Sittings · Document

OPINION (COM(2025)0102 – C100048/2025 – 2025/0102(COD)) 2025-11-11

On the 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

Committee on Industry, Research and Energy · Rapporteur: Oliver Schenk

PA_Legam

SHORT JUSTIFICATION

The Critical Medicines Act is of major importance in the broader context of strengthening the availability and security of supply of critical medicinal products. Its aim is to ensure a high level of public health protection while contributing to the Union’s overall resilience and strategic security.

Considering this, the rapporteur welcomes the Commission’s proposal as a timely and necessary initiative. However, the European pharmaceutical industry - the backbone of medicines supply - continues to face major challenges in maintaining global competitiveness and securing stable, resilient supply chains for critical medicines. The Commission proposal addresses many of these issues but does not fully tackle the underlying structural causes.

This opinion seeks to enhance the effectiveness, clarity and practical implementation of the Regulation. The proposed amendments reflect the rapporteur’s commitment to building a stronger and more responsive Union framework - one that ensures the continuous availability of essential medicines and supports a resilient, inclusive and innovation-driven pharmaceutical ecosystem.

One of the key priorities is to promote inclusive and transparent governance. The opinion emphasises the importance of involving stakeholders from across the supply chain - such as patient organisations, healthcare providers and industry representatives - whose practical knowledge is essential to ensure that Union measures reflect the specificities of healthcare systems and pharmaceutical production.

To enable the development of innovative solutions and support forward-looking investment, the opinion refines the scope of strategic projects. These projects are essential tools for addressing structural vulnerabilities, boosting resilience and stimulating pharmaceutical innovation.

The opinion also advocates for a balanced and coordinated approach to public funding and State aid. While supporting the availability of financial assistance for strategic projects, it underlines that such support must remain proportionate, transparent and in line with State aid rules. To this end, the Commission is encouraged to provide guidance to national authorities and project promoters to reduce legal uncertainty and facilitate implementation.

At the same time, the amendments call for the better use of existing data infrastructures and digital tools to improve coordination and minimise administrative burden. Rather than introducing new systems, the Regulation should build on what already exists - thereby streamlining reporting requirements, accelerating implementation and improving communication between institutions and stakeholders. The opinion also proposes incorporating the findings of the Critical Medicines Alliance to strengthen coordination efforts.

Throughout the text, a clear commitment is made to uphold the principles of subsidiarity and democratic accountability. The opinion calls for structured cooperation between the Commission, Member States, the European Parliament and stakeholders. Governance structures such as the Critical Medicines Group should operate transparently and inclusively, with appropriate involvement of Parliament and relevant actors from across the supply chain.

Furthermore, the opinion connects the goals of health resilience with the Union’s industrial and technological ambitions. The security of supply of critical medicinal products must go hand in hand with predictable regulation, sustainable production capacity, and Europe’s broader efforts to strengthen technological sovereignty. These factors are essential to long-term resilience and global competitiveness.

To support strategic investment in innovative technologies, the opinion also endorses extending the scope of the STEP instrument to cover biomanufacturing, which has been recognised as a key enabling technology for the Union’s health and industrial future.

The opinion also underscores the need to ensure the confidentiality and secure handling of sensitive information exchanged under the Regulation. Trade secrets, business-sensitive data and classified materials must be protected in accordance with Union and national law. Maintaining stakeholder trust and effective cooperation depends on safeguarding this information at all levels.

In addition, the opinion highlights the strategic value of international partnerships for the Union’s health security. It calls on the Commission to include relevant provisions in future agreements and to promote alignment of quality, safety and environmental standards with third countries. This would help diversify supply chains while ensuring fair competition and a level playing field for EU manufacturers.

Finally, the opinion stresses the importance of small and medium-sized enterprises (SMEs) and small mid-caps (SMCs) in driving innovation and production in the pharmaceutical sector. It calls for equitable access to funding and simplified procedures, recognising the challenges faced by smaller actors operating with limited resources.

Taken together, the proposed changes aim to make the Regulation more effective, targeted and future-proof - capable of addressing immediate risks while laying the foundation for a more resilient, sustainable and competitive pharmaceutical sector in the European Union.

AMENDMENTS

The Committee on Industry, Research and Energy submits the following to the Committee on Public Health, as the committee responsible:

Amendment 1

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 173 thereof,

Amendment 2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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, underpinned by a resilient and competitive pharmaceutical industry and secure, reliable supply chains forming the backbone of the supply of medicine, is vital to achieving this objective and to safeguarding public health across the Union and improving the preparedness and the Union’s overall security.

