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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)

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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

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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

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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

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• 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

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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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.

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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.

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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).

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(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.

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(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.

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(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

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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).

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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;

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(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

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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;

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(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

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(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];

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(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;

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(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.

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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;

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(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).

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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).

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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.

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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:

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(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).

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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.

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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;

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(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.

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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.

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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;

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(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;

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(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

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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

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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.

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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.

EUROPEAN COMMISSION

27.2.2026

SEC(2026) 567

REGULATORY SCRUTINY BOARD OPINION

{COM(2026) 567}

{SWD(2026) 567-568}

European Innovation Act

________________________________ Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 [email protected]

EUROPEAN COMMISSION REGULATORY SCRUTINY BOARD

Brussels, RSB

Opinion

Title: Impact assessment / European Innovation Act

Overall 2nd opinion: NEGATIVE

(A) Policy context The European Innovation Act aims to remove barriers that hinder the proper functioning of the Single Market and prevent EU innovative companies from scaling up. It proposes establishing cross-sectoral framework conditions to facilitate the commercialisation of research results, strengthen collaboration between industry, academia and the public sector, and improve access to markets and infrastructures. In doing so, it seeks to create a more coherent regulatory, policy, and investment environment across the EU.

(B) Key issues The Board notes the significant changes in the range of the proposed measures, clarifications of the context and scope of the initiative, and improvements to the presentation of the report. However, the Board maintains its negative opinion, because the revised report still contains the following significant shortcomings: (1) There are apparent overlaps with the public procurement Directives and the

report lacks the assessment of the coherence with the upcoming revision of the public procurement rules. The subsidiarity and proportionality of the measures in the area of public procurement are not demonstrated.

(2) The analysis of impacts focusses on innovative companies while the measures covering the definitions of innovative companies, startups and scaleups have been discarded and the proposed measures in this initiative are not limited to specific company categories. This makes the overall analysis incomplete and potentially misleading.

(3) Some measures are not sufficiently specified to allow for their assessment. The analysis of costs and benefits of the specific measures is not adequate.

2

(C) What to improve (1) The relation to the EU public procurement framework remains ambiguous. On the one hand the report claims that the scope is restricted to the areas outside of the public procurement Directives’ remit (i.e. below the established financial thresholds and covering also the exempted sectors), on the other hand some proposed measures seem to go beyond the pre-commercial procurement. In view of the upcoming revision of the EU public procurement framework, the rationale and the value added for supplementing it with additional elements in the European Innovation Act should be better assessed and justified, also in the light of stakeholders’ concerns. The establishment of mandatory innovation procurement targets would extend to public procurement at large, which could create an overlap with the public procurement framework, add legal complexity and unnecessary administrative burden which is not sufficiently analysed in the report. In addition, the inclusion of public procurement below the financial thresholds established in the EU framework (currently subject to national procurement law) in the measures proposed by the European Innovation Act requires further analysis in terms of their proportionality and subsidiarity. (2) In the revised report the measures for ‘operationalising the definitions of innovative companies, startups and scaleups’ have been discarded, arguing that the proposed measures would apply to all companies. Yet the issue of establishing the definitions of such companies in the overall innovation framework remains unresolved: the report refers to the forthcoming EU level company definition whereas the analysis of impact of the measures focusses heavily on innovative companies. However, the potential consequences resulting from overlaps with the existing definitions of SMEs, micro-companies and small mid-caps are not assessed. Furthermore, the impact on legal certainty for companies as well as the impact on establishing a threshold in terms of innovation spending for SMEs should be analysed. (3) Several of the options and measures analysed, (including measures 1, 2, 5, 7 and 8), are not specified at a sufficient level of detail. This makes it difficult to assess what impacts would follow from introducing these measures, including their feasibility, effectiveness, efficiency and proportionality. (4) The report should investigate the indirect effects of some measures that may have significant consequences. For instance, the costs of mandatory innovation procurement targets and other measures related to procurement are not limited to the administrative and adjustment costs of establishing the targets. The report would need to assess whether the fact that the targets would have to be met may lead to procuring (innovative) products and services at higher costs. Similarly, the EU preference in private and public procurement outside the EU procurement framework may induce higher costs to public and private stakeholders, which are not properly analysed in the report. The risk that preset or too narrow definitions and principles for sandboxes could lead to the exclusion of some potentially beneficial experiments should also be assessed. (5) The magnitude(s) of the benefits alleged to result from several of the proposed measures, (including measures 1, 2 and 3), are neither sufficiently assessed nor credibly demonstrated. The assumptions behind such benefit estimates are not always robust. (6) Given the above, the report does not provide a sufficient evidence base to be informative for the decision making.

3

(D) Conclusion The Board’s opinion is as a rule final. The lead Service can seek political guidance on whether, and under which conditions, this initiative may proceed further.

Full title European Innovation Act

Reference number PLAN/2024/2791

Submitted to RSB on 20 February 2026

Date of RSB meeting Written procedure

4

EUROPEAN COMMISSION REGULATORY SCRUTINY BOARD

Brussels, RSB

Opinion

Title: Impact assessment / European Innovation Act

Overall opinion: NEGATIVE

(A) Policy context The European Innovation Act aims to remove barriers that hinder the proper functioning of the Single Market and prevent EU innovative companies from scaling up. It proposes establishing cross-sectoral framework conditions to facilitate the commercialisation of research results, strengthen collaboration between industry academia, and the public sector, and improve access to markets, and infrastructures. In doing so, it seeks to create a more coherent regulatory, policy, and investment environment across the EU.

(B) Key issues The Board notes the additional information provided and commitments to make changes to the report.However, the Board gives a negative opinion because the report contains the following serious shortcomings that the lead Service must address: (1) The scope of the intervention is not clear. (2) The problems, their scale and their drivers are not well identified and are not

supported with the appropriate evidence. (3) The report lacks a clear logic of the intervention. The objectives are not S.M.A.R.T..

The policy measures are not clearly defined and it is not demonstrated that they address those problems at their roots causes.

(4) The report does not provide sufficient evidence supporting the feasibility, effectiveness and efficiency of many of the proposed policy measures; their proportionality is not sufficiently assessed.

(5) The report does not appropriately assess the external coherence of this initiative with other horizontal initiatives contributing to the European competitiveness and functioning of the Single Market.

(6) The level of administrative burden is not sufficiently analysed.

5

(C) What to improve (7) The report must clarify the scope of the intervention. It should better set the context of the initiative and other initiatives that the Commission is preparing in parallel, that delineate the scope of the European Innovation Act and could potentially support or complement it. A better description of the scope will enable to strictly base the impact assessment on problems identified inside this scope. (8) Currently most of the problems and problem drivers overlap. The report should better differentiate between the presented problems and their drivers, striving to identify root causes as exhaustively as possible. The report should then transparently consider what can be addressed better by parallel or future initiatives. The large divergence in the identified issues among Member States is not analysed. The problem identification should be corroborated by evidence and should focus on the issues that cannot be solved at the national/regional or local level, that have a cross-border dimension and could be addressed at the EU level. The specificities of innovative companies as opposed to SMEs should be explained and supported by evidence. The report does not provide compelling evidence that support the rationale for regulating sandboxes at the EU level, rather than proposing general guidance. (9) The logic of the intervention is not well established in the report. Once the problems and their drivers are better identified, the general and specific objectives should be aligned and narrowed down to the adjusted scope of the intervention. Formulating a general objective that is too multifaceted and vast makes it hardly possible to demonstrate causal links between the intervention and the future results. The specific objectives, selected based on a refined problem definition, should be S.M.A.R.T. to clearly understand what is expected to be achieved and to enable the assessment of the impact of the policy options. (10) The report should propose policy measures that are based on evidence demonstrating that they can solve the underlying problems/drivers and achieve the desired objectives. The feasibility of those measures should be checked upfront. Many of the measures proposed in the report are not well specified, often relying on terms that may be subject to interpretation, or are simply not fully defined. It is therefore not possible to assess their feasibility, effectiveness, efficiency, and proportionality. The evidence supporting the effectiveness of some measures is incomplete or missing. The causal links between a measure and the problem drivers it is intended to address are often not established. (11) More specifically, the feasibility of establishing a common and future proof definition of an innovative company across different sectors should be demonstrated better. The feasibility and consequences of establishing a common definition of a startup, scaleup and an innovative company and their co-existence with the established definitions of SMEs, micro companies, and small mid-caps, should be discussed in the report in view of possible overlaps as regards access to (EU) funding or any other special treatment of such companies. The report should analyse the risk that the proposed policy measures and their implementation could add more burdens than benefits. (12) The report should better analyse the external coherence with other horizontal initiatives contributing to improving European competitiveness by promoting innovation and functioning of Single Market. The report should assess the coherence with the simplification agenda (Omnibus IV); measure 2 and the supporting recommendation should describe how they would be implemented. It should discuss the coherence of the proposals on public procurement and in particular the revision of the public procurement rules, in light of the concerns of stakeholders. The discussion on the external coherence should also cover the coming European Research Area act and the “28th regime for innovative companies”.

6

(13) The report should be clear on what success will look like; targets and benchmarks for the specified monitoring indicators should be introduced. Some more technical comments have been sent directly to the author DG.

(D) Conclusion The DG must revise the report in accordance with the Board’s findings and resubmit it for a final RSB opinion.

Full title European Innovation Act

Reference number PLAN/2024/279

Submitted to RSB on 23 December 2025

Date of RSB meeting 28 January 2026

Electronically signed on 27/02/2026 13:05 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

EN EN

EUROPEAN COMMISSION

Brussels, 9.9.2026

SWD(2026) 567 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT REPORT

Accompanying the document

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)

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

EN EN

1. INTRODUCTION: POLITICAL AND POLICY CONTEXT ............................................................. 2

1.1. Low private R&D spending, insufficient scaleup funding & capital market

fragmentation in the EU .................................................................................... 5

1.2. Fragmented and complex rules for companies operating across the EU ........... 7

1.3. EU fragmentation of research systems across Member States .......................... 7

2. PROBLEM DEFINITION AND PROBLEM DRIVERS FOR THE EIA ............................................ 8

2.1. How likely is the problem to persist? .............................................................. 21

3. WHY SHOULD THE EU ACT? ........................................................................................................ 24

3.1. Legal basis ....................................................................................................... 24

3.2. Subsidiarity: Necessity of EU action ............................................................... 24

3.3. Subsidiarity: Added value of EU action .......................................................... 25

4. OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 25

4.1. General objectives ........................................................................................... 26

4.2. Specific objectives ........................................................................................... 27

5. WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 28

5.1. What is the baseline from which options are assessed? .................................. 29

5.2. Description of the policy options .................................................................... 31

5.3. Options discarded at an early stage ................................................................. 36

6. WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 37

6.1. Estimates of economically affected population ............................................... 38

6.2. Costs and benefits by stakeholder by measure ................................................ 40

6.2.1. Costs for Measure 1 - Promote valuation of IP ................................................ 40

6.2.2. Benefits for Measure 1 - Promote valuation of IP ............................................ 43

6.2.3. Costs for Measure 2 – Establish procedures for R&D procurement for public

buyers, including cross-border R&D procurement and rules to promote the use of

innovation-friendly techniques within R&D procurement ............................................... 48

6.2.4. Benefits for Measure 2 – Establish procedures for R&D procurement for public

buyers, including cross-border R&D procurement and rules to promote the use of

innovation-friendly techniques within R&D procurement ............................................... 50

6.2.5. Costs for Measure 3 – Preference for EU-made solutions in R&D procurement

for public buyers ............................................................................................................... 53

6.2.6. Benefits bundled with indirect economic costs for Measure 3 – Preference for

EU-made solutions in R&D procurement for public buyers ............................................ 55

7. HOW DO THE OPTIONS COMPARE? ............................................................................................ 58

8. PREFERRED OPTION ...................................................................................................................... 62

9. HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 67

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 69

1. LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................................. 69

2. ORGANISATION AND TIMING ...................................................................................................... 69

3. CONSULTATION OF THE RSB....................................................................................................... 70

2

5. EVIDENCE, SOURCES AND QUALITY ......................................................................................... 82

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 84

ANNEX 3: WHO IS AFFECTED AND HOW? .......................................................................................... 88

1. SUMMARY OF COSTS AND BENEFITS ....................................................................................... 88

2. RELEVANT SUSTAINABLE DEVELOPMENT GOALS ............................................................... 91

ANNEX 4: ANALYTICAL METHODS ..................................................................................................... 93

ANNEX 5: COMPETITIVENESS CHECK .............................................................................................. 132

1. OVERVIEW OF IMPACTS ON COMPETITIVENESS ................................................................. 132

2. SYNTHETIC ASSESSMENT .......................................................................................................... 132

3. COMPETITIVE POSITION OF THE MOST AFFECTED SECTORS ........................................... 134

ANNEX 6: SME CHECK .......................................................................................................................... 135

ANNEX 7: SUPPORTING GRAPHS AND TABLES .............................................................................. 138

ANNEX 8: MACROECONOMIC MODELING - JRC B.7 ...................................................................... 158

ANNEX 9: ANALYSIS OF RESPONSES TO THE EIA CALL FOR EVIDENCE – JRC T.5 ................ 162

ANNEX 10: TARGETED CONSULTATION SURVEY EVIDENCE FOR MEASURES RELATIVE

COSTS AND BENEFITS ................................................................................................................. 165

ANNEX 11: POLICY MAPPING (OVERVIEW OF THE STATUS QUO) ............................................. 175

ANNEX 12: ANALYSIS OF RESPONSES TO THE STARTUP AND SCALEUP STRATEGY CALL

FOR EVIDENCE .............................................................................................................................. 183

ANNEX 13: MONITORING AND EVALUATON FRAMEWORK ........................................................ 185

ANNEX 14: POLICY MAPPING (DETAILED LIST OF MAPPED POLICES) ..................................... 191

3

Glossary

Term or acronym Meaning or definition

Innovation

It means the implementation of a new or significantly

improved product, service or process, marketing

method, or organisational method in business practices,

workplace organisation or external relations

EU public procurement

directives’

It means Directives 2014/24/EU, 2014/25 EU,

2014/23/EU and 2009/81/EC;

Innovation procurement

Innovation procurement is an umbrella term covering

both public procurement of R&D services and public

procurement of innovative solutions (PPI).

