&D procurement

contracts as such, unless this is strictly justified by the nature of the R&D services

concerned, and should also avoid excessive administrative and financial requirements

which can unnecessarily exclude innovative enterprises from R&D procurement

opportunities. Where minimum financial capacity requirements are needed, innovative

startups or scaleups that do not have a track record of turnover or financial statements

but that are technically and financially viable as they possess other financial resources

such as venture capital investments or valuable intellectual property assets should not

be disqualified. Where financial guarantees are needed, they should be lowered for

innovative startups, scaleups and SMEs, and public buyers should timely reduce or

release financial guarantees once they are no longer justified.

(15) To ensure that innovation contributes to improving the quality of public services and

reinforcing strategic autonomy, in R&D procurement, public buyers should apply

award criteria and contract performance monitoring criteria based on the quality and

innovation impact of the tender rather than on price alone. Common rules should

therefore be established on how such criteria should be formulated in order to take

into account the added value of the tender for the internal market. R&D procurement

contracts should be awarded on the basis of the best price-quality ratio method. This

Regulation should therefore provide for a minimum weighting of 50% for quality

criteria and a minimum weighting of 15% for innovation-related award criteria in the

award phase.

(16) Excessively detailed requirements often contribute to unnecessarily reducing the

participation of economic operators and can hamper innovation. To facilitate

competitive R&D procurement markets, the characteristics of the R&D services that

are subject of the R&D procurement should, as a general rule be drafted by giving

preference to functional requirements and where needed performance requirements

instead of by designing prescriptive requirements. This could include specifying which

functionalities the testing shall have at minimum, such as either, neither or both load

testing and stress testing. It could also include which performance the intended results

of the testing shall have, for example what shall be the required accuracy level of the

test data to be produced by the testing.

EN 21 EN

(17) Allowing contractors to retain the ownership of their IP, attracts more and better-

quality offers to R&D procurements and saves public buyers IP registration,

maintenance and litigation costs. It also enables contractors to commercialise their

R&D results and sell developed products and services to the market through

economies of scale. Public buyers should be able to maintain their freedom to operate

and prevent supplier lock-in by obtaining appropriate rights to use the R&D results for

themselves and for their other contractors. Where contractors fail to commercialise

R&D results or abuse R&D results contrary to the public interest, public buyers should

be able to resort to licensing or transfer of R&D results of contractors, however this

should only be done in compliance with applicable national and Union law and other

international obligations on IP in order not to unduly deprive contractors from their IP

rights. Common rules should therefore be established to encourage that in R&D

procurement the risks and benefits related to the results and the IP rights are shared

between public buyers and contractors under market conditions. R&D procurements

that are not pre-commercial procurements should be able to derogate from risk-benefit

sharing under market conditions enabling public buyers to procure the ownership of IP

rights generated by contractors, in duly justified cases of overriding public interests.

(18) It is necessary to clarify certain aspects related to contract performance that have a

close link with the R&D procurement procedure itself, including payments,

termination of contracts, and contract modifications. Timely payments, appropriate use

of advance payments are important to minimise negatively affecting liquidity and

complicating the financial management of economic operators. Obligations to

terminate ongoing contracts should be defined to prevent infringements of Treaty

obligations or exclusion grounds. In addition to continuing to allow public buyers to

modify R&D procurement contracts for situations that were provided for from the

outset, it should be clarified how R&D procurement contracts can be modified in

unforeseen conditions. Those provisions should allow for better application in

situations justifying a modification without launching a new R&D procurement

procedure. The value of the modifications compared to the original R&D procurement

contract should however be considered only as threshold for ex ante publication and

potential review to combat potential misuse.

(19) It is necessary to provide legal certainty on how public buyers can correctly conduct

value engineering in R&D procurement, as this generates significant cost savings and

quality improvements for public buyers16by allowing the flexibility to modify R&D

procurement contracts in order to incorporate innovations emerging during the

performance of the contract. Common rules should therefore be established to foster

the use of value engineering in R&D procurement, particularly in large value R&D

procurement contracts where the potential impact on cost or quality improvements is

most significant.

(20) Multiple sourcing in R&D procurement facilitates market entry for new entrants and

enables public buyers to reduce the costs of the R&D and its intended results by

introducing competition in development (‘Competitive development’). It also helps

public buyers to retain a competitive supply chain after the R&D procurement and

reduce overdependencies on individual economic operators. Common rules for

multiple sourcing in R&D procurement should be therefore established. As regards

R&D procurements that are not pre-commercial procurements, public buyers should

16 Independent expert report, ‘Overcoming legal barriers for the uptake of innovation procurement in the

EU’, May 2026, https://data.europa.eu/doi/10.2777/4586624

EN 22 EN

be able to derogate from using multiple sourcing, in duly justified cases of overriding

public interests.

(21) Organising competitive development in phases also enables public buyers to reduce

the number of contractors after each R&D phase, which reduces the R&D and

investment risks for public buyers. A phased approach also enables contractors to

grow their business along the growing tasks and contract sizes of successive R&D

phases, which further eases market entry for smaller enterprises and new entrants. A

phased approach can also help to improve support for industrial research and

experimental development, in order to close the persistent gap between scientific

excellence and industrial deployment in the Union. Common rules for competitive

development in phases in R&D procurement should be therefore established. As

regards R&D procurements that are not pre-commercial procurements, public buyers

should be able to derogate from using competitive development in phases, in duly

justified cases of overriding public interests.

(22) Insufficient protection of confidential information and personal data in R&D

procurement can damage the contractor’s business growth, the safety of public

services and fundamental rights of third parties that participate in R&D activities.

Therefor, neither public buyers nor contractors should disclose confidential

information provided to them in the context of a R&D procurement. To ensure a

consistent and high level of protection of natural persons, public buyers may also

restrict the localisation of and access to the personal data that is processed in R&D

procurements to the Union, in accordance with limitations on the transfer of personal

data outside the Union set out in Regulation (EU) 2016/679 of the European

Parliament and of the Council 17 and Directive 2002/58/EC of the European Parliament

and of the Council 18.

(23) Security and public safety considerations may arise in a wide range of R&D

procurement procedures, including outside defence and sensitive security sectors.

Common rules should be established for public buyers on assessing and addressing

such risks in the design and conduct of R&D procurement procedures and in contract

performance.

(24) There is an increased interest from public buyers in different Member States to

cooperate in organising their R&D procurement procedures. Common rules for joint

procurement should therefore be established to overcome the hurdles that public

buyers face today due to fragmented national rules to organise R&D procurement

collaboratively, whether through central purchasing bodies or through joint

procurement, including across borders. There is also an increased interest of public

buyers in Member States to collaborate with Union entities on R&D procurement. As

many of the new provisions in this Regulation are also useful for Union entities but

Union entities are not subject to this Regulation, future revisions of the EU Financial

Regulation will aim to improve the provisions enabling Union institutions, bodies or

17 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the

protection of natural persons with regard to the processing of personal data and on the free movement of

such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4.5.2016,

pp. 1–88, https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng. 18 Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the

processing of personal data and the protection of privacy in the electronic communications sector

(Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37, ELI:

http://data.europa.eu/eli/dir/2002/58/oj)..

EN 23 EN

agencies to carry out R&D procurement, including pre-commercial procurement, for

themselves, jointly with or on behalf of other Union entities and jointly with or on

behalf of public buyers in Member States.

(25) Economic operators face difficulties in leveraging IP assets to obtain growth financing

due to the lack of consistent and reliable approaches to the valuation of intangible

assets, of structured secondary markets for intangible assets and of skills on IP backed

finance. A Competence Centre to support IP-backed finance and commercialisation of

IP should therefore be established within the European Union Intellectual Property

Office (‘the Office’) to develop a voluntary Union framework for the valuation and

disclosure of IP rights, to set up and maintain a Union-wide, multi-lingual, digital

match-making platform19 that facilitates transparent and efficient IP transactions

between investors and IP holders, and to support the financial community in designing

and implementing financial instruments that are tailored to IP assets through advisory

support, helpdesk services and skills development programmes. Access to the services

provided by the Competence Centre should be voluntary. The Competence Centre

should, where possible, make use of European Business Wallets and enable economic

operators to interact fully digitally, securely and efficiently by means of European

Business Wallets, or by alternative electronic means that meet the requirements of this

Regulation and that shall be interoperable with the European Business Wallets,

thereby enabling fully digital procedures.

(26) The Office should be able to levy charges for specific services provided through the

Competence Centre for the individual benefit of users, in accordance with Article 178

of Regulation (EU) 2017/1001 of the European Parliament and of the Council20. Such

charges should be transparent, non-discriminatory and limited to the cost of the service

provided. Certain services, including access to the voluntary valuation framework,

basic access to the digital match-making platform and the Union-level helpdesk,

should remain free of charge.

(27) The effective use of the voluntary Union valuation framework requires assessments by

qualified, independent and trustworthy professionals. The Office should therefore

establish and administer a Union certification scheme for valuators of intellectual

property assets.

(28) The lack of accessible, consistent information across the Union on transactions in

which IP rights are used as collateral hinders evidence-based policymaking and the

development of new financial solutions. To that end, the Office should, through the

Competence Centre, cooperate with Member States and relevant public and private

stakeholders to collect and analyse Union-wide data on IP-collateralised transactions,

while ensuring appropriate safeguards for trade secrets and personal data.

(29) The tasks conferred on the Office by this Regulation should be reflected in a separate

section of its multiannual strategic programme and annual work programme, setting

out the relevant objectives, activities, expected results, performance indicators and

19 IT development and procurement strategy choices will be subject to pre-approval by the European

Commission Information Technology and Cybersecurity Board. 20 Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the

European Union trade mark (OJ L 154, 16.6.2017, pp. 1,

ELI: http://data.europa.eu/eli/reg/2017/1001/oj).

EN 24 EN

estimated resources. The annual activity report should contain a corresponding

assessment of implementation, resources used and revenue from charges.

(30) Regulation (EU) 2017/1001 establishes the Office and lays down its tasks. That

Regulation should therefore be amended to reflect the new tasks entrusted to the

Office.

(31) In order to take account of technological development and maintain an efficient

framework of measures for strengthening the innovation ecosystem at Union level, the

power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of

the European Union should be delegated to the Commission in respect of:

supplementing this Regulation by excluding tenders having their origin in a third-

country that failed to provide national treatment related to Union economic operators

in R&D procurement contrary to its commitments on public procurement in an

international agreement with the Union; amending the list of cases in which public

buyers can decide not to apply risk-benefit sharing, not to apply multiple sourcing or

not to apply competitive development in phases supplement this Regulation by

establishing mandatory technical specifications, selection criteria, award criteria or

contract performance clauses to address an identified specific security and public

safety interest of the Union for specific categories of R&D procurement services or

their intended results.. It is of particular importance that the Commission carries out

appropriate consultations during its preparatory work, including at expert level, and

that those consultations be conducted in accordance with the principles laid down in

the Inter-institutional Agreement on Better Law-Making of 13 April 201621. In

particular, to ensure equal participation in the preparation of delegated acts, the

European Parliament and the Council should receive all documents at the same time as

Member States’ experts, and their experts should systematically have access to

meetings of Commission expert groups dealing with the preparation of delegated acts.

(32) In order to ensure uniform conditions for the implementation of this Regulation,

implementing powers should be conferred on the Commission for the adoption of

technical specifications for the uniform application of the voluntary Union framework

for the valuation and disclosure of IP rights; common technical standards,

interoperability requirements and operational specifications of a digital match-making

platform; and detailed conditions for the implementation of the certification scheme of

intellectual property valuators. Those powers should be exercised in accordance with

Regulation (EU) No 182/2011 of the European Parliament and of the Council.

(33) Where the power to adopt acts in accordance with Article 290 of the

Treaty is delegated to the Commission under this Regulation, it is of particular

importance that the Commission carries out appropriate consultations during its

preparatory work, including at expert level, and that those consultations be conducted

in accordance with the principles laid down in the Inter-institutional Agreement on

Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the

preparation of delegated acts, the European Parliament and the Council should receive

all documents at the same time as Member States’ experts, and their experts should

systematically have access to meetings of Commission expert groups dealing with the

preparation of delegated acts.

(34) Since the objectives of this Regulation cannot be sufficiently achieved by the Member

States but can rather, by reason of its scale and effects, be better achieved at Union

21 OJ L 123, 12.5.2016, p. 1, http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

EN 25 EN

level, the Union may adopt measures in accordance with the principle of

proportionality, as set out in Article 5 of the Treaty on European Union. Furthermore,

in accordance with the principle of proportionality, as set out in that Article, this

Regulation does not go beyond what is necessary in order to achieve those objectives.

(35) This Regulation should not affect the application of State aid and competition rules, in

particular Articles 101, 102 and 107 of the Treaty on the Functioning of the European

Union. The measures provided for in this Regulation should not be used to restrict or

distort competition in a manner contrary to the Treaty on the Functioning of the

European Union.

HAVE ADOPTED THIS REGULATION:

Chapter 1

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation lays down common rules for carrying out procurement of research and

development services (‘R&D procurement’) including a Union harmonised framework for

joint R&D procurement.

This Regulation also establishes a Competence Centre at the European Union Intellectual

Property Office and lays down the tasks of the European Union Intellectual Property Office in

relation to intellectual property-backed finance and commercialisation of intellectual property.

Article 2

Scope

1. Subject to paragraph 3, Chapter 2 of this Regulation applies to procurement of

research and development services by public buyers with a value net of value added

tax (VAT) estimated to be equal to or greater than the amount set out in Article 4(c)

of Directive 2014/24/EU.

2. By way of derogation from paragraph 1, and subject to paragraph 3, Chapter 2 of this

Regulation applies to procurement of research and development services by public

buyers, who are innovation agencies, with a value net of value added tax (VAT)

estimated to be equal to or greater than the amount set out in Article 15(a) of

Directive 2014/25/EU, provided that:

(a) the innovation agency acts on its own mandate and not merely on behalf of

another public buyer;

(b) the procurement of research and development services respects the principles

of transparency, non-discrimination and equal treatment.

3. Chapter 2 of this Regulation does not apply to:

(a) public procurement that falls within the scope of Directives 2014/23/EU,

2014/24/EU and 2014/25/EU;

(b) public procurement that falls within the scope of Directive 2009/81/EC;

(c) public procurement that is excluded from Directive 2009/81/EC by virtue of the

provisions of that Directive.

EN 26 EN

4. Chapter 3 applies to the European Union Intellectual Property Office.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘procurement of research and development services (‘R&D procurement’)

means the procurement of fundamental research, industrial research and

experimental development up to original development, where

(a) original development of a first product, service or work may include limited

production or supply in order to incorporate the results of field testing and to

demonstrate that the product, service or work concerned is suitable for

production or supply in quantity to acceptable quality standards, but shall not

include quantity production or supply to establish commercial viability or to

recover research and development costs.

(b) procurement of research and development services may include obtaining the

ownership of prototypes or first products, services or works that are developed

at the public buyer’s request in the course of and for a particular R&D

procurement contract, but shall not include the commercial deployment of end-

products, services or works;

(2) ‘pre-commercial procurement means the procurement of research and

development services that involves risk-benefit sharing under market conditions, and

competitive development in phases.

(3) ‘public buyer’ means a contracting authority as defined in Article 6(1) of Directive

2014/23/EU, in Article 2(1), point (1), of Directive 2014/24/EU, in Article 3(1) of

Directive 2014/25/EU, or a contracting entity as defined in Article 7(1) of Directive

2014/23/EU and within the meaning of Article 4(1)of Directive (EU) 2014/25;

(4) ‘innovation agency’ means a specialised agency whose principal statutory task is the

financing or procurement of research and development;

(5) ‘R&D procurement contract’ means a contract concluded in writing between one

or more economic operators and one or more public buyers and having as its subject-

matter the provision of research and development services falling within the scope of

this Regulation;

(6) ‘tenderer’ means an economic operator that has submitted a tender;

(7) ‘contractor’ means an economic operator that has been awarded an R&D

procurement contract;

(8) ‘CPV codes for research and development services’ means the codes under

Division 73 of the Common Procurement Vocabulary laid down by Commission

Regulation (EC) No 213/200822.

22 Commission Regulation (EU) 213/2008 of 28 November 2007 amending Regulation (EC) No

2195/2002 of the European Parliament and of the Council on the Common Procurement Vocabulary (CPV) and

Directives 2004/17/EC and 2004/18/EC of the European Parliament and of the Council on public procurement

procedures, as regards the revision of the CPV (O L 74, 15.3.2008, pp. 1,

ELI: http://data.europa.eu/eli/reg/2008/213/oj).

EN 27 EN

(9) ‘economic operator’ means any natural or legal person, or public entity or group of

such persons and/or entities, including any temporary association of undertakings,

which offers the execution of works and/or a work, the supply of products or the

provision of services on the market;

(10) ‘procurement document’ means any document produced or referred to by the

public buyer to describe or determine elements of the procurement or the procedure,

including the contract notice, the prior information notice where it is used as a means

of calling for competition, the technical specifications, the descriptive document,

proposed conditions of contract, formats for the presentation of documents by

tenderers, information on generally applicable obligations and any additional

documents;;

(11) ‘multiple sourcing’ means an R&D procurement whereby one or more public

buyers award multiple R&D procurement contracts in parallel to multiple economic

operators and entrust them with the execution of identical or quasi-identical R&D

services to be performed in parallel;

(12) ‘minor informality or irregularity of a tender’ means an objectively identifiable

defect in a tender that is purely formal in nature and does not concern an essential

element of the tender, the correction or clarification of which does not result in a

modification of the tender, does not amount to the submission of a new tender, and

does not distort competition or infringe the principles of equal treatment and

transparency;

(13) ‘innovation’ means the implementation of a new or significantly improved product,

service, work or process, marketing method, or organisational method in business

practices, workplace organisation or external relations;

(14) ‘SME’ means a micro, small or medium-sized enterprise as defined in the Annex to

Commission Recommendation 2003/361/EC23;

(15) ‘innovative startup’ means, for the purposes of this Act and without making such

definition binding for other purposes, an enterprise that fulfils the criteria of an

innovative startup set out in point 3 of the Annex to Commission Recommendation

(EU) 2026/72024;

(16) ‘innovative scaleup’ means, for the purposes of this Act and without making such

definition binding for other purposes, an enterprise that fulfils the criteria of an

innovative scaleup set out in point 4 of the Annex to Commission Recommendation

(EU) 2026/720;

(17) ‘innovative enterprise’ means, for the purposes of this Act and without making such

definition binding for other purposes, an enterprise that fulfils the criteria of an

innovative enterprise set out in point 2.1 of the Annex to Commission

Recommendation (EU) 2026/720;

(18) ‘emergency situation’ means a sudden, unexpected, and severe disruption to

economic operations, involving shortages of critical products, works or services,

23 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-

sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj). 24 Commission Recommendation (EU) 2026/720 of 18 March 2026 on the definition of innovative

enterprises, innovative startups and innovative scaleups, (OJ L, 2026/720, 24.03.2026, ELI:

http://data.europa.eu/eli/reco/2026/720/oj).

EN 28 EN

extreme price volatility, or supply chain breakdowns that necessitates immediate

action to prevent further harm to the economy, businesses, or consumers in the

Union;

(19) ‘functional requirement’ means a requirement that describes the functions to be

performed, without prescribing the specific technical means, design, solution or

methods by which those functions are to be achieved;

(20) ‘performance requirement’ means a requirement that defines the performance or

outcomes to be achieved, including criteria for verifying compliance, without

prescribing the specific technical means, design, solution or methods by which those

outcomes are to be achieved;

(21) ‘design requirement’ means a requirement that defines in detail technical

characteristics that prescribe how the products, services or works that are developed

at the public buyer’s request in the course of and for a particular R&D procurement

contract shall be designed, including materials, dimensions, and solutions, methods

or processes that are to be used;

(22) ‘results’ means any tangible or intangible outcomes of research, development and

innovation activities, such as data, knowledge or knowhow, whatever its form or

nature, whether or not it can be protected, as well as any rights attached to such

outcomes, including intellectual property rights, that are generated, in whole or in

part, through activities performed under the R&D procurement contract;

(23) ‘value engineering’ means a technique used by public buyers to require or allow

contractors to innovate during the performance of R&D procurement contract to

create additional value for the public buyer that improves the performance, quality,

cost or characteristics of the awarded research and development services and any

prototypes, first products, services or works that are developed in the course of and

for a particular R&D procurement contract, and to share any agreed resulting savings

between the public buyer and the contractor;

(24) ‘value engineering change proposal’ means a proposal submitted by contractors

during the performance of the R&D procurement contract to improve the awarded

research and development services and any prototypes, first goods, services or works

that are developed in the course of and for a particular R&D procurement contract or

to replace those research and development services or prototypes, first goods,

services or works by others that incorporate technological advances or innovations,

and which may involve replacing or adding a new consortium partner or

subcontractor;

(25) ‘value engineering clause’ means a contract clause in an R&D procurement contract

that defines the rights and oblig30ations of the buyer, contractors and subcontractors

regarding how value engineering shall be applied under that contract;

(26) ‘critical technologies’ means the technologies in the critical technology areas listed

in the Annex to Commission Recommendation (EU) 2023/211325;

(27) ‘critical raw material’ means a raw material listed in Annex II to Regulation (EU)

2024/1252 of the European Parliament and of the Council26;

25 Commission Recommendation (EU) 2023/2113 of 3 October 2023 on critical technology areas for the

EU’s economic security for further risk assessment with Member States (OJ L, 2023/2113, 11.10.2023,

ELI: http://data.europa.eu/eli/reco/2023/2113/oj)

EN 29 EN

(28) ‘public and private entities in the fields of finance and insurance’ means public

authorities, public sector bodies, public undertakings and other natural or legal

persons active in the provision, financing, regulation, supervision or intermediation

of financial services, as defined in of Article 2, point (120 of Directive 2011/83/EU

of the European Parliament and of the Council27.

Chapter 2

PROCUREMENT OF RESEARCH AND DEVELOPMENT

SERVICES

SECTION 1

R&D PROCUREMENT PROCEDURE AND CONTRACT PERFORMANCE

Article 4

General principles

1. Public buyers shall carry out R&D procurement in accordance with the rules laid

down in this Regulation. Public buyers and economic operators shall not circumvent

or attempt to circumvent the obligations laid down in this Regulation.

2. Public buyers shall treat economic operators equally and without discrimination and

shall act in a transparent and proportionate manner. The R&D procurement shall not

be designed with the intention of excluding it from the scope of this Regulation or of

artificially narrowing competition. Competition shall be considered to be artificially

narrowed where the design of the R&D procurement is made with the intention of

unduly favouring or disadvantaging certain economic operators.

3. Public buyers may draw up the procurement documents and carry out R&D

procurement, including the market consultation, tendering and contract performance

activities, in any of the official languages of the Union and they may allow economic

operators to submit market consultation feedback, tenders, deliverables and any other

communication exchanges throughout the procurement in any of the official

languages of the Union.

4. Public buyers shall by electronic means ensure that economic operators that have

access to the procurement procedure have unrestricted and full direct access free of

charge to any electronic communication and to the procurement documents,

including documents prepared by public buyers for a market consultation, until three

years after the award of the R&D procurementcontract. Where for certain parts of

these documents access by electronic means cannot be provided, public buyers shall

26 Regulation (EU) 2024/1252 of the European Parliament and of the Council of 11 April 2024

establishing a framework for ensuring a secure and sustainable supply of critical raw materials and

amending Regulations (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1724 and (EU) 2019/1020 (OJ L,

2024/1252, 3.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1252/oj) 27 Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer

rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament

and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European

Parliament and of the Council (OJ L 304, 22.11.2011, p. 64, ELI:

http://data.europa.eu/eli/dir/2011/83/oj)

EN 30 EN

indicate how these parts of the documents will be made available by other than

electronic means. Public buyers shall carry out all direct communication for R&D

procurement where possible by means of the European Business Wallets or by

alternative electronic means that that are interoperable with the European Business

Wallets.

5. In R&D procurement procedures requiring publication in the Official Journal of the

European Union, public buyers shall use the applicable standard forms for notices

laid down in Commission Implementing Regulation (EU) 2019/178028.

6. Public buyers shall take appropriate measures to ensure that, in the performance of

R&D procurement contracts, economic operators comply with applicable obligations

relating to the strategic priorities of the Union set out in the second subparagraph of

this paragraph, as established by Union law, national law, or collective agreements

and by the international environmental, social and labour law.

In cases where there are obligations as referred to in subparagraph 1, public buyers

shall design and execute their R&D procurement in a manner that takes into account

the strategic priorities of the Union, in particular:

(a) boosting the Union’s competitiveness through a thriving internal market,

closing the innovation gap and reinforcing the Union’s manufacturing and

industrial base;

(b) the achievement of climate and environmental objectives of the Union;

(c) the pursuit of a fair and inclusive society;

(d) the Union's economic safety, security, resilience and economic security,

including through strategic independence.

Article 5

Economic operators

1. Public buyers shall not require economic operators to have a specific legal form in

order to participate in the R&D procurement procedure.

2. Economic operators that, under the law of the Member State in which they are

established, are entitled to provide the relevant R&D services, shall not be rejected

solely on the ground that, under the law of the Member State in which the contract

will be awarded, the economic operator would have been required to be either a

natural or legal person.

3. Public buyers may, in the case of R&D services, works or siting and installation

operations, require legal persons to indicate before the start of the execution of the

tasks concerned, the names and relevant qualifications of the staff responsible for the

performance of the contract in question.

28 Commission Implementing Regulation (EU) 2019/1780 of 23 September 2019 establishing standard

forms for the publication of notices in the field of public procurement and repealing Implementing

Regulation (EU) 2015/1986 (eForms) (OJ L 272, 25.10.2019, p. 7, ELI:

http://data.europa.eu/eli/reg_impl/2019/1780/oj).

EN 31 EN

Article 6

Groups of economic operators

4. Public buyers shall not define selection criteria pursuant to Article 15 for groups of

economic operators that differ from those for individual economic operators unless

otherwise laid down in this Article.

Groups of economic operators shall be deemed to fulfil a selection criterion where:

(a) one economic operator in the group possesses the necessary technical and

professional ability or economic and financial standing; or,

(b) where such ability or standing can be established by combining the relevant

technical and professional ability or economic and financial standing from two

or several members of the group, unless such combination will not achieve the

same level of ability or standing.

5. When justified by the nature of the contract and in accordance with the principle of

proportionality, public buyers may

(a) derogate from paragraph 1, second subparagraph, point (a) or (b) for selection

criteria relevant for certain critical tasks;

(b) require that certain critical tasks be performed directly by the member of the

group that fulfils the selection criterion relevant for that task.

Public buyers shall identify the critical tasks and related, requirements, clearly

indicating them and their justification in the procurement documents.

6. Conditions for the performance of the R&D procurement contract by groups may be

permitted to differ from those imposed on individual economic operators,

only where justified by objective reasons, which are proportionate and clearly

indicated in the procurement documents.

7. Without prejudice to Member States’ competence to organise their social security

systems, public buyers shall not require groups of economic operators to assume a

specific legal form once they have been awarded the R&D procurement contract.

8. Public buyers shall give particular consideration not to create unjustified or

disproportionate barriers related to the size of the economic operators participating in

a group, in particular for SMEs, innovative startups and innovative scaleups.

Article 7

Reliance on the capacity of other entities

1. With regard to selection criteria as set out pursuant to Article 15, economic operators

may rely on the capacities of other entities, regardless of the legal nature of the links

which it has with them.

2. The public buyer shall verify whether the entities on whose capacity the economic

operator intends to rely on fulfil the relevant selection criteria and whether there are

grounds for their exclusion.

3. The public buyer shall require the economic operator to replace an entity which does

not meet the relevant selection criteria, or in respect of which there are mandatory

grounds for exclusion. The public buyer may require the economic operator to

replace an entity in respect of which there are optional grounds for exclusion.

EN 32 EN

4. Public buyers may request in the procurement documents that the economic operator

proves that it will have the relevant resources of the entity it intends to rely on at its

disposal throughout the period of execution of the R&D procurement contract, for

example by a statement to that effect by those entities.

5. Where an economic operator relies on the capacities of other entities with regard to

criteria relating to economic and financial standing, the public buyer may require that

the economic operator and those entities be jointly liable to the public buyer for the

execution of the R&D procurement contract.

6. Where an economic operator relies on the capacities of other entities to prove

technical and professional ability, the public buyer may require in the procurement

documents that such other entity will perform the works or services for which these

capacities are required.

Article 8

Subcontracting

1. Parts of an R&D procurement contract may be subcontracted. A R&D procurement

contract awarded to an economic operator shall not be subcontracted in its entirety,

nor be further subcontracted in its entirety.

2. Public buyers shall require economic operators to indicate in their tender any share of

the R&D procurement contract that they envisage to subcontract to third parties, and

any proposed subcontractors.

Public buyers shall require the main contractor to inform them after the award of the

contract and before the start of the contract performance of the tasks and activities its

intends to subcontract. Public buyers shall also require information about the identity

of any subcontractors. The public buyer shall require the main contractor to notify

the public buyer as soon as possible of any changes to this information during the

course of the R&D procurement contract.

3. The public buyer shall require the economic operator to replace a subcontractor in

respect of which there are mandatory grounds for exclusion pursuant to Article 13.

The public buyer may require the economic operator to replace a subcontractor in

respect of which there are optional grounds for exclusion pursuant to Article 14.

4. When justified by the nature of the R&D procurement contract and in accordance

with the principle of proportionality, public buyers may require that certain critical

tasks be performed directly by the main contractor. Public buyers shall identify the

critical tasks and related requirements, clearly indicating them and their justification

in the procurement documents.

5. Subcontracting under the provisions in this Article shall be without prejudice to the

main contractor’s liability.

6. Observance of the obligations referred to in Article 4(6) by subcontractors is ensured

through appropriate action by the competent national authorities acting within the

scope of their responsibility and remit. Member States may adopt or retain additional

proportionate measures limiting subcontracting where they have identified a duly

substantiated higher risk of non-compliance with social and labour law obligations.

EN 33 EN

Article 9

Market consultation

1. Prior to launching the R&D procurement call for tenders referred to in Article 23,

public buyers shall conduct a market consultation to inform economic operators of

the forthcoming R&D procurement call for tenders, and gain market knowledge,

including about the availability of, or potential of developing, innovative solutions,

and about their views on the proposed scope, value, and modalities of the

implementation of the R&D procurement.

2. Prior to starting the market consultation, public buyers shall announce the market

consultation by means of a prior information notice. The notice shall:

(a) be published in the Official Journal of the European Union and, after that, be

published on the national public procurement portal of the Member State of the

public buyer;

(b) include references to the relevant CPV codes for research and development

services, indicate that the market consultation is conducted for a R&D

procurement and relates to innovation by marking the field ‘innovation’ in the

prior information notice and by including, where applicable the words ‘Pre-

Commercial Procurement’ in the field ‘title of the procurement’.

(c) include the format chosen by the public buyer for conducting the market

consultation, such as online questionnaires, online webinars or physical

meetings, and any relevant links or contacts where further information about

the conduct of the R&D procurement can be obtained.

3. Public buyers shall consult the market widely. To this effect, after announcing the

market consultation by means of a prior information notice, public buyers may

publish and promote the announcement of the market consultations through any

widely available media.

4. By way of derogation from paragraph 2 and 3 of this Article, where necessary and

justified for ensuring the protection of the security or public safety interests of the

Union or one or several of its Member States withing the meaning of Article 28(2),

public buyers shall publish and promote to the media the prior information notice

omitting all sensitive information and requesting economic operators to express their

interest to participate in the market consultation. Sensitive information shall be sent

only to economic operators who have expressed interest, meet the qualification

criteria and do not pose a security risk within the meaning of Article 28(4), point (d).

5. By way of derogation from paragraphs 2, 3 and 9 of this Article, where the

publication and promotion in the media of a prior information notice and the

publication of documents that explain the background and the logistical details for

organising the market consultation would be contrary to the security or public safety

interests of the Union or one or several of its Member States withing the meaning of

Article 28(2), the public buyer shall not announce the market consultation pursuant

to paragraph 2, 3 and 9 of this Article but shall send an invitation to participate in the

market consultation to potentially suitable economic operators identified through a

market research and share the market consultation documents only with those who

express an interest, meet the qualification criteria and do not pose a security risk

within the meaning of Article 28(4), point (d).

EN 34 EN

6. Public buyers shall not exclude any economic operators having their origin in

countries referred to in Article 11(1), from participation in the market consultation.

By way of derogation from the first subparagraph of this paragraph, where necessary

and justified for protecting security and public safety interests of the Union or one or

several of its Member States within the meaning of Article 28(2), public buyers may

restrict market consultation only to economic operators that have their origin in

Member States.

7. Public buyers shall ensure equal access to information during the market

consultation. They shall share any information on the R&D procurement provided to

one economic operator participating in the market consultation with all other

economic operators participating in the same market consultation.

8. During the market consultation, public buyers may seek or accept information and

advice from the general public, independent experts, public authorities, market

participants or other relevant parties. The market consultation may take the form of

written or verbal exchanges, online questionnaires, webinar of physical meetings, site

visits or demonstrations, or other suitable objective formats. Information and advice

sought or accepted may be used in the planning and conduct of the R&D

procurement, respecting the principles of equal treatment, non-discrimination, fair

competition and transparency.

9. Unless contrary to the security or public safety interests of the Union or one or

several of its Member States withing the meaning of Article 28(2), public buyers

shall publish on their website any documents related to the market consultation,

including any documents that explain the background and the logistical details for

organising the market consultation, questions posed by economic operators together

with the replies to those questions by the public buyer and where available a

summary on the outcome of the market consultation or written minutes, or a video or

audio recording of any market consultation meetings.

10. The participation of an economic operator in a market consultation shall not prejudge

its eligibility to participate in a subsequent call for tenders for the R&D procurement.

11. By way of derogation from paragraph 1, the obligation to conduct a market

consultation pursuant to this Article shall not apply to R&D procurement procedures

which have as their only subject the procurement of research and development

consultancy services as covered by CPV codes 73200000-4,73210000-7 and

73220000-0.

Article 10

Procurement documents

1. Public buyers shall specify in the procurement documents at least the following

elements:

(a) the R&D procurement need in accordance with paragraph 4;

(b) the estimated value of the R&D procurement established in accordance with

the methodology laid down in paragraph 5, and any cash or in-kind

contributions that public buyers intend or may make available to contractors

during the R&D procurement;

EN 35 EN

(c) the information on the conduct and the outcome of the market consultation

made available in accordance with Article 9(7) and Article 9(9);

(d) the conditions for access to the R&D procurement, in accordance with the

obligations laid down in Articles 11;

(e) the applicable exclusion grounds, selection criteria and financial guarantees in

accordance with the obligations laid down in Articles 13, 14, 15 and 16;

(f) the minimum requirements to be met by all tenderers;

(g) the innovation-related award criteria, including their respective weightings, to

be applied in the evaluation of tenders, in accordance with the obligations laid

down in Article 17;

(h) the division of the rights and obligations related to intellectual property rights

and the ownership of results, in accordance with the obligations laid down in

Article 19;

(i) the provisions for contract modifications and, where applicable, for value

engineering, in accordance with the obligations laid down in Articles 20 to 21;

(j) the provisions for the call for tenders, including applicable provisions on

negotiation laid down in paragraphs 2 to 3 of this Article and the minimum

number of contractors that are to be selected where lots and multiple sourcing

are used, in accordance with the provisions on the use for multiple sourcing

laid down in Article 22 and with the provisions for the launch of the call for

tenders laid down in Article 23;

(k) where applicable, the number of R&D phases over which the R&D activities

are split and whether the public buyer includes the option to make use of the

possibility to invite economic operators that have not participated in previous

phases of the R&D procurement to participate in later phases of the R&D

procurement, in accordance with the obligations for competitive development

in phases laid down in Article 24;

(l) whether and how the public buyer intends to obtain the ownership of results of

the R&D procurement, including any prototypes or first products, services or

works developed as a part of the R&D procurement;

(m) the innovation-related key performance indicators defined, to the maximum

extent practicable as performance requirements, and the method for assessing

them, to monitor the contract performance throughout the R&D procurement,

in accordance with the obligations laid down in Article 24(5);

(n) the provisions for payments, in accordance with the obligations laid down in

Article 25;

(o) the applicable confidentiality and data protection obligations, in accordance

with the obligations laid down in Article 26;

(p) where applicable, any requirements for contractors to contribute to

standardisation, certification or publication of results, including by making

them available as open data or open source, without prejudice to confidentiality

and data protection obligations referred to in Article 26 and to the obligations

in respect of the protection of intellectual property rights laid down in Article

19;

EN 36 EN

(q) the provisions on the termination of R&D procurement contracts, in

accordance with the obligations laid down in Articles 27 and 29;

(r) the applicable security and public safety obligations, in accordance with the

obligations laid down in Article 28, 29 and 30;

(s) where applicable, the provisions for conducting the procedure as a joint R&D

procurement, in accordance with the obligations laid down in Article 31;

(t) that the provisions of this Regulation apply to the R&D procurement.

