Critical Medicines Act

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Proposal for a regulation · Recital 1
   Current text

   (1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in all Union policies and activities. The availability of safe, efficacious and high-quality medicinal products is vital to achieving this objective and to safeguarding public health across the Union.

   Amendment

   (1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in all Union policies and activities. The availability of safe, efficacious and high-quality medicinal products, underpinned by a resilient and competitive pharmaceutical industry and secure, reliable supply chains forming the backbone of the supply of medicinal products, is vital to achieving this objective and to safeguarding public health across the Union and improving the preparedness and the Union’s overall security.

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2. Amendment 2Proposal for a regulation · Recital 2
   Current text

   (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.

   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 and lack of transparency of supply chains results in serious harm or risk of serious harm to patients and healthcare systems.

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3. Amendment 3Proposal for a regulation · Recital 2 a (new)
   Amendment

   (2a) A stable and resilient supply of medicines critical to the health of patients in the Union is essential, as shortages can lead to deterioration of patients’ health, increased healthcare costs, and significant burdens on healthcare systems and public authorities.

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4. Amendment 4Proposal for a regulation · Recital 3
   Current text

   (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.

   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, including starting materials, intermediates and other raw pharmaceutical materials and feedstock. 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 producti…

   Excerpt — full text in the official PDF.
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5. Amendment 5Proposal for a regulation · Recital 4
   Current text

   (4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages…

   Amendment

   (4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, expanding or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce…

   Excerpt — full text in the official PDF.
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6. Amendment 6Proposal for a regulation · Recital 4 a (new)
   Amendment

   (4a) While medicine shortages can occur for any type of product, they disproportionately affect older, off-patent, and generic medicinal products, primarily due to their low profit margins, which reduce incentives for investment in robust manufacturing capacity. Older, off-patent, and generic medicinal products make up the majority of the medicinal products placed on the Union List of Critical Medicinal Products, due to low profit margins that limit investment in manufacturing. Many off-patent and generic medicinal products suppliers have outsourced manufacturing or relocated production of finished products outside the Union, and frequently source their active pharmaceutical ingredients (API…

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7. Amendment 7Proposal for a regulation · Recital 7
   Current text

   (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 faci…

   Amendment

   (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 facil…

   Excerpt — full text in the official PDF.
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8. Amendment 8Proposal for a regulation · Recital 8
   Current text

   (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…

   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, and enhance patient’s access 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 th…

   Excerpt — full text in the official PDF.
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9. Amendment 9Proposal for a regulation · Recital 9
   Current text

   (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.

   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 and accessible to patients in some Member States. This may be caused by a variety of factors, including administrative and budgetary barriers, product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States increasing inequalities between patients in the Union and undermining the Union's commitment to achieving universal access to essential medicinal products by 2030 in line with the United Nations sustainable development goal 3.8. This Regulation…

   Excerpt — full text in the official PDF.
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10. Amendment 10Proposal for a regulation · Recital 11
    Current text

    (11) The measures introduced by this Regulation are without prejudice to marketing authorisation holders’ obligations, in particular under Directive (EU) …/… of the European Parliament and of the Council [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final], Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) 2022/123, including the obligation to ensure sufficient supplies of medicinal products, within the limits of their responsibility. These measures are aligned with the principles of the internal market. This Regulation is without prejudice to Union competition law, including antitrust, merger and State…

    Amendment

    (11) The measures introduced by this Regulation are without prejudice to marketing authorisation holders’ obligations, in particular under Directive (EU) …/… of the European Parliament and of the Council [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final], Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) 2022/123, including the obligation to ensure sufficient supplies of medicinal products, within the limits of their responsibility. These measures are aligned with the principles of the internal market. This Regulation is without prejudice to Union competition law, including antitrust, merger and State…

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11. Amendment 11Proposal for a regulation · Recital 12
    Current text

    (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…

    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, reducing administrative barriers, encouraging investment and supporting innovation in the pharmaceutical sector. This should include fostering research and development of innovative treatments, such as alternatives to antimicrobials to address antimicrobial resistance, m…

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12. Amendment 12Proposal for a regulation · Recital 13 a (new)
    Amendment

    (13a) To ensure the effective allocation of administrative and technical resources, the application of Articles 7 to 15 to medicinal products of common interest should not affect the priority granted to strategic projects concerning critical medicinal products. Where support measures, such as the processing of building permits or the conduct of dispute-resolution procedures overlap or conflict, requests related to such strategic projects should receive priority.

    official amendment document ↗
13. Amendment 13Proposal for a regulation · Recital 14
    Current text

    (14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union.

    Amendment

    (14) The availability and the security of supply of critical medicinal products are essential to safeguard public health, patients’ safety and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union.

    official amendment document ↗
14. Amendment 14Proposal for a regulation · Recital 14 a (new)
    Amendment

    (14a) Novel antimicrobials are essential for protecting public health and addressing the threat of antimicrobial resistance, which poses a growing threat to human health. Due to their limited and variable use across Member States, novel antimicrobials are not well-suited to volume-based pricing and reimbursement mechanisms and therefore face economic disincentives due to market failure. This could result in low and unpredictable revenues, particularly in smaller markets, and can undermine the ability of manufacturers, including SMEs, to supply these products sustainably. Consequently, the availability of newer antimicrobials has been limited, and some products have been withdrawn from the ma…

    Excerpt — full text in the official PDF.
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15. Amendment 15Proposal for a regulation · Recital 16 a (new)
    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. In the context of contingency stocks and national stockpiles, Member States should be encouraged to explore sustainable measures that contr…

    Excerpt — full text in the official PDF.
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16. Amendment 16Proposal for a regulation · Recital 16 b (new)
    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 to support measures aimed at ensuring the continuity of supply of medicinal products.

    official amendment document ↗
17. Amendment 17Proposal for a regulation · Recital 17
    Current text

    (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 avai…

    Amendment

    (17) Certain projects and technology can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products, improve efficiencies in the production of those products, and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects, including cross-border 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 authorit…

    Excerpt — full text in the official PDF.
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18. Amendment 18Proposal for a regulation · Recital 17 a (new)
    Amendment

    (17a) In order to safeguard the Union’s strategic interests and the resilience of its industrial base, strategic projects for manufacturing critical medicinal products must operate without interruption, including during crises or supply chain disruptions. Member States should take all necessary measures to prevent or mitigate unplanned disruptions to essential supplies and to ensure the continued availability of key personnel.

    official amendment document ↗
19. Amendment 19Proposal for a regulation · Recital 18
    Current text

    (18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States…

    Amendment

    (18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States…

    Excerpt — full text in the official PDF.
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20. Amendment 20Proposal for a regulation · Recital 18 a (new)
    Amendment

    (18a) To achieve the objective of contributing to the security of supply of critical medicinal products, and where relevant, medicinal products of common interest, Member States should ensure that any accelerated procedure or public funding granted under this Regulation for strategic projects requires enforceable undertakings by the beneficiary regarding security of supply, affordability of end-products, and transparency in the use of public funds, and that the resulting medicinal products are made available within the Union.

    official amendment document ↗
21. Amendment 21Proposal for a regulation · Recital 18 b (new)
    Amendment

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

    official amendment document ↗
22. Amendment 22Proposal for a regulation · Recital 19 a (new)
    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).

    official amendment document ↗
23. Amendment 23Proposal for a regulation · Recital 21
    Current text

    (21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complie…

    Amendment

    (21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complie…

    Excerpt — full text in the official PDF.
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24. Amendment 24Proposal for a regulation · Recital 22
    Current text

    (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 vulnera…

    Amendment

    (22) In order to ensure that the Union can effectively promote strategic projects, it is essential to make full use of the range of Union funding available under the current and future Multiannual Financial Frameworks. Union funding instruments, including but not limited to regional policy programmes, should therefore be able to support such projects where this is not explicitly excluded by their respective legal bases and where the support is consistent with the objectives laid down in the regulations establishing those instruments. Looking ahead to the future Multiannual Financial Framework, dedicated Union funding should be provided to advance the objectives of this Regulation. Within thi…

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25. Amendment 25Proposal for a regulation · Recital 23
    Current text

    (23) To allow for a more coordinated approach to financial support, it is appropriate that Member States and the Commission exchange the information on financial support to strategic projects. As regards the strategic projects that have benefitted from EU funding, the beneficiaries should follow the relevant communication and visibility rules8 . _________________ 8 Communication and visibility rules - Publications Office of the EU

    Amendment

    (23) To allow for a more coordinated approach to financial support, it is appropriate that Member States and the Commission exchange the information on financial support to strategic projects. In doing so, an appropriate level of confidentiality of sensitive business information and data obtained should be respected and protected, such as details of value chains, the disclosure of which could harm the competitive position of the companies involved. The Commission and the national competent authorities, their officials, employees and other persons working under the supervision of those authorities as well as officials and employees of other authorities of the Member States should not disclose…

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26. Amendment 26Proposal for a regulation · Recital 24
    Current text

    (24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply c…

    Amendment

    (24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations as well as support the commercial viability of the procurement procedures in a way that actively encourages the participation of pharmaceutical manufacturers in procureme…

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27. Amendment 27Proposal for a regulation · Recital 24 a (new)
    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. In addition, to provide market predictability and support investment in the production of medicinal products, procurement procedures under this Regulation should, where jus…

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28. Amendment 28Proposal for a regulation · Recital 25
    Current text

    (25) Inconsistent use of procurement requirements in public procurement procedures may have negative impact on the internal market as it creates obstacles to cross-border participation and a lack of predictability for bidders. In order to avoid such negative outcomes, the use of MEAT criteria should be mandatory.

    Amendment

    (25) Inconsistent use of procurement requirements in public procurement procedures may have negative impact on the internal market as it creates obstacles to cross-border participation and a lack of predictability for bidders. In order to avoid such negative outcomes, the use of MEAT criteria should be mandatory. To minimise market fragmentation and create certainty and predictability for both public health system payers as well as for pharmaceutical manufacturers, the Commission should coordinate and maintain a catalogue of such MEAT criteria, as well as relevant best practices for using them in public procurement, for use by Member States.

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29. Amendment 29Proposal for a regulation · Recital 26
    Current text

    (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 requirem…

    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, should apply procurement requi…

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30. Amendment 30Proposal for a regulation · Recital 29
    Current text

    (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.