Public Procurement of

Innovation (PPI)

It refers to the procurement by public authorities of

innovative goods, services, or works that are not yet

widely available on the market, with the aim of

improving public services or addressing societal

challenges.

R&D procurement

It refers to the procurement by a public buyer of

research and development services aimed at

developing, testing or validating new or significantly

improved solutions. It may include the development

and acquisition of prototypes, demonstrators or limited

test volumes, but its objective is the procurement of

R&D services rather than the acquisition of products or

services for commercial-scale deployment.

Pre-commercial procurement

(PCP)

It refers to the procurement of research and

development (R&D) services involving risk-benefit

sharing under market conditions, where the procurer

does not reserve all the results and benefits of the R&D

exclusively for its own use.

4

1. INTRODUCTION: POLITICAL AND POLICY CONTEXT

For over two decades the EU has grappled with the paradox that its excellent research is not

resulting in equally excellent commercialisation of innovative products and services on its

internal market. Different measures have been tried to overcome the barriers, and the “valley

of death” along the innovation lifecycle that entrepreneurs and industries are facing.

The effect of this innovation gap is manifold. It prevents disruptive innovations from reaching

the market and creating new growth industries, indispensable for creating global champions,

growth and jobs and fiscal revenues to fund the EU social model. It also makes the EU economy

less productive compared to other economies, because of later introduction of new technologies

into public and private sector entities.

Over the past two decades the EU’s economic growth has lagged behind both the United

States and China. The EU-US gap in the level of GDP at constant 2015 prices has widened

from 17% in 2002 to 30% in 2023.1

The main reasons behind the EU’s GDP growth underperformance are a weakening

productivity growth, an ageing workforce and different working patterns, with employees in

Europe generally working fewer hours and taking longer holidays than in the United States.2 3.

Productivity growth in the EU depends heavily on research and innovation: research and

innovation drive around two-thirds of productivity growth in the EU4, driven not only by R&D

activities but also by non-R&D intangibles such as skills, software, organisational capital, and

technological efficiency gains from how labour and capital are combined.5

This is why the President of the Commission has underlined the need to place research and

innovation at the core of the EU economy, in order to achieve the Commission’s political

priority for 2024-2029 to strengthen the EU’s sustainable prosperity and competitiveness.

Nevertheless, the EU's innovation output in 2025 remained below that of leading global

innovators, notably the United States, South Korea, and Japan.6 The EU’s innovation capacity

is held back by a number of barriers along the innovation lifecycle. Figure 1 provide a

simplified visualization of where the most important barriers reside along the EU innovation

lifecycle. The problems in “blue” are those currently addressed by other EU initiatives, while

1 Draghi, M. (2024). The Future of European Competitiveness - A Competitiveness Strategy for Europe.

https://commission.europa.eu/document/97e481fd-2dc3-412d-be4c-f152a8232961_en 2 Darvas, Z. (2023). The European Union’s remarkable growth performance relative to the United States. Bruegel

(Brüssel)(https://www. bruegel. org/analysis/european-unions-remarkable-growth-performance-relative-united-states. 3 Draghi, M. (2024). The Future of European Competitiveness - A Competitiveness Strategy for Europe.

https://commission.europa.eu/document/97e481fd-2dc3-412d-be4c-f152a8232961_en 4 European Commission: Directorate-General for Research and Innovation. (2022). Science, research and innovation

performance of the EU 2022: building a sustainable future in uncertain times. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/78826. 5 Roth, F., & Mitra, A. (2025). EU competitiveness: the critical role of intangible assets in labour productivity growth. Journal

of Economic Policy Reform, 1-20. 6 Bello, M., Ravanos, P. and Tessarin, M., Tracking country innovation performance: The Innovation Output Indicator 2025,

Publications Office of the European Union, Luxembourg, 2026, https://data.europa.eu/doi/10.2760/0461350, JRC145507.

5

the problems in “orange” are those that the EIA aim to address.Below it will follow a more

detailed explanation of such problems and initiatives. The problems numbered 1 to 4 in Figure

1, addressed by the EIA, are explained in more detail in Chapter 2.

Figure 1: Position of the European Innovation Act within The European innovation

lifecycle

Source: RTD A5

The innovation lifecycle describes how ideas progress from early research to mature, market-

ready products. Each stage involves different actors and risks: uncertainty and failure risks are

highest at the beginning and decline as innovations mature. In the early phases (research and

initial prototypes), where ideas are highly uncertain and rarely resemble viable businesses,

public funding dominates. As prototypes mature, incubators, business angels and venture

capital progressively step in to support market entry. At later stages, when products are proven

and revenues are more predictable, banks, capital markets and public procurement of innovative

solutions finance scale-up and expansion.

European innovative companies commonly face two “valleys of death” during the innovation

lifecycle. The pre-commercialisation gap arises when innovations are no longer basic

research but remain too risky or fragmented to attract private investment. The scaling gap

occurs later, when firms have viable products but struggle to expand due to high capital needs,

regulatory complexity and limited access to late-stage finance. These gaps explain why market

forces alone often fail to carry innovation through the full cycle and why targeted public

intervention is needed to translate research into competitive, scalable solutions.

6

Several problems - identified by the Letta Report7, the Draghi Report8, and the 2024

Science, research and innovation performance (SRIP) Report9 - reinforce these gaps in

the EU and interrupt or slow down the innovation cycle. Addressing these problems requires a

comprehensive set of legal, financial and policy measures.

The following summarises the main such problems, also listing the main EU initiatives aiming

to address them. Section 2 will then set out the remaining problems (not addressed by other

initiatives) to be addressed by the EIA.

1.1. Low private R&D spending, insufficient scaleup funding & capital market

fragmentation in the EU

Despite being a strong global player in research and innovation, the EU continues to lag

behind its main competitors in R&D investment, primarily due to lower private sector

contributions. The public and private investment into R&D in the EU is 2.2% of GDP, below

that of the US (3.5%), Japan (3.3%) and South Korea (4.9%).10 Behind this gap there is the

sectoral composition of the EU economy: it is dominated by mid-tech industries such as

automotive, whereas the US economy has a larger share of high-tech sectors including health,

ICT hardware, and ICT services. Since high-tech sectors typically have much higher R&D

intensity, their greater weight in the US economy translates into substantially higher private

R&D investment overall. This structural imbalance is often referred to as the EU’s “middle-

technology trap”.11 Evidence of the EU’s “middle technology trap” can be seen in the

stagnation of its corporate leadership: for more than twenty years, the top three EU

companies have repeatedly been automotive firms, with almost no turnover at the top. In stark

contrast, R&D leaders have changed in the US over time. In the early 2000s, the top three US

companies spanned the automobile and pharmaceutical industries. By the 2010s, they had

shifted to the software and hardware sectors; and in the 2020s, the top-three companies included

Alphabet and Meta, global leaders in the digital sector. This dynamic business evolution has

been notably absent in the EU.

The EU also faces a persistent shortage of risk finance for innovation compared to the

US. Venture capital investment in the EU is around seven times lower than in the United States,

limiting the capacity of European start-ups and scale-ups to grow rapidly and compete globally.

This gap reflects, in part, the EU capital market fragmentation, the limited role of institutional

investors such as pension funds and insurance companies, which in the EU allocate a much

smaller share of their portfolios to high-risk, high-reward innovation finance than their US

counterparts. As a result, innovative firms in Europe continue to depend disproportionately on

7 Letta, E. (2024). Much more than a market – Speed, Security, Solidarity. Empowering the Single Market to deliver a

sustainable future and prosperity for all EU Citizens. https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-

market-report-by-enrico-letta.pdf 8 Draghi, M. (2024). The Future of European Competitiveness - A Competitiveness Strategy for Europe.

https://commission.europa.eu/document/97e481fd-2dc3-412d-be4c-f152a8232961_en 9 European Commission: Directorate-General for Research and Innovation. (2024). Science, research and innovation

performance of the EU, 2024: a competitive Europe for a sustainable future. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/965670. 10 European Commission: Directorate-General for Research and Innovation. (2024). Science, research and innovation

performance of the EU, 2024: a competitive Europe for a sustainable future. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/965670. 11 Fuest, C, D Gros, P-L Mengel, G Presidente and J Tirole (2024), “EU Innovation Policy: How to Escape the Middle

Technology Trap”, Report by the European Policy Analysis Group, Institute for European Policymaking at Bocconi University.

7

a bank-based financial system, which is less suited to financing intangible, high-risk assets

typical of breakthrough innovation.12

Measures to address these problems: at EU level, these problems are mainly addressed through

funding programmes such as Horizon Europe, Invest EU, Digital Europe, Innovation Fund,

and in particular the EIC (including the recently established Scaleup Europe Fund). In

addition, the forthcoming Advance Materials Act or Biotech Act target strategic

technologies to help the EU move beyond medium-technology specialisation. While reforms

under the Savings and Investments Union aim to deepen EU capital markets and channel

more private savings into equity, venture capital and scale-ups.

Remaining gap: Despite important progress through the European Innovation Council and the

growth of private venture capital markets, a significant scale-up financing gap persists in the

EU. While funding rounds of EUR 50-100 million are now more common, rounds above EUR

100 million remain comparatively rare, especially in capital-intensive and deep-tech sectors.13

Forthcoming initiatives, including the Savings and Investment Union and reinforced national

scale-up schemes, are expected to mobilise additional capital, but are likely to address only part

of the structural shortfall. There are remaining bottlenecks to the speed and scale of

commercialisation of research results in the EU, which negatively affect the ability to attract

innovation investments to the Union. Those bottlenecks are: fragmented and complex rules

across Member States on valuation and monetisation of intellectual property as a guarantee for

investments. Together, these barriers increase costs, dampen incentives for public and

private R&D investment, and weaken the scalability of innovative firms across the Single

Market.

Furthermore, while the EU Public Procurement Directives harmonise procedures for

contracts above defined financial thresholds, they do not cover R&D procurement where

either the benefits do not accrue exclusively to the public buyer or the services are not

wholly remunerated by it. Such R&D procurement, including pre-commercial procurement

(PCP), is therefore governed by national rules. Moreover, under the Commission proposal for

the Public Procurement Act (PPA), all forms of R&D procurement would be excluded from its

scope. However, as the proposal remains subject to the legislative process, the scope and

provisions of the PPA ultimately adopted by the European Parliament and the Council may

differ from those currently proposed.

The absence of harmonised R&D procurement rules has contributed to divergent

practices across Member States, legal uncertainty, and limited use of cross-border R&D

procurement, which is often necessary to achieve the financial critical mass required for the

development of modern technologies. The European Innovation Act therefore focuses on R&D

procurement precisely because they lie outside the harmonised EU framework, thereby

complementing rather than duplicating existing EU legislation, while enhancing legal certainty

and strengthening policy coherence in support of cross-border innovation.

12 European Commission: Directorate-General for Research and Innovation. (2024). Science, research and innovation

performance of the EU, 2024: a competitive Europe for a sustainable future. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/965670. 13 Startup and Scaleup Strategy, European Commission

8

1.2. Fragmented and complex rules for companies operating across the EU

Regulatory fragmentation across Member States makes it difficult for innovative companies,

including startups and scaleups, to operate efficiently and grow within the Single Market.

Different national legal systems, especially in areas like taxation, company law and

securities law, as well as fragmented digital systems create barriers for investors, limiting the

flow of capital. Innovative companies also face difficulties navigating varying labour laws,

high failure costs and administrative burdens, adding uncertainty and costs for both founders

and investors.

Measures to address these problems: some of these problems are expected to be addressed at

the EU level in the forthcoming proposal for the 28th regime corporate legal framework,

EU Inc., which will introduce an optional common corporate framework for companies using

the EU Inc. legal form, digital corporate rules and procedures throughout their lifecycle and an

enabling framework to invest into such companies. It also provides rules applicable to

employee stock options issued by EU Inc. companies, including the moment of their taxation,

and a simplified insolvency regime for such companies that are innovative startups. The

introduction of the European Business Wallets14 will play a crucial role in simplifying the

administrative and digital landscape for innovative companies, making it possible for them to

operate more efficiently and effectively across the EU, by providing a secure and harmonised

digital environment for identity verification, data exchange, and document management.. The

administrative burden is being further reduced by various omnibus legislations.

1.3. EU fragmentation of research systems across Member States

The EU produces almost one-fifth of the world’s scientific publications, ranking ahead of

the US and second only to China15. In terms of high-quality publications (the 10% most cited),

the EU is on par with the US, but lags behind China.

The innovation potential of the EU remains underused, as researchers and innovators do

not fully exploit economies of scale and cooperate with other partners across the EU16.

Collaboration networks for R&I activities rarely extend across national – or even regional –

borders. Today, about 70% of all co-owned patents are the result of collaboration within the

same region and almost one-in-five are created by partners in different regions of the same

country. Only around 13% of the co-patents filed each year involve organisations located in

two different European countries. By contrast, in the US, R&I collaborations across States are

much more common, accounting for almost one-third of collaborations overall. All in all, the

US has almost 2.5 times more R&I collaborations than the EU.

