Sittings · Document

Adopted text 2026-01-20

Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest

P10_TA(2026)0001

Committee on Public Health

PE775.742

Amendments adopted by the European Parliament on 20 January 2026 on the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

(Ordinary legislative procedure: first reading)

Amendment 1

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

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

Amendment 2

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages of medicinal products for which insufficient supply results in serious harm or risk of serious harm to patients.

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages of medicinal products for which insufficient supply and lack of transparency of supply chains results in serious harm or risk of serious harm to patients and healthcare systems.

Amendment 3

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

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.

Amendment 4

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Shortages of medicinal products can have very different and complex root causes, with challenges identified along the entire pharmaceutical value chain. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. These include existing dependencies on a limited number of suppliers globally and lack of Union capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, the Union can reduce its risk of exposure to shortages of medicinal products.

(3) Shortages of medicinal products 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 production, the Union can reduce its risk of exposure to shortages of medicinal products.

Amendment 5

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, expanding or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicinal products whilst upholding the highest social, health and environmental standards. Moreover, strengthening skills and knowledge transfer will help build a resilient and future-ready workforce capable of smoothly embracing innovation and technological advancement. At the same time, developing manufacturing capacity throughout the supply chain requires substantial long-term investment, adequate industrial infrastructure, strong research capabilities, regulatory predictability and a skilled workforce.

Amendment 6

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

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 (APIs) from third countries. Consequently, the Union relies on a limited number of API suppliers and manufacturers, many located outside its borders.

Amendment 7

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) However, despite regulatory obligations on marketing authorisation holders to ensure the continuous supply of medicinal products to meet patients’ demand and the additional regulatory mechanism introduced by Regulation of the European Parliament and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final] to mitigate and respond to shortages, the functioning of markets alone does not always guarantee the availability of medicinal products. This risk is particularly evident in cases of supply chain disruptions, especially when the supply of a given medicinal product relies on a limited number of global suppliers and production facilities or where there is a high dependency on a single or a limited number of third countries.

(7) However, despite regulatory obligations on marketing authorisation holders to ensure the continuous supply of medicinal products to meet patients’ needs and the additional regulatory mechanism introduced by Regulation of the European Parliament and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final] to mitigate and respond to shortages, the functioning of markets alone does not always guarantee the availability of medicinal products. This risk is particularly evident in cases of supply chain disruptions, especially when the supply of a given medicinal product relies on a limited number of global suppliers and production facilities or where there is a high dependency on a single or a limited number of third countries.

Amendment 8

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) As the Union market for medicinal products remains fragmented, there is a need for better coordination between Member States to leverage in full the Union’s potential to strengthen the security of supply of medicinal products, without calling into question Member States’ responsibilities for the organisation and delivery of health services and medical care, 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 therefore needs to be complemented by targeted actions providing for further harmonisation, while avoiding duplication or overlap of existing structures. Furthermore, existing data infrastructures and databases should be fully leveraged in order to reduce reporting burdens, streamline the monitoring of medicinal product supply chains, and improve the efficiency of data exchanges between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

Amendment 9

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available 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 aims at strengthening the resilience of supply chains, addressing concrete security-of-supply vulnerabilities, and reducing such inequalities among Member States, ensuring more equitable access to medicinal products across the Union, so that patients enjoy the same level of access regardless of their country of residence.

Amendment 10

Proposal for a regulation

Recital 11

Text proposed by the Commission

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 aid rules. The implementation of this Regulation should be coherent with Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space (EHDS) to enhance the interoperability, secure exchange, and real-time monitoring of health data relevant to the availability and supply of medicinal products. Improved integration between this Regulation and the EHDS will contribute to early detection of shortages, cross-border distribution, and streamlined access to critical medicinal products.

Amendment 11

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) While the primary objective of this Regulation should be to strengthen the security of supply and ensure the availability of critical medicinal products and of medicinal products of common interest, given a lack of critical medicinal products can affect the functioning of the economy as a whole, this Regulation should also support the Union’s competitiveness by fostering a more stable and predictable market environment, 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, more targeted cancer therapies, as well as other medicinal products responding to unmet medical needs. Ensuring the security of supply and availability of critical medicinal products and the availability and accessibility of other medicinal products of common interest should moreover contribute to the Union’s preparedness, resilience, strategic autonomy and economic and overall security, including when cross-border supply chains risk being disrupted. The past health emergencies and crises, like COVID-19, have demonstrated how the presence of critical infrastructures, including hospitals and community pharmacies, has been fundamental in achieving these objectives. Furthermore, in order to strengthen the functioning of the internal market and to ensure the uninterrupted availability of critical medicinal products across the Union, it is necessary to establish a Union coordination mechanism for critical medicinal products. Such a mechanism would enhance the Union capacity to address shortages, strengthen supply chain resilience, and enable coordinated approaches to national stockpiling and contingency stocks.