2. Public buyers shall indicate in the procurement documents that the essential

conditions of the R&D procurement contract are not subject to negotiation. Public

buyers shall not substantially alter the subject matter of the R&D procurement

contract as a result of the negotiations. Negotiations may concern all characteristics

of the research and development activities and of the intended results to be developed

for the public buyer during those research and development activities as part of the

R&D procurement, including quality, quantities as well as social, environmental and

innovative aspects, may be subject to negotiation, provided that those characteristics

do not constitute minimum requirements.

3. Public buyers shall, in the procurement documents, indicate any specific elements

not listed in paragraph 1 for which they invite tenderers to indicate, in their tender,

their preferred approach, leaving the finalisation of those elements subject to

negotiation.

4. Public buyers shall draft the procurement documents for the R&D procurement

taking into account the findings of the market consultation and any market research

that the public buyer conducted on the state of the art of any ongoing research and

development and product planning roadmaps of economic operators. Public buyers

shall formulate the R&D procurement need referred to paragraph 1, point (a), of this

Article as a problem that needs to be solved without unduly restricting possible

approaches to solve the problem. Public buyers shall give preference to use

functional requirements or performance requirements in accordance with Article 18

to formulate the requirements for addressing the R&D procurement need. The

information provided in the procurement documents shall be sufficiently precise to

enable economic operators to identify the nature and scope of the R&D procurement

and to decide whether to submit a tender.

5. Public buyers shall calculate the estimated value of the R&D procurement procedure

based on the maximum estimated value net of VAT of the research and development

services to be provided in the context of the R&D procurement contract or contracts

that are expected to be awarded as part of the R&D procurement procedure,

including any lots, options or renewals. The calculation of the estimated value shall

take into account the estimated value of all types of research and development related

expenses, irrespective of their share in the total estimated value, including the value

of labour, materials, components and tools that are needed to deliver the expected

results, including, where relevant, research and development that was performed

before the start of the R&D procurement procedure. Where public buyers intend to

obtain the exclusive ownership of intellectual property rights to results generated by

contractors, the estimated value shall include the estimated value of those intellectual

property rights. The estimated value shall not include any cash or in-kind

contributions that public buyers intend or may make available to contractors during

the R&D procurement.

EN 37 EN

6. As regards products, services or works that result from the research and development

services procured and that are needed to safeguard security and public safety

interests of the Union or one or several of its Member States within the meaning of

Article 28(2), including to avoid security of supply issues, public buyers may, in the

procurement documents, specify that public buyers have a priority right to purchase a

predefined volume or value of those products, services or works before these are

offered to other potential buyers. In such case, public buyers shall set out the priority

right to purchase as a contractual obligation in the R&D procurement contract.

Article 11

Conditions for access to R&D procurement procedures and place of performance

requirements

1. Public buyers shall open the participation in R&D procurement only to:

(a) economic operators having their origin in Member States;

(b) economic operators having their origin in countries that have concluded an

international agreement with the Union, provided that R&D procurement falls

within the scope of the Union’s public procurement commitments in that

agreement.

2. The Commission is empowered to adopt delegated acts in accordance with Article 39

to supplement this Regulation by excluding, in whole or in part, subject to the

Union’s international obligations, a third country from the scope of paragraph 1,

point (b) based on any of the following criteria:

(a) that third country has failed to provide national treatment related to Union

R&D services or entities under the agreements referred to in paragraph 1, first

subparagraph, point (b);

(b) such exclusion is justified to avoid dependencies or any other developments

that may threaten the security of supply in the Union of the relevant products,

works or services in question;

(c) such restriction is justified under any other exception under the applicable

agreement.

3. By way of derogation from paragraph 1 of this Article, where necessary and justified

for ensuring the protection of the security interests of the Union or one or several of

its Member States within the meaning of article 28(2), public buyers may restrict

participation in R&D procurement only to economic operators that have their origin

in Member States and that are not subject to control of a third country or of a legal

entity that is subject to control of a third country.

4. By way of derogation from paragraph 1 point (b), public buyers may open the access

to the R&D procurement also only to economic operators that have their origin in

countries that have concluded an international agreement with the Union in which

the Union has made public procurement commitments but not for R&D

procurements, only in one of the following cases where:

(d) through a market research that includes an extensive, widely disseminated

market consultation, the public buyer can determine that the required R&D

services cannot be provided by economic operators in the countries listed in

paragraph 1, and no reasonable alternative or substitute exists;

EN 38 EN

(e) no suitable tenders or requests to participate have been submitted, including in

response to a similar R&D procurement procedure launched by any public

buyer in the countries listed in paragraph 1 in the two years preceding the

launch of the planned new R&D procurement procedure; or

(f) limiting the access to the R&D procurement procedures in accordance with

paragraph 1 would entail that the public buyer would have to procure the R&D

services at disproportionate costs.

For the purposes of the first subparagraph, point (b), an estimated difference of more

than 20 % between the estimated cost of an offer from an economic operator having

their origin in a country referred to in paragraph 1 and that from an economic

operator having their origin in a country that has concluded an international

agreement with the Union in which the Union has made public procurement

commitments but not for R&D procurements on the basis of on objective and

transparent data, may be presumed by public buyers to be disproportionate.

5. Subcontracting shall not be used with the intent or effect to circumvent the rules on

access to R&D procurement. The conditions for access to R&D procurement shall

not apply to entities on whose capacity the tenderer relies or to subcontractors, unless

public buyers limit subcontracting:

(a) where paragraph 1 or 4 applies, to subcontractors that have their origin in the

countries listed in paragraph 1; or

(b) where paragraph 3 applies and where necessary and justified for ensuring the

protection of the security and public safety interests of the Union or one or

several of its Member State within the meaning of Article 28(2), to

subcontractors that have their origin in Member States and that are not subject

to control of a third country or of a legal entity that is subject to control of a

third country.

6. Where paragraph 4 applies, public buyers may reserve a number of R&D

procurement contracts within the same R&D procurement procedure:

(a) for economic operators that have their origin in the countries referred to in

paragraph 1, first subparagraph points (a) and (b); or

(b) where necessary and justified for protecting the security or public safety

interests of the Union or one or several of its Member States within the

meaning of article 28(2), for economic operators that have their origin in

Member States and that are not subject to control of a third country or of a

legal entity that is subject to control of a third country.

7. Unless contrary to security or public safety interest of the Union or one or several of

its Member States within the meaning of Article 28(2) for reasons justified in the

procurement documents, public buyers shall require that contractors perform at least

50% of the research and development activities under the R&D procurement contract

in the countries referred to in paragraph 1, including the work of principal research

and development staff with scientific responsibility for the R&D procurement

contract.

8. Where necessary and justified for protecting the security or public safety interests of

the Union or one or several of its Member States within the meaning of Article 28(2),

public buyers may require, in addition to the measure in paragraph 7 of this Article,

contractors to perform all research and development activities relating to new

EN 39 EN

security components of the intended results in the Union, including the work of

principal research and development staff with scientific responsibility for the R&D

procurement contract.

9. Where an economic operator fails to provide information or documentation requested

by the public buyer related to the verification of the place of performance conditions

referred in paragraphs 7 and 8 without any reasonable explanation and thereby

prevents the verification of the economic operator’s compliance with the place of

performance conditions by public buyers or makes such a verification practically

impossible or very difficult, that economic operator shall be excluded from

participation in the R&D procurement procedure.

10. In addition to, or by derogation from any rules set out under this Regulation,

including or by derogation from the list of countries referred to in paragraph 1 and

paragraph 4, for the award and execution of R&D procurement contracts supported

by a Union programme or instrument, public buyers shall apply any conditions

necessary to comply with requirements for Union support in all management modes

established in Article 62 of Regulation (EU, EURATOM) 2024/250929.

11. The Commission shall establish and make available free of charge a publicly

accessible online tool, which sets out, in a comprehensive and up-to-date manner, the

Union’s public procurement commitments, including the R&D procurement

commitments, in international agreements.

Public buyers shall determine, for the purposes of a given R&D procurement

procedure, the countries referred to in paragraph 1, point (b), and paragraph 4 on the

basis of the applicable international agreements as reflected in the online tool

referred to in subparagraph 1 of this paragraph.

12. Public buyers shall determine, for the purposes of a given procurement procedure, on

the basis of the applicable international agreements as reflected in the online tool

referred to in paragraph 1 for the parameters entered, including the public buyer

concerned, the subject-matter and the estimated value of the contract in relation to

the applicable thresholds.

13. Public buyers shall:

(a) restrict participation in R&D procurement procedures in the case of groups of

economic operators referred to in Article 6, to groups which are composed

solely of economic operators having their origin incountries referred to in

paragraphs 1 to 4 in this Article;

(b) reject a tender in the course of a R&D procurement procedure where it is not

submitted by economic operators having their origin incountries referred to in

paragraphs 1 to 4 in this Article or groups thereof as referred to in point (a).

Article 12

Determination of origin

1. The origin of an economic operator shall be deemed to be:

29 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September

2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.09.2024,

ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

EN 40 EN

(a) in the case of a natural person, the country of which the person is a national or

where that person has a right of permanent residence;

(b) in the case of a legal person, either of the following:

(i) the country under the laws of which the legal person is constituted or

otherwise organised and in the territory of which the legal person is engaged in

substantive business operations;

(ii) if the legal person is not engaged in substantive business operations in the

territory of the country in which it is constituted or otherwise organised, the

origin of the legal person is to be that of the person or persons who may

exercise, directly or indirectly, a dominant influence on the legal person by

virtue of their ownership of that legal person, their financial participation

therein, or the rules which govern that legal person.

2. For the purposes of the first subparagraph, point (b)(ii), that person or persons shall

be presumed to have a dominant influence on the legal person in any of the following

cases in which they, directly or indirectly:

(a) by holding the majority of the legal person’s subscribed capital;

(b) by controlling the majority of the votes attaching to shares issued by the legal

person; or

(c) by being able to appoint more than half of the legal person’s administrative,

management or supervisory body.

3. Public buyers may, at any time during a R&D procurement procedure, request the

economic operator to submit, supplement, clarify or complete the information or

documentation related to the verification of the economic operator’s origin within an

appropriate time limit, provided that such requests are made in compliance with the

principles of equal treatment and transparency. Where the economic operator fails to

provide such information or documentation without any reasonable explanation and

thereby prevents the verification of the economic operator’s origin by public buyers

or makes such a verification practically impossible or very difficult, that economic

operator shall be excluded from participation in the R&D procurement procedure

concerned.

Article 13

Mandatory exclusion grounds

1. Public buyers shall at any time exclude an economic operator, including individual

members of a group of economic operators, from participation in a R&D

procurement procedure where that economic operator, or a key person in the

functioning of a legal person as defined in the second subparagraph, has been the

subject, in any Member State, of a conviction by final judgment, for any of the

offences listed in this subparagraph, or, regarding Member States not bound by the

relevant Union legal act, offences as defined in equivalent national legislation:

EN 41 EN

(a) participation in a criminal organisation, as defined in Article 1, point 1, of

Council Framework Decision 2008/841/JHA30;

(b) corruption offences, within the meaning of Directive (EU) 2026/102131;

(c) fraud affecting the Union’s financial interests within the meaning of Article 1

of the Convention on the protection of the European Communities’ financial

interests and criminal offences referred to in Article 3, 4 and 5 under Directive

(EU) 2017/137132;

(d) terrorist offences and offences related to a terrorist group, as well as offences

related to terrorist activities, as defined in Articles 3 to 12 of Directive (EU)

2017/54133;

(e) Money laundering within the meaning of Article 3 of Directive

2018/1673/EU34;

(f) trafficking in human beings within the meaning of Article 2 of Directive (EU)

2011/3635; 

(g) criminal offences concerning the employment of illegally staying third-country

nationals, as referred to in Articles 2, 3 and 9 of Directive 2009/52/EC36;

(h) environmental criminal offences as referred to in Articles 3 and 4 of Directive

(EU) 2024/120337;

(i) criminal offences concerning the violation of Union Restrictive Measures as

referred to in Article 3 and 4 of Directive (EU) 2024/122638;

30 Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime

(OJ L 300, 11.11.2008, p. 42, ELI: http://data.europa.eu/eli/dec_framw/2008/841/oj). 31 Directive (EU) 2026/1021 of the European Parliament and of the Council of 29 April 2026 on

combatting corruption, replacing Council Framework Decision 2003/568/JHA and the Convention on

the fight against corruption involving officials of the European Communities or officials of Member

States of the European Union and amending Directive (EU) 2017/1371 of the European Parliament and

of the Council (OJ L, 2026/1021, 11.5.2026, ELI: http://data.europa.eu/eli/dir/2026/1021/oj). 32 Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight

against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29,

ELI: http://data.europa.eu/eli/dir/2017/1371/oj). 33 Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on

combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council

Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6, ELI: http://data.europa.eu/eli/dir/2017/541/oj). 34 Directive (EU) 2018/1673 of the European Parliament and of the Council of 23 October 2018 on

combating money laundering by criminal law (OJ L 284, 12.11.2018, p. 22, ELI:

http://data.europa.eu/eli/dir/2018/1673/oj). 35 Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and

combating trafficking in human beings and protecting its victims, and replacing Council Framework

Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1, ELI: http://data.europa.eu/eli/dir/2011/36/oj). 36 Directive (EU) 2024/1203 of the European Parliament and of the Council of 11 April 2024 on the

protection of the environment through criminal law and replacing Directives 2008/99/EC and

2009/123/EC (OJ L, 2024/1203, 30.4.2024, ELI: http://data.europa.eu/eli/dir/2024/1203/oj). 37 Directive (EU) 2024/1203 of the European Parliament and of the Council of 11 April 2024 on the

protection of the environment through criminal law and replacing Directives 2008/99/EC and

2009/123/EC (OJ L, 2024/1203, 30.4.2024, ELI: http://data.europa.eu/eli/dir/2024/1203/oj). 38 Directive (EU) 2024/1226 of the European Parliament and of the Council of 24 April 2024 on the

definition of criminal offences and penalties for the violation of Union restrictive measures and

amending Directive (EU) 2018/1673 (OJ L, 2024/1226, 29.4.2024, ELI:

http://data.europa.eu/eli/dir/2024/1226/oj).

EN 42 EN

(j) fraudulent use of non-cash payment instruments as referred to in Articles 3 to 8

of Directive 2019/713/EU39

(k) offences in the area of sexual abuse and sexual exploitation of children and

child sexual abuse material as referred to in Article 3 to 9 of Directive

2011/93/EU40;

For the purposes of the first subparagraph, a key person in the functioning of a legal

person means a person having a leading position within the legal person, based on

any of the following:

(a) a power of representation of the legal person;

(b) an authority to take decisions on behalf of the legal person; or

(c) an authority to exercise control within the legal person.

2. The exclusion grounds set out in this Article shall apply for five years from the date

of the delivery of the final judgment, except where the period of exclusion has been

set by the final judgment, meaning that no exclusion decision shall be taken after the

expiry of the periods referred to in this sentence.

3. Public buyers shall at any time during the R&D procurement procedure exclude an

economic operator from participation in a R&D procurement procedure where it

becomes aware that the economic operator or contractor is in breach of its

obligations relating to the payment of taxes or social security contributions and this

has been established by final judicial or administrative decision, except if by that

moment in time, the economic operator has concluded a binding arrangement on

paying the taxes or social security contributions due, including, where applicable,

any interest accrued or fines.

Public buyers may derogate from the mandatory exclusion provided for in the first

subparagraph where an exclusion would be clearly disproportionate, in particular

where only minor amounts are unpaid.

4. Public buyers may decide to derogate from the mandatory exclusion provided for in

this Article, on an exceptional basis, for overriding reasons relating to the public

interest such as public health or protection of the environment. Any decision to

derogate and the justification therefore shall be documented in the individual

documentation of the R&D procurement procedures.

Article 14

Optional exclusion grounds

39 Directive (EU) 2019/713 of the European Parliament and of the Council of 17 April 2019 on combating

fraud and counterfeiting of non-cash means of payment and replacing Council Framework Decision

2001/413/JHA (OJ L 123, 10.5.2019, p. 18, ELI: http://data.europa.eu/eli/dir/2019/713/oj). 40 Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on

combating the sexual abuse and sexual exploitation of children and child pornography, and replacing

Council Framework Decision 2004/68/JHA (OJ L 335, 17.12.2011, p. 1, ELI:

http://data.europa.eu/eli/dir/2011/93/oj.

EN 43 EN

1. Public buyers may at any time during the R&D procurement procedure exclude an

economic operator, including individual members of groups of economic operators,

from participation in a R&D procurement procedure, where:

(a) the public buyer can demonstrate by any appropriate means that the economic

operator has breached applicable obligations under relevant Union legislation,

as referred to in Article 4(6);

(b) the economic operator is bankrupt or is the subject of insolvency or winding-up

proceedings or a comparable situation;

(c) the public buyer can demonstrate by appropriate means grave professional

misconduct by the economic operator, which renders its integrity or reliability

questionable;

(d) the public buyer has sufficiently plausible indications to conclude that the

economic operator has entered into agreements with other economic operators

aimed at distorting competition;

(e) the economic operator has shown significant or persistent deficiencies in the

performance of a substantive requirement under a prior public contract, which

led to early termination of that prior contract, damages or other comparable

sanctions by the public buyer;

(f) the economic operator, in the context of the concerned R&D procurement

procedure, has been found accountable of serious misrepresentation with

regard to the information required for the verification of the absence of grounds

for exclusion or the fulfilment of the selection criteria; or has otherwise

undertaken to unduly obtain advantages in the R&D procurement procedure;

(g) the public buyer can demonstrate by any appropriate means, including but not

limited to classified information or non-publicly disclosable, assessments

provided by competent national authorities, that the economic operator does

not possess sufficient reliability to exclude risks to the security and public

safety interests of the Union or of one or more Member States.

(h) the economic operator has benefitted from foreign subsidies distorting the

internal market, established by an implementing act adopted by the

Commission pursuant to Article 31 (2) of Regulation (EU) 2022/256041, in the

three years preceding the public procurement procedure, and the public buyer

has sufficiently plausible indications to conclude that the foreign subsidies

concerned are likely to have an impact on the tender of the economic operator.

2. Any economic operator subject to an exclusion pursuant to paragraph1 may provide

evidence to rebut the existence of the exclusion ground or to demonstrate that it has

taken sufficient measures to demonstrate its reliability despite the existence of the

exclusion ground.

For this purpose, the economic operator shall, in particular, prove that it has

(a) paid or undertaken to pay compensation in respect of any damage caused by

the misconduct;

41 Regulation (EU) 2022/2560 of the European Parliament and of the Council of 14 December 2022 on

foreign subsidies distorting the internal market (OJ L 330, 23.12.2022, p. 1, ELI:

http://data.europa.eu/eli/reg/2022/2560/oj).

EN 44 EN

(b) clarified the facts and circumstances in a comprehensive manner by actively

cooperating with the investigating authorities; and

(c) taken concrete technical, organisational and personnel measures that are

appropriate to prevent further misconduct.

If the public buyer considers the evidence provided as sufficient, the economic

operator concerned shall not be excluded from the R&D procurement procedure.

The measures taken by the economic operators shall be evaluated taking into account

the gravity and particular circumstances of the misconduct. In assessing the measures

taken by the economic operator public buyers shall take into account the nature,

extent and timing of the cooperation with the relevant investigating authorities.

Where the measures are considered to be insufficient, the economic operator shall

receive a statement of the reasons thereto.

An economic operator which has been excluded by final judgment in any Member

State from participating in procurement procedures shall not be entitled to make use

of the possibility provided for under this paragraph during the period of exclusion

resulting from that judgment.

3. Member States may designate a national authority competent to evaluate the

evidence and decide whether it is sufficient for the purposes of this paragraph. Public

buyers shall rely on a positive decision of the national competent authority for the

purpose of their procurement procedures.

4. Where no measures as specified in paragraph 2 are taken and where the period of

exclusion has not been set by final judgment, public buyers may exclude economic

operators pursuant to this Article during a period of five years from the date of the

conduct giving rise to exclusion or, in the case of continued or repeated acts, the date

on which the conduct ceases, but not after that maximum period.

5. Where a public buyer excludes an economic operator on the basis of paragraph 1,

point (h), it shall inform the Commission thereof.

Article 15

Selection criteria

1. Where public buyers decide to make use of selection criteria as requirements for

participation in R&D procurement procedures, they shall lay down such criteria in

accordance with the conditions in this Article.

2. Selection criteria for R&D procurement procedures shall only relate to:

(a) suitability to pursue the professional activity within the meaning of paragraph

4;

(b) technical and professional ability within the meaning of paragraph 5;

(c) economic and financial standing within the meaning of paragraphs 6, 7 and 8.

3. Public buyers shall limit any requirements for selection criteria to those that are

appropriate to ensure that an economic operator has the required capacities and

abilities to perform the R&D procurement contract. All requirements for selection

criteria shall be related and proportionate to the complexity of and the risks

associated with the subject-matter of the R&D procurement contract and comply

with the principles of transparency, non-discrimination and proportionality.

EN 45 EN

Each reference to be provided as means of proof of compliance with any of the

selection criteria shall be accompanied by the words ‘or equivalent’ to allow

tenderers to provide any type of alternative evidence of compliance.

4. In R&D procurement procedures, in so far as economic operators are required to

hold a particular authorisation or to be members of a particular organisation in order

to be able to perform the research and development activities concerned in the

country where the economic operator conducts its main activity, the public buyer

may require such economic operators to prove that they hold such authorisation or

membership.

Certified registration on official lists held by the competent bodies or a certificate

issued by the certification body shall constitute a presumption of compliance with

regard to the requirements laid down in the first and second subparagraphs.

5. Public buyers may impose requirements ensuring that economic operators possess

the necessary human and technical resources and experience to perform the R&D

procurement contract to an appropriate quality standard.

Unless justified by the complexity of the R&D procurement contract or the nature of

the subject-matter, public buyers shall not require prior experience in other

contracts as a condition for participation in an R&D procurement procedure.

A public buyer may assume that an economic operator does not possess the required

professional abilities in either of the following cases where:

(a) the public buyer has established by any means that the economic operator has

conflicting interests which may negatively affect the performance of the that

contract;

(b) the public buyer has been made aware by any means that the economic

operator presents a security concern for a Member State or the Union as a

whole.

Public buyers shall not require prior experience in other contracts without requiring

that contractors possess the necessary human and technical resources to perform the

R&D procurement contract. Public buyers shall not deem economic operators non-

compliant with the requirements on technical and professional ability solely due to

lack of prior experience in other contracts.

Any references to qualifications or qualification levels included in selection criteria

shall mention the European Qualifications Framework levels set out in Annex II to

Council Recommendation of 22 May 201742.

6. Where public buyers require economic operators to have minimum economic and

financial standing, they may require economic operators to have one or both of the

following:

(a) a certain minimum financial capacity;

(b) an appropriate level of professional risk indemnity insurance.

42 Council recommendation of 22 May 2017 on the European Qualifications Framework for lifelong

learning and repealing the recommendation of the European Parliament and of the Council of 23 April

2008 on the establishment of the European Qualifications Framework for lifelong learning (OJ C 189,

15.6.2017, p.15).

EN 46 EN

7. Where public buyers require economic operators to provide proof of minimum

economic and financial standing, public buyers shall allow economic operators to

provide such proof by any appropriate means, including any of the following:

(a) statements from banks or, where appropriate, evidence of relevant professional

risk indemnity insurance;

(b) financial statements or extracts from financial statements, where publication of

financial statements is required under the law of the country in which the

economic operator is established;

(c) a statement of the economic operator’s turnover for a maximum of the last

three financial years available, depending on the date on which the economic

operator was set up or started trading, as far as the information on such

turnovers is available;

(d) a business plan supported by statements or other evidence of the economic

operator’s tangible and intangible financial assets, including its intellectual

property assets, financial contributions from financial investors or funding

bodies, or evidence of own capital invested in the economic operator.

Where a minimum financial capacity is required, it shall not exceed 50% of the

estimated value of the R&D procurement contract, except in duly justified cases such

as relating to the special risks attached to the nature of the procured research and

development services. R&D procurement contract. The public buyer shall specify the

main reasons for such a requirement in the procurement documents.

In assessing the minimum financial and economic standing, public buyers may

consider information from the annual accounts of the economic operator only where

the public buyer has specified the methods and criteria for such consideration in the

procurement documents. Such methods and criteria shall be transparent, objective

and non-discriminatory.

Where public buyers impose economic and financial standing selection criteria in

accordance with paragraph 6, public buyers shall enable tenderers to provide the

proof referred to in this paragraph, first subparagraph, point (d), between the date

that the public buyer notifies tenderers about the decision to award the R&D

procurement contract and the date of signature of that contract.

8. Where public buyers require professional risk indemnity insurance, they shall ensure

and shall provide justification in the procurement documents that the required

liability coverage is proportionate to the reasonably foreseeable amount of loss or

damage that contractors and subcontractors may cause during or as a result of the

performance of the R&D procurement contract.

9. Where the R&D procurement procedure applied by the public buyer does not include

a preselection of economic operators on the basis of exclusion grounds or selection

criteria, the public buyer shall request full documentary evidence proving compliance

with applicable exclusion grounds and selection criteria only from the winning

tenders that ranked highest based on the award criteria. Information that can be

determined from existing national databases established by a public body, or from

the registration on official lists or certifications shall not be questioned without

sufficient justification.

10. Where information or documentation submitted by economic operators is or appears

to be incomplete or erroneous or where specific documents are missing, public

EN 47 EN

buyers, in compliance with the principles of equal treatment and transparency, shall

provide the economic operators concerned with the opportunity to submit,

supplement, clarify or complete the relevant information or documentation within an

appropriate time limit to remedy any deficiency resulting from a minor informality or

irregularity of a tender that does not put into question the decision to award R&D

procurement contracts.

Article 10

Financial guarantees

1. Public buyers may require tenderers to provide tender guarantees, performance

guarantees or retention guarantees provided that all of the following conditions are

met:

(a) the amount of the tender guarantees does not exceed 2% of the total estimated

R&D procurement contract value, with a maximum amount of the tender

guarantee of EUR 500 000 for R&D procurement contracts with an estimated

value above EUR 5 000 000 and EUR 100 000 for contracts with an estimated

value below EUR 5 000 000.

(b) for R&D procurement contracts with an estimated contract value above EUR

500000, the amount of the performance and retention guarantees does not

exceed 5% of the specific contract price, which may be increased to 10% for

highly complex or risky R&D procurement contracts when justified by a risk

analysis.

(c) For R&D procurement contracts with an estimated contract value below EUR

500000, no performance or retention guarantees shall be required.

2. The values of tender, performance and retention guarantees that public buyers

require from tenderers shall be reduced by 50% for SMEs, innovative startups and

innovative scaleups.

3. Public buyers shall ensure the timely reduction or release of financial guarantees

once they are no longer justified.

Article 17

Innovation-related award criteria

1. Public buyers shall award the contract to the economic operator that offers the best

quality for money. To that effect, public buyers shall evaluate the tenders received

according to the best price-quality ratio method. To determine the best price-quality

ratio, public buyers shall evaluate the tenders through a comparison of their price,

and quality, the latter based on quality criteria linked to the subject matter of the

R&D procurement contract. Costs can also be taken into account when determining

the best price-quality ratio. When evaluating the tenders based on the best price-

quality method, the combined weight of all quality award criteria shall represent at

least 50% of the total weighting of all award criteria. The price criterion shall only

relate to the price of the tender. The weighting given to criteria related to the total

cost of ownership shall be counted within the respective percentage share.

2. Quality criteria shall refer to any criteria used to assess the degree to which a tender

proposes beneficial, efficient or sustainable outcomes in relation to the subject-matter

of the R&D procurement contract.

EN 48 EN

The quality of the tender may, for instance, relate to the following aspects:

(a) technical merit, aesthetic and functional characteristics, accessibility, design

for all users, research and development methods;

(b) environmental, climate-related, social and innovation objectives in accordance

with Article 4(6), security and public safety interests in accordance with Article

28, or European preference requirements where a public buyer applies those

requirements in the form of an allocation of award points;

(c) quality of the staff assigned that can significantly impact the level of

performance of the contract, such as the organisation, qualification and

experience of the staff assigned to performing the R&D procurement contract;

(d) quality of the organisation of the work, quality of the allocation of resources

assigned to performing the R&D procurement contract;

3. Award criteria shall be non-discriminatory, proportionate, specific, objective and

measurable; they shall be evaluated in a process containing sufficient safeguards

against irregularities. They shall allow the public buyer to effectively compare the

strengths and weaknesses of the offered R&D services and shall not have the effect

of conferring an unrestricted freedom of choice on the public buyer.

4. In R&D procurement procedures, public buyers shall apply, as part of the quality

award criteria referred to in paragraph 2, specific quality award criteria designed to

measure the potential impact of the tenders on innovation and on creating added

value for the Union. Such innovation-related quality award criteria, as referred to in

paragraph 2(e) of this Article, shall include the following:

(a) the degree of innovativeness of the tender and the extent to which this degree

of innovativeness contributes to the overall quality of the proposal that is to be

researched, developed or tested during the R&D procurement, where possible

by using quality criteria that are specific to the intended results of the R&D

procurement;

(b) the total cost of ownership and long-term benefits of the tender, including the

impact of any value engineering approach that is proposed in the tender on

those costs and benefits;

(c) the impact of the tender on reinforcing the technology supply chain and

developing an innovation ecosystem in the Union, including for critical

technologies;

(d) the share of the value of the activities that are proposed to be carried out in the

Union as a part of the R&D procurement contract;

(e) where applicable, the extent to which the tender proposes to integrate

technologies developed in the Union, including research and development

results stemming from publicly funded research and development programmes

in the internal market and makes use of tools, such as standards, specifications,

software or models or other technology developed in the Union.

5. Public buyers may apply other innovation-related award criteria in addition to those

laid down in the paragraph 4. The combined weight of all innovation-related award

criteria shall be at least 15% of the total weight of all award criteria, and the

combined weight of the innovation-related award criteria referred to in paragraph 1,

points (c), (d) and (e) shall not exceed 15% of the total weight of all award criteria.

EN 49 EN

The innovation-related award criteria are part of the quality award criteria referred to

in paragraph 2.

6. By way of derogation from paragraph 4 and 5, the obligation to apply innovation-

related award criteria pursuant to this Article shall not apply to R&D procurement

procedures which have as their only subject the procurement of research and

development consultancy services as covered by CPV codes 73200000-4, 73210000-

7 and 73220000-0.

Article 18

Formulating requirements for the characteristics of the procured R&D services

1. Public buyers shall formulate the requirements for the characteristics of the research

and development services to be procured and of their intended results in the

procurement documents in the following order of precedence:

(a) requirements mandated by law;

(b) functional requirements;

(c) performance requirements;

(d) design requirements;

Public buyers shall apply the order of preference set out in the first subparagraph to

each characteristic individually.

Unless otherwise provided in applicable Union or national law, public buyers shall

draft all requirements referred to in this paragraph in a manner that allows the

tenderer to prove compliance by means of any alternative equivalent evidence.

2. Public buyers shall only formulate a requirement as a performance requirement, or

design requirement, where it is impracticable to draft such requirement as a

functional requirement.

3. Where for a specific characteristic there is no requirement mandated by law and

where a specific characteristic cannot be sufficiently described through the

requirements in paragraph 1, the requirements for that characteristic may be

formulated in any of the following ways by reference, in order of precedence, to:

(a) harmonised standards , as well as standards and standardisation deliverables

the references of which have been published for the purpose of this paragraph

in the Official Journal of the European Union or by any other means as

provided in accordance with Union legislation and common specifications,

understood as a technical specification other than a standard and adopted by the

Commission, and the conformity with which provides for a presumption of

conformity with the requirements set out in the relevant Union legislation;

(b) European standards as defined in Article 2 of Regulation (EU) No 1025/2012,

including national standards transposing European standards;

(c) European Assessments Documents;

(d) international standards;

(e) other standardisation deliverables established by a European standardisation

organisation as defined in Regulation (EU) No 1025/2012;

EN 50 EN

(f) where any of the references listed in points (a) to (f) does not exist, national

standards, national technical approvals or national technical specifications.

Each reference shall be accompanied by the words ‘or equivalent’ unless the

reference is made to mandatory harmonised technical specifications.

4. Public buyers shall ensure that the procurement documents do not refer to a specific

make, brand name or source, or a particular process which characterises the products,

services or works provided by a specific economic operator, or to trademarks,

patents, types or a specific origin or production with the effect of favouring or

eliminating certain economic operators or products, services or works.

By way of derogation from the first subparagraph, such references shall only be

allowed where a sufficiently precise and intelligible description of the subject-matter

of the R&D procurement contract pursuant to paragraph 1, 2 and 3 is not possible.

Public buyers shall not derogate from this obligation unless justified by the subject

matter of the R&D procurement contract, and in that case, the reference shall be

accompanied by the words ‘or equivalent’.

Article 19

Risk benefit sharing under market conditions

1. Public buyers shall ensure that intellectual property rights to the results generated by

a contractor in the performance of an R&D procurement contract do not accrue

exclusively to the public buyer for its use in the conduct of its own affairs but that the

public buyer shares with the contractor under market conditions the risks and

benefits related to those intellectual property rights. To meet this requirement, public

buyers and contractors shall fulfil the obligations set out in paragraphs 2 to 9:

2. Contractors shall have the right to retain ownership of the intellectual property rights

to the results they generated in the performance of an R&D procurement contract.

The R&D procurement contract shall provide this right to contractors subject to an

obligation on contractors to protect their results, to use their best efforts to

commercialise their results and not to use the results contrary to the public interest.

3. Contractors shall notify public buyers as soon as possible of any results that can be

exploited within a maximum period from the generation of the results specified in the

R&D procurement contract. This notification shall include the contractor’s decision

to protect and commercialise these results. Where contractors decide not to protect or

commercialise results as defined in the R&D procurement contract the public buyer

shall, by way of derogation from paragraph 2 and without any prejudice to the moral

rights of authors, have the right:

(a) to grant, in agreement with the contractor, to the staff of the contractor the right

to protect those results and obtain ownership of the intellectual property rights

to those results; or

(b) to protect itself those results, obtain itself ownership of the intellectual property

rights to those results, and to transfer or license the results under fair and

reasonable conditions and in a non-discriminatory way.

4. Public buyers shall obtain at least free access to the results generated by the

contractors in the context of a R&D procurement contract for their own use and for

use by their current and future contractors in the performance of any contracts

awarded by those public buyers. Public buyers may also require that such free access

EN 51 EN

includes in addition to usage rights other access rights such as rights to modify and

maintain the results.

5. In emergency situations where contractors are unable to satisfy subsequent demand

for the results of the R&D procurement contract on the Union market, public buyers

shall have the right to grant licences or to require contractors to grant licences to

third parties to commercially use the results of the R&D procurement contract on a

non-exclusive basis, without any right to sublicense, and under fair and reasonable

conditions.

6. Where contractors fail to commercialise their results within a reasonable period as

provided for in the R&D procurement contract but provide legitimate reasons for that

failure, public buyers shall:

(a) verify with the contractors whether they are able and willing to commercialise

the results if given a reasonable amount of additional time;

(b) only in case it is verified that the contractors are unable or unwilling to

commercialise the results, or fail to commercialise the results within the

additional time referred to in point (a), have the right to:

(i) grant licences or to require contractors to grant licences to third parties,

under fair and reasonable conditions, to commercially use the results of

the R&D procurement contract on a non-exclusive basis, without any

right to sublicense; or

(ii) only in case that a licensing action as referred to in point (i) is not

sufficient to achieve the commercialisation required by the R&D

procurement contract, require the contractor to transfer ownership of

those results to the public buyers, under fair and reasonable conditions,

without any prejudice to the moral rights of authors.

7. Where contractors fail to commercialise their results within a reasonable period

provided for in the R&D procurement contract and fail to justify this with legitimate

reasons or where contractors use those results in a manner contrary to the public

interest, and where efforts undertaken by public buyers to obtain within a reasonable

amount of time authorisation from the contractors to license the results on fair and

reasonable conditions have failed, public buyers shall have the right to:

(a) grant licences or to require contractors to grant licences to third parties to

commercially use the results of the R&D procurement contract on a non-

exclusive basis, without any right to sublicense without providing financial

compensation to the contractors; or

(b) in case that the action in point (a) is not sufficient to prevent the use of the

results in a manner contrary to the public interest or achieve the

commercialisation required by the R&D procurement contract, require the

contractor to transfer ownership without of those results to the public buyers,

without providing financial compensation to the contractors, without any

prejudice to the moral rights of authors.

8. For the purpose of paragraphs 6 and 7, legitimate reasons include where the

contractor demonstrates that it used its best efforts to commercialise the results and

to avoid abuse of the results in a manner that is contrary to the public interest.

