SANT-PR-775742 — EU Parl Watch

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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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

(COM(2025)0102 – C100048/2025 – 2025/0102(COD))

(Ordinary legislative procedure: first reading)

– having regard to the Commission proposal to Parliament and the Council (COM(2025)0102),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100048/2025),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the French Senate and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

– having regard to the opinion of the European Economic and Social Committee of 18 June 2025,

– having regard to Rule 60 of its Rules of Procedure,

– having regard to the opinions of the Committee on the Environment, Climate and Food Safety, the Committee on Industry, Research and Energy, and the Committee on the Internal Market and Consumer Protection,

– having regard to the report of the Committee on Public Health (A100000/2025),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

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 of medicinal products for which insufficient supply results in serious harm or risk of serious harm to patients and health systems.

Or. en

Amendment 2

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 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 including raw materials, feedstock and other manufacturing inputs. 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.

Or. en

Amendment 3

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4a) Environmental and chemical legislation, while essential to public and environmental health, may inadvertently impact the continuity of supply of critical medicinal products or medicinal products of common interest through increased regulatory burden or production constraints. To ensure the uninterrupted availability of such medicinal products, it is necessary to assess the cumulative impacts of relevant environmental and chemical legislative frameworks on manufacturing and supply capacities. This Regulation should therefore support a coordinated assessment of such impacts to ensure minimal disruption to the availability of critical medicinal products.

Or. en

Amendment 4

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’ 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.

Or. en

Amendment 5

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.

(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 and fair and equal access of patients to the medicinal products they need. 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.

Or. en

Amendment 6

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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.

(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, increasing inequalities between Union patients and undermining the Union’s commitment to achieving universal access to essential medicinal products by 2030, in line with Sustainable Development Goal 3.8. 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.

Or. en

Amendment 7

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) 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. Furthermore, in order to strengthen the functioning of the internal market and to ensure the uninterrupted availability of critical medicinal products and medicinal products of common interest across the Union, it is necessary to establish a Union coordination mechanism for critical medicinal products and medicinal products of common interest. Such a mechanism would enhance the Union capacity to address shortages, strengthen supply chain resilience, and enable coordinated approaches to national stockpiling and contingency stocks.

Or. en

Amendment 8

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(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.

(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 as well as to investigational medicinal products only.

Or. en

Amendment 9

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

(16a) In order to ensure legal clarity and effective coordination at Union level, it is essential to distinguish between ‘contingency stock’ and ‘national stockpile’. Those two concepts refer to different types of reserves, governed by distinct legal and operational frameworks, and serving different purposes within the supply chain and public health preparedness. Thus, a clear differentiation is necessary to avoid confusion in reporting and management, and to support targeted and proportionate Union-level actions during supply disruptions or emergencies.

Or. en

Amendment 10

Proposal for a regulation

Recital 16 b (new)

Text proposed by the Commission

Amendment

(16b) The Commission should establish and regularly update a list of medicinal products originating from third countries for which no adequate substitute produced within the Union is available, in order to identify and monitor dependencies and support measures aimed at ensuring the continuity of supply of medicinal products.

Or. en

Amendment 11

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 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. To ensure the efficient use of resources and strategic coherence at Union level, the designation of strategic projects should avoid unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs, unless such duplication is justified by clearly demonstrated needs.

Or. en

Amendment 12

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17a) The construction of manufacturing facilities for medicinal products that fall within the definition of a medicinal products of common interest should also qualify as strategic projects. Those projects should therefore benefit from the streamlined permitting procedures, dedicated administrative support, and other measures set out in Chapter II of this Regulation.

Or. en

Amendment 13

Proposal for a regulation

Recital 17 b (new)

Text proposed by the Commission

Amendment

(17b) In order to safeguard the Union’s strategic interests and ensure the resilience of its industrial base, particularly in times of crisis or disruption of supply chains, it is essential that strategic projects aimed at creating or increasing manufacturing capacity are able to operate without interruption. Those projects depend on a stable and secure supply of critical inputs such as energy, gas, and heat. To that end, Member States should provide all necessary administrative and technical support to mitigate any unplanned disruptions to such supplies. Moreover, the continued availability of key personnel is vital to the functioning of those projects. Therefore, to ensure operational continuity during national emergencies or periods of mobilisation, it is important that Member States consider providing for other supportive measures, in particular to ensure that employees whose roles are essential to the implementation of strategic projects remain available. Such supportive measures could include exemption from active military service or assignment to mobilisation duties within the strategic project itself.

Or. en

Amendment 14

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19a) Acknowledging the importance of international cooperation in environmental matters, this Regulation respects the obligations arising from the United Nations Economic Commission for Europe (UNECE) Conventions. In particular, it is without prejudice to the UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (the Aarhus Convention, 1998), as well as the UNECE Convention on Environmental Impact Assessment in a Transboundary Context (the Espoo Convention, 1991) and its Protocol on Strategic Environmental Assessment (the Kyiv Protocol, 2003).

Or. en

Amendment 15

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 (relevant, for example, for active substances, 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.

_________________

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)

Or. en

Amendment 16

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22a) In order to reinforce the Union’s strategic autonomy in the area of medicinal products and to enhance its resilience in relation to global supply chain disruptions, in particular resulting from dependencies from third countries and economic coercion, it is appropriate, without prejudice to the principle of universality of the general budget of the European Union, for any revenue of that budget, including own resources stemming from potential customs duties imposed by the Union in response to tariff or other trade-restrictive measures adopted by third countries, to be used to finance measures under this Regulation. It is appropriate for those revenues, as part of the general budget of the European Union, to be used for the development and implementation of strategic projects contributing to the production, innovation, and availability of critical medicinal products and medicinal products of common interest within the Union, as well as for their acquisition through collaborative procurement mechanisms. Subject to relevant acts of Union law, the use of such revenues should be made in accordance with Regulation (EU, Euratom) 2024/2509 and should be consistent with Union’s international obligations.

Or. en

Amendment 17

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24a) In order to strengthen the resilience of supply chains for medicinal products and to mitigate the risk of supply disruptions, procurement procedures carried out under this Regulation should, where appropriate, allow for the award of contracts to multiple suppliers for the same product. Such multi-winner procurement approaches can promote diversification of supply, enhance security of supply, and ensure that production capacity is distributed across different manufacturers and geographical locations within the Union.

Or. en

Amendment 18

Proposal for a regulation

Recital 24 b (new)

Text proposed by the Commission

Amendment

(24b) To provide market predictability and support investment in the production of medicinal products, procurement procedures under this Regulation should, where justified, include minimum binding quantities. Those commitments can serve as an incentive for manufacturers to maintain or scale up production capacity, particularly for medicinal products that are essential for public health but may not be commercially attractive under standard market conditions.