Amendment 256

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission

Amendment

(12 a) Contraceptives and abortifacient medicinal products are essential for 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 the availability, affordability and security of supply of these medicinal products of common interest.

Amendment 12

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission

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.

Amendment 13

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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.

(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.

Amendment 14

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

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 market. Ensuring a sustainable supply of low-volume, high-value antimicrobials, is therefore necessary.

Amendment 15

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

(16a) In order to ensure legal clarity and effective coordination at Union level, it is essential to distinguish between ‘contingency stock’ and ‘national stockpile’. Those two concepts refer to different types of reserves, governed by distinct legal and operational frameworks, and serving different purposes within the supply chain and public health preparedness. Thus, a clear differentiation is necessary to avoid confusion in reporting and management, and to support targeted and proportionate Union-level actions during supply disruptions or emergencies. In the context of contingency stocks and national stockpiles, Member States should be encouraged to explore sustainable measures that contribute to reducing waste and improving the efficient use of available medicinal products in line with national law and national needs.

Amendment 16

Proposal for a regulation

Recital 16 b (new)

Text proposed by the Commission

Amendment

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

Amendment 17

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

(17) Certain projects 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 authorities should be provided with adequate resources to ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, whilst upholding the highest social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information. To ensure the efficient use of resources and strategic coherence at Union level, the designation of strategic projects should avoid unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs, unless such duplication is justified by clearly demonstrated needs.

Amendment 18

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

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.

Amendment 19

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs) and small mid-cap enterprises (SMCs), as well as entities not engaged in an economic activity, with a view to ensuring that they have a fair chance to initiate strategic projects. Member States and designated authorities should pay particular attention to minimising the administrative burden on SMEs and SMCs and should provide support and clear guidance through application, permitting and regulatory processes. Furthermore, requirements should be applied in a manner that guarantees fair and equal competition among all market players, regardless of their ownership structure. To support the effective implementation of this Regulation, the Commission should provide guidance to national authorities and project promoters, intended as a practical support tool. Such guidance should assist in the preparation, determination and support of strategic projects.

Amendment 20

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

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.

Amendment 21

Proposal for a regulation

Recital 18 b (new)

Text proposed by the Commission

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.

Amendment 22

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

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

Amendment 23

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complies with the Union’s State aid rules. For this purpose, specific guidance to clarify the application of EU State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Amendment 24

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Union-level funding may be leveraged to facilitate investments in strategic projects. Strategic projects may benefit from access to existing EU funding instruments, such as the EU4Health Programme4 , Digital Europe Programme5 and Horizon Europe6 (relevant, for example, for active substances referred to in Article 5(d) of Regulation (EU)2021/695), as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the criteria established in these instruments. Authorities in charge of the Union programmes covered by Regulation (EU) 2024/795 of the European Parliament and of the Council7 (STEP) should in particular consider supporting strategic projects addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended.

(22) 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 this framework, and in coordination with other relevant Union instruments, a Union medicinal security fund should be established in order to reinforce the Union’s strategic capacity to ensure a secure, resilient and sustainable supply of medicinal products, thereby strengthening preparedness and safeguarding public health across the Union.

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4 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/522/oj)

5 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240( OJ L166, 11.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21)

6 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj)

7 Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241, (OJL 2024/794, 29.2.2024, ELI: http://data.europa.eu/eli/reg/2024/795/oj)

Amendment 25

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

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

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

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8 Communication and visibility rules - Publications Office of the EU

Amendment 26

Proposal for a regulation

Recital 24

Text proposed by the Commission

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. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

(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 procurement processes. Procurement requirements based on such considerations should include value-based criteria, such as product quality measured by patient impact and clinical value, stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Amendment 27

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24a) In order to strengthen the resilience of supply chains for medicinal products and to mitigate the risk of supply disruptions, procurement procedures carried out under this Regulation should, where appropriate, allow for the award of contracts to multiple suppliers for the same product. Such multi-winner procurement approaches can promote diversification of supply, enhance security of supply, and ensure that production capacity is distributed across different manufacturers and geographical locations within the Union. In addition, to provide market predictability and support investment in the production of medicinal products, procurement procedures under this Regulation should, where justified, include predictable mix and weighting of qualitative criteria. Those commitments can serve as an incentive for manufacturers to maintain or scale up production capacity, particularly for medicinal products that are essential for public health but may not be commercially attractive under standard market conditions.

Amendment 28

Proposal for a regulation

Recital 25

Text proposed by the Commission

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.

Amendment 29

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality.

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, should apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. In order to ensure legal certainty and consistency in its application, it is important to determine what constitutes a significant proportion of production within the meaning of this Regulation. In that sense, a significant proportion of the production should take place within the Union or, where appropriate, the EFTA countries, in line with the objective of reinforcing the Union’s open strategic autonomy.