9. Contractors shall notify public buyers in advance of any intention to undertake

exclusive licensing or transfer of ownership of R&D procurement results. Public

EN 52 EN

buyers shall have the right to object to exclusive licensing or transfer of ownership of

R&D procurement results by contractors in any of the following cases:

(a) where such licensing or transfer would negatively impact the access of the

public buyer to the results or the commercial exploitation of the results;

(b) where such licensing or transfer would be contrary to the public interest in

sectors of vital importance to the socio-economic or technological development

of the Union or of the Member States of the public buyers;

(c) where those results would become subject to control or other restrictions by a

country other than those referred to in Article 11(1), in a way that would

negatively impact the access of the public buyer to or the commercialisation of

the results, as referred to in point (a) of this paragraph, or in a way that would

be contrary to the public interest, as referred to in point (b) of this paragraph.

10. For R&D procurements that are not pre-commercial procurements, by way of

derogation from paragraphs 1 to 9, where justified by any of the following overriding

reasons of public interest which shall be specified in the procurement documents,

public buyers may obtain the ownership of the intellectual property rights to the

results generated by contractors in the context of an R&D procurement contract:

(a) where necessary and justified for ensuring the protection of the security and

public safety interests of the Union or one or several of its Member State

within the meaning of Article 28(2);

(b) where necessary to prevent abuse of the results by contractors or other third

parties and there is no other effective way to prevent such abuse.

(c) where the public buyer intends to have exclusive rights to exploit the

intellectual property rights to the results generated by contractors;

Where public buyers obtain ownership of intellectual property rights in accordance

with the first subparagraph:

(a) if they fail to exploit intellectual property rights obtained under point (c) of

paragraph 10 within a period of four years from the date of obtaining the

ownership of the intellectual property rights, they shall offer to transfer the

ownership of those intellectual property rights or licence them under fair and

reasonable conditions and in a non-discriminatory manner;

(b) if they decide to transfer the ownership of these intellectual property rights or

licence them, they shall do so under fair and reasonable conditions and in a

non-discriminatory manner;

(c) they shall ensure that all results which do not give rise to intellectual property

rights may be widely disseminated, without prejudice to confidentiality and

data protection obligations a referred to in Article 26.

The Commission is empowered to adopt delegated acts in accordance with Article 39

to amend the list of cases set out in the first subparagraph of this paragraph, taking

into account the following criteria:

(a) the impact on increasing the commercialisation of R&D results;

(b) the impact on improving the access of innovative enterprises, including in

particular innovative startups and scaleups, and new entrants to the market;

(c) the impact on socio-economic or technological development in the Union;

EN 53 EN

(d) the impact on the Union’s strategic autonomy and economic security;

(e) the impact on protecting public interests;

11. Public buyers shall:

(a) require contractors to stipulate in subcontracting agreements, that

subcontractors are bound by the same intellectual property rights and

obligations as those applicable to contractors under the R&D procurement

contract, in particular that in any transfer or licensing agreement the

contractor’s obligations under the R&D procurement contract are passed on to

the new owner or licensee and that the new owner or licensee has the

obligation to pass them on in any subsequent transfer or licensing.

(b) when drawing up and implementing obligations affecting the protection of

intellectual property rights in the context of R&D procurement contracts,

comply with the applicable Union law on intellectual property, the TRIPS

Agreement43 and other international obligations of the Union or the Member

States concerned.

For the purposes of the first subparagraph, point (b), where participation in the

R&D procurement is not restricted to economic operators that have their origin

in Member States, public buyers shall treat economic operators having their

origin in other WTO Member countries no less favourable than economic

operators that have their origin in the public buyer’s own country with regard

to the protection of intellectual property, except where otherwise provided for

in the TRIPS Agreement.

Article 20

Contract modifications

1. Public buyers may modify awarded R&D procurement contracts during their term

without a new R&D procurement procedure where that possibility, irrespective of the

modifications’ monetary value, has been provided for in the initial procurement

documents in clear, precise and unequivocal review clauses, which may include price

revision clauses or options. Such clauses shall state the scope and nature of possible

modifications or options as well as the conditions under which they may be used.

Such clauses shall not provide for modifications or options that would alter the

overall nature of the R&D procurement contract.

2. Public buyers may also modify awarded R&D procurement contracts during their

term without a new R&D procurement procedure provided that both the following

conditions are fulfilled:

(a) the modification is not substantial within the meaning of paragraph 3 or where

the modification is substantial but falls within any of the cases listed in

paragraph 4;

(b) the modification responds to objective needs arising during the performance of

the R&D procurement contract, is limited to what is necessary and appropriate

43 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), set out in Annex 1C to

the Agreement establishing the World Trade Organization, OJ L 336, 23.12.1994, p. 214, ELI:

http://data.europa.eu/eli/agree_internation/1994/800(16)/oj.

EN 54 EN

for ensuring its performance and continuity and not alter the initial economic

balance of the contract in favour of the contractor in a manner which was not

provided for in the original contract.

3. A modification shall be considered substantial in one or more of the following cases:

(a) the modification introduces conditions which, had they been part of the initial

procurement procedure, would have allowed for the admission of other

candidates than those initially selected or for the acceptance of a tender other

than that originally accepted or would have attracted additional participants in

the procurement procedure;

(b) where it changes essential terms or conditions of the contract, such as

(c) a change in the economic balance of the R&D procurement contract in favour

of the contractor in a manner which was not provided for in the original

contract as a consequence of either;

(i) a considerable extension of the scope of the R&D procurement contract;

(ii) the identity of the contractor in other cases than those provided for under

paragraph 4, point (c).

4. Provided that they do not alter the initial economic balance of the R&D procurement

contract in favour of the contractor in a manner which was not provided for in the

initial R&D procurement contract, substantial modifications shall be permissible

within the meaning of paragraph 2 only in the following cases:

(a) where additional services, or supplies have become necessary during

performance of the R&D procurement contract, provided that a change of

contractor is not technically or economically feasible, including due to

interdependence with existing works or services or substantial increase of

costs;

(b) where the modification is necessary due to circumstances which could not

reasonably be anticipated by a diligent public buyer at the time of the launch of

the R&D procurement procedure, and which significantly affect the

performance or feasibility of the contract, including:

(i) substantial changes in the applicable regulatory or legal framework;

(ii) major technological developments;

(iii) severe disruptions, emergencies or crises with significant economic,

societal or operational impact;

(c) where the original contractor is replaced by another entity in one of the

following cases:

(i) following a merger, takeover, acquisition, insolvency or other corporate

restructuring, another economic operator succeeds, wholly or partly, to

the rights and obligations of the original contractor, provided that the

new entity fulfils the original qualitative selection criteria, that no other

substantial modifications are made to the R&D procurement contract and

that the replacement is intended to circumventing the application of this

Regulation; or

EN 55 EN

(ii) in the event that the public buyer itself assumes the main contractor’s

obligations towards its subcontractors where this possibility is provided

for under national law.

5. Modification, the value of which does not exceed 15 % of the value of the initial

R&D procurement contract shall be considered non-substantial and may be made

without a new procurement procedure, provided that the modification does not alter

the initial economic balance of the R&D procurement contract in favour of the

contractor in a manner which was not provided for in the initial R&D procurement

contract.

Where several successive modifications are made, the thresholds shall be assessed on

the basis of the net cumulative value of the successive modifications.

6. Before modifying the R&D procurement contract, the public buyer shall establish, on

the basis of objective and verifiable elements, that the conditions set out in paragraph

2 are satisfied. Public buyers shall maintain detailed written records of the essential

elements of the modification, including its justification, its necessity or

appropriateness, and its impact on the economic balance of the contract, in particular

on the allocation of risks and economic advantages, to justify decisions to modify the

R&D procurement contract and to enable verification of compliance with this Article

by competent supervisory, audit and review bodies.

7. Before any modification of a R&D procurement contract that exceeds 50 % of the

initial estimated value of the contract, the public buyers shall publish a contract

modification notice to that effect. Such notice shall contain the justification for the

modification without a new procurement procedure. Consecutive modifications shall

not be aimed at circumventing this Regulation.

8. Where public buyers substantially modify an R&D procurement contract in

accordance with paragraph 4, and the modification does not exceed 50 % of the

initial estimated value of the contract, they shall publish a contract modification

notice within 20 calendar days from the date on which the modification was made.

9. Modifications of an R&D procurement contract shall not be used to remedy

deficiencies of the contractor’s performance that are not justified by circumstances

beyond its control.

Article 21

Value engineering

1. Public buyers shall insert a value engineering clause in all R&D procurement

contracts subject to this Regulation with an estimated value net of VAT exceeding:

(a) EUR 10 million from… [OP please insert date 1 year from the date of entry

into force of this Regulation];

(b) EUR 9 million from… [OP please insert date 2 years from the date of entry

into force of this Regulation];

(c) EUR 8 million from… [OP please insert date 3 years from the date of entry

into force of this Regulation];

(d) EUR 7 million from… [OP please insert date 3 years from the date of entry

into force of this Regulation];

EN 56 EN

(e) EUR 6 million from… [OP please insert date 4 years from the date of entry

into force of this Regulation];

(f) EUR 5 million from… [OP please insert date 5 years from the date of entry

into force of this Regulation].

Public buyers may include a value engineering clause in R&D procurement contracts

with a lower estimated value.

2. Public buyers shall include in the R&D procurement contract:

(a) value engineering clauses that encourage contractors to submit value

engineering change proposals throughout the performance of the R&D

procurement contract (‘voluntary value engineering clauses’); or

(b) value engineering clauses that require contractors to submit to the public buyer

value engineering change proposals at regular intervals throughout the

performance of the R&D procurement contract (‘mandatory value engineering

clauses’).

Public buyers may use the mandatory value engineering referred to in the first

subparagraph, point (b), for the entire R&D procurement contract or only for parts of

the R&D procurement contract.

Where public buyers use mandatory value engineering for parts of the R&D

procurement contract, they shall formulate, in the procurement documents, the

requirements related to those parts as functional or performance requirements.

Contractors shall include corresponding mandatory or voluntary value engineering

clauses in any subcontracting agreement exceeding the values referred to in

paragraph 1 on the date of conclusion of the subcontracting agreement. They may

include corresponding mandatory or voluntary value engineering clauses in

subcontracting agreements below those values.

3. Where contractors submit value engineering change proposals as referred to in the

first subparagraph of paragraph 2, they shall include in those proposals:

(a) all the proposed changes to any of the research and development services

procured as a part of the R&D procurement

(b) a description of any impacts that the proposed changes referred to in point (a) of

this paragraph may have on the rights and obligations of the parties to the R&D

procurement contract, including on the price of different parts of the R&D

procurement contract as referred to in paragraph 2, second subparagraph, or on

the tasks of the contractor;

(c) an evidence-based analysis of the expected cost and benefit of the proposed

changes;

(d) in the case of subcontracting, any value engineering change proposals from their

subcontractors, which are necessary for implementing the contractor’s value

engineering change proposal

4. Public buyers shall not accept value engineering change proposals that:

(a) alter the subject matter of the R&D procurement contract;

(b) impair essential functions or characteristics of the R&D services procured or

their intended results as described in the functional or performance

requirements;

EN 57 EN

(c) involve a change in deliverable quantities of the procured R&D services and

their intended results only;

(d) involve a change in research and development end items or research and

development test quantities that result solely from previous testing under the

R&D procurement contract.

5. Public buyers shall specify in the procurement documents that they may approve

amendments that may decrease or increase the price of the R&D procurement

contract following a value engineering change proposal from the contractor. The

procurement documents shall specify the limits of allowed increases in the price of

the R&D procurement contract due to contract amendments applying a value

engineering change proposal. Any such contract amendments for value engineering

shall be carried out in accordance with Article 20.

6. Public buyers shall set out in the procurement documents incentive sharing rates that

share between public buyers and contractors any net cost savings realised for public

buyers from accepted value engineering change proposals on the ongoing R&D

procurement contract. Where a value engineering change proposal creates net cost

savings for public buyers on potential future R&D procurement contracts, the

procurement documents shall specify whether the public buyer will pay the

contractor’s share of contract savings as a single payment or as a series of payments

over time as future R&D procurement contracts are awarded. Public buyers shall

ensure that the contractor’s share of cost savings that it pays to the contractor as part

of the R&D procurement does not equal to or exceed the cost of research and

development services performed as part of the R&D procurement contract.

7. Public buyers may unilaterally accept or reject any value engineering change

proposal, in whole or in part. If the public buyer does not accept a value engineering

change proposal, the public buyer shall notify the contractor in writing, explaining

the reasons for the rejection. The contractor may withdraw any value engineering

change proposal, in whole or in part, at any time before it is accepted by the public

buyer. Until a contract amendment applies a value engineering change proposal to

the ongoing R&D procurement contract, the contractor shall continue performing in

accordance with the existing R&D procurement contract.

Article 22

Multiple sourcing

1. Public buyers shall apply multiple sourcing in R&D procurement procedures and

shall award multiple R&D procurement contracts to multiple contractors.

2. Public buyers shall indicate in the procurement documents the minimum number of

R&D procurement contracts that are expected to be awarded in accordance with

paragraph 1.

3. R&D procurement contracts under multiple sourcing shall be awarded and signed in

the order of the ranked list of tenders from the highest to the lowest score based on

their evaluation in accordance with Article 11 unless there are duly justified reasons

to proceed otherwise, in full compliance with the principles of equal treatment and

transparency. All R&D procurement contracts shall be awarded within the same

R&D procurement procedure.

EN 58 EN

4. To determine the number of R&D procurement contracts to be awarded in

accordance with paragraph 1, public buyers shall take into account the benefits that

multiple sourcing can generate to:

(a) avoid the over-reliance on a single or a limited number of contractors for

products, works or services that are essential to the public buyer’ internal or

external operations, or for products, works or services that are based on critical

technologies or critical raw materials;

(b) reduce technology or innovation risks including by stimulating the development,

testing or integration of alternative results from different contractors;

(c) tackle situations where there is not sufficient competition on the market or

prevent or reduce supplier lock-in by stimulating more competition on the

market;

(d) mitigate service disruptions and single point of failure by ensuring technical

redundancy in the public buyer’s infrastructure, network or service delivery

system;

(e) where necessary and justified for protection of the security and public safety

interests of the Union or one or several of its Member States within the meaning

of Article 28(2), reserve a minimum number of R&D procurement contracts for

economic operators originating in Member States in accordance with Article

11(6).

5. By way of derogation from paragraph 1, where justified by any of the following

reasons, which shall be specified in the procurement documents, public buyers may

award a single R&D procurement contract without applying multiple sourcing in

accordance with this Article:

(a) R&D procurement procedures which have as their only subject the

procurement of research and development consultancy services covered by

CPV codes 73200000-4, 73210000-7 and 73220000-0;

(b) in R&D procurements that are not pre-commercial procurements, where any of

the following conditions are fulfilled:

(i) the results of the outcomes of the market consultation referred to in

Article 9 and market research indicate that the market is too small for

multiple contractors to participate in the R&D procurement procedure;

(ii) the long-term benefits of multiple sourcing as listed in paragraph 4 of this

Article do not outweigh the extra costs for the public buyer applying

multiple sourcing;

(iii) the award of a single R&D procurement contract is necessary and

justified for ensuring the protection of the security and public safety

interests of the Union or one or several of its Member States within the

meaning of Article 28(2);

The Commission is empowered to adopt delegated acts in accordance with Article 39

to amend the list of cases set out in the first subparagraph of this paragraph taking

into account the following criteria:

(a) the impact on increasing the commercialisation of R&D results;

EN 59 EN

(b) the impact on improving the access of innovative enterprises, including in

particular innovative startups and scaleups, and new entrants to the market;

(c) the impact on socio-economic or technological development in the Union;

(d) the impact on the Union’s strategic autonomy and economic security;

(e) the impact on protecting public interests;

Article 23

R&D procurement call for tenders

1. Public buyers shall announce the launch of the call for tenders for the R&D

procurement by means of a contract notice. That notice shall:

(a) be published in the Official Journal of the European Union and, after that, be

published also on the national procurement portal of the Member State of the

public buyer;

(b) contain the following elements:

(i) references to the relevant CPV codes for research and development

services

(ii) an indication, where relevant, that the call for tenders relates to

innovation by marking the field ‘innovation’ in the contract notice and by

including, where applicable, the words ‘Pre-Commercial Procurement’ in

the field ‘title of the procurement’;

(iii) the estimated value of the R&D procurement calculated pursuant to the

methodology laid down in Article 10(5).

2. Public buyers shall widely promote the launch of the R&D procurement call for

tenders to the market. To this effect, after announcing the launch of the call for

tenders by means of a contract notice, public buyers may publish and promote the

launch of the call for tenders through any widely available media.

3. By way of derogation from paragraph 1 and 2 of this Article, where necessary and

justified for ensuring the protection of the security or public safety interests of the

Union or one or several of its Member States within the meaning of Article 28(2),

public buyers shall publish and promote the contract notice omitting all sensitive

information and requesting economic operators to express their interest to submit

tenders for the R&D procurement. Sensitive information shall be sent only to

economic operators who have expressed an interest, meet the selection criteria and

do not pose a security risk within the meaning of Article 28(4), point (d).

4. By way of derogation from paragraphs 1 and 2 of this Article, where the publication

of a contract notice referred to in paragraphs 1 and 2 of this Article and the

publication of other elements in the procurement documents referred to in Article 10

would be contrary to the security and public safety interests of the Union or one or

several of its Member States within the meaning of Article 28(2), public buyers shall

invite to tender and share the procurement documents only with potentially suitable

economic operators who have been identified during the market consultation

referred to in Article 9 and during market research, meet the qualification criteria and

do not pose a security risk within the meaning of Article 28(4), point (d).

EN 60 EN

5. The minimum time limit for receipt of tenders shall be one month from the date on

which the contract notice was sent for publication in the Official Journal of the

European Union. This minimum time limit can be shortened by the public buyer

where an emergency mode has been activated pursuant Regulation (EU)

2024/274744, the emergency framework has been activated pursuant Council

Regulation (EU) 2022/237245, serious cross-border threats to health pursuant to

Regulation (EU) 2022/237146 exist, or the Commission has declared a crisis or a state

of emergency. The maximum time limit for public buyers to complete the evaluation

of the tenders and notify tenderers of the award decision shall be 60 calendar days

from the deadline for the reception of the tenders.

6. Public buyers shall verify, based on the information in the tender, which tenderers

have access to the R&D procurement in accordance with the conditions laid down in

Article 11.

7. Without prejudice to Article 15(9), public buyers shall evaluate all tenders submitted

by tenderers that have access to the R&D procurement on the basis of objective and

non-discriminatory criteria by applying the applicable exclusion grounds and

selection criteria laid down in Articles 13, 14 and 15, the minimum requirements to

be met by all tenderers and the applicable award criteria referred to in Article 17,

including the innovation-related award criteria, and they shall draft a ranked list of

evaluated tenders.

8. After the submission of the initial tenders, public buyers may conduct interviews

with the economic operators and may conduct negotiations in one or several rounds.

Public shall ensure that in any given round of negotiations the number of solutions

discussed allows for genuine competition. After each round, and depending on the

outcome of the negotiations, the economic operators participating in the negotiations

shall be invited to submit a revised tender and public buyers may decide to reduce

the number of participants based on the award criteria set in accordance with Article

17. Public buyers shall inform economic operators when a new round of negotiations

will start and whether or not they will be invited. Public buyers shall inform all

tenderers, whose tenders have not been eliminated, of any changes to the

specifications or changes to other parts of the procurement detail as a result of the

negotiations. Public buyers shall provide sufficient time for tenderers to modify and

re-submit amended tenders, as appropriate. Economic operators may submit revised

tenders depending on the outcome of the negotiations. Where a public buyer has

decided to conclude the negotiations and proceed to the award of the R&D

procurement contract, it shall invite the remaining economic operators to submit a

final tender.

44 Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024

establishing a framework of measures related to an internal market emergency and to the resilience of

the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency

and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj). 45 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the

supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union

level (OJ L 314, 6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj). 46 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on

serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022,

p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).

EN 61 EN

9. Not later than 30 days after the conclusion of the R&D procurement contract, public

buyers shall publish a contract award notice in the Official Journal of the European

Union and, after that,alsoon their national procurement portal, except where the

publication would be contrary to the security or public safety interests of the Union

or one or several of its Member States within the meaning of Article 28(2).

The contract award notice shall indicate that the procedure concerns an R&D

procurement and relates to innovation. The public buyer shall include, where

applicable, the words ‘pre-commercial procurement’ in the field ‘title of the

procurement’ and shall mark the field ‘innovation’ in the contract award notice.

The contract award notice shall include information on the value of the awarded

contract or contracts and any awarded lots.

Article 24

Competitive development in phases and assessment of contract performance

1. Public buyers shall procure the R&D in multiple successive research and

development phases that may include any combination of fundamental research,

industrial research and experimental development activities.

2. Public buyers may organise fast-track R&D procurement that combine any of the

phases related to development and testing that are part of industrial research and

experimental development into a single phase.

3. Public buyers shall organise the R&D phases in a way to ensure that the minimum

number of contracts planned for each phase of the R&D procurement allows for

genuine competition in R&D (‘Competitive Development’) between economic

operators.

4. During each R&D phase, public buyers shall assess any value engineering change

proposals and, where needed, amend ongoing R&D procurement contracts

accordingly in accordance with the provisions on value engineering laid down in

Article 21.

5. At the end of each R&D phase of the R&D procurement, public buyers shall assess

the performance of contractors on the basis of the innovation-related key

performance indicators referred to in Article 24(13) .

6. The assessment shall determine whether the contractor has successfully completed

the specific research and development phase based on whether the results of that

specific phase are innovative, capable of meeting the requirements and commercially

viable.

7. Where the assessment determines that the contractor has not successfully completed

a specific phase, the public buyer may terminate the R&D procurement contract with

that contractor. However, where such contractor has satisfactorily performed all the

requested tasks and submitted all the requested deliverables, that contractor shall be

eligible for the payment applicable for the specific phase as agreed in the R&D

procurement contract.

8. Where under an R&D procurement contract, contractors have implemented value

engineering change proposals that have resulted in net cost savings for the public

buyer, the public buyer shall pay the contractor its share of those savings in

accordance with the agreed value engineering payment method.

EN 62 EN

9. By terminating R&D procurement contracts at the end of a phase as referred to in

paragraph 7 and by selecting the best offers for the next phase, the public buyer may

reduce the number of contractors after the completion of each phase.

10. Where despite best efforts of the public buyer to ensure competitive development

across all phases referred to in paragraph 3, the public buyer terminated an R&D

procurement contract at the end of a phase as referred to in paragraph 7 or receives

insufficient good quality offers to allow for the selection of more than one contractor

for the next phase, the public buyer may allow economic operators who have not

participated in previous phases and who have not participated in the initial R&D

procurement procedure to submit tenders only for the remaining phase or phases with

a view to concluding specific contracts. Where the public buyer wants to make use of

this option, the public buyer shall keep the possibility for economic operators that

have not participated in previous phases to express their interest to participate in later

phases of the R&D procurement, up to the moment of selection of contractors for the

last R&D phase. Any such economic operators shall be selected based on the same

exclusion grounds, selection criteria, minimum requirements and award criteria as

other contractors that participated in previous phases.

11. Where despite best efforts of the public buyer to ensure competitive development

across all phases referred to in paragraphs 3 and 10, the public buyer terminated an

R&D procurement contract at the end of a phase as referred to in paragraph 7 or

receives insufficient good quality offers to allow for the selection of multiple

contractors for the next phase, the public buyer may proceed to the next phase with

only one contractor.

12. By way of derogation from paragraph 1 to 11, where justified by any of the

following reasons which shall be specified in the procurement documents, public

buyers may decide not to organise the R&D procurement procedure in multiple

successive research and development phases in the following cases:

(a) for R&D procurement procedures which have as their only subject the

procurement of research and development consultancy services covered by

CPV codes 73200000-4, 73210000-7 and 73220000-0;

(b) for R&D procurements that are not pre-commercial procurements, whose

subject matter concerns R&D services that are limited to one technology

readiness level and those R&D services are too narrow in scope to split the

R&D over multiple phases.

The Commission is empowered to adopt delegated acts in accordance with Article 39

to amend the list of cases set out in the first subparagraph of this paragraph taking

into account the following criteria:

(a) the impact on increasing the commercialisation of R&D results;

(b) the impact on improving the access of innovative enterprises, including in

particular innovative startups and scaleups, and new entrants to the market;

(c) the impact on socio-economic or technological development in the Union;

(d) the impact on the Union’s strategic autonomy and economic security;

(e) the impact on protecting public interests;

13. Public buyers shall:

EN 63 EN

(a) regularly assess the performance of contractors on the basis of innovation-

related key performance indicators that include keeping to the time schedule,

keeping the costs under control and delivering the expected quality in terms of

achievement of the minimum requirements referred to in Article 10(1), point

(f), the functional requirements or performance requirements referred to in

Article 18, and the award criteria, including the innovation-related award

criteria, referred to in Article 17;

(b) where, following the assessment referred to in point (a), it concludes that

contract performance does not comply with the innovation-related key

performance indicators, request the contractors to take corrective action to

reach the contract performance agreed in the R&D procurement contract;

where a contractor does not take the necessary corrective actions, public buyers

may terminate the R&D procurement contract with that contractor;

(c) where value engineering is used to improve contract performance throughout

the R&D procurement pursuant to Article 21, take accepted value engineering

proposals into account when assessing contract performance and when paying

the contractor its share of cost savings that result from accepted value

engineering proposals.

Article 25

Payments

1. Without prejudice to their obligations under Directive 2011/7/EU47 of the European

Parliament and of the Council, public buyers shall ensure the timely payment of

contractors and, where applicable, subcontractors.

2. As part of the conditions for the performance of the R&D procurement contract,

public buyers may provide that the contractors pass through the supply chain

equivalent payment terms. as laid down in the relevant provisions of Directive

2011/7/EU of the European Parliament and of the Council.

3. Unless justified by an overriding interest of the public buyer, the public buyer shall

provide for an appropriate advance payment to the contractor.

4. At the request of a subcontractor and where the nature of the R&D procurement

contract so allows, the public buyer shall transfer due payments directly to the

subcontractor for R&D services, supplies or works provided to the main contractor.

Such measures may include appropriate mechanisms permitting the main contractor

to object to undue payments. The arrangements concerning that mode of payment

shall be set out in the procurement documents.

Article 26

Confidentiality and data protection

1. Without prejudice to the applicable Union and national law, public buyers shall not

disclose without prior written agreement information provided to them by economic

operators in market consultations, by tenderers during or after the call for tenders, by

47 Directive 2011/7/EU of the European Parliament and of the Council of 16 February 2011 on combating

late payment in commercial transactions (recast) (OJ L 48, 23.2.2011, p. 1, ELI:

http://data.europa.eu/eli/dir/2011/7/oj).

EN 64 EN

contractors during contract performance or by former contractors after the end of the

R&D procurement, which such economic operators have designated as confidential,

including technical or trade secrets and the confidential aspects of tenders. Tenderers,

contractors or former contactors shall also not disclose without prior written

agreement information provided to them by public buyers, which public buyers have

designated as confidential. The prior written agreement shall not take the form of a

general waiver but shall be given with reference to the intended communication of

the specific confidential information.

2. Public buyers shall ensure compliance with the personal data protection rules laid

down in Regulation (EU) 2016/679 and Directive 2002/58/EC, and in applicable

national law in all exchanges and publication of information during the market

consultation, call for tenders, contract performance and after completion of the R&D

procurement.

3. Public buyers shall specify in the procurement documents referred to in Article 10

any requirements on the localisation of and access to the personal data processed by

the contractor. Such requirements may include that:

(a) the personal data shall only be processed within the territory of those countries

referred to in Article 11(1) and shall not be removed from not that territory;

(b) the data shall only be held in data centres located with the territory of those

countries referred to in Article 11(1);

(c) no access shall be given to such data outside of the countries referred to in

Article 11(1);

(d) the contractor may not change the location of data processing without the prior

written authorisation of the public buyer;

(e) any transfer of personal data under the R&D procurement contract to third

countries or international organisations shall comply fully with the requirements

laid down in Regulation (EU) 2016/679.

Article 27

Termination of R&D procurement contracts

Without prejudice to any other grounds for termination provided for in this Act or under

applicable national law, public buyers shall terminate the R&D procurement contract where:

(a) the economic operator becomes subject of a final conviction for one of the

mandatory exclusion grounds referred to in Article 13, except where the public buyer

establishes that such termination is not warranted for reasons of overriding public

interest and the final judgment does not preclude this;

(b) the R&D procurement contract or its modification should not have been awarded to

the contractor in view of a serious infringement of the obligations under the Treaties

and this Regulation that has been declared by the Court of Justice of the European

Union in a procedure pursuant to Article 258 of the Treaty.

EN 65 EN

SECTION 2

SECURITY

Article 28

Security considerations in R&D procurement

1. Public buyers shall take appropriate measures, in addition to measures required or

imposed by virtue of other Union legislation, where relevant, at any stage of the

R&D procurement procedure, from planning and market consultation to contract

award and contract performance, to ensure the protection of the security and public

safety interests of the Union or one or more Member States for any R&D

procurement procedure identified as presenting or including a risk for security or

public safety. This Chapter is without prejudice to other requirements under relevant

Union legislation.

2. Security and public safety interests of the Union or a Member State relevant for a

given R&D procurement contract may include, but are not limited to, the following:

(a) protection of critical infrastructure, strategic dual-use infrastructure, identified

by Member States in accordance with [Article 33 of the Military Mobility

Regulation], especially for those located on a military mobility corridor,

essential services, critical supply chains, critical technologies, resilience

against physical, cyber, or hybrid threats, and prevention across and protection

against risks of any disruption including due to harmful strategic dependencies

on third-country suppliers;

(b) prevention of espionage, sabotage or technology leakage;

(c) crisis preparedness, including business continuity and contingency planning for

disruptions in case of natural disasters or geopolitical instability, pandemics or

cyberattacks;

(d) the prevention of other harmful interference, including third-country and third-

country State-controlled influence;

(e) the cybersecurity of systems, networks, and data processed;

(f) the protection of classified information, sensitive data, research, or intellectual

property from unauthorised access or transfer;

(g) ensuring public health, including crisis-prepared and self-sufficient health

services; or

(h) protection of the environment and resilience to climate-related disruptions.

3. Risks for security and public safety in a R&D procurement contract may arise in

particular from:

(a) the subject matter of the R&D procurement contract, including:

(i) sensitivity of the assets involved or to be developed in its

implementation;

(ii) access to and handling sensitive data;

(iii) critical dependency or risk of critical dependency on a limited number of

third-country suppliers, goods, services or technologies;

EN 66 EN

(iv) risks associated with access to critical infrastructure, strategic dual-use

infrastructure identified by Member States in accordance with [Article 33

of the Military Mobility Regulation], research facilities, IT systems, or

critical materials;

(v) dual-use nature of the results of research and development services

procured;

(vi) the nature of the public interests attached to it and the potential

consequences of a malfunction or malperformance, such as harm to

public safety, national security, economic stability, health security or

fundamental rights.

(b) the characteristics of economic operators, including:

(i) ownership, control, or financing structure bearing risks of undue

interference or influence over the economic operator;

(ii) security track record, including past breaches, non-compliance with

security standards, or exclusion from other procurement procedures on

security grounds;

(iii) capacity to meet applicable security clearance, personnel vetting, or

information security requirements;

(iv) exposure to third-country legislation that may compel disclosure of

sensitive information or interference with contract performance.

4. Public buyers shall, to the extent possible specify in the procurement documents in a

clear and sufficiently detailed manner appropriate measures that are proportionate to

the risks referred to in paragraph 3 and non-discriminatory. Such measures may be

implemented, in particular through:

(a) specifications and market consultation documents, including mandatory

security standards, certifications, personnel vetting or security clearance

obligations, or risk management and assurance requirements;

(b) award criteria, such as evaluating bidders’ security management systems,

security compliance standards, incident response capabilities, supply chain

security;

(c) conditions for the performance of contracts, including clauses enabling security

oversight of suppliers through audits, inspections, or documentation reviews

and implementation of corrective measures in the case of breaches, as well as

provisions on subcontracting, ownership change notification, and the protection

of classified or sensitive information;

(d) selection criteria, where justified, such as possessing security clearances or

otherwise requiring tenderers to establish that they do not present risks for

security or public safety pursuant to paragraph 3, point (b) of this Article. This

shall be without prejudice to Article 14.

(e) invite to submit a tender only those economic operators who meet specific

objective and non-discriminatory security-related requirements, provided that

the public buyer has indicated its intention to do so, and the security-related

requirements it intends to apply, in the contract notice for the R&D

procurement in question.

EN 67 EN

Public buyers may also indicate in the procurement documents which security

measures they intend to implement where risks for security or public safety arise

during the R&D procurement procedure.

5. Public buyers shall at any time during an R&D procurement procedure exclude an

economic operator from participation in a R&D procurement procedure where the

operator has been identified as a high-risk supplier pursuant to Regulation (EU)

XXXX/XXX [Cyber Security Act 2] in relation to the provision of ICT components

or components that include ICT components to be used in key ICT assets.

6. Where there is evidence that disparities in measures affect the functioning of the

internal market, the Commission is empowered to adopt delegated acts in accordance

with Article 39 in order to supplement this Regulation by establishing mandatory

technical specifications, selection criteria, award criteria or contract performance

clauses, for specific categories of R&D procurement services or their intended results

where such elements address an identified specific security and public safety interest

of the Union.

Article 29

Security measures during contract implementation

1. Without prejudice to contract law of the Member States, the public buyer may

terminate a R&D procurement contract in whole or in part where it determines that

the contractor has failed to comply with measures or obligations aiming at preventing

or mitigating risks for security and public safety, or a risk to security or public safety

has materialised or is likely to materialise. Under the same conditions, they may

exclude certain economic operators during contract implementation.

2. Termination and exclusion pursuant to this Article shall be proportionate in relation

to the risk for security or public safety. Before terminating a R&D procurement

contract or excluding an economic operator, the public buyer shall conduct a written

assessment. The public buyer shall take into account in particular:

(a) the severity of the risk for security or public safety;

(b) the impact of termination or exclusion on the delivery of public services;

(c) alternative mitigation measures such as contract amendments or enhanced

monitoring.

3. Unless justified by the severity of the risks involved, the imminence of the threat or

where notification may aggravate the risk, the public buyer shall notify the contractor

in writing of its intent to terminate or exclude, specifying:

(a) the grounds for termination or exclusion;

(b) the facts and evidence supporting the decision, with the exception of classified

information;

(c) the proposed date of termination or exclusion.

4. The contractor shall have an appropriate time, determined by the public buyer, which

shall not be shorter than at least 10 calendar days, to submit observations on the

grounds for termination and propose remedial actions. The public buyer may shorten

the deadline in case of emergency.

EN 68 EN

5. The contractor shall cooperate with the public buyer to secure or transfer data,

documents, or assets related to the R&D procurement contract and ensure continuity

of critical services until the termination or exclusion takes effect.

Article 30

Cybersecurity

1. For all products with digital elements used and developed as part of the research and

development services procured that fall within the scope of Regulation (EU)

2024/2847 of the European Parliament and of the Council48, public buyers shall

ensure compliance with the essential cybersecurity requirements set out in Annex I to

that Regulation, including the manufacturers’ ability to handle vulnerabilities

effectively are taken into consideration in the R&D procurement process.

2. This Regulation shall not prevent public buyers from subjecting products with digital

elements referred to in paragraph 1 to additional cybersecurity requirements for the

R&D procurement or use of those products for specific purposes, including where

those products developed, obtained or used for national security or defence purposes,

provided that such requirements are consistent with Member States’ obligations laid

down in Union law and that they are necessary and proportionate for the achievement

of those purposes.

3. Without prejudice to paragraph 1, and without prejudice to Directive (EU)

2022/2555 of the European Parliament and of the Council49 where applicable, public

buyers may specify in the procurement documents requirements relating to

cybersecurity for the research and development services procured and their intended

results. To that end, they may include specifications, selection criteria, exclusion

criteria, award criteria or conditions for the performance of contracts. Such

requirements shall be linked to the subject-matter of the R&D procurement contract

and comply with the principles of transparency, non-discrimination and

proportionality.

4. Public buyers shall at any time during an R&D procurement procedure exclude an

economic operator from participation in an R&D procurement procedure where the

operator has been identified as a high-risk supplier in relation to the provision of ICT

components or components that include ICT components to be used in key ICT

assets.

48 Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on

horizontal cybersecurity requirements for products with digital elements and amending Regulations

(EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L,

2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj). 49 Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on

measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No

910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive)

(OJ L 333, 27.12.2022, p. 80, ELI: http://data.europa.eu/eli/dir/2022/2555/oj).