    Amendment

    (29) The Commission should, after consultation with relevant stakeholders such as patients and consumer organisations, healthcare professionals, public healthcare payers and marketing authorisation holders, 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.

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31. Amendment 31Proposal for a regulation · Recital 30
    Current text

    (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 strengt…

    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 strengt…

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32. Amendment 32Proposal for a regulation · Recital 30 a (new)
    Amendment

    (30a) In view of the increasing vulnerabilities in the supply chains of critical medicinal products 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 a…

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33. Amendment 33Proposal for a regulation · Recital 30 b (new)
    Amendment

    (30b) 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, including the voluntary mechanisms provided for in Union legislation, 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…

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34. Amendment 34Proposal for a regulation · Recital 30 c (new)
    Amendment

    (30c) In order to promote solidarity, candidate countries should be allowed, on a voluntary basis, to participate in the procedures established by this Regulation where a bilateral agreement with the Union governing the relevant procurement activities is in place. Such participation should be without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law.

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35. Amendment 35Proposal for a regulation · Recital 30 d (new)
    Amendment

    (30d) To improve the functioning of the pharmaceutical market in the Union, Member States and the Commission should, when implementing pricing and public procurement practices, take action to achieve the objectives of the 2019 World Health Assembly Resolution on Improving the transparency of markets for medicines, vaccines, and other health products.

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36. Amendment 36Proposal for a regulation · Recital 31
    Current text

    (31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these obligations should be designed taking into consideration the principles of proportionality, transparency and solidarity. The Member States should give due consideration to forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks.

    Amendment

    (31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these obligations should be designed taking into consideration the principles of proportionality, transparency and solidarity and non-discrimination. The Member States should give due consideration to forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold…

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37. Amendment 37Proposal for a regulation · Recital 32
    Current text

    (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.

    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 including medicinal products for rare diseases, antimicrobials, and other innovative, high-cost, or specialised treatments across various therapeutic areas, such as oncology. Economic operators participate in collaborative procurement procedures conducted pursuant to this Regulation on a voluntary basis.

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38. Amendment 38Proposal for a regulation · Recital 37
    Current text

    (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…

    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 European Medicines Agency (‘the Agency’) and representatives from patient organisations and healthc…

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39. Amendment 39Proposal for a regulation · Recital 38
    Current text

    (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 nee…

    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 nee…

    Excerpt — full text in the official PDF.
    official amendment document ↗
40. Amendment 40Proposal for a regulation · Recital 38 a (new)
    Amendment

    (38a) In order to strengthen the Union’s preparedness and ensure an inclusive, needs-driven, transparent and coordinated approach to future challenges in the supply of critical medicinal products, the Critical medicines group, after consultation with the Commission, the Agency and the Critical Medicines Alliance, should establish a strategic foresight process. This process should identify and assess potential strategic projects, taking into account long-term trends, vulnerabilities, and opportunities for enhancing the resilience and sustainability of supply chains within the Union, specifically based on unmet medical needs.

    official amendment document ↗
41. Amendment 41Proposal for a regulation · Recital 39
    Current text

    (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 concl…

    Amendment

    (39) The Union should 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 should, 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 con…

    Excerpt — full text in the official PDF.
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42. Amendment 42Proposal for a regulation · Recital 41
    Current text

    (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 co…

    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 co…

    Excerpt — full text in the official PDF.
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43. Amendment 43Proposal for a regulation · Recital 42 a (new)
    Amendment

    (42a) 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 the determination of the categories, types and quantities of critical medicinal products 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. The exercise of these delegated powers should fully respect the principles of subsidiarity and proportionality. In order to…

    Excerpt — full text in the official PDF.
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44. Amendment 44Proposal for a regulation · Article 1 – paragraph 1
    Current text

    1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

    Amendment

    1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby reducing its dependency on third countries and 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 accessibility and affordability of…

    Excerpt — full text in the official PDF.
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45. Amendment 45Proposal for a regulation · Article 1 – paragraph 1 a (new)
    Amendment

    1a. Strengthening manufacturing capacities and the resilience of supply chains, as well as competitiveness, strategic autonomy and innovation in the Union’s pharmaceutical sector, is also an objective of this Regulation.

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46. Amendment 46Proposal for a regulation · Article 1 – paragraph 2 – introductory part
    Current text

    2. To achieve the objectives referred to in paragraph 1, the Regulation sets out a framework to:

    Amendment

    2. To achieve the objectives set out in paragraphs 1 and 1a, the Regulation sets out a framework to:

    official amendment document ↗
47. Amendment 47Proposal for a regulation · Article 1 – paragraph 2 – point a
    Current text

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

    Amendment

    (a) facilitate, support and incentivise investments in new manufacturing capacity and strengthen existing manufacturing capacity for critical medicinal products and, where applicable, medicinal products of common interest, their active substances and other key inputs in the Union with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain, by making available any accelerated permit granting processes related to the strategic projects that exist in applicable Union and national law;

    official amendment document ↗
48. Amendment 48Proposal for a regulation · Article 1 – paragraph 2 – point b a (new)
    Amendment

    (ba) prevent shortages and strengthen availability of medicinal products by facilitating the adoption of common standards governing contingency stocks and national stockpiles of critical medicinal products and medicinal products of common interest, and by enhancing transparency and coordination among Member States in this regard;

    official amendment document ↗
49. Amendment 49Proposal for a regulation · Article 1 – paragraph 2 – point c
    Current text

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

    Amendment

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

    official amendment document ↗
50. Amendment 50Proposal for a regulation · Article 1 – paragraph 2 – point d
    Current text

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

    Amendment

    (d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain;

    official amendment document ↗
51. Amendment 51Proposal for a regulation · Article 1 – paragraph 2 – point d a (new)
    Amendment

    (da) facilitate investments in critical distribution infrastructure capacity for critical medicinal products ensuring security of supply, availability and accessibility in the Union; and

    official amendment document ↗
52. Amendment 52Proposal for a regulation · Article 1 – paragraph 2 – point d b (new)
    Amendment

    (db) strengthen the resilience of supply chains and promote the sustainable access to and supply of active substances of critical medicinal products, their API starting materials, and other key inputs within the Union insofar as they are used for the manufacture of critical medicinal products.

    official amendment document ↗
53. Amendment 53Proposal for a regulation · Article 2 – paragraph 1
    Current text

    1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final].

    Amendment

    1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product’s supply chain.

    official amendment document ↗
54. Amendment 54Proposal for a regulation · Article 2 – paragraph 1 a (new)
    Amendment

    1a. Chapter III also applies to active substances of critical medicinal products, their starting materials, and other key inputs within the Union, insofar as they are used for the manufacture of critical medicinal products.

    official amendment document ↗
55. Amendment 55Proposal for a regulation · Article 2 – paragraph 2
    Current text

    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.

    Amendment

    2. Chapter III, Articles 5 to 15, Chapter IV with the exception of its Section Ia new, and Article 26(2), point (c), also apply to medicinal products of common interest, where the Critical Medicines Coordination Group has issued a positive recommendation pursuant to Article 26(2)(dj). Articles 16 and 17 apply, mutatis mutandis, to medicinal products of common interest subject to the condition that the Union funding allocation under Article 16 exceeds EUR 500 million.

    official amendment document ↗
56. Amendment 56Proposal for a regulation · Article 3 – paragraph 1 – introductory part
    Current text

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

    Amendment

    For the purposes of this Regulation, relevant 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 mutatis mutandis. The following definitions shall also apply:

    official amendment document ↗
57. Amendment 57Proposal for a regulation · Article 3 – paragraph 1 – point 1
    Current text

    (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];

    Amendment

    deleted

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58. Amendment 58Proposal for a regulation · Article 3 – paragraph 1 – point 2
    Current text

    (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;

    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, raw materials, feedstock and starting materials;

    official amendment document ↗
59. Amendment 59Proposal for a regulation · Article 3 – paragraph 1 – point 3
    Current text

    (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];

    Amendment

    deleted

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60. Amendment 60Proposal for a regulation · Article 3 – paragraph 1 – point 4
    Current text

    (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];

    Amendment

    deleted

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61. Amendment 61Proposal for a regulation · Article 3 – paragraph 1 – point 4 a (new)
    Amendment

    (4a) ‘substance of human origin’ or ‘SoHO’ means a ‘substance of human origin’ or ‘SoHO’, as defined in Regulation (EU) 2024/19381a; _________________ 1a Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC.

    official amendment document ↗
62. Amendment 62Proposal for a regulation · Article 3 – paragraph 1 – point 5
    Current text

    (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;

    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, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or is designated as orphan medicinal product pursuant to Article 67 of Regulation (EU).../... [reference to be added after adoption cf. COM(2023) 193 final)];

    official amendment document ↗
63. Amendment 63Proposal for a regulation · Article 3 – paragraph 1 – point 5 a (new)
    Amendment

    (5a) 'API starting material’ means a raw material, an intermediate product, or an active substance that is used in the production of an active pharmaceutical ingredient (API) and that is incorporated as a significant structural fragment into the structure of the API;

    official amendment document ↗
64. Amendment 64Proposal for a regulation · Article 3 – paragraph 1 – point 5 b (new)
    Amendment

    (5b) ‘systemic wholesaler’ means a wholesaler of medicinal products that holds a wholesale distribution authorisation and fulfils all obligations laid down in Article 166 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final]. They wholesale and continuously distribute either the full range of prescription medicines, meaning more than 80% of the prescription medicines available for retail sale in a Member State market, or above 20% of the total market share of prescription medicines available for retail sale in a Member State market;

    official amendment document ↗
65. Amendment 65Proposal for a regulation · Article 3 – paragraph 1 – point 6
    Current text

    (6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, that compromise the continuous supply of such medicinal products to patients in the Union;

    Amendment

    (6) ‘vulnerability in the supply chains’ means structural and non-structural risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, and the specific features of the supply chains of each product, that compromise the continuous supply of such medicinal products to patients in the Union;

    official amendment document ↗
66. Amendment 66Proposal for a regulation · Article 3 – paragraph 1 – point 10
    Current text

    (10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

    Amendment

    (10) ‘strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation;

    official amendment document ↗
67. Amendment 67Proposal for a regulation · Article 3 – paragraph 1 – point 10 a (new)
    Amendment

    (10a) ‘cross-border strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation, which may be carried out by a minimum of two Member States;

    official amendment document ↗
68. Amendment 68Proposal for a regulation · Article 3 – paragraph 1 – point 11 a (new)
    Amendment