Amendment 3

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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.

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages which have resulted in serious harm or risk of serious harm to patients’ health and safety. Beyond their impact on healthcare systems, such shortages could also undermine national security, disrupt critical supply chains, and have detrimental effects on the broader economy.

Amendment 4

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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.

(3) Shortages of medicinal products 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. Addressing those challenges requires diversification of supply sources and substantial investments in modern production facilities, research and development, and workforce training within the Union. However, factors such as complex permitting and regulatory processes, significant investments needed to maintain high-quality production, and the demand for specialised skilled labour necessitate targeted efforts to expand local manufacturing capacities. Furthermore, strengthening the resilience of pharmaceutical supply chains requires enhanced coordination with industry stakeholders to promote innovation, transparency and flexibility. Through those measures the Union can reduce its risk of exposure to shortages of medicinal products in the long term.

Amendment 5

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(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, 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.

(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, expanding, 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, in compliance with Union environmental, health, and social standards, can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines. Moreover, strengthening skills and knowledge transfer will help build a resilient and future-ready workforce capable of smoothly embracing innovation and technological advancement.

Amendment 6

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4a) A horizontal approach should guide both existing and new legislative acts of the Union to ensure coherence between policy objectives. Such an approach would help avoid unintended overlaps or conflicting requirements and support the Union’s broader goal of strengthening resilience, security of supply and competitiveness across strategic sectors, including the pharmaceutical industry. While doing so, coherence between environmental and health policy objectives should be ensured through structured coordination, dialogue with stakeholders and impact assessments that take into account the specificities of pharmaceutical manufacturing.

Amendment 7

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(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.

(7) However, despite regulatory obligations on marketing authorisation holders to ensure the continuous supply of medicinal products to meet patients’ demand and needs 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.

Amendment 8

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(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, while avoiding duplication or overlap of existing structures. That principle should also apply to existing Union law, including the ongoing revision of the general pharmaceutical legislative acts, the European Health Data Space (Regulation (EU) 2025/327 of the European Parliament and of the Council1a), the Clinical Trials Regulation (Regulation (EU) No 536/2014 of the European Parliament and of the Council 1b), and other relevant legal frameworks, with a view to ensuring consistency. Furthermore, existing data infrastructures and databases, such as epidemiological data from the European Centre for Disease Prevention and Control (ECDC), should be fully leveraged in order to reduce reporting burdens, streamline the monitoring of medicinal product supply chains, and improve the efficiency of data exchange between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

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1a Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj);

1b Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, ELI: http://data.europa.eu/eli/reg/2014/536/oj).

Amendment 9

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(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.

(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 along the entire supply chain 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.

Amendment 10

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(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.

(12) Strengthening the security of supply and ensuring the availability, and supporting the accessibility of critical medicinal products and of medicinal products of common interest, and strengthening the Union’s competitiveness in the pharmaceutical sector are key and mutually reinforcing objectives of this Regulation. This Regulation should foster a stable and predictable market environment, encourage investment, and promote innovation across the Union. Enhancing the availability and accessibility of critical and other medicinal products of common interest, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products, should also contribute to the Union’s preparedness, resilience, strategic autonomy and overall economic and strategic security, particularly in the face of potential disruptions to cross-border supply chains.

Amendment 11

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission

Amendment

(12a) To ensure Europe’s long-term strategic autonomy in the pharmaceutical sector, it is imperative to prioritise the reinforcement of European manufacturing capacity through strategic projects that secure raw materials supply, the continuous and reliable production of critical medicines and active pharmaceutical ingredients in the Union. By investing in research and innovation, supporting the modernisation of infrastructure, the Union can strengthen its pharmaceutical industrial base, reduce dependencies on third countries, and diversify supply chains.

Amendment 12

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(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.

(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, including cross-border joint 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 be provided with adequate resources to 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 their streamlining as well as enable digital submission of required information.

Amendment 13

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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, Member States should give particular attention to small and medium sized enterprises (SMEs) and small mid-cap enterprises (SMCs), with a view to ensuring that they have a fair chance to initiate strategic projects. Member States and designated authorities should pay particular attention to minimising the administrative burden on SMEs and SMCs and should provide support and clear guidance through the application, permitting and regulatory processes. Furthermore, requirements should be applied in a manner that guarantees fair and equal competition among all market players, regardless of their ownership structure. To support the effective implementation of this Regulation, the Commission should provide guidance to national authorities and project promoters, intended as a practical support tool. Such guidance should assist in the preparation, recognition and support of strategic projects.