Or. en

Amendment 19

Proposal for a regulation

Recital 24 c (new)

Text proposed by the Commission

Amendment

(24c) In view of the increasing vulnerabilities in the supply chains of critical medicinal products and medicinal products of common interest, and the resulting risks of supply disruptions and shortages that can seriously endanger public health and disrupt the functioning of the internal market, it is necessary to establish a Union coordination mechanism operated by the Commission. That mechanism should serve as a structured, solidarity-based instrument to monitor availability, coordinate responses, and, where necessary, enable medicinal products to be redistributed equitably across the Union. While safeguarding the principle of subsidiarity, the mechanism should only be activated as a measure of last resort when all other national and voluntary Union-level means have been exhausted and where shortages or disruptions in one or more Member States are likely to result in serious harm to patients or affect other Member States. Binding redistribution decisions should be based on objective risk assessments and real-time data, and should ensure that the Member States providing assistance retain adequate minimum stock levels. To support timely and informed decisions, Member States should report regularly on their stockpiles and contingency stocks through a harmonised, digital reporting system. Additionally, fair reimbursement and cost-sharing provisions should ensure that solidarity is matched by equity, with the possibility of recourse to Union financial instruments where justified

Or. en

Amendment 20

Proposal for a regulation

Recital 24 d (new)

Text proposed by the Commission

Amendment

(24d) In order to ensure uniform conditions for the implementation of reporting obligations in relation to national stockpiles and contingency stocks, as well as of procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States, in the event of a binding redistribution decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

Or. en

Amendment 21

Proposal for a regulation

Recital 24 e (new)

Text proposed by the Commission

Amendment

(24e) To address vulnerabilities in the supply chains of critical medicinal products and medicinal products of common interest, a Union Stockpile may be established as a last-resort mechanism when other national or Union-level measures are insufficient. The Commission should be empowered to adopt delegated acts to define the categories of products, minimum quantities, and operational arrangements for storage, maintenance and deployment. The Union Stockpile should be coordinated with Member States to ensure alignment with national stocks and avoid duplication or disruption. It should be possible for Union budgetary support to be provided where appropriate. In exceptional cases, it should be possible for investigational medicinal products to be included, subject to strict conditions of necessity, effectiveness and safety, and the commitment to apply for a marketing authorisation.

Or. en

Amendment 22

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(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.

(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. In order to ensure legal certainty and consistency in its application, it is important to determine what constitutes a significant proportion of production within the meaning of this Regulation. For the purposes of designating strategic projects related to medicinal products, a significant proportion of the production should take place within the Union, the European Economic Area or the Swiss Confederation, in line with the objective of reinforcing the Union’s open strategic autonomy. However, for medicinal products of common interest, including orphan medicinal products and other medicinal products addressing specific public health needs, the scope of eligible production locations should also encompass countries with which the Union has a strategic partnership, within the meaning of this Regulation. That approach recognises the importance of trusted international cooperation while safeguarding security of supply.

Or. en

Amendment 23

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(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.

(29) The Commission intends to issue guidelines in consultation with patients, healthcare professionals and marketing authorisation holders, 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 if appropriate.

Or. en

Amendment 24

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(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.

(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 (‘the Critical Medicines 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.

Or. en

Amendment 25

Proposal for a regulation

Recital 31 a (new)

Text proposed by the Commission

Amendment

(31a) To ensure a coherent and effective Union-wide approach to contingency stocks, the Commission should be empowered to adopt delegated acts to specify and harmonise the conditions applicable to stock requirements. Such delegated acts should allow for flexibility based on product characteristics and market differences, while also enhancing the efficiency of stock management and distribution. Harmonised measures may include quantitative thresholds for contingency stocks, the use of white-label or semi-finished products to allow for agile deployment, and standardised packaging formats to facilitate cross-border supply. In emergency contexts, the package leaflet should be permitted in electronic format only for certain categories of medicinal products, where this facilitates rapid and effective use of contingency stocks.

Or. en

Amendment 26

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(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.

(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. Economic operators participate in collaborative procurement procedures conducted pursuant to this Regulation on a voluntary basis.

Or. en

Amendment 27

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(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 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.

(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 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. In order to ensure the effectiveness of joint procurement procedures for critical medicinal products and medicinal products of common interest, certain conditions should apply. Those conditions should include the application of permanent regulatory flexibilities, such as electronic packaging information, harmonised pack sizes, and labelling adjustments, to facilitate supply and distribution. Participating Member States should commit to binding minimum quantities and take all necessary steps to ensure the timely availability of the procured products within their territories. To preserve the integrity of the joint procurement procedure and the negotiating power under such procedure, participating Member States should refrain from engaging in parallel procurement or separate negotiations for the same product during the joint procurement process.

_________________

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)

Or. en

Amendment 28

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.

(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 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, the European Medicines Agency (‘the Agency) and patient organisations 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.

Or. en

Amendment 29

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.

(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 order to ensure solidarity and an effective Union-level response to shortages or supply disruptions of critical medicinal products or medicinal products of common interest, it is necessary to establish a clear decision-making process for the redistribution of such products. To that end, the Member States should be included in the decision-making process through the Critical Medicines Group established under this Regulation.

Or. en

Amendment 30

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 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. Those partnerships should be identified through a structured methodology, distinguishing between those reinforcing existing cooperation and those aiming to reduce strategic dependencies. They should also address trade and regulatory barriers, promote regulatory cooperation, and facilitate cross-border movement of critical medicinal products or medicinal products of common interest, in compliance with international obligations.

Or. en

Amendment 31

Proposal for a regulation

Recital 41

Text proposed by the Commission

Amendment

(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 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.

(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 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. The Commission should continuously monitor the application of this Regulation and assess its impact on competition and the functioning of the internal market. Where such monitoring or a comprehensive evaluation reveals that the application of this Regulation leads to significant distortions of competition or serious disruptions to the internal market, the Commission should take appropriate corrective measures, including, where necessary, proposing amendments to this Regulation. In cases of urgency and where such distortions or disruptions are both significant and immediate, the Commission should be empowered to adopt delegated acts to temporarily suspend specific provisions of this Regulation, subject to appropriate oversight by the European Parliament and the Council in accordance with Article 290 TFEU.

Or. en

Amendment 32

Proposal for a regulation

Recital 41 a (new)

Text proposed by the Commission

Amendment

(41a) In order to supplement this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the specification and harmonisation of the conditions applicable to Member States’ contingency stock requirements, as well as the determination of the categories, types and quantities of critical medicinal products and medicinal products of common interest to be included in the Union Stockpile, the determination of the specific arrangements for storage and maintenance of such Stockpile, and the criteria and procedures for the deployment of the stockpiled products. In order to amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distorsions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making* . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

___________________

* OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 33

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.