    (11a) ‘economic operator’ means an economic operator as defined in Directive 2014/24/EU;

    official amendment document ↗
69. Amendment 69Proposal for a regulation · Article 3 – paragraph 1 – point 12
    Current text

    (12) ‘permit granting process’ means a process covering all relevant permits to build and operate a strategic project, including building, chemical and grid connection permits and environmental assessments and authorisations where those are required and encompassing all applications and procedures;

    Amendment

    (12) ‘permit granting process’ means a process covering all relevant permits to build, expand, convert and operate a strategic project, including building, chemical and grid connection permits and environmental assessments and authorisations where those are required and encompassing all applications and procedures;

    official amendment document ↗
70. Amendment 70Proposal for a regulation · Article 3 – paragraph 1 – point 13
    Current text

    (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;

    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, 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;

    official amendment document ↗
71. Amendment 71Proposal for a regulation · Article 3 – paragraph 1 – point 13 a (new)
    Amendment

    (13a) ‘contingency stock’ means the quantity of critical medicinal products or, where applicable, medicinal products of common interest that manufacturers and wholesalers might be required to hold under national law in order to have a buffer when shortages or supply disruptions occur, including because of fluctuations in demand or supply;

    official amendment document ↗
72. Amendment 72Proposal for a regulation · Article 3 – paragraph 1 – point 13 b (new)
    Amendment

    (13b) ‘contingency stock requirement’ means an obligation imposed by a Member State law on manufacturers and wholesalers in the supply chain to establish buffer stocks of certain medicinal products to mitigate the risk of shortages or supply disruptions;

    official amendment document ↗
73. Amendment 73Proposal for a regulation · Article 3 – paragraph 1 – point 13 c (new)
    Amendment

    (13c) ‘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;

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74. Amendment 74Proposal for a regulation · Article 3 – paragraph 1 – point 13 d (new)
    Amendment

    (13d) ‘redistribution’ means the transfer of critical medicinal products 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 shortages or supply disruptions in one or more Member States;

    official amendment document ↗
75. Amendment 75Proposal for a regulation · Article 3 – paragraph 1 – point 18
    Current text

    (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.

    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 or its supply chain, their active substances and key inputs 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;

    official amendment document ↗
76. Amendment 76Proposal for a regulation · Article 3 – paragraph 1 – point 18 a (new)
    Amendment

    (18a) 'resilience of supply chains' means the ability of the supply chain to maintain a continuous and demand-oriented supply of medicinal products, active substances, API starting materials, and key inputs in the Union, even during disruptions or external shocks;

    official amendment document ↗
77. Amendment 77Proposal for a regulation · Article 3 – paragraph 1 – point 18 b (new)
    Amendment

    (18b) 'diversification of supply chains' means the existence of several independent sources or production sites, so that the supply of a medicinal product, active substances, API starting materials, and key inputs does not depend on a single supplier or third country of supply.

    official amendment document ↗
78. Amendment 78Proposal for a regulation · Article 4 – paragraph 1
    Current text

    1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

    Amendment

    1. The security of supply, availability and affordability of critical medicinal products and, where applicable, medicinal products of common interest, for patients shall be considered a strategic objective of the Union. In order to achieve such an objective, the determination of strategic projects that meet the criteria laid down in Article 5 shall be made in accordance with Article 6.

    official amendment document ↗
79. Amendment 79Proposal for a regulation · Article 4 – paragraph 2
    Current text

    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.

    Amendment

    2. The Member States and the Commission shall work together to achieve the strategic objective of the Union referred to in paragraph 1 including by gathering information from healthcare professional organisations, patient organisations and economic operators including marketing authorisation holders, to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures provided for in Sections II and III of this Chapter that take full advantage of the potential of the internal market, reflecting the principles of solidarity and coordination between Member States and reducing dependencies on third countries, while ensuring predictability…

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80. Amendment 80Proposal for a regulation · Article 4 – paragraph 3
    Current text

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

    Amendment

    3. The Commission shall support the coordinated efforts of the Members States and foster a secure cross-border exchange of relevant information and facilitate the distribution of critical medicinal products throughout the Union.

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81. Amendment 81Proposal for a regulation · Article 5 – paragraph 1 – introductory part
    Current text

    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:

    Amendment

    1. A project located in the Union and related to creating, modernising, increasing or improving manufacturing capacity, as well as decreasing Union dependency in relation to key inputs or otherwise contributing to the security of supply or availability of medicinal products, shall be considered as a strategic project if it meets at least one of the following criteria:

    official amendment document ↗
82. Amendment 82Proposal for a regulation · Article 5 – paragraph 1 – point a
    Current text

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

    Amendment

    (a) it creates or increases manufacturing capacity, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or, where applicable, medicinal products of common interest, or for collecting or manufacturing their active substances, or it creates capacity for compounding techniques within pharmacies or hospitals;

    official amendment document ↗
83. Amendment 83Proposal for a regulation · Article 5 – paragraph 1 – point b
    Current text

    (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;

    Amendment

    (b) it modernises an existing manufacturing site, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or where applicable, medicinal products of common interest, their active substances or key inputs to strengthen supply chain resilience, to ensure greater sustainability or increased efficiency;

    official amendment document ↗
84. Amendment 84Proposal for a regulation · Article 5 – paragraph 1 – point c
    Current text

    (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;

    Amendment

    (c) it creates, increases or modernises manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or, where applicable, medicinal products of common interest, their active substances or key inputs;

    official amendment document ↗
85. Amendment 85Proposal for a regulation · Article 5 – paragraph 1 – point d
    Current text

    (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.

    Amendment

    (d) it contributes to the roll-out or transfer of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products, or, where applicable, medicinal products of common interest, their active substances or key inputs;

    official amendment document ↗
86. Amendment 86Proposal for a regulation · Article 5 – paragraph 1 – point d a (new)
    Amendment

    (da) it reserves a defined portion of manufacturing capacity, within a fixed timeframe, to produce specific critical medicinal products or, where applicable, medicinal products of common interest, their pharmaceutical forms, their active substances, key inputs, or enabling technologies, at the request of the Critical Medicines Coordination Group, in order to address current, emerging or potential shortages.

    official amendment document ↗
87. Amendment 87Proposal for a regulation · Article 5 – paragraph 1 a (new)
    Amendment

    Notwithstanding paragraph 1, a project shall not receive financial support from the Union pursuant to Article 16 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 the Critical Medicines Group has assessed the need and 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.

    official amendment document ↗
88. Amendment 88Proposal for a regulation · Article 6 – title
    Current text

    Recognition of Strategic Projects

    Amendment

    Determination of Strategic Projects

    official amendment document ↗
89. Amendment 89Proposal for a regulation · Article 6 – paragraph 1 – subparagraph 1
    Current text

    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.

    Amendment

    Within three months of the entry into force of this Regulation, each Member State shall designate an authority (‘the designated authority’) to be in charge of assessing and verifying whether or not a project meets at least one of the criteria set out in Article 5 and is therefore to be considered a strategic project.

    official amendment document ↗
90. Amendment 90Proposal for a regulation · Article 6 – paragraph 1 – subparagraph 2
    Current text

    A promoter may request the designated authority to assess whether a project is a strategic project.

    Amendment

    A promoter may request the designated authority to assess whether a project constitutes a strategic project.

    official amendment document ↗
91. Amendment 91Proposal for a regulation · Article 6 – paragraph 1 – subparagraph 3
    Current text

    Any Member State authority may request the designated authority to verify its determination of whether a project is a strategic project.

    Amendment

    Any Member State authority may request the designated authority to verify its determination of a project as a strategic project.

    official amendment document ↗
92. Amendment 92Proposal for a regulation · Article 6 – paragraph 3
    Current text

    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.

    Amendment

    3. The Commission shall provide a simple, accessible, and user-friendly webpage serving as the central hub for project promoters on which at least the following elements shall be clearly listed:

    official amendment document ↗
93. Amendment 93Proposal for a regulation · Article 6 – paragraph 3 – point a (new)
    Amendment

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

    official amendment document ↗
94. Amendment 94Proposal for a regulation · Article 6 – paragraph 3 – point b (new)
    Amendment

    (b) information on available administrative or financial support from the Union; and

    official amendment document ↗
95. Amendment 95Proposal for a regulation · Article 6 – paragraph 3 – point c (new)
    Amendment

    (c) a standard template for the project promoter’s request available in all official languages of the Union.

    official amendment document ↗
96. Amendment 96Proposal for a regulation · Article 6 – paragraph 3 – subparagraph 1 a (new)
    Amendment

    The Commission shall adopt implementing acts to provide for a standard template for the project promoter’s request referred to in point (c) of the first subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20e(2).

    official amendment document ↗
97. Amendment 97Proposal for a regulation · Article 6 – paragraph 3 a (new)
    Amendment

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

    official amendment document ↗
98. Amendment 98Proposal for a regulation · Article 6 – paragraph 5
    Current text

    5. Where the verification whether a project is a strategic project has been performed by an authority in accordance with this Article, any other authority shall rely on that verification.

    Amendment

    5. Where the verification whether a project constitutes a strategic project has been performed by a designated authority in accordance with this Article, any other authority shall rely on that verification.

    official amendment document ↗
99. Amendment 99Proposal for a regulation · Article 6 – paragraph 5 a (new)
    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 determination of projects as strategic projects for critical medicinal products and, where applicable, medicinal products of common interest. Designated authorities shall take into consideration those guidelines, as appropriate, when assessing and determining projects as strategic

    official amendment document ↗
100. Amendment 100Proposal for a regulation · Article 6 – paragraph 5 b (new)
     Amendment

     5b. The guidelines referred to in paragraph 5a shall, in particular, specify: (a) measurable 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) indicative timelines for operational readiness, transparency requirements, and steps for submission and assessment of requests; (c) available mechanisms for cooperation and exchange of information between the Commission and the designated authority to allow for consistent application of the guidelines.

     official amendment document ↗
101. Amendment 101Proposal for a regulation · Article 6 – paragraph 5 c (new)
     Amendment

     5c. The Commission shall act as a coordinator for cross-border strategic projects and shall ensure effective cooperation between the designated authorities of the Member States concerned, to avoid duplication of efforts in bordering Member States and to promote complementarity and efficiency in the implementation of such projects.

     official amendment document ↗
102. Amendment 102Proposal for a regulation · Article 6 – paragraph 5 d (new)
     Amendment

     5d. Prior to the determination of a project as strategic, the designated authority shall notify the Critical Medicines Coordination Group of its intention to make such a determination. Within one month of receipt of such notification, the Critical Medicines Coordination Group shall assess whether the project would result in a significant duplication of existing or planned manufacturing capacities within the Union. Where the Critical Medicines Coordination Group does not complete the assessment within that period, the project shall be presumed not to result in significant duplication. Where the Critical Medicines Coordination Group considers that the project would result in a significant dupl…

     Excerpt — full text in the official PDF.
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103. Amendment 103Proposal for a regulation · Article 7 – paragraph 1
     Current text

     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.