Amendment 14

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18a) To avoid a fragmented approach across the Union and to ensure coherent and coordinated implementation of this Regulation, the criteria for the recognition of strategic projects should be applied in a consistent and transparent manner, while allowing for a degree of flexibility to reflect national specificities and capacities. Such a balanced approach should support a wide uptake of strategic projects across the Union.

Amendment 15

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(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.

(21) The establishment or expansion of existing manufacturing capacities for critical medicinal products and their supply chains requires significant financial investment. Private investment by companies and financial investors is essential. 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, private investment alone may not always be sufficient. In such cases, the effective roll-out of projects across the supply chain may require public support, for example in the form of guarantees, loans or equity and quasi-equity investments. Such public support can include State aid. Such State aid should have an incentive effect and be necessary, appropriate and proportionate. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, in accordance with Union State aid rules. For this purpose, the Commission services have provided specific guidance to assist Member States in the application of the Union’s State aid framework, which will be updated as necessary. In order to ensure that public support effectively contributes to strengthening the Union’s security of supply, strategic projects receiving financial support should prioritise supply to the Union market for as long as the medicinal product concerned remains on the Union List of Critical Medicinal Products. Those strategic projects should make reasonable efforts to maintain the availability of those products in the Member States where they are placed on the market, without undermining their supply to other Union markets. That obligation should apply without prejudice to situations of force majeure, such as natural disasters or cyberattacks that significantly affect the manufacturing site, which shall not be considered a breach of that obligation.

Amendment 16

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(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 strategic projects addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended.

(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 , as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the criteria established in these instruments. Moreover, STEP should contribute to more effectively channelling existing Union funds towards supporting the development of strategic projects. Authorities in charge of STEP should support in particular strategic projects aiming to establish or expand manufacturing capacities for critical medicines products or addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended accordingly. In that context, strategic projects receiving public support should be compliant with relevant Union law. To ensure the continued implementation of this Regulation after 2027, Union level funding should be considered in the context of the multi-annual financial framework for 2028-2034.

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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 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)

Amendment 17

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(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 .

(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. In doing so, an appropriate level of confidentiality of sensitive business information and data obtained should be respected and protected, such as details of value chains, the disclosure of which could harm the competitive position of the companies involved. The Commission and the national competent authorities, their officials, employees and other persons working under the supervision of those authorities as well as officials and employees of other authorities of the Member States should not disclose information acquired or exchanged by them pursuant to this Regulation where such information is covered by the obligation of professional secrecy. This should also apply to the Critical Medicines Coordination Group. The data collated pursuant to this Regulation should be handled and stored in a secure environment. As regards the strategic projects that have benefitted from EU funding, the beneficiaries should follow the relevant communication and visibility rules8 .

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8 Communication and visibility rules - Publications Office of the EU

Amendment 18

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(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, solidarity and non-discrimination. To ensure transparency and mutual understanding among Member States they should notify the Critical Medicines Group of planned measures before their implementation. The Member States should give due consideration to forthcoming Commission guidelines, to be regularly reviewed, designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market, supply continuity and patient access when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks. When drafting the guidelines the Commission should consult with relevant stakeholders, including market authorisation holders, and take into account transparency and waste management measures.

Amendment 19

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(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.

Amendment 20

Proposal for a regulation

Recital 37 a (new)

Text proposed by the Commission

Amendment

(37a) The effective implementation of this Regulation requires the meaningful involvement of relevant stakeholders across the pharmaceutical supply chain. To that end, the Critical Medicines Group should be able to establish working groups and invite key actors such as patient organisations, marketing authorisation holders, manufacturers, relevant social partners, and social insurance bodies to contribute their expertise and perspectives. The work of the Critical Medicines Group should build on and be informed by the insights of the Critical Medicines Alliance, which brings together a wide range of public and private stakeholders. Regular and structured cooperation between the Critical Medicines Group and the Critical Medicines Alliance should help ensure that actions taken under this Regulation are grounded in practical experience, scientific knowledge and the needs of patients and healthcare systems.

