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From · opinion parliamentary committee · 2025-11-11 IMCO-AD-776854 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

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To · opinion parliamentary committee · 2025-11-06 ENVI-AD-775606 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

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SHORT JUSTIFICATION

The Critical Medicines Act is an important step towards ensuring the availability and security of critical medicinal products and other medicinal products of common interest throughout the EU. Its objectives are ambitious yet essential: ensuring timely access for patients, enhancing the resilience of supply chains, and reducing vulnerabilities in the European pharmaceutical system.

The amendments proposed by the rapporteur in his opinion on the proposal for a Regulation 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 the availability and accessibility of medicinal products of common interest, and amending Regulation (EU) 2024/795, aim to boost EU manufacturing of critical medicines by fast-tracking permits, simplifying environmental assessments, and supporting strategic projects. The proposal also promotes better coordination among Member States and introduces limited reporting obligations.

Against this background, the rapporteur welcomes the Commission's proposal as a solid and pragmatic foundation. However, further targeted improvements are necessary to ensure that the Regulation can deliver on its objectives and be implemented effectively. The proposed amendments in this opinion focus on four key priorities to reinforce resilience, improve coherence, and strengthen legal certainty.

To avoid unintended disruptions resulting from overlapping environmental and chemical legislation, a balanced, data-driven approach is needed, one that safeguards the availability of medicines while upholding high environmental standards. The rapporteur believes that coordination between pharmaceutical, environmental, and chemical legislation is essential to prevent negative impacts on patient access to medicines and to ensure the sustainability and competitiveness of the European pharmaceutical and healthcare sectors.

A first priority is the reform of procurement practices. The current framework places excessive emphasis on the lowest price, which undermines resilience and availability. To safeguard equal and timely access for patients throughout the Union, procurement procedures must prioritise security of supply, stability of deliveries and fair competition. However, flexibility is also crucial: multi-winner procedures can reduce dependency on single suppliers, and carefully designed exemptions are necessary in specific market segments, such as orphan medicines, where diversification is not feasible.

To ensure transparency, all data related to environmental assessments, authorisations, and planning should be easily accessible (including online) and presented clearly through a centralised portal. These procedures must be efficient, time-bound, and must not create undue financial or administrative burdens, aligned with international conventions.

The second area of focus is strengthening joint procurement initiatives at the Union level. These mechanisms are particularly beneficial for smaller Member States, embodying the principle of solidarity within the internal market. However, to ensure they provide genuine added value, the provisions must be streamlined to avoid duplication and ensure they are coherent with existing tools.

Rapid timelines for activating strategic projects should be maintained, especially when urgent action is needed to respond to shortages of critical medicines.

The third objective is to clarify the role of sustainability criteria in procurement. While environmental and social considerations are important in many policy areas, they must not conflict with this Regulation's primary aim of safeguarding the security of supply of critical medicinal products. The inconsistent application of such criteria could unintentionally restrict availability. Therefore, a systematic assessment of possible interactions is required to ensure that sustainability goals complement, rather than undermine, resilience.

Finally, the rapporteur supports the establishment of a European preference system, as proposed by the Commission. This instrument must be carefully designed to remain compatible with international obligations and avoid protectionist tendencies. A flexible, incentive-based approach is essential to strengthen European production capacities while maintaining WTO compliance.

Taken together, the proposed changes enhance the Commission's proposal in a balanced way. They provide a more resilient and secure supply of critical medicines, ensure clearer and more coherent rules, and support the successful implementation of the Critical Medicines Act, benefiting patients across Europe.

AMENDMENTS

The Committee on the ~~Internal~~Environment, ~~Market~~Climate and ~~Consumer~~Food ~~Protection~~Safety submits the following to the Committee on Public Health, as the committee responsible:

Amendment 1

Proposal for a regulation

Recital 24

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.

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

(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 and stocks result in serious harm or risk of serious harm to patients.

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

Amendment 2

Proposal for a regulation

~~Recital 10~~

Recital 4 a (new)

Text proposed by the Commission

Amendment

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

(4a) The 2019 Commission Strategic Approach to Pharmaceuticals in the Environment acknowledges that pharmaceuticals may pose risks to the environment and human health and highlights the need for a comprehensive and proportionate strategy, consistent with the Union’s commitment to the One Health approach.