     Amendment

     Strategic projects shall be considered as contributing to the security of supply of critical medicinal products, or where applicable, medicinal products of common interest, in the Union and, therefore, to be in the public interest as serving the objectives of public health, safety and the protection of patients’ interests.

     official amendment document ↗
104. Amendment 104Proposal for a regulation · Article 7 – paragraph 2
     Current text

     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.

     Amendment

     The Member States’ authorities shall ensure that the relevant permit granting processes and corresponding certification and inspection processes related to strategic projects are fast tracked, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring the quality and robustness of assessments and upholding the relevant environmental, health and work safety standards.

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105. Amendment 105Proposal for a regulation · Article 8 – title
     Current text

     Administrative support

     Amendment

     Administrative and technical support

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106. Amendment 106Proposal for a regulation · Article 8 – paragraph 1 – point b
     Current text

     (b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project;

     Amendment

     (b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project and, where relevant, facilitating required consultations of local communities, organisations and social partners;

     official amendment document ↗
107. Amendment 107Proposal for a regulation · Article 8 – paragraph 2
     Current text

     2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs) and, where appropriate, establish a dedicated channel for communication with SMEs to provide guidance and respond to queries related to the implementation of this Regulation.

     Amendment

     2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs), small mid-cap enterprises (SMCs), as well as to entities not engaged in an economic activity and, where appropriate, establish a dedicated channel for communication with them to provide guidance and respond to queries related to the implementation of this Regulation.

     official amendment document ↗
108. Amendment 108Proposal for a regulation · Article 8 – paragraph 2 a (new)
     Amendment

     2a. Member States shall ensure that a strategic project located within its territory is provided with the administrative and technical support necessary to prevent or mitigate unplanned interruptions in the supply of energy, gas or heat required for the establishment or expansion of manufacturing capacity, including facilitating timely access to relevant network connections and capacity, and coordinating with the competent network operators to ensure the stability and continuity of supply.

     official amendment document ↗
109. Amendment 109Proposal for a regulation · Article 8 – paragraph 2 b (new)
     Amendment

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

     official amendment document ↗
110. Amendment 110Proposal for a regulation · Article 11 – paragraph 1
     Current text

     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.

     Amendment

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

     official amendment document ↗
111. Amendment 111Proposal for a regulation · Article 11 – paragraph 2
     Current text

     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.

     Amendment

     2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall, where appropriate, with the support of national competent authorities for medicinal products, provide dedicated advice to assist project promoters, including those developing projects relying on innovative manufacturing processes.

     official amendment document ↗
112. Amendment 112Proposal for a regulation · Article 12 – paragraph 1 – subparagraph 1
     Current text

     A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 , Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint proce…

     Amendment

     A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 , Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint proce…

     Excerpt — full text in the official PDF.
     official amendment document ↗
113. Amendment 113Proposal for a regulation · Article 12 – paragraph 2
     Current text

     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.

     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 pursuant to Articles 5, 6 and 7 of that Directive and after completing the consultations referred to in Articles 6 and 7 of that Directive, with a possibility of extension by a maximum of 45 days in duly justified cases.

     official amendment document ↗
114. Amendment 114Proposal for a regulation · Article 12 – paragraph 5 a (new)
     Amendment

     5a. Member States shall ensure that their competent authorities and other authorities designated pursuant to Article 6(1) of Directive 2011/92/EU have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary to fulfil their obligations under this Article.

     official amendment document ↗
115. Amendment 115Proposal for a regulation · Article 13 – paragraph 1
     Current text

     1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant spatial planning data is available.

     Amendment

     1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data are available and accessible, including online.

     official amendment document ↗
116. Amendment 116Proposal for a regulation · Article 13 – paragraph 2
     Current text

     2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23 , the combined assessment sh…

     Amendment

     2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23 , the combined assessment sh…

     Excerpt — full text in the official PDF.
     official amendment document ↗
117. Amendment 117Proposal for a regulation · Article 13 – paragraph 2 a (new)
     Amendment

     2a. Where the development of Strategic Projects or their related infrastructure has potential cross-border implications, the Member States concerned shall coordinate their planning and assessment procedures, with the support of the Commission, in order to avoid duplication of efforts, ensure complementarity, and reflect the principles of solidarity and cooperation between Member States.

     official amendment document ↗
118. Amendment 118Proposal for a regulation · Article 14 – paragraph 2
     Current text

     2. All decisions adopted pursuant to the Articles in this section shall be made publicly available.

     Amendment

     2. All decisions adopted pursuant to the Articles in this section shall be made publicly available in an easily understandable manner, including online, and all decisions concerning one project shall be available on the same website.

     official amendment document ↗
119. Amendment 119Proposal for a regulation · Article 15 – paragraph 1
     Current text

     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).

     Amendment

     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, and, where applicable, medicinal products of common interest, 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). Financial support shall be proportionate to the financing needs of the strategic project and shall be subject to transparency requirements.

     official amendment document ↗
120. Amendment 120Proposal for a regulation · Article 15 – paragraph 1 a (new)
     Amendment

     1a. Member States may, at the request of the Critical Medicines Group, establish contractual arrangements with economic operators on strategic projects to dedicate a portion of their manufacturing capacity to produce specific medicinal products, their pharmaceutical forms, their active substances and key inputs or technologies, or categories thereof, in order to address current, emerging or potential shortages within a fixed timeframe, determined by the Critical Medicines Group.

     official amendment document ↗
121. Amendment 121Proposal for a regulation · Article 15 – paragraph 1 b (new)
     Amendment

     1b. The Commission shall facilitate the consistent application of this Article by providing sufficient guidance to Member States on the possibilities offered under existing State aid rules for the granting of State aid to strategic projects that meet the criteria of Article 5. This guidance shall in particular facilitate the financing of strategic projects that are aimed to improve the security of supply of medicinal products in the Union, both in terms of manufacturing capacity and in terms of innovative manufacturing processes.

     official amendment document ↗
122. Amendment 122Proposal for a regulation · Article 15 – paragraph 2
     Current text

     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.

     Amendment

     2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, a project promoter that has benefitted from financial support by a Member State for a strategic project shall prioritise appropriate and continued supply to the Union market so that the needs of patients in the Member State in question are covered and ensure that the critical medicinal product remains available in the Member States where it is being marketed. This paragraph applies mutatis mutandis to medicinal products of common interest.

     official amendment document ↗
123. Amendment 123Proposal for a regulation · Article 15 – paragraph 2 a (new)
     Amendment

     2a. The Member State providing financial support to a strategic project shall require the beneficiary economic operator to adopt measures that contribute to the availability and affordability of the critical medicinal product and medicinal product of common interest in the Union market, following guidelines referred to in Article 26(2)(ca).

     official amendment document ↗
124. Amendment 124Proposal for a regulation · Article 15 – paragraph 3 – subparagraph 1
     Current text

     The Member State that provided financial support to a strategic project may request such undertaking to provide the necessary supplies of a critical medicinal product, active substance or key inputs, as applicable, to the Union market to avoid shortages in one or several Member States.

     Amendment

     The Member State that provided financial support to a strategic project may request such project promoter to prioritise and provide the necessary supplies of a critical medicinal product, or, where applicable, medicinal product of common interest, active substance or key inputs, as applicable, to the Union market as a priority to avoid shortages in one or several Member States.

     official amendment document ↗
125. Amendment 125Proposal for a regulation · Article 15 – paragraph 3 – subparagraph 2
     Current text

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

     Amendment

     Any Member State that encounters a threat of shortages of the critical medicinal product or medicinal product of common interest in question may demand the Member State that provided financial support to submit a request on its behalf. The project promoter shall undertake its very best efforts to supply such products in the requesting Member State.

     official amendment document ↗
126. Amendment 126Proposal for a regulation · Article 15 – paragraph 3 a (new)
     Amendment

     3a. Where a project promoter that receives financial support fails to comply with the obligations in paragraphs 2 and 3, the financial support granted to the strategic project may be suspended, revoked or recovered, in whole or in part, by the Member State concerned. In addition, the project promoter may be subject to an effective, proportionate and dissuasive financial penalty in accordance with national law of the Member State concerned or an exclusion from funding proportionate to the impact and severity of non-compliance.

     official amendment document ↗
127. Amendment 127Proposal for a regulation · Article 15 – paragraph 3 b (new)
     Amendment

     3b. Where there is a substantiated risk that export of a critical medicinal product or, where applicable, medicinal product of common interest, would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the project promoter benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited and targeted to safeguard public health within the Union.

     official amendment document ↗
128. Amendment 128Proposal for a regulation · Article 15 – paragraph 3 c (new)
     Amendment

     3c. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

     official amendment document ↗
129. Amendment 129Proposal for a regulation · Article 16 – paragraph 1
     Current text

     1. For the duration of the Multiannual Financial Framework 2021-202724 strategic projects may be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , and the Digital Europe Programme27 provided that such support is in line with the objectives set out in the regulations establishing those programmes. _________________ 24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for years 2021 to 2027, as amended (OJ LI 433, 22.12.2020, p.11, ELI: http://data.europa.eu/eli/reg/2020/2093/oj) 25 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establ…

     Amendment

     1. All the Union funding under the current and future Multiannual Financial Frameworks, including regional policy funding programmes, may support strategic projects unless explicitly excluded by the legal basis or the scope of relevant programmes and provided that such support is in line with the objectives set out in the regulations establishing those programmes.