Measures to address these problems: at EU level, this problem is mainly addressed through

Horizon Europe and the European Research Area (ERA), including the forthcoming

ERA Act, which incentivise and structurally support cross-border R&I collaboration and

14 Proposal for a Regulation on the establishment of European Business Wallets | Shaping Europe’s digital future. 15 Draghi, M. (2024), The future of European competitiveness. Part B: In-depth analysis and recommendations, European

Commission, Brussels. 16 Draghi, M. (2024), The future of European competitiveness. Part B: In-depth analysis and recommendations, European

Commission, Brussels.

9

researcher mobility. In addition, the EIT and Important Projects of Common European

Interest. (IPCEIs) promote large-scale, transnational innovation ecosystems that help

overcome national and regional fragmentation.

Remaining gap: Despite progress under the European Research Area in promoting the free

circulation of researchers and cross-border research collaboration, significant fragmentation

persists in the valuation methods and monetisation opportunities of intellectual property.

As a result, bottlenecks remain in the stages following basic research, particularly in the

transition from laboratory results to prototyping and early commercial development. This

fragmentation contributes to a structural under-exploitation of publicly funded research. In

2019, only 43% of patented inventions originating from universities and public research

organisations in the EU reached the implementation or operational stage, while SMEs achieved

roughly twice that rate.17 This indicates that substantial potential for knowledge diffusion and

economic impact remains untapped.

2. PROBLEM DEFINITION AND PROBLEM DRIVERS FOR THE EIA

The European Innovation Act is intended to address the specific problems causing the EU

innovation gap, which are not addressed by other existing or forthcoming measures. The scope

of the European Innovation Act has therefore been framed by the mission letter of

Commissioner Zaharieva and a number of policy documents adopted by the Commission such

as the Competitiveness Compass18 and the EU Startup & Scaleup Strategy19.

The purpose of this Impact Assessment is to provide an ex-ante, evidence-based analysis

of remaining problems causing the European innovation gap. It identifies a specific set of

problems – not addressed by other initiatives - that hinder innovative companies from scaling

up within the EU Single Market, examines their underlying drivers, and identifies and assesses

the impacts of the policy options available to address those problems.

2.1 General problem

The general problem of the EU is the lack of speed and scale for innovative products and

services to commercialise within the EU, thereby contributing to counter stagnation of EU GDP

growth.

There is a set of persistent regulatory and market failures that arise at specific stages of

the innovation lifecycle, in particular during testing, product development, and early

market entry.

17 EPO (2020), Valorisation of scientific results, p. 22. 18 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 Competitiveness Compass for the EU, COM(2025)30

final, https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52025DC0030. 19 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)270 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0270.

10

Figure 2 summarises the problems and consequences of the EU innovation gap.

Figure 2.Problem tree EIA

There are a number of sub-problems at different steps and levels of the innovation cycle that

are driving the problem.

Problem 1: The EU underperforms in converting research and intangible assets into

commercially scalable innovation and tech leaders.

The Draghi report highlighted that Europe’s innovation deficit isn’t a lack of ideas or

research capacity, but a systemic inability to turn those ideas into commercially successful

products. Despite representing only about 7% of the world’s population, the EU produces

roughly 20% of global scientific publications and has a strong (yet eroding) position in

patenting. In 2021, it accounted for 17% of the world’s patent applications, compared with a

share of 21% for the US and 25% for China. The EU share in patents is not reflected in patenting

for important technologies, and it does not necessarily lead to industrial applications.20

Indeed, the EU disciplinary composition of its scientific and innovation output is skewed

toward less technology-intensive fields, such as social sciences and humanities, while the

United States leads in health and biomedical sciences and China in natural and applied sciences.

20 Draghi, M. (2024), The future of European competitiveness. Part B: In-depth analysis and recommendations, European

Commission, Brussels.

11

A similar pattern appears in patenting: EU activity lags behind the US and China in several key

enabling technologies and is more concentrated in mature, lower technology-intensity domains,

which typically offer more limited potential for productivity growth and global

competitiveness. As a result, the EU represents only 6% of R&D expenditure among leading

firms in software and computer services, while US firms account for 74%.21

The European Investment Bank (EIB) Report 2025 confirms this gap by explaining that

EU firms are less successful than US firms at scaling and commercialising innovation,

especially in deep tech and breakthrough sectors. Innovation is now largely driven by intangible

assets, with over 90% of corporate value in leading firms coming from intellectual property

(IP). Yet in the EU, intellectual property is still rarely used as collateral in debt financing.

Because financial institutions focus on tangible assets and traditional accounting, IP-rich

companies struggle to secure funding. As a result, EU start-ups 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.22

The European Innovation Scoreboard (EIS) 2025 confirms this pattern across multiple

indicators: the EU performs strongly in research and knowledge-creation metrics, but records

comparatively weaker results on indicators related to commercialisation and scale-up of

innovation. The gap is most pronounced in high-growth firm levels; the EU currently has only

111 unicorns, while the United States has 687 and China has 162. Finally, the EU ranks last

among all global competitors for the level of innovative SMEs collaborating with others, a

critical factor for scaling breakthrough innovation.23 Relocation patterns of high-potential

European startup and scaleups firms, which predominantly move to the United States, provide

additional evidence of impediments to scaling innovation in Europe.24

Intellectual property is inherently difficult to value because it is intangible, uncertain, and

highly context-dependent: its future returns depend on market adoption, legal protection,

complementary assets, and firm capabilities, all of which are hard to predict and verify.

Difficulties in valuing IP makes commercialisation harder because it blocks one of the key

bridges from ideas to markets: financing and transactions. When a patent portfolio, software,

data, or know-how cannot be valued credibly, lenders are reluctant to accept it as collateral,

investors struggle to price equity, and partners cannot agree on licensing terms. Hence, firms

either under-invest, sell early, or fail to scale.25

21 SRIP 2024, EIB 2025 report 22 European Investment Bank. (2025). Investment Report 2024/2025: Innovation, integration and simplification in Europe.

Luxembourg: EIB. 23 European Commission (2025), European Innovation Scoreboard 2025, Publications Office of the European Union,

Luxembourg.

24 Startup relocation, in particular to the US, is a symptom that illustrates bottlenecks for those firms to scaleup successfully

in the EU, while it raises concerns about weaking the EU’s innovation ecosystem and competitiveness.

S Weik, A-K Achleitner, R Braun, ‘Venture capital and the international relocation of startups’, Research Policy, Volume 53,

Issue 7, (2024)

S Weik, A-K Achleitner, R Braun, Venture capital and the international relocation of startups, Research Policy, Volume 53,

Issue 7, 2024,

M Colombo, R Compañó, C Domnick, V Ponferrada, A Quas, B. Tofan What do we know about startup relocation? JRC

Science-to-Policy Brief, forthcoming (2026). 25 European Commission: Directorate-General for Research and Innovation. (2022). Science, research and innovation

performance of the EU 2022 : building a sustainable future in uncertain times. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/78826.

12

In the EU this problem is often more pronounced than in the US because the IP valuation

ecosystem is less mature and less standardised, with fewer widely used valuation practices,

thinner transaction comparable, and more fragmented markets and legal frameworks across

Member States. In the US, by contrast, there is broader use of patents and other IP as financing

and deal-making assets, supported by deeper capital markets, more specialised intermediaries,

and more established valuation and collateralisation practices, which makes it easier to translate

intangible assets into funded and scalable commercial products.26

Stakeholder consultation confirms this gap: 80% (93) of EIA Open Public Consultation

participants that expressed an opinion agreed that there is a prudent attitude toward IPR-backed

financing from banks and institutional investors. 73 % (84) agreed that there is a lack of

trustworthy, widely accepted standards for valuing IPR. 81% (96) agreed that there is a lack of

experience with IPR valuation among startup/scaleup in the EU. 84% (108) agreed that creating

a trustworthy EU wide accepted methodology for IPR valuation and providing templates and

guidance on how to apply it would be a good step forward. 62% (72) agreed that creating an

EU wide IPR marketplace with sufficient critical mass and liquidity would be a good step

forward.

Problem driver 1.1: IPR valuation models in the EU are not standardised, while

being complex and expensive

The EU’s underperformance in translating research and intangible assets into commercially

deployed innovation is partly linked to EU capital market fragmentation; however, this driver

is being addressed through the Savings and Investment Union agenda and related financial

market initiatives. The EIA therefore concentrates instead on the remaining key drivers

within its scope, notably the heterogeneous, complex and expensive IPR valuation models that

hamper the bankability and scalability of intellectual property in the EU, and the lack of

sufficient incentives and capacity for publicly funded institutions to manage IPR and

commercialise research results.

The effective use of intellectual property rights (IPR) as a financing and

commercialisation asset depends on reliable, transparent, and comparable valuation

approaches. However, current evidence shows that IPR valuation practices remain non-

standardised, methodologically diverse, and costly, creating uncertainty for both firms and

financial market participants. The World Intellectual Property Organization (WIPO) notes that

IP valuation requires case-specific judgement and that in practice there is a lack of a single

framework with a set of commonly agreed methodologies for valuating different types of IPR.

As a result, lenders and investors apply divergent valuation methods and assumptions, leading

to inconsistent outcomes and legal and financial uncertainty in IP-backed transactions.27

This lack of standardisation translates into limited practical use of IP valuation by firms,

especially SMEs. According to a joint study by the European Patent Office and EUIPO, in the

26 European Commission (2025), Commission Staff Working Document accompanying the EU Startup and Scaleup Strategy:

Choose Europe to start and scale, SWD(2025) 138 final, Brussels, 28 May 2025 27 World Intellectual Property Organization (2025). Moving IP Finance from the Margins to the Mainstream.

13

absence of recognised and trusted models, financial institutions tend to apply strong discounts

to IP valuations, reducing their usefulness as collateral and discouraging both borrowers and

lenders. The problem is compounded by the limited development of secondary markets for IP-

backed loans, which further reduces liquidity and increases perceived risk.28

Available evidence provided by the World Intellectual Property Organization (WIPO)

also shows that valuation practices vary widely across investors and jurisdictions. Some

market participants rely on simplified checklist approaches, while others require deep technical

and legal assessments supported by specialised external providers, often located outside the

borrower’s jurisdiction. These specialised valuation services are frequently expensive, with

reported costs often exceeding €100,000 per case, creating a disproportionate burden for

startups and SMEs.29 High transaction and assessment costs, combined with methodological

complexity, reduce the practical usability of intangible assets (including IPR) in attracting

external finance.30

Some Member States have introduced initiatives addressing intellectual property valuation

as a distinct policy area. These initiatives vary in form and scope, ranging from analytical work

to practical guidance. Examples include Austria’s 2024 study IP Financing in Austria, which

analyses the use of intellectual property in financing and balance-sheet treatment, and

Belgium’s federal Practical Guide to valorise IP to raise funds, which provides information to

SMEs on different financing options and the role of intellectual property valuation within those

options.

A European Commission Expert Group on Intellectual Property Valuation has identified

lack of confidence in existing IPR valuation methods as a primary barrier to IP

transactions, monetisation, and commercialisation in the EU.31 In addition, analysis from the

OECD shows that the absence of reliable and predictable liquidation channels (notably

underdeveloped secondary markets for IP assets) makes it difficult for lenders to recover value

in case of default. This structural illiquidity leads financial institutions to heavily discount IP

collateral or avoid it altogether.32

Taken together, this evidence indicates that the absence of broadly accepted and operational

IPR valuation models in the EU increases transaction costs, reduces legal and financial

certainty, and limits the capacity of firms (particularly innovative SMEs) to leverage IP assets

for financing and commercialisation.

Problem 2. Public Procurement is not sufficiently used in the EU to support research and

innovation

28 EPO & EUIPO (2023). Patents, trade marks and startup finance. Funding and exit performance of European startups, Munich

(Germany) and Alicante (Spain). 29 World Intellectual Property Organization. (2024). Unlocking IP-Backed Financing Series – Country Perspectives:

Switzerland’s Journey. WIPO. https://www.wipo.int/publications/en/details.jsp?id=4710&plang=EN 30 Brassell, M. and K. Boschmans (2019), “Fostering the use of intangibles to strengthen SME access to finance”, OECD SME

and Entrepreneurship Papers, No. 12, OECD Publishing, Paris, https://doi.org/10.1787/729bf864-en. 31 (2014). Final report from the Expert Group on Intellectual Property Valuation. Publications Office.

https://data.europa.eu/doi/10.2777/72196. 32 https://one.oecd.org/document/DSTI/ICCP(2014)17/CHAP9/FINAL/en/pdf

14

Public procurement is the process through which public buyers purchase works, supplies

and services to deliver public services, address societal challenges, maintain infrastructure and

support administrative functions. The EU Public Procurement Directives (most notably

Directives 2014/24/EU, 2014/25/EU and 2009/81/EC) define the entities and contracts subject

to EU procurement rules and the applicable procedures and exemptions.

In general, the Directives apply where a contracting authority or contracting entity purchases

works, supplies or services from an economic operator and the estimated contract value reaches

the applicable financial threshold, unless a specific exclusion applies. For R&D services, they

apply only where the benefits accrue exclusively to the public buyer for use in its own affairs

and the services are wholly remunerated by it.

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

procurement, falls outside their scope. Moreover, the forthcoming revision of the EU public

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

procurement.

R&D procurement concerns the procurement of research and development services

rather than the acquisition of products or services for commercial-scale deployment. It

may nevertheless include the development and acquisition of prototypes, demonstrators or

limited volumes of first products or services for testing and validation purposes.

For example, a city may launch an R&D procurement to develop environmentally

sustainable asphalt. During the testing phase, a section of existing asphalt may be replaced

with the newly developed material, and the city may retain that test section at the end of the

procurement. This would not constitute commercial deployment, as removing the tested asphalt

merely to restore the previous material would serve no practical or economic purpose. By

contrast, any subsequent purchase of the new asphalt for additional roads or locations would

constitute commercial procurement and would therefore fall under the EU Public Procurement

Directives or their expected replacement, the Public Procurement Act33.

