Kriitiliste ravimite määrus

EN EN

EUROPEAN COMMISSION

Strasbourg, 11.3.2025

COM(2025) 102 final

2025/102 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying a framework for strengthening the availability and security of supply of critical

medicinal products as well as the availability of, and accessibility of, medicinal products

of common interest, and amending Regulation (EU) 2024/795

(Text with EEA relevance)

EN 1 EN

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The EU has a strong and competitive pharmaceutical sector, which is a global leader in the

production of medicines and a major contributor to the EU economy and directly employs

around 800 000 people1. It is particularly strong in the research and development of

innovative medicines. However, the landscape for pharmaceutical manufacturing has evolved

in recent decades. Pharmaceutical production in the EU has focused on more complex

products, which require high-tech infrastructure, a skilled workforce and sophisticated

processes. Production of inputs for generic medicines has increasingly moved outside Europe.

At the same time, almost 70% of the medicines dispensed in Europe are generics2.

The EU faces increasing challenges to secure a stable and resilient supply of medicines that

are critical to ensure the health of the EU patients. Recent global events, including the

COVID-19 pandemic and Russia’s war against Ukraine, have exposed vulnerabilities in the

EU’s pharmaceutical supply chains. Shortages of critical medicines present substantial risks

to patients and public health and undermine the functioning of healthcare systems.

The root causes of shortages have shown themselves to be complex and multifactorial, with

challenges identified along the entire pharmaceutical value chain, from quality and

manufacturing problems, commercial decisions, and complex supply chains to industry’s

competitiveness. Specifically, shortages of medicines result from supply chain disruptions due

to lack of diversification of key suppliers and vulnerabilities affecting the supply of key

ingredients and components.

When looking at the causes of shortages of critical medicines, which are medicines for which

no appropriate alternative is available and for which insufficient supply would result in

serious harm or risk of harm to patients, it is important to distinguish between off-patent or

generic medicines3 and innovative or on-patent4 medicines. Some of the market dynamics,

which are observable for generic medicines do not necessarily apply to innovative medicines.

EU health systems have made increasing use of generic medicines and tend to procure these,

based on lowest cost, to reduce the burden on national healthcare budgets.

Industrial challenges have been pointed out as impacting the availability of critical medicines

in the EU including the lack of investments in EU manufacturing capacity which has

contributed to the increased supply dependency from outside the EU. Fragmented

procurement practices across the Member States constitute a challenge and do not contribute

to creating the most favourable conditions for investments. Additionally, workforce shortages

and the need for specialised skills in pharmaceutical manufacturing further strain the

industry’s capacity to ensure a stable supply of critical medicines.

The COVID-19 pandemic clearly exposed significant vulnerabilities in the EU’s

pharmaceutical supply chain, in particular the heavy dependence on foreign sources for active

substances. Export restrictions imposed by some countries during the pandemic revealed

limitations in Europe’s ability to independently produce certain medicines, putting public

1 Impact assessment report and executive summary accompanying the revision of the general

pharmaceutical legislation, annex 5, 2023. 2 IQVIA White paper. Beneath the Surface: Unravelling the True Value of Generic Medicines April 2024 3 Generic and hybrid medicines | European Medicines Agency (EMA) 4 Patent protection in the EU - European Commission

EN 2 EN

health across the EU at risk. This situation underscored the critical importance of economic

security, as disruptions in global supply chains—whether due to pandemics, geopolitical

tensions, or other factors—can have severe implications for national and regional security,

economic resilience, and public health.

The pandemic highlighted how vital certain sectors, especially medicines, are for maintaining

the EU's economic security. As Europe is facing rising geopolitical tensions and global

disruptions which may become more frequent, ensuring the stability and reliability of critical

supply chains, including those for medicines, is essential. By addressing these vulnerabilities,

the EU can enhance its preparedness and resilience, safeguarding the well-being and public

health of its citizens and strengthening its overall security.

A survey conducted by the EU4Health programme-funded Joint Action of Member States on

shortages (CHESSMEN)5 identified that over 50% of reported shortages are caused by

manufacturing issues, a category which includes shortages related to the availability of active

substances.

Figure 1: Root causes of medicines shortages in 2022 and 2023 in EU/EEA countries, grouped according to SPOC

working party classification (CHESSMEN joint action)

Furthermore, for some medicines such as those for rare diseases, access can vary considerably

from Member State to Member State. Due to various factors, including the size of the

markets, companies market medicines differently across the EU. As a result, patients across

the EU may not have equal access to the medicines they need and market failures remain,

including within the development of priority antimicrobials that can help address

antimicrobial resistance.

Shortages of medicines have been on the EU’s political agenda for almost a decade6. The

pharmaceutical strategy for Europe in 20207 acknowledged the need to create a future-

5 CHESSMEN (2024) Analysis Report on root-causes. 6 See for instance the European Parliament resolution of 2 March 2017 on EU options for improving

access to medicine and the EPSCO Council Conclusions (2021/C 269 I/02) 7 A pharmaceutical strategy for Europe - European Commission (europa.eu)

EN 3 EN

proof regulatory pharmaceutical framework and give additional support to the pharmaceutical

industry in promoting research, innovation and technologies that meet the therapeutic needs of

patients while ensuring affordable access to medicines for patients.

The pharmaceutical strategy also included the launch of a structured dialogue8 on the

industrial dimension of security of supply. Starting in 2021, this initiative brought together

stakeholders from the pharmaceutical industry (including manufacturers of active substances),

wholesalers, healthcare professionals and patients, and Member State authorities.

Subsequently, the Commission published a staff working document on vulnerabilities of

the global supply chains of medicines in 20229 which presented the main findings of the

structured dialogue with the aim of informing further actions to improve the security of

supply and the availability of critical medicines, active substances and raw and starting

materials for pharmaceuticals.

Additional steps have been taken since to address the above-mentioned challenges, including

the challenge of ensuring supply-chain security of critical medicines. These steps relate in

particular to the proposed revision of the EU pharmaceutical general legislation10, which is

being negotiated by the co-legislators and the extended mandate of the European Medicines

Agency (EMA)11.

In 2023, the Commission published a Communication on addressing medicine shortages

in the EU12, setting out a number of actions to better prevent and mitigate critical

medicine shortages in the EU. While pharmaceutical companies are responsible for ensuring

sufficient supply of medicines to cover the needs of patients, Member States ensure the

supervision of medicines supply in their territory. Most shortages are managed and resolved at

the national level. However, to prevent and mitigate critical shortages where no alternative

medicines are available and that cannot be solved at the national level, coordinated action is

needed to address supply challenges and to make Europe’s medicine supply chains more

resilient in the long run.

The 2023 Communication therefore put a particular focus on the most critical medicines, for

which security of supply in the EU must be ensured at all times. It highlighted the need to

publish a Union list of critical medicines prior to the adoption of the revised EU

pharmaceutical legislation. The first Union list of critical medicines, identified by

combining the criteria of seriousness of the disease and the availability of alternative

medicines, was published by the European Commission, the EMA and the Heads of

Medicines Agencies of the Member States in December 2023 and reviewed in December

202413. It provides a first list from which to analyse the vulnerabilities in the supply chain of

these medicines and where further actions are needed to reinforce these supply chains. The list

8 Structured dialogue on security of medicines supply - European Commission (europa.eu) 9 mp_vulnerabilities_global-supply_swd_en.pdf (europa.eu) 10 Reform of the EU general pharmaceutical legislation (europa.eu): the proposals include actions to

address systemic shortages and improve security of supply of critical medicines at all times by

introducing stronger obligations on supply, earlier notification and a stronger role for EMA in

coordinating this with the Member States. Actions are also proposed to strengthen the supply chains of

critical medicines by introducing a European alert system for shortages and shortage prevention plans

for all medicines. 11 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a

reinforced role for the European Medicines Agency in crisis preparedness and management for

medicinal products and medical devices. 12 Communication_medicines_shortages_EN_0.pdf 13 Union list of critical medicines | European Medicines Agency (EMA)

EN 4 EN

includes over 270 active substances, covering treatments for various illnesses such as

infections, cardiovascular diseases, mental health conditions and cancer.

As a key measure towards boosting the security of supply of critical medicines, the

Commission also announced in its Communication the launch of a ‘Critical Medicines

Alliance’14. This Alliance was formally launched in April 202415 and follows an approach

successfully used by the Commission in other areas (batteries, semiconductors, critical raw

materials). The main objective of the Alliance was to ‘identify challenges resulting from

vulnerabilities and the most appropriate actions and instruments to address the vulnerabilities

in the supply chains of critical medicines, with the primary public health goal of reducing the

risk of shortages of those critical medicines’. It brought together over 300 organisations (from

patient and scientific communities to healthcare providers, industry and public authorities).

Following intensive consultations with its members during 2024, the Alliance published its

Strategic Report including a set of recommendations on 28 February 202516.

This proposed Regulation delivers on the political commitment of President von der Leyen to

propose a Critical Medicines Act to address severe shortages of medicines and reduce

dependencies linked to critical medicines and ingredients, as well as to ensure the supply of

affordable medicines17. The proposed Regulation will be an important stage in completing the

European Health Union; it builds on (1) the measures proposed as part of the ongoing

revision of the pharmaceutical legislation of the EU; (2) the extended mandate of the EMA in

the realm of crisis preparedness and management of medicines; (3) key actions towards

completing a European Health Union in which all EU Member States prepare and respond

together to health crises and in which medical supplies are available, affordable and

innovative18; and (4) new industrial policy measures that recently came into force in other

‘critical’ domains19.

Scope and objectives

In light of the current geopolitical situation and the importance of a viable European based

pharmaceutical industry for the EU’s economic security, the proposed Regulation aims to

complement the measures proposed in the revision of the EU pharmaceutical legislation in

order to address the supply chain vulnerabilities of critical medicines and support the security

of supply and availability of these medicines.

The scope of the proposed Regulation is primarily focused on critical medicines on the Union

List of Critical Medicinal Products which is formally established in the proposed

pharmaceutical Regulation. Following the 2023 Communication, a first Union List of Critical

Medicines was compiled with the expertise of the Heads of Medicines Agencies of the

Member States, the European Commission, and the EMA in consultation with key

stakeholders, including patient organisations and industry associations. This list was

published for the first time in December 2023 and updated one year later.

The proposed Regulation also introduces actions to improve access to and availability of other

medicines of common interest, to ensure patients across the EU can benefit from these

14 Critical Medicines Alliance - European Commission 15 https://ec.europa.eu/commission/presscorner/detail/en/ip_24_2229 16 3da9dfc0-c5e0-4583-a0f1-1652c7c18c3c_en 17 https://commission.europa.eu/document/download/b1817a1b-e62e-4949-bbb8-

ebf29b54c8bd_en?filename=Mission%20letter%20-%20VARHELYI.pdf 18 European Health Union - European Commission 19 European Critical Raw Materials Act and The Net-Zero Industry Act, for instance.

EN 5 EN

medicines when and where they need them. These medicines can include medicines for rare

diseases (orphan medicinal products)20 or novel antimicrobials.

General and specific objectives

The general objective of this Regulation is to strengthen the security of supply and the

availability of critical medicines within the EU, thereby ensuring a high level of public health

protection and supporting the security of the Union, and to improve the availability and

accessibility of other specific medicines, where the functioning of the market does not

otherwise sufficiently ensure their availability and accessibility to patients, whilst giving due

consideration to the appropriateness to ensure the affordability of medicinal products.

The specific objectives of the initiative are:

– to facilitate investments in manufacturing capacities for critical medicines, their

active substances and other key inputs in the EU;

– to lower the risk of supply disruptions and strengthen availability by incentivising

supply chain diversification and resilience in the public procurement procedures for

critical medicines and other medicinal products of common interest;

– to leverage the aggregated demand of participating Member States through

collaborative procurement procedures;

– to support the diversification of supply chains also by facilitating the conclusion of

strategic partnerships.

• Consistency with existing policy provisions in the policy area

The proposal aims to ensure consistency with several existing EU policy provisions and

initiatives in the health and pharmaceutical areas, therefore ensuring a high level of human

health protection in the definition and implementation of EU policy.21

The proposed Regulation complements the ongoing revision of the EU pharmaceutical

legislation22 and the main actions of the pharmaceutical strategy for Europe23. It aligns

with its objectives of increasing access to medicines, improving security of supply, and

addressing shortages, whilst giving due consideration to the affordability of medicinal

products. It complements the main provisions on the availability and security of supply of

medicinal products as proposed in the new pharmaceutical legislation24. While the revised EU

pharmaceutical framework strengthens obligations for marketing authorisation holders to

prevent shortages and introduces EU coordinated actions to mitigate critical shortages, this

proposed Regulation creates the necessary conditions – investments, procurement

coordination – to proactively reduce dependencies and strengthen EU production capacity.

The proposed Regulation upholds the “once-only” principle by preventing duplication of

provisions and requirements related to data collection for identifying critical medicines and

assessing supply chain vulnerabilities. The proposed Regulation builds on the Union List of

Critical Medicinal Products established in Article 131 of the proposed pharmaceutical

Regulation. In addition, the proposed Regulation builds on the data collection framework and

the methodology for identifying vulnerabilities in the supply chains of critical medicines

20 Orphan medicinal products - European Commission 21 Consolidated version of the Treaty on European Union (Consolidated Version) 22 Reform of the EU pharmaceutical legislation - European Commission 23 A pharmaceutical strategy for Europe - European Commission (europa.eu) 24 Regulation COM(2023) 193 final, Chapter X.

EN 6 EN

proposed to be drawn up under the EU pharmaceutical legislation. This guarantees that the

assessment of supply chain vulnerabilities is based on a harmonised and scientifically robust

methodology developed at the EU level.

Furthermore, the proposed Regulation builds upon the outcomes of the structured dialogue

on pharmaceuticals25, and the staff working document on vulnerabilities of the global supply

chains of medicines26, with actions to address vulnerabilities in the pharmaceutical supply

chain.

The proposed Regulation also builds on the EMA’s extended mandate27. In this respect, the

launch of the European Shortages Monitoring Platform28 was a key requirement of this

extended mandate to enhance the monitoring of shortages across the EU. This platform will

enable both marketing authorisation holders and national competent authorities to submit data

on the supply, demand and availability of centrally and nationally authorised medicines

during crises and preparedness situations. The platform will be further expanded in the

context of the revision of the EU’s pharmaceutical legislation.

The measures in the proposed Regulation regarding collaborative procurement are

complementary to the existing collaborative procurement tools under Regulation (EU)

2022/2371 on serious cross-border threats to health29, Regulation (EU) 2022/2372 on a

framework of measures for ensuring the supply of crisis-relevant medical countermeasures in

the event of a public health emergency at Union level30. The measures for collaborative

procurement of medicinal products of common interest also build on the joint clinical

assessments and voluntary cooperation among Member States under Regulation (EU)

2021/2282 on health technology assessment31.

The proposed Regulation takes into consideration the work of the Critical Medicines

Alliance32, focusing on addressing vulnerabilities in the supply chains of critical medicines.

Finally, this proposal takes into account all funding opportunities available under the current

MFF that can support the objectives of this proposed Regulation.

• Consistency with other EU policies

This proposal is consistent with the EU’s innovation and competitiveness policy, in

particular with the Competitiveness Compass33. This Communication lists the proposed

Regulation as one of the flagship actions under Pillar 3 (reducing excessive dependencies and

increasing security). It also mentions critical medicines as one of the possible selected areas

for pilot cases where the Commission will propose to coordinate EU and Member States’

policies. The proposed Regulation will have an indirect positive impact on the EU’s

competitiveness by fostering a more stable and predictable market environment, encouraging

investment and supporting innovation in the pharmaceutical sector, which has traditionally

25 Structured dialogue on security of medicines supply - European Commission 26 mp_vulnerabilities_global-supply_swd_en.pdf (europa.eu) 27 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a

reinforced role for the European Medicines Agency in crisis preparedness and management for

medicinal products and medical devices. 28 European Shortages Monitoring Platform (ESMP) | European Medicines Agency (EMA) – Platform

fully operational as of January 2025. 29 Regulation - 2022/2371 - EN - EUR-Lex 30 Regulation - 2022/2372 - EN - EUR-Lex 31 Regulation - 2021/2282 - EN - EUR-Lex 32 Critical Medicines Alliance - European Commission 33 A Competitive Compass which includes new plans for Europe's sustainable prosperity and

competitiveness. See also: Competitiveness - European Commission

EN 7 EN

played a fundamental role in the EU’s competitiveness34. The provisions under the proposed

Regulation may be supported by Horizon Europe Partnerships35, which provide funding for

areas such as research and innovation in technologies with the potential to become essential

enablers in the production process.

Furthermore, the European Industrial Strategy36 aims to strengthen the single market's

resilience and addresses the EU's strategic dependencies. The proposed Regulation supports

these objectives by strengthening the pharmaceutical supply chain's resilience and reducing

dependence on non-EU sources for critical medicines and active pharmaceutical ingredients.