EN 69 EN

SECTION 3

JOINT PROCUREMENT OF RESEARCH AND DEVELOPMENT SERVICES

Article 31

Common rules on joint R&D procurement

1. Public buyers carrying out joint R&D procurement shall comply with the rules laid

down in this Regulation.

2. Public buyers may organise joint R&D procurement with two or more public buyers

from one or more Member States. Public buyers. Where two or more public buyers

from one or more Member States wish to conduct a joint R&D procurement, they

shall conclude a joint procurement agreement establishing a buyers’ group and

appointing the lead buyer. That agreement shall specify at least the following:

(a) the financial commitments provided by each public buyer in the buyers’ group

for the joint R&D procurement;

(b) the division of roles and responsibilities between the lead buyer and the public

buyers that are members of the buyers’ group regarding the R&D procurement

procedure, contract performance and post-contract interactions with former

contractors as referred to in Chapter 2, Section 1 and 2;

(c) the applicable Union or national law related to dispute resolution, related to

any procedures or approvals needed for testing prototypes or first products,

services or works developed during the R&D procurement and any other

aspects of the conduct of the joint R&D procurement that are not governed by

this Regulation;

(d) the mechanism for the allocation and exploitation of the results of the joint

R&D procurement.

In addition to the elements listed in Article 10, the procurement documents for joint

R&D procurement shall include the information referred to in the first subparagraph,

points (b), (c) and (d), of this paragraph.

3. The members of the buyers’ group shall jointly provide the financial commitments

for the R&D procurement and jointly conduct the market consultation, draft

procurement documents for their common R&D procurement need, and carry out the

evaluation of tenders.

4. The lead buyer shall launch the joint R&D procurement procedure and award the

R&D procurement contracts in the name and on behalf of all public buyers that are

members of the buyers’ group. Public buyers that conduct joint R&D procurement

may do so in any of the official languages of the Union and they may allow tenderers

to submit tenders in any of those official languages.

5. Public buyers may organise joint R&D procurement through central purchasing

bodies of one or more Member States.

6. For the purpose of this Regulation, central purchasing bodies shall be any public

buyer that carries out the following R&D procurement related activities:

(a) acting as a wholesaler by buying and re-selling R&D services procured on the

market or results of those R&D services;

EN 70 EN

(b) acting as an intermediary, by publishing notices and awarding R&D

procurement contracts for public buyers;

Central purchasing bodies may also, in addition to the activities set out above, carry

out or take part in joint R&D procurement activities or provide ancillary R&D

related procurement support services to public buyers, including infrastructure,

advice or technical assistance, including the preparation and management of R&D

procurement procedures on behalf and for the account of the public buyer concerned.

Public buyers shall indicate in the notices referred to in Article 4(5) when they are

acting as a central purchasing body.

Any public buyer may procure R&D services and obtain their intended results from

or through any central purchasing body established in the Union offering centralised

purchasing activities. A public buyer shall be deemed to fulfil its obligations

pursuant to this Regulation when it procures research and development services from

or through a central purchasing body which for that R&D procurement was obliged

to and has applied this Regulation. Central purchasing bodies that are not themselves

a public buyer shall conduct R&D procurement procedures in accordance with this

Regulation.

7. Union institutions, bodies or agencies may carry out R&D procurement, including

pre-commercial procurement, for themselves, jointly with or on behalf of other

Union entities and jointly with or on behalf of public buyers in Member States

according to the rules set out in Regulation (EU, Euratom) 2024/2509 of the

European Parliament and of the Council.

Chapter 3

COMMERCIALISATION OF RESEARCH AND INNOVATION

RESULTS

Article 32

Union Competence Centre for intellectual property-backed finance and

commercialisation of intellectual property assets

1. The European Union Intellectual Property Office (‘the Office’) shall establish a

Competence Centre to support and promote intellectual property-backed finance and

commercialisation of intellectual property, including intellectual property resulting

from research and innovation and regulatory exclusivities for pharmaceuticals (‘the

Competence Centre’)

2. The Competence Centre shall support the following entities through its tasks:

(a) researchers established in a Member State;

(b) innovative enterprises established in a Member State, including innovative

startups, innovative scaleups and spin-offs, whose innovative and competitive

performance is driven by the ownership or use and commercialisation of

intellectual property rights;

(c) other public and private entities established in a Member State that have an

interest in the commercialisation of intellectual property assets;

EN 71 EN

(d) entities whose function is to support any of the entities referred to in points (a),

(b) and (c).

3. To improve access to finance for the entities referred to in paragraph 2, the Office

through the Competence Centre shall:

(a) by… [OP please insert date 4 years from the date of entry into force of this

Regulation], develop a voluntary Union framework for the valuation and

disclosure of intellectual property assets based on all types of intellectual

property rights and regulatory exclusivities for pharmaceuticals and designed

to facilitate its use across different sectors and its uptake by financial

stakeholders, where possible making use of the European Business Wallets,

established in accordance with [Regulation XXX of the European Parliament

and of the Council on the establishment of European Business Wallets], or

alternative electronic means that that are interoperable with the European

Business Wallets, including by:

(i) setting up and maintaining digital processes and services related to the

disclosure, screening and valuation of intellectual property assets;

(ii) identifying and compiling best practices to support the development of

the voluntary valuation framework;

(iii) establishing, as an integral part of the framework, a voluntary disclosure

arrangements enabling undertakings to present information on their

intellectual property assets in a comparable and structured manner for

financing purposes.

(b) by… [OP please insert date 4 years from the date of entry into force of this

Regulation], establish and maintain, in close cooperation with the Commission,

a Union-wide digital match-making platform, where possible making use of the

European Business Wallets or alternative electronic means that that are

interoperable with the European Business Wallets, to facilitate, on a voluntary

basis, the licensing and transfer of intellectual property rights protected in the

Union.

(c) facilitate the development of a secondary market to support the disposal of

intellectual property assets held by the entities referred to in paragraph 2;

(d) support the relevant public and private financial stakeholders, including Union

institutions, bodies, offices and agencies, as well as financial institutions and

commercial banks, in defining and implementing new public and private

financial instruments backed by intellectual property, including the provision

of sound evidence on market needs, the analysis of data stemming from the

implementation of such financial instruments and the provision of IP-related

technical advisory services;

(e) establish and implement skill development programmes across the innovation

ecosystem in relation to intellectual property-backed finance and

commercialisation of intellectual property assets;

(f) raise awareness about intellectual property rights as a driver for the Union’s

innovation, growth and competitiveness and about intellectual property-backed

finance;

(g) support the progressive development of an evidence database on intellectual

property-backed financing, including by collecting on a voluntary basis and

EN 72 EN

analysing anonymised or other non-personal data from intellectual property-

backed financing transactions and, where appropriate, by establishing

mechanisms to facilitate the availability and use of such data, including, where

possible, through the use of European Business Wallets or alternative

electronic means that that are interoperable with the European Business

Wallets;

(h) provide support to the persons and entities referred to in paragraph 2 in the

valorisation and commercialisation of intellectual property resulting from

publicly funded research and innovation, including through awareness raising

and capacity building in management of intellectual property, providing

assistance in defining intellectual property management and commercialisation

strategies;

(i) coordinate a Union-level helpdesk offering information and support services

related to intellectual property-backed financing to entities listed in paragraph

2.

The Commission shall, by means of implementing acts, lay down the technical

specifications necessary for the uniform implementation of the voluntary Union

framework referred to in the first subparagraph, point (a), of this paragraph,

including the specifications concerning the content, comparability and

interoperability of disclosures. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 38(2). The Office

shall, in accordance with the technical specifications laid down pursuant to the

second subparagraph, develop, maintain and, where necessary, update the templates

and related operational tools for the implementation of the voluntary Union

framework

The Commission shall, by means of implementing acts, lay down common technical

standards, interoperability requirements and operational specifications for the digital

match-making platform referred to in the first subparagraph, point (b), of this Article.

Those implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 38(2).

4. Subject to the availability of an accumulated budgetary surplus and of the approval

of the Office’s Budget Committee, the Office may conclude contribution agreements

with the Commission for the implementation of clearly defined Union activities

falling within the scope of the tasks entrusted to the Office under this Regulation and

relating to intellectual property-backed finance and the commercialisation of

intellectual property assets. Such contribution agreements shall specify the respective

responsibilities and financial contributions of the parties, the activities and

deliverables to be financed, the eligible costs, implementation arrangements,

reporting obligations, internal control measures, audit rights and the treatment of any

unused amounts.

5. Regulation (EU) 2017/1001 shall apply to the fulfilment of the tasks entrusted to the

Office under this Article. The Competence Centre shall form part of the Office and

shall not have separate legal personality, financial autonomy or decision-making

powers. All activities carried out through the Competence Centre shall remain

subject to the governance, programming, budgetary, accounting, internal control and

reporting framework applicable to the Office.

EN 73 EN

6. The set-up costs of the Competence Centre and the running costs arising from the

tasks entrusted to the Office by this Regulation shall be covered by its operational

budget. The set-up costs may include, at least, the costs related to the development of

the IT support systems and the setting up of the corresponding administrative

infrastructure, as well as the time-limited preparation or setting up of new initiatives.

The Office’s Budget Committee may authorise the use of the accumulated budgetary

surplus of the Office for necessary, clearly defined, non-recurrent and time-limited

set-up costs.

7. The Executive Director of the Office may introduce charges for specific services

referred to in this Article provided to the entities referred to in paragraph 2 of this

Article in accordance with Article 178 of Regulation (EU) 2017/1001. Such charges

shall be transparent, non-discriminatory and limited to the cost of the specific

service.

Access to the voluntary valuation framework developed in accordance with

paragraph 3, first subparagraph, point (a), access to the digital match-making

platform developed in accordance with paragraph 3, first subparagraph, point (b),

support services referred to in paragraph 3, first subparagraph, point (d) provided to

public stakeholders, including the Union institutions, bodies, offices and agencies,

and access to the Union-level helpdesk referred to in paragraph 3, first subparagraph,

point (i) shall not be subject to fees or charges.

Article 33

Data collection

1. With a view to supporting the fulfilment of the tasks entrusted to the Office under

Article 32, and in particular those relating to the development of an evidence base,

the analysis of data and the support to improved access to finance for the entities

referred to in Article 32(2), the Office shall collect and analyse anonymised or other

non-personal data, provided on a voluntary basis, relating to transactions in which

intellectual property rights are used as collateral for credit or insurance purposes or

as in-kind contribution in equity investment scenarios, without prejudice to

applicable rules on classified information.

2. When collecting and analysing data in accordance with this Article, the Office shall,

in accordance with Union law, cooperate with Union institutions, bodies and

agencies, the competent public authorities of the Member States, national and

regional intellectual property offices, and relevant public and private stakeholders in

the fields of finance and insurance, with a view to facilitating the availability,

comparability and reuse of existing data, as well as to exploring, on the basis of

existing data sources and practices, possible approaches for improving transparency

and interoperability across the Union.

3. The data collected and analysed by the Office in accordance with this Article may

include, where available and appropriate, information originating from intellectual

property registers, business registers, registers of pledges or other rights in rem over

intellectual property and similar sources, as well as other relevant information made

available by public authorities or private sector actors, including information on how

intellectual property used as collateral for credit or insurance purposes or as in-kind

contribution in equity investment scenarios has been evaluated, on the size and

characteristics of the corresponding transaction, on the type of intellectual property

EN 74 EN

right concerned, and on relevant indicators such as equity valuation, collateralisation,

or loan-to-value ratios.

4. The Office shall, in cooperation with the stakeholders concerned, promote the

development of common standards and practices relating to data quality, formats and

access conditions, including differentiated and proportionate access modalities, and

shall provide guidance and support measures aimed at enabling innovative

enterprises, innovative startups, innovative scaleups and SMEs to benefit from the

improved evidence base and analytical outputs.

5. Where justified by experience gained through the activities referred to in this Article,

the Office may consider, in cooperation with the stakeholders concerned, the

development of digital tools or structured data systems to further support the

fulfilment of the tasks of the Competence Centre set out in Article 32, including by

investigating the feasibility of a Union-wide register of pledges over intellectual

property assets.

6. The Office shall put in place guidance and support measures to ensure that

innovative enterprises, innovative startups, innovative scaleups and SMEs can

effectively benefit from the data collected in accordance with this Article.

Article 34

Intellectual property valuators

1. The persons and entities referred to in Article 32(2) and relevant public and private

entities in the fields of finance and insurance may request an assessment of the value

of the intellectual property rights under the voluntary Union framework in

accordance with Article 32(3), first subparagraph, point (a). Such assessment may be

carried out by an intellectual property valuator certified in accordance with Article

35.

2. Where the assessment is commissioned in connection with a financing transaction,

the information necessary for the assessment shall be provided in accordance with

the arrangements agreed between the parties concerned and subject to applicable

rules on confidentiality and the protection of trade secrets.

3. When carrying out an assessment, the intellectual property valuator shall act

independently and shall avoid any conflict of interest with the persons or entities

concerned by the assessment.

4. The fees and other costs relating to an assessment shall be borne by the person or

entity commissioning the assessment, unless otherwise agreed between the parties.

They shall be transparent, reasonable and proportionate to the nature, scope and

complexity of the assessment.

Article 35

Certification of intellectual property valuators

1. The Office shall establish and administer a Union certification scheme for

intellectual property valuators. The certification shall attest that a valuator has

acquired the knowledge and professional competence necessary to carry out

EN 75 EN

valuations under the voluntary Union framework referred to in Article 32(3), first

subparagraph, point (a).

2. Certification under this Article shall be voluntary and shall attest competence in

applying the Union valuation framework. It shall not constitute a professional licence

or confer a right to exercise a regulated profession, nor shall it be a prerequisite for

carrying out intellectual property valuations under Union or national law. It shall be

without prejudice to national rules governing regulated professions, professional

qualifications and the provision of valuation services.

3. Certification by the Office shall not make the Office responsible for individual

valuations carried out by a certified valuer and shall not confer binding or

presumptive legal effect on such valuations.

4. To be eligible for certification, the prospective valuator shall:

(a) possess an appropriate educational or professional background and relevant

professional experience, and technical competence in the valuation of

intellectual property assets;

(b) successfully complete specialised training on the application of the voluntary

Union framework referred to in Article 32(3), first subparagraph, point (a), and

an assessment demonstrating sufficient knowledge and practical ability to

apply that framework;

(c) demonstrate objectivity, integrity and adherence to appropriate professional

standards or codes of conduct.

The training and assessment referred to in the first subparagraph, points (b) and (c)

shall be organised by the Office. The Office may develop and provide such training

and assessment in cooperation with national intellectual property offices and relevant

European or international professional organisations and valuation bodies.

5. The Commission shall, by means of implementing acts, lay down the following

detailed conditions for the implementation of the certification scheme established by

this Article:

(a) the minimum educational or professional background and professional

experience required for admission to the certification scheme and the evidence

to be submitted for that purpose;

(b) the minimum content, learning outcomes and practical components of the

specialised training referred to in paragraph 4, first subparagraph point (b),

including any requirements concerning attendance;

(c) the form, content, assessment methodology and minimum pass requirements

for the assessment referred to in paragraph 4, first subparagraph, point (c);

(d) the application procedure, including the documents and evidence to be

submitted and the arrangements for verifying compliance with the conditions

laid down in paragraph 4;

(e) the period of validity of the certification and the conditions and procedure for

its renewal, including requirements relating to continuing professional

development;

EN 76 EN

(f) the grounds and procedure for suspension and withdrawal of certification,

including appropriate procedural safeguards and the right of the person

concerned to be heard;

(g) the conditions governing the use, presentation and communication of the Union

certification and certified status, including rules intended to prevent any

misleading representation as to the scope or legal effects of the certification;

and

(h) the information concerning certified valuators to be included in the database

referred to in paragraph 7 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 38(2).

6. The Office, through the Competence Centre, shall grant, renew, suspend or withdraw

certification in accordance with this Article.

7. The Office, through the Competence Centre, shall establish and maintain a publicly

accessible Union database of intellectual property valuators certified in accordance

with this Article.

8. The Executive Director may introduce charges for the certification, assessment and

renewal services provided under this Article in accordance with Article 178 of

Regulation (EU) 2017/1001. Such charges shall be transparent, non-discriminatory

and shall not exceed the cost of the specific services concerned

Article 36

Programming and reporting

1. The Office shall reflect the activities necessary for the performance of the tasks

entrusted to the Office in accordance with this Regulation in a separate section of the

multiannual strategic programme and the annual work programme of the Office

referred to in Article 153(1), points (a) and (b), of Regulation (EU) 2017/1001.

2. The separate section referred to in paragraph 1 of this Article shall set out the

objectives, activities, expected results, performance indicators and estimated human

and financial resources relating to those tasks, taking into account the relevant Union

policies and priorities. The preparation, adoption, implementation and amendment of

the multiannual strategic programme and the annual work programme shall be

governed by Regulation (EU) 2017/1001.

3. The Office shall include in the annual report on the activities of the Office referred to

in Article 153(1), point (c), of Regulation (EU) 2017/1001 a specific section on the

tasks entrusted to the Office under this Article. That specific section shall contain all

of the following:

(a) a review of the main activities carried out during the preceding year;

(b) the results achieved in relation to the objectives and performance indicators set

out in the annual work programme;

(c) an overall assessment of the fulfilment of those tasks, including the financial and

staff resources used, any revenue obtained from charges and any material effect

on the performance of the other statutory tasks of the Office;

(d) an overview of the activities planned for the following years.

EN 77 EN

Article 37

Amendment to Regulation (EU) 2017/1001

In Article 151(1) of Regulation (EU) 2017/1001, the following point (f) is added:

‘(f) the tasks entrusted to it under Regulation (EU) 202X/XXXX of the European Parliament

and of the Council. *+’

_________________________

* Regulation (EU) 202X/XXXX of the European Parliament and of the Council (OJ…,

ELI…).’.

Chapter 4

FINAL PROVISIONS

Article 38

Committee procedure

1. The Commission shall be assisted by the Committee on Implementation Rules

established by Regulation (EU) 2017/1001. That committee shall be a committee

within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No

182/2011 shall apply.

Article 39

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the

conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 11(2), Article19(10), Article

22(5), Article 24(12), Article 28(5) and Article 31(8) shall be conferred on the

Commission for a period of five years from the entry into force of this Regulation.

The Commission shall draw up a report in respect of the delegation of power not

later than nine months before the end of the five-year period. The delegation of

power shall be tacitly extended for periods of an identical duration, unless the

European Parliament or the Council opposes such extension not later than three

months before the end of each period.

3. The delegation of power referred to in Article 7(2), Article 19(11), Article 22(5),

Article 24(12), Article 28(5) and Article 31(8) may be revoked at any time by the

European Parliament or by the Council. A decision to revoke shall put an end to the

delegation of the power specified in that decision. It shall take effect on the day

following the publication of the decision in the Official Journal of the European

+ OJ: Please insert in the text the number, date, title and OJ reference of the present Regulation (European

Innovation Act) in the footnote.

EN 78 EN

Union or at a later date specified therein. It shall not affect the validity of any

delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by

each Member State in accordance with the principles laid down in the

Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to

the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 11(2), Article 19(10), Article 22(5),

Article 24(12), Article 28(5) and Article 31(8) shall enter into force only if no

objection has been expressed either by the European Parliament or by the Council

within a period of two months of notification of that act to the European Parliament

and the Council or if, before the expiry of that period, the European Parliament and

the Council have both informed the Commission that they will not object. That

period shall be extended by two months at the initiative of the European Parliament

or of the Council.

Article 40

Evaluation

By [OP please insert date four years from the date of entry into force of this Regulation] and

every five years thereafter, the Commission shall carry out an evaluation of this Regulation in

light of the objectives that it pursues, in particular on strengthening the role of public

procurement as a driver of innovation and enhancing the valuation, commercialisation and use

of IP, and shall present a report thereon to the European Parliament, to the Council and to the

European Economic and Social Committee. Where appropriate, this evaluation shall be

accompanied by a proposal for amendments to or a repeal of this Regulation.

Article 41

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

[...] [...]

EN 1 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

Contents

1. CONTEXT OF THE PROPOSAL ............................................................................... 1

1.1. Reasons for and objectives of the proposal .................................................................. 1

1.2. Consistency with existing policy provisions in the policy area ................................... 4

1.3. Consistency with other Union policies ........................................................................ 5

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY ............................... 6

2.1. Legal basis .................................................................................................................... 6

2.2. Subsidiarity (for non-exclusive competence)............................................................... 7

2.3. Proportionality ............................................................................................................. 8

2.4. Choice of the instrument .............................................................................................. 9

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS

AND IMPACT ASSESSMENTS ................................................................................ 9

3.1. Stakeholder consultations ............................................................................................ 9

3.2. Collection and use of expertise .................................................................................. 10

3.3. Impact assessment ...................................................................................................... 11

3.4. Regulatory fitness and simplification ........................................................................ 14

4. Fundamental rights ..................................................................................................... 14

5. BUDGETARY IMPLICATIONS .............................................................................. 14

6. OTHER ELEMENTS ................................................................................................ 15

• Implementation plans and monitoring, evaluation and reporting arrangements ........ 15

• Detailed explanation of the specific provisions of the proposal ................................ 15

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 4

1.1. Title of the proposal/initiative ...................................................................................... 4

1.2. Policy area(s) concerned .............................................................................................. 4

1.3. Objective(s) .................................................................................................................. 4

1.3.1. General objective(s) ..................................................................................................... 4

1.3.2. Specific objective(s) ..................................................................................................... 4

1.3.3. Expected result(s) and impact ...................................................................................... 4

1.3.4. Indicators of performance ............................................................................................ 6

1.4. The proposal/initiative relates to: ................................................................................. 6

1.5. Grounds for the proposal/initiative .............................................................................. 6

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative ............................................................ 6

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). ....... 7

EN 2 EN

1.5.3. Lessons learned from similar experiences in the past .................................................. 7

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments ....................................................................................... 8

1.5.5. Assessment of the different available financing options, including scope for

redeployment ................................................................................................................ 8

1.6. Duration of the proposal/initiative and of its financial impact .................................... 9

1.7. Method(s) of budget implementation planned ............................................................. 9

2. MANAGEMENT MEASURES................................................................................. 10

2.1. Monitoring and reporting rules .................................................................................. 10

2.2. Management and control system(s) ........................................................................... 10

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed ................ 10

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them.......................................................................................................... 10

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure) ......................................... 10

2.3. Measures to prevent fraud and irregularities .............................................................. 11

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 12

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s)

affected ....................................................................................................................... 12

3.2. Estimated financial impact of the proposal on appropriations ................................... 13

3.2.1. Summary of estimated impact on operational appropriations.................................... 13

3.2.1.1. Appropriations from voted budget ............................................................................. 13

3.2.3. Summary of estimated impact on administrative appropriations ............................... 15

3.2.3.1. Appropriations from voted budget .............................................................................. 15

3.2.4. Estimated requirements of human resources.............................................................. 15

3.2.4.1. Financed from voted budget....................................................................................... 15

3.2.5. Overview of estimated impact on digital technology-related investments ................ 17

3.2.6. Compatibility with the current multiannual financial framework.............................. 17

3.2.7. Third-party contributions ........................................................................................... 18

3.2.8. Estimated human resources and the use of appropriations required in a

decentralised agency .................................................................................................. 18

3.3. Estimated impact on revenue ..................................................................................... 20

4. DIGITAL DIMENSIONS .......................................................................................... 20

4.1. Requirements of digital relevance .............................................................................. 20

4.2. Data ............................................................................................................................ 22

4.3. Digital solutions ......................................................................................................... 24

EN 3 EN

4.4. Interoperability assessment ........................................................................................ 24

4.5. Measures to support digital implementation .............................................................. 25

EN 4 EN

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a framework of measures for strengthening Europe’s innovation

ecosystem (European Innovation Act)

1.2. Policy area(s) concerned

Single market, competitiveness, research and innovation

1.3. Objective(s)

1.3.1. General objective(s)

The general objective of the initiative is to improve the functioning of the Single

Market for innovation by reducing barriers to the development, testing and scale-up

of innovative solutions, thereby speeding up their commercialisation in the Union.

1.3.2. Specific objective(s)

Specific objective No 1

Lower valuation costs and increase licensing and transfer of IPs in the EU in the next

4 years.

Specific objective No 2

Increase spending on procurement of R&D services in the next 5 years.

Specific objective No 3

Increase the procurement of EU-based R&D solutions in the next 5 years.

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

Economic benefits

The introduction of a harmonised EU-wide IP valuation framework,

complemented by an EU IP Training Centre and an IP matchmaking platform,

is expected to reduce the costs and complexity associated with the valuation,

management, and monetisation of intellectual property assets. By providing

standardised valuation methodologies, specialised expertise, and improved market

infrastructure, these measures would reduce information asymmetries between firms

and external financiers regarding the economic value of IP assets.

Improved transparency and credibility in IP valuation are expected to facilitate the

use of patents and other IP assets as collateral, thereby increasing access to both debt

and equity financing. In particular, standardised valuation systems can strengthen the

collateral function of IP for banks and the signalling function of IP for venture

capital investors, contributing to greater volumes of IP-backed finance. As firms

become better able to capture and communicate the economic value of their

intellectual property, the expected returns from patenting are likely to increase,

creating stronger incentives to invest in innovation and seek formal IP protection.

The literature suggests that this relationship may generate a virtuous cycle between

patenting and financing. Stronger IP portfolios facilitate access to external finance,

EN 5 EN

while improved financing conditions support additional R&D investments and

innovation activities, leading to further patent generation. Beyond increasing the

quantity of patent applications, more reliable valuation mechanisms may also

improve patent quality by encouraging firms to focus on inventions with greater

technological and commercial potential.

Several strands of evidence support this mechanism. From a real-options perspective,

credible valuation systems and secondary IP markets increase the reversibility of

patent-related investments by transforming patents into tradable assets rather than

purely legal instruments. This reduces the effective risk of patenting and encourages

firms to file patents that can subsequently be licensed, sold, or used to support

financing transactions. Evidence from the United States shows that exposure to

secondary patent markets increases patenting activity, particularly under conditions

of economic uncertainty, while also encouraging firms to patent inventions that

would otherwise be kept as trade secrets.

The introduction of a harmonised EU-level framework for R&D procurement is

expected to significantly reduce the legal uncertainty and procedural complexity

currently associated with R&D procurement across Member States. This is expected

to facilitate the implementation of cross-border R&D procurement projects, enabling

public buyers to pool demand and achieve greater critical mass, thereby unlocking

the full potential of the Single Market for innovation procurement.

Embedding proven innovation-oriented procurement practices within a common

framework would also improve the effectiveness and efficiency of R&D

procurement processes, increasing the return on public investment in innovation.

Clearer procedures would enhance public buyers' capacity to design and manage

R&D procurement projects, while lowering participation costs and barriers for

suppliers. This is expected to encourage a larger number of firms, including those

from different Member States, to participate in R&D procurement call for tenders,

thereby increasing competition, improving the quality of proposed solutions, and

broadening access to innovative technologies.

Furthermore, the introduction of an EU preference within R&D procurement

procedures would increase the likelihood that significant economic and technological

benefits generated through publicly funded R&D procurement remain within the

European Union. Strengthening demand for innovative solutions developed by EU-

based firms would support private R&D investment, foster the growth of European

innovation ecosystems, and contribute to the creation of high-value jobs. In doing so,

it would reinforce the EU's strategic autonomy and technological sovereignty in

critical technologies and sectors.

Overall, the European Innovation Act is estimated to increase EU GDP by between

0.25% and 0.42% over a ten-year horizon relative to a baseline scenario without the

European Innovation Act.

Beyond its effects on GDP and employment, the European Innovation Act is

expected to generate broader societal benefits by strengthening the translation of

research and innovation into marketable solutions. A substantial body of empirical

evidence shows that sustained public and private investment in research and

innovation accelerates the development, diffusion, and cost reduction of clean

technologies, contributing to lower greenhouse gas emissions, improved energy

efficiency, and more sustainable production processes. These benefits are likely to

EN 6 EN

generate positive environmental and social externalities that are only partially

captured by conventional macroeconomic indicators such as GDP.

1.3.4. Indicators of performance

Specify the indicators for monitoring progress and achievements.

Progress towards the specific objective of reducing IP valuation costs and increasing

the licensing, transfer, and financial utilisation of intellectual property rights (IP

rights) in the EU will be monitored through several indicators. These include the

number of Member States integrating the European Union Intellectual Property

Office valuation standards into their national valuation practices, the number of

transactions applying the EU IP valuation methodology, the average IP valuation

costs borne by firms, and the number of companies using IP assets as collateral or in

financing transactions.

Progress towards the specific objective of increasing expenditure on the procurement

of R&D services will be measured by the share of R&D expenditure in total public

procurement and the number and value of cross-border R&D procurement contracts.

Progress towards the specific objective of increasing the procurement of EU-based

R&D solutions will be monitored through the number and value of R&D

procurement contracts awarded to EU-based suppliers and solutions.

1.4. The proposal/initiative relates to:

a new action

a new action following a pilot project / preparatory action50

the extension of an existing action

a merger or redirection of one or more actions towards another/a new action

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative

The proposal responds to the need to address the existing fragmentations in the

Single Market in the field of R&D procurement by establishing a harmonised

procedure for R&D procurements and joint cross-border R&D procurements to be

implemented by public buyers in all Member States in accordance with this

Regulation once it enters into force.

Furthermore, the entrusts new tasks to the European Union Intellectual Property

Office, including the establishment of a European Union Competence Centre for

intellectual property-backed finance and commercialisation of intellectual

property once the Regulation enters into force. Once established within the

European Union Intellectual Property Office, the Competence Centre will start

discharging the tasks conferred upon it by the Regulation including providing

support to various stakeholders in the fields of intellectual property-backed financing

and commercialisation of intellectual property assets. Finally, by 1 September 2028

(to be intended as tentative date, as IT development require time), the European

Union Intellectual Property Office, through the Competence Centre, will develop a

valuation framework for all intangible assets and establish a digital matchmaking

50 As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 7 EN

platform to facilitate the licensing and transfer of all types of intellectual property

rights protected at Union level.

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities).

For the purposes of this section 'added value of EU involvement' is the value resulting from

EU action, that is additional to the value that would have been otherwise created by Member

States alone.

Reasons for action at EU level (ex-ante)

The proposed measures focus on areas where there is clear added value in acting at

Union level due to the scale, speed and scope of the efforts needed. Actions aim at

improving the business case for innovators to bring innovations to the market by

facilitating the valuation, commercialisation and use of IP rights as a collateral to

obtain IP-backed finance and by making it easier to find first customers through

R&D procurement. It enhances efficiency by enabling better cross-border

cooperation, ensures fairer access to opportunities for innovative companies

irrespective of their location, and strengthens the Union’s capacity to compete

globally.

Expected generated EU added value (ex-post)

EU intervention will generate lasting benefits through economies of scale, lower

transaction costs, and improved legal certainty for public buyers, companies and

investors. It will strengthen Europe’s capacity to place innovative solutions on the

market and to commercialise intellectual property assets and leverage them in

company financing. Harmonised and digitalised procedures for R&D procurement

will reduce transaction costs and administrative burden for public buyers and

companies participating in R&D procurements, while providing uniform market

conditions across Member States. Establishment of the Competence Centre within

the European Union Intellectual Property Office will increase the uptake of

intellectual property-backed financing in Europe, increasing financing opportunities

for innovative companies.

1.5.3. Lessons learned from similar experiences in the past

The European Union Intellectual Property Office has gathered a significant expertise

in the field of IP rights through its tasks related to the protection of EU trademarks,

designs and geographic indications, as well as monitoring infringements of all types

of intellectual property rights through the European Observatory on Infringements of

Intellectual Property Rights. Taking into account this experience, the proposal builds

on European Union Intellectual Property Office’s expertise by entrusting to it

additional tasks related to valuation and commercialisation of IP.

The Innovation Partnership procedure, which was introduced in the 2014 EU public

procurement directives, is used only to a very limited extent. The evaluation of the

2014 EU public procurement directives concluded that in the ongoing revision of the

EU public procurement directives the obligation that this procedure must involve the

procurement of R&D should be removed, because public buyers do not like buying

R&D as part of a procedure that buys commercial volumes of solutions and that is

open to providers from all third countries with who the Union has an international

agreement on public procurement. Taking into account this experience, the European

the proposal aims to provide a procedure for R&D procurement for buying R&D

EN 8 EN

services that does not involve the procurement of commercial volumes of solutions

and that can be open only to providers from Member States, EEA countries and

Western Balkan countries.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

The proposal is fully consistent with the 2021-2027 Multiannual Financial

Framework and will be implemented through existing Union programmes without

creating new spending envelopes or financial obligations beyond existing resources.

Should the co-legislators approve the proposal and decide that the EUIPO sets up,

runs the Center and contributes funds (either from the operational or the surplus), it

should be noted that this EUIPO contribution would not come from the EU budget (it

is not EU contribution) but from the EUIPO’s budget and therefore, it does not

depend on the MFF.

In that sense, the decision on the specific budgetary elements would be subject to the

decision and approval of the Management Board and Budgetary Committee (MBBC)

of the EUIPO.

1.5.5. Assessment of the different available financing options, including scope for

redeployment

All financing will be ensured through redeployments from programmes. Without

prejudice to the outcome of negotiations on the next MFF, the appropriations

foreseen from 2028 onwards are strictly indicative.

EN 9 EN

1.6. Duration of the proposal/initiative and of its financial impact

limited duration

–  in effect from [DD/MM]YYYY to [DD/MM]YYYY

–  financial impact from YYYY to YYYY for commitment appropriations and

from YYYY to YYYY for payment appropriations.

unlimited duration

– Implementation with a start-up period from YYYY to YYYY,

– followed by full-scale operation.

1.7. Method(s) of budget implementation planned51

Direct management by the Commission

–  by its departments, including by its staff in the Union delegations;

–  by the executive agencies

Shared management with the Member States

Indirect management by entrusting budget implementation tasks to:

–  third countries or the bodies they have designated

–  international organisations and their agencies (to be specified)

–  the European Investment Bank and the European Investment Fund

–  bodies referred to in Articles 70 and 71 of the Financial Regulation

–  public law bodies

–  bodies governed by private law with a public service mission to the extent that

they are provided with adequate financial guarantees

–  bodies governed by the private law of a Member State that are entrusted with

the implementation of a public-private partnership and that are provided with

adequate financial guarantees

–  bodies or persons entrusted with the implementation of specific actions in the

common foreign and security policy pursuant to Title V of the Treaty on

European Union, and identified in the relevant basic act

– bodies established in a Member State, governed by the private law of a

Member State or Union law and eligible to be entrusted, in accordance with

sector-specific rules, with the implementation of Union funds or budgetary

guarantees, to the extent that such bodies are controlled by public law bodies or

by bodies governed by private law with a public service mission, and are provided

with adequate financial guarantees in the form of joint and several liability by the

controlling bodies or equivalent financial guarantees and which may be, for each

action, limited to the maximum amount of the Union support.

51 Details of budget implementation methods and references to the Financial Regulation may be found on

the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-

implementation/Pages/implementation-methods.aspx.

EN 10 EN

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

This Statement includes staff expenditures. Standard rules for this type of

expenditure apply. The Commission will evaluate the output, results and impact of

this proposal every three years after the date on which it becomes applicable. The

evaluation will assess the contribution of this Regulation to the functioning of the

single market, including the objectives specified in in this Regulation.

2.2. Management and control system(s)

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed

The management mode for the initiative is direct management by the Commission.

This is the most appropriate approach given the limited scope of Union expenditure,

which is confined to standard administrative and monitoring-related costs. Using

established internal procedures ensures effective and efficient controls, low error

rates, fast processing of transactions and minimal control costs

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

Overall, the initiative requires staff expenditure. Standard rules for this type of

expenditure apply. Most aspects of the initiative follow established procedures for

monitoring the implementation of this Regulation.

The main operational risk is insufficient administrative capacity to monitor the

implementation of the obligations laid down in the Regulation. This proposal is

accompanied by an impact assessment report, which provides the analytics

underpinning the chosen policy approach. The preparation of the initiative also drew

on a public consultation as well as targeted consultations with industry stakeholders,

Member States and trade associations, which ensured the collection of relevant data,

information and feedback. Nonetheless, unintentional consequences or unforeseen

impacts may still occur during implementation. These will be identified through the

monitoring procedures set out in the Regulation, allowing the Commission to address

them in an appropriate and timely manner.

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure)

The initiative involves limited administrative expenditure. Standard Commission

control procedures apply. As no funding programmes or multi-layered delivery

mechanisms are created, control activities remain straightforward and cost-effective.

Controls are carried out entirely under direct management, using standard ex-post

audits under the Commission’s internal control framework. This ensures an

appropriate balance between control effort and the limited value of funds managed.

Given the simplified set-up and the absence of high-risk financial operations, the

expected error rate at payment and at closure is low and comfortably below the

materiality threshold. The control system therefore provides a high level of assurance

at proportionate cost.