     Excerpt — full text in the official PDF.
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130. Amendment 130Proposal for a regulation · Article 16 – paragraph 1 – subparagraph 1 a (new)
     Amendment

     Subject to a Council regulation laying down the multiannual financial framework for the years 2028 to 2034 (MFF 2028–2034), strategic projects may be supported by Union funding, including any relevant Union instrument financed within the limits of the ceilings established in the MFF 2028–2034, provided that such support is in line with the objectives set out in the regulations establishing any such relevant instrument. A critical medicines security fund shall be established within the framework of MFF 2028–2034, in coordination with other relevant Union instruments, to support the achievement of the objectives of this Regulation.

     official amendment document ↗
131. Amendment 131Proposal for a regulation · Article 16 – paragraph 1 – subparagraph 1 b (new)
     Amendment

     If a project promoter has received financial support for a strategic project from Union funding, it shall prioritise supply to the Union market and shall ensure that the critical medicinal product or, where applicable, medicinal product of common interest, remains available in the Member States where it is being marketed.

     official amendment document ↗
132. Amendment 132Proposal for a regulation · Article 16 – paragraph 2 a (new)
     Amendment

     2a. A project promoter receiving Union financial support under this Article shall comply with any obligations linked to such support including any reporting obligations pursuant to Article 57 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]. Where a project promoter fails to comply with those obligations, the Commission may suspend, revoke or recover the funding, 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 that is proportionate to the impact of the non-compliance, time-limited…

     Excerpt — full text in the official PDF.
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133. Amendment 133Proposal for a regulation · Article 16 – paragraph 2 b (new)
     Amendment

     2b. Where there is a substantiated risk that export of a critical medicinal product would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the project promoter benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited, and targeted to safeguard public health within the Union.

     official amendment document ↗
134. Amendment 134Proposal for a regulation · Article 16 – paragraph 2 c (new)
     Amendment

     2c. The Commission shall establish a ‘one-stop-shop’ to coordinate the award of Union funds pursuant to this Article and to support Member States’ authorities with the prioritisation of financial support to strategic projects pursuant to Article 15.

     official amendment document ↗
135. Amendment 135Proposal for a regulation · Article 16 – paragraph 2 d (new)
     Amendment

     2d. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

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136. Amendment 136Proposal for a regulation · Article 17 – paragraph 1
     Current text

     1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical Medicines Group’) referred to in Article 24 of the intention to provide financial support to strategic projects sufficiently in advance to allow the group to carry out its coordination task as set out in Article 25.

     Amendment

     1. Member States shall inform the Critical Medicines Coordination Group (‘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. This information shall include a description of how the project meets one or more of the criteria listed in Article 5.

     official amendment document ↗
137. Amendment 137Proposal for a regulation · Article 17 – paragraph 2 – subparagraph 1
     Current text

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

     Amendment

     The Commission shall regularly inform the Critical Medicines Group of the strategic projects that benefited from financial support from the Union including information on how these projects meet the criteria listed in Article 5.

     official amendment document ↗
138. Amendment 138Proposal for a regulation · Article 17 – paragraph 2 – subparagraph 2
     Current text

     The Commission may inform the Critical Medicines Group of the intention to propose the establishment of funding possibilities specifically designed to address vulnerabilities in the supply chains as well as inform of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

     Amendment

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

     official amendment document ↗
139. Amendment 139Proposal for a regulation · Article 18 – paragraph 1
     Current text

     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.

     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 implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs and the size of the patient population in consultation with healthcare professionals, with predictable procurement timelines and predictable mix and weighting of qualitative criteria, and shall 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 diversificat…

     Excerpt — full text in the official PDF.
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140. Amendment 140Proposal for a regulation · Article 18 – paragraph 1 a (new)
     Amendment

     1a. In contracts which provide for the possibility of unilateral prolongation by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

     official amendment document ↗
141. Amendment 141Proposal for a regulation · Article 18 – paragraph 2
     Current text

     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.

     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, while taking into account the distinctive characteristics of the supply chains of different medicinal products. Those requirements shall be applied in compliance with the Union’s international commitments.

     official amendment document ↗
142. Amendment 142Proposal for a regulation · Article 18 – paragraph 2 – subparagraph 1 a (new)
     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 substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; (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 EFTA countries; (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, wh…

     Excerpt — full text in the official PDF.
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143. Amendment 143Proposal for a regulation · Article 18 – paragraph 3
     Current text

     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.

     Amendment

     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 and shall take into account the distinctive characteristics of the supply chains of different medicinal products. These requirements shall be applied in compliance with the Union’s international commitments.

     official amendment document ↗
144. Amendment 144Proposal for a regulation · Article 18 – paragraph 3 – subparagraph 1 a (new)
     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 substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; 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 result…

     Excerpt — full text in the official PDF.
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145. Amendment 145Proposal for a regulation · Article 18 – paragraph 4
     Current text

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

     Amendment

     4. Procurement procedures under this Chapter shall, include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights.

     official amendment document ↗
146. Amendment 146Proposal for a regulation · Article 18 – paragraph 5
     Current text

     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.

     Amendment

     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 the application of those paragraphs would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be accompanied by a written justification specifying the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

     official amendment document ↗
147. Amendment 147Proposal for a regulation · Article 18 – paragraph 5 a (new)
     Amendment

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

     official amendment document ↗
148. Amendment 148Proposal for a regulation · Article 19 – paragraph 1
     Current text

     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.

     Amendment

     1. By 6 months after entry into force of this Regulation each Member State shall establish, after having consulted patient and consumer organisations and healthcare professional organisations, a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. National programmes shall include 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 beneficia…

     Excerpt — full text in the official PDF.
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149. Amendment 149Proposal for a regulation · Article 19 – paragraph 2
     Current text

     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.

     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, involving representatives of marketing authorisation holders, patient and consumer organisations and healthcare professional organisations, and other relevant actors in the supply chain, 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…

     Excerpt — full text in the official PDF.
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150. Amendment 150Proposal for a regulation · Article 20 – paragraph 1
     Current text

     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.

     Amendment

     Measures relating to security of supply applied in one or more Member States shall not result in any negative impact on the availability of critical medicinal products and medicinal products of common interest 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 economic operators to hold contingency stocks.

     official amendment document ↗
151. Amendment 151Proposal for a regulation · Article 20 – paragraph 2
     Current text

     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.

     Amendment

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

     official amendment document ↗
152. Amendment 152Proposal for a regulation · Article 20 – paragraph 2 a (new)
     Amendment

     Where Member Stats impose contingency stock requirements on economic operators, they shall notify the Commission and the Agency. Member States shall also encourage the implementation of rolling stockpiling systems amongst manufactures.

     official amendment document ↗
153. Amendment 153Proposal for a regulation · Article 20 – paragraph 2 b (new)
     Amendment

     All contingency stock requirements and other security of supply measures shall be implemented in a manner that minimises waste and environmental impact, including through effective stock rotation based on the ‘first expired, first out’ system to prevent the destruction of medicinal products.

     official amendment document ↗
154. Amendment 154Proposal for a regulation · Article 20 – paragraph 2 c (new)
     Amendment

     The Commission shall, following a consultation with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers, and marketing authorisation holders, issue Union guidelines recommending the establishment of common standards for contingency stocks and national stockpiles to support Member State activities, ensuring predictability for economic operators. Those common standards may include: (a) the establishment of maximum 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 ass…

     Excerpt — full text in the official PDF.
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155. Amendment 155Proposal for a regulation · Article 20 – paragraph 2 d (new)
     Amendment

     During health emergencies and crises, Member States authorities and Union preparedness authorities shall closely coordinate the distribution of critical medicinal products, in particular with systemic wholesalers, in order to ensure equitable and fair distribution. Member States may also undertake the distribution of critical medicinal products via their civil preparedness authorities or military authorities if deemed necessary in accordance with national law.

     official amendment document ↗
156. Amendment 156Proposal for a regulation · Chapter IV – Section I a (new)
     Amendment

     Ia UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS

     official amendment document ↗
157. Amendment 157Proposal for a regulation · Article 20 a (new)
     Amendment

     Article 20a Establishment of a Union coordination mechanism for critical medicinal products A Union coordination mechanism for national stockpiles and contingency stocks of critical medicinal products is hereby established. It shall be operated by the Commission in collaboration with the Agency and the Critical Medicines Coordination Group. Through that coordination mechanism, the Commission shall: (a) monitor the availability and distribution of critical medicinal products across the Union; (b) enable effective and equitable redistribution in cases of a shortage or a supply disruption in one or more Member States that has a negative impact on the internal market or on other Member States.

     official amendment document ↗
158. Amendment 158Proposal for a regulation · Article 20 b (new)
     Amendment

     Article20b Redistribution decisions 1. Where a shortage or a supply disruption of a critical medicinal product is identified in one or more Member States, the Commission shall, as a last resort and only after all other measures have been exhausted, including the voluntary mechanisms provided for in Union legislation, and upon a justified and substantiated request of one or more Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring redistribution from a national stockpile or a contingency stock. 2. Any distribution decision as referred to in the first paragraph shall: (a) be based on an objective risk assessment and regul…

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159. Amendment 159Proposal for a regulation · Article 20 c (new)
     Amendment

     Article 20c Appeal mechanism 1. A Member State concerned by a redistribution decision adopted and notified pursuant to Article 20b may submit a reasoned request for a review of the decision referred to in that Article. Such a request shall be submitted to the Commission within 10 days of the notification referred to in that Article and shall state in detail the reasons for which that Member State considers that the decision does not comply with the conditions laid down in that Article or that its application would pose a disproportionate risk to public health. 2. Following consultation of the Critical Medicines Coordination Group, the Commission shall adopt a review decision within 10 days o…

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160. Amendment 160Proposal for a regulation · Article 20 d (new)
     Amendment

     Article 20d Stockpile information and reporting obligations 1. 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 such national stockpiles or contingency stocks are established under national law. Each Member State shall report to the European Commission at least quarterly on the status of their national stockpiles and contingency stocks, and immediately upon any significant change in stock levels. 2. The report referred to in paragraph 1 shall include the following information: (a) a list of critical medicinal products for which contingency stocks or a national stockpile are…

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161. Amendment 161Proposal for a regulation · Article 20 e (new)
     Amendment

     Article 20e 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 5 of Regulation (EU) No 182/2011 shall apply.

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162. Amendment 162Proposal for a regulation · Article 20 f (new)
     Amendment

     Article 20f Obligations of Member States Where the Commission adopts a redistribution decision pursuant to Article 20b, Member States shall: (a) comply with that redistribution decision; (b) notify, without undue delay, the Commission and the Agency if they impose contingency stocks requirements on economic operators; (c) cooperate fully and without delay and, where necessary, provide mutual support to any other Member State that has requested assistance pursuant to Article 20b(1), with a view to preventing or mitigating shortages of critical medicinal products.