The proposed Regulation is also consistent with the Commission communication on a Clean

Industrial Deal37, which outlines concrete actions to turn decarbonisation into a driver of

growth, in particular for energy-intensive industries. This includes demand side measures to

create the right conditions for companies to thrive, similar to those proposed in this

Regulation.

The EU’s Financial Regulation is the main point of reference for the principles and

procedures governing the EU budget, including on joint procurement and procurement on

behalf of, or in the name of Member States. Last year, the recast of the Financial Regulation

entered into force38. The proposed Regulation provides a sector-by-sector basis for these types

of procurement to be conducted for critical medicines and other medicines of common

interest, being consistent with the procedural framework set out in the Financial Regulation,

but setting specific conditions under which the joint procurement and procurement on behalf

or in the name of Member states can be launched. These specific conditions related to certain

threshold of Member states participating in the procedure and eligibility criteria as regards the

medicinal products, reflect the assessment of where the Commission intervention would be

the most appropriate in the light of the objectives of the act.

An evaluation of the EU’s public procurement directives is currently ongoing39 and the

Commission will make a proposal to revise the framework in 2026. It will allow for

sustainability, resilience and European preference criteria in EU public procurement for

strategic sectors. The proposed Regulation would introduce measures related to national

public procurement of certain pharmaceuticals in line with the objectives of this upcoming

revision, to help ensure security of supply and enable preference for European products in

public procurement for critical medicines and other medicines of common interest, to the

extent this is necessary and in line with the Union’s international commitments.

The proposed Regulation is consistent with broader efforts to modernise and adapt EU

legislation to current challenges since it aims at reducing administrative burdens and

facilitating permit-granting processes for strategic projects. The proposed Regulation is in line

34 See also Chapter 1. Medicines - a strong ecosystem at an important crossroads (Pharmaceutical Strategy

for Europe). 35 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing

Horizon Europe – the Framework Programme for Research and Innovation 36 A New Industrial Strategy for Europe 37 Clean Industrial Deal - European Commission 38 EU Financial Regulation - European Commission 39 Commission launches call for evidence and public consultation on the evaluation of the Public

Procurement Directives - European Commission

EN 8 EN

with the Omnibus Proposal40 and aims to address vulnerabilities of medicine supply chains

without increasing the overall burden on industry.

Digital

The proposed Regulation is aligned with recent key European digital initiatives (Artificial

Intelligence (AI) and NIS 2 Directive) that aim to promote secure and interoperable data

exchange, the use of advanced technologies and a high common level of cybersecurity across

the Union. The AI Act41 and the NIS 2 Directive42 provide frameworks for responsible AI use

and a high common level of cybersecurity.

Furthermore, the Interoperable Europe Act43, along with dedicated tools like the European

Interoperability Framework (EIF) Toolbox and reusable components, supports

standardised data exchange across Member States. The recently redesigned Tenders

Electronic Daily portal44 (‘TED’) serves as an efficient tool for sharing and monitoring

procurement procedures.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union

(TFEU). This is consistent with the legal basis of existing EU pharmaceutical legislation.

Article 114(1) has as its object the establishment and functioning of the internal market. In

accordance with Article 114(3) TFEU, the proposal takes as a base a high level of health

protection.

• Subsidiarity (for non-exclusive competence)

The objectives of this proposal cannot be sufficiently achieved by Member States acting

individually, as the challenges of medicine shortages and supply chain vulnerabilities extend

beyond national borders. EU-level action is needed to ensure a coordinated and effective

response to these cross-border issues. The proposal takes into account this principle in the

design of the individual actions, particularly when procuring critical medicines and other

medicinal products of common interest.

• Proportionality

The proposal targets critical medicines for which there is a demonstrated need to intervene,

and the selected intervention can lead to an effective reduction in the risk of shortages.

Specific measures also apply to other medicines of common interest affected by market access

issues in Member States.

40 Commission simplifies rules on sustainability and EU investments, delivering over €6 billion in

administrative relief - European Commission 41 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence 42 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) 43 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) 44 TED – EU Tenders, the Supplement to the Official Journal - TED

EN 9 EN

• Choice of the instrument

The proposal takes the form of a Regulation of the European Parliament and of the Council.

The selection of a Regulation over a Directive is driven by the need for immediate and

uniform application across the EU. This choice ensures legal certainty by minimising the risk

of divergent interpretations and implementations by Member States. In addition, the cross-

border implications of the legislation require a cohesive and consistent approach, achievable

through a Regulation.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

The growing issue of medicines shortages poses an immediate and alarming threat to public

health. Without swift action to address vulnerabilities in the supply of critical medicines,

disruptions could have severe consequences for patient care, including delayed treatments for

life-threatening conditions. Our heavy reliance on non-EU suppliers, fragile global supply

chains, and geopolitical tensions exacerbate the risk of shortages, making this a pressing

challenge.

A rich evidence base and extensive stakeholder input concerning medicine shortages and

critical medicines have been gathered and analysed in preparation for the revision of the

pharmaceutical reform45. In addition, the proposed Regulation was preceded by

comprehensive consultations with stakeholders through the structured dialogue on the security

of medicines supply46 and the Critical Medicines Alliance47.

Given that security of supply and addressing medicine shortages were a central focus during

the evidence-gathering activities for the above initiatives, along with the pressing need for

urgent action, no dedicated impact assessment or online public consultation could be

conducted ex-ante for this proposed Regulation.

The evaluation of the EU pharmaceutical legislation48 highlighted that medicine shortages are

an increasing problem in the EU and that they have grown worse since the COVID-19

pandemic. Overall, there has been a marked increase in the number of reported shortages

across the EU. These shortages are placing a significant burden on health systems and health

professionals, putting patients at risk of sub-optimal care and health systems at risk of higher

healthcare costs49.

Supporting evidence

The analysis and supporting evidence including studies commissioned by the Commission

will be summarised in a staff working document and published within three months of the

proposal’s publication.

• Ex-post evaluations/fitness checks of existing legislation

Not applicable

45 Reform of the EU pharmaceutical legislation - European Commission 46 Structured dialogue on security of medicines supply - European Commission 47 Critical Medicines Alliance - European Commission 48 Reform of the EU pharmaceutical legislation - European Commission 49 Future-proofing pharmaceutical legislation - Publications Office of the EU.

EN 10 EN

• Stakeholder consultations

In February 2021, the Commission brought stakeholders together in a structured dialogue on

security of medicines supply50. Participants in this dialogue included: (i) actors in the supply

chains of critical medicines; (ii) public authorities; (iii) patient and health non-governmental

organisations; and (iv) the research community. This dialogue further deepened the

understanding of global pharmaceutical supply chains.

Consultations for the EU pharmaceutical reform in the domain of shortages also explored

the stakeholders’ view on this topic51. These consultations confirmed that stakeholders (in

particular, civil society organisations and healthcare professionals) see medicine shortages as

a crucial issue. In the targeted surveys, civil society, public authorities and health service

stakeholders considered that the area that legislation was the least effective in addressing was

issues related to security of supply and medicine shortages. They also gave their view on

policy measures, such as shortage prevention plans, a shortage monitoring system at EU level

or the shortage notification. Furthermore, a dedicated validation workshop was held on supply

chains in April 2022. During this workshop, various stakeholders explained that

diversification of the supply chain is challenging and not always feasible due to the difficulty

of finding alternative suppliers upstream in the supply chain52.

More than 300 stakeholders of critical medicine supply chains, as members of the Critical

Medicines Alliance that includes industry representatives, trade associations, patient

organisations, medical profession organisations and Member States, have been consulted on

key topics of interest for critical medicines’ supply chain strengthening. After the launch of

the Alliance in 2024, technical discussions took place at working group level throughout the

rest of the year, aiming to prepare recommendations of actions to strengthen manufacturing

capacity and diversify supply chain through partnerships with like-minded non-EU countries.

The results of these recommendations, compiled by the Steering Board in its Strategic

Report53, provide for actions on vulnerability assessment, incentives for investments in

manufacturing capacity, contingency stocks and procurement approaches, as well as

leveraging partnerships with non-EU countries. In particular, the Alliance recommends: (i)

establishing a European list of Critical Vulnerable Medicines; (ii) implementing a European

Investment plan to strengthen production capacities for critical medicines in Europe by

combining EU funding programmes and State aid; (iii) implementing a comprehensive

harmonised and balanced framework on contingency stocks; (iv) promoting virtuous public

procurement practices by means of applying specific ‘MEAT’ criteria54 and making further

use of joint procurement; and (v) promoting a level playing field for environmental and social

standards, as well as fair competition between critical medicines manufactured in the EU and

in the rest of the world. On partnerships with non-EU countries, the Alliance specifically

recommends making use of the developed methodology to assess the prospects of countries

for different types of partnerships. Finally, the Alliance recommends that the MSSG

(Executive Steering Group on Shortages and Safety of Medicinal Products) formalises the

50 The list of organisations can be consulted here:

https://health.ec.europa.eu/document/download/bd92f46c-4c55-4fed-8642-

81b0aa30ff22_en?filename=structured-dialogue_lp_en.pdf 51 Reform of the EU pharmaceutical legislation - European Commission 52 See Annex 2 synopsis report (stakeholder consultation) for the reform of the EU pharmaceutical

legislation: GP_Annexes 1 to 4 - 6 to 9 - 14 to 16_v28102022 53 Critical Medicines Alliance - European Commission 54 Most economically advantageous tender which allows for more prominence to be given to quality

beyond price considerations alone.

EN 11 EN

possibility for outreach to non-EU country jurisdictions, as part of the Voluntary Solidarity

Mechanism.

A general consultation on the proposed Regulation was launched in a Call for Evidence that

was published on 30 January 202555.

The Commission received 121 valid contributions, submitted by business associations (26%),

company/businesses (25%), non-governmental organisations (22%), EU citizen (5%), public

authorities (5%), trade unions (4%), consumer organisations (2%), academic/research

institutions (1%), and other (9%).

The responses came from 22 countries (including 5 non-EU countries). Among these,

Belgium is the most represented (32%) as most European business associations and civil

society organisations are headquartered in the country, followed by Germany (15%), France

(7%), Italy (6%) and Spain (5%).

A broad majority of the responses supported the Commission in tabling a Critical Medicines

Act, seeing it as a crucial tool to address shortages of critical medicines. To highlight some

key considerations, the various stakeholders’ groups, companies and business associations

noted the persistent dependencies on non-EU suppliers, particularly for active pharmaceutical

ingredients (APIs), and the resulting increased risk of medicine shortages. They welcomed the

European Commission's commitment to securing supply chains, and called for a

comprehensive legal framework, promoting EU-based production of APIs, coupled with an

improved access to funding mechanisms. To ensure transparency, accountability and

efficiency, many NGOs proposed regular risk assessments and vulnerability analyses of the

pharmaceutical supply chains and a coordinated monitoring system taking into account

existing national systems, to avoid duplications. Public authorities in particular supported the

voluntary joint procurement of critical medicines. Responses from various stakeholder groups

noted the need to address fragmentation stemming from national stockpiling requirements.

The importance of global partnerships aimed at maintaining robust supply chains was widely

emphasised. A more detailed analysis of the responses will be included in the staff working

document to be produced that will be published by the second quarter of 2025. The

Commission has also commissioned a study by an external contractor regarding the proposed

regulation, which includes targeted consultations with various stakeholders.

• Collection and use of expertise

The Union List of Critical Medicines56 was compiled with the expertise of the Heads of

Medicines Agencies of the Member States, the European Commission, and the EMA in

consultation with key stakeholders, including patient organisations and industry associations.

Published for the first time in December 2023 and updated one year later, the list contains 276

active substances used in medicines for human use that are deemed critical using an agreed

methodology, based on two key criteria:

• The medicine's therapeutic indication targeting a serious condition;

• The limited availability of appropriate alternatives.

Medicines are included on the Union list if they meet the above-mentioned criteria on their

critical status and if they meet additional criteria, such as the number of Member States

considering the medicine critical or the marketing status of the medicine. It is important to

55 Critical Medicines Act 56 Union list of critical medicines | European Medicines Agency (EMA)

EN 12 EN

note that inclusion on the list does not necessarily indicate an imminent shortage, rather it

prioritises prevention efforts for these critical medicines.

The Commission conducted a technical assessment of supply chain vulnerabilities for critical

medicines57. The analysis focused on a selection of 11 critical medicines from the Union list.

The issues identified by the pilot included the significant dependences on non-EU active

substances suppliers for 4 of the 11 molecules and risks stemming from market concentration.

The pilot pointed to the need to strengthen resilience, such as diversifying supply sources,

increasing production capacity flexibility and developing robust risk management frameworks

to handle economic and market variability effectively. The outcomes of this pilot exercise

also showed some limitations, such as the lack of legal basis for data collection and

information sharing, the absence of harmonised data format and standards leading to

interoperability issues, and the hesitancy of pharmaceutical companies to share highly

sensitive commercial data.

Studies: a study by an external contractor is being conducted that focuses on the assessment

of policy options in the realm of three main policy strands: horizontal (scope, governance,

data); enabling conditions for investments in critical medicines; demand-side measures. The

interim report of the study has been taken into account in the preparation of this proposed

Regulation, and further results of the study will feed into the staff working document that will

be published by the second quarter of 2025 to provide the analysis and all supporting evidence

underpinning this proposal.

The Study on best practices in the public procurement of medicines58, published in 2022,

mapped and analysed practices in the public procurement of medicines across 32 European

countries. The report presents findings on organisational forms of procurement and the use of

different forms of procedures and techniques (including the use of different procurement

requirements, such as the Most Economically Advantageous Tender). The possible impacts of

public procurement of medicines on access to medicines, affordability and availability of

medicines and security of supply were assessed.

Through the work of the Alliance, several studies have also been used as evidence for the

preparation of the recommendations, including the Advancy study on ‘Strengthening API

production industry in France and Europe’59. This study highlights the significant

competitiveness deficit faced by the European pharmaceutical sector, particularly in the

production of essential medicines and active substances. Furthermore, the OECD Report on

‘Shortages of medicines in OECD countries’60 also served as evidence to the Alliance; this

study examined the nature and extent of medicine shortages pre-COVID and explored the

reasons for this global problem. It concludes that a global multistakeholder approach is

necessary, involving all relevant actors, also beyond healthcare.

• Impact assessment

Given the urgent need to address the policy challenges identified, the proposed Regulation

will be proposed without an impact assessment. However, its provisions are based on existing

analyses, stakeholder consultations, and lessons learned from past initiatives to ensure a

proportionate and evidence– based approach. To further assess its expected impacts, a staff

working document will be published within three months of the proposal’s adoption,

57 Commission assessment shows the need to reinforce resilience of critical medicines supply chains -

European Commission

58 https://op.europa.eu/s/z1Rz 59 https://efcg.cefic.org/wp-content/uploads/2025/01/Advancy-Sicos-report-extract-protected.pdf 60 https://www.oecd.org/en/publications/shortages-of-medicines-in-oecd-countries_b5d9e15d-en.html

EN 13 EN

providing a summary of available evidence on the expected impacts of the proposed

Regulation and the analysis underpinning the proposal.

• Regulatory fitness and simplification

The proposal does not envisage significant additional regulatory burden. For undertakings

developing a strategic project, it will facilitate the creation or expansion of manufacturing

capacities of critical medicines, their active substances and key inputs in the EU by fast-

tracking permit-granting procedures, streamlining environmental assessments and providing

targeted support when needed. For national public administrations, certain reporting

obligations are foreseen in relation to financial support provided to strategic projects, national

programmes to ensure sustainability and resilience in public procurement and collaborative

procurement initiatives. Nevertheless, the proposed Regulation will also generate further

synergies and ensure efficient coordination and collaboration between Member States to reach

the Union’s strategic objective to strengthen the security of supply and availability of critical

medicines.

• Fundamental rights

The proposal helps achieve a high level of human health protection and is therefore consistent

with Article 35 of the Charter of Fundamental Rights of the European Union (‘the Charter’).

Article 16 of the Charter provides for the freedom to conduct a business. The measures under

this proposal support creation or expansion of manufacturing capacity and foster demand for

critical medicines and other medicines of common interest with resilient supply chains, which

can reinforce the freedom to conduct a business in accordance with Union law and national

laws and practices.

4. BUDGETARY IMPLICATIONS

The legislative financial statement attached to this proposal sets out the budgetary, human and

administrative resource implications. Appropriations will be reallocated within the financial

envelope. The costs of this proposal will be fully covered through redeployments within

existing financial envelopes of the current multiannual financial framework. For the duration

of the 2021-2027 MFF61, the Strategic Projects may be supported by EU funding, including

but not limited to EU4Health Programme62, Horizon Europe63, and the Digital Europe

programme64, provided that they comply with the requirements provided for in these

instruments.