A further real-world example is the Danish hospital disinfection R&D procurement

launched in 2014. Through this process, Blue Ocean Robotics developed an autonomous

ultraviolet disinfection robot capable of eliminating 99.99% of viruses and bacteria. The

participating hospitals retained the robots used during the testing phase, but this did not

constitute commercialisation, as their retention formed part of the R&D procurement and

testing process. Commercial procurement occurred only subsequently, when other Danish

hospitals purchased the solution through separate procedures under the EU public procurement

framework. The project also supported the subsequent creation and growth of UVD Robots,

which reportedly reached a valuation exceeding DKK 850 million, employed more than 200

people and attracted USD 48.7 million in venture funding.

Importantly, the procurement of innovative solutions (PPI) for commercial deployment

may include limited R&D elements without constituting R&D procurement. This is

because, despite the presence of such elements, the objective of the procurement is to develop

and acquire a product or service for commercial use, rather than to procure R&D services as

33 This reflects the scope of the PPA proposal at the time of writing and is without prejudice to amendments that may be

introduced during the legislative process.

15

such. It therefore remains within the scope of the EU Public Procurement Directives or their

expected replacement, the Public Procurement Act34.

A pre-commercial procurement (PCP) is a type of R&D procurement in which public

buyers share the risks and benefits of developing, prototyping and testing innovative

solutions with suppliers. The European Commission’s 2007 PCP Communication defines

PCP specifically as an R&D procurement involving risk-benefit sharing under market

conditions and competitive development in phases. In practice, this means that suppliers retain

part of the benefits and intellectual property rights, while the public authority does not fully

finance the R&D costs. Because of this risk-benefit sharing, PCP falls under the exclusion

provided in Article 14 of EU Public Procurement Directive 2014/24/EU and is therefore outside

of its scope.35

Figure 4 provides a schematic overview of the procurement types falling within and outside the

scope of the current EU Public Procurement Directives and the Commission proposal for their

revision, known as the Public Procurement Act (PPA). Under the PPA Commission proposal,

all types of R&D procurement would fall outside the scope of the PPA, irrespective of whether

the R&D services are fully remunerated by the contracting authority and whether risks and

benefits are shared between the contracting authority and the provider. By contrast, the

procurement of innovative solutions would remain within the scope of the proposed PPA, as is

currently the case under the EU Public Procurement Directives. However, as the proposal

remains subject to the legislative process, its final scope and provisions may differ from those

currently proposed.

34 This reflects the scope of the PPA proposal at the time of writing and is without prejudice to amendments that may be

introduced during the legislative process. 35 More specifically: Pre-commercial procurement was defined in the PCP communication COM(2007)799 and associated

staff working document SEC(2007)1668. PCP is exempted from the EU public procurement directives according as it is

implemented in line with the conditions for the exemptions for R&D services in article 25 of Directive 2014/23/EU, article 14

of Directive 2014/24/EU, article 32 of Directive 2014/25/EU and article 13(f)(j) of Directive 2009/81/EC.

16

Figure 4: Public procurement typology: financial thresholds and innovation stages

Source: Science, Research and Innovation Performance of the EU (2026) report

Public procurement36 alone accounts for roughly 17 % of EU GDP (EUR 2.8 trillion per

year)37, meaning governments are among the largest buyers in the economy. Large private

firms also spend significant amounts on procurement. The EU private procurement (B2B)

market was valued at €6,5 trillion or 36% of GDP in 2024.

Innovation procurement is the purchase of R&D or innovative solutions, i.e. new or

significantly improved products, services, or processes that are not yet widely available as they

36 From the classical and utilities sectors to the defence sector, all included. 37 Directorate-General for Research and Innovation & PwC. (2026). EU innovation procurement observatory: final study

report. Publications Office of the European Union. https://data.europa.eu/doi/10.2777/1638226.

17

are still in their early adoption phase and are not deployed yet by more than 20% of the

customers in the EU38.

Innovation procurement accounts for around 10% of total public procurement in the

EU27, corresponding to approximately €298.5 billion (including both R&D procurement

and the procurement of innovative solutions), or 1.76% of EU GDP.39 However, the EU lags

behind global peers: the share reaches about 20% in the United States and 25% in South Korea.

Matching U.S. levels of intensity would imply an additional €300 billion annually directed

towards innovative solutions. (See Figure 5)

Figure 5. Public innovation procurement as a share of total public procurement (2022)

Source: Author owns elaboration based on European Commission: Directorate-General for Research and Innovation & PwC.

(2026). EU innovation procurement observatory: final study report. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/1638226.

Within this total, R&D procurement in the EU27 amounts to €17.3 billion, representing

0.61% of total public procurement and 0.1% of GDP, and approximately 6.1% of total

innovation procurement.40. This compares to around $50 billion annually in the United States,

where federal agencies allocate approximately 7.5% of their procurement budgets to R&D,

reflecting a more systematic use of procurement to support early-stage innovation. DARPA is

a leading example of buying R&D to trigger high-risk, high-reward R&D for defence

38 See definition of innovation in the context of public procurement in the EU public procurement directive 24/2024/EU and

in the EU’s 2021 guidance notice on innovation procurement.

39 Directorate-General for Research and Innovation & PwC. (2026). EU innovation procurement observatory: final study

report. Publications Office of the European Union. https://data.europa.eu/doi/10.2777/1638226. 40 Directorate-General for Research and Innovation & PwC. (2026). EU innovation procurement observatory: final study

report. Publications Office of the European Union. https://data.europa.eu/doi/10.2777/1638226.

18

innovations for which no market yet exists. Operating outside traditional procurement rules

through Other Transaction Authority (OTA), it contracts flexibly with startups, universities,

and consortia. Its approach is outcome-oriented, milestone-based, and mission-driven, focusing

on creating breakthrough technologies through pre-commercial procurement rather than

optimizing cost or efficiency in known markets. Many important innovations such as the

Internet (ARPANET), Global Positioning System (GPS), stealth technology, and autonomous

vehicles all stemmed from DARPA projects.41

US global leadership in supercomputing is thanks to R&D procurements implemented by

the Department of Energy and the Department of Defense: IBM, Cray, HP, Silicon graphics

and Sun microsystems were all startups when they started their first R&D procurements in the

1950s. In the biotech sector, Amgen and Genentech brought their first blockbuster products to

the market thanks to procurements by the National Institutes of Health (NIH) and the

Biomedical Advanced Research and Development Authority (BARDA).

In the EU, legal barriers discourage experimentation with emerging technologies and favours

well-established solutions, making it difficult for innovative startups and scaleups to compete

and bring novel approaches into the public sector. 73 42 43 44 Different studies show how

procurement frameworks remain highly heterogeneous and uncoordinated across EU

Member States. Diverging rules, standards, and procedures for pre-commercial and innovation

procurement create a fragmented landscape that limits cross-border opportunities. This lack of

alignment makes it challenging for innovative companies to scale solutions across different

national markets, undermining the potential for a true single market for innovation-driven

procurement.45 46 47 48

At national level, pre-commercial procurement (PCP) is used in a limited number of

Member States, primarily through programmes or pilot schemes rather than through national

legal frameworks that provide the legal certainty needed to convince procurers to apply it

widely on their own, reflecting its exclusion from the scope of the EU public procurement

directives. Structured use of PCP can be observed in countries such as Spain, Poland, Sweden,

Germany, where it is integrated into the public procurement of innovation framework and

supported through national funding instruments, and Italy, where PCP has been implemented

through targeted calls supported by national innovation agencies. Finland and the Netherlands

have also applied PCP-type approaches through innovation agencies and sectoral programmes,

notably in health, energy and digital public services. In most other Member States, PCP is

41 European Commission: Directorate-General for Research and Innovation. (2024). Science, research and innovation

performance of the EU, 2024 : a competitive Europe for a sustainable future. Publications Office of the European Union.

https://data.europa.eu/doi/10.2777/965670. 42 Suresh, K. (2022). Analysing Incentive Issues and Failures in Innovation Procurement. SSRN Electronic Journal. 43 Uyarra, E., Edler, J., Garcia-Estevez, J., Georghiou, L., & Yeow, J. (2014). Barriers to innovation through public

procurement: A supplier perspective. Technovation, 34(10), 631–645. 44 Georghiou, L., Edler, J., Uyarra, E., & Yeow, J. (2014). Policy instruments for public procurement of innovation: Choice,

design and assessment. Technological Forecasting and Social Change, 86, 1–12. 45 L. Rubini, M. Andov, and A. Biondi, Regulating for a Sustainable and Resilient Single Market: Challenges and Reforms in

the Areas of State Aid, Competition, and Public Procurement Law (Brussels: European Trade Union Institute, 2023) 46 M. Andhov, A. Biondi, and L. Rubini, “Regulating for a Sustainable and Resilient Single Market: Challenges and Reforms

in the Areas of State Aid, Competition, and Public Procurement Law,” ETUI Research Paper (2023) 47 P. C. Gomes, EU Public Procurement and Innovation: The Innovation Partnership Procedure and Harmonization Challenges

(Cheltenham: Edward Elgar Publishing, 2021) 48 G. M. Racca and C. R. Yukins, eds., Joint Public Procurement and Innovation: Lessons Across Borders (Cheltenham: Edward

Elgar Publishing, 2020)

19

applied on an ad hoc basis, rather than through permanent national schemes. Joint cross-border

PCPs have been supported mainly by the EU’s R&I funding programs. No mapped national

measures were identified that establish systematic arrangements for joint cross-border pre-

commercial procurement.

Private procurement refers to purchases by firms that are not public buyers, undertaken

to develop products, operate production processes, and maintain infrastructure and services

across the EU economy. Unlike public procurement, there is currently no EU or national

framework encouraging private buyers to adopt innovation-friendly procurement practices,

beyond existing requirements related to environmental sustainability. Available surveys and

studies indicate that, compared to the United States, private buyers in the EU are less mature in

procuring innovative solutions from other firms and tend to prioritise cost reduction and process

standardisation over innovation-oriented sourcing. Studies indeed show that private buyers in

the US are more mature in buying R&D from other companies (they procured €3,3Bn of R&D

from other companies in 2024) than private buyers in the EU (who procured 2,5Bn of R&D

from other companies in 2024).

Problem driver 2.1 - Lack of legal certainty on how to procure R&D services

The limited use of public procurement for innovation is partly linked to framework conditions

under the Public Procurement Directives, which are subject to separate review. The EIA

correspondingly focuses on pre-commercial procurement instruments operating outside those

directives49.

Public authorities can use procurement of R&D services, including pre-commercial

procurement (PCP), to support the development of innovative solutions that are not yet

market ready. However, in practice these instruments are used only to a limited extent in the

EU, partly due to legal and procedural uncertainty.

Pre-commercial procurement falls outside the scope of the EU public procurement

Directives and international procurement agreements and instead relies on Treaty principles

and basic principles in the State aid rules to avoid State aid in procurements. Specifically, the

Research, Development and Innovation Framework (RDIF) set out the conditions under which

pre-commercial procurement does not involve State aid. This regulatory positioning has led to

multiple legal interpretations and complex compliance requirements. A Commission study

quantifying the impact of PCP in Europe finds that this combination of legal complexity,

fragmented interpretation, and procedural uncertainty has been a significant factor behind the

underuse of PCP, particularly in the ICT sector.50

More recent benchmarking confirms that the legal treatment of PCP varies widely across

Member States. According to the 2024 benchmarking of national innovation procurement

frameworks, only two Member States have a clear PCP definition in national legislation that is

49 According to the November 2025 Commission report on the evaluation of the 2024 EU public procurement directives, in

2023 30% of public procurement in the EU was subject to the EU public procurement directives. 70% of public procurement

in the EU does not fall under the scope of the EU public procurement directives. 50 (2015). Quantifying the impact of Pre-Commercial Procurement (PCP) in Europe based on evidence from the ICT sector :

final report. Publications Office. https://data.europa.eu/doi/10.2759/113472.

20

applicable nationwide and aligned with the EU-level definition in the Commission’s PCP

Communication51. In other Member States, PCP is addressed only through non-binding

guidelines or partial legal provisions, such as R&D service exemptions in procurement law,

resulting in uneven legal clarity and operational approaches across jurisdictions.52

Taken together, this evidence indicates that the fragmented and unclear legal framework

for procuring R&D services increases risk and administrative burden for contracting

authorities. This reduces incentives to use PCP and related R&D procurement approaches,

thereby limiting public sector capacity to stimulate innovation through demand-side

instruments.

Problem driver 2.2 - Procurement practices favour incumbents and limit the

participation of innovative companies in procurement procedures

Current procurement practices in many cases favour established suppliers and make it

difficult for startups and other innovative companies to participate effectively in public tenders.

Tender specifications are often highly prescriptive and frequently reused from past

procedures, describing specific solutions rather than the problem to be solved. This approach

advantages incumbent vendors and reduces the scope for alternative or innovative solutions to

compete.53 54 55

Award and selection practices further reinforce this effect. Contracting authorities often

rely heavily on minimum turnover requirements and prior track record criteria when assessing

eligibility. While intended to reduce risk, these requirements disadvantage startups and

scaleups, which may offer innovative solutions but lack extensive prior track record. At the

same time, procurement decisions frequently prioritise lowest upfront cost over higher potential

lifecycle value, which discourages solutions with higher initial prices but stronger long-term

performance or efficiency benefits.56 57

In addition, procurers often require companies to fully transfer their intellectual property

rights to the procurer, which can deter innovation-driven companies whose business models

depend on retaining and commercialising their IP. Rigid contract structures with little

flexibility and little financial incentives for companies to update solutions during contract

implementation further reduce incentives for companies to propose innovative approaches.