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163. Amendment 163Proposal for a regulation · Article 20 g (new)
     Amendment

     Article 20g Reimbursement and replacement 1. Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20b, it shall be entitled to full reimbursement from the receiving Member State for the value of the critical medicinal products transferred and the costs of transport and a reasonable mark-up. 2. The value of the medicinal products shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned. The transferring Member State or economic operator shall be entitled to reimbursement of the determined value as soon as pos…

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164. Amendment 164Proposal for a regulation · Article 20 h (new)
     Amendment

     Article 20h Union Stockpile 1. In order to ensure the timely and effective availability of critical medicinal products with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism to be activated in situations where the Union coordination mechanism for critical medicinal products indicates the existence of a recurrent or persistent shortage in national stockpiles and contingency stocks. 2. The Commission is empowered to adopt delegated acts in accordance with Article 30a to supplement this Regulation by establishing: (a) the categories and specific types of critical medicinal products to be included in the Union Stockpile; (b) the mi…

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165. Amendment 165Proposal for a regulation · Article 21 – paragraph 1
     Current text

     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. _________________ 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 ).

     Amendment

     1. Upon a reasoned request of three or more Member States (‘the request’), the Commission shall act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive 2014/24/EC of the European Parliament and of the Council for medicinal products of common interest.

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166. Amendment 166Proposal for a regulation · Article 21 – paragraph 3
     Current text

     3. The Commission shall assess the request in light of the objectives of this Regulation. The Commission shall communicate to the interested Member States its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request.

     Amendment

     3. The Commission shall assess the request in light of the objectives of this Regulation. The Commission shall communicate to the requesting Member States its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request. It shall inform the European Parliament thereof.

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167. Amendment 167Proposal for a regulation · Article 21 – paragraph 5
     Current text

     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.

     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 interested 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.

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168. Amendment 168Proposal for a regulation · Article 21 – paragraph 6
     Current text

     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.

     Amendment

     6. The facilitation offered by the Commission shall be limited in time and end, unless otherwise requested by the requesting Member States, upon signature of the procurement contract by the participating contracting authorities. Where requested by requesting Member States, the facilitation offered by the Commission shall end upon delivery of the medicinal products of common interest.

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169. Amendment 169Proposal for a regulation · Article 21 – paragraph 6 a (new)
     Amendment

     6a. The Commission shall act as a facilitator under this Article subject to the acceptance of the following conditions by the requesting Member States: (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patients needs in their territory; (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; (c) participating Member States, for the duration of the contract, refrai…

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170. Amendment 170Proposal for a regulation · Article 21 – paragraph 7 a (new)
     Amendment

     7a. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein and with which the Union has entered into a bilateral agreement governing the facilitation of cross-border procurement, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the need for three or more Member States to initiate the procedure.

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171. Amendment 171Proposal for a regulation · Article 22 – paragraph 1 – introductory part
     Current text

     1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where nine or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

     Amendment

     1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where five or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission shall initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below:

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172. Amendment 172Proposal for a regulation · Article 22 – paragraph 2
     Current text

     2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

     Amendment

     2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply, availability and affordability of critical medicinal products in the Union or to ensure the availability, accessibility and affordability of medicinal products of common interest, as applicable.

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173. Amendment 173Proposal for a regulation · Article 22 – paragraph 3
     Current text

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

     Amendment

     3. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the joint request referred to in paragraph 1, through the Critical Medicines Group, and invite them to join the procedure.

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174. Amendment 174Proposal for a regulation · Article 22 – paragraph 4
     Current text

     4. The Commission shall assess the utility, necessity and proportionality of the request and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

     Amendment

     4. The Commission shall assess the utility, necessity and proportionality of the joint request referred to in paragraph 1 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.

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175. Amendment 175Proposal for a regulation · Article 22 – paragraph 5
     Current text

     5. The Commission shall inform the interested Member States within one month of the request of its decision and state its reasons in case of a refusal.

     Amendment

     5. The Commission shall communicate to the requesting Member States its decision within one month of the request of its decision and state its reasons in case of a refusal. It shall inform the European Parliament thereof.

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176. Amendment 176Proposal for a regulation · Article 22 – paragraph 5 a (new)
     Amendment

     5a. The Commission shall ensure that any procurement procedure under this Article applies to the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

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177. Amendment 177Proposal for a regulation · Article 22 – paragraph 5 b (new)
     Amendment

     5b. The Commission shall conduct a procurement on behalf or in the name of Member States under this Article subject to the acceptance of the following conditions by the requesting Member States: (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their territory; (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; (c) participating Member States…

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178. Amendment 178Proposal for a regulation · Article 22 – paragraph 5 c (new)
     Amendment

     5c. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procurement procedure established herein and with which the Union has concluded a bilateral agreement providing for such a participation, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the requirement of a minimum of five participating Member States in accordance with paragraph 1.

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179. Amendment 179Proposal for a regulation · Article 22 – paragraph 6
     Current text

     6. If in light of the Commission assessment, it is necessary, in order to achieve the objectives of this Regulation, to conduct the procurement as exclusive for the Member States or to agree to minimum binding quantities, the Commission agreement to pursue the procedure may be conditioned upon acceptance of these conditions by interested Member States.

     Amendment

     deleted

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180. Amendment 180Proposal for a regulation · Article 23 – paragraph 1
     Current text

     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.

     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 five Member States may engage, as contracting parties, in a joint procurement procedure.

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181. Amendment 181Proposal for a regulation · Article 23 – paragraph 2 – introductory part
     Current text

     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:

     Amendment

     2. A joint procurement procedure shall be organised following a request by the Member States or may be organised at the Commission’s initiative when the procurement relates to medicinal products belonging to one of the categories below:

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182. Amendment 182Proposal for a regulation · Article 23 – paragraph 3
     Current text

     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.

     Amendment

     3. The Commission may decide to conduct the joint procurement procedure if the procurement procedure helps to improve the security of supply, availability and affordability of critical medicinal products in the Union or to ensure the availability, accessibility and affordability of medicinal products of common interest, as applicable.

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183. Amendment 183Proposal for a regulation · Article 23 – paragraph 4
     Current text

     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.

     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. It shall inform the European Parliament thereof.

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184. Amendment 184Proposal for a regulation · Article 23 – paragraph 5
     Current text

     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.

     Amendment

     5. The Commission shall assess the necessity of a joint action and whether the request referred in paragraph 2 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.

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185. Amendment 185Proposal for a regulation · Article 23 – paragraph 5 a (new)
     Amendment

     5a. The Commission shall ensure that any procurement procedure under this Article applies to the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

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186. Amendment 186Proposal for a regulation · Article 23 – paragraph 5 b (new)
     Amendment

     5b. The Commission shall conduct a joint procurement under this Article subject to the acceptance of the following conditions by requesting Member States: (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their territory; (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; (c) participating Member States, for the duration of the contract, refr…

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187. Amendment 187Proposal for a regulation · Article 23 – paragraph 5 c (new)
     Amendment

     5c. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein and with which the Union has entered into a bilateral agreement governing the procurement activities referenced in this Article, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the need for five Member States to engage in the procedure.

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188. Amendment 188Proposal for a regulation · Article 23 – paragraph 6
     Current text

     6. If in light of the Commission assessment, it is necessary, in order to achieve the objectives of this Regulation, to conduct the procurement as exclusive for the Member States or to agree to minimum binding quantities, the Commission agreement to pursue the procedure may be conditioned upon acceptance of these conditions by interested Member States.

     Amendment

     deleted

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189. Amendment 189Proposal for a regulation · Article 23 – paragraph 7
     Current text

     7. The Commission shall inform the interested Member States within one month of the request of its decision and state its reasons in case of a refusal.

     Amendment

     7. The Commission shall communicate to the requesting Member States its decision within one month of the request, and state its reasons in case of a refusal.

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190. Amendment 190Proposal for a regulation · Article 24 – paragraph 1
     Current text

     1. Member States participating in the procurement procedures covered by Articles 22 and 23 shall share with the Commission any information relevant for the procurement procedure. Member States shall provide resources necessary for the successful conclusion of the procedure, in particular through involvement of staff with expertise and knowledge.

     Amendment

     1. Member States participating in the procurement procedures covered by Articles 22 and 23 shall share with the Commission any information relevant for the procurement procedure. Member States shall provide resources necessary for the successful conclusion of the procedure, in particular through involvement of staff with expertise and knowledge. Procurement procedures shall ensure that smaller Member States and SMEs can participate effectively, avoiding market distortion and ensuring equitable access to critical medicinal products.

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191. Amendment 191Proposal for a regulation · Article 24 – paragraph 2
     Current text

     2. An agreement between the Member States and the Commission shall determine the practical arrangements governing the procurement procedure, liabilities to be assumed and the decision-making process.

     Amendment

     2. An agreement between the Member States and the Commission shall determine the practical arrangements governing the procurement procedure, liabilities to be assumed and the decision-making process. Those practical arrangements shall also cover, where appropriate, the designation of the contracting authority, the distribution of procured stocks, and the identification of storage locations. Regulatory flexibilities may be granted with regard to packaging and labelling requirements, including the use of electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

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192. Amendment 192Proposal for a regulation · Article 24 – paragraph 2 a (new)
     Amendment

     2a. The Commission shall, following a consultation with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers, and marketing authorisation holders, issue Union guidelines recommending common standards for procurement activities under Articles 22 and 23 of this Regulation, ensuring predictability for companies.

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193. Amendment 193Proposal for a regulation · Article 25 – paragraph 2
     Current text

     2. The Member States and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall have an observer status.

     Amendment

     2. The Member States, the Agency, the Commission and representatives from patient organisations and healthcare professional organisations shall be 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 representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of th…

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194. Amendment 194Proposal for a regulation · Article 25 – paragraph 2 a (new)
     Amendment

     2a. The representatives appointed to the Critical Medicines Group and its working group or working groups shall make a declaration of their financial and other interests and update it annually and whenever necessary. They shall disclose any other facts of which they become aware that might in good faith reasonably be expected to involve, or give rise to, a conflict of interest.

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195. Amendment 195Proposal for a regulation · Article 25 – paragraph 3
     Current text

     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.