The indicative overall budgetary impact of the proposal is EUR 83.02 million for the period

2026-2027 under Heading 2b. This amount will finance manufacturing investments and

manufacturing capacity and will also cover expenses for meetings. These appropriations will

be redeployed within the existing financial envelope of the EU4Health programme. This

61 Council Regulation (EU, Euratom) 2024/2093 laying down the multiannual financial framework for

years 2021 to 2027, as amended (OJ LI 433, 22.12.2020) 62 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021

establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for

the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021) 63 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing

Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for

participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No

1291/2013, OJ L170, 12.5.2021, p. 1. 64 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing

the Digital Europe Programme and repealing Decision (EU) 2015/2240, OJ L166, 11.5.2021, p. 1.

EN 14 EN

amount will also cover the increase to the EU contribution to EMA (EUR 1.4 million), due to

increased EMA costs for staff, IT investments, and meeting costs. The increased EU

contribution to EMA will be covered by the EU4Health programme's budgetary envelope in

2026 and 2027.

The budgetary impact under Heading 7 amounts to EUR 5,5. This amount will cover staff

costs and missions’ costs and will be covered through internal redeployment.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission will evaluate the impact of this proposed Regulation and whether its

objectives have been achieved by five years after the date of application and every five years

thereafter. The main findings of the evaluation will be presented in a report to the European

Parliament and the Council, which will be made public.

This proposal introduces a requirement for Member States to inform the Critical Medicines

Coordination Group about their intention to provide national financial support to strategic

projects, as well as for the Commission to inform periodically the Critical Medicines Group of

the Strategic Projects that benefited from financial support from the Union and of setting up

any new funding possibilities. The data gathered is necessary to monitor and evaluate the

success of this Regulation over time.

• Detailed explanation of the specific provisions of the proposal

This proposal consists of a proposal for a new regulation. The proposed Regulation includes

the following main areas:

General provisions

Chapter I presents the objectives and subject matter of the proposed Regulation. The proposal

establishes a framework for strengthening the security of supply and the availability of critical

medicines as well as the availability of and accessibility to certain other medicines. It also

clarifies the scope of the proposed Regulation. While the proposal applies mainly to critical

medicines on the Union List of Critical Medicinal Products which is established in the

proposed Pharmaceutical Regulation, some provisions of the proposed Regulation also apply

to medicines of common interest facing market access issues in a number of Member States,

especially demand-side measures. Finally, key definitions used throughout the proposed

Regulation are introduced.

Strengthening the EU’s security of supply

Chapter II clarifies that the security of supply and availability of critical medicines for all

patients is one of the EU’s strategic objectives. This objective requires a coordinated approach

from the Member States and the Commission.

Enabling conditions for investment

Criteria and procedure for the recognition of strategic projects

Section I of Chapter III defines criteria for recognising some projects as Strategic Projects and

describes the steps to recognise such projects at Member State level. A Member State’s

authority is designated to assess and confirm, upon request, whether the specific project meets

the criteria laid down.

Facilitating administrative and permit-granting processes

EN 15 EN

Section II of Chapter III provides for a priority status for Strategic Projects that are considered

to be in the public interest, in the context of permit-granting processes. To ensure the fast-

tracking of permit-granting processes, Strategic Projects may also request to be granted the

status of highest national significance in Member States where such status exists and request a

coordinated or joint procedure when an environmental assessment is required under different

EU legislation. Finally, the proposal also provides for the possibility for Strategic Projects

promotors to request administrative, regulatory and scientific support from the relevant

authorities.

Financial incentives

Section III of Chapter III provides for the possibility for Member States to prioritise financial

support for strategic projects that address a supply chain vulnerability and requires due

consideration to the outcome of vulnerability evaluations and the strategic orientations of the

Critical Medicines Group. Strategic projects may be supported by EU funding under the

current MFF, if strategic projects fulfil the conditions and requirements of the calls under the

available programmes. Finally, exchange of information on strategic projects that have or will

receive financial support at Member State or EU level is ensured via the Critical Medicines

Group.

Demand side measures

Award criteria and other procurement requirements and related measures

Section I of Chapter IV imposes the use of procurement requirements other than price in the

context of public procurement procedures by contracting authorities in the Member States,

unless justified by market analysis and considerations related to the financing of health

services. The proposal also requires, in specific cases, when justified by a vulnerability

analysis, that the contracting authorities apply procurement requirements that favour suppliers

that manufacture a significant portion of these critical medicines in the EU. The compliance

with Union’s international commitments should be ensured. Finally, Member States will be

required to develop national programmes to ensure security of supply of critical medicines via

procurement, and, possibly, pricing and reimbursement practices. When imposing

contingency stocks on supply chain actors, Member States shall ensure these requirements are

proportionate and respect the principles of transparency and solidarity.

Collaborative procurements

Section II of Chapter IV provides a framework for Member States to request Commission

support in the use of different collaborative procurement tools for critical medicines and other

medicines of common interest, depending on the context and respecting the principles of

subsidiarity and proportionality. This includes Commission facilitation of cross-border

procurement between Member States, Commission procurement on behalf of or in the name

of Member States, as well as the Commission and Member States engagement in Joint

Procurement.

Critical Medicines Coordination Group

Chapter V established the Critical Medicines Coordination Group, which is composed of the

Commission and Member States’ representatives. The Critical Medicines Group’s main task

is to facilitate the application of the Regulation including by facilitating: a) discussion on

strategic orientation for financial support of Strategic Projects; b) exchanges and, where

appropriate, cooperation on national procurement policies; c) discussion on a need for

collaborative procurement initiatives; d) advice on the order of priority for the vulnerability

evaluation of critical medicines;. The Critical Medicines Group will also enable a discussion

on strategic partnerships.

EN 16 EN

International cooperation

Chapter VI requires the Commission to investigate the possibility of establishing strategic

partnerships.

Final provisions

Chapter VII contains provisions amending Regulation (EU) 2024/795. Chapter VIII imposes

an obligation on the market actors to provide the information necessary for the application of

the proposed regulation. It also defines the timeline for the evaluation of the proposed

Regulation and sets the dates of entry into force and application of the different provisions.

EN 17 EN

2025/102 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying a framework for strengthening the availability and security of supply of critical

medicinal products as well as the availability of, and accessibility of, medicinal products

of common interest, and amending Regulation (EU) 2024/795

(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 Committee1,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union

(‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union

(the ‘Charter’), the Union is to ensure a high level of human health protection in all

Union policies and activities. The availability of safe, efficacious and high-quality

medicinal products is vital to achieving this objective and to safeguarding public

health across the Union.

(2) In recent years, the Union has experienced an increasing number of shortages of

medicinal products, including shortages of medicinal products for which insufficient

supply results in serious harm or risk of serious harm to patients.

(3) Shortages of medicinal products can have very different and complex root causes, with

challenges identified along the entire pharmaceutical value chain. In particular,

shortages of medicinal products can result from supply chain disruptions and

vulnerabilities affecting the supply of key ingredients and components. These include

existing dependencies on a limited number of suppliers globally and lack of Union

capacities to produce certain medicinal products, their active substances or key raw

pharmaceutical materials. Through diversification of supply sources and investment in

local production, the Union can reduce its risk of exposure to shortages of medicinal

products.

(4) Industrial challenges and a lack of investments in manufacturing capacities in the

Union have contributed to increased dependency on third country suppliers, in

particular, for key raw pharmaceutical materials and active substances. Setting up new,

1 OJ C , , p. .

EN 18 EN

or modernising existing manufacturing capacities in the Union for critical medicinal

products, their key inputs and active substances, which have often been on the market

for a long time and are considered to be relatively inexpensive, is currently not seen as

a sufficiently attractive option for private investment, also in view of lower energy

costs, lesser environmental and other legal requirements elsewhere in the world.

Workforce shortages and the need for specialised skills in pharmaceutical

manufacturing further add to the industrial challenges to manufacturing in the Union.

Targeted financial incentives, simplified administrative processes, and better Union-

level coordination can contribute to supporting efforts to increase manufacturing

capacities in the Union and strengthen the supply chains for critical medicines.

(5) To enhance the security of supply for medicinal products and thereby contribute to a

high level of public health protection, the Union has implemented a range of measures

that contribute to building a European Health Union. In particular, Regulation (EU)

2022/123 of the European Parliament and of the Council2 has reinforced the European

Medicines Agency’s (‘the Agency’) mandate by enhancing monitoring, coordination,

and reporting mechanisms to prevent and mitigate supply disruptions of critical

medicinal products across Member States. That Regulation also established the

Agency’s Executive Steering Group on Shortages and Safety of Medicinal Products

(‘the MSSG’), which brings together representatives from the Agency and Member

States, to coordinate urgent actions within the Union to manage existing shortages and

issues related to the quality, safety, and efficacy of medicinal products.

(6) In addition, Regulation (EU) …/… of the European Parliament and of the Council3 No

[reference to be added after adoption cf. COM(2023) 193 final] further strengthens the

continuity of supply and availability of medicinal products through developing the

core tasks already granted to the Agency by Regulation (EU) 2022/123 and setting out

a framework for the activities to be deployed by the Member States and the Agency to

improve the Union capacity to react efficiently and in coordinated manner to support

the shortages management and security of supply of medicinal products, including by

strengthening the obligations of marketing authorisation holders as it regards the

shortages prevention and reporting.

(7) However, despite regulatory obligations on marketing authorisation holders to ensure

the continuous supply of medicinal products to meet patients’ demand and the

additional regulatory mechanism introduced by Regulation of the European Parliament

and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added

after adoption cf. COM(2023)193 final] to mitigate and respond to shortages, the

functioning of markets alone does not always guarantee the availability of medicinal

products. This risk is particularly evident in cases of supply chain disruptions,

especially when the supply of a given medicinal product relies on a limited number of

global suppliers and production facilities or where there is a high dependency on a

single or a limited number of third countries.

2 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a

reinforced role for the European Medicines Agency in crisis preparedness and management for

medicinal products and medical devices (OJ L 20, 31.2.2022, p. 1,

ELI: http://data.europa.eu/eli/reg/2022/123/oj) 3 Regulation (EU) …/… of the European Parliament and of the Council laying down Union procedures

for the authorisation and supervision of medicinal products for human use and establishing rules

governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation

(EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and

Regulation (EC) No 1901/2006 (OJ … [OP: Please complete publication references]).

EN 19 EN

(8) As the Union market for medicinal products remains fragmented, there is a need for

better coordination between Member States to leverage in full the Union’s potential to

strengthen the security of supply of medicinal products, without calling into question

Member States’ responsibilities for the organisation and delivery of health services

and medical care. Uncoordinated national measures risk disrupting the internal market,

fail to address broader supply chain issues, and are insufficient to resolve cross-border

issues, including the Union's dependency on third countries. The regulatory framework

for medicinal products therefore needs to be complemented by targeted actions

providing for further harmonisation.

(9) Some medicinal products of common interest which are key for the provision of

adapted care to patients, while not affected by supply security issues, may still not be

available to patients in some Member States. This may be caused by a variety of

factors, including product or geographical demand market size, which can impact the

timely availability of medicinal products in certain Member States.

(10) The smooth functioning of the internal market and a high level of protection of human

health should be ensured as regards medicinal products and it should be aimed to

complementing other Union pharmaceutical legislation by providing for a harmonised

framework supporting Member States’ coordinated efforts to encourage investments in

new and existing manufacturing capacities for critical medicinal products, encouraging

the strategic use of public procurement instruments by the Member States as well as

the coordination of the Member States’ approaches, including through leveraging

aggregated demand through Commission facilitated collaborative procurement

procedures of critical medicinal products and medicinal products of common interest.

Due to the international dimension of the security of supply, in particular taking into

account that diversification of supply chains and an overall increase of supply are

elements of a solution for ensuring the security of supply, international cooperation

should be encouraged.

(11) The measures introduced by this Regulation are without prejudice to marketing

authorisation holders’ obligations, in particular under Directive (EU) …/… of the

European Parliament and of the Council [reference to be added to corresponding

Article after adoption of cf. COM(2023)192 final], Regulation (EU) …/… [reference

to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) 2022/123,

including the obligation to ensure sufficient supplies of medicinal products, within the

limits of their responsibility. These measures are aligned with the principles of the

internal market. This Regulation is without prejudice to Union competition law,

including antitrust, merger and State aid rules.

(12) While the primary objective of this Regulation should be to strengthen the security of

supply and ensure the availability of critical medicinal products and of medicinal

products of common interest, given a lack of critical medicinal products can affect the

functioning of the economy as a whole, this Regulation should also support the

Union’s competitiveness by fostering a more stable and predictable market

environment, encouraging investment and supporting innovation in the pharmaceutical

sector. Ensuring the security of supply and availability of critical medicinal products

and the availability and accessibility of other medicinal products of common interest

should moreover contribute to the Union’s preparedness, resilience, and economic and

overall security, including when cross-border supply chains risk being disrupted.

EN 20 EN

(13) Taking into account the different root causes of the availability issues affecting critical

medicinal products and medicinal products of common interest, some measures should

apply to critical medicinal products only.

(14) The availability and the security of supply of critical medicinal products are essential

to safeguard public health and the economic and overall security of the Union and

therefore should be considered strategic objectives of the Union.

(15) A well-defined list of critical medicinal products is essential to ensure that the

measures are targeted, effective, and proportionate. The critical medicinal products

covered by this Regulation should be those for which insufficient supply results in

serious harm or risk of serious harm to patients. For this reason this Regulation should

apply to critical medicinal products on the Union list of critical medicinal products, as

established by Regulation (EU) …/… [reference to be added after adoption cf.

COM(2023) 193 final]. That list builds upon the experiences of the European

Medicines Agency and Member States’ Agencies that in 2024, in anticipation of the

reform of pharmaceutical legislation, identified a list of 276 critical medicinal

products.

(16) To ensure that the measures are applied where justified and proportionate, it is

necessary to demonstrate that some measures address a vulnerability in the supply

chains of a given critical medicinal product. This Regulation should rely on the

vulnerability evaluation performed for the purpose of the application of the general

pharmaceutical legislation as per Regulation (EU) No …/… [reference to be added

after adoption cf. COM(2023) 193 final]. To detect a vulnerability in the supply chains

it is necessary to look at aggregated data across all medicinal products authorised in

the Union and containing the same active substance, route of administration and

formulation. Such an approach allows for the determination whether, for a critical

medicinal product with a given active substance, the Union is highly dependent on a

single or a limited number of third countries, or a limited number of sites, for active

substances, key inputs, or finished dosage forms.

(17) Certain projects can have a positive impact on security of supply as they increase the

Union’s manufacturing capacity for critical medicinal products and strengthen the

resilience of the Union’s supply chains. In order to encourage private investments in

these projects, the concept of strategic projects should be introduced. Given their role

in ensuring the Union’s security of supply for critical medicinal products, the relevant

permitting authority should consider strategic projects to be in the public interest. To

ensure their expedient implementation, national authorities should ensure that the

relevant permit granting processes are carried out in the fastest way possible making

available, in particular any form of accelerated procedures that exists in applicable

Union and national law. National authorities should consider, when possible, their

streamlining as well as enable digital submission of required information.

(18) To avoid unnecessary delays and the creation of additional administrative layers, the

verification of whether a project fulfils the strategic project criteria should be

performed by any Member State authority requested to provide advantages offered in

this Regulation. A designated authority should, when solicited, verify whether a given

project is a strategic project. In order to accelerate and facilitate their deployment,

strategic projects should benefit from streamlined administrative processes, priority

status in the context of permit granting procedures and related dispute resolution

procedures, as well as, be offered targeted regulatory support. In this context, the

EN 21 EN

Member States should give particular attention to small and medium sized enterprises

(SMEs) which should have a fair chance to initiate strategic projects.

(19) The production of medicinal products has environmental implications and may

negatively impact not only the environment itself but also human health. The

environmental assessments and authorisations required under Union law are an

integral part of the permit-granting process for strategic projects and an essential

safeguard to ensure negative environmental impacts are prevented or minimised.

However, to ensure that permit-granting processes for strategic projects are predictable

and timely, it should be possible to streamline the required assessments and

authorisations by the relevant authority, while not lowering the level of environmental

protection.

(20) Land use conflicts can create barriers to the deployment of strategic projects. The

relevant national, regional or local authority responsible for preparing zoning, spatial

and land use plans should consider whether to introduce in these plans certain

provisions related to strategic projects. Those plans have the potential to help balance

the public interest and common good, decreasing the potential for conflict and

accelerating the sustainable deployment of strategic projects in the Union.

(21) Given the capital-intensive nature of pharmaceutical production, including the

establishment or expansion of manufacturing sites for critical medicinal products,

active substances, and key inputs, targeted financial support can play a crucial role in

incentivising production within the Union. To strengthen the security of supply of

critical medicinal products, and where private investment alone is not sufficient,

financial support of investments in manufacturing capacity within the Union may be

justified. Member States should be able to prioritise financial support for strategic

projects that address specific vulnerabilities in the supply chains, while ensuring that

such support complies with the Union’s State aid rules. For this purpose, specific

guidance to clarify the application of EU State aid rules to assist the Member States

has been provided by the Commission services and will be updated as necessary.