Amendment 21

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(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. In addition, the Critical Medicines Group should facilitate discussion, and advise the Commission on the implementation of the objectives of this Regulation and on a horizontal approach guiding existing and new legislative acts of the Union to ensure coherence between policy objectives. Such an approach would help avoid unintended overlaps or conflicting requirements and support the Union’s broader goal of strengthening resilience, security of supply and competitiveness across strategic sectors, including the pharmaceutical industry. Furthermore, the Critical Medicines Group should facilitate discussions on measures to be taken during public health crises in order to support the continuity of the supply of medicines in the Union.

Amendment 22

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

(38a) The Critical Medicines Group, where appropriate within a dedicated working group, should, at the request of a strategic project promoter, discuss and advise on how the financing of the project could be completed, taking into account the funding already secured and considering additional private sources of financing, support through resources from the EIB Group or other international financial institutions including the European Bank for Reconstruction and Development, existing Member State instruments and programmes, including from national promotional banks, institutions and Export Credit Agencies, and relevant Union funding and financing programmes. The Critical Medicines Group should regularly provide recommendations on ways to ensure sufficient funding, including through the Union budget, to pursue the objectives of this Regulation.

Amendment 23

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(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.

(39) The Union could further enhance the availability and security of supply of critical medicinal products, as well as their active substances and key inputs needed for their manufacturing, 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.

Amendment 24

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

(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. In order to ensure trust-based and constructive cooperation between economic operators and competent authorities at both Union and national level, all parties involved in the implementation and evaluation of this Regulation should respect the confidentiality of any information and data obtained in the performance of their tasks.

Amendment 25

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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.

Amendment 26

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

(a) facilitate, support and incentivise investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

Amendment 27

Proposal for a regulation

Article 1 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(aa) simplify and accelerate administrative and permit-granting processes related to the strategic projects, and provide regulatory support;

Amendment 28

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(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;

(2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including raw materials, intermediates, primary packaging materials, including those with safety-related features, excipients, solvents and reagents, as well as technical and technological resources necessary for the manufacturing processes;

Amendment 29

Proposal for a regulation

Article 3 – paragraph 1 – point 12

Text proposed by the Commission

Amendment

(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;

(12) ‘permit granting process’ means a process covering all relevant permits to build, expand, convert 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;

Amendment 30

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(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;

(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, automation, Artificial Intelligence, platform techniques, 3D manufacturing;

Amendment 31

Proposal for a regulation

Article 3 – paragraph 1 – point 18

Text proposed by the Commission

Amendment

(18) ‘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.

(18) ‘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 or its supply chain that is established through a non-binding instrument setting out actions of mutual interest and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation.

Amendment 32

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18a) ‘cross-border joint strategic project’ means a strategic project that meets the standards established in Article 5 and is conducted between at least two Member States.

Amendment 33

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

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. In doing so, they shall take into account the roles of relevant stakeholders, including the pharmaceutical industry, in particular manufacturers and marketing authorisation holders, as well as relevant social partners, patient and healthcare organisations, and health insurance bodies, and shall involve them, where appropriate.

Amendment 34

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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 project located in the Union and related to creating, improving or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

Amendment 35

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or for collecting or manufacturing their active substances;

Amendment 36

Proposal for a regulation

Article 5 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(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;

(b) it modernises an existing manufacturing site, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;

Amendment 37

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(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.

(d) it contributes to the roll-out or transfer of a technology, including through new and innovative technologies, that plays a key role in enabling the manufacturing or strengthening the resilience of supply chain of one or more critical medicinal products, their active substances or key inputs.

Amendment 38

Proposal for a regulation

Article 5 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) it reserves a clearly defined share of its manufacturing capacity for one or more critical medicinal products or their active substances or for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances, upon request by the Critical Medicines Coordination Group and within a specified timeframe, in order to address potential, emerging or existing shortages;

Amendment 39

Proposal for a regulation

Article 5 – paragraph 1 – point d b (new)

Text proposed by the Commission

Amendment

(db) it makes a meaningful contribution to strengthening the security of supply and the availability of critical medicinal products in the Union.

Amendment 40

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

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.

Each Member State shall within 90 days from the date of entry into force of this Regulation designate a single 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. Strategic projects shall be implemented in compliance with Union environmental, health, and social standards.