     Amendment

     3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the Commission and national authorities responsible for medicinal products. For discussions where input from the national regulatory authorities’ responsible for medicinal products' perspective is necessary, the Critical Medicines Group and the MSSG shall organise joint meetings. The Group shall also cooperate closely with patient and consumer organisations, healthcare professional organisations, and relevant marketing authorisation holders to fulfil its tasks, consulting them and other stakeholders as needed, including through structured joint meetings.

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196. Amendment 196Proposal for a regulation · Article 25 – paragraph 4
     Current text

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

     Amendment

     4. The Commission, acting as the Secretariat of the Critical Medicines Group, shall organise regular meetings and coordinate the work of the Critical Medicines Group.

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197. Amendment 197Proposal for a regulation · Article 25 – paragraph 6
     Current text

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

     Amendment

     6. The Critical Medicines Group, at the proposal of the Chair or any of its members, may, on a case-by-case basis, decide to establish one or more working groups.

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198. Amendment 198Proposal for a regulation · Article 25 – paragraph 6 a (new)
     Amendment

     6a. The Critical Medicines Group shall have biannual meetings, and additional meetings when needed, to consult with the Critical Medicines Alliance on vulnerabilities in supply chains and on mitigation measures to address structural risks and reinforce supply. The Critical Medicines Group shall take into account the findings from the Critical Medicines Alliance, where relevant. The Commission, as the Group’s secretariat, shall ensure regular and transparent communication with the Alliance.

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199. Amendment 199Proposal for a regulation · Article 26 – paragraph 1
     Current text

     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.

     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 or on national healthcare systems.

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200. Amendment 200Proposal for a regulation · Article 26 – paragraph 1 a (new)
     Amendment

     1a. The Critical Medicines Group shall include in its rules of procedure provisions for the systematic consultation of Union and national patient organisations and other relevant stakeholder to encourage the exchange of information about the working group’s activities and promote transparency. It shall ensure alignment and data coherence with the EMA’s MSSG.

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201. Amendment 201Proposal for a regulation · Article 26 – paragraph 2 – introductory part
     Current text

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

     Amendment

     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 of protection of commercial confidential information:

     official amendment document ↗
202. Amendment 202Proposal for a regulation · Article 26 – paragraph 2 – point a
     Current text

     (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;

     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, as well as critical distribution infrastructure capacity and facilitate discussion on the capacity needed in the Union to strengthen its supply security, availability and affordability of critical medicinal products, active substances and key inputs 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;

     official amendment document ↗
203. Amendment 203Proposal for a regulation · Article 26 – paragraph 2 – point c a (new)
     Amendment

     (ca) issue guidelines on measures to support availability and affordability in the Union market of critical medicinal products in the context of strategic projects that have received financial support;

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204. Amendment 204Proposal for a regulation · Article 26 – paragraph 2 – point d
     Current text

     (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.

     Amendment

     (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;

     official amendment document ↗
205. Amendment 205Proposal for a regulation · Article 26 – paragraph 2 – point d a (new)
     Amendment

     (da) facilitate discussion and exchange among members of the Critical Medicines Group and, where appropriate, coordinate and exchange with the EU stockpiling network, as established by the Commission with Member States, in relation to Article 20, specifically sharing best practices in stock management, including real-time tracking, condition monitoring, expiry alerts, stock rotation, shelf-life and waste management, including waste reduction facilities, and evaluations where necessary;

     official amendment document ↗
206. Amendment 206Proposal for a regulation · Article 26 – paragraph 2 – point d b (new)
     Amendment

     (db) assess national stockpiling strategies, their proportionality, compatibility with the internal market, and feasibility for implementation by industry, and, where appropriate, issue recommendations on Union-wide minimum standards;

     official amendment document ↗
207. Amendment 207Proposal for a regulation · Article 26 – paragraph 2 – point d c (new)
     Amendment

     (dc) decide on whether to give to the Commission its prior approval to requests for the redistribution of critical medicinal products submitted by one or more Member States pursuant to Article 20b in the event of a shortage or supply disruption;

     official amendment document ↗
208. Amendment 208Proposal for a regulation · Article 26 – paragraph 2 – point d d (new)
     Amendment

     (dd) assess Union needs to determine whether specific projects concerning medicinal products of common interest should qualify as strategic projects;

     official amendment document ↗
209. Amendment 209Proposal for a regulation · Article 26 – paragraph 2 – point d e (new)
     Amendment

     (de) assess Union needs to reserve a defined portion of manufacturing capacity, within a fixed timeframe, for the production of specific medicinal products, including their pharmaceutical forms, active substances, key inputs, or enabling technologies;

     official amendment document ↗
210. Amendment 210Proposal for a regulation · Article 26 – paragraph 2 – point d f (new)
     Amendment

     (df) assess, in accordance with Article 6, whether a proposed strategic project would result in a significant duplication of existing or planned manufacturing capacities within the Union;

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211. Amendment 211Proposal for a regulation · Article 26 – paragraph 2 – point d g (new)
     Amendment

     (dg) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of national programmes referred to in Article 19, ensuring proportionality and avoiding duplication;

     official amendment document ↗
212. Amendment 212Proposal for a regulation · Article 26 – paragraph 2 – point d h (new)
     Amendment

     (dh) based on relevant financial expertise, examine the bottlenecks and Union wide financial needs of strategic projects, advise on ways of coordinating Union and national financing with regard to those financial needs, and share best practices;

     official amendment document ↗
213. Amendment 213Proposal for a regulation · Article 26 – paragraph 2 – point d i (new)
     Amendment

     (di) establish the process for the strategic foresight report and prepare the annual strategic foresight report on strategic projects in accordance with Article 26a;

     official amendment document ↗
214. Amendment 214Proposal for a regulation · Article 26 – paragraph 2 – point d j (new)
     Amendment

     (dj) issue a recommendation concerning the applicability of any of the provisions referred to in Article 2(2a) to medicinal products of common interest.

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215. Amendment 215Proposal for a regulation · Article 26 – paragraph 2 a (new)
     Amendment

     2a. In carrying out the task referred to in paragraph 2(dc) 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.

     official amendment document ↗
216. Amendment 216Proposal for a regulation · Article 26 – paragraph 5 a (new)
     Amendment

     5a. The Critical Medicines Group shall assess the Union-wide financial needs of strategic projects and issue recommendations on how to ensure adequate financing, including through the Union budget, in order to support the achievement of the objectives of this Regulation; and advise on the coordination of financing by the Union, Member States, the European Investment Bank and the private sector.

     official amendment document ↗
217. Amendment 217Proposal for a regulation · Article 26 a (new)
     Amendment

     Article 26a Strategic Foresight on Critical Medicinal Products 1. In order to strengthen the Union’s preparedness and ensure a coordinated approach to future challenges in the supply of critical medicinal products, the Critical Medicines Group shall establish a strategic foresight process. 2. The strategic foresight process shall be established after consultation with the Commission, the Agency, and the Critical Medicines Alliance. 3. The strategic foresight process shall identify medicinal products of common interest that would advance the objectives of this Regulation if included in Chapter III. 4. The strategic foresight process shall identify and assess potential strategic projects, taki…

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218. Amendment 218Proposal for a regulation · Article 27 – title
     Current text

     Strategic partnerships

     Amendment

     International cooperation and strategic partnerships

     official amendment document ↗
219. Amendment 219Proposal for a regulation · Article 27 – paragraph 1
     Current text

     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.

     Amendment

     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 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.

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220. Amendment 220Proposal for a regulation · Article 27 – paragraph 1 a (new)
     Amendment

     The Commission shall endeavour to incorporate health security aspects into strategic partnerships. Such aspects 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. The Commission shall endeavour to include access to active substances and API starting materials within strategic partnerships, in order to ensure timely availability of critical medicinal products under this mechanism.

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221. Amendment 221Proposal for a regulation · Article 27 – paragraph 1 b (new)
     Amendment

     The Commission shall establish and regularly update a list of countries that meet Union regulatory standards for the quality and safety of medicinal products, including key inputs and active substances. It shall make that list available to contracting authorities and healthcare professionals involved in the selection, procurement, prescribing, management, dispensing, and monitoring of such products.

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222. Amendment 222Proposal for a regulation · Article 27 – paragraph 1 c (new)
     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.

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223. Amendment 223Proposal for a regulation · Article 27 – paragraph 1 d (new)
     Amendment

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

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224. Amendment 224Proposal for a regulation · Article 27 – paragraph 1 e (new)
     Amendment

     The Commission shall, within the framework of strategic partnerships, promote the harmonisation of Union quality, safety and environmental standards for pharmaceutical production between the Union and third countries.

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225. Amendment 225Proposal for a regulation · Article 27 – paragraph 1 f (new)
     Amendment

     By ... [two years from the entry into force of this Regulation], the Commission shall develop 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.

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226. Amendment 226Proposal for a regulation · Article 27 – paragraph 1 g (new)
     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.

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227. Amendment 227Proposal for a regulation · Article 27 – paragraph 1 h (new)
     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 and key inputs in the Union and globally.

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228. Amendment 228Proposal for a regulation · Article 28 – paragraph 1 – point a · Regulation (EU) 2024/795 · Article 2 – paragraph 1 – point a – point iii
     Current text

     (iii) biotechnologies, and any other technologies relevant for manufacturing of critical medicinal products as defined in Critical Medicines Act *; _________ * Regulation (EU) … of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as for improving the availability of, and access to, medicinal products of common interest, and amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed with the definitive title of the ‘Critical Medicines Act’ and with its publications references once they are available]

     Amendment

     (iii) biotechnologies, and directly related enabling technologies necessary for the development or manufacturing of critical medicinal products, including their active substances and key inputs, as defined in Critical Medicines Act*; _________ * Regulation (EU) … of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as for improving the availability of, and access to, medicinal products of common interest, and amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed with the definitive title of the ‘Critical Medicines Act’ and with its publications references once they…

     Excerpt — full text in the official PDF.
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229. Amendment 229Proposal for a regulation · Article 29 – paragraph 1
     Current text

     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.

     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, the Agency or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

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230. Amendment 230Proposal for a regulation · Article 29 – paragraph 2
     Current text

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

     Amendment

     2. The Commission, the Agency and national authorities of the Member States shall take all appropriate measures to avoid duplication of the information requested and submitted, making full use of information already available to them under Union pharmaceutical legislation, including data submitted in the context of marketing authorisation procedures, variations, inspections, and other regulatory filings, so as to minimise additional administrative burden on economic operators. Requests for supplementary information shall be limited to what is necessary to ensure effective monitoring, analysis and assessment.