(22) Union-level funding may be leveraged to facilitate investments in strategic projects.

Strategic projects may benefit from access to existing EU funding instruments, such as

the EU4Health Programme4, Digital Europe Programme5 and Horizon Europe6

(relevant, for example, for active substances referred to in Article 5(d) of Regulation

(EU)2021/695), as well as the Strategic Technologies for Europe Platform (STEP),

when they fulfil the criteria established in these instruments. Authorities in charge of

the Union programmes covered by Regulation (EU) 2024/795 of the European

Parliament and of the Council7 (STEP) should in particular consider supporting

4 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021

establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for

the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021, p. 1,

ELI: http://data.europa.eu/eli/reg/2021/522/oj) 5 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing

the Digital Europe Programme and repealing Decision (EU) 2015/2240( OJ L166, 11.5.2021, p. 1,

ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21) 6 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing

Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for

participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013

(OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj) 7 Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024

establishing the Strategic Technologies for Europe Platform (STEP), and amending

EN 22 EN

strategic projects addressing a vulnerability in the supply chains of critical medicinal

products and therefore Regulation (EU) 2024/795 should be amended.

(23) To allow for a more coordinated approach to financial support, it is appropriate that

Member States and the Commission exchange the information on financial support to

strategic projects. As regards the strategic projects that have benefitted from EU

funding, the beneficiaries should follow the relevant communication and visibility

rules8.

(24) Given that public authorities or entities are the principal buyers of medicinal products

for the inpatient sector and that the public procurement of medicinal products is a

powerful tool to improve security of supply and the availability and accessibility of

other medicinal products of common interest, it is necessary to establish rules that

require the use of the procurement requirements referring to Most Economically

Advantageous Tender (MEAT) that take into account the supply security and

availability considerations. Procurement requirements based on such considerations

should include stockholding obligations, a number of diversified suppliers, state of the

art monitoring of supply chains, their transparency to the contracting authority and

contract performance clauses on timely delivery and measures in case of non-timely

delivery.

(25) Inconsistent use of procurement requirements in public procurement procedures may

have negative impact on the internal market as it creates obstacles to cross-border

participation and a lack of predictability for bidders. In order to avoid such negative

outcomes, the use of MEAT criteria should be mandatory.

(26) To ensure a high level of health protection and security of supply, it is necessary to

procure in a way that promotes diversification of suppliers where dependency on a

single or a limited number of third countries, threatening the security of supply, has

been established through a vulnerability evaluation. In such situations, contracting

authorities in the Member States should introduce procurement requirements that

favour suppliers of critical medicinal products that manufacture a significant portion of

these products in the EU. Moreover, the contracting authorities in the Member States,

when justified by market analysis and public health considerations, may apply

procurement requirements that favour suppliers of medicinal products of common

interest that manufacture a significant portion of these medicinal products in the EU.

These measures should be designed and applied in line with the Union's international

obligations including the principles of non-discrimination and proportionality.

(27) The application of procurement requirements should take into account the specific

market conditions and public health needs of each procurement procedure, whilst

bearing in mind the considerations related to affordability of medicinal products.

Certain procurement requirements may not be justified if they result in

disproportionate cost for procurers or discourage participation, leading to no bids.

(28) In accordance with Article 168(7) TFEU Member States’ responsibilities for the

definition of their health policy and for the organisation and delivery of health services

and medical care, including the allocation of financial resources, are to be respected.

The contracting authorities should therefore retain the ability, where justified by the

Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU)

No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697

and (EU) 2021/241, (OJL 2024/794, 29.2.2024, ELI: http://data.europa.eu/eli/reg/2024/795/oj) 8 Communication and visibility rules - Publications Office of the EU

EN 23 EN

considerations related to the market analysis or considerations related to financing of

health services, to adopt procurement approaches that differ from those set out in this

Regulation as long as they are in line with the Union’s international obligations.

(29) The Commission intends to issue guidelines designed to support Member States in

implementing their obligations to use procurement requirements including award

criteria beyond price considerations with a view to strengthening the security of

supply, building on best practices identified in the context of the cooperation of

national competent authorities on pricing and reimbursement and public health care

payers and detailing procurement practices that support availability and security of

supply is appropriate.

(30) The procurement of medicinal products is organised differently across Member States,

involving various actors. To strengthen the security of supply chains for critical

medicinal products, Member States should establish national programmes that

promote the consistent use of procurement criteria by contracting authorities within

their territory, including the application of multi-winner approaches where beneficial,

based on thorough market analysis. To ensure a comprehensive approach, and

considering that critical medicinal products are also relevant for outpatient sector

where they are often not purchased through public procurement, these programmes

may also encompass measures to strengthen supply chain resilience and sustainability

through measures related to pricing and reimbursement, where appropriate. The

programmes should be shared with the Commission and the Critical Medicines

Coordination Group, established by this Regulation, to facilitate the exchange of best

practices and coordination between the Member States. This cooperation should

enhance the overall effectiveness of the various measures put forward to secure the

supply of critical medicinal products, while respecting the principles of subsidiarity

and proportionality.

(31) Obligations imposed by the Member States on companies in the pharmaceutical

supply chain to hold contingency stocks can have a serious negative impact on the

internal market and other Member States. To avoid such an impact, these obligations

should be designed taking into consideration the principles of proportionality,

transparency and solidarity. The Member States should give due consideration to

forthcoming Commission guidelines designed to facilitate the fulfilment of Member

States’ obligations as regards the absence of any negative impact on the internal

market when proposing and defining the scope and timing of any form of requirements

for companies to hold such stocks.

(32) Availability and access disparities exist for critical medicinal products and medicinal

products of common interest throughout the Union, disproportionately affecting some

Member States. The collaborative procurement of critical medicinal products and of

medicinal products of common interest can be a powerful tool to improve their

security of supply and accessibility.

(33) Directive 2014/24/EU of the European Parliament and of the Council9 provides for the

possibility of procurement involving contracting authorities from different Member

States. Whereas it has been found helpful to make small markets attractive for

suppliers, thereby achieving better availability of medicinal products, its

9 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, p. 65, ELI:

http://data.europa.eu/eli/dir/2014/24/oj).

EN 24 EN

implementation is time- and resource-intensive, especially in the starting phase, and

considered a limiting factor. To facilitate the deployment of procurement initiatives

involving contracting authorities from different Member States, the Commission,

when requested, should provide its assistance during the preliminary phase of setting

up such a procurement initiative.

(34) Taking into account experiences resulting from the implementation of joint

procurement of medical countermeasures pursuant to Regulation (EU) 2022/2371 of

the European Parliament and of the Council10 and of COVID-19 vaccines, pursuant to

Council Regulation (EU) 2016/36911 in the context of the EU Vaccines Strategy and

acknowledging potential benefits that leveraging of several Member States demand in

one procurement procedure may have, Member States should be able to consider the

use of joint procurement or to consider requesting the Commission to procure on their

behalf, or in their name, where such procurement could contribute to the achievement

of the objectives of this Regulation.

(35) To ensure that the collaborative procurement initiatives contribute to the achievement

of the objectives of this Regulation, while fully respecting the principle of subsidiarity,

the Commission’s involvement in joint procurement and procurement on behalf, or in

the name of the Member States, should be limited to defined cases. For this reason

derogations from Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509 of

the European Parliament and of the Council12 should be provided.

(36) To ensure transparency, legal clarity, and effective coordination, structured agreement

between the Member States and the Commission should govern procurement

procedures under this Regulation that rely on an active Commission involvement.

Such agreement should set out the division of responsibilities, decision-making

processes, the information to be shared as relevant to the procurement procedure,

including information on Member States’ participation in parallel negotiations through

different channels in relation to the same medicinal products or the same active

substances as appropriate, and liability provisions, ensuring a fair and efficient

framework for participating Member States while preventing market distortions and

supply disruptions. This Regulation is without prejudice to and does not prevent the

use of joint procurement procedures established under Regulation (EU) 2022/2371 of

the European Parliament and of the Council for those critical medicinal products and

other medicinal products that also fall within the definition of medical

countermeasures as set out in that Regulation. For such medicinal products, the

objective of the joint procurement initiative should determine the applicable

framework. Where a joint procurement procedure is initiated with the aim of advance

purchasing of these medicinal products as medical countermeasures to prepare for and

respond to serious cross-border threats to health, such a procurement procedure should

be carried out in accordance with Regulation (EU) 2022/2371. This Regulation is

10 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). 11 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within

the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj) 12 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, 26.9.2024,

ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

EN 25 EN

without prejudice to Council Regulation (EU) 2022/237213 setting the framework of

measures for ensuring the supply of crisis-relevant medical countermeasures in the

event of a public health emergency at Union level.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply

of critical medicinal products requires collaboration between the Member States and

the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the

Critical Medicines Group’) should be established to facilitate effective coordination

across the relevant policy areas. The Critical Medicines Group should be composed of

high-level representatives of Member States with expertise in medicinal product

procurement policies, industrial policy related to pharmaceuticals and public health.

The Commission should be a member of the group. To ensure structured discussions,

the Commission should chair the Critical Medicines Group and perform the functions

of its secretariat.

(38) To ensure coordinated implementation of this Regulation, the Critical Medicines

Group should enable exchanges of information related to funding of strategic projects

and facilitate the strategic orientation of financial support for strategic projects. The

Critical Medicines Group should also facilitate the exchange of information on

national programmes, including on the approach to contingency stock requirements in

public procurement contracts. When relevant, the Critical Medicines Group should

facilitate the coordination of national programmes. The Critical Medicines Group

should furthermore facilitate discussions on the need to launch a collaborative

procurement initiative and the need to prioritise the vulnerability evaluation for

specific critical medicinal products.

(39) The Union could further enhance the availability and security of supply of critical

medicinal products by providing access to alternative sources of supply in third

countries through international trade agreements or other forms of international

cooperation. The Union could, to that end, rely on its network of existing trade

agreements and additionally pursue strategic partnerships with third countries to

further deepen bilateral cooperation, especially with candidate countries. In this

context, the Commission should assess whether existing partnerships effectively

address the intended aims or could be further improved or upgraded, and what types of

potential partnerships could be concluded with the most relevant third countries. This

should be done without prejudice to the prerogatives of the Council in accordance with

the Treaties.

(40) To ensure the application of this Regulation, it is necessary that economic operators

make available information and data to public authorities. The Member States and the

Commission must therefore be able to request, when necessary and avoid duplication

of information requests, the information necessary for the application of this

Regulation, including its evaluation, from any economic operator in the supply and

distribution chains of critical medicinal products and medicinal products of common

interest.

(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to

assess its implementation and impact over time. The Commission should carry out an

evaluation of this Regulation five years after its application and every five years

13 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, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj)

EN 26 EN

thereafter. This evaluation should include an assessment of the extent to which the

Regulation’s objectives, as set out in Article 1, have been achieved, including its

impact on stakeholders, regulatory procedures, and market dynamics. In particular, the

Commission’s evaluation should take into account the views of Member States,

economic operators, and other relevant stakeholders, ensuring that their feedback

contributes to the continuous improvement of the regulatory framework. The results of

this evaluation should be presented to the European Parliament, the Council, the

European Economic and Social Committee and the Committee of the Regions. In

order to facilitate this evaluation, national authorities and economic operators should

provide relevant data and information upon request to support the Commission’s

assessment.

(42) Since the objectives of this Regulation to establish a framework to strengthen the

availability and security of supply of critical medicinal products within the Union and

to improve the availability and accessibility of medicinal products of common interest

through coordinated and targeted action of Member States cannot be sufficiently

achieved by the Member States acting alone, but can rather, by reason of its scale, be

better achieved at Union level, the Union may adopt measures in accordance with the

principle of subsidiarity, as set out in Article 5 of the TFEU. 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 its objectives.

HAVE ADOPTED THIS REGULATION:

Chapter I

General provisions

Article 1

Objectives and subject matter

1. The objective of this Regulation is to strengthen the security of supply and the

availability of critical medicinal products within the Union, thereby ensuring a high

level of public health protection and supporting the security of the Union. The

objective of this Regulation is also to improve the availability and accessibility of

other medicinal products, where the functioning of the market does not otherwise

sufficiently ensure the availability and accessibility of those medicinal products to

patients, whilst giving due consideration to the appropriateness to ensure the

affordability of medicinal products.

2. To achieve the objectives referred to in paragraph 1, the Regulation sets out a

framework to:

(a) facilitate investments in manufacturing capacity for critical medicinal products,

their active substances and other key inputs in the Union;

(b) lower the risk of supply disruptions and strengthen availability by incentivising

supply chain diversification and resilience in the public procurement

procedures of critical medicinal products and other medicinal products of

common interest;

(c) leverage the aggregated demand of participating Member States through

collaborative procurement procedures, and

EN 27 EN

(d) support the diversification of supply chains also by facilitating the conclusion

of strategic partnerships.

Article 2

Scope

1. This Regulation applies to the critical medicinal products listed in the Union List of

Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/…

[reference to be added after adoption cf. COM(2023) 193 final].

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common

interest. Chapter III does not apply to medicinal products of common interest.

Article 3

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(1) ‘medicinal product’ means a medicinal product as defined in Article 4 point (1) of

Directive (EU) …/… of the European Parliament and of the Council [reference to be

added to corresponding Article after adoption of cf. COM(2023)192 final];

(2) ‘key input’ means input material other than an active substance required in the

manufacturing process of a given medicinal product, including primary packaging

materials, excipients, solvents and reagents;

(3) ‘active substance’ means an active substance as defined in Article 4 point (3) of

Directive (EU) …/… [reference to be added to corresponding Article after adoption

of cf. COM(2023)192 final];

(4) ‘critical medicinal product’ means a medicinal product for which insufficient supply

results in serious harm or risk of serious harm to patients as defined in Article 4 point

(13) of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)

193 final];

(5) ‘medicinal product of common interest’ means a medicinal product, other than a

critical medicinal product, for which in three or more Member States the functioning

of the market does not sufficiently ensure the availability and accessibility to patients

in the quantities and presentations necessary to cover the needs of patients in those

Member States;

(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply

chains of critical medicinal products, identified at the aggregated level, taking into

account all authorised medicinal products in the EU and grouped under a common

name with the same route of administration and formulation, that compromise the

continuous supply of such medicinal products to patients in the Union;

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical

medicinal products to identify their vulnerabilities performed by the MSSG in

accordance with Regulation (EU) …/… of the European Parliament and of the

Council14 [reference to be added after adoption cf. COM(2023) 193 final];

14 Regulation (EU) …. of the European Parliament and of the Council laying down Union procedures for

the authorisation and supervision of medicinal products for human use and establishing rules governing

EN 28 EN

(8) ‘common name’ means a common name as defined in Article 4 point (48) of

Directive (EU) …/… of the European Parliament and of the Council [reference to be

added to corresponding Article after adoption of cf. COM(2023)192 final];

(9) ‘contracting authorities’ means contracting authorities as defined in Article 2(1)

point (1) of Directive 2014/24/EU;

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set

out in Article 5;

(11) ‘project promoter’ means any undertaking or consortium of undertakings developing

a strategic project;

(12) ‘permit granting process’ means a process covering all relevant permits to build and

operate a strategic project, including building, chemical and grid connection permits

and environmental assessments and authorisations where those are required and

encompassing all applications and procedures;

(13) ‘innovative manufacturing process’ means a novel manufacturing process and

technology or novel application of an existing technology, including, but not limited

to, decentralised manufacturing, continuous manufacturing, Artificial Intelligence,

platform techniques, 3D manufacturing;

(15) ‘Member States’ cross-border procurement’ means a procurement procedure initiated

between the contracting authorities from different Member States on the basis of

Article 39 of Directive 2014/24/EC;

(16) ‘procurement on behalf of or in the name of the Member States’ means a

procurement procedure initiated at the request of Member States and mandating the

Commission to act as a central purchasing body on behalf of, or in the name of, the

requesting Member States, as provided for in Article 168(3) of Regulation (EU)

2024/2509;

(17) ‘joint procurement’ means a procurement procedure carried out jointly by the

Commission and Member States, as provided for in Article 168(2) of Regulation

(EU) 2024/2509;

(18) ‘supplier’ means the manufacturer or marketing authorisation holder of finished

dosage forms, or manufacturer of key inputs or active substances;

(19) ‘strategic partnership’ means a commitment between the Union and a third country,

group of third countries or international organisations to increase cooperation related

to one or more critical medicinal products that is established through a non-binding

instrument and which facilitates beneficial outcomes for both the Union and the

relevant third country, group of third countries or international organisation.

the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No

536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation

(EC) No 1901/2006 (OJ …) [D.G.: Title according to COM(2023) 193 final. Please check against

latest version of this draft Regulation].

EN 29 EN

Chapter II

Strengthening the Union’s security of supply

Article 4

Strategic objective of the Union

1. The security of supply and availability of critical medicinal products for patients is a

strategic objective of the Union.