51 COM (2007)799 final and SEC (2007) 1668 defined pre-commercial procurement 52 European Commission (2024). Synthesis report for the benchmarking of national policy frameworks for innovation

procurement, Directorate General for Research & Innovation. 53 Startup and scaleup strategy, EC 54 Uyarra, E., Edler, J., Garcia-Estevez, J., Georghiou, L., & Yeow, J. (2014). Barriers to innovation through public

procurement: A supplier perspective. Technovation, 34(10), 631-645. 55 Uyarra, E., Edler, J., Garcia-Estevez, J., Georghiou, L., & Yeow, J. (2014). Barriers to innovation through public

procurement: A supplier perspective. Technovation, 34(10), 631-645. 56 Herron, T. (2025). Understanding SME Constraints in Public Procurement: A Capability-Based Synthesis of Barriers and

Treatments. SCIENTIA MORALITAS-International Journal of Multidisciplinary Research, 10(2), 356-378. 57 OECD (2017), Public Procurement for Innovation: Good Practices and Strategies, OECD Public Governance Reviews,

OECD Publishing, Paris, https://doi.org/10.1787/9789264265820-en.

21

Together, these practices reduce effective competition, favour incumbents, and limit the

participation of innovative companies in public procurement markets.

Problem driver 2.3 - Fragmentation and barriers to joint cross-border innovation

procurement

Joint and cross-border innovation procurement can generate significant benefits,

including pooling of demand, economies of scale, shared risk, and faster diffusion of

innovative solutions across markets. However, in practice, cross-border public procurement

within the EU remains limited, and joint cross-border innovation procurement is rare.

Available evidence shows that cross-border procurement in the Single Market accounts

for only a small share of total procurement value: around 3% of contract value awarded to

suppliers from other Member States. This low level of cross-border participation is linked to

diverging national legal transpositions of procurement rules, additional national restrictions on

cross-border purchasing, and conflicting language and documentation requirements. These

differences increase legal and operational complexity for contracting authorities and suppliers

seeking to participate across borders.58

Evidence on joint cross-border innovation procurement projects confirms the scale of the

problem. A 2020 survey among European public procurers revealed only 10 out of 41

respondents had previous practical experience with joint cross-border public procurement

projects Reported barriers include legal complexity, lack of experience among contracting

authorities, and difficulties in coordinating funding and procedures across jurisdictions. These

constraints are also highlighted by the EC Expert Group on innovation procurement, which

finds that cross-border joint procurement remains operationally and legally challenging in

practice.59 60

Academic analysis reaches similar conclusions, noting that despite recognised benefits,

cross-border procurement remains uncommon due to legal coordination challenges, high

transaction costs, and incompatible national systems and processes.61.

Taken together, this evidence indicates that regulatory, administrative, and technical

fragmentation across Member States creates persistent barriers to joint cross-border

innovation procurements. This limits the ability of public buyers to aggregate demand and

reduces the scale and effectiveness of innovation procurement as a policy instrument across the

Single Market.

58 Becker, Jörg et al. (2019). Contribution to Growth: European Public Procurement – Delivering Economic Benefits for

Citizens and Businesses” (Study for European Parliament IMCO Committee) – Policy study on cross-border procurement.

https://www.europarl.europa.eu/RegData/etudes/STUD/2018/631048/IPOL_STU%282018%29631048_EN.pdf 59 EC Expert Group on innovation procurement (2025). Overcoming legal barriers for the uptake of innovation procurement

in the EU, final report November 2025 60 Kubinec, J. & Kostolny, M. (2020). Joint cross-border public procurement in Europe, Analysis of the iProcureNet survey

and case studies, iProcurement. 61 Malatinec, T. (2021). Cross–Border Public Procurement in the European Union. EU agrarian Law, 10(2), 2021. 7-12.

https://doi.org/10.2478/eual-2021-0007

22

Problem driver 2.4 - Europe’s strategic autonomy depends on innovation but is

insufficiently considered in procurements

Recent policy and academic work highlight that Europe’s strategic autonomy

increasingly depends on its capacity to develop and retain critical technologies and

innovation capabilities. Research shows that “technology sovereignty” has become a central

rationale for innovation policy, as dependencies in key technologies can limit economic

resilience, security, and policy choice.62 European Parliament studies similarly conclude that

competitiveness and security rely on strengthening Europe’s position in key enabling and

strategic technologies, which requires sustained innovation and industrial capability building.63 64

Overdependency on solutions from third countries is particularly problematic for

solutions that are based on critical technologies that need to be procured by public and

private procurers that are critical entities, because critical entities need to be able to ensure

service continuity in the critical infrastructures that they operate and in the essential services

that they provide to the EU economy and society. Both US and Asia (e.g. China) have a

systematic approach that requires all their critical entities to give preference in their

procurements to suppliers that produce delivered goods, services or works substantially

domestically. The EU lacks such an approach both for public and private procurers that are

critical entities. As a result, critical entities in the EU have become over reliant on critical

technologies from third countries.

Europe’s strategic autonomy is already pursued by some sectoral legislation (such as the

Net-Zero Industry Act, the Critical Raw Materials Act, the proposed Critical Medicines Act,

and the forthcoming Industrial Accelerator Act) by mainly addressing security of supply and

dependency risks in specific sectors. However, those Acts only start reinforcing EU strategic

autonomy when the innovation cycle is already finished and when Europe is already overly

dependent on solutions made in third countries because suppliers have already setup

commercial scale production capacities outside the EU. At this stage it is typically too late and

too costly for suppliers to move back production capacity to the EU for individual procurement

contracts, especially for critical technologies which involve expensive R&I and production

capacity investments. Unlike the US and Asia that start reinforcing strategic autonomy in a

systematic way across all public procurements from the R&D stage onwards and continue to

do so across the innovation cycle up to commercial scale production, in the EU there is no

established innovation-centred approach to apply a EU preference in public procurement to

support early-stage technological development and long-term strategic innovation capacity in

the EU.

62 Edler, J., Blind, K., Kroll, H., & Schubert, T. (2023). Technology sovereignty as an emerging frame for innovation policy.

Defining rationales, ends and means. Research Policy, 52(6), 104765. 63 EPRS/STOA (European Parliament) (2021), Key enabling technologies for Europe’s technological sovereignty.

https://www.europarl.europa.eu/thinktank/en/document/EPRS_STU(2021)697184 64 European Parliament study (2025), “Strategic autonomy and European competitiveness: Security now comes first.

https://www.europarl.europa.eu/thinktank/en/document/ECTI_STU(2025)764371

23

2.1. How likely is the problem to persist?

Across the problem areas examined, current trends suggest that the problems identified

are unlikely to resolve themselves without significant external intervention capable of altering

the present trajectory. Figure 6 presents the historical trends and naïve linear forecasts for the

EU and the US for the available and relevant economic indicators that can be used to proxy the

scale of the problem. In all cases, the EU-US gap has been historically persistent and, under a

simple linear extrapolation65, is expected to continue. These projections should be interpreted

with caution, as linear forecasts do not account for structural breaks or policy changes; they

serve only to illustrate that, absent EU intervention to modify current framework conditions,

the gap is unlikely to close on its own.

65 A simple linear extrapolation is a basic estimation method used to project values beyond the observed data range by assuming

that the existing trend continues at the same constant rate. In practical terms, it means taking an observed change over time (or

across units) and extending that same straight-line relationship forward to produce an approximate estimate where direct data

is not available. It does not introduce additional behavioural assumptions or model dynamics; it only assumes proportional

continuation of the measured trend.

24

Figure 6. Historical trend and linear forecast for EU vs US economic indicators

0,8 0,9

1 1,1 1,2 1,3 1,4 1,5 1,6 1,7

2 0

1 4

2 0

1 5

2 0

1 6

2 0

1 7

2 0

1 8

2 0

1 9

2 0

2 0

2 0

2 1

2 0

2 2

2 0

2 3

2 0

2 4

2 0

2 5

2 0

2 6

2 0

2 7

2 0

2 8

2 0

2 9

2 0

3 0

Actual Forecast

R eg

u la

to ry

q u

al it

y In

d ex

( W

o rl

d B

an k)

EU and US trends in regulatory quality, with linear forecasts based on 2014-2023 data

US EU

US (linear trend forecast, 2014-2023) EU (linear trend forecast, 2014-2023)

90 100 110 120 130 140 150 160 170

2 0

1 8

2 0

1 9

2 0

2 0

2 0

2 1

2 0

2 2

2 0

2 3

2 0

2 4

2 0

2 5

2 0

2 6

2 0

2 7

2 0

2 8

2 0

2 9

2 0

3 0

Actual Forecast

P u

b lic

-p ri

va te

c o

-p u

b lic

at io

n s

(E IS

)

EU and US trends in Public-private co-publications, with linear forecasts based on 2018-2025 data

US EU

US (linear trend forecast, 2018-2025) EU (linear trend forecast, 2018-2025)

80

90

100

110

120

2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030

Actual Forecast

P C

T p

at en

t ap

p lic

at io

n s

(E IS

)

EU and US trends in PCT patent applications, with linear forecasts based on 2018- 2025 data

US EU

US (linear trend forecast, 2018-2025) EU (linear trend forecast, 2018-2025)

25

Source: Source: DG Research and Innovation, Innovation policy & Access to finance Unit’s own elaboration according to the

methodology explained above, based on EIS and World Bank data.

3. WHY SHOULD THE EU ACT?

3.1. Legal basis

The appropriate legal basis for the European Innovation Act (EIA) is Article 114 TFEU,

which empowers the Union to adopt measures for the approximation of the laws, regulations

or administrative provisions of the Member States which have as their object the establishment

and functioning of the internal market. This reflects the core objective of the EIA: to remove

the regulatory and structural barriers that hinder the testing, commercialisation and diffusion

of innovation, within the Single Market.

The choice of legal basis is further supported by the fact that the identified problems produce

a direct and demonstrable impact on the proper functioning of the Single Market. The

fragmented approaches to pre-commercial procurement and valuation of intellectual property

rights, impede cross-border movement of goods, services and capital within the Single Market.

Diverging national rules on pre-commercial procurement constitute barriers that prevent

companies from participating in and offering their innovative products and solutions to public

buyers in different Member States. The absence of a harmonised methodology for valuing

intellectual property assets creates divergent conditions across Member States for the use of

such assets in company financing, notably as collateral for debt financing. This fragmentation

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

growth and investment.

The final decision on the most appropriate legal basis will however be subject to a centre of

gravity test done on the basis of a draft legal text.

3.2. Subsidiarity: Necessity of EU action

The innovation gap cannot be overcome by Member States acting alone. This because

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

nature yet remain fragmented along national lines. In addition, the objectives of the initiative

to increase commercialisation and diffusion of innovation require a critical mass, both in terms

of support and in terms of potential customers, that individual Member States cannot achieve

in isolation.

EU action is the most feasible way to address the identified problems. While some there

buyers in some Member States that conduct pre-commercial procurements applying the

national rules and procedures, these procedures are often incompatible, making implementation

of cross-border pre-commercial procurements especially difficult. At the same time, diverging

national approaches undermine the ability of innovators and innovative companies to

participate in pre-commercial procurements in other Member States. No single Member State

can establish a pre-commercial procurement procedure applicable in the entire Single Market.

Therefore, only an action at the Union level can achieve the necessary level of harmonisation

opening pre-commercial procedures to all companies established in the Single Market and

enabling the implementation of cross-border pre-commercial procurements by buyers from two

26

or more Member States. Any single Member State would face difficulties in establishing an

IP valuation framework recognised by lenders in the entire Single Market. Therefore,

developing a common EU valuation framework is necessary to ensure that IP assets can serve

as effective collateral on a cross-border basis.

An action at the EU level would achieve the necessary level of harmonisation through

establishing framework conditions at the EU level that support commercialisation and diffusion

of innovation in the Single Market, thus leveraging the potential of the internal market for

innovators and innovative companies to develop, test, and find customers for their innovations.

In this respect, only EU-level frameworks can provide the scale and level playing field

Europe’s innovators need. EU-wide harmonised frameworks for accessing key resources,

including markets and financing can generate the necessary economies of scale and ensure a

level playing field for Europe’s most innovative companies. This reduces duplication,

strengthens spillovers, and positions Europe to compete effectively with global innovation

leaders such as the United States and China.

3.3. Subsidiarity: Added value of EU action

EU-level action generates clear added value by improving efficiency, fairness, and global

impact.

1. Efficiency gains arise from the optimal allocation of resources across the wider

European landscape, enabling better matching of talent, capital, and ideas throughout

the Union rather than within fragmented national ecosystems. This broader matching

unleashes innovation potential that would otherwise remain untapped in smaller or less

connected markets, thereby fostering stronger growth and allowing additional resources

to be directed towards priority policy objectives.66 67

2. Fairness stems from granting all innovative companies across the EU equal access to

resources and a consistent set of rules. This prevents firms in Member States with less

supportive framework conditions from being disadvantaged for reasons unrelated to

their own merit. Ensuring such fairness allows all deserving innovators to benefit

equally, rather than only those located in the most advanced ecosystems.68 69

66 European Commission: Directorate-General for Research and Innovation, Balland, P.-A., Di Girolamo, V., Benoit, F., Ravet,

J., & Hobza, A. (2025). Divided we fall behind: why a fragmented EU cannot compete in complex technologies, Publications

Office of the European Union. https://data.europa.eu/doi/10.2777/8548441 67 Oyun Erdene Adilbish, et al. (2024). Europe’s Productivity Weakness: Firm-Level Roots and Remedies. IMF Working

Papers. https://doi.org/10.5089/9798229001441.001 68 Quas, A., Mason, C., Compañó, R., Testa, G., & Gavigan, J. P. (2022). The scale-up finance gap in the EU: Causes,

consequences, and policy solutions. European Management Journal, 40(5), 645-652. 69 Ferrando, Annalisa; Lekpek, Senad (2018): Access to finance and innovative activity of EU firms: A cluster analysis, EIB

Working Papers, No. 2018/02, European Investment Bank (EIB), Luxembourg

27

3. Global impact is achieved by giving EU innovation output the scale and weight needed

to compete with international competitors and to engage with major global priorities

such as the green and digital transition or artificial intelligence.70 71

4. OBJECTIVES: WHAT IS TO BE ACHIEVED?

To address the problems and drivers identified in the previous sections, it is important to

set out a clear hierarchy of objectives. The general objectives reflect the broader EU policy

goals and strategic priorities that the EIA contributes to. The specific objectives translate these

into more concrete aims, directly targeting the main problems identified in section 2. Figure 7

summarises the objectives of this initiative.