Amendment 41

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. The Commission shall provide a simple, accessible webpage for project promoters and national authorities. That webpage shall provide the contact details and other relevant information on the Member States’ designated authorities, guidance documents prepared by the Commission, intended as a practical support tool to assist national authorities and project promoters in the preparation, recognition and support of strategic projects, as well as information on opportunities for financial and, where applicable, other forms of support from the Union.

Amendment 42

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

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.

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and as serving the interests of public health and safety, and shall therefore be deemed to be in the public interest.

Amendment 43

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission

Amendment

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.

For the purpose of ensuring the efficient administration of the permit-granting and regulatory processes related to strategic projects in the Union, project promoters and all authorities concerned shall ensure that that process is carried out in the most rapid way possible, and making available any form of accelerated procedures that exists in applicable Union and national law.

Amendment 44

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The application of accelerated administrative and permit-granting procedures for strategic projects shall be without prejudice to the timely and proper processing of other single permitting procedures not covered by this Regulation, such as those related to manufacturing projects for non-critical medicinal products that fall outside the scope of strategic projects.

Amendment 45

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

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 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.

2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State and its authorities shall pay particular attention to small and medium size enterprises (SMEs) and small mid-cap enterprises (SMCs) and shall provide those undertakings with the appropriate guidance and assistance for the implementation of this Regulation, including responding to queries related to the implementation of this Regulation.

Amendment 46

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Member States shall ensure that their authorities providing administrative support and authorities involved in the permit-granting process have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary for the effective performance of their tasks under this Regulation.

Amendment 47

Proposal for a regulation

Article 9 – title

Text proposed by the Commission

Amendment

Request for granting the status of highest national significance

Granting the status of highest national significance

Amendment 48

Proposal for a regulation

Article 9 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. Without prejudice to obligations provided for in Union law, strategic projects in the Union shall be granted the status of the highest national significance possible, where such a status exists in national law, and be treated accordingly in the permit-granting processes.

Amendment 49

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

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.

deleted

Amendment 50

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. Each Member State, including all levels of administration, shall provide regulatory support and a single contact point 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.

Amendment 51

Proposal for a regulation

Article 11 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. At the request of a promoter of a strategic project, a Member State may offer regulatory assistance for critical medicinal products produced at a manufacturing facility classified as a strategic project, including accelerated procedures and fast-tracked reimbursement processes.

Amendment 52

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

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.

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall provide dedicated technical and administrative advice and fast-tracked review process to assist project promoters developing projects relying on innovative manufacturing processes for medicinal products, their active substances, or key inputs.

Amendment 53

Proposal for a regulation

Chapter III – Section III – title

Text proposed by the Commission

Amendment

Financial incentives

Accelerating implementation of strategic projects, including financial incentives

Amendment 54

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

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).

1. Without prejudice to Articles 107 and 108 TFEU, Member States are encouraged to prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products and meet the criteria as set out in Article 5 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).

Amendment 55

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

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.

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 by a Member State 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, while ensuring that availability in other Union markets is not undermined. Force majeure situations shall not be considered to be a breach of that obligation.

Amendment 56

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

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.

Any Member State that encounters a threat of shortages of the critical medicinal product in question may request the Member State that provided financial support to submit a request on its behalf.

Amendment 57

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

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. To ensure the continued implementation of this Regulation after 2027, Union level funding may be considered in the context of the multi-annual financial framework for 2028-2034.

__________________

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)

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)

Amendment 58

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

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.

Amendment 59

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

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.

The Commission shall inform the Critical Medicines Group of the intention to propose the establishment of funding possibilities to support strategic projects. It shall also inform the Critical Medicines Group of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

Amendment 60

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

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.

Measures on security of supply applied in one or more Member States shall not result in any negative impact in other Member States including the availability of the relevant medicinal products. 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.

Amendment 61

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate, targeted, and evidence-based and respect the principles of transparency and solidarity and non-discrimination.

Amendment 62

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Those requirements shall also avoid unintended consequences for supply continuity and patient access in the Union.

Amendment 63

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

Member States shall notify the Critical Medicines Group of planned measures before their implementation.

Amendment 64

Proposal for a regulation

Article 20 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

The Commission shall adopt guidelines to the Member States on ways to avoid negative impacts on the internal market of requirements for companies to hold contingency stocks.

Amendment 65

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

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.

Amendment 66

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. The Critical Medicines Group shall work closely with the relevant stakeholders, including but not limited to marketing authorisation holders, industry representatives, relevant social partners, patient and consumer organisations, healthcare professionals, 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.

