Forslag til EUROPA-PARLAMENTETS OG RÅDETS FORORDNING om fastlæggelse af rammer, der skal styrke tilgængeligheden af og forsyningssikkerheden for kritiske lægemidler samt tilgængeligheden af og adgangen til lægemidler af fælles interesse, og om ændring af forordning (EU) 2024/795

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)
Offentligt
KOM (2025) 0102 - Forslag til forordning
Europaudvalget 2025
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