Figure 7. EIA intervention logic

70 Fratto, C., Gatti, M., Kivernyk, A., Sinnott, E., & Wielen, W. V. D. (2024). The scale-up gap: Financial market constraints

holding back innovative firms in the European Union. European Investment Bank (EIB), Luxembourg 71 European Commission: Directorate-General for Research and Innovation, Ambrosio, F., Brasili, A. and Niakaros, K.,

European scale-up gap – Too few good companies or too few good investors?, Publications Office of the European Union,

2021, https://data.europa.eu/doi/10.2777/886042

28

4.1. General objectives

The general objective 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 EU.

This objective derives directly from the problems identified in Chapter 2. All four

problems addressed by the EIA concern barriers that prevent the Single Market from realising

its full potential to bring innovative ideas from development to market across borders. They

reflect fragmented or inconsistent framework conditions across Member States: including

divergent testing and experimentation rules, non-standardised IPR valuation practices, uneven,

and differing interpretations of pre-commercial procurement. Together, these factors reduce

efficiency and predictability for innovators operating cross-border. The EIA therefore aims to

address these framework inefficiencies and improve the functioning of the Single Market for

innovation.

Progress toward this objective is operationalised through the specific objectives set out below

and monitored through defined monitoring indicators.

4.2. Specific objectives

Specific objectives translate the high-level general objectives into more concrete and

operational aims. They are directly linked to the identified problems and describe the targeted

changes that the EIA seeks to achieve through EU action. While general objectives capture the

ultimate purpose of the intervention, specific objectives clarify how the proposed measures will

contribute to those broader goals.

SO1. Lower valuation costs, and increase licensing and transfer of IPRs in the EU in the

next 4 years

This specific objective aims to reduce the cost and complexity of intellectual property rights

(IPR) valuation and to increase the licensing, transfer, and financing use of IPR assets in the

EU over the next four years.

The objective is to improve comparability, transparency, and practical usability of IPR

valuation approaches across the EU, thereby lowering transaction costs and uncertainty in IP-

related transactions. This is expected to facilitate more licensing agreements, technology

transfer operations, and financing transactions involving IP assets, supporting the

commercialisation and scale-up of innovation.

Progress toward this objective will be monitored through indicators covering the cost of IP

valuations, the uptake of common valuation approaches, their use in transactions, and the use

of IP assets in financing operations.

SO2. Increase spending on procurement of R&D services in the next 5 years

29

This specific objective aims to significantly increase the use of public procurement for R&D

services in the EU over the next five years.

The objective is to strengthen the role of public demand as a driver of innovation by increasing

the share of procurement budgets dedicated to R&D purchasing. This is expected to expand

market opportunities for innovative firms, and support early deployment of new solutions.

Progress toward this objective will be monitored through indicators measuring the share of

procurement expenditure dedicated to innovation and R&D procurements and the number and

value of innovation-oriented procurement contracts awarded.

SO4. Increase the procurement of EU-based R&D solutions in the next five years

This specific objective aims to increase the uptake of R&D solutions developed and

commercialised by EU-based companies through public procurement over the next five years.

The objective is to reinforce the contribution of public procurement to Europe’s strategic

autonomy by encouraging contracting authorities to take into account security, resilience and

long-term innovation capacity when designing and awarding procurement procedures, in line

with EU internal market and international obligations. This is expected to increase market

opportunities for EU-based innovative firms in critical sectors, support the scaling of key

technologies within the Union, and reduce strategic dependencies in areas of high economic

and geopolitical relevance.

Progress toward this objective will be monitored through indicators measuring the share and

value of procurement contracts awarded to EU-based innovative companies in identified

strategic sectors, as well as the integration of resilience- and autonomy-related criteria in

procurement procedures.

5. WHAT ARE THE AVAILABLE POLICY OPTIONS?

The Impact Assessment examines 3 potential measures designed to address the problem

drivers identified in Chapter 2. Figure 8 provides an overview of the measures and their

thematic focus. As several measures can be implemented through different instruments, target

populations, sectors, levels of regulatory intensity and ambition, each measure is usually72

presented in up to four mutually exclusive versions (A, B, C, D).

The assessment is carried out at the level of each individual measure, with the different

measure-versions representing alternative policy options for that measure. This approach

is appropriate given the horizontal scope of the EIA and the heterogeneity of both the problem

drivers and the measures addressing them. Depending on the specific problem driver and the

characteristics of the measure, the most suitable implementing instrument, and level of

regulatory intervention may differ substantially across measures.

72 Measure-versions are usually mutually exclusive, when they are not, an additional variant with the combination of the non-

mutually exclusive variants is added.

30

Finally, the preferred option for the whole EIA is constructed as a composite package by

selecting, for each of the 3 measures, the measure-version that performs best in terms of

effectiveness, efficiency, and coherence. Since the EIA covers a wide range of heterogeneous

problem drivers and instruments, assessing measures individually allows the analysis to

identify the most appropriate intervention for each specific problem area. The preferred option

therefore does not correspond to any single predefined bundle but is the coherent combination

of the strongest-performing versions across all measures.

Figure 8: Summary of the analysed measures

5.1. What is the baseline from which options are assessed?

Under the baseline scenario, there would be no specific legislation at European level

comprehensively addressing the innovation-specific problems discussed above. Existing

EU initiatives and national measures would continue to apply in their current form, and no new

intervention would be introduced to tackle the four main problems (described in Chapter 2) that

hinder the optimal uptake and diffusion of innovation in the EU Single Market.

Implementation of ongoing programmes under the EU's Multiannual Financial

Framework for 2021-2027 (e.g. Horizon Europe, Digital Europe, Invest-EU, Innovation fund,

cohesion policy instruments) would proceed as currently planned, without additional

coordination or harmonisation efforts targeting the barriers identified in Chapter 2. While some

Member States may introduce incremental reforms, these efforts are likely to remain uneven

and insufficiently coordinated to address EU cross-border regulatory and market fragmentation.

Incentivising commercialisation of research and innovation results

31

The EU would continue to rely on its initiatives related to intellectual assets, including the

EU Intellectual Property Action Plan, the Unitary Patent and the Unified Patent Court, the IP

SME Helpdesks, and existing guidance on intellectual property licensing. For results generated

by EU-funded projects, Horizon Europe model grant agreements include standardised

provisions on ownership, access rights and exploitation of results, which influence practices

related to intellectual property management and technology transfer.

Without a mandate to EUIPO it would be more difficult to develop a common EU-level

methodology for the valuation of all types of intellectual property rights, and the EU would

continue to lack a valuation framework for the use of intellectual property as collateral in

banking or investment.

Without EU-level action, the EU will continue to underperform in translating strong research

and patent output into commercially successful innovation. The existing EU and Member State

initiatives related to IP will not address the lack of a common, trusted methodology for valuing

intellectual property rights. As a result, IP-rich firms, particularly startups and scaleups, will

continue to face difficulties using intellectual property rights as collateral, limiting access to

finance and scaleup opportunities.

Access to procurement markets

In the field of innovation procurement in the public sector, the baseline is a common EU legal

framework on public procurement. Directive 2014/24/EU, Directive 2014/23/EU, Directive

2014/25/EU and Directive 2009/81/EC provide public buyers with 9 different procurement

procedures that can be applied in ways compatible with innovation-oriented objectives. The

directives also provide for the possibility to divide contracts into lots, which can facilitate

the participation of smaller companies, including SMEs or startups, in procurement calls.

In the field of innovation procurement in the private sector, the baseline is fragmented EU

legislation that regulates bits and pieces (e.g. on the protection of trade secrets, safeguarding

confidentiality and avoiding unlawful practices in contracting) but EU and national legislation

does not stimulate private procurers to organise their procurements in an innovation-friendly

way or in way that reinforces EU strategic autonomy, also not for private procurers that operate

critical infrastructures or provide services that are essential for the EU economy.

At the same time, the directives do not provide an EU wide definition of R&D procurement

or of procurement of innovative solutions, and do not require public buyers to use

procurement practices that stimulate innovation in the available procurement

procedures. In addition, pre-commercial procurement (PCP) is not regulated under these

directives and remains outside their scope. In addition, the directives apply only to public

procurements valued above certain thresholds (EUR 215,000 for supplies and services,

EUR 431,000 for utilities, 5,382,000 for works, EUR 700,000 for health contracts, EUR

900,000 for defence contracts). For procurements valued below those thresholds, national

procurement rules apply which are different per country and also do not sufficiently encourage

public buyers to use procurement practices that stimulate innovation.

The baseline also takes into account the Commission proposal to revise the EU public

procurement framework through the Public Procurement Act (PPA). As currently

proposed, the PPA would exclude all R&D procurement from its scope, while continuing to

32

cover the procurement of innovative solutions, including procurements that contain R&D

elements without constituting R&D procurement as such. This assumption reflects the

Commission proposal at the time of writing and is without prejudice to possible changes during

the subsequent legislative process in the European Parliament and the Council.

Of stakeholders that replied 82% (116) agreed that public buyers should procure R&D and

innovative solutions in a simpler way. 93% (144) agreed that a fast-track procedure for public

procurements buying R&D and/or innovative solutions, with contracts awarded based not only

on lowest price, but also on other criteria, would be a good step forward. 83% (124) agreed that

a fast-track procedure for public procurements buying R&D and/or innovative solutions, which

make wider use of functional or performance-based specifications, would be a good step

forward. 86% (127) agreed that a fast-track procedure for public procurements buying R&D

and/or innovative solutions, without legal hurdles that make it difficult for public buyers from

different EU countries to procure R&D and/or innovative solutions collaboratively, would be

a good step forward. 65% (123) agreed that when private buyers in the EU procure solutions,

even if without public funding, they should adopt procurement practices that promote

innovation and support the participation of start-ups and innovative companies. 80% of

stakeholders also agreed that both public and private procurers that operate critical

infrastructures should organise their procurements in a more innovation friendly way and in a

way that safeguards EU strategic autonomy.

All 27 Member States have adopted policies (see Annex 11 & 14 on Policy Mapping) that refer

to the stimulation of public or private innovation procurement. At the same time, only a limited

number of Member States have introduced dedicated procedures for pre-commercial

procurement and dedicated procurement practices to foster innovation in procurements

outside the EU procurement directives.

The European Business Wallets will facilitate innovation procurement by enabling public and

private buyers to securely verify suppliers’ identities and credentials and exchange procurement

documents efficiently. They will provide a digital infrastructure to store and manage

procurement data, helping procurers track processes more easily.

Without EU-level action, innovation procurement will remain underused and fragmented, with

public and private buyers continuing to prioritise cost and risk minimisation over innovation.

In particular, the absence of a harmonised EU framework for pre-commercial procurement will

keep its use uneven and largely ad hoc across Member States, limiting legal certainty and cross-

border uptake. As a result, startups and scale-ups will struggle to find early adopters in the EU,

slowing the commercialisation and scaling of innovative solutions and widening the gap with

global competitors.

5.2. Description of the policy options

Measure 1: Establishing IP valuation methodology and facilitating licensing

Measure 1 would address the lack of standardisation, complexity and high costs of existing

intellectual property rights (IPR) valuation models in the EU (problem driver 1.1) by

establishing a centralised and trusted framework for IP-backed finance at Union level. By

33

mandating EUIPO to set up a Competence Centre for IP-backed finance, the measure

would leverage EUIPO’s existing expertise, data and digital infrastructure to develop a

common IP valuation framework, set up a digital match-making platform to facilitate the

licensing and transfer of all types of intellectual property rights, provide secondary market

facilitation services (e.g. collaboration with brokerage services and IP auctioneers), support the

design and implementation of financial instruments related to IP assets, provide training,

awareness-raising and helpdesk services.

This would increase the transparency, comparability and credibility of IP valuations

across Member States, reduce information asymmetries between IP holders and financial

actors, and lower transaction costs. In parallel, support for the design of IP-backed financial

instruments, skills development and helpdesk services would improve the readiness of financial

institutions and innovators to engage in IP-backed finance. Together, these elements would aim

to enable innovative, IP-rich but tangible-poor companies to access finance earlier and more

reliably, thereby improving the allocation of capital to innovation, supporting scale-up, and

contributing to a more integrated and competitive EU innovation and capital markets

ecosystem.

The IP valuation framework would provide for a number of methodologies for valuation of

different types of IPRs and for different purposes (e.g. collateral for financing or for licensing).

The IP valuation framework would be aligned with International Valuation Standards and

principles while adding purpose-driven and sector-specific guidance for all IP rights. The IP

Valuation framework would also include the development of standardised templates and

checklists for credit and investment use in order to translate the IP valuation results into a

format that banks and investors can understand, trust, and use.

Of stakeholder replies 89% (141) of respondents agreed that Member States should adopt

(where not yet in place) strategies to promote the commercialisation of publicly funded

research, including intellectual asset management, spin-off creation, and go-to-market support.

76% (109) agreed that IPR policies in European Universities and RTOs are not sufficiently

geared to fostering the commercialisation of academic research results. 90% (131) agreed that

European universities and RTOs should have an IPR policy in place that clearly outline how

they handle protection, licensing, and transfer of IP.