Amendment 30

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate.

(29) The Commission 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.

Amendment 31

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for outpatient sector where they are often not purchased through public procurement, these programmes may also encompass measures to strengthen supply chain resilience and sustainability through measures related to pricing and reimbursement, where appropriate. Such programmes should take into account the economic viability of critical medicines, and recommend relevant measures, including exemptions of specific categories of critical medicines, such as products derived from substances of human origin (SoHO), from national cost containment measures. The programmes should be shared with the Commission and the Critical Medicines Coordination Group, established by this Regulation, to facilitate the exchange of best practices and coordination between the Member States. This cooperation should enhance the overall effectiveness of the various measures put forward to secure the supply of critical medicinal products, while respecting the principles of subsidiarity and proportionality, as well as the exchange of best practices in stock management, real-time monitoring, expiry alerts, stock rotation, shelf-life optimisation and waste reduction to further strengthen the Union’s preparedness and operational effectiveness. These practices will contribute to greater efficiency, minimise losses, and ensure the availability of critical medicinal products during periods of high demand.

Amendment 32

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

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 and voluntary Union-level means have been exhausted and where shortages or disruptions in one or more Member States are likely to result in serious harm to patients or affect other Member States. Binding redistribution decisions should be based on objective risk assessments and real-time data and should ensure that the Member States providing assistance retain adequate minimum stock levels. To support timely and informed decisions, Member States should report regularly on their national stockpiles and contingency stocks through a harmonised, digital reporting system. Additionally, fair reimbursement and cost-sharing provisions should ensure that solidarity is matched by equity. In order to ensure uniform conditions for the implementation of reporting obligations in relation to national stockpiles and contingency stocks, as well as of procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States, in the event of a binding redistribution decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

Amendment 33

Proposal for a regulation

Recital 30 b (new)

Text proposed by the Commission

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 to be provided where appropriate.

Amendment 34

Proposal for a regulation

Recital 30 c (new)

Text proposed by the Commission

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.

Amendment 35

Proposal for a regulation

Recital 30 d (new)

Text proposed by the Commission

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.

Amendment 36

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these obligations should be designed taking into consideration the principles of proportionality, transparency 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.

(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 such stocks. Effective coordination mechanisms at Union level are therefore necessary to address possible conflicts and to ensure that national measures do not delay patient access, distort supply chains, or fragment the internal market.

Amendment 37

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32) Availability and access disparities exist for critical medicinal products and medicinal products of common interest throughout the Union, disproportionately affecting some Member States. The collaborative procurement of critical medicinal products and of medicinal products of common interest can be a powerful tool to improve their security of supply and accessibility 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.

Amendment 38

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines 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 healthcare professional organisations. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Amendment 39

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(38) To ensure coordinated implementation of this Regulation, the Critical Medicines Group should enable exchanges of information related to funding of strategic projects and facilitate the strategic orientation of financial support for strategic projects. The Critical Medicines Group should also facilitate the exchange of information on national programmes, including on the approach to contingency stock requirements in public procurement contracts. When relevant, the Critical Medicines Group should facilitate the coordination of national programmes. The Critical Medicines Group should furthermore facilitate discussions on the need to launch a collaborative procurement initiative and the need to prioritise the vulnerability evaluation for specific critical medicinal products. In order to ensure solidarity and an effective Union-level response to shortages or supply disruptions of critical medicinal products, it is necessary to establish a clear decision-making process for the redistribution of such products. To that end, the Member States should be included in the decision-making process through the Critical Medicines Group established under this Regulation.

Amendment 40

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

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.

Amendment 41

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties.

(39) The Union 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 concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. As part of these partnerships, the Commission should promote a collaborative innovation ecosystem that integrates small and medium-sized enterprises, start-ups and deep-tech innovators alongside established pharmaceutical companies in order to enhance resilience, foster technological advancement and boost the competitiveness of the Union’s pharmaceutical sector. The Commission should specifically consider the inclusion of access to APIs and their starting materials in the scope of international partnerships.

Amendment 42

Proposal for a regulation

Recital 41

Text proposed by the Commission

Amendment

(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.

Amendment 43

Proposal for a regulation

Recital 42 a (new)

Text proposed by the Commission

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 amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distortions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Amendment 44

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby 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 medicinal products.

Amendment 45

Proposal for a regulation

Article 1 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 46

Proposal for a regulation

Article 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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

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

Amendment 47

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

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

(a) facilitate, support and incentivise investments in 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;

Amendment 48

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 49

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

Amendment 50

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

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

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

Amendment 51

Proposal for a regulation

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

Text proposed by the Commission

Amendment

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

Amendment 52

Proposal for a regulation

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

Text proposed by the Commission

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.

Amendment 53

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

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].