EN 11 EN

2.3. Measures to prevent fraud and irregularities

The initiative does not establish funding programmes or financial support schemes. It

therefore relies on the Commission’s existing internal control framework and Anti-

Fraud Strategy. Standard preventive and detective measures apply, including risk-

based internal controls, segregation of duties and established workflows for

administrative expenditure.

The Office shall ensure, in accordance with Regulation (EU) 2017/1001 and the

financial rules applicable to the Office, that appropriate measures are in place to

protect the financial interests of the Union in the performance of the tasks entrusted

to it under this Regulation, including measures to prevent, detect and address fraud,

corruption, conflicts of interest and other irregularities. The Commission shall

exercise the oversight and monitoring functions conferred on it under the applicable

governance framework.

As with all Commission-managed activities, the European Anti-Fraud Office

(OLAF) and the European Public Prosecutor’s Office (EPPO) may exercise their

powers in accordance with their respective legal bases to investigate fraud,

corruption or other illegal activities affecting the EU’s financial interests. The

European Court of Auditors retains its standard audit rights over Commission

expenditure.

EN 12 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

The estimated impact on expenditure and staffing for 2028 and beyond is added for

illustrative purposes only and does not pre-judge the next Multiannual Financial

Framework. The source of financing and scope of Union financial commitment in the

post-2027 period remain subject to the outcome of interinstitutional negotiations on

the MFF 2028-2034 and thereafter shall be determined through the annual budgetary

procedure. All appropriations and staffing allocations as of 2028 are indicative. As

regards the EUIPO budget, the figures are indicative and subject to approval by the

EUIPO governing bodies in accordance with the EUTMR.

3.1. Heading(s) of the multiannual financial framework and expenditure budget

line(s) affected

• Existing budget lines

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.52

from

EFTA

countries 53

from

candidate

countries

and

potential

candidates 54

From

other

third

countries

other assigned

revenue

02 01 01 01 01

Non-diff. YES YES NO NO

• New budget lines requested

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.

from

EFTA

countries

from

candidate

countries

and

potential

candidates

from

other

third

countries

other assigned

revenue

N/A

52 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 53 EFTA: European Free Trade Association. 54 Candidate countries and, where applicable, potential candidates from the Western Balkans.

EN 13 EN

3.2. Estimated financial impact of the proposal on appropriations

3.2.1. Summary of estimated impact on operational appropriations

–  The proposal/initiative does not require the use of operational appropriations

–  The proposal/initiative requires the use of operational appropriations, as explained below

3.2.1.1. Appropriations from voted budget

EUR million (to three decimal places)

Heading of multiannual financial framework Number 02

DG: RTD Year Year Year Year Year Year Year

TOTAL MFF 2028-2034 2028 2029 2030 2031 2032 2033 2034

Operational appropriations

Budget line Commitments (1a) 0

Payments (2a) 0

Budget line Commitments (1b) 0

Payments (2b) 0

Appropriations of an administrative nature financed from the envelope of specific programmes55

Budget line 01 01 01 01 (3) 0.582 0.582 0.582 0.582 0.582 0.582 0.582 4.074

TOTAL appropriations Commitments =1a+1b+3 0.582 0.582 0.582 0.582 0.582 0.582 0.582 4.074

for DG RTD Payments =2a+2b+3 0.582 0.582 0.582 0.582 0.582 0.582 0.582 4.074

55 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.

EN 14 EN

EUR million (to three decimal places)

Year Year Year Year Year Year Year TOTAL

MFF 2028-

2034 2028 2029 2030 2031 2032 2033 2034

TOTAL

appropriations under

HEADINGS 1 to 4

Commitments 0.582 0.582 0.582 0.582 0.582 0.582 0.582 4.074

of the multiannual

financial framework Payments 0.582 0.582 0.582 0.582 0.582 0.582 0.582 4.074

EN 15 EN

3.2.3. Summary of estimated impact on administrative appropriations

–  The proposal/initiative does not require the use of appropriations of an

administrative nature

–  The proposal/initiative requires the use of appropriations of an administrative

nature, as explained below

3.2.3.1. Appropriations from voted budget

VOTED APPROPRIATIONS Year Year Year Year Year Year Year TOTAL

2028 -

2034 2028 2029 2030 2031 2032 2033 2034

HEADING 4

Human resources 0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Other administrative expenditure 0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Subtotal HEADING 4 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000

Outside HEADING 4

Human resources 0.582 0.582 0.582 0.582 0.5820.5820.582 4.074

Other expenditure of an administrative

nature 0

0 0 0 000 0

Subtotal outside HEADING 4 0.5820.5820.5820.5820.5820.5820.582 4.074

TOTAL 0.5820.5820.5820.5820.5820.5820.582 4.074

The estimated impact on expenditure and staffing for 2028 and beyond is added for illustrative

purposes only and does not pre-judge the next Multiannual Financial Framework. The source of

financing and scope of Union financial commitment in the post-2027 period remain subject to the

outcome of interinstitutional negotiations on the MFF 2028-2034 and thereafter shall be determined

through the annual budgetary procedure. All appropriations and staffing allocations as of 2028 are

indicative.

3.2.4. Estimated requirements of human resources

–  The proposal/initiative does not require the use of human resources

–  The proposal/initiative requires the use of human resources, as explained

below

3.2.4.1. Financed from voted budget

Estimate to be expressed in full-time equivalent units (FTEs)56

VOTED APPROPRIATIONS Year Year Year Year Year Year Year

2028 2029 2030 2031 2032 2033 2034

 Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission’s Representation

Offices)

0 0 0 0 0 0 0

20 01 02 03 (EU Delegations) 0 0 0 0 0 0 0

(Indirect research) 3 3 3 3 3 3 3

(Direct research) 0 0 0 0 0 0 0

56 Please specify below the table how many FTEs within the number indicated are already assigned to the

management of the action and/or can be redeployed within your DG and what are your net needs.

EN 16 EN

Other budget lines (specify) 0 0 0 0 0 0 0

• External staff (in FTEs)

20 02 01 (AC, END from the

‘global envelope’) 0 0 0 0 0 0 0

20 02 03 (AC, AL, END and JPD

in the EU Delegations) 0 0 0 0 0 0 0

Admin. Support

line

• at Headquart ers

0 0 0 0 0 0 0

[XX.01.YY.YY] • in EU

Delegations 0 0 0 0 0 0 0

(AC, END - Indirect research) 0 0 0 0 0 0 0

(AC, END - Direct research) 0 0 0 0 0 0 0

Other budget lines (specify) -

Heading 4 0 0 0 0 0 0 0

Other budget lines (specify) -

Outside Heading 4 0 0 0 0 0 0 0

TOTAL 0 0 0 0 0 0 0

The staff required to implement the proposal (in FTEs):

To be covered by

current staff

available in the

Commission services

Exceptional additional staff*

To be financed

under Heading

4 or Research

To be financed

from BA line

To be financed

from fees

Establishment

plan posts

3

[N.B. Considering the

overall strained

situation in Heading 4,

in terms of both

staffing and the level

of appropriations, the

human resources

required will be met by

staff from the DG who

are already assigned to

the management of the

action and/or have

been redeployed within

the DG or other

Commission services]

N/A

External staff

(CA, SNEs, INT)

Description of tasks to be carried out by:

Officials and temporary staff 3 FTEs are needed to monitor the implementation and enforcement of

the Regulation.

EN 17 EN

External staff

3.2.5. Overview of estimated impact on digital technology-related investments

Compulsory: the best estimate of the digital technology-related investments entailed

by the proposal/initiative should be included in the table below.

Exceptionally, when required for the implementation of the proposal/initiative, the

appropriations under Heading 4 should be presented in the designated line.

The appropriations under Headings 1-3 should be reflected as “Policy IT expenditure

on operational programmes”. This expenditure refers to the operational budget to be

used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation

of the initiative and their associated investments (e.g. licences, studies, data storage

etc). The information provided in this table should be consistent with details

presented under Section 4 “Digital dimensions”.

TOTAL Digital

and IT

appropriations

Year Year Year Year Year Year Year TOTAL

MFF

2028 -

2034 2028 2029 2030 2031 2032 2033 2034

HEADING 4

IT expenditure (corporate)

0 0 0 0 0 0 0 0

Subtotal

HEADING 4 0 0 0 0 0 0 0 0

Outside HEADING 4

Policy IT expenditure on operational programmes

0 0 0 0 0 0 0 0

Subtotal outside

HEADING 4 0 0 0 0 0 0 0 0

TOTAL 0 0 0 0 0 0 0 0

3.2.6. Compatibility with the current multiannual financial framework

The proposal/initiative:

–  can be fully financed through redeployment within the relevant heading of the

multiannual financial framework (MFF)

–  requires use of the unallocated margin under the relevant heading of the MFF

and/or use of the special instruments as defined in the MFF Regulation

–  requires a revision of the MFF

3.2.7. Third-party contributions

The proposal/initiative:

–  does not provide for co-financing by third parties

EN 18 EN

–  provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

Year Year Year Year Year Year Year

Total 2028 2029 2030 2031 2032 2033 2034

Specify the co-

financing body

TOTAL

appropriations

co-financed

3.2.8. Estimated human resources and the use of appropriations required in a decentralised

agency

The Competence Centre would provide support in areas such as IP exploitation,

commercialisation and access to finance. The implementation of these activities is estimated

to require 10 FTEs per year during the implementation phase, assuming a two-year

development period. If the Act enters into force in 2028, this phase would therefore cover

2028 and 2029. Once the Competence Centre becomes fully operational, the estimated

staffing requirement would decrease to 8 FTEs per year.

Staff requirements (full-time equivalent units)

Agency: EUIPO Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Year

2033

Year

2034

Temporary agents

(AD Grades) 6 6 4 4 4 4 4

Temporary agents

(AST grades) 0 0 0 0 0 0 0

Temporary agents

(AD+AST) subtotal 6 6 4 4 4 4 4

Contract agents 4 4 4 4 4 4 4

Seconded national

experts 0 0 0 0 0 0 0

Contract agents and

seconded national

experts subtotal

4 4 4 4 4 4 4

EN 19 EN

TOTAL staff 10 10 8 8 8 8 8

Overview/summary of human resources and appropriations (in EUR million) required by the

proposal/initiative in a decentralised agency

Agency: EUIPO Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Year

2033

Year

2034

Temporary agents

(AD+AST) 6 6 4 4 4 4 4

Contract agents 4 4 4 4 4 4 4

Seconded national experts 0 0 0 0 0 0 0

Total staff 10 10 8 8 8 8 8

Appropriations covered by

the EU budget 0.000 0.000 0.000 0.000 0.000 0.000 0.000

Appropriations covered by

fees

(if applicable)

0.000 0.000 0.000 0.000 0.000 0.000 0.000

Appropriations covered by

EUIPO operative budget /

surplus

(as applicable)

0.746 1.523 1.173 1.196 1.220 1.245 1.269

Appropriations co-

financed

(if applicable)

0.000 0.000 0.000 0.000 0.000 0.000 0.000

TOTAL appropriations 0.746 1.523 1.173 1.196 1.220 1.245 1.269

The Office reserves its position as regards the calculation of the revenue derivable from the

relevant EIA provision.

3.3. Estimated impact on revenue

–  The proposal/initiative has no financial impact on revenue.

–  The proposal/initiative has the following financial impact:

EN 20 EN

–  on own resources

–  on other revenue

–  please indicate, if the revenue is assigned to expenditure lines

EUR million (to three decimal places)

Budget revenue line:

Appropriations

available for

the current

financial year

Impact of the proposal/initiative57

Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Year

2033

Year

2034

Article ………….

For assigned revenue, specify the budget expenditure line(s) affected.

Other remarks (e.g. method/formula used for calculating the impact on revenue or

any other information).

4. DIGITAL DIMENSIONS

4.1. Requirements of digital relevance

Reference to

the

requirement

Requirement

description

Actor(s)

affected or

concerned by

the

requirement

High-level

Processes

Categories

Article 4(4) R&D

procurements

to be carried

out through the

TED platform

(digital

interface to

upload

procurement

notices in the

Official Journal

of the European

Union)

Public buyers

Economic

operators

R&D

procurement

Data

Digital Solution

Digital Public

Service

Process

digitalisation and

automation

Interoperability

Articles 4(4) Requirement to

use electronic

format for

Public buyers

Economic

R&D

procurement

Data

Digital Solution

57 In the case of traditional own resources (customs duties, sugar levies), the amounts indicated must be

net amounts, i.e. gross amounts after deduction of 10 % for collection costs, as proposed in

COM(2025)574.

EN 21 EN

procurement

documents

operators Digital Public

Service

Process

digitalisation and

automation

Interoperability

Article 10 Requirement on

public buyers to

specify

requirements

on contractors

to contribute to

publication of

results, where

appropriate, as

open data or

open source

Public buyers

Economic

operators

R&D

procurement

Data

Digital Solution

Digital Public

Service

Process

digitalisation and

automation

Article 26 Requirement to

respect data

protection

rules, including

those for

electronic

communication

Public buyers

Economic

operators

R&D

procurement

Data

Digital Solution

Digital Public

Service

Process

digitalisation and

automation

Article 32(3)(a) European

Union

Intellectual

Property Office

to develop a

valuation

framework for

valuation of

intangible

assets and

related digital

processes and

services related

to the

disclosure,

screening and

valuation of IP

Economic

operators

Member States

Union entities

IP valuation Data

Digital Solution

Digital Public

Service

Process

digitalisation and

automation

Article 32(3)(b) European

Union

Intellectual

Property Office

Union entities

Economic

operators

Facilitation of

IP licensing and

transfer

Data

Digital Solution

Digital Public

EN 22 EN

to establish and

maintain a

digital match-

making

platform to

facilitate the

licensing and

transfer of all

types of IP

rights protected

at Union level.

Service

Article 32(3)(g)

and Article 35

Development

of an evidence

database on IP-

backed

financing

Member States

Competent

authorities

Economic

operators

Union entities

Data processing

and analysis

Data

4.2. Data

Type of data Reference to

requirement(s)

Standard and/or specification (if

applicable)

Data related to R&D

procurement procedures on

the scope of the

procurement, on public

buyers and on

tenderers/contractors

Articles 4(4), 6, 16 and

17

Standards and specifications used

in the EU public procurment portal

(eForms, OASIS UBL, TED APIs,

eProcurement ontology)

Data related to IP-backed

financing, including

information on how

intellectual property used

as collateral for credit or

insurance purposes or as

in-kind contribution in

equity investment

scenarios has been

evaluated, on the size and

characteristics of the

corresponding transaction,

on the type of intellectual

property right concerned,

and on relevant indicators

such as equity valuation,

collateralisation, or loan to

value ratios.

Article 32(3)g) and

Article 33

Standards and specifications to be

defined by the European Union

Intellectual Property Office

Competence Centre for IP-backed

finance, in cooperation with the

Commission, covering:

harmonised data requirements for

IP asset type, collateral structure,

transaction size, and loan

outcomes; data sharing and access

protocols consistent with

applicable data protection rules;

interoperability requirements

enabling linkage between IP

registries, commercial registries,

and public instrument records; and

standards for the anonymisation

and aggregation of transaction-

EN 23 EN

level data collected through EU-

supported IP-backed finance

instruments.

Alignment with the European Data Strategy

Explain how the requirement(s) are aligned with the European Data Strategy

• The proposal promotes the use of digital tools for R&D procurement procedures and

for valuation and commercialisation of IP, which is in line with the European Data

Strategy's objective of promoting digitalization and data-driven innovation.

• The proposal builds on the existing digital tools for public procurement, including the

national procurement portals. This is consistent with the European Data Strategy's goal

of improving data sharing and interoperability.

• The proposal promotes transparency while respecting data protection and data

confidentiality rules, the protection of intellectual property rights and the safeguarding

of trade secrets. This is in line with the European Data Strategy's objective of

promoting transparency and trust in data-driven ecosystems.

• The proposal aims to create a favorable environment for startups and scaleups, which

is consistent with the European Data Strategy's goal of promoting innovation and

entrepreneurship through data-driven technologies.

Explanation of how newly created data is findable, accessible, interoperable and reusable, and

meets high-quality standards

The accessibility, findability, interoperability and reusability of data and the data-quality

requirements related to R&D procurements is currently defined in the rules for

publication of and access to data on the TED portal

Data collected under the Act will be managed by European Union Intellectual Property

Office. The European Union Intellectual Property Office Competence Centre will

maintain a structured repository with defined metadata standards to support discoverability

and reuse. The Office is the legal entity that will maintain the repository. Access will be

governed by clear protocols, distinguishing between publicly available data and data

accessible only to authorised bodies. Interoperability with existing IP registries and

commercial registers will be pursued through common data formats and shared identifiers.

Data quality standards, including validation rules and reporting obligations for participating

entities, will be defined by the Competence Centre in cooperation with the Commission.

Data flows

High-level description of the data flows

Type of data Reference(s)

to the

requirement(s)

Actor who

provides the

data

Actor

who

receives

the data

Trigger for

the data

exchange

Frequency

(if

applicable)

Procurement

documents

and notices

Articles 4(4),

6, 16 and 17

Public buyer Tenderers Publication of

notices and

link to

procurement

EN 24 EN

documents

IP valuation

tools

Article

32(3)(a)

EUIPO Economic

operators

Public

bodies

IP valuation

request

IP

matchmaking

information

Article

32(3)(b)

EUIPO Economic

operators

Public

bodies

Matchmaking

request

IP-based

finance

related

evidence

Article

32(3)(g)

National

guarantee

institutions

Financial

intermediaries

EUIPO Request for

collection of

evidence

4.3. Digital solutions

4.4. Interoperability assessment

Under this proposal, R&D procurements will be carried out through the digital solutions

used in the TED portal.

Under this proposal, European Union Intellectual Property Office is tasked with developing

the following digital solutions:

• digital tools supporting the disclosure, screening and indicative valuation of IP

assets, accessible to economic operators and financial institutions

• an IP licensing and transfer platform facilitating the licensing and transfer of IP

rights protected at Union level

• IP-backed finance evidence database collecting transaction-level data on IP-backed

finance instruments

All three solutions will be operated by European Union Intellectual Property Office and

will comply with applicable cybersecurity requirements and relevant Union digital rules.

Where AI-assisted tools are used, in particular for screening and indicative valuation,

compliance with rules applicable to use of AI will be ensured and the relevant risk

classification will be assessed at design stage.

The digital solutions mandated by the Act require interaction across Member State borders

and involve multiple EU entities and public sector bodies, satisfying both conditions for an

interoperability assessment.

Currently the TED portal provides an interoperable way for public buyers to upload R&D

procurements notices that were published on national public procurement portals also on

the TED portal. In the future, the EU digital market place for public procurements is

expected to further improve interoperability between different national and EU public

procurement portals and databases, enabling economic operators from one Member State to

participate more easily in a R&D procurement procedure of a public buyer in another

EN 25 EN

4.5. Measures to support digital implementation

58 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying

down measures for a high level of public sector interoperability across the Union (Interoperable Europe

Act) (OJ L, 2024/903, 22.03.2024, ELI: http://data.europa.eu/eli/reg/2024/903/oj).

Member State, and simplifying the process for public buyers from two or more Member

States to carry out R&D procurement procedures jointly. The TED portal will remain the

interface for public buyers to launch R&D procurement procedures and for economic

operators to find R&D procurement business opportunities. Therefore, the interactions

between national and EU public procurement portals and databases are not part of this

interoperability assessment.

The European Union Intellectual Property Office valuation tools and matchmaking platform

will be accessible to economic operators and public bodies across all Member States,

requiring semantic interoperability with national IP registries and commercial registers. The

IP-backed finance evidence database will aggregate data from national guarantee

institutions and financial intermediaries, requiring harmonised data formats and shared

identifiers. Relevant interoperability solutions available at EU level will be assessed for

reuse during the design and implementation phase. Key remaining barriers include

divergent national IP registry formats and the absence of a central EU-level IP pledge

register.

Since this proposal introduces new binding requirements for cross-border digital public

services within the meaning of Regulation (EU) 2024/903 of the European Parliament and

of the Council58, an interoperability assessment has been carried out, and the resulting

report is to be published on the Interoperable Europe Portal.

The following implementation measures are planned to support the implementation of the

digital solutions under this proposal:

For R&D procurement:

• the use of existing features for launching R&D procurement procedures through the

TED portal, and the integration of new digital features for launching R&D

procurement procedures through the EU digital market place for public

procurements

• capacity building activities targeting Member States, public buyers and economic

operators to support wide and correct use of launching R&D procurements through

the TED portal

For the European Union Intellectual Property Office activities:

• the establishment and operationalisation of the European Union Intellectual

Property Office Competence Centre for IP-backed finance, responsible for the

digital tools, the matchmaking platform, and the evidence database.

• capacity building programme targeting financial institutions, developed jointly by

European Union Intellectual Property Office and the Commission, to support uptake

of the valuation framework and digital tools.

• pilot phase for the evidence database involving selected national guarantee

institutions and financial intermediaries, enabling iterative refinement before full

EN 26 EN

deployment.

ET ET

EUROOPA KOMISJON

Brüssel, 9.9.2026 COM(2026) 568 final

2026/0267 (NLE)

Ettepanek:

NÕUKOGU SOOVITUS,

milles käsitletakse regulatiivliivakastidega seotud ühiseid põhimõtteid, et toetada

innovatsiooni ja tulevikukindla õigusraamistiku loomist

ET 1 ET

SELETUSKIRI

1. ETTEPANEKU TAUST

• Ettepaneku põhjused ja eesmärgid

Kogu Euroopas pööratakse suurt poliitilist tähelepanu konkurentsivõimele ja

innovatsioonisõbralikule reguleerimisele ning edendatakse ettevõtjate juurdepääsu

maailmaturule. Euroopa Liit soovib jääda paigaks, kus on võimalik luua murrangulist

innovatsiooni ja suurendada innovaatiliste lahenduste kasutuselevõttu, säilitades samal ajal

kõrged ohutus-, usaldus- ja õiglusstandardid. Samal ajal võivad Euroopas kasvada soovivate

innovaatiliste ettevõtjate jaoks olla takistuseks eeskirjad, mis ei ole piisavalt paindlikud1 ning

tekitavad novaatoritele teatavaid probleeme. Liikmesriigiti erinevad eeskirjad valdkondades,

kus puuduvad ühtlustatud ELi õigusaktid, loovad ka ebavõrdsed tingimused ja tekitavad

suuremaid nõuete täitmisega seotud kulusid novaatoritele, kes sooviksid katsetada, kuidas

nende lahendused eri liikmesriikide tegelikes tingimustes toimivad.

Seda silmas pidades võttis komisjon 2025. aasta mais vastu ELi idu- ja kasvufirmade

strateegia,2 milles esitatakse kavad liidu regulatiivse paindlikkuse suurendamiseks.

Kõnealuses strateegias on ühe meetmena esile toodud nn regulatiivliivakastid, mis võimaldaks

pakkuda ettevõtjatele, sealhulgas VKEdele, idufirmadele ja muudele huvitatud isikutele,

katsekeskkondi ning kiirendada nende sisenemist turule. Samal ajal aitavad need

reguleerivatel asutustel paremini mõista kujunemisjärgus innovaatiliste lahendustega

kaasnevaid vajadusi ja kohandada eeskirju, et tõhusamalt reageerida nende ees seisvatele

probleemidele. Regulatiivliivakastid luuakse tavaliselt igal üksikjuhul eraldi ja nende

kohaldamisala on selgelt kindlaks määratud. Oluline on silmas pidada, et see

eksperimenteerimist toetav vahend ei tähenda dereguleerimist. Pigem on selle eesmärk luua

turvaline ruum, kus innovatsioon ja regulatiivne õpe saavad käsikäes areneda.

Regulatiivliivakastid pakuvad praktilist võimalust õppida tegevuse käigus ja annavad vahetu

ülevaate kujunemisjärgus innovatsioonist, sealhulgas selle riskidest ja mõjust. Ühtlasi võivad

regulatiivliivakastid vähendada novaatorite jaoks turule sisenemise tõkkeid ning tõhustada

teabevahetust ja koordineerimist eri ametiasutuste ja novaatorite vahel, eelkõige sektoriülese

innovatsiooniga seotud küsimustes.

Komisjon korraldas 2025. aastal liikmesriikide seas ka uuringu nende kogemuste kohta

regulatiivliivakastidega3. Liikmesriikide vastustes rõhutati, et regulatiivliivakastide tõhususe

suurendamiseks on vaja poliitilist toetust, avatud teabevahetust, piisavate ressursside

eraldamist ning paindlikke ja täpselt määratletud raamistikke. Jätkuv koostöö, pidevad

kohandused ja sidusrühmade tihe kaasamine on endiselt väga olulised, et

regulatiivliivakastide pakutavaid võimalusi täiel määral ära kasutada. Kokkuvõttes näitavad

liikmesriikide vastused, et regulatiivliivakastid vajavad selgeid menetlusraamistikke, tihedat

koostööd sidusrühmade vahel, paindlikku ülesehitust, tõhusat teabevahetust ning strateegilist

kooskõla laiemate majanduslike ja sotsiaalsete eesmärkidega.

1 Draghi aruanne „Euroopa konkurentsivõime strateegia“, 2024, lk 6,

https://commission.europa.eu/topics/competitiveness/draghi-report_en#paragraph_47059. 2 COM/2025/270final, https://eur-lex.europa.eu/legal-content/ET/TXT/?uri=celex:52025DC0270. 3 Euroopa Komisjon, teadusuuringute ja innovatsiooni peadirektoraat, Vuorinen, H., Isakovic, S. M. ja

Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report (Regulatiivliivakastide

kasutamine ELi liikmesriikides – 2025. aasta uuringu aruanne), Euroopa Liidu Väljaannete Talitus, 2026,

https://data.europa.eu/doi/10.2777/9535645.

ET 2 ET

Käesoleva nõukogu soovituse ettepaneku eesmärk on aidata luua keskkond, kus innovatsioon

ja õigusraamistik edendavad majanduskasvu, konkurentsivõimet ja vastupanuvõimet kogu

ELis. Soovituses esitatakse regulatiivliivakastide ühine ELi võrdlusraamistik kohaldamiseks

valdkondades, kus puuduvad asjaomased liidu õigusaktid, ning regulatiivliivakastide

määratlus koos põhimõtetega, mida nende loomise, järelevalve ja piiriülese rakendamise

puhul tuleks järgida. Soovituses pakutakse välja selle regulatiivse eksperimenteerimisvahendi

ühtne käsitlus, mis kehtib kogu liidus ja võimaldab seda vahendit tulemuslikumalt ja

tõhusamalt rakendada, tuginedes liikmesriikide praegustele kogemustele ja parimatele

tavadele ning olemasolevatele algatustele. Praktilisest küljest aitab see selgitada ka

juurdepääsu regulatiivliivakastidele ja vähendada liikmesriikidevahelist killustatust.

Komisjoni ettepanekuga edendatakse regulatiivset õppimist ja süvendatakse tulevikus veelgi

dialoogi liikmesriikidega. Novaatorite jaoks võivad tõhusalt rakendatud regulatiivliivakastid

suurendada regulatiivset selgust ja hõlbustada innovaatiliste lahenduste, näiteks tehnoloogiate,

toodete, teenuste ja ärimudelite väljatöötamist.

• Kooskõla poliitikavaldkonnas praegu kehtivate õigusnormidega

Nõukogu 30. septembri 2025. aasta järeldustes, milles käsitletakse teadusuuringute ja

innovatsiooni tähtsust ELi idu- ja kasvufirmade strateegia jaoks,4 tunnistati

regulatiivliivakastide tähtsust innovatsiooni turule sisenemise hõlbustamisel: need toetavad

innovaatilisi idu- ja kasvufirmasid uute ideede väljatöötamisel ja katsetamisel, aitavad hinnata

uute lahenduste vastavust õigusnormidele, täiustada regulatiivset õpet ning anda soovitusi

regulatiivsete takistuste ületamiseks. Selleks et tagada regulatiivliivakastide kiire ja

tulemuslik rakendamine, julgustati kõnealustes nõukogu järeldustes liitu töötama tulevases

Euroopa innovatsioonimääruses regulatiivliivakastide, sealhulgas kogu liitu hõlmavate

regulatiivliivakastide jaoks välja selged ja tõhusad normid.

Käesolev nõukogu soovituse ettepanek võetakse vastu koos Euroopa innovatsioonimääruse5

ettepanekuga.

Käesolev ettepanek on jätkuks nõukogu 2020. aasta järeldustele regulatiivliivakastide ja

katsetamissätete rolli kohta innovatsioonisõbralikus, tulevikukindlas, kestlikus ja vastupidavas

ELi õigusraamistikus6. Nendes järeldustes kutsuti komisjoni üles korraldama koostöös

liikmesriikidega regulatiivliivakaste käsitleva teabe ja heade tavade vahetust liikmesriikide ja

komisjoni vahel, et:

(a) koostada ülevaade regulatiivliivakastide kasutamise hetkeolukorrast ELis;

(b) teha kindlaks regulatiivliivakastide õigusliku aluse, rakendamise ja hindamisega

seotud kogemused;

(c) analüüsida, kuidas regulatiivliivakastidest riigi tasandil saadud teadmised võivad

aidata kaasa tõenditel põhineva poliitika kujundamisele ELi tasandil.

4 Teadusuuringute ja innovatsiooni tähtsus ELi idu- ja kasvufirmade strateegia jaoks – nõukogu

järeldused https://data.consilium.europa.eu/doc/document/ST-13357-2025-INIT/et/pdf. 5 Komisjoni ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS – Euroopa

innovatsioonimäärus – COM(2026) 567. 6 Nõukogu järeldused, milles käsitletakse regulatsiooni testkeskkondi ja katsetamissätteid kui

innovatsioonisõbraliku, tulevikukindla ja vastupidava õigusraamistiku vahendeid, mis aitavad

lahendada murrangulisi probleeme digiajastul https://data.consilium.europa.eu/doc/document/ST-

13026-2020-INIT/et/pdf.

ET 3 ET

Vastuseks on komisjon juba vastu võtnud komisjoni talituste 2023. aasta töödokumendi

regulatiivse õppe kohta ELis,7 mis on üks Euroopa uue innovatsioonikava8 meetmetest, ning

viinud 2025. aastal läbi liikmesriikide järeluuringu regulatiivliivakastide kohta.

• Kooskõla muude liidu tegevuspõhimõtetega

Käesolevas ettepanekus tunnustatakse kõiki poliitikavaldkondi, kus liit ja liikmesriigid

pädevust jagavad. Ettepanekus võetakse arvesse, et regulatiivliivakastid on õigusaktidesse

juba lisatud või moodustavad osa menetluses olevatest seadusandlikest ettepanekutest,

sealhulgas:

• tehisintellekti valdkonnas, mille puhul määrusega (EL) 2024/1689 (tehisintellekti

käsitlev määrus)9 nõutakse, et liikmesriigid looksid selles valdkonnas vähemalt ühe

kogu riiki hõlmava regulatiivliivakasti;

• biotehnoloogia valdkonnas vastavalt komisjoni 2025. aasta ettepanekule Euroopa

biotehnoloogiamääruse kohta,10 milles esitati viis regulatiivliivakasti raamistikku

ning mis tugineb ELi konkurentsivõimelise ja kestliku biomajanduse strateegilisele

raamistikule11;

• küberturvalisuse valdkonnas, mille puhul 2024. aastal vastu võetud küberkerksuse

määrusega12 lisati sätted digielemente sisaldavate toodete regulatiivliivakastide

kohta;

• avaliku sektori koostalitlusvõime valdkonnas, kus 2024. aastal vastu võetud

koostalitleva Euroopa määrusega13 nähti ette luua piiriülesed regulatiivliivakastid;

• energia-, kliima- ja keskkonnaalase ülemineku valdkonnas, kus 2024. aastal võeti

vastu nullnetotööstuse määrus,14 mis sisaldab ka regulatiivliivakaste käsitlevaid

7 SWD(2023) 277/2 final, https://research-and-innovation.ec.europa.eu/document/download/fc6f35cd-

a8d6-4770-aefe-c09ca85cff8c_en?filename=swd_2023_277_f1.pdf. 8 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „Euroopa uus innovatsioonikava“ (COM(2022) 332 final), https://eur-

lex.europa.eu/legal-content/ET/TXT/?uri=CELEX:52022DC0332. 9 Euroopa Parlamendi ja nõukogu 13. juuni 2024. aasta määrus (EL) 2024/1689, millega nähakse ette

tehisintellekti käsitlevad ühtlustatud õigusnormid ja muudetakse määrusi (EÜ) nr 300/2008, (EL)

nr 167/2013, (EL) nr 168/2013, (EL) 2018/858, (EL) 2018/1139 ja (EL) 2019/2144 ja direktiivid

2014/90/EL, (EL) 2016/797 ja (EL) 2020/1828 (tehisintellektimäärus) (ELT L, 2024/1689, 12.7.2024,

ELI: http://data.europa.eu/eli/reg/2024/1689/oj). 10 Ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, millega kehtestatakse meetmete

raamistik liidu biotehnoloogia- ja biotootmissektorite tugevdamiseks eelkõige tervisevaldkonnas ning

muudetakse määrusi (EÜ) nr 178/2002, (EÜ) nr 1394/2007, (EL) nr 536/2014, (EL) 2019/6,

(EL) 2024/795 ja (EL) 2024/1938 (Euroopa biotehnoloogiamäärus), COM(2025) 1022 final, EUR-Lex -

52025PC1022(01) - EN - EUR-Lex. 11 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „ELi konkurentsivõimelise ja kestliku biomajanduse strateegiline raamistik“,

COM(2025) 960 final, https://eur-lex.europa.eu/legal-

content/EN/TXT/PDF/?uri=CELEX:52025DC0960. 12 Euroopa Parlamendi ja nõukogu 23. oktoobri 2024. aasta määrus (EL) 2024/2847, mis käsitleb

digielemente sisaldavate toodete küberturvalisuse horisontaalseid nõudeid ja millega muudetakse

määrusi (EL) nr 168/2013 ja (EL) 2019/1020 ning direktiivi (EL) 2020/1828 (küberkerksuse määrus)

(EMPs kohaldatav tekst) https://eur-lex.europa.eu/eli/reg/2024/2847/oj/eng. 13 Euroopa Parlamendi ja nõukogu 13. märtsi 2024. aasta määrus (EL) 2024/903, millega kehtestatakse

meetmed avaliku sektori koostalitlusvõime kõrge taseme tagamiseks kogu liidus (Koostalitleva Euroopa

määrus) Regulation - EU - 2024/903 - EN - EUR-Lex. 14 Euroopa Parlamendi ja nõukogu 13. juuni 2024. aasta määrus (EL) 2024/1735, millega kehtestatakse

meetmete raamistik Euroopa nullnetotehnoloogia toodete tootmise ökosüsteemi tugevdamiseks ja

ET 4 ET

sätteid. 2026. aasta merendustööstuse strateegias, mis aitab Euroopal saada

merendustehnoloogia valdkonnas juhtpositsioonile, suurendada tööstuslikku

suveräänsust ja saavutada kaksikülemineku eesmärk, julgustatakse liikmesriike

veelgi toetama innovaatiliste lahenduste kiiret kasutuselevõttu, muu hulgas

katsestendide ja regulatiivse eksperimenteerimise kaudu15. Ühtlasi on 2026. aasta

dokumendis „Strateegia väikeste moodulreaktorite arendamiseks ja kasutuselevõtuks

Euroopas“ märgitud, et komisjon abistab liikmesriike väikeste moodulreaktorite

regulatiivliivakastide väljatöötamisel, tuginedes nullnetotööstuse määruse16 kohastele

regulatiivliivakastidele;

• finantssektori puhul, kus hajusraamatu tehnoloogial põhinevate turutaristute suhtes

kohaldati määruses (EL) 2022/85817 (hajusraamatu tehnoloogia katsekorra määrus)

sätestatud katsekorda;

• liikuvuse valdkonnas, kus regulatiivliivakaste käsitletakse Euroopa autotööstuse

tegevuskavas, mille eesmärk on suurendada autonoomsete sõidukite turuvalmidust ja

turustamist. Need on lisatud ka komisjoni ettepanekusse, mille eesmärk on

hõlbustada innovaatiliste kahesuguse kasutusega transpordilahenduste kiiremat ja

autonoomsemat väljatöötamist tsiviil- ja sõjaväeliste asutuste koostöös;18.