2. The Member States and the Commission shall work together to strengthen the

security of supply and continuous availability of critical medicinal products in the

Union through measures that take full advantage of the potential of the internal

market.

3. The Commission shall support the coordinated efforts of the Members States.

Chapter III

Enabling conditions for investment

SECTION I

CRITERIA AND PROCEDURE FOR THE RECOGNITION OF STRATEGIC

PROJECTS

Article 5

Strategic Projects

A project located in the Union and related to creating or increasing manufacturing capacity

shall be considered as a strategic project if it meets at least one of the following criteria:

(a) it creates or increases manufacturing capacity for one or more critical medicinal

products or for collecting or manufacturing their active substances;

(b) it modernises an existing manufacturing site for one or more critical medicinal

products or their active substances to ensure greater sustainability or increased

efficiency;

(c) it creates or increases manufacturing capacity for key inputs necessary for the

manufacturing of one or more critical medicinal products or their active substances;

(d) it contributes to the roll-out of a technology that plays a key role in enabling the

manufacturing of one or more critical medicinal products, their active substances or

key inputs.

Article 6

Recognition of Strategic Projects

1. Each Member State shall designate an authority (‘the designated authority’) that shall

assess and verify whether or not a project meets at least one of the criteria set out in

Article 5 and therefore constitutes a strategic project.

EN 30 EN

A promoter may request the designated authority to assess whether a project is a

strategic project.

Any Member State authority may request the designated authority to verify its

determination of whether a project is a strategic project.

2. Member States shall communicate to the Commission what is the designated

authority for the purposes of paragraph 1.

3. The Commission shall provide a simple, accessible webpage on which the contact

details and other relevant information on the Member States’ designated authorities

shall be clearly listed.

4. Any other Member State authority that receives a request from a promoter

concerning Articles 8 to 14 shall assess whether that given project meets the criteria

to be considered a strategic project as provided for in Article 5 and where necessary,

request the verification of its determination from the designated authority.

5. Where the verification whether a project is a strategic project has been performed by

an authority in accordance with this Article, any other authority shall rely on that

verification.

SECTION II

FACILITATING ADMINISTRATIVE AND PERMIT-GRANTING PROCESSES

Article 7

Priority status of strategic projects

Strategic projects shall be considered as contributing to the security of supply of critical

medicinal products in the Union and, therefore, to be in the public interest.

The Member States’ authorities shall ensure that the relevant permit granting processes

related to strategic projects are carried out in the fastest way possible, making available, in

particular, any form of accelerated procedures that exists in applicable Union and national

law.

Article 8

Administrative support

1. Upon request of a project promoter, a Member State shall provide to a strategic

project located on its territory all the administrative support necessary to facilitate its

timely and effective implementation, including assistance:

(a) with regard to compliance with applicable administrative and reporting

obligations;

(b) with regard to informing the public, with the aim of increasing public

acceptance of the strategic project;

(c) along the permit-granting process.

2. When providing the administrative support and the assistance referred to in

paragraph 1, the Member State shall pay particular attention to small and medium

EN 31 EN

size enterprises (SMEs) and, where appropriate, establish a dedicated channel for

communication with SMEs to provide guidance and respond to queries related to the

implementation of this Regulation.

Article 9

Request for granting the status of highest national significance

1. A project promoter may request that their application for a permit is granted the

status of the highest national significance, when such a status exists in national law,

and be treated accordingly.

2. National authorities shall grant the status of the highest national significance to an

application for a permit without prejudice to obligations provided for in Union law.

Article 10

Procedures relating to dispute resolution

A project promoter may request that any dispute resolution procedure, litigation, appeal and

proceedings on judicial remedies related to the permit-granting process and the issuance of

permits for a strategic project in the Union before any national courts, tribunals or panels,

including with regard to mediation or arbitration, where they exist in national law, is treated

as urgent if and to the extent to which national law provides for such an urgency procedure.

The applicable rights of defence of individuals or of local communities shall be respected

during such urgency procedure.

The project promoter shall participate in such urgency procedures, where applicable.

Article 11

Regulatory and scientific support from medicines agencies and pharmaceutical

inspectorates

1. Upon request of a project promoter, a Member State shall provide regulatory support

to a strategic project located on its territory, including by prioritising Good

Manufacturing Practices inspections for approval of new and extended

manufacturing sites and for the manufacturing sites modernised in the context of the

concerned strategic project.

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’)

shall provide dedicated advice to assist project promoters developing projects relying

on innovative manufacturing processes.

Article 12

Environmental assessments and authorisation

1. A project promoter may request, where the obligation to assess the effects on the

environment arises simultaneously from two or more of Council Directive

92/43/EEC15, Directive 2000/60/EC of the European Parliament and of the Council16,

15 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna

and flora (OJ L 206, 22.7.1992, p. 7, ELI: http://data.europa.eu/eli/dir/1992/43/oj).

EN 32 EN

Directive 2001/42/EC of the European Parliament and of the Council17, Directive

2008/98/EC of the European Parliament and of the Council18, Directive 2009/147/EC

of the European Parliament and of the Council19, Directive 2010/75/EU of the

European Parliament and of the Council20, Directive 2011/92/EU of the European

Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament

and of the Council22, that a coordinated or joint procedure fulfilling the requirements

of those Union legislative acts are applied.

Under the coordinated procedure referred to in the first subparagraph, a competent

authority shall coordinate the various individual assessments of the environmental

impact of a particular project required by the relevant Directive.

Under the joint procedure referred to in the first subparagraph, a competent authority

shall provide for a single assessment of the environmental impact of a particular

project required by the relevant Directive.

2. Member States shall ensure that the competent authorities issue the reasoned

conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the

environmental impact assessment within 45 days of receiving all necessary

information.

3. In exceptional cases, where the nature, complexity, location or size of the proposed

project so requires, Member States may extend the time limit referred to in paragraph

2 once by a maximum of 15 days, before its expiry and on a case-by-case basis. In

that event, the competent authority shall inform the project promoter in writing of the

reasons justifying the extension and of the deadline for its reasoned conclusion.

4. The deadlines for consulting the public concerned as referred to in Article 1(2), point

(e), of Directive 2011/92/EU and the authorities referred to in Article 6(1) of that

Directive on the environmental impact assessment report referred to in Article 5(1)

of that Directive shall not be longer than 85 days and not shorter than the 30 day

period referred to in Article 6(7) of that Directive.

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of

Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles

16 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1, ELI:

http://data.europa.eu/eli/dir/2000/60/oj). 17 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the

assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p.

30, ELI: http://data.europa.eu/eli/dir/2001/42/oj). 18 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste

and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI:

http://data.europa.eu/eli/dir/2008/98/oj). 19 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the

conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI: http://data.europa.eu/eli/dir/2009/147/oj). 20 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on

industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI:

http://data.europa.eu/eli/dir/2010/75/oj). 21 Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the

assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012,

p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj). 22 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of

major-accident hazards involving dangerous substances, amending and subsequently repealing Council

Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj).

EN 33 EN

6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15)

and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the

Union may be considered to have an overriding public interest and to serve the

interests of public health and safety provided that all the conditions set out in those

acts are fulfilled.

Article 13

Planning

1. National, regional and local authorities responsible for preparing plans, including

zoning, spatial plans and land use plans, shall consider including in such plans,

where appropriate, provisions for the development of Strategic Projects, as well as

the necessary infrastructure. To facilitate the development of strategic projects,

Member States shall ensure that all relevant spatial planning data is available.

2. Where plans including provisions for the development of strategic projects are

subject to an assessment pursuant to Directive 2001/42/EC of the European

Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC,

those assessments shall be combined. Where applicable, the combined assessment

shall also address the impact on potentially affected water bodies referred to in

Directive 2000/60/EC. Where Member States are required to assess the impacts of

existing and future activities on the marine environment, including land-sea

interactions, in accordance with Article 4 of Directive 2014/89/EU of the European

Parliament and of the Council23, the combined assessment shall also cover those

impacts.

Article 14

Applicability of UNECE Conventions

1. This Regulation is without prejudice to the obligations under the United Nations

Economic Commission for Europe (UNECE) Convention on Access to Information,

Public Participation in Decision-making and Access to Justice in Environmental

Matters, signed at Aarhus on 25 June 1998, and under the UNECE Convention on

environmental impact assessment in a transboundary context, signed at Espoo on 25

February 1991 and its Protocol on Strategic Environmental Assessment, signed in

Kyiv on 21 May 2003.

2. All decisions adopted pursuant to the Articles in this section shall be made publicly

available.

23 Directive 2014/89/EU of the European Parliament and of the Council of 23 ELI:

http://data.europa.eu/eli/dir/2014/89/oj July 2014 establishing a framework for maritime spatial

planning (OJ L 257, 28.8.2014, p. 135, ELI: http://data.europa.eu/eli/dir/2014/89/oj).

EN 34 EN

SECTION III

FINANCIAL INCENTIVES

Article 15

Financial support by Member States

1. Without prejudice to Articles 107 and 108 TFEU, Member States may prioritise

financial support to strategic projects that address a vulnerability in the supply chains

of critical medicinal products identified following a vulnerability evaluation and with

due consideration to the strategic orientations of the Critical Medicines Group

referred to in Article 26(2) point (a).

2. For as long as the critical medicinal product is on the Union List of Critical

Medicinal Products, an undertaking that has benefitted from financial support for a

strategic project shall prioritise supply to the Union market and use its very best

efforts to ensure that the critical medicinal product remains available in the Member

States where it is being marketed.

3. The Member State that provided financial support to a strategic project may request

such undertaking to provide the necessary supplies of a critical medicinal product,

active substance or key inputs, as applicable, to the Union market to avoid shortages

in one or several Member States.

Any Member State that encounters a threat of shortages of the critical medicinal

product in question may demand the Member State that provided financial support to

submit a request on its behalf.

Article 16

Financial support from the Union

1. For the duration of the Multiannual Financial Framework 2021-202724 strategic

projects may be supported by Union funding, including but not limited to such Union

programmes as the EU4Health Programme25, Horizon Europe26, and the Digital

Europe Programme27 provided that such support is in line with the objectives set out

in the regulations establishing those programmes.

24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for

years 2021 to 2027, as amended (OJ LI 433, 22.12.2020, p.11,

ELI: http://data.europa.eu/eli/reg/2020/2093/oj) 25 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021

establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for

the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021, p.1,

ELI: http://data.europa.eu/eli/reg/2021/522/oj) 26 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing

Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for

participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013

(OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj) 27 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing

the Digital Europe Programme and repealing Decision (EU) 2015/2240( OJ L166, 11.5.2021, p.1,

ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21)

EN 35 EN

2. At the request of a project promoter, justified by necessity to provide results of

vulnerability evaluation for the purpose of an application for Union funding, the

designated authority shall assess whether a strategic project addresses a vulnerability

in the supply chains identified following the vulnerability evaluation. The designated

authority shall provide its assessment to a project promoter within 15 working days

of its request. The designated authority shall inform the Commission about the

strategic projects identified as addressing an existing vulnerability in the supply

chains without delay.

Article 17

Exchange of information on funded projects

1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical

Medicines Group’) referred to in Article 24 of the intention to provide financial

support to strategic projects sufficiently in advance to allow the group to carry out its

coordination task as set out in Article 25.

2. The Commission shall inform periodically the Critical Medicines Group of the

strategic projects that benefited from financial support from the Union.

The Commission may inform the Critical Medicines Group of the intention to

propose the establishment of funding possibilities specifically designed to address

vulnerabilities in the supply chains as well as inform of any other programmes that

may benefit the availability of critical medicinal products, under specific rules and

conditions of these Union funding programmes.

Chapter IV

Demand side measures

SECTION I

AWARD CRITERIA AND OTHER PROCUREMENT REQUIREMENTS AND RELATED

MEASURES

Article 18

Incentivising resilience, sustainability and positive social impacts in public procurement

procedures

1. For award procedures of critical medicinal products falling within the scope of

Directive 2014/24/EU of the European Parliament and of the Council, contracting

authorities in the Member States shall apply procurement requirements other than

price-only award criteria such as procurement requirements that promote the

resilience of supply in the Union. Those procurement requirements shall be defined

in accordance with Directive 2014/24/EU and may relate to stockholding obligations,

the number of diversified suppliers, monitoring of supply chains, their transparency

to the contracting authority and contract performance clauses on timely delivery.

2. With regard to critical medicinal products for which a vulnerability in the supply

chains has been confirmed through a vulnerability evaluation pointing to the high

EN 36 EN

level of dependency on a single or a limited number of third countries, the

contracting authorities shall, where justified, apply procurement requirements that

favour suppliers that manufacture a significant proportion of these critical medicinal

products in the Union. These requirements shall be applied in compliance with the

Union’s international commitments.

3. With regard to other medicinal products of common interest, where justified by

market analysis and public health considerations, the contracting authorities may

apply procurement requirements that favour suppliers that manufacture at least a

significant proportion of these medicinal products in the Union. These requirements

shall be applied in compliance with the Union’s international commitments.

4. This Article shall not preclude contracting authorities from using additional

qualitative requirements, including in relation to environmental sustainability and

social rights.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3

where justified by market analysis or considerations related to the financing of health

services.

Article 19

Programmes supporting sustainability and resilience in public procurement procedures

1. By 6 months after entry into force of this Regulation each Member State shall

establish a national programme supporting security of supply of critical medicinal

products, including in public procurement procedures. Such programmes shall

promote the consistent use of procurement requirements by contracting authorities

within a given Member State as well as multi-winner approaches, where beneficial in

light of the market analysis. Such programmes may also include measures for pricing

and reimbursement supporting security of supply of those critical medicinal products

that are not purchased through public procurement procedures.

2. Member States shall notify their programmes to the Commission in its role of the

secretariat of the Critical Medicines Group. The Commission shall ensure the

distribution to all members of the Critical Medicines Group forthwith. The Critical

Medicines Group shall facilitate a discussion aiming to ensure coordination of

national programmes including as regards the application of criteria mentioned in

Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an

opinion concerning the national programmes, Member States shall give it due

consideration and may take it into account when revising their programmes.

Article 20

Safeguards related to Member States’ contingency stocks requirements and other security of

supply measures

Measures on security of supply applied in one Member State shall not result in any negative

impact in other Member States. Member States shall, in particular, avoid such an impact when

proposing and defining the scope and timing of any form of requirements for companies to

hold contingency stocks.

Member States shall ensure that any requirements they impose on companies in the supply

chain to hold contingency stocks are proportionate and respect the principles of transparency

and solidarity.

EN 37 EN

SECTION II

COLLABORATIVE PROCUREMENTS

Article 21

Commission facilitated Member States’ cross-border procurement

1. Upon a reasoned request of three or more Member States (‘the request’), the

Commission may act as facilitator for the requesting Member States’ cross-border

procurement as laid down in Article 39 of Directive of the European Parliament and

of the Council 2014/24/EC28 for medicinal products of common interest.

2. Having received the request, the Commission shall inform all other Member States of

the initiative and set an appropriate deadline for them to declare interest. Such a

deadline shall not exceed three weeks.

3. The Commission shall assess the request in light of the objectives of this Regulation.

The Commission shall communicate to the interested Member States its decision on

whether it agrees, or not, to facilitate the proposed initiative within three weeks of

receiving the request.

4. If the Commission declines the request, it shall provide reasons for the refusal.

5. If the Commission accepts the request, the Commission shall provide secretarial and

logistical support to the interested Member States. The Commission shall facilitate

communication and cooperation between the involved Member States and provide

advice on applicable Union public procurement rules and on regulatory matters

related to medicinal products.

6. The facilitation offered by the Commission shall be limited in time and end at the

latest upon signature of the procurement contract by the participating contracting

authorities.

7. The Commission shall not be responsible, nor held liable, for any breaches of Union

or national procurement laws by the participating contracting authorities. The

Commission shall not bear any liability associated with the conduct of the

procurement procedure by interested Member States and implementation of the

contract resulting from the procedure.

Article 22

Commission procurement on behalf of or in the name of Member States

1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509

where nine or more Member States jointly request the Commission to procure on

their behalf, or in their name, the Commission may initiate a procurement procedure

under the conditions set out in this Article when the procurement relates to medicinal

products belonging to one of the following categories below;

28 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, p. 65,

ELI: http://data.europa.eu/eli/dir/2014/24/2024-01-01 ).

EN 38 EN

(a) critical medicinal products for which a vulnerability evaluation has identified a

vulnerability in the supply chains or for which the MSSG has recommended a

common procurement initiative;

(b) medicinal products of common interest, for which a joint clinical assessment

report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282

of the European Parliament and the Council 29, or which have undergone a

clinical assessment carried out under the voluntary cooperation among Member

States as per Article 23(1) point (e) of that Regulation.

2. The joint request referred to in paragraph 1 shall only be made where the medicinal

product concerned fulfils one of the criteria set out in that paragraph and if the

requested procurement procedure will help to improve the security of supply and

availability of critical medicinal products in the Union or ensure the availability and

accessibility of medicinal products of common interest, as applicable.