Amendment 54

Proposal for a regulation

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 55

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common interest. Chapter III does not apply to medicinal products of common interest.

2. Chapter III, 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.

Amendment 56

Proposal for a regulation

Article 3 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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

For the purposes of this Regulation, 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:

Amendment 57

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) ‘medicinal product’ means a medicinal product as defined in Article 4 point (1) of Directive (EU) …/… of the European Parliament and of the Council [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final];

deleted

Amendment 58

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including primary packaging materials, excipients, solvents and reagents;

Amendment 59

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) ‘active substance’ means an active substance as defined in Article 4 point (3) of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final];

deleted

Amendment 60

Proposal for a regulation

Article 3 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(4) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients as defined in Article 4 point (13) of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final];

deleted

Amendment 61

Proposal for a regulation

Article 3 – paragraph 1 – point 4 a (new)

Text proposed by the Commission

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.

Amendment 257

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability, 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;

Amendment 63

Proposal for a regulation

Article 3 – paragraph 1 – point 5 a (new)

Text proposed by the Commission

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;

Amendment 64

Proposal for a regulation

Article 3 – paragraph 1 – point 5 b (new)

Text proposed by the Commission

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;

Amendment 65

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(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;

(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;

Amendment 66

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

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

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

Amendment 67

Proposal for a regulation

Article 3 – paragraph 1 – point 10 a (new)

Text proposed by the Commission

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;

Amendment 68

Proposal for a regulation

Article 3 – paragraph 1 – point 11 a (new)

Text proposed by the Commission

Amendment

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

Amendment 69

Proposal for a regulation

Article 3 – paragraph 1 – point 12

Text proposed by the Commission

Amendment

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

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

Amendment 70

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, 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;

Amendment 71

Proposal for a regulation

Article 3 – paragraph 1 – point 13 a (new)

Text proposed by the Commission

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;

Amendment 72

Proposal for a regulation

Article 3 – paragraph 1 – point 13 b (new)

Text proposed by the Commission

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;

Amendment 73

Proposal for a regulation

Article 3 – paragraph 1 – point 13 c (new)

Text proposed by the Commission

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;

Amendment 74

Proposal for a regulation

Article 3 – paragraph 1 – point 13 d (new)

Text proposed by the Commission

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;

Amendment 75

Proposal for a regulation

Article 3 – paragraph 1 – point 18

Text proposed by the Commission

Amendment

(18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products that is established through a non-binding instrument and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation.

(18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products or its supply chain, 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;

Amendment 76

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 77

Proposal for a regulation

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

Text proposed by the Commission

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.

Amendment 78

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

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

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.

Amendment 79

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market.

2. The Member States and the Commission shall work together 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 for project promoters.

Amendment 80

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

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

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

Amendment 81

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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

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:

Amendment 82

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

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

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

Amendment 83

Proposal for a regulation

Article 5 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;

(b) it modernises an existing manufacturing site, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or 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;

Amendment 84

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

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

(c) it creates, increases 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;

Amendment 85

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out or transfer of a technology 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;

Amendment 86

Proposal for a regulation

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

Text proposed by the Commission

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.

Amendment 87

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 88

Proposal for a regulation

Article 6 – title

Text proposed by the Commission

Amendment

Recognition of Strategic Projects

Determination of Strategic Projects

Amendment 89

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall designate an authority (‘the designated authority’) that shall assess and verify whether or not a project meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project.

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.

Amendment 90

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

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

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

Amendment 91

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

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

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

Amendment 92

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed.

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

Amendment 93

Proposal for a regulation

Article 6 – paragraph 3 – point a (new)

Text proposed by the Commission

Amendment

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

Amendment 94

Proposal for a regulation

Article 6 – paragraph 3 – point b (new)

Text proposed by the Commission

Amendment

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

Amendment 95

Proposal for a regulation

Article 6 – paragraph 3 – point c (new)

Text proposed by the Commission

Amendment

Amendment 96

Proposal for a regulation

Article 6 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

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).

Amendment 97

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

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

Amendment 98

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

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.

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.

Amendment 99

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. In order to promote a consistent and coordinated approach across the Union and to ensure legal certainty for project promoters, the Commission shall adopt guidelines setting out common criteria and procedural principles for the assessment and 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

Amendment 100

Proposal for a regulation

Article 6 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

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

(a) 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.

Amendment 101

Proposal for a regulation

Article 6 – paragraph 5 c (new)

Text proposed by the Commission

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.

Amendment 102

Proposal for a regulation

Article 6 – paragraph 5 d (new)

Text proposed by the Commission

Amendment

5d. Prior to the determination of a project as strategic, the 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 duplication of existing or planned manufacturing capacities within the Union, it shall inform the designated authority thereof. Such projects shall not be eligible to receive financial support from the Union pursuant to Article 16.