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, maintaining patient safety 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, including both critical medicinal products and medicinal products of common interest.

Or. en

Amendment 34

Proposal for a regulation

Article 1 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. It is also an objective of this Regulation to support the competitiveness of the Union’s pharmaceutical sector as a strategic asset and to promote targeted, evidence-based measures that avoid unintended consequences for the continuity of supply of critical medicinal products and for the accessibility of medicinal products of common interest to patients.

Or. en

Amendment 35

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) leverage the aggregated demand of participating Member States through collaborative procurement procedures, and

(c) leverage the aggregated demand of participating Member States through collaborative procurement procedures,

Or. en

Amendment 36

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships.

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships,

Or. en

Amendment 37

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) strengthen the resilience and promote the sustainable access to and supply of raw materials and feedstock essential for the manufacture of medicinal products; and

Or. en

Amendment 38

Proposal for a regulation

Article 1 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) coordinate contingency stocks and national stockpiles for critical medicinal products and medicinal products of common interest.

Or. en

Amendment 39

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

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.

2. Chapter III, Chapter IV and Article 26(2), point (c), also apply to medicinal products of common interest.

Or. en

Amendment 40

Proposal for a regulation

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Articles 20g and Article 23 apply to investigational medicinal products.

Or. en

Amendment 41

Proposal for a regulation

Article 3 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

For the purpose of this Regulation, the following definitions shall apply:

For the purposes of this Regulation, the definitions laid down in Article 4 of Directive (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] and in Article 2 of Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall apply. For the purpose of this Regulation, the following definitions shall apply:

Or. en

Amendment 42

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(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];

deleted

Or. en

Amendment 43

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 primary packaging materials, excipients, solvents, reagents, raw materials, feedstock and starting materials;

Or. en

Amendment 44

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(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];

deleted

Or. en

Amendment 45

Proposal for a regulation

Article 3 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(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];

deleted

Or. en

Amendment 46

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(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;

(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 or which meets at least one of the following criteria:

(a) it is designated as orphan medicinal product pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;

(b) it is a novel antimicrobial medicinal product which:

(i) contains an active substance with a new chemical structure or a new mechanism of action not previously authorised within the Union for the treatment or prevention of infections;

(ii) is intended for the treatment or prevention of infections caused by pathogens which are resistant to existing antimicrobial agents; or

(iii) addresses an unmet medical need in accordance with Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final];

Or. en

Amendment 47

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(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];

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities, taking into consideration shortages of those products in the two years preceding the evaluation, as well as their complexities and specific characteristics, performed by the MSSG in consultation with the respective marketing authorisation holders in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final] and in compliance with the Union’s international commitments;

_________________

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 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].

Or. en

Amendment 48

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

(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];

deleted

Or. en

Amendment 49

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, yield improvements or other chemistry or biotechnology process that contribute to increase the level of security, energy and environmental performance of the production, and use of Artificial Intelligence, platform technologies or 3D technologies in manufacturing;

Or. en

Amendment 50

Proposal for a regulation

Article 3 – paragraph 1 – point 15

Text proposed by the Commission

Amendment

(15) ‘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;

(15) ‘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, Euratom) 2024/2509;

Or. en

Amendment 51

Proposal for a regulation

Article 3 – paragraph 1 – point 17 a (new)

Text proposed by the Commission

Amendment

(17a) 'economic operator' means marketing authorisation holders, suppliers, manufacturers, wholesalers, and other actors dealing with medicinal products in the supply chain.

Or. en

Amendment 52

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 medicinal products of common interest, their active substances, key inputs, raw materials and feedstock 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.

Or. en

Amendment 53

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(18a) ‘Contingency stock’ means the quantity of critical medicinal products or medicinal products of common interest that economic operators are required to hold under national law in order to have a buffer when shortages occur, including because of fluctuations in demand or supply.

Or. en

Amendment 54

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(18b) ‘National stockpile’ means the reserves of a quantity of critical medicinal products or medicinal products of common interest established under national law by a Member State for a public health use, such as national strategic reserves.

Or. en

Amendment 55

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(18c) ‘Redistribution’ means the transfer of critical medicinal products or medicinal products of common interest from a contingency stock or national stockpile from one or several Member States to other Member States following a decision of the Commission in response to supply disruptions or shortages in one or more Member States.

Or. en

Amendment 56

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(18d) 'Resilience of supply chains' means the ability of the supply chain to maintain a continuous and demand-oriented supply of medicinal products in the Union, even during disruptions or external shocks.

Or. en

Amendment 57

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(18e) 'Diversification of supply chains' means the existence of several independent sources or production sites, so that the supply of a medicinal product does not depend on a single supplier or third country.

Or. en

Amendment 58

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.

2. The Member States and the Commission shall work together, including by gathering information from patient organisations and economic operators, 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.

Or. en

Amendment 59

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall support the coordinated efforts of the Members States.

3. The Commission shall support the coordinated efforts of the Members States, including by operating a coordination mechanism for critical medicinal products and medicinal products of common interest.

Or. en

Amendment 60

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The Commission shall adopt guidelines establishing a set of objective and transparent criteria for determining when the functioning of the internal market does not sufficiently ensure the availability and accessibility of medicinal products of common interest to patients, in the quantities and presentations necessary to meet patient needs in one or more Member States. Those criteria may include the following:

(a) the absence of clinical trials conducted in the relevant Member State;

(b) the unavailability of the medicinal product under compassionate use programmes;

(c) the failure of the marketing authorisation holder to make the medicinal product available and to ensure its continuous supply in adequate quantities and in the necessary presentations within 12 months from the date of the granting of the marketing authorisation, in response to a duly substantiated request from a Member State.

Or. en

Amendment 61

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article4a

List of medicinal products with no adequate Union substitute

1. The Commission shall establish and regularly update a list of medicinal products originating from third countries for which no adequate substitute produced within the Union is available.

2. The purpose of the list shall be to identify and monitor strategic dependencies and to support the adoption of appropriate measures aimed at ensuring the continuity of supply of medicinal products within the Union.

Or. en

Amendment 62

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 or increasing manufacturing capacity as well as decreasing Union dependency in relation to raw materials, feedstock, and key components shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 63

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 or collection capacity for one or more critical medicinal products or medicinal products of common interest or for collecting or manufacturing their active substances, or it sets aside a defined portion of manufacturing capacity for the production of specific critical medicinal products, their active substances or categories of those products or active substances within a fixed timeframe and at the request of the Critical Medicines Group in order to address potential or emerging shortages;

Or. en

Amendment 64

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 for one or more critical medicinal products or medicinal products of common interest or their active substances or key inputs to strengthen supply chain resilience, ensure greater sustainability or increased efficiency;

Or. en

Amendment 65

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(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;

(c) it creates, increases, collects or sets aside a defined portion of manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or medicinal products of common interest or their active substances;

Or. en

Amendment 66

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 of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products or medicinal products of common interest, their active substances or key inputs;

Or. en

Amendment 67

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) it supports innovative manufacturing processes for one or more critical medicinal products or medicinal products of common interest, or their active substances or key inputs;

Or. en

Amendment 68

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) it demonstrably reduces the Union’s dependency on a single supplier country or a limited set of suppliers for one or more critical medicinal products or medicinal products of common interest, or their active substances or key inputs, and thereby contributes to supply chain diversification.

