Changes from plenary report to adopted text

RemovedDRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

AddedP10_TA(2026)0001

Changedon the proposal for a regulation of the European Parliament and of the Council laying a frameworkFramework 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) 2024/795interest

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

AddedCommittee on Public Health

AddedPE775.742

AddedAmendments 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)

Change 1

RemovedThe European Parliament,

AddedRecital 1: (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.

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

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

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

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

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

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

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

Removed– having regard to the report of the Committee on Public Health (A10-0272/2025),

Removed1. Adopts its position at first reading hereinafter set out;

Removed2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

Removed3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

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

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Recital 2: (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.

Recital 2 a (new): (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.

Recital 3: (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.

Recital 4: (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 industr…

Change 2

ChangedRecital 4 a (new): (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 APIsactive pharmaceutical ingredients (APIs) from third countries. Consequently, the Union relies on a limited number of API suppliers and manufacturers, many located outside its borders.

Recital 7: (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.

Change 3

ChangedRecital 8: (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 exchangeexchanges between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

Change 4

ChangedRecital 9: (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 medicinemedicinal 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.

Recital 11: (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.

Recital 12: (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 critic…

Change 5

AddedRecital 12 a (new): (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.

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Recital 13 a (new): (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.

Recital 14: (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.

Recital 14 a (new): (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.

Recital 16 a (new): (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.

Change 6

ChangedRecital 16 b (new): (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.

Change 7

ChangedRecital 17: (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, inlcludingincluding 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 demonstr…demonstra…

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Recital 17 a (new): (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.

Recital 18: (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 promote…

Recital 18 a (new): (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.

Recital 18 b (new): (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.

Recital 19 a (new): (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).

Recital 21: (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. Furthermore, any public financial support should ensure full transparency of funding amounts and conditions, be tied to clear supply and access obligations, include effective monitoring measures, and have enforceable sanctions for non-compliance.

Recital 22: (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. / (deleted) / (deleted) / (deleted) / (deleted)

Recital 23: (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.

Recital 24: (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.

Recital 24 a (new): (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.

Change 8

ChangedRecital 25: (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 tofor using them in public procurement, for use by the Member States.

Recital 26: (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.

Recital 29: (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.

Change 9

ChangedRecital 30: (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 offrom 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 …th…

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Recital 30 a (new): (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 stoc…

Recital 30 b (new): (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.

Recital 30 c (new): (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.

Recital 30 d (new): (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.

Recital 31: (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.

Change 10

ChangedRecital 32: (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 medicinesmedicinal 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.

Change 11

ChangedRecital 37: (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)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.