Amendment 103

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

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

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products, 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.

Amendment 104

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission

Amendment

The Member States’ authorities shall ensure that the relevant permit granting processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law.

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

Amendment 105

Proposal for a regulation

Article 8 – title

Text proposed by the Commission

Amendment

Administrative support

Administrative and technical support

Amendment 106

Proposal for a regulation

Article 8 – paragraph 1 – point b

Text proposed by the Commission

Amendment

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

(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;

Amendment 107

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

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

2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State 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.

Amendment 108

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

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.

Amendment 109

Proposal for a regulation

Article 8 – paragraph 2 b (new)

Text proposed by the Commission

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.

Amendment 110

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

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

1. Upon request of a project promoter, a Member State, with support of the Agency as necessary 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.

Amendment 111

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall provide dedicated advice to assist project promoters developing projects relying on innovative manufacturing processes.

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall, 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.

Amendment 112

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 1

Text proposed by the Commission

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 procedure fulfilling the requirements of those Union legislative acts are applied.

_________________

15 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7, ELI: http://data.europa.eu/eli/dir/1992/43/oj).

16 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1, ELI: http://data.europa.eu/eli/dir/2000/60/oj).

17 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30, ELI: http://data.europa.eu/eli/dir/2001/42/oj).

18 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj).

19 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI: http://data.europa.eu/eli/dir/2009/147/oj).

20 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).

21 Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj).

22 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj).

Amendment 113

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that the competent authorities issue the reasoned conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact assessment within 45 days of receiving all necessary information 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.

Amendment 114

Proposal for a regulation

Article 12 – paragraph 5 a (new)

Text proposed by the Commission

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.

Amendment 115

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the Commission

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 spatial planning data is available.

Amendment 116

Proposal for a regulation

Article 13 – paragraph 2

Text proposed by the Commission

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 shall also cover those impacts.

_________________

23 Directive 2014/89/EU of the European Parliament and of the Council of 23 July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135, ELI: http://data.europa.eu/eli/dir/2014/89/oj).

Amendment 117

Proposal for a regulation

Article 13 – paragraph 2 a (new)

Text proposed by the Commission

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.

Amendment 118

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

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

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.

Amendment 119

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States may prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

1. Without prejudice to Articles 107 and 108 TFEU, Member States shall prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products, 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.

Amendment 120

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 121

Proposal for a regulation

Article 15 – paragraph 1 b (new)

Text proposed by the Commission

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.

Amendment 122

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed.

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, 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.

Amendment 123

Proposal for a regulation

Article 15 – paragraph 2 a (new)

Text proposed by the Commission

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).

Amendment 124

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

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.

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.

Amendment 125

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

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

Any Member State that encounters a threat of shortages of the critical medicinal product 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.

Amendment 126

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

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.

Amendment 127

Proposal for a regulation

Article 15 – paragraph 3 b (new)

Text proposed by the Commission

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.

Amendment 128

Proposal for a regulation

Article 15 – paragraph 3 c (new)

Text proposed by the Commission

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.

Amendment 129

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. For the duration of the Multiannual Financial Framework 2021-202724 strategic projects may be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , and the Digital Europe Programme27 provided that such support is in line with the objectives set out in the regulations establishing those programmes.

1. All the Union funding under the 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.

_________________

24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for years 2021 to 2027, as amended (OJ LI 433, 22.12.2020, p.11, ELI: http://data.europa.eu/eli/reg/2020/2093/oj)

25 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021, p.1, ELI: http://data.europa.eu/eli/reg/2021/522/oj)

26 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj)

27 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240( OJ L166, 11.5.2021, p.1, ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21)

Amendment 130

Proposal for a regulation

Article 16 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

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.

Amendment 131

Proposal for a regulation

Article 16 – paragraph 1 – subparagraph 1 b (new)

Text proposed by the Commission

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.

Amendment 132

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

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, and targeted to safeguard public health within the Union.

Amendment 133

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

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.

Amendment 134

Proposal for a regulation

Article 16 – paragraph 2 c (new)

Text proposed by the Commission

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.

Amendment 135

Proposal for a regulation

Article 16 – paragraph 2 d (new)

Text proposed by the Commission

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.

Amendment 136

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

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

1. Member States shall inform the Critical Medicines 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.

Amendment 137

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

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

The Commission shall 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.

Amendment 138

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

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

The Commission shall inform the Critical Medicines Group of 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.

Amendment 139

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery.

1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs 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 diversification of supply sources, and take into account the distance between manufacturing sites and points of delivery within the Union. Such criteria shall form the main basis for award decisions and shall, in any case, be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and may also include innovation, supply chain robustness, the number of diversified suppliers, obligations on the monitoring of supply chains, transparency of supply chains upon request of the contracting authority and contract performance clauses on timely delivery.

Amendment 140

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 141

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, 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.