Or. en

Amendment 69

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Notwithstanding the first paragraph, a project shall not be considered strategic if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs within the Union, unless such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

Or. en

Amendment 70

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 as soon as possible, and in any event not later than ... [90 days from the date of entry into force of this Regulation], 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.

Or. en

Amendment 71

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, easily accessible webpage serving as the central hub for project promoters on which at least the following information shall be clearly listed:

(a) the contact details and other relevant information on the Member States’ designated authorities; and

(b) details of the opportunities for financial support from the Union.

Or. en

Amendment 72

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The designated authority shall assess the project promoter’s request referred to in paragraph 1, second subparagraph, within 6 months of that request.

Or. en

Amendment 73

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. In order to promote a consistent and coordinated approach across the Union and to ensure legal certainty for project promoters, the Commission shall adopt guidelines setting out common criteria and procedural principles for the assessment and recognition of projects as strategic projects for critical medicinal products and medicinal products of common interest.

Or. en

Amendment 74

Proposal for a regulation

Article 6 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. The guidelines referred to in paragraph 5a shall, in particular, specify:

(a) objective criteria for the assessment of strategic relevance, including the project's potential to address supply vulnerabilities, enhance manufacturing capacity or resilience, ensure security of supply, or contribute to Union-wide public health preparedness;

(b) procedural aspects, including timelines, transparency requirements, and modalities for submission and evaluation of applications;

(c) mechanisms for cooperation and exchange of information between the Commission and the designated authority to ensure consistent application of the guidelines.

Or. en

Amendment 75

Proposal for a regulation

Article 6 – paragraph 5 c (new)

Text proposed by the Commission

Amendment

5c. Member States shall take due account of the guidelines when assessing and recognising strategic projects.

Or. en

Amendment 76

Proposal for a regulation

Article 6 – paragraph 5 d (new)

Text proposed by the Commission

Amendment

5d. Prior to the determination of a project as strategic, the Commission shall assess whether the project would result in a significant duplication of existing or planned manufacturing capacities within the Union. The Commission shall carry out that assessment within one month of receiving a complete application. If the Commission does not complete the assessment within that period, it shall be presumed that the project does not result in significant duplication.

Or. en

Amendment 77

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, therefore, to be in the public and patient interests.

Or. en

Amendment 78

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.

The Member States’ authorities shall ensure that the relevant permit granting and regulatory support 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.

Or. en

Amendment 79

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Commission shall establish a ‘one-stop-shop’ to coordinate the award of Union funds pursuant to Article 16 and to support Member States’ authorities with the prioritisation of financial support to strategic projects pursuant to Article 15.

Or. en

Amendment 80

Proposal for a regulation

Article 8 – title

Text proposed by the Commission

Amendment

Administrative support

Administrative and technical support

Or. en

Amendment 81

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Each Member State shall provide all necessary administrative and technical support to any strategic project located within its territory, for the purpose of mitigating unplanned interruptions in the supply of energy, gas or heat that are essential for establishing or increasing manufacturing capacity.

Or. en

Amendment 82

Proposal for a regulation

Article 8 a (new)

Text proposed by the Commission

Amendment

Article 8a

Other supportive measures

Member States may provide for other supportive measures, in particular to ensure that employees whose roles are essential to the implementation of a strategic project aimed at creating or increasing manufacturing capacity remain available in case of supply chain vulnerabilities or disruptions that need to be addressed, especially in times of national emergency or mobilisation. In particular, they may provide for measures such as:

(a) (a) exempting those employees from active military service;

(b) assigning those employees mobilisation duties within the strategic project itself.

Or. en

Amendment 83

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. Upon request of a project promoter, a Member State, with support of the Agency as necessary, shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing Practices inspections for approval of new or extended manufacturing sites or modernisation of the manufacturing sites in the context of the concerned strategic project.

Or. en

Amendment 84

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 Agency shall provide dedicated advice to assist project promoters in accordance with Article 5, including those promoters developing projects relying on innovative manufacturing processes.

Or. en

Amendment 85

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the Commission

Amendment

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.

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 30 days of receiving all necessary information.

Or. en

Amendment 86

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

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 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.

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 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 shall 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.

Or. en

Amendment 87

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

Article 12a

Coordination with environmental and chemical legislation

The Commission and Member States shall ensure that the application of this Regulation is coordinated with the application of environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products or medicinal products of common interest.

Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products or medicinal products of common interest, the Commission shall conduct a coordinated impact assessment and consult with the Critical Medicines Group to propose mitigating actions including, where appropriate, legislative proposals.

Or. en

Amendment 88

Proposal for a regulation

Article 14

Text proposed by the Commission

Amendment

Article 14

deleted

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.

Or. en

Amendment 89

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 shall 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).

Or. en

Amendment 90

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Member States may establish contractual arrangements on strategic projects to dedicate a portion of their manufacturing capacity for the production of specific critical medicinal products, their active substances and key inputs or technologies, or categories thereof, in order to address potential or emerging shortages at the request of the Critical Medicines Group within a fixed timeframe.

Or. en

Amendment 91

Proposal for a regulation

Article 15 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1b. The Commission shall adopt guidelines to facilitate the consistent application of this Article by Member States and the granting of State aid to strategic projects that meet the criteria of Article 5. Those State aid guidelines should include specific provisions for financing strategic projects that are aimed to improve the security of supply of medicinal products in the Union, both in terms of capacity (increased manufacturing of medicinal products in the Union) as well as in terms of innovative manufacturing process (improved manufacturing of medicinal products in the Union).

Or. en

Amendment 92

Proposal for a regulation

Article 15 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1c. An undertaking that benefits from financial support for a strategic project shall comply with the obligations laid down in paragraphs 2 and 3. Where an undertaking fails to comply with those obligations, the financial support granted to the strategic project may be recovered, in whole or in part, by the Member State concerned. In addition, the undertaking shall be subject to a financial penalty or an exclusion from funding proportionate to the impact of non-compliance.

Or. en

Amendment 93

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 for a strategic project shall prioritise supply to the Union market and ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 94

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.