• bioteaduste ja ravimisektoris, kus regulatiivliivakasti käsitlevad sätted lisati

poliitiliselt kokku lepitud määrusesse, milles sätestatakse liidu kord inimtervishoius

kasutatavate ravimite müügilubade andmise ja järelevalve kohta ning millega

kehtestatakse Euroopa Ravimiametit reguleerivad reeglid,19 meditsiiniseadmeid

käsitleva ELi määruse ja in vitro diagnostika meditsiiniseadmeid käsitleva ELi

määruse20 kavandatavatesse muudatustesse ning Euroopa

biotehnoloogiamäärusesse,21 milles käsitletakse ka toiduahela valdkonna

muudetakse määrust (EL) 2018/1724 (EMPs kohaldatav tekst) Regulation - EU - 2024/1735 - EN -

EUR-Lex. 15 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „ELi merendustööstuse strateegia“, COM(2026) 111 (final), https://eur-

lex.europa.eu/legal-content/EN/TXT/?uri=celex:52026DC0111. 16 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „Strateegia väikeste moodulreaktorite arendamiseks ja kasutuselevõtuks“

(COM(2026) 117 final), https://eur-lex.europa.eu/legal-content/ET/TXT/?uri=CELEX:52026DC0117. 17 Euroopa Parlamendi ja nõukogu 30. mai 2022. aasta määrus (EL) 2022/858, mis käsitleb hajusraamatu

tehnoloogial põhinevate turutaristute katsekorda ning millega muudetakse määrusi (EL) nr 600/2014 ja

(EL) nr 909/2014 ning direktiivi 2014/65/EL (EMPs kohaldatav tekst) Regulation - 2022/858 - EN - dlt

- EUR-Lex. 18 Ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, millega kehtestatakse meetmete

raamistik, et hõlbustada kaitseotstarbelise varustuse, sõjaliste kaupade ja sõjaväelaste transporti liidus

(COM(2025) 847 final), https://eur-lex.europa.eu/legal-content/ET/TXT/?uri=celex:52025PC0847. 19 Ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, milles sätestatakse liidu kord

inimtervishoius kasutatavate ravimite müügilubade andmise ja järelevalve kohta ning millega

kehtestatakse Euroopa Ravimiametit reguleerivad eeskirjad, muudetakse määrust (EÜ) nr 1394/2007 ja

määrust (EL) nr 536/2014 ning tunnistatakse kehtetuks määrus (EÜ) nr 726/2004, määrus (EÜ) nr

141/2000 ja määrus (EÜ) nr 1901/2006 EUR-Lex - 52023PC0193 - ET - EUR-Lex. 20 EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, millega muudetakse määrusi (EL) 2017/745

ja (EL) 2017/746 seoses meditsiiniseadmeid ja in vitro diagnostikameditsiiniseadmeid käsitlevate

eeskirjade lihtsustamisega ja neist tuleneva koormuse vähendamisega, määrust (EL) 2022/123 seoses

Euroopa Ravimiameti toega meditsiiniseadmete eksperdirühmadele ja määrust (EL) 2024/1689 seoses

I lisas osutatud liidu ühtlustamisõigusaktide loeteluga EUR-Lex - 52025PC1023 - EN - EUR-Lex. 21 Ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, millega kehtestatakse meetmete

raamistik liidu biotehnoloogia- ja biotootmissektorite tugevdamiseks eelkõige tervisevaldkonnas ning

muudetakse määrusi (EÜ) nr 178/2002, (EÜ) nr 1394/2007, (EL) nr 536/2014, (EL) 2019/6, (EL)

2024/795 ja (EL) 2024/1938.

ET 5 ET

regulatiivliivakaste.Komisjoni strateegias, mille eesmärk on muuta liit maailma

kõige atraktiivsemaks bioteadustega tegelemise kohaks aastaks 2030, on märgitud, et

õigusraamistikud peavad reageerima kujunemisjärgus tehnoloogiatele ja pidama

sammu teadusliku arenguga. Tulevased seadusandlikud meetmed peaksid ühendama

katsetamissätted, erandid ja katsekeskkonnad, nt regulatiivliivakastid22.

Käesolevas ettepanekus keskendutakse liikmesriikide loodud riiklikele regulatiivliivakastidele

ning see ei mõjuta regulatiivliivakaste käsitlevaid kehtivaid liidu õigusnorme ega komisjoni

poolt uute seadusandlike algatuste kohta tehtud ettepanekuid. Selles julgustatakse liikmesriike

tuginema liidu õiguse alusel loodud regulatiivliivakastide suhtes kehtivale õigusraamistikule,

kui see on asjakohane.

2. ÕIGUSLIK ALUS, SUBSIDIAARSUS JA PROPORTSIONAALSUS

• Õiguslik alus

Käesoleva ettepaneku õiguslik alus on Euroopa Liidu toimimise lepingu artikli 173 lõige 3 ja

artikkel 292. ELi toimimise lepingu artikli 292 kohaselt võib nõukogu võtta vastu soovitusi ja

teeb otsuseid komisjoni ettepaneku põhjal kõikidel juhtudel, mille puhul aluslepingutes

sätestatakse, et ta peab õigusakti vastu võtma komisjoni ettepaneku põhjal.

ELi toimimise lepingu artikli 173 kohaselt peavad liit ja liikmesriigid tagama liidu tööstuse

konkurentsivõimelisuseks vajalikud tingimused. See hõlmab meetmeid, mille eesmärk on

kasutada paremini ära innovatsiooni, teadusuuringute ja tehnoloogia arendamise poliitika

tööstuslikku potentsiaali. Eelkõige aitab liit artikli 173 lõike 3 kohaselt kaasa artikli 173

lõikes 1 sätestatud eesmärkide saavutamisele sellise poliitika ja tegevuse kaudu, mida ta järgib

aluslepingute muude sätete kohaselt.

Algatusega ei tehta ettepanekut laiendada liidu reguleerimispädevust ega panda

liikmesriikidele siduvaid kohustusi. Liikmesriigid otsustavad kohalike olude põhjal, kuidas

nad käesolevat nõukogu soovitust rakendavad, võttes arvesse asjakohaseid kohaldatavaid liidu

õigusakte.

• Subsidiaarsus (ainupädevusse mittekuuluva valdkonna puhul)

Käesolev ettepanek on kooskõlas Euroopa Liidu lepingu (ELi leping) artikli 5 lõikes 3

sätestatud subsidiaarsuse põhimõttega.

Regulatiivliivakastide, sealhulgas piiriüleste regulatiivliivakastide kasutamine peaks

lähiaastatel kogu liidus jätkuvalt kasvama. Kiiresti muutuvas keskkonnas on eri sektorites ja

liikmesriikides hakatud mõistet „regulatiivliivakast“ erinevalt tõlgendama ja kohaldama. Kui

meetmeid võtavad ühtlustamata valdkondades üksnes liikmesriigid, on tõenäoliselt

tulemuseks erinevad lähenemisviisid, mis tekitavad märkimisväärseid koordineerimiskulusid

nendele liikmesriikidele, kes soovivad teha koostööd või töötada välja ühiseid tavasid.

Seepärast on vaja kooskõlastatud lähenemisviisi, mis võimaldab minimeerida

regulatiivliivakasti kasutavate Euroopa ettevõtjate ja ametiasutuste toimingukulusid.

Ettepanekuga nähakse ette tõhus vahend, mille raames luuakse ELi ühine võrdlusraamistik,

vähendatakse liikmesriikidevahelist killustatust ja lõppkokkuvõttes toetatakse ühtset turgu.

22 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „Vali bioteadustega tegelemise kohaks Euroopa. Strateegia ELi muutmiseks

maailma kõige atraktiivsemaks bioteadustega tegelemise kohaks aastaks 2030“ (COM(2025)525 final),

https://eur-lex.europa.eu/legal-content/ET/TXT/?uri=celex:52025DC0525.

ET 6 ET

Käesoleva ettepanekuga püütakse arendada kollektiivset tegutsemist, aidates luua soodsaid

raamtingimusi ja pakkudes ühist lähenemisviisi regulatiivsele eksperimenteerimisele.

Ettepaneku eesmärk on saavutada sihipärasemaid ja tõhusamaid tulemusi, kui see oleks

võimalik eraldiseisvate riiklikute algatuste kaudu. Ühine lähenemisviis lihtsustaks

regulatiivliivakastide piiriülest loomist liikmesriikide vahel, jäädes samal ajal piisavalt

paindlikuks, et võtta arvesse liikmesriikide erinevaid kogemusi ja valmisolekut innovatsiooni

kiirendamisel ning asjakohaseid kohaldatavaid liidu õigusakte.

Kavandatud lähenemisviis on kooskõlas loogikaga, mis on aluseks hiljutistele liidu

seadusandlikele algatustele, eelkõige tehisintellektimäärusele ja Koostalitleva Euroopa

määrusele, milles mõlemas tunnistatakse, et riiklikud regulatiivliivakastid üksi ei suuda

tagada piiriülest regulatiivset õppimist, tulemuste vastastikust tunnustamist ega innovaatiliste

lahenduste laiendamist kogu ühtse turu piires.

Seega loob ettepanek liidu lisaväärtust, edendades ühist regulatiivset eksperimenteerimist eri

jurisdiktsioonides ja vähendades novaatorite jaoks riiklike kordade erinevustest tulenevaid

kulusid, ent jättes riiklike regulatiivliivakastide kavandamise ja rakendamise siiski

liikmesriikide hooleks.

• Proportsionaalsus

Käesolev ettepanek on kooskõlas ELi lepingu artikli 5 lõikes 4 sätestatud proportsionaalsuse

põhimõttega. Kavandatava nõukogu soovituse sisu ega vorm ei lähe kaugemale sellest, mis on

vajalik, et saavutada kogu ELis lähenemisviiside minimaalne järjepidevus.

Käesoleva algatuse õiguslik seisund peaks tagama liikmesriikide isevastutuse ja heakskiidu.

Käesolev soovitus aitab liikmesriikidel ja liidul välja töötada ja rakendada regulatiivliivakasti

raamistikke ning edendada regulatiivset õppimist. Väga oluline on tagada, et ELi

lähenemisviiside vahel valitseks vähemalt minimaalne kooskõla. Soovituses rõhutatakse, et

regulatiivliivakastide loomisel ja rakendamisel on oluline läbipaistvus ning et tuleks järgida

põhimõtet „nii avatud kui võimalik, nii suletud kui vajalik“. Ühtlasi soovitatakse kaaluda

eksperimenteerimisega seotud riskijuhtimismeetmeid.

• Vahendi valik

Kavandatavas nõukogu soovituses antakse liikmesriikidele suuniseid selle kohta, kuidas

määratleda regulatiivliivakaste ja leppida kokku ühised põhimõtted nende loomiseks,

kavandamiseks, rakendamiseks, sealhulgas piiriüleselt, ning hindamiseks ja regulatiivseks

õppeks. Komitee soovitab liikmesriikidel toetada oma innovatsioonisektorit ja ametiasutusi

ning võtta asjakohaseid meetmeid teadlikkuse suurendamiseks.

Nõukogu soovituse kasuks otsustamisega tagatakse, et kõik liikmesriigid on poliitilisel

tasandil aktiivselt kaasatud ja pühendunud, kuid samas võimaldab see piisavat paindlikkust,

võttes arvesse, et liikmesriigid on õigusraamistike, ressursside kättesaadavuse ja innovatsiooni

ökosüsteemi küpsuse osas erinevatel lähtepositsioonidel.

3. JÄRELHINDAMISE, SIDUSRÜHMADEGA KONSULTEERIMISE JA MÕJU

HINDAMISE TULEMUSED

• Praegu kehtivate õigusaktide järelhindamine või toimivuse kontroll

Tegemist on uue algatusega, seega eelnevat hindamist ei tehtud.

ET 7 ET

• Konsulteerimine sidusrühmadega

Käesoleva algatuse puhul on võimalik tugineda põhjalikule sidusrühmadega konsulteerimise

kavale, mis koostati Euroopa innovatsioonimääruse jaoks.

Enamik sidusrühmadega konsulteerimise käigus regulatiivliivakastide kohta arvamust

avaldanutest23 leidis, et regulatiivliivakasti määratlemine ELi tasandil aitaks saavutada

ühtsema käsitlusviisi kogu Euroopas, et täiendavate võimaluste loomine piiriüleste ELi

tasandi regulatiivliivakastide kasutuselevõtuks aitaks neid laialdasemalt rakendada ning et

regulatiivliivakastide loomine hõlbustaks uute kujunemisjärgus tehnoloogiate kasutuselevõttu.

Vastajad, kes märkisid, et neil on regulatiivliivakastides osalemise või nende loomisega

seotud kogemusi, on eespool esitatud väidetega rohkem nõus kui need, kel sellised

kogemused puuduvad.

Euroopa innovatsioonimäärust käsitlevale tagasisidekorjele vastuseks esitatud

seisukohavõttudes rõhutasid sidusrühmad, et innovaatiliste lahenduste katsetamiseks ei ole

piisavalt võimalusi ning et regulatiivliivakastidel on väga oluline roll piiratud

katsetamisvõimaluste probleemi lahendamisel liidus, samuti märgiti, et liidu rahastamine ja

regulatiivsed menetlused on aeglased, dubleerivad ja kättesaamatud. Mõned vastajad leidsid,

et liikmesriikide olemasolevad õigussüsteemid on aegunud ja tehnoloogia muutustega sammu

pidamiseks liiga aeglased ning sageli juhtub, et uute tehnoloogiate, näiteks tehisintellekti ja

biotehnoloogia suhtes kohaldatakse vananenud eeskirju.

Sidusrühmadega peetud vestluste käigus suhtusid tööstussektori, VKEde ja idufirmade

ühendused regulatiivliivakastide ühtlustamise ideesse positiivselt, kuna see võimaldab

innovaatilistel toodetel siseneda turule kontrollitud tingimustes ning vähendada

turulejõudmiseks kuluvat aega. Finantssektori esindajad tegid ettepaneku luua idufirmade

jaoks regulatiivliivakastide jurisdiktsioon, millega nähakse ette lihtsustatud kord ettevõtete

asutamiseks ja tegevuslubade saamiseks ning ühtlustatud äritegevuse eeskirjad piiriülese

tegevuse hõlbustamiseks.

2025. aasta aprillis algatas komisjon nõukogu eesistujariigi Poola juhtimisel nõukogu

konkurentsivõime ja majanduskasvu töörühmas (parem õigusloome) liikmesriikide seas

uuringu regulatiivliivakastide riigisisese kasutamise kohta. See põhineb sarnasel uuringul,

mille korraldas 2021. aastal nõukogu eesistujariigiks olnud Sloveenia. 2025. aasta septembris

tutvustati Taani eesistumise ajal samas töörühmas24 kõige värskemaid andmeid. Ettekandele

järgnenud arutelu käigus esitas kaks liikmesriiki täiendavaid andmeid regulatiivliivakasti

tavade kohta oma riigis ja muid vastuseid koguti kuni 2026. aasta jaanuarini. Komisjoni poolt

2026. aasta märtsis avaldatud lõpparuandes saab tutvuda kõikide esitatud andmetega25.

• Eksperdiarvamuste kogumine ja kasutamine

Lisaks konsultatsioonide käigus saadud teabele on käesolevas ettepanekus arvesse võetud

viimastel aastatel kogutud ulatuslikke tõendeid, aruandeid ja uuringuid. Peamised tõendite

allikad on kaks liikmesriikide seas korraldatud uuringut, mille komisjon viis läbi 2021. ja

23 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14593-European-Innovation-

Act/public-consultation_et. 24 https://data.consilium.europa.eu/doc/document/WK-12252-2025-INIT/en/pdf. 25 Euroopa Komisjon, teadusuuringute ja innovatsiooni peadirektoraat, Vuorinen, H., Isakovic, S. M. ja

Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report (Regulatiivliivakastide

kasutamine ELi liikmesriikides – 2025. aasta uuringu aruanne), Euroopa Liidu Väljaannete Talitus, 2026,

https://data.europa.eu/doi/10.2777/9535645.

ET 8 ET

2025. aastal, 2026. aastal koostatud hinnang innovatsioonipõhimõtte järgimise olukorra kohta

ELi õigusaktide ettevalmistamisel ning komisjoni poolt iga kahe aasta tagant esitatav aruanne

ELi teaduse, teadusuuringute ja innovatsiooni tulemuslikkuse kohta.

2025. aastal korraldas komisjon liikmesriikide seas uuringu regulatiivliivakastide

kasutamise kohta riiklikul tasandil26. Uuringu kohaselt on riiklikul tasandil loodud 132

regulatiivliivakasti 15 liikmesriigis, kuid peamiselt Saksamaal ja Prantsusmaal (2021. aasta

uuringu ajal oli loodud 40 regulatiivliivakasti). Käesolev aruanne näitab, et liikmesriikide

kasutatavad lähenemisviisid erinevad näiteks õigusliku aluse (horisontaalne või

sektoripõhine), regulatiivliivakasti raamistike suhtes kehtestatud geograafiliste piirangute

(mõnel juhul võimaldatakse eksperimenteerimist ainult mõnes konkreetses piirkonnas), teistes

liikmesriikides registreeritud ettevõtjatele juurdepääsu tagamise, järelevalve ja hindamise ning

muude aspektide poolest.

Kui vaadelda regulatiivliivakastide ja innovatsiooni kaasamist ELi õigusaktide

ettevalmistamisse üldisemalt, leiti 2026. aasta hindamise27 käigus, et katsetamissätteid,

katseprojekte või regulatiivliivakaste on käsitletud aastatel 2020–2025 tehtud

mõjuhinnangutest ligikaudu 10–15 % puhul, eelkõige digi- ja finantsvaldkonnas ning

kujunemisjärgus tehnoloogiatega seotud poliitikavaldkondades. Ekspertide sõnul näivad

regulatiivliivakastid olevat sulandunud Euroopa Komisjoni parema õigusloome tegevuskavva

paremini kui muud vahendid.

Lisaks pandi regulatiivliivakastide pakutavatele võimalustele erilist rõhku komisjoni iga kahe

aasta tagant avaldatava aruande „ELi tulemused teaduse, teadusuuringute ja innovatsiooni

valdkonnas“ kahes viimases väljaandes. 2024. aasta aruandes rõhutati, et kohandatav

õigusraamistik ja ennetav standardimisstrateegia on innovatsiooni edendamisel endiselt

keskse tähtsusega28. Aruande koostajad selgitavad, et ELi keskendumine regulatiivliivakastide

kasutamisele peaks hõlbustama teadusuuringute integreerimist turule, pakkudes samas

vajalikku seadusandlikku paindlikkust, et pidada sammu tehnoloogia kiire arenguga. 2022.

aasta aruande koostajad rõhutasid, et uute tavade, tehnoloogiate ja ärimudelite esilekerkimine

ning innovatsiooni kiirenemine nõuavad paindlikumaid ja eksperimentaalsemaid

lähenemisviise reguleerimisele, näiteks regulatiivliivakaste29.

• Mõjuhinnang

Käesolev ettepanek ei nõua eraldi mõjuhinnangut, kuna kavandatav õigusakt ei ole õiguslikult

siduv.

Sellele vaatamata on alates 2026. aasta juulist igale liidu määrusele ja ettepanekule, mis

sisaldavad regulatiivliivakastidega seotud sätteid, lisatud ka mõjuhinnang või komisjoni

talituste analüütiline töödokument30.

26 Ibid. 27 Euroopa Komisjon: Teadusuuringute ja innovatsiooni peadirektoraat, Renda, A., Dell’’Aquila, M.,

Nyoka Rukudzo, I., Vu, H. jt, „Assessment of the state of play of the innovation principle in the preparation of

EU legislation“ (Hinnang innovatsioonipõhimõtte järgimise kohta ELi õigusaktide ettevalmistamisel), Euroopa

Liidu Väljaannete Talitus, 2026, https://data.europa.eu/doi/10.2777/8779303. 28 2024. aasta aruanne tulemuste kohta teaduse, teadusuuringute ja innovatsiooni valdkonnas, lk 349,

https://ec.europa.eu/assets/rtd/srip/2024/ec_rtd_srip-report-2024-chap-05.pdf. 29 2022. aasta aruanne tulemuste kohta teaduse, teadusuuringute ja innovatsiooni valdkonnas, lk 17,

https://data.europa.eu/doi/10.2777/78826. 30 SWD(2020) 201 final; SWD(2020) 201 final; SWD(2022) 721 final; SWD(2023) 219 final;

SWD(2022) 282 final; SWD(2023) 192 final; SWD(2025) 1050 final; SWD(2026) 450 final.

ET 9 ET

• Põhiõigused

Ettepaneku üks peamisi eesmärke on toetada regulatiivliivakastide töös osalevaid liikmesriike

ja organisatsioone ning tagada, et loapõhine eksperimenteerimine toetab innovatsiooni,

säilitades samal ajal usaldusväärsuse ning põhiõiguste ja -väärtuste kaitse. Kehtestada tuleb

eetilised ja õiguslikud kaitsemeetmed (nt andmete kogumine, läbipaistvus, põhiõiguste kaitse,

aus konkurents) ning nõuetekohaselt hallata näiteks tervise, ohutuse või põhiõigustega seotud

riske. Ettepanek põhineb mittediskrimineerival lähenemisviisil ja suurendab

regulatiivliivakastide läbipaistvust.

4. MÕJU EELARVELE

Käesoleva nõukogu soovitusega kaasnevat kulude muutumist on keeruline hinnata, kuna

soovitus ei ole siduv. Liikmesriikides soovituse rakendamise jälgimise ja hindamise alusel

võib kuluprognooside koostamine olla tulevikus võimalik.

5. MUU TEAVE

• Rakenduskavad ning järelevalve, hindamise ja aruandluse kord

Selleks et toetada liikmesriike ja sidusrühmi käesoleva soovituse rakendamisel, kasutatakse

täielikult ära olemasolevaid juhtimisstruktuure, näiteks nõukogu konkurentsivõime ja

majanduskasvu töörühma.

Ettepanekus rõhutatakse järelevalve, hindamise ja aruandluse tähtsust seoses

regulatiivliivakastides toimuva regulatiivse õppega, mis aitab tagada õigusaktide

eesmärgipärasuse.

• Selgitavad dokumendid (direktiivide puhul)

Ei kohaldata.

• Ettepaneku sätete üksikasjalik selgitus

Kavandatav nõukogu soovitus sisaldab järgmisi osi:

– Pärast kõnealuse küsimuse ja ettepaneku poliitilise tausta tutvustamist põhjendustes

selgitatakse ettepaneku kohaldamisala. Tehakse ettepanek mõiste

„regulatiivliivakast“ määratluse kohta, mis tugineb rahvusvaheliselt kasutatavate

erinevate määratluste põhielementidele. Määratletakse ka muud asjakohased mõisted,

sealhulgas „eksperimenteerimine“, „kontrollitud keskkond“, „pädev asutus“ ja

„piiriülesed regulatiivliivakastid“.

– Seejärel esitatakse regulatiivliivakastide loomise põhimõtted ning soovitatakse

liikmesriikidel nendes liidu ühise raamistiku miinimumaspektides kokku leppida.

Eespool nimetatud põhimõtted on kavandatud nii, et need toetaksid

regulatiivliivakastide kujundamist ja kavandamist kõikidel tasanditel ja kõikides

sektorites. Need põhimõtted sõnastati parimate kättesaadavate tavade põhjal, võttes

arvesse liikmesriikides 2025. aastal teostatud uuringu31 tulemusi.

31 Euroopa Komisjon, teadusuuringute ja innovatsiooni peadirektoraat, Vuorinen, H., Isakovic, S. M. ja

Bonel, E., Use of regulatory sandboxes in EU Member States – 2025 survey report (Regulatiivliivakastide

kasutamine ELi liikmesriikides – 2025. aasta uuringu aruanne), Euroopa Liidu Väljaannete Talitus, 2026,

https://data.europa.eu/doi/10.2777/9535645.

ET 10 ET

– Eraldi punktis kirjeldatakse miinimumaspekte, milles piiriüleste

regulatiivliivakastide suhtes tuleks kokku leppida, et aidata kõigi liikmesriikide

innovaatilistel ettevõtjatel oma tooteid eri liikmesriikides ulatuslikumalt katsetada,

mis aitab neil kasvada. Pädevate asutuste koostöö piiriülestes regulatiivliivakastides

võib hõlbustada koordineeritud järelevalvet, suurendada regulatiivset sidusust ja

rakendada piiriülest innovatsioonisünergiat. Samuti võimaldab see mitme

liikmesriigi jaoks olulise innovatsiooni korral edendada ühist õppimist ning jagada

regulatiivliivakastide loomise, haldamise ja järelevalvega seotud kulusid.

– Eksperimentides ning regulatiivliivakastides osalemise kestus ja muud täpsustamist

vajavad tingimused on loetletud allpool. Selleks et regulatiivliivakastid saaksid

tõhusalt toimida, peaksid pädevad asutused kasutama läbipaistvaid ja objektiivseid

osalemisprotsesse, sealhulgas kehtestama kõlblikkuskriteeriumid, taotlemiskorra

ning selged osalemistingimused, samuti intellektuaalomandiga seotud õiguste ja

kohustuste käsitlemise tingimused, et tagada prognoositav ning innovaatiliste

lahenduste väljatöötamist toetav keskkond. Ühtlasi tuleks osalemistingimustes

eelnevalt selgelt kindlaks määrata kõik osalejatele ette nähtud asjakohased

toetusmeetmed, nagu regulatiivne nõustamine, koolitusvõimalused ja vajaduse korral

rahastamine. See aitab tagada, et regulatiivliivakastides sündinud innovatsiooni on

võimalik piisaval määral edasi arendada ja et regulatiivliivakastis edukad katsed

läbinud innovaatilised lahendused saaks edukalt ka laiemale turule viia. Seejärel

vaadeldakse konkreetseid punkte, mis on seotud läbipaistvuse ja

mittediskrimineeriva juurdepääsu tagamisega regulatiivliivakastidele.

– Regulatiivset õppimist ja järelmeetmeid käsitleva soovituse kohaselt peaksid

liikmesriigid nõudma, et pärast regulatiivliivakasti töö lõpetamist analüüsiksid

pädevad asutused kogu kättesaadavat teavet ja hindaksid vajadust õigusraamistiku

muutmise järele. Ühtlasi on soovituses märgitud, et regulatiivliivakasti tegevuses

osalejatel peaks olema võimalik saada väljumisaruanne, et kiirendada

regulatiivliivakastis katsetatud innovaatiliste lahenduste vastavushindamist,

standardimist või müügiloa saamist liikmesriigi turul.

– Viimases osas täpsustatakse, kuidas toetatakse ja jälgitakse soovituse järelmeetmeid.

ET 11 ET

2026/0267 (NLE)

Ettepanek:

NÕUKOGU SOOVITUS,

milles käsitletakse regulatiivliivakastidega seotud ühiseid põhimõtteid, et toetada

innovatsiooni ja tulevikukindla õigusraamistiku loomist

EUROOPA LIIDU NÕUKOGU,

võttes arvesse Euroopa Liidu toimimise lepingut, eriti selle artiklit 292 koostoimes artikli 173

lõikega 3,

võttes arvesse Euroopa Komisjoni ettepanekut

ning arvestades järgmist:

(1) Innovatsioon aitab suurendada liidu konkurentsivõimet ja jõukust. Samas on teatavate

valdkondade õigusraamistikud kiiresti muutuvate ja kujunemisjärgus tehnoloogiate

arengule jalgu jäänud. Novaatorid, kes toovad turule uusi tooteid ja teenuseid, mis ei

sobi hästi olemasolevatesse õigusraamistikesse, tunnevad puudust õiguskindlusest.

(2) Innovatsioon põhineb eksperimenteerimisel ja katsetamisel. Regulatiivliivakastid on

sihipärane eksperimenteerimisvõimalus, mis võib aidata komisjonil ja liikmesriikidel

hinnata, kas kehtivad õiguslikud nõuded on endiselt eesmärgipärased või vajavad

kiiresti areneva tehnoloogia tõttu kohandamist. Regulatiivliivakastid luuakse tavaliselt

iga konkreetse juhtumi jaoks eraldi ja nende kohaldamisala on selgelt kindlaks

määratud. Need pakuvad praktilist võimalust õppida tegevuse käigus ja annavad

vahetu ülevaate kujunemisjärgus innovatsioonist, sealhulgas selle riskidest ja mõjust.

Ühtlasi võimaldavad regulatiivliivakastid vähendada turule sisenemise tõkkeid ja

tõhustada teabevahetust ning koordineerimist eri ametiasutuste ja novaatorite vahel,

eelkõige sektoriülese innovatsiooni valdkonnas. Regulatiivliivakastides osalemist ei

tohiks siiski käsitleda kui alalist erandit regulatiivsetest nõuetest või alternatiivset

võimalust regulatiivsete lubade hankimiseks liidus.

(3) Viimastel aastatel on regulatiivliivakaste kogu liidus üha rohkem tutvustatud kui

vahendit innovatsiooni edendamiseks, sealhulgas nõukogu järeldustes,1 kus

julgustatakse jagama teadmisi seoses parimate tavade ja liikmesriikide algatustega,

ning peamistesse liidu õigusaktidesse on lisatud regulatiivliivakaste käsitlevad sätted2.

1 Nõukogu järeldused, milles käsitletakse regulatsiooni testkeskkondi ja katsetamissätteid kui

innovatsioonisõbraliku, tulevikukindla ja vastupidava õigusraamistiku vahendeid, mis aitavad

lahendada murrangulisi probleeme digiajastul https://data.consilium.europa.eu/doc/document/ST-

13026-2020-INIT/et/pdf. 2 Euroopa Parlamendi ja nõukogu 13. märtsi 2024. aasta määrus (EL) 2024/903, millega kehtestatakse

meetmed avaliku sektori koostalitlusvõime kõrge taseme tagamiseks kogu liidus (Koostalitleva Euroopa

määrus) (ELT L, 2024/903, 22.3.2024, ELI: http://data.europa.eu/eli/reg/2024/903/oj); Euroopa

Parlamendi ja nõukogu 13. juuni 2024. aasta määrus (EL) 2024/1689, millega nähakse ette

tehisintellekti käsitlevad ühtlustatud õigusnormid ja muudetakse määrusi (EÜ) nr 300/2008, (EL)

nr 167/2013, (EL) nr 168/2013, (EL) 2018/858, (EL) 2018/1139 ja (EL) 2019/2144 ja direktiivid

2014/90/EL, (EL) 2016/797 ja (EL) 2020/1828 (tehisintellektimäärus) (ELT L, 2024/1689, 12.7.2024,

ELI: http://data.europa.eu/eli/reg/2024/1689/oj); Euroopa Parlamendi ja nõukogu 13. juuni 2024. aasta

määrus (EL) 2024/1735, millega kehtestatakse meetmete raamistik Euroopa nullnetotehnoloogia

ET 12 ET

Nende algatuste eesmärk on juhtida tähelepanu võimalustele, mida

regulatiivliivakastid pakutavad komisjoni soovituses 2003/361/EÜ3 määratletud

väikeste ja keskmise suurusega ettevõtjate (VKEd) ja komisjoni soovituses (EL)

2026/7204 määratletud innovaatiliste idu- ja kasvufirmade toetamiseks ning

tõenduspõhise poliitikakujundamise jaoks vajaliku teabe hankimiseks. Komisjon on

veel kord kinnitanud oma kindlat kavatsust valmistada ette seadusandlikud

ettepanekud, mis sisaldavad innovatsioonisõbralikke ja tulevikukindlaid eeskirju,

luues tasakaalu õiguskindluse ja tehnoloogia arenguga kohanemise võime vahel,5

kaitstes samas tõhusalt avaliku huvi eesmärke.

(4) Kuna regulatiivliivakastidele pööratakse üha rohkem tähelepanu, on nende eesmärgi,

kohaldamisala ja kontseptsiooni tõlgenduste erinevused muutunud nähtavamaks.

Regulatiivliivakastide määratlus ning nende loomise ja rakendamise tingimused on

liikmesriigiti erinevad, mis muudab novaatorite olukorra veelgi keerukamaks. Ühtne

käsitlus võiks hõlbustada innovaatiliste lahenduste väljatöötamist kogu siseturul ja

vähendada regulatiivseid tõkkeid, mis tulenevad sellest, et liikmesriigid kohaldavad

eksperimenteerimise suhtes eri lähenemisviise. Ühtlasi võiks see ühine arusaam olla

piisavalt paindlik, et võtta arvesse liikmesriikide eri lähtepositsioone, suutlikkust,

valdkondlikke erinevusi ning konkreetsete sektorite regulatiivliivakastide määratlusi

sisaldavate liidu õigusaktide olemasolu.

(5) Selleks et aidata novaatoritel ja muudel huvitatud isikutel välja selgitada võimalused

regulatiivliivakastides osalemiseks, on vaja kehtestada kogu liidus ühised ja

läbipaistvad põhimõtted regulatiivliivakastide loomise, nendes osalemise tingimuste ja

tulemuste kohta. Need põhimõtted aitaksid suurendada üldsuse usaldust ja

hõlbustaksid teadmiste jagamist pädevate asutuste vahel kogu liidus, säilitades samal

ajal võrdsed tingimused. Osalemiskriteeriumid ja tegevustingimused peaksid olema

läbipaistvad, objektiivsed ja proportsionaalsed ning tagama, et regulatiivliivakastid ei

loo põhjendamatuid konkurentsieeliseid ega takista kaupade vaba liikumist

valdkondades, mille suhtes kohaldatakse liidu ühtlustamisõigusakte.

(6) Selleks et tagada prognoositav keskkond, mis toetab innovaatiliste lahenduste

väljatöötamist siseturul, peaksid liikmesriikide pädevad asutused kasutama

regulatiivliivakastide puhul läbipaistvaid ja objektiivseid protsesse, sealhulgas

kehtestama kõlblikkuskriteeriumid, taotlemiskorra ja selged osalemis- ja

rakendamistingimused, ning regulatiivset õpet. Õiguskindluse tagamiseks peaks

toodete tootmise ökosüsteemi tugevdamiseks ja muudetakse määrust (EL) 2018/1724 (ELT L,

2024/1735, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1735/oj); Euroopa Parlamendi ja

nõukogu 23. oktoobri 2024. aasta määrus (EL) 2024/2847, mis käsitleb digielemente sisaldavate toodete

küberturvalisuse horisontaalseid nõudeid ja millega muudetakse määrusi (EL) nr 168/2013 ja

(EL) 2019/1020 ning direktiivi (EL) 2020/1828 (küberkerksuse määrus) (ELT L, 2024/2847,

20.11.2024, ELI:. http://data.europa.eu/eli/reg/2024/2847/oj). Vt ka Euroopa Parlamendi ja nõukogu 30.

mai 2022. aasta määrus (EL) 2022/858, mis käsitleb hajusraamatu tehnoloogial põhinevate turutaristute

katsekorda ning millega muudetakse määrusi (EL) nr 600/2014 ja (EL) nr 909/2014 ning direktiivi

2014/65/EL (ELT L 151, 2.6.2022, lk 1, ELI: http://data.europa.eu/eli/reg/2022/858/oj). 3 Komisjoni 6. mai 2003. aasta soovitus 2003/361/EÜ mikro-, väikeste ja keskmise suurusega ettevõtjate

määratluse kohta (ELT L 124, 20.5.2003, lk 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj). 4 Komisjoni 18. märtsi 2026. aasta soovitus (EL) 2026/720 innovaatiliste ettevõtjate, innovaatiliste

idufirmade ja innovaatiliste kasvufirmade määratluse kohta (ELT L, 2026/720, 24.3.2026, ELI:

http://data.europa.eu/eli/reco/2026/720/oj). 5 Komisjoni teatis Euroopa Parlamendile, Euroopa Ülemkogule, nõukogule, Euroopa Majandus- ja

Sotsiaalkomiteele ning Regioonide Komiteele „Lihtsam, selgem ja paremini täidetav ELi normistik“,

COM(2026) 380 final, EUR-Lex - 52026DC0380 - EN - EUR-Lex.

ET 13 ET

igasugune võimalus erandite tegemiseks kehtivatest õiguslikest nõuetest olema

konkreetne, selgelt määratletud ja kooskõlas liidu õigusaktidega.

(7) Regulatiivliivakastide ühtseks käsitlemiseks on vaja suurendada teadlikkust,

ühtlustada teabevahetust, hõlbustada vastastikust õppimist liikmesriikide ja nende

pädevate asutuste vahel ning aidata luua õppimisviis, mis oleks nii paindlik kui ka

kiiresti kohandatav.

(8) Regulatiivliivakasti töö tulemusi käsitleva teabe jagamine vastavushindamisasutuste,

standardiorganisatsioonide, turujärelevalveasutuste ja muude asjaomaste osalejatega

(näiteks väljumisaruannete vormis) võib aidata kiirendada innovaatiliste lahenduste

vastavushindamist, standardimist või müügiloa saamist liikmesriigi turul. Nii saaks

innovatsiooni piisaval määral toetada ja regulatiivliivakastis katsed läbinud

innovaatilised lahendused edukalt turule suunata.