The digital marketplace would operate as a digital platform enabling IPR holders to offer

their rights for transfer or licensing. An online EU-wide matchmaking platform that connects

IP-rich companies with investors and the resulting transfer or licensing contractors would be

done outside the platform.

Several versions of Measure 1 are envisaged, reflecting different levels of ambition and

scope. Version A would mandate EUIPO, through the European Innovation Act, to develop an

EU-wide IP valuation framework. Version B would focus on establishing an EU-wide digital

marketplace functioning as a secondary market for IP transactions. Version C would assign

EUIPO the role of an EU-wide IP competence centre providing advice, training and support on

IP valuation. Version D would combine the valuation framework and the marketplace, while

Version E would integrate all three elements, representing the most comprehensive approach

to addressing barriers to IP-backed finance.

34

Measure 2: Establish procedures for R&D procurement for public buyers, including cross-

border R&D procurement and rules to promote the use of innovation-friendly techniques within

R&D procurement

Measure 2 would contribute to addressing the problem that public R&D procurement is

not sufficiently used in the EU to develop and commercialise innovation by tackling three

interrelated problem drivers: lack of legal certainty on how to procure R&D services (problem

driver 2.1), overutilisation of procurement practices that favour incumbents and limit the

participation of innovative companies (problem driver 2.2), and fragmentation and barriers to

cross-border R&D procurement (problem driver 2.3).

The measure establishes a dedicated procedure for R&D procurement for public buyers,

including cross-border R&D procurement and rules to promote the use of innovation-friendly

techniques within R&D procurement. Two versions (A, B) of the measure were considered.

Version A would recommend the use of innovation-friendly techniques for R&D procurement

by public buyers, while Version B would make the use of such techniques mandatory for R&D

procurement procedures carried out by public buyers. Across all versions, a minimum EU

financial threshold,consistent with those used in other provisions of EU law is used, ensuring

compliance with the principles of proportionality and subsidiarity.

By establishing a dedicated procedure for R&D procurement, including cross-border R&D

procurement, the measure would clarify how public buyers can lawfully and effectively

procure R&D services that fall outside of the EU public procurement directives and cooperate

across borders, thereby reducing legal uncertainty and coordination barriers. Importantly, the

measure would not address defence R&D procurement.

As noted in the problem definition chapter, pre-commercial procurement (PCP) is not

subject to the EU Public Procurement Directives, while, under the Commission proposal

for the Public Procurement Act (PPA), the remaining forms of R&D procurement would

also be excluded from its scope73. In the absence of a harmonised EU framework, national

approaches to R&D procurement remain fragmented across the Union. The measure would

address this fragmentation by establishing a harmonised procedure for R&D procurement,

building on existing best practices. The procedure would apply exclusively to public buyers.

Innovation procurement techniques include start-up friendly selection criteria, innovation-

oriented award and contract monitoring criteria, functional specifications, value engineering,

innovation-friendly intellectual property arrangements, multiple sourcing provisions, place-of-

performance requirements and other EU preference clauses.

Measure 3: Preference for EU-made solutions in R&D procurement for public buyers

Measure 3 would address the insufficient consideration of Europe’s strategic autonomy

in R&D procurement (problem driver 2.4) by introducing an EU preference for public

buyers procuring R&D services. This would ensure that there are sufficient suppliers that

produce critical technology-based solutions in the EU by the time that EU preference provisions

in other EU sectorial acts (e.g. in the Industrial accelerator act, Critical medicines act) kick in

73 This reflects the scope of the PPA proposal at the time of writing and is without prejudice to amendments that

may be introduced during the legislative process.

35

that focus on the procurement of widely commercially available solutions that fall under the

EU public procurement directives. The EU preference would strengthen incentives for

investment and scale-up in critical technologies, and reduce reliance on external providers.

Over time, this demand-side signal would support the development of resilient EU value chains,

enhance security of supply for critical technologies, and contribute to a more strategically

autonomous and competitive European innovation ecosystem.

The measure would build on approaches already used in recent Union legislation, such as

the Net-Zero Industry Act, the Critical Raw Materials Act, the Chips Act, as well as the

forthcoming European Industrial Accelerator Act, which introduce EU-level tools to reduce

strategic dependencies and strengthen Union supply chains in clearly defined sectors, but focus

only on procurements that target commercial volumes of widely available solutions that are

procured under the EU public procurement directives. The objective of the measure would be

to de-risk innovation procurements that precede large scale deployment contracts and

ensure security of supply by using the EU preference only where strategic dependencies are

evidenced. The provision would be framed as an EU preference obligation with appropriate

escape clauses, e: Global sourcing would remain possible where no suitable EU-made solution

is available or when applying the EU preference would lead to disproportionate costs or

technical incompatibilities for the procurers.

Importantly, the measure does not overlap with other existing or foreseen EU preference

provisions in sectoral acts or in the EU Public Procurements Directives, as those only focus on

procurements that are / will be covered by the EU public Procurement Directives, while the

EIA focuses on procurements that are not / will not covered by the EU Public Procurement

Directives.

Three versions (A, B, C) of the measure were considered. Version A would introduce a non-

mandatory preference for EU-made solutions in R&D procurement. Version B would introduce

a mandatory preference for EU-made solutions in R&D procurement with flexibility clauses

allowing non-EU suppliers to participate where there are no sufficient suitable tenderers within

the Union or where compliance would impose disproportionate costs. Version C would

introduce a strict mandatory preference for EU-made solutions in R&D procurement, with no

exceptions for public buyers.

More specifically, under Alternative B, public buyers may decide not to restrict access to EU-

based tenderers through the following opt-out clauses:

• where no suitable or sufficient EU-based suppliers are available, as demonstrated

through a market search, preliminary market consultation, or a previously unsuccessful

call for tenders;

• where restricting access would result in disproportionate costs or technical

incompatibility. For assessing disproportionate costs, a price difference exceeding 20%

between an EU-based offer and a third-country offer, based on objective and transparent

data, may be considered excessive.

The rationale for these clauses is twofold. First, they aim to mitigate potential negative

economic effects by ensuring that EU preferences are not applied where they would lead to

36

significant inefficiencies or where the EU market cannot meet demand. Second, they help

ensure compatibility with international obligations.

Across all versions, the EU preference could be applied to different types of contracts,

including supplies, works and services. Implementation modalities could combine price

preferences with award-criteria weighting, for example by assigning higher scores under

innovation-related criteria to offers demonstrating stronger contributions to innovation,

manufacturing capacity and EU strategic autonomy contribution within the Union.

Furthermore, across all versions, a minimum EU financial threshold,consistent with those

used in other provisions of EU law, is used, ensuring compliance with the principles of

proportionality and subsidiarity.

Figure 9 shows how the EIA procurement related measures (measure 2, and 3) would

complement, without overlapping with, the revision of the EU public procurement framework,

referred to as the Public Procurement Act (PPA)74.

Figure 9. Scope of the European Innovation Act in relation to the Public Procurement

Act

Source: Author own elaboration. Note: This reflects the scope of the PPA proposal at the time of writing and is without

prejudice to amendments that may be introduced during the legislative process. Unlike the existing EU Public Procurement

Directives, which cover certain types of R&D procurement where the benefits accrue exclusively to the contracting authority

for use in the conduct of its own affairs and the service is wholly remunerated by it, the Commission proposal for the

revision of the EU public procurement framework, the Public Procurement Act (PPA), does not cover any type of R&D

procurement. It would, however, continue to cover procurement of innovative solutions and procurements containing R&D

elements that do not constitute R&D procurement as such.

74 This reflects the scope of the PPA proposal at the time of writing and is without prejudice to amendments that

may be introduced during the legislative process.

37

Box 3. How would the EIA R&D procurement procedure work in practice?

In practice, the EIA R&D procurement procedure could operate as follows:

i. A municipality seeks innovative solutions to improve flood prevention, detection,

early warning and mitigation. It launches an EIA R&D procurement preliminary

market consultation to understand the state of the art and identify potential

technological approaches.

ii. Based on the consultation, the municipality identifies the main market players and,

where applicable, applies the EIA R&D procurement EU preference to reduce

dependence on large non-EU suppliers.

iii. The municipality uses the EIA R&D procurement innovation-friendly exclusion

and selection criteria that facilitate the participation of startups and other innovative

companies in the R&D procurement.

iv. The tender is based on EIA R&D procurement functional and performance

requirements that define the problem to be solved and the expected outcomes

without prescribing a specific technical solution, design or technology.

v. As the municipality has no intention of commercialising the R&D results, it allows

suppliers to retain ownership of the intellectual property generated, while

securing the necessary usage rights, thereby strengthening incentives to participate.

If a prototype is developed, the municipality can acquire ownership of that prototype.

vi. To prevent supplier lock-in and foster competition, the municipality applies the EIA

R&D procurement multiple sourcing by awarding parallel R&D contracts to several

competing suppliers, progressively reducing their number as the project advances.

This increases the likelihood of achieving the best solution while generating

knowledge spillovers that strengthen the EU innovation ecosystem.

vii. Contracts are awarded on the basis of the best value for money, with innovation-

related award criteria rather than lowest price alone.

viii. If a promising new technology emerges during contract implementation, the value

engineering EIA R&D procurement provisions allow the municipality to amend the

contract and incorporate the improved solution.

ix. Key performance indicators (KPIs) are used to monitor suppliers' progress

throughout the project and identify the best-performing solution.

x. By the end of the R&D procurement, the municipality has obtained an innovative

solution tailored to its needs while promoting competition, supporting innovative

European firms, and contributing to EU technological sovereignty.

5.3. Options discarded at an early stage

In line with the Better Regulation guidelines, a broad range of potential measures was initially

identified and screened at an early stage of the analysis. This screening assessed their relevance

38

to the identified problems and objectives, proportionality, coherence with existing Union

instruments, expected added value of EU action, and feasibility of implementation.

The measures listed below were examined but not retained for further development in the policy

options, as they were found to be outside the appropriate scope of this initiative, duplicative of

existing frameworks, insufficiently proportionate, or better addressed through non-legislative

or alternative instruments.

Operational rules for applying definitions of startups, scaleups and innovation

companies.

This measure concerned verification and operational eligibility procedures linked to the

adopted Commission Recommendation of 18 March 2026 on the definition of innovative

enterprises, innovative startups and innovative scaleups. It was discarded because, although the

benefits and costs of the initiative are likely to accrue primarily to certain types of firms (e.g.

those engaged in innovation activities, which are more likely to use IP valuation, pre-

commercial procurement, or regulatory sandboxes), the measures themselves are not legally

restricted to specific company categories. There are no formal eligibility criteria limiting access

to these instruments. Introducing such operational eligibility rules would therefore fall outside

the scope and rationale of the initiative.

Common definition, basic principles, and experimentation clauses for establishing

regulatory sandboxes. This measure was identified as potentially beneficial to improve clarity

and consistency in the use of regulatory sandboxes across the Union. By reducing

fragmentation in national approaches, the measure would have increased legal predictability

for innovators and competent authorities and facilitated the testing of innovative solutions

under controlled conditions, enhancing later commercialisation activities.However, it was not

retained, as it was considered would be more appropriately pursued through soft-law

instruments outside the scope of this intervention.

National commercialisation and IPR ownership allocation strategies.

This measure was identified as potentially beneficial for promoting the commercialisation of

publicly funded R&I results. However, it was not retained, as it was considered that such

strategies would be more appropriately pursued through soft-law instruments outside the scope

of this intervention.

Innovation friendly techniques and EU preference for all Innovation procurement. The

procurement measures on innovation-friendly procurement procedures and EU preference were

narrowed to focus exclusively on public R&D procurement to ensure better coherence with the

Public Procurement Directives. Hence, the innovation-friendly procurement techniques

applicable to other forms of procurement, such as public or private innovation procurement

more broadly, was removed from the scope of the EIA. In addition, an EU financial threshold,

consistent with those used in other provisions of EU law, was introduced, ensuring compliance

with the principles of proportionality and subsidiarity.

Innovation procurement target for public buyers. This measure was identified as potentially

beneficial, as it could incentivise Member States to allocate a higher share of public

procurement expenditure to innovation procurement. However, it was ultimately not retained.

39

Since the measure was not limited to R&D procurement and also covered procurement of

innovative solution (PPI), concerns were raised about potential overlaps with the ongoing

revision of those Directives. It was therefore considered that another policy framework could

be more appropriate for such an intervention. In addition, concerns were raised regarding the

potential administrative and financial burden on Member States.

6. WHAT ARE THE IMPACTS OF THE POLICY OPTIONS?

In line with the European Commission’s Better Regulation Toolbox and the OECD’

guidelines on policy evaluation75 , when quantification is not feasible or would rely on

highly speculative assumptions, a transparent qualitative assessment is favoured as it

provides a more appropriate basis for decision-making. This approach is consistent with

established evaluation theory and economic literature, which caution against unwarranted

numerical certainty in the absence of reliable evidence.76 77 78

Where quantification is feasible, costs and benefits are presented at aggregated EU level.

Estimates are derived by combining average unit cost or benefit values with the estimated

number of economically affected entities in the Union.

In practice, aggregate impacts are calculated by multiplying the average unit effect per

entity by the number of entities expected to be affected. In line with the European

Commission’s Better Regulation Toolbox, a distinction is made between the legally eligible

population and the economically affected population. The latter includes only those entities

realistically expected to use or be impacted by the measure and therefore constitutes a subset

of the former.

Although access to instruments such IP valuation services, or pre-commercial procurement is

not legally restricted, their use is concentrated among firms engaged in innovation activities

(e.g. R&D, IP generation, or product testing). Accordingly, entities unlikely to make use of

these instruments are excluded from the quantification to ensure realistic estimates.