Amendment 142

Proposal for a regulation

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

Text proposed by the Commission

Amendment

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

(a) at least 50% of the active 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, where appropriate, the EFTA countries.

Amendment 143

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union 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.

Amendment 144

Proposal for a regulation

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

Text proposed by the Commission

Amendment

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

(a) at least 50 % of the active 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 results from manufacturing or processing operations carried out 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;

(c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out 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.

Amendment 145

Proposal for a regulation

Article 18 – paragraph 4

Text proposed by the Commission

Amendment

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

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

Amendment 146

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where such a decision is duly justified on the basis of a documented market analysis, or where 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.

Amendment 147

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. To support the implementation of this Article by 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].

Amendment 148

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

1. By 6 months after entry into force of this Regulation each Member State shall establish, 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 beneficial in light of the market analysis and shall align reporting and shortage signals with mechanisms operated by MSSG to avoid duplication. Such programmes shall also, where appropriate, include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures as well as review any price freezes, cost containment measures or stockholding obligations applicable. Member States may involve their national pricing and reimbursement authorities in the planning and evaluation of such programmes.

Amendment 149

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate a discussion aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate 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 national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Amendment 150

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Measures on security of supply applied in one Member State shall not result in any negative impact in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for companies to hold contingency stocks.

Measures 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.

Amendment 151

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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

Member States shall ensure that any 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.

Amendment 152

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

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.

Amendment 153

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

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.

Amendment 154

Proposal for a regulation

Article 20 – paragraph 2 c (new)

Text proposed by the Commission

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 assessments;

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

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

(d) practices on sustainable stockpiling, including practices to reduce emissions, improve packing, including leaflet, manager expiry dates, and ensure responsible disposal of unused or obsolete medicinal products.

Amendment 155

Proposal for a regulation

Article 20 – paragraph 2 d (new)

Text proposed by the Commission

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.

Amendment 156

Proposal for a regulation

Chapter IV – Section I a (new)

Text proposed by the Commission

Amendment

Ia UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS

Amendment 157

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

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.

Amendment 158

Proposal for a regulation

Article 20 b (new)

Text proposed by the Commission

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 regularly updated data establishing both the shortage or supply disruption resulting in serious harm or risk of serious harm to patients and the negative impact in the internal market;

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

3. A distribution decision adopted pursuant to this Article shall specify the date at which it takes effect and shall be notified by the Commission to the Member States concerned without delay/within ... [and at least 20 days before its date of application].

Amendment 159

Proposal for a regulation

Article 20 c (new)

Text proposed by the Commission

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 of receipt of the reasoned request referred to in paragraph 1. That decision shall confirm, amend or revoke the distribution decision adopted and notified pursuant to Article 20b and shall state the reasons on which it is based.

3.The submission of a request for review shall not suspend the application of the distribution decision adopted and notified pursuant to Article 20b, unless the Commission, on duly justified grounds, decides to grant a suspension pending the outcome of the review.

Amendment 160

Proposal for a regulation

Article 20 d (new)

Text proposed by the Commission

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 held;

(b) the quantities of such stocks;

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

4. Information reported under this Article that relates to national stockpiles and contingency stocks shall be treated as strictly confidential. Such information shall not be made publicly available and shall be used solely for the purposes of this Chapter. The Commission and the competent authorities of the Member States shall ensure that commercially sensitive information, including trade secrets within the meaning of Directive (EU) 2016/943, and information the disclosure of which may compromise national security is protected under the applicable Union and national rules on confidentiality and the handling of sensitive or classified information. The Commission shall not publish, disseminate or otherwise disclose such information to third parties.

5. The Commission may adopt implementing acts specifying the format, structure and detailed content of the reports referred to in paragraphs 2 and 3 of this Article and of the digital reporting system referred to paragraph 1 in order to ensure their consistency, completeness and comparability across Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20e(2).

Amendment 161

Proposal for a regulation

Article 20 e (new)

Text proposed by the Commission

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.

Amendment 162

Proposal for a regulation

Article 20 f (new)

Text proposed by the Commission

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.

Amendment 163

Proposal for a regulation

Article 20 g (new)

Text proposed by the Commission

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 possible, but not later than 30 day from the date of receipt of concerned medicinal product by receiving Member State.

The Commission is empowered to adopt delegated acts in accordance with Article 30a, to supplement this Regulation by laying down procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate.

Amendment 164

Proposal for a regulation

Article 20 h (new)

Text proposed by the Commission

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

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

3. In the event that the Commission decides to establish a Union Stockpile for critical medicinal products with identified vulnerabilities in accordance with paragraphs 1 and 2, it shall:

(a) coordinate with national competent authorities to ensure alignment and ensure that the Union stockpile does not duplicate national contingency stock arrangements:

(b) design and implement the measures to be taken in a way that does not result in any negative impact on availability of medicinal products in other Member States;

(c) in accordance with applicable law, ensure that packaging, labelling, and storage conditions are such as to enable the rapid and safe distribution and use of the products across the Union.