(9) Mittediskrimineeriva juurdepääsu tagamine regulatiivliivakastidele kogu liidus aitaks

edendada ausat konkurentsi ja soodustada kõigi asjaomaste sidusrühmade, sealhulgas

ettevõtjate laialdast osalemist, mis võib anda pädevatele asutustele regulatiivse õppe

eesmärgil kasulikku teavet. Seoses regulatiivliivakastidele juurdepääsu piiramise või

eelisjuurdepääsu tagamise võimalusega, mis peaks olema kooskõlas kohustustega,

mille liit on võtnud kohaldatavate rahvusvaheliste lepingute alusel, tuleks hoolikalt

kaaluda asjaomase piirangu või eelise vajalikkust, lähtudes sellistest objektiivsetest

elementidest nagu registreerimisriik ja osalevate üksuste suurus.

(10) Regulatiivliivakastid ja nendes läbi viidud eksperimenteerimise käigus saadud tõendid

peaksid toetama õigusraamistike arengut. Eksperimenteerimisest saadud teabe

süstemaatiline analüüs peaks aitama õigusraamistiku muutuvate olude ja tehnoloogia

arenguga paremini kooskõlla viia. Ühtlasi peaksid regulatiivliivakastid toetama

reguleerimist suure ebakindluse ja häirivate probleemide korral ning seoses uute

poliitikameetmete ettevalmistamisega.

(11) Võttes arvesse olemasolevatest liidu ja liikmesriikide regulatiivliivakastidest saadud

kogemusi, tervitab nõukogu komisjoni kavatsust jälgida asjakohaseid arenguid ja

hinnata vajaduse korral, kas liidu tasandil tuleks võtta täiendavaid meetmeid. Kõik

sellised meetmed peaksid olema innovatsioonisõbralikud ja kavandatud viisil, millega

välditakse tarbetut halduskoormust või liiga rangeid ettekirjutusi,

SOOVITAB JÄRGMIST:

1. Käesolevas soovituses kasutatakse järgmisi mõisteid:

(1) „regulatiivliivakast“ – struktureeritud raamistik, mis võimaldab selle tegevuses

osalejatel piiratud aja jooksul katsetada innovaatilisi lahendusi kontrollitud

keskkonnas ühe või mitme pädeva asutuse järelevalve all ja mis toetab

tõenduspõhist regulatiivset õpet;

(2) „eksperimenteerimine“ – mis tahes kombinatsioon innovaatiliste lahenduste

väljatöötamisest, katsetamisest ja valideerimisest, mis toimub tegelikes

tingimustes ja kontrollitud keskkonnas enne asjaomaste lahenduste

kättesaadavaks tegemist või nende muul viisil kasutusele võtmist või

kasutamist;

(3) „kontrollitud keskkond“ – füüsiline, digitaalne või hübriidkeskkond laboris,

väljaspool laborit või mõnes muus simuleeritud keskkonnas, mis pakub

võimalust regulatiivliivakastis ühe või mitme pädeva asutuse järelevalve all

eksperimenteerida, järgides eelnevalt kindlaksmääratud tingimusi ja

ET 14 ET

kaitsemeetmeid ning võttes vajalikke meetmeid võimalike riskidega

tegelemiseks ja nende maandamiseks;

(4) „pädev asutus“ – liikmesriigis riiklikul, piirkondlikul või kohalikul tasandil

tegutsev avaliku sektori asutus, mis liidu või riigisisese õiguse kohaselt

vastutab selliste õigusaktide järelevalve või täitmise tagamise eest, mis on

seotud innovaatiliste lahendustega või mõjutavad innovaatilisi lahendusi,

millega regulatiivliivakastis eksperimenteeritakse või mille üle seal järelevalvet

tehakse;

(5) „piiriülene regulatiivliivakast“ – regulatiivliivakast, mille on loonud ning mida

rakendavad või mille üle teevad ühiselt järelevalvet rohkem kui ühe

liikmesriigi pädevad asutused.

2. Regulatiivliivakaste käsitlevaid riigisiseseid sätteid välja töötades peaksid

liikmesriigid tegema järgmist:

(a) hindama, kas regulatiivliivakast on konkreetses sektoris vajalik;

(b) kohaldama regulatiivliivakastide loomise ja rakendamise suhtes kehtivaid liidu

õigusnorme, kui see on asjakohane;

(c) põhjendama vajadust lisada asjaomasesse riigisisesesse õigusakti

regulatiivliivakaste käsitlevad sätted ja asjaomases õigusaktis selgelt kindlaks

määrama regulatiivliivakasti eesmärgid;

(d) kui on kavas teha erandeid kehtivatest õiguslikest nõuetest, tagama, et need

erandid on konkreetsed, selgelt kindlaks määratud ja nõuetekohaselt

põhjendatud;

(e) tagama, et liidu kohaldatavatest teisestest õigusaktidest tehtavaid erandeid

nähakse ette üksnes juhul, kui selliste erandite tegemise võimalus on ette

nähtud kohaldatavates liidu õigusaktides;

(f) sätestama asjaomases riigisiseses õigusaktis, et regulatiivliivakaste võib luua

pädeva(te) asutus(t)e algatusel või taotleja soovil, kui sellele asutusele või

nendele asutustele on liidu ja liikmesriigi õiguse alusel antud asjakohane

pädevus;

(g) kontrollima vajaduse korral, kas regulatiivliivakastis läbi viidavaks

eksperimenteerimiseks saaks teha kättesaadavaks katserajatisi, sealhulgas neid,

mis on akrediteeritud vastavushindamiseks Euroopa Parlamendi ja nõukogu

määruse (EÜ) nr 765/20086 alusel;

(h) tegema koostööd teadus- ja tehnoloogiataristutega,7 et anda

regulatiivliivakastide tegevuses osalejatele vajaduse korral juurdepääs nende

taristutega seotud rajatistele ja teenustele.

3. Liikmesriigid ja nende pädevad asutused peaksid täpsustama, millistel tingimustel on

eksperimenteerimine lubatud, käsitledes vähemalt järgmisi aspekte:

6 Euroopa Parlamendi ja nõukogu 9. juuli 2008. aasta määrus (EÜ) nr 765/2008, millega sätestatakse

akrediteerimise ja turujärelevalve nõuded seoses toodete turustamisega ja tunnistatakse kehtetuks

määrus (EMÜ) nr 339/93 (ELT L 218, 13.8.2008, lk 30, ELI: http://data.europa.eu/eli/reg/2008/765/oj). 7 Euroopa teadus- ja tehnoloogiataristute strateegia, https://research-and-

innovation.ec.europa.eu/strategy/strategy-research-and-innovation/our-digital-future/european-strategy-

research-and-technology-infrastructures_en.

ET 15 ET

(1) eksperimenteerimise eesmärgid ja kohaldamisala, mis peaksid aitama edendada

selliseid innovaatilisi lahendusi, mida ei ole praegu kohaldatavate eeskirjade

alusel võimalik välja töötada, ning regulatiivset õppimist;

(2) mis liiki eksperimenteerimine on lubatud;

(3) eksperimenteerimise suhtes kohaldatavad piirangud, sealhulgas selle

maksimaalne kestus ja mis tahes geograafilised kitsendused;

(4) võimalike riskide ja leevendusmeetmete ning selliste kaitsemeetmete

hindamine, mida on vaja avalike huvide, põhiõiguste, riikide põhiseadustega

tagatud õiguste ja aluslepingutega tagatud õiguste, eelkõige inimeste ja vara,

tarbijate ja keskkonna kaitsega seotud õiguste ning rahvatervise ja avaliku

korra kaitsmiseks, võttes muu hulgas arvesse ka rahvusvahelisi kohustusi ja

ausat konkurentsi;

(5) eksperimenteerimise hindamist käsitlevad tingimused;

(6) eksperimenteerimise laiendamise, pikendamise, peatamise, muutmise või

lõpetamise tingimused, sealhulgas tõsistest intsidentidest teatamine;

(7) tingimused, mille alusel võib kohaldada mis tahes erandit selles piirkonnas

kehtivatest õigusaktidest, kus asjaomast eksperimenteerimist kavandatakse.

4. Liikmesriigid peaksid tagama, et regulatiivliivakastis eksperimenteerimise kestus on

proportsionaalne selle eesmärkidega, võimaldab saavutada kavandatud eesmärgi ja

saada piisavat regulatiivset õpet.

5. Liikmesriigid peaksid tagama, et regulatiivliivakastide tegevuses osalemise ja nende

rakendamise suhtes kohaldatakse selgelt määratletud tingimusi, mis hõlmavad

asjakohasel määral järgmisi aspekte:

(a) kõlblikkuskriteeriumid, taotlemiskord, valikukriteeriumid ja -menetlused,

regulatiivliivakasti tegevuses osalemise ja regulatiivliivakastist väljumise

tingimused ning juhul, kui see on kohaldatav, konkreetsele

eksperimenteerimiskeskkonnale juurdepääsu tingimused, sealhulgas sellise

juurdepääsu finantstingimused, samuti regulatiivliivakasti tegevuses osalevate

füüsiliste isikute selgesõnalise ja eelneva nõusoleku andmise kord;

(b) osalejate ja muude regulatiivliivakastiga seotud isikute vastutus liidu ja

liikmesriigi kohaldatava õiguse alusel mis tahes kahju eest, mida

eksperimenteerimise tulemusel on tekitatud kolmandatele isikutele, sealhulgas

kasutajatele, katsealustele isikutele ja tarbijatele;

(c) intellektuaalomandi õiguste haldamine, andmekaitse ja eraelu puutumatuse

kaitseks võetavad meetmed ning konfidentsiaalse teabe kaitse;

(d) erisätted, milles täpsustatakse materjalid ja ressursid, mille osalejad või pädev

asutus või mõlemad teevad regulatiivliivakastiga seotud projekti jaoks

kättesaadavaks;

(e) seire, aruandluse, hindamise ja teadmiste jagamise kord; regulatiivliivakasti

käsitlevates riigisisestes sätetes tuleks kindlaks määrata vähemalt

hindamisprotsessi kaasatavad osalejad ning vajaduse korral ka

aruandluskohustused;

(f) väljumisstrateegia, sealhulgas võimalused regulatiivliivakastis

eksperimenteerimise edukalt läbinud innovaatiliste lahenduste

ET 16 ET

kasutuselevõtuks, ning ebaõnnestunud või potentsiaalselt kahjuliku mõjuga

eksperimentide nõuetekohase lõpetamise protsess;

(g) kõik asjakohased toetusmeetmed, sealhulgas regulatiivsete ootuste, koolituse,

teadlikkuse suurendamise ja vajaduse korral rahastamisega seotud suunised ja

nõuanded, mille puhul on arvesse võetud innovaatiliste idufirmade,

innovaatiliste kasvufirmade, väikeste ja keskmise suurusega ettevõtjate

(VKEde), võimalike avaliku või erasektori klientide või muude innovatsiooni

lõppkasutajate vajadusi.

6. Liikmesriike ja nende pädevaid asutusi julgustatakse looma piiriüleseid

regulatiivliivakaste ning edendama nendes osalemist. Piiriülese regulatiivliivakasti

loomisel peaksid pädevad asutused sõlmima kokkuleppe, milles määratakse kindlaks

vähemalt järgmine:

a) tingimused, mille korral eksperimenteerimine on lubatud;

b) eri liikmesriikide pädevate asutuste asjaomaste rollide ja kohustuste jaotus

regulatiivliivakasti loomise, selle rakendamise ja seire, selle üle tehtava

järelevalve ning tegevuse lõpetamise käigus;

c) piiriülese regulatiivliivakasti suhtes kohaldatavad õigusnormid ja

halduskokkulepped (sealhulgas punktis 5 loetletud kokkulepped), võttes

arvesse vastavate rollide ja kohustuste jaotust asjaomaste pädevate asutuste

vahel.

7. Liikmesriigid peaksid tagama, et kõiki regulatiivliivakastide loomiseks ja nende

tegevuses osalemiseks esitatud taotlusi hinnatakse läbipaistvalt ja

mittediskrimineerivalt.

8. Kui liidu poolt vastavalt kohaldatavatele rahvusvahelistele lepingutele võetud

kohustustest ei tulene teisiti, võivad liikmesriigid niivõrd, kuivõrd see on vajalik, ja

tingimusel, et seda põhjendatakse objektiivselt, teha järgmist:

a) piirata regulatiivliivakastides osalemise võimalusi, pakkudes neid üksnes liidu

kodanikele ja liidus asutatud üksustele;

b) anda regulatiivliivakastides osalemiseks eelisõigus liidus asutatud VKEdele,

innovaatilistele idufirmadele või innovaatilistele kasvufirmadele või

c) nõuda regulatiivliivakastis osalejatelt, et nad teeksid liidus teatavaid teadus-,

arendus- ja innovatsioonitoiminguid, mis on regulatiivliivakastis

eksperimenteerimiseks vajalikud.

9. Liikmesriigid peaksid pädevate asutuste toel koguma ja analüüsima

regulatiivliivakastis tehtud eksperimentide tulemusi ja saadud õppetunde. Sellele

analüüsile tuginedes peaksid liikmesriigid hindama vajadust integreerida saadud

õppetunnid riiklikku õigusraamistikku, mida kohaldatakse eksperimenteerimise

objektiks olnud innovaatilise lahenduse suhtes.

10. Liikmesriigid peaksid nõudma, et pädevad asutused koostaksid regulatiivliivakastis

osaleja taotluse korral väljumisaruande, milles kirjeldatakse üksikasjalikult

regulatiivliivakastis tehtud toiminguid, eksperimenteerimise tulemusi ja

õpiväljundeid, et kiirendada innovaatiliste lahenduste vastavushindamist,

standardimist või müügiloa saamist liikmesriigi turul.

11. Liikmesriigid peaksid tegema üldsusele kättesaadavaks kogu teabe nii

eksperimenteerimise alguse kui ka selle tulemuste kohta, kaitstes samal ajal täielikult

ET 17 ET

ärisaladusi või muud konfidentsiaalset teavet, sealhulgas regulatiivse õppe eesmärgil

saadud kogemused, välja arvatud juhul, kui see oleks vastuolus liikmesriigi või liidu

julgeolekuhuvidega.

12. Liikmesriikidel soovitatakse käesolev soovitus võimalikult kiiresti rakendada.

13. Liikmesriike kutsutakse üles komisjoni toel jälgima käesoleva soovituse

rakendamisel tehtud edusamme.

Brüssel,

Nõukogu nimel

eesistuja

ET ET

EUROOPA KOMISJON

Brüssel, 9.9.2026 COM(2026) 567 final

2026/0264 (COD)

Ettepanek:

EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS,

millega kehtestatakse meetmete raamistik liidu innovatsiooniökosüsteemi tugevdamiseks

ja muudetakse määrust (EL) 2017/1001 (Euroopa innovatsioonimäärus)

{SEC(2026) 567 final} - {SWD(2026) 567 final} - {SWD(2026) 568 final}

(EMPs kohaldatav tekst)

ET 1 ET

SELETUSKIRI

1. ETTEPANEKU TAUST

1.1. Ettepaneku põhjused ja eesmärgid

Euroopa Liit on teadusuuringute valdkonnas maailmas juhtpositsioonil, andes märkimisväärse

osa maailma kvaliteetsest teadusväljundist. See tugevus ei tähenda siiski samaväärset edukust

innovatsioonis ja kaubanduses ELi ühtsel turul ja üle maailma. Liiga sageli ei jõua Euroopas

väljatöötatud uuenduslikud ideed turule, neid ei võeta kasutusele piiriüleselt ega uute

kasvavate sektorite loomiseks. Selle tulemusena kasutab liit vaid osaliselt ära majanduse ja

ühiskonna võimekust, mille aluseks on tema teaduslik ja tehnoloogiline tugevus, ning see

takistab ka ülemaailmselt konkurentsivõimeliste ettevõtete tekkimist, mis vähendab Euroopa

suutlikkust tagada elutähtsaid tehnoloogiaid ja väärtusahelaid ning tootlikkuse pikaajalist

kasvu.

Uuenduslike lahenduste väljatöötamise, turuleviimise ja ulatuslikuma kasutuselevõtmise

tingimuste parandamine on kujunenud keskseks prioriteediks komisjoni 2024.–2029.

aasta poliitilises tegevuskavas, milles teadusuuringud ja innovatsioon on kesksel kohal, et

parandada Euroopa konkurentsivõimet ja kestlikku heaolu. Samuti on see oluline liidu

vastupanuvõime, majandusjulgeoleku ja strateegilise sõltumatuse tugevdamiseks aina enam

polariseeruvas geopoliitilises keskkonnas. Sellega seoses aitab kavandatav määrus kaasa ELi

idu- ja kasvufirmade strateegia1 rakendamisele ning vastab volinik Zaharieva missioonikirjas

esitatud ülesandele töötada välja raamistik, mis hõlbustab uuenduslike lahenduste katsetamist,

rahastamist ja laiemat kasutuselevõtmist ELis.

Viimase kahe aastakümne jooksul on ELi majanduskasv olnud aeglasem kui teistes suurtes

majandusriikides, eelkõige Ameerika Ühendriikides ja Hiinas, kusjuures sisemajanduse

koguprodukti taseme erinevus on suurenenud. Selle erinevuse peamine põhjus on tootlikkuse

aeglasem kasv ELis. Kuna teadusuuringud ja innovatsioon on need, mille tulemusena

saavutatakse suur osa tootlikkuse kasvust, on liidu suutlikkus muuta teadmised

turuleviidavateks uuenduslikeks lahendusteks tema pikaajalise konkurentsivõime ja heaolu

otsustava tähtsusega tegur. See suutlikkus määrab ka liidu võime vähendada ülemäärast

strateegilist sõltuvust, säilitada oma tegevusvabadus ning tagada turvaline juurdepääs

elutähtsale tehnoloogiale, toodetele ja tööstussuutlikkusele.

Peamine probleem seisneb struktuursetes tõketes kogu innovatsioonitsükli jooksul. Kuigi ELi

tulemused varase etapi teadusuuringutes on head, esineb püsivaid raskusi üleminekul

uuringutulemustelt turuleviimisvalmis toodetele ja laiendamiskõlblikele ettevõtetele.

Innovaatilistel ettevõtjatel võivad ette tulla kaks suurt kitsaskohta: turustamisviive, mille

puhul projektid jäävad erainvesteeringute kaasamiseks liiga riskantseks või killustatuks, ning

kasvuviive, mille puhul ettevõtjatel on finants-, regulatiivsete ja turupiirangute tõttu raskusi

laienemisega. Need kitsaskohad vähendavad motivatsiooni investeerida ning piiravad uute

innovaatiliste ettevõtjate ja sektorite tekkimist.

Viimastel aastatel on liit nende probleemide lahendamisel suurte sammudega edasi liikunud.

Innovatsiooni raamtingimusi on aidanud parandada ELi rahastamisprogrammid, nagu

programm „Euroopa horisont“, taaste- ja vastupidavusrahastu, innovatsioonifond, programm

1 Komisjoni teatis Euroopa Parlamendile, nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele „ELi idu- ja kasvufirmade strateegia. Euroopa kui eelistatud alustamis- ja

laienemiskoht“, COM/2025/270 final, https://eur-lex.europa.eu/legal-

content/ET/TXT/?uri=celex:52025DC0270.

ET 2 ET

„Digitaalne Euroopa“ ja programm „InvestEU“, ning algatused, mille eesmärk on suurendada

kapitaliturgusid ja tugevdada Euroopa teadusruumi. Need jõupingutused toetavad ka liidu

laiemat eesmärki tugevdada strateegilise tähtsusega sektorites vastupanuvõimet, valmisolekut

ja tehnoloogilist suutlikkust.

Nendele edusammudele vaatamata püsivad liikmesriikide vahel suured tõkked ja

erinevused, eelkõige üleminekul teadusuuringutelt turuleviimisele. Need tõkked mitte ainult

ei kahjusta innovatsiooni toimimist, vaid ka lükkavad edasi selliste tehnoloogiate laiemat

kasutuselevõtmist, mis on Euroopa julgeoleku, vastupanuvõime ja majandusliku suveräänsuse

jaoks eluliselt vajalikud.

Esiteks on teadus- ja arendusteenuste hangete, sealhulgas kommertskasutusele eelnevate

hangete turud selge õigusraamistiku puudumise tõttu endiselt vähe arenenud. ELi

riigihankedirektiivid hõlmavad teadus- ja arendusteenuseid üksnes juhul, kui on täidetud

mõlemad järgmised tingimused:

• lepingust tuleneb kasu üksnes avaliku sektori hankijale tema enda tegevuse

läbiviimiseks ja

• teenuse eest tasub täielikult avaliku sektori hankija.

Selle tulemusena jääb märkimisväärne osa teadus- ja arendusteenuste hangetest, sealhulgas

kommertskasutusele eelnevad hanked, nende direktiivide kohaldamisalast välja. Pärast seda,

kui komisjon selgitas kommertskasutusele eelnevate hangete mõistet oma 2007. aasta

teatises,2 on seda liiki teadus- ja arendusteenuste hangete arv suurenenud ning edujuhtumid

näitavad, et selle vahendi strateegiline kasutamine võimaldab ELil kõrgtehnoloogia turgudel

taas juhtpositsiooni ja strateegilise autonoomia saavutada. Kogu ELis on areng

investeeringute taseme tõstmiseks endiselt siiski liiga aeglane ja ebaühtlane. Peamised

põhjused on ühtlustatud õigusnormide puudumine ja selle tõttu tekkinud erinevad tavad

liikmesriikides, õiguskindlusetus ning teadus- ja arendusteenuste piiriüleste ühishangete

vähene kasutamine, kuigi selliseid hankeid on sageli vaja uuenduslike tehnoloogiate

väljatöötamiseks otsustava tähtsusega rahalise mahu saavutamiseks. See on eriti

problemaatiline strateegilistes sektorites, kus hajus nõudlus, dubleeritud riiklikud

lähenemisviisid ja sõltuvus ELi-välistest tarnijatest võivad liidule tekitada haavatavusi ja

tarneriske. Lisaks tehakse ELi riigihangete raamistiku (riigihangete õigusakti) eelseisva

läbivaatamise raames ettepanek jätta sellest välja kõik teadus- ja arendusteenuste hangete

vormid.

Sellised teadus- ja arendusteenuste riigihanked on väga olulised, et luua uuenduslikke

lahendusi, mis võivad parandada avalike teenuste kvaliteeti ja tulemuslikkust, lahendada

ühiskonnaprobleeme ning luua ELis uuenduslike lahenduste ja tehnoloogiate jaoks piisava

tööstussuutlikkuse, et kaitsta ELi majandusjulgeolekut ja strateegilist autonoomiat. Need on

ka peamine vahend elutähtsa tehnoloogia turu arengu kiirendamiseks, Euroopa tööstusliku ja

tehnoloogilise baasi tugevdamiseks, varustuskindluse parandamiseks ning selle tagamiseks, et

strateegiliselt olulist suutlikkust arendatakse liidus ja võetakse selles kasutusele. Teised

maailma juhtivad majandusriigid investeerivad teadus- ja arendusteenuste riigihangetesse 5–8

korda rohkem kui EL3. Sellega, kui avaliku sektori investeeringuid teadus- ja arendusteenuste

2 Komisjoni teatis Euroopa Parlamendile, Nõukogule, Euroopa Majandus- ja Sotsiaalkomiteele ning

Regioonide Komiteele - Kommertskasutusele eelnevad hanked: Innovatsiooni kiirendamine

jätkusuutlike ja kõrgekvaliteediliste avalike teenuste tagamiseks Euroopas, 14.12.2007, KOM(2007)

799 lõplik. 3 EL kulutab teadus- ja arendustegevusele 0,6 % riigihangetest, USA 3,5 % ja Lõuna-Korea 5 %.

Investeeringute suurendamine 3 %ni kõigist ELi teadus- ja arendusteenuste riigihangetest tooks kaasa

ET 3 ET

hangetesse suurendataks, nii et need moodustaksid kõigist ELi riigihangetest 0,6 % asemel

3 % ehk 17,28 miljardi euro asemel 86,4 miljardit eurot, saaks EL suurendada avaliku sektori

investeeringuid teadus- ja arendustegevusse umbes 0,5 % võrra SKPst. Arvestades et see võib

samas mahus suurendada teadus- ja arendustegevusse tehtavaid erainvesteeringuid, võib

teadus- ja arendustegevuse investeeringute kogusumma ELis seega suureneda 2,2 %-lt 3 %-le

SKPst4.

Teiseks takistab teadusuuringute ja innovatsiooni tulemuste turuleviimist endiselt ebapiisav

selgus ja võrreldavus intellektuaalomandi väärtuse määramisel ja rahalisel

väljendamisel. Praegune innovatsioon põhineb suures osas immateriaalsel varal, kusjuures

teatud juhtivates ettevõtetes moodustab üle 90 % ettevõtja väärtusest intellektuaalomand.

Kuid ELis kasutatakse intellektuaalomandit rahastuse tagatisena harva. Kuna ELi

finantseerimisasutused keskenduvad endiselt materiaalsele varale ja traditsioonilisele

raamatupidamisele, on intellektuaalomandipõhiste varade suure osakaaluga ettevõtjatel

raskusi rahastuse tagamisega. Selle tulemusena kaasavad ELi idufirmad kümnendaks

tegevusaastaks ligikaudu 50 % vähem kapitali kui USA idufirmad. See ebakõla on vähese

varaga innovaatilistele ettevõtjatele suure kasvu perioodil tekitanud rahastamispuudujäägi,

mille hinnanguline suurus on kuni 18 miljardit eurot aastas5. Intellektuaalomandipõhise vara

hindamise ühtlustatud metoodika puudumine on üks peamisi põhjuseid, miks ELis puudub

intellektuaalomandiga tagatav rahastamine. See tekitas liikmesriikides erinevad tingimused

selliste varade kasutamiseks ettevõtja rahastamisel, sealhulgas võlapõhise rahastamise

tagatisena, ning nende arvessevõtmiseks omakapitaliinvesteeringutes ja muudes

rahastamisotsustes. Teised peamised põhjused on, et kogu ELi hõlmav immateriaalse vara

järelturg ei ole väljakujunenud ning finantseerimisasutustes ja innovaatilistes idufirmades

puuduvad intellektuaalomandiga tagatava rahastamisega seotud oskused. See vähendab ühtsel

turul ettevõtjate juurdepääsu kapitalile ning ühtlasi takistab nende piiriülest kasvu ja nendesse

investeerimist. Selle tulemusena on ELi ettevõtjad teiste riikide, näiteks USA, Hiina ja Lõuna-

Korea, ettevõtjatega võrreldes innovatsiooni kasutuselevõtmisel ja turuleviimisel vähem

edukad, eelkõige süvatehnoloogias ja murrangulise innovatsiooni sektorites.

Seega võib käesolev ettepanek nende kahe tõkke kõrvaldamisega aidata suurel määral

parandada teadus- ja arendustegevuse investeeringute ühtse turu toimimist ja

intellektuaalomandipõhiste varade turuleviimist, mis toetab Euroopa sõltumatust ja

konkurentsivõimet. Samuti aitaks see tagada, et Euroopa hoiab rahandust ülal ja võtab

elutähtsa tehnoloogia ja sellega seotud intellektuaalomandipõhise vara laiemalt kasutusele

kooskõlas oma julgeoleku, vastupanuvõime ja strateegilise autonoomia eesmärkidega. Seda

arvesse võttes viiakse käesoleva ettepanekuga ellu president von der Leyeni 2024.–2027.

aasta komisjoni poliitilisi suuniseid, milles peetakse prioriteetseks seada teadusuuringud ja

innovatsioon majanduse keskmesse. Euroopa innovatsioonimäärus tehti teatavaks ELi idu-

ja kasvufirmade strateegias ning ELi konkurentsivõime kompassis kui üks peamisi algatusi,

millega tugevdatakse ELi innovatsiooni ökosüsteemi ja suurendatakse suutlikkust

ülemaailmselt konkureerida.

täiendavaid avaliku sektori investeeringuid teadus- ja arendustegevusse mahus 0,5 % SKPst (EU wide

benchmarking of innovation procurement policy frameworks and investments). 4 2023. aastal moodustasid avaliku ja erasektori investeeringud teadus- ja arendustegevusse ELis 2,2 %

SKPst, samal ajal kui Jaapanis oli see näitaja 3,3 %, USAs 3,46 % ja Lõuna-Koreas 4,93 % (Science,

Research and Innovation Performance (SRIP) report 2024, Euroopa Komisjon). 5 Euroopa Investeerimispank (2025). Investment Report 2024/2025: Innovation, integration and simplification in

Europe.

ET 4 ET

Algatuse üldine eesmärk on parandada innovatsiooni puhul ühtse turu toimimist, vähendades

struktuurseid tõkkeid, et ELis kiirendada uuenduslike lahenduste turuleviimist. See eesmärk

aitab otseselt kaasa liidu laiematele prioriteetidele, milleks on konkurentsivõime

suurendamine, kestliku majanduskasvu edendamine ja tehnoloogilise suveräänsuse

suurendamine, ja tugevdab samal ajal ka majandusjulgeolekut, vastupanuvõimet ja liidu

suutlikkust tegutseda strateegiliselt olulistes valdkondades iseseisvalt.

Selle saavutamiseks seatakse ettepanekus konkreetsed eesmärgid. Siia kuuluvad riigihangete

osakaalu suurendamine innovatsiooni hoogustamisel ning intellektuaalomandi väärtuse

määramise, turuleviimise ja kasutamise tõhusamaks muutmine.

Euroopa innovatsioonimääruses on nende eesmärkide saavutamiseks ette nähtud

• liidu tasandil luua teadus- ja arendusteenuste hangete, sealhulgas

kommertskasutusele eelnevate hangete ühtlustatud raamistik ning

• anda volitus Euroopa Liidu Intellektuaalomandi Ametile intellektuaalomandiga

tagatava rahastamise pädevuskeskuse loomiseks liidu tasandil, kogu liidu jaoks

intellektuaalomandi väärtuse määramise raamistiku loomiseks ja kogu liitu hõlmava

kauplemiskoha loomiseks, mis on mõeldud intellektuaalomandi turuleviimiseks.

Kõnealuseid sõlmküsimusi ühtsel ja sihipärasel viisil käsitledes soovitakse kavandatava

määrusega tagada, et Euroopas väljatöötatud uuenduslikke ideid oleks paremini võimalik

teadusuuringutest turule edasi viia ja piiriüleselt kasutusele võtta, ning aidata kaasa liidu

pikaajalisele konkurentsivõimele ja heaolule, samuti liidu vastupanuvõimele,

majandusjulgeolekule ja strateegilisele autonoomiale.

1.2. Kooskõla poliitikavaldkonnas praegu kehtivate õigusnormidega

Praegu ei ole liidus terviklikku õigusraamistikku, mis käsitleks konkreetselt horisontaalseid

tõkkeid, mis mõjutavad uuenduslike lahenduste väljatöötamist, katsetamist ja kogu ühtsel

turul ulatuslikumat kasutuselevõtmist. Teadusuuringute ja innovatsiooni valdkonnas

keskendub liidu praegune poliitika eelkõige teadmiste loomise toetamisele, koostöö

edendamisele ning teadus- ja innovatsioonitegevuse rahastamisele, ning vaid vähesel määral

tegeldakse raamtingimustega, mis reguleerivad üleminekut teadusuuringutelt turuleviimisele.

Kavandatav määrus täiendab olemasolevaid algatusi, tegeldes innovatsioonitsükli allesjäänud

kitsaskohtadega, eelkõige nendega, mis on seotud teadus- ja arendusteenuste hangete

kasutamisega ning innovaatiliste ettevõtjate rahastamisega intellektuaalomandi

turuleviimiseks ja kasutuselevõtmiseks.

Seda arvestades on liidu poliitika kõige olulisemad põhimõtted teadusuuringute ja

innovatsiooni valdkonnas järgmised.

Euroopa teadusruum stimuleerib ja toetab struktuurselt piiriülest teadus- ja arenduskoostööd

ning teadlaste liikuvust, keskendudes peamiselt teadusuuringute ja innovatsiooniga seotud

olelusringi varastele etappidele. Osaliselt viiakse seda ellu selliste liidu programmide kaudu

nagu „Euroopa horisont“, millega rahastatakse teaduskoostööd, liikuvuskavasid ja

teadustaristuid. Samal ajal kasutatakse Euroopa teadusruumi foorumit mittesiduva

koordineerimisvahendina, mille kaudu liikmesriigid kooskõlastavad oma teaduspoliitikat,

prioriteete ja reforme.

Liidu rahastamisprogrammidest saab teadus- ja innovatsioonitegevus innovatsioonitsükli eri

etappidel suurt rahalist toetust. Eelkõige selliste programmidega nagu „Euroopa horisont“

(sealhulgas Euroopa Innovatsiooninõukogu), samuti programm „InvestEU“, programm

„Digitaalne Euroopa“, Euroopa Kaitsefond, ühtekuuluvuspoliitika fondid ja innovatsioonifond

toetatakse uuenduslike lahenduste väljatöötamist, tutvustamist ja teataval määral ka

ET 5 ET

ulatuslikumat kasutuselevõtmist, kasutades toetusi, segarahastamist, riskijagamismehhanisme

ning teadus- ja arendusteenuste hankeid. Ilma et see piiraks järgmist mitmeaastast

finantsraamistikku ja ELi tulevaste rahastamisprogrammide rakendamist, võib järgmises

mitmeaastases finantsraamistikus seda rahalist toetust tugevdada, suurendades liidu

suutlikkust kaasata avaliku ja erasektori investeeringuid innovatsiooni ja strateegilisse

tehnoloogiasse. Kavandatav määrus on nende liidu programmidega kooskõlas, kuna sellega ei

pakuta välja rahastamismeetmeid, vaid tõhustatakse kõigis liikmesriikides innovatsiooni

raamtingimusi, mis võivad liidu rahastamisprogramme täiendada ja aidata nende mõju mitmel

viisil suurendada.

• Mitme sellise liidu rahastamisprogrammiga toetatakse avaliku sektori hankijaid

teadus- ja arendusteenuste hangete läbiviimisel. Need kogemused on toonud esile ka

selle, et avaliku sektori hankijatel puudub endiselt kindlustunne kommertskasutusele

eelnevate hangete alustamiseks, sest selliste hangete ELi-ülene õigusraamistik ei ole

piisavalt selge. Samuti on avaliku sektori hankijad juhtinud tähelepanu tegevustele ja

ajale, mis neil täiendavalt kulub kommertskasutusele eelnevate piiriüleste

ühishangete korraldamiseks, sest hankelepingute sõlmimise korras on liikmesriigiti

palju erinevusi. Kavandatav määrus aitab seda probleemi lahendada, kehtestades

teadus- ja arendusteenuste hangete, sealhulgas kommertskasutusele eelnevate

hangete ühiste normide ning teadus- ja arendusteenuste piiriüleste ühishangete,

sealhulgas kommertskasutusele eelnevate piiriüleste hangete ühtlustatud raamistiku.

• Mõned nendest liidu rahastamisprogrammidest toetavad innovaatilisi ettevõtjaid

nende intellektuaalomandi turuleviimisel või intellektuaalomandiõiguste kasutamisel

tagatisena investeeringute saamiseks. Kogemused on näidanud, et innovaatilistel

ettevõtjatel on probleeme selliste sobivate osaliste leidmisega, kes on huvitatud

nende intellektuaalomandi või litsentsi ostmisest, ning oma

intellektuaalomandiõiguste hea investeerimisväärtuse näitamisega, kuna teadmisi

napib ning puudub kogu liidus tunnustatud väärtuse määramise raamistik ja kogu

liitu hõlmav intellektuaalomandiga kauplemise koht. Kavandatav määrus aitab seda

probleemi lahendada, laiendades Euroopa Liidu Intellektuaalomandi Ameti

ülesandeid, et luua intellektuaalomandiga tagatava rahastamise pädevuskeskus,

intellektuaalomandi väärtuse määramise ühine raamistik ja kogu liitu hõlmav

kauplemiskoht intellektuaalomandi turuleviimiseks.

Seega on kavandatav määrus kooskõlas liidu kehtivate õigusnormidega teadusuuringute ja

innovatsiooni valdkonnas, täiendades olemasolevaid rahastamisprogramme teadus- ja

arendusteenuste hangete sidusa raamistikuga ning Euroopa Liidu Intellektuaalomandi Ameti

uute ülesannetega, millega aidatakse innovaatilistel ettevõtjatel saada intellektuaalomandiga

tagatavat rahastust.

1.3. Kooskõla muude liidu tegevuspõhimõtetega

Kavandatav määrus kujutab endast sektoriülest algatust, mille eesmärk on luua

innovaatilistele ettevõtjatele kogu liidus ja kõigis sektorites võrdsed tingimused, mitte

keskenduda konkreetsetele rakendussektoritele, tehnoloogiavaldkondadele või

tööstusharudele. Selle meetmed on oma laadilt horisontaalsed ja aitavad kõrvaldada

liikmesriikides esinevaid struktuurseid tõkkeid, mis mõjutavad innovatsioonimahukat

tegevust.