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231. Amendment 231Proposal for a regulation · Article 29 – paragraph 3
     Current text

     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.

     Amendment

     3. The Commission, the Agency and the competent 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, shall protect any information that is commercially confidential against unjustified disclosure, and shall restrict access to such information strictly to staff responsible for applying this Regulation. The Commission and the national authorities, their officials, employees and other persons working under the supervision of those authorities shall ensure the confidentiality of information obtained in carrying out their…

     Excerpt — full text in the official PDF.
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232. Amendment 232Proposal for a regulation · Article 29 a (new)
     Amendment

     Article 29a Obligation of the Commission to collect information on medicinal products with no adequate Union substitute 1. The Commission shall collect the necessary information from the Agency and national authorities of the Member States and establish, taking as a basis the list of critical shortages of medicinal products referred to in Chapter X of Regulation (EU) No …/… [reference to be added after adoption cf. COM(2023) 193 final], a list of critical medicinal products originating from third countries for which no adequate substitute produced within the Union is available. The Commission shall maintain and keep that list regularly updated. 2. The list referred to in paragraph 1 shall se…

     Excerpt — full text in the official PDF.
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233. Amendment 233Proposal for a regulation · Article 30 – paragraph 1
     Current text

     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.

     Amendment

     1. The Commission shall regularly 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 within its evaluation assess the impact of other relevant Union legislation on 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.

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234. Amendment 234Proposal for a regulation · Article 30 – paragraph 2
     Current text

     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.

     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. The evaluation shall in particular assess:

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235. Amendment 235Proposal for a regulation · Article 30 – paragraph 2 – point a (new)
     Amendment

     (a) data on the number of new manufacturing sites opened or modernised within the Union and the number of existing manufacturing lines extended;

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236. Amendment 236Proposal for a regulation · Article 30 – paragraph 2 – point b (new)
     Amendment

     (b) the number and nature of projects confirmed, supported, or recommended by the Critical Medicines Group under this Regulation;

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237. Amendment 237Proposal for a regulation · Article 30 – paragraph 2 – point c (new)
     Amendment

     (c) progress made in diversifying sources of active substances, starting materials, and other key inputs;

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238. Amendment 238Proposal for a regulation · Article 30 – paragraph 2 – point d (new)
     Amendment

     (d) the effectiveness of measures adopted to mitigate structural risks and strengthen supply resilience;

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239. Amendment 239Proposal for a regulation · Article 30 – paragraph 2 – point e (new)
     Amendment

     (e) unintended effects on market concentration, competition including impact on SMEs, innovation incentives, or barriers to entry, and assess whether the Regulation remains proportionate and effective.

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240. Amendment 240Proposal for a regulation · Article 30 – paragraph 3
     Current text

     3. The national authorities and the economic operators shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1.

     Amendment

     3. The national authorities and the economic operators, patient and consumer organisations, as well as healthcare professional organisations shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1.

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241. Amendment 241Proposal for a regulation · Article 30 – paragraph 3 a (new)
     Amendment

     3a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.

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242. Amendment 242Proposal for a regulation · Article 30 a (new)
     Amendment

     Article 30a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 20g(4) and 20h(2) shall be conferred on the Commission for an indeterminate period from … [date of application of this Regulation]. 3. The delegation of power referred to in Articles 20g(4) and 20h(2) 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…

     Excerpt — full text in the official PDF.
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243. Amendment 243The LeftProposal for a regulation · Recital 1 a (new)
     Amendment

     (1 a) The Critical Medicines Act should contribute to the achievement of the Union’s commitments on gender equality, as set out in the EU Gender Equality Strategy 2020–2025 and Article 8 TFEU requiring gender mainstreaming in all Union policies

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244. Amendment 244The LeftProposal for a regulation · Recital 3 a (new)
     Amendment

     (3 a) Shortages of medicines disproportionately affect women, particularly in areas such as reproductive health, maternal health, menopause treatment, and female cancers. This Regulation should take into account the gender impact and provide for specific measures to address gender inequalities and safeguard equitable access to medicines.

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245. Amendment 245The LeftProposal for a regulation · Recital 12 a (new)
     Amendment

     (12 a) To ensure Europe’s long-term strategic autonomy in the pharmaceutical sector, it is imperative to establish a long-term planification of the industrial policy based on societal needs and the general interest. This policy must prioritise the reinforcement of European manufacturing capacities through strategic projects that secure the raw materials supply, the continuous and reliable production of medicines and active pharmaceutical ingredients within the Union. By investing in research and innovation, supporting the modernisation of infrastructure, guarantying quality working conditions and promoting sustainable and circular production, the EU can both strengthen its industrial base an…

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246. Amendment 246The LeftProposal for a regulation · Recital 22
     Current text

     (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 vulnera…

     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 , European Defence Fund, 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 projec…

     Excerpt — full text in the official PDF.
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247. Amendment 247The LeftProposal for a regulation · Recital 22 a (new)
     Amendment

     (22 a) On 9 March 2025, 11 Union Health Ministers signed a letter stating that the Critical Medicines Act must be expanded into an effective, full-scale strategic programme, backed by EU defence funding, to secure the continent’s strategic autonomy and that anything less would be a grave miscalculation that could turn the Union's dependence on critical medicines into the Achilles’ heel of Europe’s security. In that context, it is essential that the Critical Medicines Act and the newly proposed Critical Medicines Security Fund act as robust instruments and that part of their funding be embedded in broader EU defence spending plans, including the financial mechanisms in the new Rearm Europe Pl…

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248. Amendment 248The LeftProposal for a regulation · Article 3 – paragraph 1 – point 5
     Current text

     (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;

     Amendment

     (5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in one 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;

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249. Amendment 249The LeftProposal for a regulation · Article 16 – paragraph 1
     Current text

     1. For the duration of the Multiannual Financial Framework 2021-202724 strategic projects may be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , and the Digital Europe Programme27 provided that such support is in line with the objectives set out in the regulations establishing those programmes. _________________ 24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for years 2021 to 2027, as amended (OJ LI 433, 22.12.2020, p.11, ELI: http://data.europa.eu/eli/reg/2020/2093/oj) 25 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establ…

     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 , European Defence Fund, the Digital Europe Programme27 as well as the European Regional Development Fund and the Cohesion fund provided that such support is in line with the objectives set out in the regulations establishing those programmes. The amount of the Union support available for the Strategig projects during the designated period shall not be less than EUR 300 billion. _________________ 24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual fi…

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250. Amendment 250The LeftProposal for a regulation · Article 16 – paragraph 2 a (new)
     Amendment

     2 a. Undertakings benefiting from Union funding must comply with sectorial collective agreements, offer good working conditions and decent wages. They shall not be allowed to distribute excessive dividends, resort to tax heavens, or proceed with collective layoffs and shall reimburse public funding received in case of non-compliance with their obligations. They shall also comply with their obligations related to social and environmental reporting. Undertakings that do not comply with labour law and health and safety regulations shall not be able to benefit from direct public subsidies and shall be excluded from public procurement tendering procedures.

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251. Amendment 251The LeftProposal for a regulation · Article 22 – paragraph 1 – introductory part
     Current text

     1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where nine or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

     Amendment

     1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where three or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

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252. Amendment 252The LeftProposal for a regulation · Article 23 – paragraph 1
     Current text

     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.

     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 three Member States may engage, as contracting parties, in a joint procurement procedure.

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253. Amendment 253ECRProposal for a regulation · Recital 42 a (new)
     Amendment

     (42 a) The availability of critical medicines might be affected by Union legislation in other sectors, in particular environmental legislation such as the Urban Wastewater Treatment Directive. In order to ensure coherence and avoid unintended consequences leading to shortages, it is important to assess the impact of such measures on the supply of medicines.

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254. Amendment 254ECRProposal for a regulation · Article 12 a (new)
     Amendment

     Article12a Coordination with environmental and chemical legislation The Commission and the Member States shall ensure that the application of this Regulation is coordinated with existing and forthcoming environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products and ensure the future availability of critical medicinal products, while maintaining the best possible environmental and health standards. Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products, the Commission shall conduct a coordinated impact assessment and consult wi…

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255. Amendment 255ECRProposal for a regulation · Article 30 – paragraph 2 a (new)
     Amendment

     2 a. The Commission shall carry out a yearly assessment of the impact of the Urban Wastewater Treatment Directive, and in particular of the extended producer responsibility provisions set out in Article 9 and 10 thereof and Annex III thereto, on the availability or security of supply of critical medicines in the Union. Where such assessments identify a negative impact on the availability of critical medicines, Member States shall temporarily suspend the application of the extended producer responsibility provisions until appropriate mitigating measures are adopted.

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256. Amendment 256RenewProposal for a regulation · Recital 12 a (new)
     Amendment

     (12 a) Contraceptives and abortifacient medicinal products are essential in safeguarding sexual and reproductive health rights, gender equality and the full enjoyment of fundamental rights everywhere in the Union. Shortages and supply disruptions affecting these medicinal products of common interest undermine patient safety and contribute to unequal access to healthcare across the Union. In order to safeguard sexual and reproductive health rights and equal access to contraceptive and abortifacient medicinal products for all women in the Union, Member States should ensure availability, affordability and security of supply of these medicinal products of common interest.

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257. Amendment 257RenewProposal for a regulation · Article 3 – paragraph 1 – point 5
     Current text

     (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;

     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, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or is designated as an orphan medicinal product pursuant to Article 67 of Regulation (EU).../... [reference to be added after adoption cf. COM(2023)193 final)], or as a contraceptive or abortifacient medicinal product;

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258. Amendment 258ESNProposal for a regulation

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259. Amendment 259PfEProposal for a regulation · Recital 4
     Current text

     (4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages…

     Amendment

     (4) Industrial challenges, burdensome EU environmental legislation and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances imported from China and India. Setting up new, expanding or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser envir…

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260. Amendment 260PfEProposal for a regulation · Article 30 – paragraph 3 a (new)
     Amendment

     3 a. The Commission shall regularly monitor the coordinated application of this Regulation with environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products. Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products, the Commission shall carry out a coordinated impact assessment and consult with the Critical Medicines Group to propose appropriate mitigating actions, including, where appropriate, legislative proposals.

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