4. The establishment, maintenance, and deployment of the Union Stockpile shall be supported by the Union budget. Expenditures under this article shall be subject to annual reporting to the European Parliament and the Council, and to audits by the European Court of Auditors.

Amendment 165

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon a reasoned request of three or more Member States (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EC28 for medicinal products of common interest.

1. Upon a reasoned request of three or more Member States (‘the request’), the Commission 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.

_________________

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 166

Proposal for a regulation

Article 21 – paragraph 3

Text proposed by the Commission

Amendment

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.

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.

Amendment 167

Proposal for a regulation

Article 21 – paragraph 5

Text proposed by the Commission

Amendment

5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the involved Member States and provide advice on applicable Union public procurement rules and on regulatory matters related to medicinal products.

5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the 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.

Amendment 168

Proposal for a regulation

Article 21 – paragraph 6

Text proposed by the Commission

Amendment

6. The facilitation offered by the Commission shall be limited in time and end at the latest upon signature of the procurement contract by the participating contracting authorities.

6. The facilitation offered by the Commission shall be limited in time and end, 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.

Amendment 169

Proposal for a regulation

Article 21 – paragraph 6 a (new)

Text proposed by the Commission

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, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract;

(d) regulatory flexibilities available under applicable Union law are applied to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities;

(e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

Amendment 170

Proposal for a regulation

Article 21 – paragraph 7 a (new)

Text proposed by the Commission

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.

Amendment 171

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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;

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:

Amendment 172

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the Commission

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 and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

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.

Amendment 173

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

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.

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.

Amendment 174

Proposal for a regulation

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

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.

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.

Amendment 175

Proposal for a regulation

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

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.

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.

Amendment 176

Proposal for a regulation

Article 22 – paragraph 5 a (new)

Text proposed by the Commission

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.

Amendment 177

Proposal for a regulation

Article 22 – paragraph 5 b (new)

Text proposed by the Commission

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:

(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, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract;

(e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

Amendment 178

Proposal for a regulation

Article 22 – paragraph 5 c (new)

Text proposed by the Commission

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.

Amendment 179

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the Commission

Amendment

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.

deleted

Amendment 180

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

1. Under conditions laid down in this Article and by way of derogation from Article 168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least nine Member States may engage, as contracting parties, in a joint procurement procedure.

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.

Amendment 181

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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

2. 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:

Amendment 182

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

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

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.

Amendment 183

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

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

Amendment 184

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission

Amendment

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

5. The Commission shall assess the 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.

Amendment 185

Proposal for a regulation

Article 23 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

Amendment 186

Proposal for a regulation

Article 23 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. The Commission shall conduct a joint procurement under this Article subject to the acceptance of the following conditions by requesting Member States:

(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, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract;

(e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

Amendment 187

Proposal for a regulation

Article 23 – paragraph 5 c (new)

Text proposed by the Commission

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.

Amendment 188

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission

Amendment

deleted

Amendment 189

Proposal for a regulation

Article 23 – paragraph 7

Text proposed by the Commission

Amendment

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.

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.

Amendment 190

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

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.

Amendment 191

Proposal for a regulation

Article 24 – paragraph 2

Text proposed by the Commission

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.

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.

Amendment 192

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Text proposed by the Commission

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.

Amendment 193

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The Member States, the Agency, 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 the MSSG as representatives. The Critical Medicines Group shall appoint two representatives from patient organisations and two permanent representatives from healthcare professional organisations. The European Parliament shall have observer status and shall be represented by two Members of the European Parliament. The European Parliament shall be entitled to receive meeting agendas, documents, reports, and any other materials circulated to members of the Critical Medicines Group, and to participate in debates. The European Parliament shall not have voting rights and shall not be counted for the purpose of determining the quorum.

Amendment 194

Proposal for a regulation

Article 25 – paragraph 2 a (new)

Text proposed by the Commission

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.

Amendment 195

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the 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.

Amendment 196

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

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

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

Amendment 197

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the Commission

Amendment

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

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

Amendment 198

Proposal for a regulation

Article 25 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

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

Amendment 199

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

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

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission 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.

Amendment 200

Proposal for a regulation

Article 26 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 201

Proposal for a regulation

Article 26 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines Group shall perform the following tasks in compliance with the necessary guarantees of protection of commercial confidential information:

Amendment 202

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States, 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;

Amendment 203

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 204

Proposal for a regulation

Article 26 – paragraph 2 – point d

Text proposed by the Commission

Amendment

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

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

Amendment 205

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 206

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 207

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 208

Proposal for a regulation

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

Text proposed by the Commission

Amendment

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

Amendment 209

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 210

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 211

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 212

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 213

Proposal for a regulation

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

Text proposed by the Commission

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;

Amendment 214

Proposal for a regulation

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

Text proposed by the Commission

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.