Amendment 67

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat. Meetings of the Critical Medicines Group shall be convened by the Commission on a regular basis.

Amendment 68

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the Commission

Amendment

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may decide to establish a working group.

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may decide to establish a working group. The working group may invite relevant stakeholders, including, but not limited to patients’ and doctors’ organisations, pharmacists, research and developments institutes, marketing authorisation holders, manufacturers, relevant social partners, and social insurance bodies, to participate in its meetings, in order to ensure that the implementation of this Regulation duly takes into account the distinctive characteristics of the supply chain for critical medicines products.

Amendment 69

Proposal for a regulation

Article 26 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(aa) facilitate coordination and implementation of cross-border joint strategic projects;

Amendment 70

Proposal for a regulation

Article 26 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) facilitate discussion on contingency stocks and other security of supply measures;

Amendment 71

Proposal for a regulation

Article 26 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(ca) facilitate discussion on measures to be taken during public health crises;

Amendment 72

Proposal for a regulation

Article 26 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) facilitate discussion and advise the Commission on the implementation of the objectives of this Regulation and a horizontal approach guiding existing and new legislative acts of the Union to ensure coherence between policy objectives. Such an approach would help avoid unintended overlaps or conflicting requirements and support the Union’s broader goal of strengthening resilience, security of supply and competitiveness across strategic sectors, including the pharmaceutical industry;

Amendment 73

Proposal for a regulation

Article 26 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) enable dialogue with relevant stakeholders regarding implementation of this Regulation and its objectives;

Amendment 74

Proposal for a regulation

Article 26 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. The Critical Medicines Group shall examine the bottlenecks and Union-wide financial needs of strategic projects, advise on ways of coordinating Union and national financing with regard to those financial needs, and share best practices. While doing so the Critical Medicines Group shall ensure relevant financial expertise necessary to undertake that task.

Amendment 75

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. When invited to do so, the Critical Medicines Group shall inform the European Parliament about its activities and tasks.

Amendment 76

Proposal for a regulation

Article 26 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. The Critical Medicines Group shall perform its tasks in compliance with the necessary confidentiality requirements, including those laid down in Article 30a.

Amendment 77

Proposal for a regulation

Article 26 – paragraph 5 c (new)

Text proposed by the Commission

Amendment

5c. The findings from the Critical Medicines Alliance shall be taken into account and actively incorporated into the work of the Critical Medicines Group, where relevant and in accordance with relevant Union or national law. The Commission, in its role as the secretariat of the Critical Medicines Group, shall ensure regular, targeted and transparent communication with the Critical Medicines Alliance.

Amendment 78

Proposal for a regulation

Chapter VI – title

Text proposed by the Commission

Amendment

International cooperation

International cooperation and strategic partnerships

Amendment 79

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

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.

Without prejudice to the prerogatives of the Council, the Commission, shall explore and, when possible, seek to conclude strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs taking into account the full breadth of the supply chain to increase the security of supply of critical medicinal products in the Union, and in order to achieve the objectives of this Regulation. The Commission shall also aim to build 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.

Amendment 80

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall explore the possibility of including in existing and future partnerships, agreements, and other relevant international cooperation frameworks chapters related to health security that support the achievement of the objectives of this Regulation, promote open and resilient supply chain and foster cooperation in the pharmaceutical sector.

Amendment 81

Proposal for a regulation

Article 27 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

To ensure fair competition and avoid disadvantages for producers in the Union, the Commission shall, within the framework of strategic partnerships, promote the harmonisation of quality, safety and environmental standards for pharmaceutical production between the Union and third countries. Those partnerships shall include regulatory measures requiring third-country manufacturers exporting to the Union to comply with standards equivalent to those applicable in the Union for imported critical medicinal products, active pharmaceutical ingredients and key inputs.

Amendment 82

Proposal for a regulation

Article 27 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

The Commission shall inform the Critical Medicines Group about possible strategic partnerships on an annual basis.

Amendment 83

Proposal for a regulation

Article 28 – paragraph 1 – point a

Regulation (EU) 2024/795

Article 2 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

biotechnologies, and any other technologies relevant for manufacturing of critical medicinal products as defined in Critical Medicines Act *;

biotechnologies, biomanufacturing 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];’

Amendment 84

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

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.