1. All the Union funding under the Multiannual Financial Framework, including but not limited to regional policy funding programmes, may support strategic projects unless explicitly excluded by the legal basis or the scope of each programme and 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)

Or. en

Amendment 95

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Subject to relevant acts of Union law, strategic projects under this Regulation may be financed through the general budget of the European Union, including revenues generated from customs duties imposed by the Union on critical medicinal products or medicinal products of common interest in response to tariff or other trade-restrictive measures adopted by third countries.

Or. en

Amendment 96

Proposal for a regulation

Article 16 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1b. Subject to Regulation (EU, Euratom) 2024/2509, the revenues of the general budget of the European Union may be used to support:

(a) the development, expansion or implementation of strategic projects aimed at enhancing manufacturing capacities of, innovation in, or security of supply of, critical medicinal products or medicinal product of common interest within the Union;

(b) the acquisition of critical medicinal products and medicinal products of common interest through collaborative procurement procedures pursuant to Articles 21 and 23.

Or. en

Amendment 97

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. An undertaking receiving Union financial support under this Article shall comply with any obligations linked to such support. Where an undertaking fails to comply with those obligations, the Union funding may be recovered, in whole or in part, in accordance with the applicable rules. In addition, the Commission may impose a financial penalty or exclusion from future funding proportionate to the impact of the non-compliance.

Or. en

Amendment 98

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.

1. Member States shall inform the Critical Medicines Group referred to in Article 25 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 26.

Or. en

Amendment 99

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. The Critical Medicines Group shall notify the Agency of strategic projects that benefited from financial support at Member State or Union level in accordance with this Article.

Or. en

Amendment 100

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform at least once every six months the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

Or. en

Amendment 101

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

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.

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 implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs in consultation with healthcare professionals, with predictable procurement timelines and minimum binding quantities, and apply procurement requirements other than price-only award criteria. Those requirements shall include award criteria that promote the resilience of supply in the Union, support the diversification of supply sources, and take into account the geographical proximity of manufacturing within the Union. Where justified, such criteria shall be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include an appropriate and predictable mix and weighting of qualitative criteria. Those criteria shall include patient impact and clinical value, innovation, supply chain robustness and agility, the number of diversified suppliers, where appropriate, depending on the product’s indication, clinical and supply chain characteristics, monitoring of supply chains, their transparency upon request of the contracting authority and subject to safeguarding the confidentiality of trade secrets, and contract performance clauses on timely delivery.

Or. en

Amendment 102

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. In multiannual contracts or contracts that have been unilaterally prolonged by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

Or. en

Amendment 103

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

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 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.

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 level of dependency on a single or a limited number of third countries, the contracting authorities shall, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. Where these requirements are introduced, the contracting authority shall apply multi-winner approaches and shall ensure that significant quantities are purchased from suppliers that manufacture a significant proportion in the Union. Those requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 104

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product shall be considered to take place within the Union if at least one of the following conditions is met:

(a) at least 50% of the active pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation;

(b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EEA or the Swiss Confederation;

(c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation.

Or. en

Amendment 105

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall 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.

Or. en

Amendment 106

Proposal for a regulation

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

Text proposed by the Commission

Amendment

For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a medicinal product of common interest shall be considered to take place within the Union if at least one of the following conditions is met:

(a) at least 50 % of the active pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation;

(b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation;

(c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation.

Or. en

Amendment 107

Proposal for a regulation

Article 18 – paragraph 4

Text proposed by the Commission

Amendment

4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability and social rights.

4. Procurement procedures under this Chapter may include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights, insofar as they are linked to the subject-matter of the contract.

Or. en

Amendment 108

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

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.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where such a decision is duly justified on the basis of a documented market analysis, or where application of those provisions would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be supported by a written justification outlining the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

Or. en

Amendment 109

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. To support the implementation of this Article by the Member States, the Commission shall develop guidelines for application of non-price criteria by ... [18 months from the date of entry into force of this Regulation].

Or. en

Amendment 110

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

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.

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. Each national programme shall include, at a minimum, measures to promote the use of procurement award criteria relating to supply chain resilience and diversification of supply sources in accordance with Article 18. 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, where appropriate and non-discriminatory, include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures as well as review any price freezes, cost containment measures or stockholding obligations applicable.

Or. en

Amendment 111

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

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.

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 an annual structured discussion involving marketing authorisation holders, patient organisations and other relevant economic operators aiming to ensure coordinating and improving national programmes including as regards the application of criteria mentioned in Article 18 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.

Or. en

Amendment 112

Proposal for a regulation

Article 20

Text proposed by the Commission

Amendment

Article 20

deleted

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.

Or. en

Amendment 113

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Safeguards relating to national contingency stock requirements and Union-level coordination measures to ensure security of supply

1. Measures adopted by Member States to safeguard the security of supply of critical medicinal products and medicinal products of common interest shall not adversely affect the availability of such products in other Member States or compromise the functioning of the internal market.

In particular, Member States shall:

(a) refrain from introducing or maintaining requirements on economic operators in relation to the holding of contingency stocks that could result in disproportionate or discriminatory effects on the supply of such products in other Member States;

(b) ensure that any obligations they impose on economic operators in relation to the holding of contingency stocks are proportionate, non-discriminatory, and consistent with the principles of transparency and solidarity;

(c) take due account of any guidelines on improving the security of supply to and avoiding supply shortages that have been issued by the Commission pursuant to Article 134 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final], including those on facilitating the fulfilment of Member State’s obligations pursuant to points (a) and (b) of this subparagraph;

(d) take due account of the guidelines referred to in point (c) of this subparagraph when establishing national programmes in accordance with Article 19 of this Regulation.

2. The Commission is empowered to adopt delegated acts, in accordance with Article 30a, in order to supplement this Regulation by specifying and harmonising the conditions applicable to Member States’ contingency stock requirements, taking into account the characteristics of specific categories of medicinal products, differences across Member State markets, and the supply risk and shortage prevention plans adopted by marketing authorisation holders pursuant to Article 117 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final]. Those conditions may include:

(a) the establishment of defined quantitative thresholds for contingency stocks at both national and aggregated Union level, to be determined in cooperation with economic operators and reviewed periodically in light of evolving risk assessments;

(b) provisions allowing for the holding of contingency stocks in the form of white-label semi-finished or bulk products, where appropriate to ensure flexibility and timely deployment;

(c) the use of harmonised packaging formats, including multi-language or Union-wide packs, with a view to facilitating cross-border supply and reducing relabelling burdens;

By way of derogation from Article 63 [Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC], those delegated acts may provide that the package leaflet be made available electronically only for categories of critical medicinal products when such a measure may support the effective distribution and use of contingency stocks in emergency contexts.