6.1. Estimates of economically affected population

For the purpose of the cost-benefit analysis, it is necessary to identify the population of

entities that are economically affected by each measure. This differs from the legally

eligible population. While the legally eligible population includes all entities that could, in

principle, benefit from or bear costs under a measure, the economically affected population

comprises only of those entities realistically expected to use or be impacted by it, and therefore

constitutes a subset of the eligible population. This distinction is essential to ensure that

quantified impacts reflect actual behavioural responses rather than purely theoretical legal

eligibility.

In practice, although access to EIA measures (such as IP valuation services, and pre-

commercial procurement) is not legally restricted, and all 33.5 million enterprises and

75 OECD (2020), Improving Governance with Policy Evaluation: Lessons From Country Experiences, OECD Public

Governance Reviews, OECD Publishing, Paris, https://doi.org/10.1787/89b1577d-en. 76 Manski, C. F. (2013). Public policy in an uncertain world: analysis and decisions. Harvard University Press. 77 Kahneman, D. (2011). Thinking, fast and slow. Farrar, Straus and Giroux. 78 Scriven, M. (1991). Evaluation thesaurus. Sage.

40

approximately 250,000 public authorities in the EU are formally eligible, the estimation of costs

and benefits focuses only on those entities likely to make use of these instruments. For IP

valuation, it includes firms holding or generating intellectual property. For pre-commercial

procurement, the economically affected population includes firms able to provide R&D

services, not any company, as well as public buyers with specific needs for R&D solutions,

rather than all contracting authorities.

The economically affected populations used in the cost-benefit analysis are presented

below:

Innovative firms: The number of innovative firms used in this analysis is 373,722, of which

94% SMEs (n = 350,075) and 6% large enterprises (n = 23,646), based on Eurostat estimates

from the 2022 Community Innovation Survey (CIS).79

The Community Innovation Survey (CIS), coordinated by Eurostat, is a harmonised survey

collecting firm-level data on innovation across EU countries and covers enterprises with 10 or

more employees to ensure statistical reliability and comparability, as very small firms are more

difficult to survey consistently. It follows the Oslo Manual definition, classifying firms as

“innovation-active” if they have introduced a new or significantly improved product or process,

or have ongoing or abandoned innovation activities during the reference period; estimates are

then derived by extrapolating survey responses to the full business population using statistical

weighting.

Startups: The total number used in this analysis is 35,000 startups, with a possible range

between 27,000 and 41,000. This is based on the Invest Europe State of European Tech 2024

report, according to which there are approximately 35,000 early-stage startups in Europe, while

27,000 European companies received VC funding in the past 10 years.

IP rich firms within capacity of EUIPO: the number used for this analysis is 14,515 firms, of

which 1,036 Startups, 10,398 SMEs, and 3,081 large enterprises. This is estimated based on

the following facts:

➢ The number of innovative firms used in this analysis is 373,722, of which 94% SMEs

(n = 350,075) and 6% large enterprises (n = 23,646), based on Eurostat estimates from

the 2022 Community Innovation Survey (CIS).

➢ The number of startups used this study is 35,000 startups.

➢ The number of firms that register IP rights: 10% of EU SMEs; 60% of large firms in

EU.80

➢ The number of startup that that register IP rights is assumed to be 10%, namely the same

as innovative SMEs.

79 Eurostat Online data code: inn_cis13_bas. DOI : https://doi.org/10.2908/INN_CIS13_BAS 80 European Union Intellectual Property Office (2022). 2022 Intellectual Property SME Scoreboard; European Union Intellectual Property Office and European Patent Office (2021). Intellectual property rights and firm performance in the European Union: Firm- level analysis report. Executive summary.

41

By combining this information, we obtain: (94% × 10% × 373,722) + (6% × 60% × 373,722)

+ (10% × 35,000) = (35,130 SMEs) + (13,454 large companies) + (3,500 startups) = 52,084 IP

rich firms in total.

Subsequently, the number of IP-rich firms within EUIPO capacity is estimated using EUIPO

(2025) data, according to which SMEs account for 29.6% of European patent holders, while

large enterprises represent 22.9%.81 Yielding to: (29.6% × 35,130) + (22.9% × 13,454) +

(29.6% × 3,500) = (10,398 SMEs) + (3,081 large companies) + (1,036 startups) = 14,515 IP

rich firms within capacity of EUIPO.

EU Innovation Procurement Volume: EUR 295 billion, corresponding to 10.5% of total public

procurement. Based on EU benchmarking of innovation procurement study.82

EU R&D Procurement Volume: EUR 17.28 billion, corresponding to 0,61% of the total amount

of public procurement, and 6,1% of the innovation procurement. Based on EU benchmarking

of innovation procurement study.83

Public buyers of R&D procurement: the number used in this analysis is 1,500-2,000 public

buyers. This estimate is based on a 2025 European Commission study indicating that more than

1,000 public buyers across Europe have already implemented PCPs. The analysis assumes

2,000 public buyers under Measure 2 Alternative B and 1,500 under Measure 2 Alternative A.

6.2. Costs and benefits by stakeholder by measure

6.2.1. Costs for Measure 1 - Promote valuation of IP

The estimated costs for the EU public sector are based on two elements: (i) the staff time

required for IP valuation and promotion activities, and (ii) the monetisation of that time based

on the salaries of the staff involved. Administrative and adjustment costs are grounded in

evidence provided by the European Union Intellectual Property Office, which was consulted

on the full-time equivalent (FTE) staff needed to implement the different measure options and

the baseline scenario.

Under the baseline, administrative cost for the EU public sector is estimated using the Standard

Cost Model, based on current EU IP Helpdesk services, assuming monthly inputs of 1 person-

81 EUIPO (2025, Table 5). Intellectual property rights and firm performance in the European Union. Firm-level analysis report, January 2025. The report classifies firms into three categories: (i) those holding patents only at the European level, (ii) those holding patents only at the national level, and (iii) those holding both European and national patents. The shares reported in the main text refer exclusively to firms in the first category. However, firms holding both European and national patents could also be included in the calculation of benefits. Due to the lack of access to the underlying raw data, it is not possible to isolate and account for the number of firms in this category 82 European Commission: Directorate-General for Research and Innovation & PwC. (2026). EU innovation procurement

observatory : final study report. Publications Office of the European Union. https://data.europa.eu/doi/10.2777/1638226. 83 European Commission: Directorate-General for Research and Innovation & PwC. (2026). EU innovation procurement

observatory : final study report. Publications Office of the European Union. https://data.europa.eu/doi/10.2777/1638226.

42

day (AD10), 3 person-days (AD6), and 2 person-days (AST/SC3), corresponding to 72 person-

days per year (around 0.33 FTE), valued at EUR 40.5 per hour84 (EUR 23,328 annually).

Under the measure, additional tasks would generate administrative costs for the EU public

sector. These are assumed to require no additional FTEs for the EU IP valuation methodology

(Alternative A), 2 FTEs per year for the secondary IP marketplace (Alternative B), and 8 FTEs

per year for the IP competence centre (Alternative C). Alternatives D and E combine the

previous components respectively as A+B and A+B+C.85 Staff time is monetised using an

average hourly rate of EUR 40.5.

Adjustment costs are estimated based on the staff required to establish the different components

of the measure: 3–4 FTEs for the development of the EU IP valuation methodology (Alternative

A), 4 FTEs for the development of the secondary IP marketplace platform (Alternative B), and

10 FTEs for the establishment of the IP competence centre, including training activities

(Alternative C).86 Staff time is monetised using an average hourly rate of EUR 40.5.87

Table 4. Administrative and adjustment costs for EU public sector

Baseline

(continuation of current scenario)

Alternative A –

EUIPO EU wide IP valuation

framework

Alternative B Give

EUIPO EU wide IP marketplace

Alternative C -

Give EUIPO EU wide IP

competence centre

Alternative D (A + B) Alternative E (A + B+

C)

⚫ Adjustment

costs: No costs

⚫

Adjustment costs:

3–4 FTEs per year over 2 years

(1,320–1,760

person-days in total) × EUR 324 =

EUR 427,680 –

EUR 570,240

⚫

Adjustment

costs: 4 FTEs per year over 2 years

(1,760 person-days

in total) × EUR 324 = EUR

570,240

⚫

Adjustment costs:

10 FTEs per year over 2 years (4,400

person-days in

total) × EUR 324 =

EUR 1,425,600

⚫

Adjustment costs:

Combination of A and B. It is conservatively

assumed that it is the

sum of A + B, which results in the range of

EUR 997,920–

1,140,480

The approach is

conservative because the total cost under

this alternative is

likely to be some lower than the simple

sum because of some

overlapping activity,

⚫

Adjustment costs:

Combination of A, B and C. Following the

conservative approach

discussed under Alternative D, the

simple sum of costs

under A, B, and C leads to a range of

EUR 2,423,520–

2,566,080

⚫

Administrative

costs:

6 person-days per month × 12

months × EUR

324

= EUR 23,330

per year (72

person- days/year: 0.33

FTE/year)

⚫

Administrative

costs: No material

increase once the methodology is

established

(broadly in line

with the baseline

level above)

= EUR 23,330 per

year

⚫

Administrative

costs: 2 FTE/year

(440 person-days per year) × EUR

324 = EUR

142,560 per year

⚫

Administrative

costs: 8 FTE/year

(1,760 person-days per year) × EUR

324 = EUR

570,240 per year

⚫

Administrative costs.

Following the same

logic as used for the adjustment costs, the

sum of A and B would

imply around 2.33

FTE/year (2 FTE +

0.33 FTE),

corresponding to approximately EUR

165,890 per year.

⚫

Administrative

costs: Sum of A, B

and C leads to around 10.33 FTE/year,

corresponding to

approximately EUR

736,000 per year.

84 The EU average hourly salary rate for the job category “Professionals” (Category 2 under the International

Standard Classification of Organisations – ISCO) is EUR 40.5 per hour (incl. overhead). 85 FTEs estimates are based on consultation with the EUIPO. 86 FTEs estimates are based on consultation with the EUIPO. 87 The EU average hourly salary rate for the job category “Professionals” (Category 2 under the International

Standard Classification of Organisations – ISCO) is EUR 40.5 per hour (incl. overhead).

43

The estimated costs for the businesses are based on three elements: (i) the time (hours worked),

IP-rich companies spend to valuate and license their IP, (ii) the monetisation of the time spent,

which is based on the salaries of the staff performing the necessary activities, and (iii) the

number of IP rich companies affected by the measures. This translates into the application of

the following Standard Cost Model formula: Cost = (Hours worked × salary rate) × number of

companies affected.

Under the baseline, IP-rich firms are assumed to spend around 40–80 hours per year on IP-

related documentation and coordination activities, corresponding to approximately 20–40% of

total administrative time across functions such as tax, HR, licensing, and compliance.88 This

includes activities such as maintaining inventories of registered rights, drafting short

descriptions of inventions or software, and coordination between technical and legal teams.

Staff time is monetised using an average hourly rate of EUR 40.5.89

Under the measure, firms’ administrative workload is expected to decline progressively across

the different alternatives compared with the baseline. Under Alternative A, the reduction is

estimated at around 20%, reflecting the simplification effects of a common IP valuation

methodology. Under Alternative B, the introduction of an EU-wide matchmaking marketplace

is assumed to reduce administrative effort by around 30%, as firms would no longer need to

rely as extensively on dedicated expertise for buying and selling decisions. Under Alternative

C, firms would benefit from advisory and training services for IP valuation, resulting, for

simplicity, in a similar level of cost reduction as under Alternative B. Alternative D, which

combines Alternatives A and B, is assumed to reduce administrative workload by around 50%,

while Alternative E is estimated to achieve a reduction of approximately 75% compared with

the baseline.

Table 5. Total Administrative costs (in absolute terms) by business type, per year

Baseline

(continuation of

current scenario)

Alternative A -

EUIPO EU

wide IP

valuation

framework

Alternative B -

Give EUIPO

EU wide IP

marketplace

Alternative C -

Give EUIPO

EU wide IP

competence

centre

Alternative D

(A + B)

Alternative E

(A + B+ C)

Effort per year

(hours)

40 – 80h 30 – 60h

(-20%)

28-56h

(-30%)

28-56h

(-30%)

20-40h

(50%)

10-20h

(-75%)

Administrative

costs for Startups

EUR 1.6 – 3.5

million (= (40–

80h) × 40.5 x

1,036)

EUR 1.2 – 2.5

million (=

(30h– 60h) ×

40.5 x 1,036)

EUR 1.1 – 2.3

million (=

(28h– 56h) ×

40.5 x 1,036)

EUR 1.1 – 2.3

million (=

(28h– 56h) ×

40.5 x 1,036)

EUR 0.8–1.7

million (=

(20h– 40h) ×

40.5 x 1,036)

EUR 0.4 – 0.8

million (=

(10h– 20h) ×

40.5 x 1,036)

Administrative

costs for SMEs

EUR 17 – 34

million (= (40–

80h) × 40.5 x

10,398)

EUR 12.6 –

25.3 million (=

(30– 60h) ×

40.5 x 10,398)

EUR 12 – 23.5

million (= (28–

56h) × 40.5 x

10,398)

EUR 12 – 23.8

million (= (28–

56h) × 40.5 x

10,398)

EUR 8.4 – 17

million (=

(20– 40h) ×

40.5 x 10,398)

EUR 4.2 – 8.4

million (= (10

– 20h) × 40.5 x

10,398)

88 KfW (2025); The study estimates that companies spend around 15 hours per month, corresponding to 180 hours

per year, on administrative activities such as tax reporting, HR administration, licensing, and compliance. 89 The EU average hourly salary rate for the job category “Professionals” (Category 2 under the International

Standard Classification of Organisations – ISCO) is EUR 40.5 per hour (incl. overhead).

44

Administrative

costs for large

enterprises

EUR 5 – 10

million (= (40–

80h) × 40.5 x

3,081)

EUR 3.7 – 7.5

million (=