Kavandatav määrus täiendab tulevast äriühingute 28. õigusraamistiku kohast äriühinguvormi

„EU Inc.“, milles esitatakse vabatahtlik ühtlustatud äriühingu raamistik kogu liidus

ET 6 ET

tegutsevatele äriühingutele. Ettepanek täiendab ka hoiuste ja investeeringute liidu reforme,

mille eesmärk on süvendada liidu kapitaliturge ja suunata rohkem erasääste omakapitali,

riskikapitali ja kasvufirmade rahastamisse, et parandada innovaatiliste ettevõtjate

rahastamisvõimalusi. Vaatamata eeldatud edusammudele õigusnormide ühtlustamisel

Euroopa Komisjoni ettepaneku „EU Inc.“ raames, säilib eeldatavasti endiselt suur erinevus

selles, kuidas ettevõtjatel on võimalik innovatsioonitsüklit läbida. Selline killustatus võib

takistada ettevõtjatel uuenduslikke lahendusi turule viia ja see võib piirata innovaatiliste

ettevõtjate kasvupotentsiaali, sealhulgas nende, mis on asutatud ühtlustatud õigusraamistiku

äriühinguvormi „EU Inc.“ alusel. Teisisõnu, kui „EU Inc.“ ettepaneku eesmärk on hõlbustada

ettevõtte asutamist ja käigus hoidmist kõikjal liidus ning aidata kaasata investeeringuid, siis

kavandatava määrusega soovitakse kõrvaldada edasisi kitsaskohti innovatsioonitsüklis ja

tagada, et ettevõtjad saavad oma uuenduslikke lahendusi kogu ühtsel turul lihtsamini arendada

ja turustada.

Samuti ei eemaldata hoiuste ja investeeringute liidu raames oodatavate edusammudega liidu

kapitaliturgude süvendamisel ja erainvesteeringute kaasamisel suuri takistusi

innovatsioonitsükli muudest osadest. Eelkõige piiravad investeerimisvalmis projektide

koondamist endiselt takistused, mis on seotud uuenduslike lahenduste väljatöötamise,

katsetamise, väärtuse määramise ja kiire kasutuselevõtuga. Hoiuste ja investeeringute liidu

eesmärk on seega parandada juurdepääsu rahastamisele ja toetada innovaatiliste ettevõtjate

kasvu, kavandatava määrusega aga kõrvaldatakse kitsaskohti, mis takistavad uuenduslikel

ideedel tõmmata ligi intellektuaalomandiga tagatavat rahastust, ning aidatakse innovaatilistel

ettevõtjatel kapitaliturgude paremast integratsioonist täit kasu saada.

Kavandatav määrus tugineb ka tulevastele Euroopa ettevõtluskukrutele, mis lihtsustavad

piiriüleseid hankemenetlusi ning digitaalset suhtlust ettevõtjate ja avaliku sektori asutuste

vahel. Euroopa ettevõtluskukrutega luuakse ettevõtjatele digitaalne identiteet ning

võimaldatakse turvalist andmevahetust atribuutide elektrooniliste tõendite vormis ja turvalise

sidekanali kaudu. See lihtsustab litsentsimist, registreerimist, maksudeklaratsioonide esitamist

ja hankelubade saamist ning ettevõtjad ei pea enam portaalides olevat teavet dubleerima, mis

vähendab halduskoormust ja nõuete täitmisega seotud kulusid. Seepärast nähakse

kavandatava määrusega ette, et teadus- ja arendusteenuste hankemenetlused viiakse läbi

üksnes digitaalsel kujul ja võimaluse korral Euroopa ettevõtluskukrute või selliste

alternatiivsete elektrooniliste vahendite kaudu, mis on koostalitlusvõimelised Euroopa

ettevõtluskukrutega.

Kavandatav määrus täiendab ka valdkondlikke algatusi, nagu praegune esmatähtsate ravimite

määrus, pilvandmetöötluse ja tehisintellekti arendamise määrus, biotehnoloogia I määrus ning

tulevane kõrgtehnoloogiliste materjalide õigusakt, biotehnoloogia II määrus ja maailmamerd

käsitlev õigusakt, mille keskmes on strateegilised sektorid või tehnoloogiad eesmärgiga

tugevdada liidu positsiooni kõrgtehnoloogia suurjõuna. Vajadust mööda pakuvad need

algatused valdkonna järgi kohandatud lahendusi, kuid Euroopa innovatsioonimääruses

käsitletakse valdkonnaüleseid probleeme, millel on mõju innovatsioonile eri sektorites ja

tehnoloogiavaldkondades. Sellega ei piirata sektoripõhiseid raamistikke ega sekkuta neisse,

vaid tagatakse liidu üldise innovatsioonipoliitika sidusus.

Kavandatav määrus täiendab ka ELi riigihankedirektiive ja nende kavandatud läbivaatamist

riigihangete õigusaktiga. ELi riigihankedirektiividest on välja jäetud kommertskasutusele

eelnevad hanked, aga siiski kuuluvad nende kohaldamisalasse teatavad teadus- ja

arendusteenuste hanked ning teadus- ja arendusteenuste hanked on innovatsioonipartnerluse

menetluse kohustuslik osa. Riigihangete õigusakti ettepanekust on seevastu välja jäetud kõik

teadus- ja arendusteenuste hanke vormid ning praegusest innovatsioonipartnerluse

menetlusest on kohustusliku komponendina välja jäetud ka teadus- ja arendusteenuste hanked,

ET 7 ET

mis on asendatud uue innovatsiooni vaidlustamise menetlusega, mille kohustuslikeks

elementideks on katseetapp ja kaubandusliku kasutuselevõtu hanke etapp, mis võib hõlmata

uuenduslike lahenduste mahtusid.

2. ÕIGUSLIK ALUS, SUBSIDIAARSUS JA PROPORTSIONAALSUS

2.1. Õiguslik alus

Kavandatava määruse õiguslik alus on Euroopa Liidu toimimise lepingu artikkel 114, mis

võimaldab liidul siseturu nõuetekohaseks toimimiseks võtta ühtlustamismeetmeid. Seda on

vaja, et kõrvaldada piiriülesed regulatiivsed ja struktuursed tõkked, mis takistavad ühtse turu

nõuetekohast toimimist. Liikmesriikide erinevad õigusnormid teadus- ja arendusteenuste

hangete, sealhulgas kommertskasutusele eelnevate hangete kohta kujutavad endast tõkkeid,

mis takistavad ettevõtjatel osaleda ja pakkuda oma teenuseid avaliku sektori hankijatele eri

liikmesriikides. Samuti takistavad intellektuaalomandi väärtuse määramise ja turuleviimise

erinevad lähenemisviisid innovaatilistel ettevõtjatel kaasata intellektuaalomandiga tagatavat

rahastust ja oma äritegevust kogu liidus laiendada. Selline killustatud lähenemine teadus- ja

arendusteenuste hangetele ning intellektuaalomandi väärtuse määramisele ja turuleviimisele

takistab kaupade, teenuste ja kapitali piiriülest liikumist ühtsel turul.

2.2. Subsidiaarsus (ainupädevusse mittekuuluva valdkonna puhul)

Kavandatav määrus on kooskõlas Euroopa Liidu lepingu artikli 5 lõikes 3 sätestatud

subsidiaarsuse põhimõttega.

Liidu konkurentsivõime ja strateegilise autonoomia tugevdamiseks on väga oluline

suurendada liidu suutlikkust töötada välja, viia turule ja ulatuslikumalt kasutusele võtta

uuenduslikke lahendusi. Innovatsiooni ökosüsteemid ja innovaatiliste ettevõtjate turud on üha

enam piiriülest laadi, samal ajal kui regulatiivsed ja raamtingimused on liidu liikmesriikides

väga erinevad. See, kui liidu tasandil meetmed puuduvad, ajendab liikmesriike tõenäoliselt

rakendama veelgi ühepoolsemaid meetmeid, et tulla toime tööstuse ees seisvate

konkurentsivõime probleemidega. Sellised sammud võivad olla põhjendatud, sest sellel, kui

riiklikud meetmed jäetakse koordineerimata ja piiriüleste probleemide lahendamiseks ei võeta

riiklikke meetmeid, võib olla negatiivne ja killustatust suurendav mõju ühtse turu toimimisele.

See võib muuta liidu haavatavamaks ja liiga sõltuvaks kolmandate riikide uuenduslikest

lahendustest ja tehnoloogiast, nii et liidul ei ole võimalik ära kasutada ühtse turu eeliseid, mis

tooksid kasu riiklikele ja Euroopa ökosüsteemidele.

Eelkõige ei suudaks liikmesriigid eraldi saavutada vajalikku mahtu, et toetada

teadusuuringutelt turule üleminekut ja tulemuslikult tagada innovatsiooni ulatuslikum

kasutuselevõtt. Liikmesriikide erinevad lahendused intellektuaalomandi väärtuse määramiseks

ja turuleviimiseks, et kaasata intellektuaalomandiga tagatavat rahastust, ning teadus- ja

arendusteenuste hangete korraldamiseks tekitavad õiguskindlusetust, suurendavad kulusid ja

piiravad innovaatiliste ettevõtjate piiriülest tegevust. Nendel erinevustel on otsene ja

tõendatav mõju ühtse turu toimimisele, sest need takistavad liidus kaupade, teenuste ja

kapitali piiriülest liikumist.

Seevastu liidu tasandi meetmetega saab kehtestada ühised raamtingimused ja tagada

koordineerimise liikmesriikide vahel, et innovaatilistel ettevõtjatel oleks võimalik arendada

innovatsiooni, meelitada ligi intellektuaalomandiga tagatavat rahastamist ja oma tegevust

kogu ühtsel turul laiendada. Liidu tasandi meetmed võimaldavad luua võrdsed tingimused,

vähendavad killustatust ja dubleerimist ning aitavad kaasa ressursside otstarbekale jaotamisele

kogu liidu piires.

ET 8 ET

Ükski liikmesriik üksi ei suuda neid probleeme tulemuslikult lahendada, sest tegemist on

kompleksse küsimusega ja siseturg peab hästi toimima, et uuenduslikke lahendusi saaks kogu

liidu piires välja töötada, katsetada, turule viia ja ulatuslikumalt kasutusele võtta. Seepärast on

liidu tasandil vaja ühtlustatud lähenemisviisi, et tagada ühtse turu hea toimimine ning leida

lahendusi liidu konkurentsivõime ja strateegilise autonoomia tugevdamiseks. Ka käesoleva

algatuse meetmed ei oleks sama tulemuslikud, kui neid rakendaksid liikmesriigid üksi, sest

käsitletavad probleemid on seotud ühtse turuga. Need ei piirdu konkreetsete liikmesriikide või

liikmesriikide rühmaga, vaid on seotud liidu tööstusbaasi ja kogu liitu hõlmavate

väärtusahelatega. Peale selle ei vasta liikmesriigi tasandi meetmed tõenäoliselt piisavalt

omavahel tihedalt seotud tarneahelate vajadustele ühtsel turul ning võivad põhjustada turu

edasist killustatust, innovatsiooni väljalekkimist ja tööstuse ümberpaigutamist teistesse

maailma osadesse ning liidu konkurentsivõime ja strateegilise autonoomia üldist nõrgenemist.

Piiriülese laadi tõttu on innovatsiooni puhul vaja liidu tasandi meetmeid, mis piirkondliku,

liikmesriigi ja kohaliku tasandi meetmeid mõjusalt täiendaksid ja tugevdaksid. Meetmete

võtmata jätmine maksab kätte kogu Euroopas. Ilma liidu täiendavate meetmeteta jääb

praegune olukord tõenäoliselt püsima ja see suurendab ohtu, et liit kaotab strateegilise

tööstussuutlikkuse ja tootmisvõime, ühtne turg killustub veelgi ning liit muutub rohe-, digi-,

kaitse- ja majandusjulgeoleku eesmärkide saavutamisel suurel määral sõltuvaks kolmandatest

riikidest. Sellel võib omakorda olla negatiivne mõju liidu majandusjulgeolekule, kaitsele,

sotsiaalsele ja territoriaalsele ühtekuuluvusele ning see on eelkõige tingitud mõjust

tööhõivele, regionaalarengule ja võrdsele juurdepääsule tööstusvõimalustele.

Kavandatud meetmed keskenduvad seega valdkondadele, milles liidu tasandi tegevused

loovad vajalike meetmete ulatuse, kiiruse ja haarde tõttu kindlasti lisaväärtust. Meetmete

eesmärk on parandada innovaatiliste ettevõtjate ärilist huvi tuua turule uuenduslikke

lahendusi. Selleks hõlbustatakse intellektuaalomandi väärtuse määramist, turuleviimist ja

rahastuse saamiseks kasutamist ning esimeste klientide leidmist teadus- ja arendusteenuste

hangete, sealhulgas kommertskasutusele eelnevate hangete kaudu. See suurendab tasuvust,

võimaldades paremat piiriülest koostööd, tagab innovaatilistele ettevõtjatele nende asukohast

olenemata õiglasema juurdepääsu võimalustele ning suurendab liidu suutlikkust püsida

ülemaailmses konkurentsis. Kavandatud meetmed võimaldavad suurendada ka liidu

konkurentsivõimet ja strateegilist autonoomiat ning ühtlasi järgida liidu rahvusvahelisi

kohustusi oma kaubanduspartnerite ees.

2.3. Proportsionaalsus

Kavandatav määrus on proportsionaalne selle eesmärgiga parandada ühtse innovatsioonituru

toimimist. Kõik määruse komponendid on suunatud konkreetsele eesmärgile ja piirduvad

sellega, mis on selle eesmärgi saavutamiseks asjakohane ja vajalik, tegeldes vaid sellega,

mida on vaja kindlakstehtud tõkete kõrvaldamiseks. Liikmesriikidele ja liikmesriikide

asjaomastele üksustele ei tekitata ebaproportsionaalset koormust, mis oleks eeldatava kasuga

võrreldes ülemäärane.

Esiteks võimaldavad teadus- ja arendusteenuste hangete, sealhulgas kommertskasutusele

eelnevate hangete ühised normid avaliku sektori hankijatel märkimisväärselt kokku hoida

menetluste läbiviimise aega ja kulusid. Samuti saavad avaliku sektori hankijad avalikke

teenuseid kiiremini ajakohastada ja ettevõtjad kiirendada äritegevuse kasvu kogu ühtsel turul.

Teadus- ja arendusteenuste piiriüleste ühishangete ühtlustatud raamistik võimaldab avaliku

sektori hankijatel saavutada otsustava tähtsusega rahalise mahu, mis on vajalik, et

stimuleerida tööstust välja töötama kulutõhusamaid lahendusi ja võimaldada ettevõtjatel oma

äritegevust kogu ühtsel turul kiiremini laiendada. Teadus- ja arendusteenuste hangete nõue, et

ET 9 ET

toode oleks valmistatud Euroopa Liidus, on proportsionaalne Euroopa teadus- ja

arendustegevuse mahuga ja kavandatud nii, et see ei tekitaks halduseelarvetele väga suurt

finantskoormust. Juhtivate turgude loomine on keskse tähtsusega, et suurendada ELi

konkurentsivõimet kõigis sektorites ja tehnoloogiates ning seeläbi tugevdada liidu

tööstusbaasi ja tagada liidu strateegilise autonoomia. Selline teadus- ja arendusteenuste

hangetega seotud meetmete kombinatsioon on vajalik õiguskindluse tagamiseks, liidu

konkurentsivõime suurendamiseks ning aluslepingu põhimõtete ja liidu rahvusvaheliste

riigihankealaste kohustuste tulemusliku järgimise tagamiseks. Meetmed on proportsionaalsed,

sest need piirduvad oma eesmärkide saavutamiseks vajalikuga, nende väljatöötamisel on

silmas peetud, et need ei tekitaks liikmesriikidele ja avaliku sektori hankijatele lisakoormust,

need tuginevad olemasolevatele ja laialdaselt kasutatavatele tavadele ning võimaldavad

praktilisel rakendamisel paindlikkust.

Teiseks tehakse Euroopa Liidu Intellektuaalomandi Ametile ülesandeks luua

intellektuaalomandiga tagatava rahastamise pädevuskeskus ning töötada kogu liidu jaoks välja

intellektuaalomandi väärtuse määramise raamistik ja intellektuaalomandi veebipõhine

kauplemiskoht, et võimaldada innovaatilistel ettevõtjatel, äriühingutel, ülikoolidel ja

finantsinvestoritel vähendada väärtuse määramise kulusid ning suurendada liidus

intellektuaalomandiõiguste litsentsimist ja üleandmist. See on keskse tähtsusega

teadusuuringute ja innovatsiooni tulemuste turuleviimise suurendamiseks kogu liidus.

Euroopa Liidu Intellektuaalomandi Ameti olemasolevatele volitustele, eksperditeadmistele ja

ressurssidele tuginedes tagatakse nende meetmete tulemuslik rakendamine. Sellega, et

väärtuse määramise raamistik põhineb parimatel tavadel eri liiki intellektuaalomandi õiguste

jaoks ja et intellektuaalomandi veebipõhine kauplemiskoht on kavandatud täiendama

olemasolevaid kauplemiskoht ja ühtlasi pakkuma täiendavat ELi lisaväärtust, tagatakse nende

meetmete proportsionaalsus, sest need kasutavad olemasolevaid struktuure ja vähendavad

seeläbi liikmesriikide lisakoormust, ning piiratakse liidu sekkumist, mida rakendatakse vaid

siis, kui see on vajalik läbipaistvuse, võrreldavuse ja intellektuaalomandiga seotud tehingutele

juurdepääsu parandamiseks.

2.4. Vahendi valik

Euroopa Liidu toimimise lepingu artikliga 114 antakse seadusandjale võimalus võtta vastu

määrusi ja direktiive. Käesoleva ettepaneku puhul peetakse määrust kõige sobivamaks

vahendiks, kuna seda kohaldatakse viivitamata ja see võimaldab kehtestada nõudeid, mida

kohaldatakse vahetult kõigi avaliku ja erasektori osalejate suhtes, kellele kavandatud meetmed

on suunatud. See aitab tagada, et nõudeid täidetakse õigel ajal ja ühtsel viisil, mis omakorda

suurendab õiguskindlust. Sellega tagatakse kogu liidus järjekindel ja ühtne raamistik ning

välditakse erinevusi liikmesriikide õigusnormides, mis takistaksid uuenduslike lahenduste

väljatöötamist, katsetamist ja ühtsel turul ulatuslikumat kasutuselevõtmist. Määrus on vajalik

selleks, et kehtestada ühtsed raamtingimused, vähendada õiguskindlusetust ning tagada

piiriüleselt tegutsevatele novaatoritele ja innovaatilistele ettevõtjatele võrdsed tingimused.

Direktiiv ei oleks kavandatud eesmärkide saavutamiseks piisav, kuna selle ülevõtmiseks

läheks aega ning liikmesriikides võidakse see üle võtta ja seda rakendada erineval viisil, nii et

innovatsiooni raamtingimuste killustatus jätkub.

Määrus on vajalik ja asjakohane õigusakt ka määruse (EL) 2017/1011 muutmiseks, et

laiendada Euroopa Liidu Intellektuaalomandi Ameti ülesandeid ja tagada kooskõlas ELi

toimimise lepingu artikliga 207 liidu ainupädevuse tulemuslik kohaldamine nende meetmete

puhul, mis on seotud kolmandate riikide ettevõtjate juurdepääsuga teadus- ja arendusteenuste

hankemenetlustele.

ET 10 ET

3. JÄRELHINDAMISE, SIDUSRÜHMADEGA KONSULTEERIMISE JA MÕJU

HINDAMISE TULEMUSED

3.1. Konsulteerimine sidusrühmadega

Käesolev ettepanek põhineb ulatuslikel sidusrühmadega peetud konsultatsioonidel, mis viidi

läbi kooskõlas komisjoni parema õigusloome põhimõtete ja miinimumstandarditega.

Komisjon alustas sidusrühmadega konsulteerimist Euroopa innovatsioonimääruses käsitletud

innovatsioonitõkete teemal juba ELi idu- ja kasvufirmade strateegia raames. Tagasisidekorje

kutse ELi idu- ja kasvufirmade strateegia kohta avaldati 17. veebruaril 2025 ja tagasisidekorje

kestis 17. märtsini 2025. Selle käigus koguti teavet paljudelt sidusrühmadelt, sealhulgas

ettevõtjatelt, ettevõtjate ühendustelt, teadusasutustelt, avaliku sektori asutustelt ja

üksikisikutelt. 36 riigi sidusrühmadelt saadi 589 vastust. Peamised tõkked, mille sidusrühmad

kindlaks tegid, olid innovaatiliste ettevõtjate raskused hangetele juurdepääsul ja liiga vähene

investeerimine innovatiivse lahenduse hangetesse ELis, takistused teadusuuringute ja

innovatsiooni tulemuste turuleviimisel ja intellektuaalomandi väärtuse määramisel,

innovaatiliste ettevõtjate raskused teadus- ja tehnoloogiataristule juurdepääsul,

katsetamisvõimaluste puudumine ELi õigusaktides ning ebapiisav koordineerimine

liikmesriikide ja ELi innovatsioonipoliitika ja -programmide vahel. 28. mail 2025 vastuvõetud

ELi idu- ja kasvufirmade strateegias on esitatud terviklik strateegia seadusandlike ja muude

kui seadusandlike meetmete koondamiseks, et kõrvaldada kindlakstehtud innovatsioonitõkked

ja leida neile lahendusi Euroopa innovatsioonimääruses.

Seejärel korraldas komisjon käesoleva ettepaneku ettevalmistamise käigus spetsiaalse

tagasisidekorje ja avaliku konsultatsiooni, et saada tagasisidet konkreetsete küsimuste kohta ja

teha kindlaks võimalikud lahendused nende õiguslike tõkete korral, mis olid ELi idu- ja

kasvufirmade strateegias juba kindlaks tehtud. Selle tagasisidekorje ja avaliku konsultatsiooni

kutsed avaldati 8. juulil 2025 ja need kestsid 3. oktoobrini 2025. Nende käigus koguti teavet

paljudelt sidusrühmadelt, sealhulgas ettevõtjatelt, ettevõtjate ühendustelt, teadusasutustelt,

avaliku sektori asutustelt ja üksikisikutelt. Tagasisidekorjele saadi kokku 336 vastust,

sealhulgas 193 seisukohavõttu. Avaliku konsultatsiooni käigus saadi 202 vastust, mida

täiendasid 54 lisatud dokumenti.

Euroopa innovatsioonimäärust käsitleva avaliku konsultatsiooni vastused olid sidusrühmade

vahel ühtlaselt jaotunud. Äriühingutelt ja ettevõtjatelt saadi 27 % vastustest (55 vastust), neile

järgnesid ettevõtjate ühendused (23 %, 47 vastust) ning akadeemilised ja teadusasutused

(16 %, 33 vastust). Vastuseid saadi ka ELi kodanikelt (8 %, 17 vastust), valitsusvälistelt

organisatsioonidelt (8 %, 17 vastust), avaliku sektori asutustelt (4 %, 8 vastust),

ametiühingutelt (2 %, 4 vastust), kolmandate riikide kodanikelt (1 %, 3 vastust) ja muudelt

sidusrühmadelt (9 %, 18 vastust). Osalevatest ettevõtjatest moodustasid suurima rühma (1–9

töötajaga) mikroettevõtjad (33 %, 18 vastust), kellele järgnesid suurettevõtjad (29 %, 16

vastust), väikeettevõtjad (20 %, 11 vastust) ja keskmise suurusega ettevõtjad (18 %, 10

vastust).

Avaliku konsultatsiooni tulemused ja selle kokkuvõttev aruanne Euroopa

innovatsioonimääruse kohta avaldati 4. detsembril 2025 ning on kättesaadavad veebis6.

Peale selle korraldati 2025. aasta oktoobrist novembrini Euroopa innovatsioonimääruse kohta

sihtkonsultatsioon, et toetada kavandatud meetmete eeldatavate kulude ja tulude hindamist.

6 Avaliku konsultatsiooni tulemused ja kokkuvõttev aruanne, 4. detsember 2025,

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14593-European-Innovation-

Act/public-consultation_et.

ET 11 ET

Konsultatsiooni käigus viidi läbi kokku 18 poolstruktureeritud küsitlust valitud

sidusrühmadega eespool nimetatud sektoritest, saadi 55 vastust veebiküsitlusele ning töötas

kolm teemarühma, kes 24., 26. ja 27. novembril 2025 said kokku veebi kaudu.

Teemarühmade peamine eesmärk oli kontrollida kulude-tulude analüüsi tulemusi.

Lõpuks korraldati Euroopa Innovatsiooninõukogu foorumil osalevate liikmesriikide ja

programmiga „Euroopa horisont“ assotsieerunud riikide teadus- ja innovatsioonipoliitika ja -

programmide eest vastutavate esindajatega sihtkonsultatsioon Euroopa innovatsioonimääruse

teemal. Euroopa Innovatsiooninõukogu foorumi liikmed võtsid 2025. aasta novembris vastu

ühise seisukoha ja soovide loetelu Euroopa innovatsioonimääruse kohta7.

Nende eri voorude ja konsultatsiooniliikide käigus koguti kokku 1210 vastust, mis olid abiks

käesoleva Euroopa innovatsioonimääruse ettepaneku koostamisel. Üldiselt väljendasid

sidusrühmad laialdast toetust ELi meetmetele, mille eesmärk on kõrvaldada kindlakstehtud

innovatsioonitõkked. Enamik vastanutest kinnitas, et kindlakstehtud probleemid on olemas ja

Euroopa innovatsioonimääruse jaoks kavandatud meetmed, mille eesmärk on parandada

uuenduslike lahenduste väljatöötamist, katsetamist ja ulatuslikumat kasutuselevõtmist kogu

ühtsel turul, on asjakohased.

3.2. Eksperdiarvamuste kogumine ja kasutamine

Käesoleva ettepaneku koostamisel tugineti ulatuslikule tõendusbaasile, sealhulgas

analüütilisele tööle, kirjandusülevaatele, sidusrühmade esitatud teabele ja spetsialistide

nõuannetele.

Komisjon viis läbi dokumentide analüüsi ja vaatas läbi asjakohase akadeemilise kirjanduse,

poliitikaaruanded ja andmeallikad, et toetada probleemide ja poliitikavariantide analüüsi. See

hõlmas muu hulgas Eurostati andmeid, Euroopa innovatsioonitegevuse tulemustabelit,

ühenduse innovatsiooniuuringut, riiklike poliitikaraamistike ja innovatiivse lahenduse

hangetesse tehtavate investeeringute Euroopa võrdlusuuringut ning Maailma Intellektuaalse

Omandi Organisatsiooni andmeid, samuti rahvusvaheliste organisatsioonide, näiteks OECD ja

Euroopa Patendiameti aruandeid ning eelretsenseeritud akadeemilist kirjandust.

Kasutati ka EIC foorumi töörühmade ja ekspertide esitatud teavet, sealhulgas komisjoni

määratud 33 riigi eksperdirühma aruannet,8 milles esitati ELi ja Euroopa

Innovatsiooninõukogu foorumi liikmesriikidele soovitused selle kohta, kuidas ületada

õiguslikke tõkkeid, mis takistavad innovatiivse lahenduse hangete, sealhulgas teadus- ja

arendusteenuste hangete laiemat rakendamist liidus võrreldes teiste maailma juhtivate

majandusriikidega.

Väline töövõtja toetas komisjoni dokumentide täiendaval analüüsimisel, avaliku

konsultatsiooni ja sihtkonsultatsioonide tulemuste analüüsimisel, teemarühmade ja

sidusrühmade küsitluste korraldamisel ning kavandatavate meetmete kulude-tulude

analüüsimisel.

Komisjoni Teadusuuringute Ühiskeskus pakkus täiendavat analüütilist tuge, sealhulgas

analüüsides tagasisidekorjet ja tehes makromajandusliku analüüsimudeli, et hinnata algatuse

võimalikku mõju.

7 Position paper and wishlist for the European Innovation Act, EIC Forum, november 2025,

https://op.europa.eu/en/publication-detail/-/publication/b690e2af-d0bd-11f0-8da2-

01aa75ed71a1/language-en. 8 Independent expert report „Overcoming legal barriers for the uptake of innovation procurement in the

EU“, mai 2026, https://data.europa.eu/doi/10.2777/4586624.

ET 12 ET

3.3. Mõjuhinnang

Kooskõlas parema õigusloome suunistega on käesoleva seadusandliku ettepaneku

toetuseks koostatud mõjuhinnang, milles ülemaailmse konkurentsivõime üha suuremat

probleemi arvesse võttes analüüsitakse vajadust kiirendada uuenduslike lahenduste

turuleviimist ja kasutuselevõttu ning luua innovaatilistele ettevõtjatele innovatsiooni

soodustavad võrdsed tingimused, et nad saaksid laieneda kogu ELi ühtsel turul.

Mõjuhinnangus tehakse kindlaks poliitikavariandid probleemide algpõhjustega tegelemiseks

ja hinnatakse nende tõenäolist mõju. See töötati välja tihedas koostöös komisjoni

talitustevahelise juhtrühmaga Euroopa innovatsioonimääruse teemal.

Mõjuhinnangu kavand esitati õiguskontrollikomiteele (edaspidi „komitee“) 23. detsembril

2025. 28. jaanuaril 2026 toimus kohtumine komiteega, mille järel esitati negatiivne arvamus.

Pärast sisulist läbivaatamist komitee märkuste arvessevõtmiseks esitati mõjuhinnang

20. veebruaril 2026 uuesti. Teises esildises märkis komitee, et tehtud on suuri edusamme,

eelkõige seoses kavandatavate meetmete väiksema ulatusega, algatuse tausta ja mahu

selgitamisega ning aruande üldise esitusviisiga. Mõnede sisuliste märkuste kohta, eelkõige

seoses sellega, et vältida kattumist ELi riigihankedirektiivide eelseisva läbivaatamisega, oli

endiselt raske seisukohta võtta, kuna avalik konsultatsioon nende direktiivide läbivaatamise

üle ei olnud veel lõppenud ning kavandatavad meetmed ja nende direktiivide läbivaatamise

mõjuhinnang ei olnud sel ajal veel kättesaadavad. Seepärast jäi komitee 27. veebruaril 2026

negatiivse arvamuse juurde ja määras kindlaks kolm peamist valdkonda, mida tuleb Euroopa

innovatsioonimääruse mõju hindamise aruandes veelgi parandada. Need on järgmised.

(1) Tagada Euroopa innovatsioonimääruse riigihankemeetmete suurem ühtsus ELi

riigihankedirektiivide eelseisva läbivaatamisega ning hinnata täiendavalt

hankemeetmete proportsionaalsust ja subsidiaarsust, eelkõige seoses innovatiivse

lahenduse hangete kohustuslike eesmärkidega ja riigihangete kasutamisega

väiksemate rahaliste piirmäärade korral, kui on ELi raamistikuga ette nähtud.

(1) Tagada täielikum mõjuanalüüs, hinnates Euroopa innovatsioonimääruse meetmeid

laiemalt, mitte ainult innovaatiliste ettevõtjate hinnangulise arvu alusel, sest

kavandatavad meetmed ei ole õiguslikult piiratud konkreetse ettevõtjate

kategooriaga. Samuti peetakse vajalikuks tegelda innovaatiliste ettevõtjate õigusliku

määratlusega, mida Euroopa innovatsioonimääruses ei ole.

(2) Anda põhjalikum hinnang Euroopa innovatsioonimääruse mõne meetme kulude ja

tulude kohta, pöörates eriti tähelepanu järgmisele:

• hinnata täpsemalt innovatiivse lahenduse hangete kohustuslike eesmärkidega

seotud majanduslikke kulusid ja ELi eelistamist riigihangetes;

• hinnata ohtu, et regulatiivliivakastide liiga kitsad määratlused ja põhimõtted

võivad välja jätta potentsiaalselt kasulikke katsetusvõimalusi.

Pärast komitee teist negatiivset arvamust vaadati mõjuhinnang tuvastatud puuduste

kõrvaldamiseks veel kord põhjalikult läbi. Põhjalikuma analüüsi käigus võeti eespool

nimetatud punkte täielikult arvesse ja vajaduse korral kohandati ettepaneku kohaldamisala.

Eelkõige käsitleti komitee märkusi järgmiselt.

• Innovatsiooni soodustavate hankemenetluste ja ELi eelistamise hankemeetmeid

kitsendati, et keskenduda üksnes avaliku sektori hankijate korraldatavatele

teadus- ja arendusteenuste hangetele. Innovatsiooni soodustavad hankemeetodid,

mida kasutatakse muude riigihankevormide korral laiemalt, jäeti Euroopa

innovatsioonimääruse kohaldamisalast välja. Peale selle kehtestati ELi rahaline

ET 13 ET

piirmäär 216 000 eurot (vastab ELi rahalisele piirmäärale, mida kasutatakse peamises

riigihangete direktiivis keskvalitsusest madalama tasandi ametiasutuste puhul),

millega tagatakse proportsionaalsuse ja subsidiaarsuse põhimõtte järgimine.

• Liikmesriikide kohustuslik eesmärk suurendada üldisi kulutusi innovatiivse

lahenduse hangetele jäeti Euroopa innovatsioonimääruse kohaldamisalast välja.

• Lisati innovaatiliste ettevõtjate, idu- ja kasvufirmade mõistete selgitus.

Mõjuhinnangus selgitatakse, et pärast innovaatiliste ettevõtjate, innovaatiliste

idufirmade ja innovaatiliste kasvufirmade määratlusi käsitleva ELi soovituse

vastuvõtmist ei sisalda Euroopa innovatsioonimääruse ettepanek enam neid

määratlusi. Samas selgitatakse, et kooskõlas parema õigusloome suunistega ei

hinnata kulusid ja tulusid kõigi õiguspäraselt rahastamiskõlblike üksuste põhjal, vaid

selle elanikkonna alusel, keda see majanduslikult mõjutab (eelkõige innovaatilised

ettevõtjad). Selles täpsustati erinevust õiguspäraselt kõlblike ja majanduslikult

mõjutatud ettevõtjate vahel ning selgitati põhjalikumalt, kuidas mõjutatud üksuste

arvu hinnati.

• Lisati kvantitatiivsed hinnangud. Mõjuhinnangus esitati täiendav kulude-tulude

analüüs, kus kõigi meetmete korral võeti arvesse nii standardkulude mudelit kui ka

kulude ja tulude elastsuspõhiseid kvantitatiivseid hinnanguid. Eelkõige lisati

hankemeetmete majandusriskiga seotud kulud, täpsustati intellektuaalomandi

väärtuse määramise hinnanguid ja lisati eraldi jaotised, milles selgitatakse

üksikasjalikumalt iga hinnangu aluseks olevaid eeldusi.

• Regulatiivliivakastide määratlused ja põhimõtted jäeti Euroopa

innovatsioonimääruse kohaldamisalast välja ja viidi üle ettepanekusse võtta vastu

nõukogu soovitus regulatiivsete katsekeskkondade kohta.

Õiguskontrollikomitee arvamused ning ka lõplik mõjuhinnang ja selle kommenteeritud

kokkuvõte avaldatakse koos käesoleva ettepanekuga.

Komisjon tegi mõju hindamise üksikmeetmete tasandil, kaaludes iga meetme puhul

alternatiivsete poliitikavariantidena kuni nelja varianti. See lähenemisviis võimaldas iga

konkreetse probleemse valdkonna jaoks kindlaks teha kõige sobivama meetme.

Euroopa innovatsioonimääruse eelistatud poliitikavariant on esitatud koondpaketina, kuhu

kuuluvad kõigi üheksa hinnatud meetme kõige toimivamad variandid. Iga meetme jaoks on

valitud variant, mis toimivuse, tasuvuse, sidususe ja proportsionaalsuse poolest täidab

eesmärke kõige paremini. Eelistatud poliitikavariant vastab seega pigem kõigi meetmete

kõige tulemuslikumate elementide sidusale kombinatsioonile kui ühele ettemääratud

poliitikapaketile.

Eelistatud poliitikavariant koosneb järgmistest meetmetest.

Esimene meede: Euroopa Liidu Intellektuaalomandi Ameti kaudu luuakse

intellektuaalomandiga tagatava rahastamise pädevuskeskus ning töötatakse kogu liidu jaoks

välja intellektuaalomandi väärtuse määramise raamistik ja veebipõhine kauplemiskoht.

Eeldatakse, et see meede suurendab intellektuaalomandiõiguste üleandmist ja litsentsimist

ning innovaatiliste ettevõtjate suutlikkust tõmmata ligi intellektuaalomandiga tagatavat

rahastust. See tooks Euroopa Liidu Intellektuaalomandi Ametile kaasa hinnanguliselt

712 000 euro suurused halduskulud ja ligikaudu 2,5 miljoni euro suurused kohandamiskulud,

mis kaetakse ameti omavahenditest ilma rahalise toetuseta liidu eelarvest. Samas peaks see

meede aitama ettevõtjatel halduskuludelt kokku hoida ligikaudu 35 miljonit eurot.

ET 14 ET