3. When using contingency stocks in accordance with Article 20b, economic operators shall not be subject to penalties.

Or. en

Amendment 114

Proposal for a regulation

Chapter IV – Section I a (new)

Text proposed by the Commission

Amendment

SECTION Ia

UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS AND MEDICINAL PRODUCTS OF COMMON INTEREST

Or. en

Amendment 115

Proposal for a regulation

Article 20 b (new)

Text proposed by the Commission

Amendment

Article 20b

Establishment of a Union coordination mechanism for critical medicinal products and medicinal products of common interest

A Union coordination mechanism for critical medicinal products and medicinal products of common interest is hereby established. It shall be operated by the Commission. Through that coordination mechanism the Commission shall:

(a) monitor the availability and distribution of critical medicinal products and medicinal products of common interest across the Union;

(b) ensure effective and equitable redistribution in cases of shortage or supply disruption in one or more Member States having a negative impact in the internal market or in other Member States.

Or. en

Amendment 116

Proposal for a regulation

Article 20 c (new)

Text proposed by the Commission

Amendment

Article20c

Redistribution decisions

Where, for a critical medicinal product or medicinal product of common interest, a shortage or supply disruption is identified in one or more Member States, the Commission shall, upon request of the Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring a redistribution from a national stockpile or a contingency stock. Such a decision shall:

(a) be based on an objective risk assessment and real-time data establishing both the shortage or supply disruption resulting in serious harm or risk of serious harm to patients and the negative impact in the internal market or in other Member States;

(b) specify the quantities to be transferred, the timeframe for delivery, and any logistical arrangements;

(c) ensure that the transferring Member States retain adequate minimum levels of the relevant medicinal product.

Or. en

Amendment 117

Proposal for a regulation

Article 20 d (new)

Text proposed by the Commission

Amendment

Article20d

Stockpile information and reporting obligations

The Commission shall establish and maintain a digital reporting system that enables real-time updates on the status of national stockpiles and contingency stocks where they are established under national law.

Each Member State shall report to the Commission at least once per month, and immediately upon any significant change in stock levels. The Member States’ reports shall contain, at a minimum, the following information:

(a) a list of medicinal products for which contingency stocks or a national stockpile are held;

(b) the quantities of such stocks;

(c) the measures in place to ensure proper stock management, including rotation and the prevention of expiry.

For the purposes of this Article, the Commission shall make use of existing Union data infrastructures and reporting mechanisms, including but not limited to the Technical Regulation Information System (TRIS), the European Medicines Verification System (EMVS), the European Shortages Monitoring Platform (ESMP), EudraGMDP, the Industry Single Point of Contact (iSPOC) network, and relevant instruments established under the Union Civil Protection Mechanism. The Commission shall be granted timely access to data held by the Agency, and by the competent authorities of the Member States, to the extent necessary to support its mandate in the areas of situational awareness, risk assessment, and the coordination under this Chapter.

The Commission may adopt implementing acts to specify the format, structure and detailed content of the digital reporting system referred to in the first paragraph and of the reports referred to in the second paragraph in order to ensure their consistency, completeness and comparability across Member States. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 20h(2).

Or. en

Amendment 118

Proposal for a regulation

Article 20 e (new)

Text proposed by the Commission

Amendment

Article 20e

Obligations of Member States

Member States shall:

(a) comply with binding redistribution decisions adopted pursuant to Article 20c;

(b) cooperate fully with the Commission in the implementation of this Regulation.

The Commission may initiate an infringement procedure against a Member State in the event of non-compliance with the obligations laid down in this Regulation.

Or. en

Amendment 119

Proposal for a regulation

Article 20 f (new)

Text proposed by the Commission

Amendment

Article 20f

Reimbursement and replacement

Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20c, it shall be entitled to full reimbursement from the receiving Member State for the value of the medicinal products transferred and the costs of transport and a reasonable mark-up.

The value of the medicinal products transferred shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned or, in the absence of agreement, as determined by the Commission.

The transferring Member State shall be entitled to reimbursement of the determined value within a period not exceeding [60] calendar days from the date of receipt of the critical medicinal products by the receiving Member State.

The Commission shall adopt implementing acts specifying procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 20h(2).

In duly justified circumstances, and in the interest of solidarity, the Commission may authorise the use of Union financial instruments or emergency health funds to support or partially offset the cost borne by the receiving Member State, in accordance with applicable Union law.

Or. en

Amendment 120

Proposal for a regulation

Article 20 g (new)

Text proposed by the Commission

Amendment

Article 20g

Union Stockpile

In order to ensure the timely and effective availability of critical medicinal products or medicinal products of common interest with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism.

The Commission is empowered to adopt delegated acts in accordance with Article 30a, to determine:

(a) the categories and specific types of critical medicinal products and medicinal products of common interest to be included in the Stockpile;

(b) the minimum quantities to be stocked for each product, taking into account Union-level risk assessments, supply vulnerabilities, and public health needs;

(c) the logistical, technical and operational arrangements for storage and maintenance of the stockpile;

(d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States.

Should the Commission decide to establish the Union Stockpile, it shall coordinate with national competent authorities to ensure that it does not duplicate national stockpiles or contingency stocks arrangements. The establishment of the Union Stockpile shall be designed and implemented in a way that does not result in any negative impact on availability of medicinal products in other Member States.

The Commission shall further ensure that packaging, labelling, and storage conditions are such as to enable the rapid and safe distribution and use of the medicinal products across the Union.

The establishment, maintenance, and deployment of the Union Stockpile shall be supported by the general budget of the European Union.

Stockpiling of investigational medicinal products under this Article may be done under the following cumulative conditions:

(a) there are no similar investigational medicinal products currently authorised and available within the Union to address the specific threat,

(b) the nature of the public health threat requires the rapid deployment and distribution of medical countermeasures, such that early availability is essential to an effective response, and

(c) the manufacturer of the investigational medicinal product has demonstrated a commitment to the continued development of the product, including an agreement to apply for a marketing authorisation in the Union. This may include, where possible, prior engagement with the Agency to define an appropriate regulatory pathway before a crisis arises, or a commitment to submit data and apply for a marketing authorisation once sufficient evidence is generated following an emergency.

Or. en

Amendment 121

Proposal for a regulation

Article 20 h (new)

Text proposed by the Commission

Amendment

Article 20h

Committee procedure

1. The Commission shall be assisted by the Standing Committee on medicinal products for human use established by Article 214 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Or. en

Amendment 122

Proposal for a regulation

Article 20 i (new)

Text proposed by the Commission

Amendment

Article 20i

Removal of obstacles to implementation

Where Member States identify obstacles to the effective implementation of Section Ia of this Chapter, they shall take all necessary measures to remove such obstacles within one year from the date of application of this Regulation.