3. The participation in the procurement procedure shall be open to all Member States.

The Commission shall inform all Member States of the request, through the Critical

Medicines Group, and invite them to join the procedure.

4. The Commission shall assess the utility, necessity and proportionality of the request

and whether the request is justified in light of the objectives of this Regulation. The

Commission shall in particular verify whether the procurement could constitute

discrimination or restriction to trade or a distortion to competition.

5. The Commission shall inform the interested Member States within one month of the

request of its decision and state its reasons in case of a refusal.

6. If in light of the Commission assessment, it is necessary, in order to achieve the

objectives of this Regulation, to conduct the procurement as exclusive for the

Member States or to agree to minimum binding quantities, the Commission

agreement to pursue the procedure may be conditioned upon acceptance of these

conditions by interested Member States.

7. Except for the derogations provided for in this Regulation, the procurement referred

to in this Article shall be carried out in accordance with Article 168 (3) of Regulation

(EU, Euratom) 2024/250930.

Article 23

Joint Procurement

1. Under conditions laid down in this Article and by way of derogation from Article

168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the

implementation of the joint action between the Commission and Member States, the

Commission and at least nine Member States may engage, as contracting parties, in a

joint procurement procedure.

29 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on

health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI:

http://data.europa.eu/eli/reg/2021/2282/oj) 30 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 (recast) (OJ L, 26.9.2024, p. 1,

ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

EN 39 EN

2. A joint procurement procedure may be organised following a request by the Member

States or at the Commission’s initiative when the procurement relates to medicinal

products belonging to one of the categories below:

(a) critical medicinal products for which a vulnerability evaluation has identified a

vulnerability in the supply chains or for which the MSSG has recommended a

common procurement initiative;

(b) medicinal products of common interest, for which a joint clinical assessment

report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282

of the European Parliament and the Council 31, or which have undergone a

clinical assessment carried out under the voluntary cooperation among Member

States as per Article 23(1) point (e) of that Regulation.

3. The Commission may decide to conduct the joint procurement procedure if the

procurement procedure helps to improve the security of supply and availability of

critical medicinal products in the Union or ensure the availability and accessibility of

medicinal products of common interest, as applicable.

4. The participation in the procurement procedure shall be open to all Member States.

The Commission shall inform all Member States of the request through the Critical

Medicines Group and invite them to join the procedure.

5. The Commission shall assess the necessity of a joint action and whether the request

is justified in light of the objectives of this Regulation. The Commission shall in

particular verify whether the procurement could constitute discrimination or

restriction to trade or a distortion to competition.

6. If in light of the Commission assessment, it is necessary, in order to achieve the

objectives of this Regulation, to conduct the procurement as exclusive for the

Member States or to agree to minimum binding quantities, the Commission

agreement to pursue the procedure may be conditioned upon acceptance of these

conditions by interested Member States.

7. The Commission shall inform the interested Member States within one month of the

request of its decision and state its reasons in case of a refusal.

8. Except for the derogations provided for in this Regulation, the joint procurement

procedure shall be carried out by the Commission in accordance with Article 168 (2)

of Regulation (EU, Euratom) 2024/2509.

Article 24

Agreement concerning procedures under Articles 22 and 23

1. Member States participating in the procurement procedures covered by Articles 22

and 23 shall share with the Commission any information relevant for the

procurement procedure. Member States shall provide resources necessary for the

successful conclusion of the procedure, in particular through involvement of staff

with expertise and knowledge.

31 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on

health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI:

http://data.europa.eu/eli/reg/2021/2282/oj)

EN 40 EN

2. An agreement between the Member States and the Commission shall determine the

practical arrangements governing the procurement procedure, liabilities to be

assumed and the decision-making process.

Chapter V

Critical Medicines Coordination Group

Article 25

Establishment of Critical Medicines Coordination Group

1. A Critical Medicines Coordination Group (‘Critical Medicines Group’) is hereby

established.

2. The Member States and the Commission are Members of the Critical Medicines

Group. Each Member State shall appoint a maximum of two high-level permanent

representatives, with the expertise relevant for implementing all the different measures

set out in this Regulation. Where relevant as regards the function and expertise,

Member States may appoint different representatives in relation to different tasks of

the Critical Medicines Group. Appointed permanent representatives shall ensure the

necessary coordination within their respective Member State. The Agency shall have

an observer status.

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, and

national authorities responsible for medicinal products. For discussions where input

from the medicines regulatory authorities’ perspective is necessary, the Critical

Medicines Group may organise joint meetings with the MSSG.

4. The Commission shall organise and coordinate the work of the Critical Medicines

Group by means of the Secretariat.

5. A representative of the Commission shall chair the meetings of the Critical Medicines

Group.

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may

decide to establish a working group.

7. The Critical Medicines Group shall use its best endeavours to reach consensus, where

possible. Members with diverging positions may request that their positions and the

grounds on which they are based be recorded in the Critical Medicines Group’s

position.

Article 26

Tasks of the Critical Medicines Coordination Group

1. The Critical Medicines Group shall facilitate coordination in the implementation of

this Regulation and, where appropriate, advise the Commission, so as to maximise

the impact of the measures envisaged and to avoid any unintended effects on the

internal market.

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines

Group shall perform the following tasks:

EN 41 EN

(a) facilitate coordination on strategic orientation of the financial support for

strategic projects, including by exchanging information on the manufacturing

capacity for a given critical medicinal product, existing or planned, in the

Member States and facilitate discussion on the capacity needed in the Union to

strengthen its supply security and availability of critical medicinal products

within the Union;

(b) facilitate exchanges on the national programmes referred to in Article 19 and

enable cooperation on and coordination of Member States public procurement

policies with regard to critical medicinal products;

(c) facilitate discussion of the need for a collaborative procurement initiative for a

given medicinal product;

(d) advise the MSSG to provide the order of priority of critical medicinal products

for vulnerability evaluation, and propose a review or an update of existing

evaluations where necessary.

3. The Critical Medicines Group shall enable the exchanges of information between the

Member States and the Commission as referred to in Article 17 and shall enable,

where necessary, a coordination of respective actions aiming to attain the objectives

of this Regulation.

4. The Critical Medicines Group shall periodically discuss the potential contribution of

strategic partnerships to the objectives of this Regulation, prioritisation of third

countries for this purpose, and the consistency and potential synergies between

Member States’ cooperation with relevant third countries and the actions carried out

by the Union.

5. The Critical Medicines Group, at the Commission’s request, may provide an opinion

on matters related to the application of this Regulation in the context of performing

tasks as referred to in this Article.

Chapter VI

International cooperation

Article 27

Strategic partnerships

Without prejudice to the prerogatives of the Council, the Commission, shall explore

possibilities of concluding strategic partnerships aiming to diversify sourcing of critical

medicinal products, their active substances and key inputs to increase the security of supply of

critical medicinal products in the Union. The Commission shall also explore the possibility of

building on existing forms of cooperation, when possible, to support security of supply and

reinforce efforts to strengthen the production of critical medicinal products in the Union.

EN 42 EN

Chapter VII

Amendments to Regulation (EU) 2024/795

Article 28

Regulation (EU) 2024/795 is amended as follows:

(a) in Article 2, (1) point (a), subparagraph (iii) is replaced by the following:

‘(iii) biotechnologies, and any other technologies relevant for manufacturing

of critical medicinal products as defined in Critical Medicines Act *;

_________

* Regulation (EU) … of the European Parliament and of the Council laying

down a framework for strengthening the availability and security of

supply of critical medicinal products as well as for improving the

availability of, and access to, medicinal products of common interest, and

amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed

with the definitive title of the ‘Critical Medicines Act’ and with its

publications references once they are available];’

(b) in Article 2, the following subparagraph is added in paragraph 3:

‘By way of derogation from the first subparagraph of this paragraph, the value

chain for the development or manufacturing of medicinal products that fall

within the scope of the [Critical Medicines Act] and that are referred to in

paragraph 1, point (a)(iii) of this Article, relates to finished dosage forms, as

well as to active pharmaceutical ingredients and other key inputs necessary for

the production of the finished dosage forms of critical medicinal products as

defined in the Regulation.’;

(c) in article 2, paragraph 8 is added:

‘8. Strategic projects designated in accordance with the [Critical Medicines

Act] that address a vulnerability in the supply chains of critical medicinal

products shall be deemed to contribute to the STEP objective referred to

in paragraph 1, point (a)(iii).’;

(d) in Article 4, paragraph 7 is replaced by the following:

‘7. Strategic projects recognised in accordance with the relevant provisions

of the Net-Zero Industry Act, the Critical Raw Materials Act [and the

Critical Medicines Act] that fall within the scope of Article 2 of this

Regulation and that receive a contribution under the programmes referred

to in Article 3 of this Regulation may also receive a contribution from

any other Union programme, including funds under shared management,

provided that those contributions do not cover the same costs. The rules

of the relevant Union programme shall apply to the corresponding

contribution to the strategic project. The cumulative funding shall not

exceed the total eligible costs of the strategic project. The support from

the different Union programmes may be calculated on a pro rata basis in

accordance with the documents setting out the conditions for support.’;

(e) in Article 6, paragraph 1, point c is replaced by the following:

EN 43 EN

(c) details of projects that have been recognized as strategic projects under

the Net-Zero Industry Act, the Critical Raw Materials Act and the

[Critical Medicines Act], to the extent that they fall within the scope of

Article 2 of this Regulation.

Chapter VIII

Final provisions

Article 29

Obligation of the market actors to provide information

1. Marketing authorisation holders and other economic operators in the supply and

distribution chains of critical medicinal products including their key inputs and active

substances or medicinal products of common interest shall upon request provide the

Commission or national authorities, as relevant, the requested information necessary

for the purpose of application of this Regulation.

2. The Commission and national authorities of the Member States shall aim to avoid

duplication of the information requested and submitted.

3. The Commission and national authorities of the Member States shall assess the

merits of duly substantiated confidentiality claims made by marketing authorisation

holders and other economic operators, requested to provide information per

paragraph 1, and shall protect any information that is commercially confidential

against unjustified disclosure.

Article 30

Evaluation

1. By [OP please insert the date of:] five years after the date of application of this

Regulation and every five years thereafter, the Commission shall evaluate this

Regulation and present a report on the main findings to the European Parliament, the

Council, the European Economic and Social Committee, and the Committee of the

Regions.

2. The Commission shall in its evaluation assess the impact of this Regulation and to

what extent its objectives as established in Article 1 have been achieved.

3. The national authorities and the economic operators shall, upon request, provide the

Commission with any relevant information they have and that the Commission may

need for its assessment pursuant to in paragraph 1.

Article 31

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

It shall apply from [….].

EN 44 EN

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg,

For the European Parliament For the Council

The President The President

EN 1 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3

1.1. Title of the proposal/initiative ...................................................................................... 3

1.2. Policy area(s) concerned .............................................................................................. 3

1.3. Objective(s) .................................................................................................................. 3

1.3.1. General objective(s) ..................................................................................................... 3

1.3.2. Specific objective(s) ..................................................................................................... 3

1.3.3. Expected result(s) and impact ...................................................................................... 3

1.3.4. Indicators of performance ............................................................................................ 3

1.4. The proposal/initiative relates to: ................................................................................. 4

1.5. Grounds for the proposal/initiative .............................................................................. 5

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 ............................................................ 5

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. ................................................................................. 5

1.5.3. Lessons learned from similar experiences in the past .................................................. 5

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments ....................................................................................... 5

1.5.5. Assessment of the different available financing options, including scope for

redeployment ................................................................................................................ 6

1.6. Duration of the proposal/initiative and of its financial impact .................................... 7

1.7. Method(s) of budget implementation planned ............................................................. 7

2. MANAGEMENT MEASURES................................................................................... 8

2.1. Monitoring and reporting rules .................................................................................... 8

2.2. Management and control system(s) ............................................................................. 8

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed .................. 8

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them............................................................................................................ 8

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 .............................................................. 10

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

EN 2 EN

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

3.2.1.2. Appropriations from external assigned revenues ....................................................... 16

3.2.2. Estimated output funded from operational appropriations......................................... 16

3.2.3. Summary of estimated impact on administrative appropriations ............................... 18

3.2.3.1. Appropriations from voted budget .............................................................................. 18

3.2.3.2. Appropriations from external assigned revenues ....................................................... 18

3.2.3.3. Total appropriations ................................................................................................... 18

3.2.4. Estimated requirements of human resources.............................................................. 19

3.2.4.1. Financed from voted budget....................................................................................... 19

3.2.4.2. Financed from external assigned revenues ................................................................ 20

3.2.4.3. Total requirements of human resources ..................................................................... 20

3.2.5. Overview of estimated impact on digital technology-related investments ................ 23

3.2.6. Compatibility with the current multiannual financial framework.............................. 23

3.2.7. Third-party contributions ........................................................................................... 24

3.3. Estimated impact on revenue ..................................................................................... 24

4. DIGITAL DIMENSIONS .......................................................................................... 24

4.1. Requirements of digital relevance .............................................................................. 24

4.2. Data ............................................................................................................................ 25

4.3. Digital solutions ......................................................................................................... 27

4.4. Interoperability assessment ........................................................................................ 27

4.5. Measures to support digital implementation .............................................................. 28

EN 3 EN

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying a framework for strengthening the availability and security of supply of

critical medicinal products as well as the availability of, and accessibility of,

medicinal products of common interest, and amending Regulation (EU) 2024/795.

1.2. Policy area(s) concerned

Heading 2: Cohesion, Resilience and Values

EU4Health

1.3. Objective(s)

1.3.1. General objective(s)

The general objective of this Regulation is to strengthen of the security of supply and

the availability of critical medicines within the EU, thereby ensuring a high level of

public health protection and supporting the security of the Union. It is also to

improve the availability and accessibility of other specific medicines, where the

functioning of the market does not otherwise sufficiently ensure the availability and

accessibility of those medicines to patients, whilst giving due consideration to the

appropriateness to ensure the affordability of medicines.

1.3.2. Specific objective(s)

The specific objectives of the initiative are:

a) to facilitate investments in manufacturing capacity for critical medicines, their

active substances and other key inputs in the EU;

b) to lower the risk of supply disruptions and strengthen availability by

incentivising supply chain diversification and resilience in the public procurement

procedures for critical medicines and other medicines of common interest;

c) to leverage the aggregated demand of the interested Member States through

collaborative procurement procedures;

d) to support the diversification of supply chains also by facilitating the

conclusion of strategic partnerships.

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

The proposed act is expected to strengthen the resilience of the EU's medicines

supply chains, contributing to improved security of supply. It should also reduce

shortages of critical medicines and enhance public health and trust. Economically,

the proposal is expected to strengthen the manufacturing base of critical medicines

and make the pharmaceutical sector more competitive, including through

diversification. On a social level, the proposed act should improve access to critical

medicines and certain other medicines for EU patients. These outcomes will directly

contribute to achieving Sustainable Development Goal (SDG) 3, ‘Good health and

well-being’. Besides the public health-related benefits, the proposal is expected to

mostly affect the pharmaceutical industry involved in the supply of critical

EN 4 EN

medicines, as the industry may benefit from administrative and regulatory support

and access to funding for certain strategic projects. In addition, the proposed act will

likely affect national administrative authorities and procurers active in the public

procurement of critical medicines and other medicines of common interest.

1.3.4. Indicators of performance

Specify the indicators for monitoring progress and achievements.

Objective Indicator Target and baseline

Data source and

availibility

/

# of critical medicinal products on the Union

List of Critical Medicinal products

276 – this number is expected to

increase then plateau

EMA/Union List of

Critical Medicines

already available

/

# of critical shortages escalated to the SPOC

WP for the critical medicinal products on the

Union list

The number of reported shortages of

critical medicines is dependent on the

reporting rate. Shortages of critical

medicines may be driven by external

forces (such as increased demand due

to a new pandemic), therefore any

trends in this number should be

interpreted with prudence. EMA/already available

/

Proportion (%) of critical shortages escalated

to the SPOC WP that corresponded to a critical

medicinal product listed on the Union list.

Of the 63 INN critical shortages

received by EMA from EU/EEA

countries in 2024, 29 (~45%)

corresponded to the critical medicines

on the Union list. The proportion s

expected to decrease. EMA/already available

Specific

objective a)

# of strategic projects identified as addressing

an existing vulnerability in the supply chains of

critical medicinal products

0 / target: highly dependent on

demand

MS reporting as

defined in article 16

Specific

objective a)

# of strategic projects for critical medicines

that benefit from national financial support

0 / target: highly dependent on

demand and

MS reporting as

defined in article 17

Specific

objective a)

# of strategic projects for critical medicines

that benefit from financial support from the

Union

0 / target: highly dependent on

demand

MS reporting as

defined in article 17

Specific

objective a)

# of dedicated advice provided by EMA to

project promoters of Strategic Projects with

innovative manufacturing processes

0 / target: highly dependent on

demand EMA

Specific

objective b) # of national programmes issued 0 / target: 27

MS reporting as

defined in article 19

Specific

objective c)

# of cross-border procurement, procurement on

behalf or joint procurements for critical

medicines and other medicines of common

interest

0 / target: highly dependent on

demand

as procurement would

be done by the EC, data

will be easily available

Specific

objective c)

# countries benefiting from cross-border

procurement, procurement on behalf or joint

procurements for critical medicines and other

medicines of common interest

0 / target: highly dependent on

demand

as procurement would

be done by the EC, data

will be easily available

1.4. The proposal/initiative relates to:

 a new action

 a new action following a pilot project / preparatory action96

96 As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 5 EN

 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 adoption is expected for Q4 2025 and the implementation will start in 2026.