Amendment 215

Proposal for a regulation

Article 26 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In carrying out the task referred to in 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.

Amendment 216

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

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.

Amendment 217

Proposal for a regulation

Article 26 a (new)

Text proposed by the Commission

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, taking into account long-term trends, vulnerabilities, opportunities for enhancing the resilience and sustainability of supply chains within the Union, and patients’ unmet medical needs.

5. The Critical Medicines Group shall prepare the report and communicate it to the Commission, the Agency and the European Parliament.

6. Following the preparation of the foresight report, the Critical Medicines Group shall make recommendations to the Commission and Member States on actions to be taken, including the identification and support of projects. Where there is a need to strategically reserve manufacturing capacity, recommendations shall specifically include proposals for strategic projects pursuant to Article 5(2), for the production of specific pharmaceutical forms, active substances, key inputs, or technologies within a defined timeframe.

Amendment 218

Proposal for a regulation

Article 27 – title

Text proposed by the Commission

Amendment

Strategic partnerships

International cooperation and strategic partnerships

Amendment 219

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union.

Without prejudice to the prerogatives of the Council, the Commission, shall seek to conclude strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs 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.

Amendment 220

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

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.

Amendment 221

Proposal for a regulation

Article 27 – paragraph 1 b (new)

Text proposed by the Commission

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.

Amendment 222

Proposal for a regulation

Article 27 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

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

Amendment 223

Proposal for a regulation

Article 27 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

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

Amendment 224

Proposal for a regulation

Article 27 – paragraph 1 e (new)

Text proposed by the Commission

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.

Amendment 225

Proposal for a regulation

Article 27 – paragraph 1 f (new)

Text proposed by the Commission

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.

Amendment 226

Proposal for a regulation

Article 27 – paragraph 1 g (new)

Text proposed by the Commission

Amendment

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

Amendment 227

Proposal for a regulation

Article 27 – paragraph 1 h (new)

Text proposed by the Commission

Amendment

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

Amendment 228

Proposal for a regulation

Article 28 – paragraph 1 – point a

Regulation (EU) 2024/795

Article 2 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

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

(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 are available]

Amendment 229

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances or medicinal products of common interest shall upon request provide the Commission or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances or medicinal products of common interest shall upon request provide the Commission, the Agency or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Amendment 230

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The Commission, the Agency and national authorities of the Member States shall 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.

Amendment 231

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission and national authorities of the Member States shall assess the merits of duly substantiated confidentiality claims made by marketing authorisation holders and other economic operators, requested to provide information per paragraph 1, and shall protect any information that is commercially confidential against unjustified disclosure.

3. The Commission, the Agency and 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 tasks and activities in accordance with relevant Union and national law. This paragraph shall also apply to all representatives of Member States, observers, experts and other participants attending meetings of the Critical Medicines Group. In addition, they shall also ensure that digital systems used for data collection and analysis include appropriate cybersecurity measures.

Amendment 232

Proposal for a regulation

Article 29 a (new)

Text proposed by the Commission

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 serve to identify and monitor strategic dependencies and to support the adoption of appropriate measures under this Regulation aimed at ensuring the continuous supply and availability of such medicinal products within the Union.

3. In developing and updating the list referred to in paragraph 1, the Commission shall take into account the public health relevance, therapeutic importance, and criticality of the medicinal products.

Amendment 233

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall evaluate this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.

1. The Commission shall 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.

Amendment 234

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. The evaluation shall in particular assess:

Amendment 235

Proposal for a regulation

Article 30 – paragraph 2 – point a (new)

Text proposed by the Commission

Amendment

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

Amendment 236

Proposal for a regulation

Article 30 – paragraph 2 – point b (new)

Text proposed by the Commission

Amendment

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

Amendment 237

Proposal for a regulation

Article 30 – paragraph 2 – point c (new)

Text proposed by the Commission

Amendment

Amendment 238

Proposal for a regulation

Article 30 – paragraph 2 – point d (new)

Text proposed by the Commission

Amendment

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

Amendment 239

Proposal for a regulation

Article 30 – paragraph 2 – point e (new)

Text proposed by the Commission

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.

Amendment 240

Proposal for a regulation

Article 30 – paragraph 3

Text proposed by the Commission

Amendment

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.

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.

Amendment 241

Proposal for a regulation

Article 30 – paragraph 3 a (new)

Text proposed by the Commission

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.

Amendment 242

Proposal for a regulation

Article 30 a (new)

Text proposed by the Commission

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 Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

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

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

6. A delegated act adopted pursuant to Articles 20g(4) and 20h(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act. to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.