To that end, Member States shall, where appropriate, amend or repeal national legislative, regulatory or administrative provisions that are incompatible with the requirements laid down in Section Ia of this Chapter.

Or. en

Amendment 123

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

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.

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/EU28 for medicinal products of common interest.

_________________

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 ).

Or. en

Amendment 124

Proposal for a regulation

Article 21 – paragraph 5

Text proposed by the Commission

Amendment

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.

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, including on the use of award criteria as set out in Article 18 and on regulatory matters related to medicinal products.

Or. en

Amendment 125

Proposal for a regulation

Article 21 – paragraph 6

Text proposed by the Commission

Amendment

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.

6. The facilitation offered by the Commission shall be limited in time and end at the latest upon delivery of the medicinal products of common interest.

Or. en

Amendment 126

Proposal for a regulation

Article 21 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6a. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements:

(a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions;

(b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such;

(c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product;

(d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities;

(e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

Or. en

Amendment 127

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 128

Proposal for a regulation

Article 23 – title

Text proposed by the Commission

Amendment

Joint Procurement

Joint Procurement and procurement on behalf of Member States

Or. en

Amendment 129

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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.

deleted

Or. en

Amendment 130

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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:

2. Notwithstanding Article 16/(2) and (3) of Regulation (EU, Euratom) 2024/2509, a joint procurement procedure as provided for in paragraph 2a of this Article, or a procurement by the Commission on behalf of Member States as provided for in paragraph 2b of this Article, may be organised in accordance with paragraphs 4 to 7 of this Article if it complies with the following requirements:

Or. en

Amendment 131

Proposal for a regulation

Article 23 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(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;

(a) the procurement relates to medicinal products belonging to one of the categories below:

(i) 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;

(ii) 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, 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 including medicinal products intended for the treatment of paediatric cancers, which have been authorised before 12 January 2025.

Or. en

Amendment 132

Proposal for a regulation

Article 23 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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 Council31 , 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.

(b) the procurement procedure helps to improve the security of supply and availability of critical medicinal products in the Union or to ensure the availability and accessibility of medicinal products of common interest, as applicable.

_________________

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)

Or. en

Amendment 133

Proposal for a regulation

Article 23 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Unless otherwise provided for in this Article, the procurement procedure shall be carried out in accordance with Article 168(2) and (3) of Regulation (EU, Euratom) 2024/2509.

Or. en

Amendment 134

Proposal for a regulation

Article 23 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. At the Commission’s initiative, the Commission and at least nine Member States with a similar epidemiological or economic situation may engage, as contracting parties, in a joint procurement procedure as provided for in Article 168(2) of Regulation (EU, Euratom) 2024/2509, if the requirements laid down in paragraph 2 of this Article are fulfilled. Such a joint procurement procedure shall be conducted in accordance with paragraphs 4 to 7 of this Article.

Or. en

Amendment 135

Proposal for a regulation

Article 23 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2c. Where nine or more Member States consider it appropriate to mandate the Commission to act as a central purchasing body, those Member States may jointly request the Commission to procure on their behalf, or in their name, as a mandated contracting authority, in a procurement procedure on behalf of Member States as provided for in Article 168(3) of Regulation (EU, Euratom) 2024/2509. If the requirements laid down in paragraph 2 of this Article are fulfilled, the Commission may initiate such a procurement procedure in accordance with paragraphs 4 to 7 of this Article.

Or. en

Amendment 136

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

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.

deleted

Or. en

Amendment 137

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

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.

4. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request referred to in paragraph 2c, through the Critical Medicines Group, and invite them to join the procedure.

Or. en

Amendment 138

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission

Amendment

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.

5. The Commission shall assess the utility, the necessity and proportionality of the request referred to in paragraphs 2b and 2c 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.

Or. en

Amendment 139

Proposal for a regulation

Article 23 – paragraph 8

Text proposed by the Commission

Amendment

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.

deleted

Or. en

Amendment 140

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. The Commission shall ensure that any procurement procedure under this Article applies, to the greatest extent possible, the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

Or. en

Amendment 141

Proposal for a regulation

Article 23 – paragraph 8 b (new)

Text proposed by the Commission

Amendment

8b. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements:

(a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions;

(b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such;

(c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product;

(d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities;

(e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

Or. en

Amendment 142

Proposal for a regulation

Article 24 – title

Text proposed by the Commission

Amendment

Agreement concerning procedures under Articles 22 and 23

Agreement concerning procedures under Article 23

Or. en

Amendment 143

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.

2. The Member States, the Agency 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 national permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of the MSSG as permanent representatives. The Critical Medicines Group shall appoint two permanent representatives from patient organisations.

Or. en

Amendment 144

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 MSSG, the Agency, the relevant marketing authorisation holders and other relevant stakeholders and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group and the MSSG may organise joint meetings. For discussions where input from the industry perspective is necessary, the Critical Medicines Group shall consult the relevant marketing authorisation holders and/or trade associations including through the organisation of structured joint meetings as required.

Or. en

Amendment 145

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 regular meetings and coordinate the work of the Critical Medicines Group by means of the Secretariat.

Or. en

Amendment 146

Proposal for a regulation

Article 25 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6a. The Critical Medicines Group shall have biannual meetings, and additional meetings when needed, to consult with the Critical Medicines Alliance.

Or. en

Amendment 147

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission and inform the relevant marketing authorisation holder, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Or. en

Amendment 148

Proposal for a regulation

Article 26 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines Group shall perform the following tasks:

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines Group shall perform the following tasks in compliance with the necessary guarantees to safeguarding the confidentiality of trade secrets and in consultation with the marketing authorisation holders and other relevant economic operators:

Or. en

Amendment 149

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(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;

(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, as well as to ensure that the public health and patient safety implications are explicitly assessed and taken into account in all related decisions;

Or. en

Amendment 150

Proposal for a regulation

Article 26 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(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.

(d) provide recommendations to the MSSG on order of priority of critical medicinal products for vulnerability evaluation, and propose a review or an update of existing evaluations where necessary;

Or. en

Amendment 151

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) facilitate structured dialogue discussions with marketing authorisation holders on a regular basis, in particular to discuss the feasibility and effectiveness of measures adopted under this Regulation in light of the objectives thereof, including implementation timelines, vulnerabilities in the supply chain and other requirements imposed under this Regulation;

Or. en

Amendment 152

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) decide whether to give its prior approval to requests for the redistribution of medicinal products submitted by one or more Member States in the event of a shortage or supply disruption.

Or. en

Amendment 153

Proposal for a regulation

Article 26 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In carrying out the task referred to in point (db) of the second paragraph of this Article, only the representatives of the Member States within the Critical Medicines Group shall have the right to vote. The decision shall be adopted by a two-thirds majority of the Member States present and voting.