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.

Medicine shortages have hit every Member State in the EU over the last decade.

While an individual Member State can act to improve its supply of certain medicines,

these efforts are fragmented and insufficient to address the broader, cross-border

supply chain problems, including dependency on certain non-EU countries. To

address these challenges and to achieve a secure and reliable supply of critical

medicines, a common effort at EU level is needed through this proposed Act. Adding

to this issue, access problems can also exist for other medicines of common interest,

disproportionately affecting some Member States, such as those with a smaller

market size. To improve the availability of and access to these medicines, this Act

therefore proposes measures to leverage the aggregated demand of the interested

Member States through collaborative procurement procedures.

1.5.3. Lessons learned from similar experiences in the past

The Union List of Critical Medicines, created collaboratively by Member States, the

European Medicines Agency and the European Commission, identifies medicines

crucial for treating serious conditions with limited alternatives. Initially published in

December 2023 and updated a year later, it includes 276 active substances. The

Commission’s analysis of supply chain vulnerabilities for 11 representative

medicines found reliance on non-EU suppliers and market concentration risks,

underscoring the need for strategic interventions to bolster resilience through

diversified supply sources, flexible production capacity, and robust risk management.

Some Member States have been involved in cross-border procurement of medicinal

products, pursuant to the public procurement directive. Whereas it has been found

helpful to make small markets attractive for suppliers, thereby achieving better

availability of medicinal products, its implementation is time and resource-intensive,

especially in the starting phase, what is considered a limiting factor. The potential

benefits that leveraging of several Member States demand in one procurement

procedure may have is also illustrated by the experiences resulting from the

implementation of joint procurement of medical countermeasures and COVID-19

vaccines.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

For the duration of the Multiannual Financial Framework 2021-2027, the strategic

projects may be supported by EU funding, including but not limited to EU4Health

programme, Horizon Europe, and the Digital Europe Programme, in line with the

EN 6 EN

objectives set out in the Regulation establishing those programmes. Authorities in

charge of the Union programmes covered by the STEP Regulation should in

particular consider supporting Strategic projects addressing vulnerability in the

supply chain of critical medicinal products. These projects should be deemed to

contribute to STEP.

1.5.5. Assessment of the different available financing options, including scope for

redeployment

N/A

EN 7 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 2026 to 2027,

– followed by full-scale operation as of 2027.

1.7. Method(s) of budget implementation planned97

 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.

Comments

97 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 8 EN

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

Annual monitoring foreseen on the defined indicators

The proposal relies on existing workstreams in the European Commission and the

European Medicinal Agency, which will facilitate monitoring of several indicators.

For these, continuous data/information will be available.

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 actions for strengthening of the security of supply and the availability of critical

medicinal products within the Union and for improving the availability and

accessibility of other medicinal products, where the functioning of the market does

not otherwise sufficiently ensure the availability and accessibility of these medicinal

products to patients, will be implemented through direct management, using the

implementation modes offered by the Financial Regulation, mainly being grants and

procurement. Direct management allows to establish grant agreements/contracts with

beneficiaries/contractors directly engaged in activities that serve Union policies. The

Commission ensures direct monitoring over the outcome of the actions financed. The

payment modalities of the actions funded will be adapted to the risks pertaining to

the financial transactions.

In order to ensure the effectiveness, efficiency and economy of the Commission

controls, the control strategy will be oriented towards a balance of ex-ante and ex-

post checks and focus on three key stages of grant/contract implementation, in

accordance with the Financial Regulation:

– Selection of proposals/tenders that fit the policy objectives of the Regulation;

– Operational, monitoring and ex-ante controls that cover project

implementation, public procurement, pre-financing, interim and final

payments, management of guarantees; Ex-post controls at the

beneficiaries/contractors’ sites will also be carried out on a sample of

transactions. The selection of these transactions will combine a risk assessment

and a random selection

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

The proposal will be implemented through grants and public procurement, taking

into account the funding opportunities facilitated by the Strategic Technologies for

Europe Platform (‘STEP’), and those offered by, inter alia, the InvestEU programme,

the Recovery and Resilience Facility, Horizon Europe, EU4Health, Digital Europe

Programme and cohesion policy programmes as well as the Technical Support

Instrument. The grants and procurements will mainly be awarded and concluded to

support Strategic Projects, as well as to support activities to non-governmental

organisations, respective competent authorities of the Member States.

The main risks are the following:

• Risk of not fully achieving the objectives of the Regulation due to insufficient

uptake or quality/delays in the implementation of the selected projects or contracts;

EN 9 EN

Risk of inefficient or non-economic use of funds awarded, both for grants

(complexity of funding rules) and for procurement (limited number of economic

providers with the required specialist knowledge entailing insufficient possibilities to

compare price offers in some sectors);

• Reputational risk for the Commission, if fraud or criminal activities are discovered;

only partial assurance can be drawn from the third parties' internal control systems

due to the rather large number of heterogeneous contractors and beneficiaries, each

operating their own control system.

The Commission put in place internal procedures that aim at covering the risks

identified above. The internal procedures are in full compliance with the Financial

Regulation and include anti-fraud measures and cost-benefit considerations. Within

this framework, the Commission continues to explore possibilities to enhance the

management and to realise efficiency gains. Main features of the control framework

are the following:

Controls before and during the implementation of the projects:

• An appropriate project management system will be put in place focusing on the

contributions of projects and contracts to the policy objectives, ensuring a systematic

involvement of all actors, establishing a regular project management reporting

complemented by on-site-visits on a case by case basis, including risk reports to

senior management, as well as maintaining appropriate budgetary flexibility.

• Model grant agreements and service contracts used are developed within the

Commission. They provide for a number of control provisions such as audit

certificates, financial guarantees, on-site audits as well as inspections by OLAF. The

rules governing the eligibility of costs are being simplified, for example, by using

unit costs, lump sums, contributions not linked to costs and other possibilities offered

by the Financial Regulation. This will reduce the cost of controls and put the focus

on checks and controls in high risk areas.

• All staff sign up to the code of good administrative behaviour. Staff who are

involved in the selection procedure or in the management of the grant

agreements/contracts (also) sign a declaration of absence of a conflict of interest.

Staff is regularly trained and uses networks to exchange best practices.

• Technical implementation of a project is checked at regular intervals at the desk on

the basis of technical progress reports of the contractors and beneficiaries; in addition

contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case

basis.

Controls at the end of the project: Ex-post audits are performed on a sample of

transactions to verify on-the-spot the eligibility of cost claims. The aim of these

controls is to prevent, detect and correct material errors related to the legality and

regularity of financial transactions. With a view to achieving a high control impact,

the selection of beneficiaries to be audited foresees to combine a risk based selection

with a random sampling, and to pay attention to operational aspects whenever

possible during the on-site audit.

EN 10 EN

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 yearly costs of the suggested level of controls under the third Health programme

2014-2020 represented approximately 4 to 7% of the yearly budget of the operational

expenditure. This is justified by the diversity of transactions to be controlled. Indeed,

in the area of health, direct management involves the attribution of numerous

contracts and grants for actions of very small to very large sizes, and the payment of

numerous operating grants to non-governmental organisations. The risk related to

these activities concerns the capacity of (especially) smaller organisations to

effectively control expenditure.

The Commission considers that the average costs of controls is likely to be the same

for the actions proposed under this Regulation.

Under the third Health Programme 2014-2020, on a 5 years basis, the error rate for

the on-the-spot audits of grants under direct management was 1.8% while for

procurement contracts it was below 1%. This level of error is considered acceptable,

as it is under the materiality level of 2%.

The proposed actions will not affect the way the appropriations are currently

managed. The existing control system proved to be able to prevent and/or to detect

errors and/or irregularities, and in case of errors or irregularities, to correct them. It

will be adapted to include the new actions and to ensure that residual error rates

(after correction) remain below the threshold of 2%.

2.3 Measures to prevent fraud and irregularities

As for its activities in direct management, the Commission shall take appropriate

measures ensuring that the financial interests of the European Union are protected by

the application of preventive measures against fraud, corruption and any other illegal

activities, by effective checks and, if irregularities are detected, by the recovery of

the amounts wrongly paid and, where appropriate, by effective, proportional and

deterrent penalties. To this effect, the Commission adopted an anti-fraud strategy,

latest update of April 2019 (COM(2019) 196), covering notably the following

preventive, detective and corrective measures:

The Commission or its representatives and the Court of Auditors shall have the

power of audit, on the basis of documents and on-the-spot, over all grant

beneficiaries, contractors and subcontractors who have received Union funds. OLAF

shall be authorised to carry out on-the-spot checks and inspections on economic

operators concerned directly or indirectly by such funding.

The Commission also implements a series of measures such as:

- decisions, agreements and contracts resulting from the implementation of the

Regulation will expressly entitle the Commission, including OLAF, and the Court of

Auditors to conduct audits, on-the-spot checks and inspections and to recover

amounts unduly paid and, where appropriate, impose administrative sanctions;

- during the evaluation phase of a call for proposals/tender, the applicants and

tenderers are checked against the published exclusion criteria based on declarations

and the Early Detection and Exclusion System (EDES);

EN 11 EN

- the rules governing the eligibility of costs will be simplified in accordance with the

provisions of the Financial Regulation ;

- regular training on issues related to fraud and irregularities is given to all staff

involved in contract management as well as to auditors and controllers who verify

the beneficiaries' declarations on the spot.

EN 12 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

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.98

from

EFTA

countries 99

from

candidate

countries

and

potential

candidates 100

From

other

third

countries

other assigned

revenue

2 06 06 01 - EU4Health Programme

Diff. YES YES YES NO

98 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 99 EFTA: European Free Trade Association. 100 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

The allocations will be redeployed within the existing envelope of the EU4Health programme

3.2.1.1. Appropriations from voted budget

EUR million (to three decimal places)

Year Year Year Year TOTAL

MFF

2021-2027 2024 2025 2026 2027

Operational appropriations

06 06 01 - EU4Health Programme Commitments (1a) 40,405 41,213 81,618

Payments (2a) 28,284 40,971 69,254

06 10 03 Union contribution to the European

Medicines Agency

Commitments (1b) 0,651 0,758 1,408

Payments (2b) 0,651 0,758 1,408

Appropriations of an administrative nature financed from the envelope of specific programmes

Budget line (3) 0,000

TOTAL appropriations Commitments =1a+1b+3 0,000 0,000 41,056 41,971 83,027

Payments =2a+2b+3 0,000 0,000 28,934 41,729 70,663

EN 14 EN

EUR million (to three decimal places)

Year Year Year Year TOTAL

MFF

2021-2027 2024 2025 2026 2027

TOTAL operational appropriations

(including contribution to

decentralised agency)

Commitments (4) 0,000 0,000 41,056 41,971 83,027

Payments (5) 0,000 0,000 28,934 41,729 70,663

Ÿ TOTAL appropriations of an administrative

nature financed from the envelope for specific

programmes

(6) 0,000 0,000 0,000 0,000 0,000

TOTAL appropriations

under HEADING 2 Commitments =4+6 0,000 0,000 41,056 41,971 83,027

of the multiannual financial

framework Payments =5+6 0,000 0,000 28,934 41,729 70,663

EUR million (to three decimal places)

Year Year Year Year TOTAL

MFF

2021-2027 2024 2025 2026 2027

• TOTAL operational

appropriations (all operational

headings)

Commitments (4) 0,000 0,000 41,056 41,971 83,027

Payments (5) 0,000 0,000 28,934 41,729 70,663

• TOTAL appropriations of an administrative

nature financed from the envelope for specific

programmes (all operational headings)

(6) 0,000 0,000 0,000 0,000 0,000

TOTAL appropriations

Under Heading 1 to 6 Commitments =4+6 0,000 0,000 41,056 41,971 83,027

of the multiannual financial

framework

(Reference amount)

Payments =5+6 0,000 0,000 28,934 41,729 70,663

EN 15 EN

Heading of multiannual financial framework 7 ‘Administrative expenditure’101

EUR million (to three decimal places)

Year Year Year Year TOTAL

MFF

2021-2027 2024 2025 2026 2027

Ÿ Human resources 0,000 0,000 1,793 3,586 5,379

Ÿ Other administrative expenditure 0,000 0,000 0,035 0,070 0,105

Total Appropriations 0,000 0,000 1,828 3,656 5,484

TOTAL appropriations

under HEADING 7

of the multiannual financial framework

(Total

commitments

= Total

payments)

0,000 0,000 1,828 3,656 5,484

EUR million (to three decimal places)

Year Year Year Year TOTAL

MFF

2021-2027 2024 2025 2026 2027

TOTAL appropriations

under HEADINGS 1 to 7 Commitments 0,000 0,000 42,884 45,627 88,511

of the multiannual financial framework Payments 0,000 0,000 30,762 45,385 76,147

101 The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.

EN 16 EN

3.2.1.2. Appropriations from external assigned revenues

N/A

3.2.2. Estimated output funded from operational appropriations (not to be completed for decentralised agencies)

Indicate objectives and

outputs

Year Year TOTAL

2021-2027

 2026 2027

06 06 01 - EU4Health Programme OUTPUTS

Type Average

cost No Cost No Cost No Cost

OBJECTIVE No 1: Security of supply and the availability of critical medicinal products

A. facilitate investments in

manufacturing capacities Grants 40,000 40,800 0 80,800

A. facilitate investments in

manufacturing capacities Meetings 0,027 0,028 0 0,055

B. National public

procurement criteria Meetings 0,027 0,028 0 0,055

C. collaborative procurement

procedures Meetings 0,027 0,028 0 0,055

D. International Cooperation Meetings 0,027 0,028 0,055

Subtotal for objective No 1 0 40,108 0 40,910 0 81,018

OBJECTIVE 2: Availability and accessibility of certain other medicinal products

B. National public

procurement criteria Meetings 0,027 0,028 0 0,055

C. collaborative procurement

procedures Meetings 0,270 0,275 0 0,545

Subtotal for objective No 2 0 0,297 0 0,303 0 0,600

EN 17 EN

TOTALS 0 40,405 0 41,213 0 81,618

EUR million (to three decimal places)

Indicate objectives and outputs Year Year TOTAL

2021-2027  2026 2027

06 10 03 Union contribution to the European Medicines Agency OUTPUTS

Type

Average

cost No Cost No Cost No Cost

OBJECTIVE No 1: Security of supply and the availability of critical medicinal products

A. facilitate investments in

manufacturing capacities -

EMA Staff

costs 0,524 0,628 0 1,152

A. facilitate investments in

manufacturing capacities IT 0,100 0,102 0 0,202

A. facilitate investments in

manufacturing capacities Meetings 0,027 0,028 0 0,055

Subtotal for objective No 1 0 0,651 0 0,758 0 1,408

TOTALS 0 0,651 0 0,758 0 1,408

EN 0 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

EUR million (to three decimal places)

VOTED APPROPRIATIONS Year Year Year Year TOTAL

2021 -

2027 2024 2025 2026 2027

HEADING 7

Human resources 0,000 0,000 1,793 3,586 5,379

Other administrative expenditure 0,000 0,000 0,035 0,070 0,105

Subtotal HEADING 7 0,000 0,000 1,828 3,656 5,484

Outside HEADING 7

Human resources 0,000 0,000 0,000 0,000 0,000

Other expenditure of an administrative nature 0,000 0,000 0,000 0,000 0,000

Subtotal outside HEADING 7 0,000 0,000 0,000 0,000 0,000

TOTAL 0,000 0,000 1,828 3,656 5,484

3.2.3.3. Total appropriations

TOTAL

VOTED APPROPRIATIONS

+

EXTERNAL ASSIGNED REVENUES

Year Year Year Year

TOTAL

2021 -

2027

2024 2025 2026 2027

HEADING 7

Human resources 0,000 0,000 1,793 3,586 5,379

Other administrative expenditure 0,000 0,000 0,035 0,070 0,105

Subtotal HEADING 7 0,000 0,000 1,828 3,656 5,484

EN 1 EN

Outside HEADING 7

Human resources 0,000 0,000 0,000 0,000 0,000

Other expenditure of an administrative nature 0,000 0,000 0,000 0,000 0,000

Subtotal outside HEADING 7 0,000 0,000 0,000 0,000 0,000

TOTAL 0,000 0,000 1,828 3,656 5,484

The appropriations 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.

