Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

▸11 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

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

(Ordinary legislative procedure: first reading)

The European Parliament,

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

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

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

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

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

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

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

Changed– having regard to the report of the Committee on Public Health (A100000/2025),(A10-0272/2025),

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

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

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

Change 1

RemovedRecital 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 results in serious harm or risk of serious harm to patients and health systems.

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 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.

RemovedRecital 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 raw materials, feedstock and other manufacturing inputs. These include existing dependencies on a limited number of suppliers globally and lack of Union capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, the Union can reduce its risk of exposure to shortages of medicinal products.

AddedRecital 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.

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

AddedRecital 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.

AddedRecital 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.

AddedRecital 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…

AddedRecital 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 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 2

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 carecare, and fair andenhance equalpatient’s access of patients to the medicinal products they need. Uncoordinated national measures risk disrupting the internal market, fail to address broader supply chain issues, and are insufficient to resolve cross-border issues, including the Union's dependency on third countries. The regulatory framework for medicinal products therefore needs to be complemented by targeted actions providing for further harmonisation.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 exchange between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

Change 3

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,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 Union patients in the Union and undermining the Union’sUnion's commitment to achieving universal access to essential medicinal productsmedicine by 2030,2030 in line with Sustainablethe DevelopmentUnited GoalNations sustainable development goal 3.8. This mayRegulation beaims causedat bystrengthening athe varietyresilience of factors,supply includingchains, productaddressing orconcrete geographicalsecurity-of-supply demandvulnerabilities, marketand size,reducing whichsuch caninequalities impactamong theMember timelyStates, availabilityensuring ofmore equitable access to medicinal products inacross certainthe MemberUnion, States.so that patients enjoy the same level of access regardless of their country of residence.

Change 4

RemovedRecital 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, encouraging investment and supporting innovation in the pharmaceutical sector. Ensuring the security of supply and availability of critical medicinal products and the availability and accessibility of other medicinal products of common interest should moreover contribute to the Union’s preparedness, resilience, and economic and overall security, including when cross-border supply chains risk being disrupted. Furthermore, in order to strengthen the functioning of the internal market and to ensure the uninterrupted availability of critical medicinal products and medicinal products of common interest across the Union, it is necessary to establish a Union coordination mechanism for critical medicinal products and medicinal products of common interest. Such a mechanism would enhance the Union capacity to address shortages, strengthen supply chain resilience, and enable coordinated approaches to national stockpiling and contingency stocks.

AddedRecital 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.

RemovedRecital 13: (13) Taking into account the different root causes of the availability issues affecting critical medicinal products and medicinal products of common interest, some measures should apply to critical medicinal products as well as to investigational medicinal products only.

AddedRecital 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…

RemovedRecital 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.

AddedRecital 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.

AddedRecital 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.

AddedRecital 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.

AddedRecital 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.

Recital 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 support measures aimed at ensuring the continuity of supply of medicinal products.

Change 5

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 productsproducts, 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, inlcluding 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.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.demonstr…

Change 6

ChangedRecital 17 a (new): (17a) The construction ofIn manufacturingorder facilitiesto forsafeguard medicinalthe productsUnion’s thatstrategic fallinterests withinand the definitionresilience of aits industrial base, strategic projects for manufacturing critical medicinal products ofmust commonoperate interestwithout shouldinterruption, alsoincluding qualifyduring ascrises strategicor projects.supply Thosechain projectsdisruptions. Member States should thereforetake benefitall fromnecessary themeasures streamlinedto permittingprevent procedures,or dedicatedmitigate administrativeunplanned support,disruptions andto otheressential measuressupplies setand outto inensure Chapterthe IIcontinued availability of thiskey Regulation.personnel.

Change 7

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

AddedRecital 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…

AddedRecital 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.

AddedRecital 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).

Change 8

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

AddedRecital 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.

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

AddedRecital 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)

RemovedRecital 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.

AddedRecital 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.

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

AddedRecital 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.

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

AddedRecital 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.

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

AddedRecital 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 to using them in public procurement, for use by the Member States.

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

AddedRecital 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.

RemovedRecital 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, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. In order to ensure legal certainty and consistency in its application, it is important to determine what constitutes a significant proportion of production within the meaning of this Regulation. For the purposes of designating strategic projects related to medicinal products, a significant proportion of the production should take place within the Union, the European Economic Area or the Swiss Confederation, in line with the objective of reinforcing the Union’s open strategic autonomy.…