Or. en

Amendment 154

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 seek to conclude strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs, raw materials and feedstock to increase the security of supply of critical medicinal products in the Union. 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. However, such partnership shall fulfil the same requirements in terms of safety, quality, and effectiveness.

Or. en

Amendment 155

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall endeavour to incorporate health security provisions into free trade agreements and other relevant international agreements and instruments. Such provisions may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies, and to foster regulatory convergence and cooperation in the pharmaceutical sector.

Or. en

Amendment 156

Proposal for a regulation

Article 27 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

In the context of accession negotiations, the Commission shall support the progressive alignment of candidate countries with the Union acquis in the field of pharmaceuticals, with a view to facilitating their gradual integration into the Union’s internal market and strengthening the resilience of the Union’s supply chains for critical medicinal products.

Or. en

Amendment 157

Proposal for a regulation

Article 27 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

Strategic partnerships shall be guided by a clear Union-level framework to ensure coherence with the Union’s exclusive competence on trade, avoid uncoordinated national initiatives, and support a unified and consistent external approach to Union health resilience.

Or. en

Amendment 158

Proposal for a regulation

Article 27 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

The Commission shall develop no later than ... [2 years from the entry into force of this Regulation] a structured methodology when identifying and prioritising such partnerships, distinguishing between:

(a) partnerships designed to leverage and strengthen existing cooperation frameworks and trade relations that contribute to security of supply and supply chain stability; and

(b) partnerships designed to develop new or intensified cooperation to reduce strategic dependencies and ensure geographical diversification of supply chains.

Or. en

Amendment 159

Proposal for a regulation

Article 27 – paragraph 1 e (new)

Text proposed by the Commission

Amendment

Strategic partnerships shall also seek to address trade and regulatory barriers that impede supply chain resilience, promote regulatory cooperation to facilitate faster and more predictable market access, and support the smooth cross-border movement of medicinal products and critical components, while remaining fully consistent with the Union’s international obligations.

Or. en

Amendment 160

Proposal for a regulation

Article 27 – paragraph 1 f (new)

Text proposed by the Commission

Amendment

The Commission shall also build on existing forms of cooperation, where relevant, to reinforce efforts to strengthen the production and supply resilience of critical medicinal products, their active substances, key inputs, raw materials and feedstock in the Union and globally.

Or. en

Amendment 161

Proposal for a regulation

Article 28 – paragraph 1 – point a

Regulation (EU) 2024/795

Article 2 – paragraph 1 – point a– subparagraph 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, and directly related enabling technologies necessary for the development or manufacturing of critical medicinal products and medicinal products of common interest, including their active substances, key inputs, raw materials and feedstock, as defined in Critical Medicines Act *;

Or. en

Amendment 162

Proposal for a regulation

Article 28 – paragraph 1 – point b

Regulation (EU) 2024/795

Article 2 – paragraph 3 – subparagraph 3 a (new)

Text proposed by the Commission

Amendment

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.;

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, raw materials, feedstock and other key inputs necessary for the production of the finished dosage forms of critical medicinal products as defined in the Regulation.

Or. en

Amendment 163

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, the Agency or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation and adhering to the principles of the Better Regulation framework and subject to safeguarding the confidentiality of trade secrets.

Or. en

Amendment 164

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, the Agency and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted, by maximising the use of data already submitted by marketing authorisation holders (e.g. during registration process) as well as existing tools, such as the European Medicines Verification System (EMVS) and the European Shortages Monitoring Platform (ESMP).

Or. en

Amendment 165

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. The Commission, the Agency 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. They shall ensure that commercially confidential information and trade secrets are duly protected in full respect of Union law, and shall restrict access to such information strictly to staff responsible for applying this Regulation.

Or. en

Amendment 166

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. The Commission shall continuously monitor the implementation of this Regulation and its impact on the functioning of the internal market, competition, and the security of supply of medicinal products in the Union. In addition, 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.

Or. en

Amendment 167

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

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.

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. The evaluation shall pay particular attention to any unintended effects on market concentration, competition, innovation incentives, or barriers to entry, and assess whether this Regulation remains proportionate and effective.

Or. en

Amendment 168

Proposal for a regulation

Article 30 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. If, on the basis of its continuous monitoring or the comprehensive evaluation, the Commission identifies that the application of this Regulation leads to significant distortions of competition or serious disruptions of the functioning of the internal market, it shall take the necessary corrective measures, including by proposing amendments to this Regulation. In the case of urgent and significant distortions, the Commission may adopt a delegated act in accordance with Article 30a in order to temporarily suspend specific provisions of this Regulation until appropriate corrective measures are adopted.

Or. en

Amendment 169

Proposal for a regulation

Article 30 a (new)

Text proposed by the Commission

Amendment

Article 30a

Exercise of the delegation

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Articles 20a, 20g and 30(3a) shall be conferred on the Commission for an indeterminate period from … [date of application of this Regulation].

The delegation of power referred to in Articles 20a, 20g and 30(3a) may be revoked at any time by the European Parliament or the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Articles 20a, 20g and 30(3a) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act. to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Or. en

ANNEX: DECLARATION OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the draft report, 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 ORGANISATION FOR RARE DISEASES

European Society for Paediatric Oncology

European Patients' Forum (EPF)

European Federation of Pharmaceutical Industries and Associations

MEDICINES FOR EUROPE

BGP Products Operations GmbH a Viatris Company

CSL Behring

Sandoz International GmbH

Fondazione Telethon ETS

Pharmaceutical Group of the European Union

AbbVie

European Patient Organisation for Dysimmune and Inflammatory Neuropathies

European Social Insurance Platform AISBL

Bureau Européen des Unions de Consommateurs

BioForum

Deutsche Sozialversicherung Europavertretung

Merck

Teva Pharmaceuticals Europe BV

European Haemophilia Consortium

Cerus Europe B.V.

The European Association of Hospital Pharmacists

EuropaBio

Affordable Medicines Europe

Coalition for Epidemic Preparedness Innovations

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Novo Nordisk A/S

Bristol-Myers Squibb Company

European Blood Alliance

European Healthcare Distribution Association

Johnson & Johnson

Flint Europ

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Pfizer Inc.

SPARC Europe

Xellia

BIOTON

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Permanent Representation of the Kingdom of the Netherlands to the European Union

Permanent Representation of the Czech Republic to the European Union

Représentation permanente de la France auprès de l'Union européenne

Permanent representation of Finland to the EU

Permanent Representation of Denmark to the European Union

Health Emergency Preparedness and Response Authority (DG HERA, European Commission)

Directorate-General for Health & Food Safety (DG SANTE, European Commission)

The European Medicines Agency (EMA)

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

The Mission of Japan to the EU

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

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.