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, proportionate and clearly defined, the requested information necessary for the purpose of application of this Regulation, with due regard to the principles of the Better Regulation framework.

Amendment 85

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted by optimising the use of data already provided by marketing authorisation holders. To that end, existing data infrastructures and relevant databases at national and Union level, including but not limited to epidemiological data compiled by the European Centre for Disease Prevention and Control and the European Shortages Monitoring Platform (ESMP), shall be fully utilised with a view to minimising administrative and reporting obligations.

Amendment 86

Proposal for a regulation

Article 30 a (new)

Text proposed by the Commission

Amendment

Article 30a

Handling of confidential information

1. Information acquired in the course of implementing this Regulation shall be used only for the purposes of this Regulation and shall be protected by the relevant Union and national law.

2. Member States and the Commission shall ensure the protection of trade and business secrets and other commercially confidential information obtained and processed in application of this Regulation, including recommendations and measures to be taken, in accordance with the relevant Union and national law.

3. The Commission and the national authorities, their officials, employees and other persons working under the supervision of those authorities shall ensure the confidentiality of information obtained in carrying out their tasks and activities in accordance with relevant Union and national law. This paragraph shall also apply to all representatives of Member States, observers, experts and other participants attending meetings of the Critical Medicines Group.

4. Any obligations on sharing information pursuant to this Regulation shall not apply to data that concerns the essential interests of the Member States’ security.

ANNEX: DECLARATION OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that he included in his opinion input on matters pertaining to the subject of the file that he received, in the preparation of the draft opinion (prior to the adoption thereof in committee), from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register

European Commission, Directorate-General for Health and Food Safety

Directorate-General for Health and Food Safety

European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

European Investment Bank, Life Sciences and Health Division

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Medicines for Europe

Bundesverband der Pharmazeutischen Industrie e.V.

Pharma Deutschland e.V.

Verband forschender Arzneimittelhersteller (vfa)

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

2. Representatives of public authorities of third countries, including their diplomatic missions and embassies

Mission of Japan to the EU

The list above is drawn up under the exclusive responsibility of the rapporteur for opinion.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

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

References

COM(2025)0102 – C10-0048/2025 – 2025/0102(COD)

Committee(s) responsible

Date announced in plenary

SANT

21.5.2025

Opinion by

Date announced in plenary

ITRE

21.5.2025

Rapporteur for the opinion

Date appointed

Oliver Schenk

15.4.2025

Discussed in committee

4.9.2025

Date adopted

11.11.2025

Result of final vote

–:

Members present for the final vote

Wouter Beke, Hildegard Bentele, Tom Berendsen, Michael Bloss, Paolo Borchia, Markus Buchheit, Raúl de la Hoz Quintano, Pilar del Castillo Vera, Matthias Ecke, Christian Ehler, Sofie Eriksson, Jan Farský, Sigrid Friis, Lina Gálvez, Alexandra Geese, Bart Groothuis, Christophe Grudler, Elisabetta Gualmini, András Gyürk, Niels Flemming Hansen, Eero Heinäluoma, Ivars Ijabs, Seán Kelly, Ondřej Knotek, Michał Kobosko, Ondřej Krutílek, Eszter Lakos, Morten Løkkegaard, Sara Matthieu, Eva Maydell, Marina Mesure, Dan Nica, Aleksandar Nikolic, Mirosława Nykiel, Daniel Obajtek, Nikos Pappas, Thomas Pellerin-Carlin, Tsvetelina Penkova, Pascale Piera, Jüri Ratas, Julie Rechagneux, Aura Salla, Elena Sancho Murillo, Paulius Saudargas, Diego Solier, Nicolae Ștefănuță, Anna Stürgkh, Dario Tamburrano, Bruno Tobback, Matej Tonin, Kris Van Dijck, Yvan Verougstraete, Mariateresa Vivaldini, Andrea Wechsler, Angelika Winzig, Anna Zalewska, Auke Zijlstra

Substitutes present for the final vote

René Aust, Marc Botenga, Annalisa Corrado, Krzysztof Hetman, Rihards Kols, Lara Magoni, Oliver Schenk, Virginijus Sinkevičius, Marion Walsmann

Members under Rule 216(7) present for the final vote

Francisco Assis, Marieke Ehlers, Hanna Gronkiewicz-Waltz, Volker Schnurrbusch

FINAL VOTE BY ROLL CALL BY THE COMMITTEE ASKED FOR OPINION

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