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)1

VOTED APPROPRIATIONS Year Year Year Year POST

2024 2025 2026 2027 2027

 Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission’s Representation Offices) 0 0 9 18 18

20 01 02 03 (EU Delegations) 0 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0 0

Other budget lines (specify) 0 0 0 0 0

• External staff (in Full Time Equivalent unit: FTE)

20 02 01 (AC, END from the ‘global envelope’) 0 0 1 2 2

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0 0

Admin. Support

line

[XX.01.YY.YY] [2]

- at Headquarters 0 0 0 0 0

- in EU Delegations 0 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0 0

1 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 2 EN

Other budget lines (specify) - Outside Heading 7 0 0 0 0 0

TOTAL 0 0 10 20 20

3.2.4.2. Financed from external assigned revenues

N/A

3.2.4.3. Total requirements of human resources

TOTAL

VOTED APPROPRIATIONS

+

EXTERNAL ASSIGNED REVENUES

Year Year Year Year

2024 2025 2026 2027

 Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission’s Representation Offices) 0 0 9 18

20 01 02 03 (EU Delegations) 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0

Other budget lines (specify) 0 0 0 0

• External staff (in Full Time Equivalent unit: FTE)

20 02 01 (AC, END from the ‘global envelope’) 0 0 1 2

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0

Admin. Support line

[XX.01.YY.YY] [2]

- at Headquarters 0 0 0 0

- in EU Delegations 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0

Other budget lines (specify) - Outside Heading 7 0 0 0 0

TOTAL 0 0 10 20

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 7

or Research

To be financed

from BA line

To be financed

from fees

Establishment

plan posts

2026: 9 posts

2027: 18 post

Post MMF: 18 posts

N/A

EN 3 EN

External staff

(CA, SNEs, INT)

2026: 1 CA

2027: 2 CA

Post MFF: 2 CA

3.2.4.4. Total requirements of human resources EMA

EMA Year Year Year Year TOTAL

2021 -

2027 2024 2025 2026 2027

Temporary agents

(AD+AST) 0 0 32 3

Contract agents 0 0 0 0

Seconded National Experts 0 0 0 0

Total staff 0 0 3 3

Appropriations covered by

the EU Budget 0,000 0,000 0,524 0,628 1,152

Appropriations covered by

fees 0,000 0,000 0,000 0,000 0,000

Appropriations co-financed

(if applicable) 0,000 0,000 0,000 0,000 0,000

TOTAL appropriations 0,000 0,000 0,524 0,628 1,152

EMA

Year Year Year Year

Total

2021-2027

MFF

2024 2025 2026 2027

Temporary

agents (AD

Grades) 0,314 0,419 0,733

Temporary

agents (AST

grades)

0,209 0,209 0,419

2 For the 1st year the costs of the 1 AD for the scientific advice is accounted for 50% as it is expected that

implementation of strategic projects will not fully kick in in 2026. For the rest of the FTEs the cost is

accounted in full.

EN 4 EN

Contract

staff 0,000

Seconded

National

Experts 0,000

Total 0,524 0,628 1,152

Staff requirements (FTE): Total posts Union funded

Year 2026

Year 2027

TOTAL

Temporary agents (AD Grades) 23 2

2

Temporary agents (AST grades) 1 1

1

Contract staff as of

Seconded National Experts

TOTAL 3 3 3

Description of tasks to be carried out by:

Officials and temporary staff 1 AD to provide scientific advice in accordance to article 11 stating that EMA

shall provide dedicated advice to assist project promoters developing projects

relying on innovative manufacturing processes , 1 AD and 1 AST to address

the increased volume of vulnerability analysis plus provision of aggregated

data (AD)

External staff

3 For the 1st year the costs of the 1 AD for the scientific advice is accounted for 50% as it is expected that

implementation of strategic projects will not fully kick in in 2026. For the rest of the FTEs the cost is

accounted in full

EN 5 EN

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 7 should be presented in the designated line.

The appropriations under Headings 1-6 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 TOTAL

MFF

2021 -

2027 2024 2025 2026 2027

HEADING 7

IT expenditure (corporate) 0.000 0.000 0.000 0.000 0.000

Subtotal HEADING 7 0.000 0.000 0.000 0.000 0.000

Outside HEADING 7

Policy IT expenditure on operational programmes

0.000 0.000 0.000 0.000 0.000

Subtotal outside HEADING 7 0.000 0.000 0.000 0.000 0.000

TOTAL 0.000 0.000 0.000 0.000 0.000

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)

The increase of appropriations for EMA budget line 06.100301 in years 2026 and

2027 by 1,4 million EUR, will be done via internal redeployment within heading 2b,

i.e. by an equal reduction of the EU4Health budget line 06.0601 for this period. The

appropriations managed by the Commission will be redeployed withing the existing

financial envelope of the EU4Health programme.

–  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

–  provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

EN 6 EN

Year 2024

Year 2025

Year 2026

Year 2027

Total

Specify the co-financing body

TOTAL appropriations co-

financed

3.3. Estimated impact on revenue

–  The proposal/initiative has no financial impact on revenue.

–  The proposal/initiative has the following financial impact:

–  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/initiative4

Year 2024 Year 2025 Year 2026 Year 2027

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

requirement Requirement description

Stakeholder

categories

affected

High-level processes

affected by this

requirement

Category

Article 6

paragraph 1

Recognition of Strategic

Projects

Project promoter

National

authority

Request recognition of

Strategic project

Data

Digital Public

Service

Article 6

paragraph 2 Member States shall

communicate to the

Commission which authority

is designated for assessing

and confirming Strategic

Projects;

EC, MS Notify Data

Digital Public

Service

4 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net

amounts, i.e. gross amounts after deduction of 20% for collection costs.

EN 7 EN

Article 6

paragraph 3 EC publishes online the list of

MS designated authorities EC, MS Publish Data

Article 12 Combination of

environmental assessments

required under several legal

bases via joint or coordinated

procedures

Project promoter

National

authority

Assess strategic

projects for more legal

bases

Data

Digital solution

Digital public

service

Article 13

Paragraph 1

Availability of relevant

spatial planning data

MS Make available spatial

planning data

Data

Digital solution

Article 13

Paragraph 2

Combination of plans

assessments

MS Assess plans for more

legal bases

Data

Digital public

service

Article 16 Request assessment of

addressing vulnerability

Inform on the existence of

Strategic projects addressing

an existing vulnerability

Project promoter,

Designated

authority

Commission

Request for assessment

Inform on addressed

vulnerabilities

Data

Digital solution

Digital public

service

Chapter IV Public procurement rules for

critical medicine products

Member States

Public

administrations,

Economic

operator

Launch procurement Data

Article 19 Notification of national

programmes

Member States

Commission

CMG

Notification of national

programmes

Data

4.2. Data

Type of data Reference requirements Standard and/or specification

List of MS Authorities designated

for assessing and confirming

Strategic Projects;

Article 6 Standard list of MS

Strategic Project Article 6 Not defined

Status of the highest national

significance for Strategic Projects

Article 9 Not defined

Combined environmental

assessment

Article 12 Defined under other legal bases

Spatial planning data Article 13

Paragraph 1

Not defined

Combined urbanistic assessments Article 13

Paragraph 2

Not defined

Assessment whether strategic Article 16 Not defined

EN 8 EN

projects address a supply chain

vulnerability

National programmes Article 19 Not defined

The list of Member States’ Authorities designated for assessing and confirming Strategic

Projects will be published on the ec.europa.eu website, relying on its standards for being

findable and accessible.

The act follows the only-once principle by not duplicating data collection for identification of

critical medicines and evaluation of vulnerabilities in their supply chains, by re-using data

collected under the Revision of the General Pharmaceutical Legislation.

Data related to assessments are governed by the relevant legal basis that trigger the

assessments.

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)

List of MS

Authorities

designated for

assessing and

confirming

Strategic Projects

Article 6 Member

States

Commission Not defined NA

Project Article 6 Project

promoter

Designated

authority

at the initiative of

the project

promoter

Strategic Project Article 6 Designated

authority

Project

promoter

At Project promoter

request

No deadline set

Status of the

highest national

significance for

Strategic Projects

Article 9 National

authorities

Strategic

Project

promoter

No deadline set

Combined

environmental

assessment

Article 12 Competent

authority

Strategic

Project

promoter

Within 45 days

after receiving all

necessary

information and

subject to

exceptions

EN 9 EN

Spatial planning

data

Article 13 paragraph 1 Member

States

General public

Combined

urbanistic

assessments

Article 13 paragraph 2 Member

States

competent

authorities

Strategic

Project

promoter

No deadline set

Request for

assessment of

addressing

vulnerability by

Strategic

Projects

Article 16 paragraph 2 Strategic

Project

promoter

Designated

authority

At the initiative of

the project

promoter

Assessment of

addressing

vulnerability by

Strategic

Projects

Article 16 paragraph 2 Designated

authority

Strategic

Project

promoter

Within 15 working

days

Assessment of

addressing

vulnerability by

Strategic

Projects

Article 16 paragraph 2 Designated

authority

The

Commission

If Strategic project

addresses an

existing

vulnerability in the

supply chain.

No deadline set

National

programmes

Article 19 paragraph 2 Member

States

Commission By 6 months after

entry into force of

this Regulation

4.3. Digital solutions

4.4. Interoperability assessment

No new digital solution is foreseen.

Reference

to the legal

provision

Description of the

requirement

Interaction

across

Member

State

borders,

among EU

entities or

between EU

entities and

public sector

bodies

Effect on ‘cross-border

interoperability’

EN 10 EN

4.5. Measures to support digital implementation

Article 6

paragraph 2

Member States shall

communicate to the

Commission which

authority is designated

for assessing and

confirming Strategic

Projects;

No interaction just one simple notification and/or

publishing

Article 6

paragraph 3

EC publishes online

the list of MS

designated authorities

    Resolutsiooni liik: Riigikantselei resolutsioon Viide: Sotsiaalministeerium /  / ; Riigikantselei /  / 2-5/25-00547

Resolutsiooni teema: Kriitiliste ravimite määrus

Adressaat: Sotsiaalministeerium Ülesanne: Tulenevalt Riigikogu kodu- ja töökorra seaduse § 152` lg 1 p 2 ning Vabariigi Valitsuse reglemendi § 3 lg 4 palun valmistada ette Vabariigi Valitsuse seisukoha ja otsuse eelnõu järgneva algatuse kohta, kaasates seejuures olulisi huvigruppe ja osapooli:

- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795, COM(2025) 102.

EISi toimiku nr: 25-0118

Tähtaeg: 05.05.2025

Adressaat: Majandus- ja Kommunikatsiooniministeerium, Rahandusministeerium, Regionaal- ja Põllumajandusministeerium, Siseministeerium Ülesanne: Palun esitada oma sisend Sotsiaalministeeriumile seisukohtade kujundamiseks antud eelnõu kohta (eelnõude infosüsteemi (EIS) kaudu).

Tähtaeg: 04.04.2025

Lisainfo: Eelnõu on kavas arutada valitsuse 22.05.2025 istungil ja Vabariigi Valitsuse reglemendi § 6 lg 6 kohaselt sellele eelnevalt 07.05.2025 EL koordinatsioonikogus. Esialgsed materjalid EL koordinatsioonikoguks palume esitada hiljemalt 02.05.2025.

Kinnitaja: Merli Vahar, Euroopa Liidu asjade direktori asetäitja Kinnitamise kuupäev: 27.03.2025 Resolutsiooni koostaja: Elen Nurme [email protected], 693 5201  

.

25.03.2025

Ettepanek: Kriitiliste ravimite määrus (COM (2025) 102)

Otsuse ettepanek koordinatsioonikogule

Kujundada seisukoht

Kaasvastutaja sisendi tähtpäev 04.04.2025

KOKi esitamise tähtpäev 07.05.2025

VV esitamise tähtpäev 22.05.2025

Vastutav ministeerium: Sotsiaalministeerium

Kaasvastutajad: Rahandusministeerium, Majandus- ja Kommunikatsiooniministeerium, Siseministeerium, Regionaal- ja Põllumajandusministeerium

Seisukoha valitsusse toomise alus ja põhjendus

Algatuse reguleerimisala nõuab vastavalt Eesti Vabariigi põhiseadusele seaduse või Riigikogu otsuse vastuvõtmist, muutmist või kehtetuks tunnistamist (RKKTS § 152¹ lg 1 p 1);

Sisukokkuvõte

I peatükk: Sissejuhatus ja eesmärgid – eelnõu kohaldamisalas on peamiselt kriitilised ravimid, mis on kantud liidu kriitiliste ravimite nimekirja (EL ravimipaketist tulenevalt Euroopa Ravimiameti koostatav nimekiri). Lisaks on sisse toodud ühishuvi ravimite (medicinal product of common interest) mõiste, millega on kättesaadavuse probleemid vähemalt kolmes liikmesriigis. Ühishuvi ravimitele kohaldatakse nõudlust toetavaid meetmeid (ptk IV) st ühishangete regulatsiooni ja neile ei kohaldu investeeringutoetuse meetmed (ptk III).

II peatükk: EL-i varustuskindluse tugevdamine – määratletakse kriitiliste ravimite varustuskindlus EL strateegilise eesmärgina. Sätestatakse liikmesriikide ja Euroopa Komisjoni koostöökohustus, et tugevdada liidu kriitiliste ravimite varustuskindlust ja pidevat kättesaadavust meetmete abil, mis kasutavad täiel määral ära siseturu potentsiaali.

III peatükk: Investeerimistingimuste parandamine – määratletakse strateegiliste projektide kriteeriumid. Liikmesriik peab määrama asutuse, mis hakkab taotluste alusel hindama, kas projekt vastab strateegilise projekti määratlusele. Strateegilisi projekte tuleb loamenetlustes käsitleda kiirendatud korras. Neil on õigus saada administratiivset tuge ning regulatiivset ja teaduslikku tuge ravimite pädevatelt asutustelt (hea tootmistava

2

inspektsioonid, tootmislubade menetlus) ja Euroopa Ravimiametilt ning taotleda koordineeritud hindamisprotsessi keskkonnamõjude hindamise nõuete täitmiseks. Samuti tuleb arvestada strateegiliste projektidega maakasutuse planeeringutes. Nähakse ette liikmesriikide ja EL rahaliste toetuste andmine.

IV peatükk: Nõudluse juhtimine – sätestatakse kohustus kriitiliste ravimite hankeprotsessis kasutada lisaks hinnale muid kriteeriumeid, mis varustuskindlust toetavad. Liikmesriikidel on kohustus luua riiklik varustuskindluse toetamise programm, mis hõlmaks hangete korraldamise põhimõtteid ning hinna- ja hüvitamispoliitika meetmeid. Nähakse ette kolm erinevat ühishangete korraldamise mehhanismi: 1) Euroopa Komisjon tegutseb vahendajana ühishuvi ravimite piiriüleses riigihankes (vähemalt kolme liikmesriigi põhjendatud taotluse alusel) 2) Euroopa Komisjon korraldab riigihanke liikmesriikide nimel või nende eest (erandkorras teatud ravimitele, kui vähemalt üheksa liikmesriiki esitavad ühise taotluse) 3) Komisjoni ja liikmesriikide ühishankemenetlus, kus osaleb vähemalt üheksa liikmesriiki (liikmesriigi või komisjoni algatusel, teatud ravimitele).

V peatükk: Kriitiliste ravimite koordineerimisgrupp – luuakse liikmesriikide ja komisjoni esindajatest koosnev koordinatsioonigrupp, et hõlbustada määruse rakendamist ja strateegilisi arutelusid.

VI peatükk: Rahvusvaheline koostöö – sätestatakse komisjoni kohustus sõlmida võimalikke strateegilisi partnerlusi, et mitmekesistada kriitiliste ravimite, nende toimeainete ja oluliste koostisosade hankimist ning suurendada varustuskindlust EL-is.

VII peatükk: muudetakse Euroopa strateegiliste tehnoloogiate platvormi (STEP) määrust 2024/795.

VII peatükk: Lõppsätted – sätestatakse turuosapooltele info andmise kohustus. Komisjon viib 5 aastat pärast määruse kohaldamist ning edaspidi iga 5 aasta tagant läbi hindamise.

Algatus ei reguleeri karistusi või haldustrahve. Algatus näeb ette uue asutuse loomise, nimelt liikmesriik peab määrama asutuse, mis hindab projektitaotluste vastavust strateegilise projekti määratlusele. Algatus ei nõua liikmesriikidelt IT-arenduste tegemist, kuid vajab veel põhjalikumat analüüsi, kas määruse parema rakendamise nimel võib see siiski osutuda vajalikuks tulevikus.

Kaasamine

Kaasata kõik asjassepuutuvad partnerid ja huvirühmad, sh Ravimiamet, Tervisekassa, Ravimitootjate Liit, Eesti Kaubandus-Tööstuskoda, Ettevõtluse ja Innovatsiooni Sihtasutus.