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Those instruments should be aligned with Directive 2014/24/EU. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

Amendment 3

Proposal for a regulation

Recital 1217

Text proposed by the Commission

Amendment

(12) While the primary objective of this Regulation should be to strengthen the security of supply and ensure the availability of critical medicinal products and of medicinal products of common interest, given a lack of critical medicinal products can affect the functioning of the economy as a whole, this Regulation should also support the Union’s competitiveness by fostering a more stable and predictable market environment, encouraging investment and supporting innovation in the pharmaceutical sector. Ensuring the security of supply and availability of critical medicinal products and the availability and accessibility of other medicinal products of common interest should moreover contribute to the Union’s preparedness, resilience, and economic and overall security, including when cross-border supply chains risk being disrupted.

(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.

(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, strategic autonomy and economic and overall security, including when cross-border supply chains risk being disrupted.

(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, upholding social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Amendment 4

Proposal for a regulation

~~Recital 14~~

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18a) It is essential to ensure that the production of pharmaceutical products within the Union is conducted in a safe, responsible and sustainable manner over the long term, such as by reducing environmental pollution by manufacturing waste, this form of pollution may contribute to the spread of antimicrobial resistance, impact ecosystems and biodiversity, and thereby create possible risks for public health.

(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 and pursued with measures that take full advantage of the potential of the internal market and safeguard the free movement of goods.

Amendment 5

Proposal for a regulation

Recital 1819

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) which should have a fair chance to initiate strategic projects.

(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, while not lowering the level of environmental protection.

(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), as well as small mid-cap enterprises as defined in Commission Recommendation (EU) 2025/1099, which should have a fair chance to initiate strategic projects, and should offer them clear guidance throughout the application, permitting, and regulatory procedures with the aim of reducing the administrative burden on SMEs and small mid-caps.

(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, without undermining the quality and robustness of the assessments and while not lowering the level of health and environmental protection.

Amendment 6

Proposal for a regulation

~~Recital 19 a (new)~~

Recital 24

Text proposed by the Commission

Amendment

(19a) In order to strengthen the Union’s capacity to respond effectively and in a coordinated manner to critical shortages of medicinal products, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as part of its work to ensure Union coordination on the availability of medicines, should contribute to the strengthening and effective implementation of the Solidary Mechanism framework, in particular through communication between Member States and relevant stakeholders, taking into account the principles of solidarity, proportionality, and confidentiality.

(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 an appropriate and predictable balance of qualitative criteria including product quality measured by patient impact and clinical value, environmental sustainability, such as the use of sustainable and innovative manufacturing technologies and the minimisation of active substance emissions during production, pharmaceutical innovation for patients, and the society, in addition to 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 7

Proposal for a regulation

~~Recital 19 b (new)~~

Recital 39

Text proposed by the Commission

Amendment

(19b) Member States should cooperate in good faith and should, where necessary, provide mutual support to any other Member State that has requested assistance through the Solidarity Mechanism, with a view to preventing or mitigating shortages of critical medicinal products.

(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.

Amendment 8

Proposal for a regulation

Recital 2441

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.

(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 critical medicines and 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 a significant weighting of qualitative and non-price criteria, including stockholding obligations, diversification of supply, efficient and effective monitoring of supply chains for potential supply bottlenecks, their transparency to the contracting authority contract performance clauses on timely delivery and measures in case of non-timely delivery. Procurement obligations should be applied proportionately and adapted to the specific market conditions. Where diversification of supply chains is de facto not possible or not economically feasible, targeted exemptions from certain award criteria may be granted. Contracting authorities should not be precluded from using additional qualitative requirements, where relevant, including sustainability and social factors, in accordance with Directive 2014/24/EU.

(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. At the same time and to safeguard the availability and security of supply of critical medicinal products, all market actors, competent authorities, Member States and the Commission should ensure that all barriers, such as regulatory, economic and market-based, are identified and evaluated as part of the Commission’s assessment on the achievement of the objectives of this Regulation. 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 9

Proposal for a regulation

~~Recital 26~~

Recital 41 a (new)

Text proposed by the Commission

Amendment

(41a) This Regulation should be implemented in line with existing Union legislation. Where the evaluation has identified that such legislation has the possibility to impact in an adverse manner on the accessibility, availability or affordability of medicinal products, the Commission should carry out comprehensive, evidence-based assessments and, where appropriate, propose proportionate mitigating measures to safeguard supply, availability and affordability of medicinal products and to support the Union's competitiveness.

(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, taking into account product-specific characteristics. 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 not lead to protectionism and weakened competition and be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. To safeguard the Union’s strategic autonomy and reduce critical dependencies, a significant proportion of the production of critical medicinal products, medicinal products of common interest, or their active pharmaceutical ingredients intended for the Union market should be located within the Union, as defined in this Regulation. While trusted international cooperation and strategic partnerships remain important, ensuring resilience and security of supply means that production capacity needs to meet a certain threshold on Union territory. The assessment of whether this threshold is met should be carried out by the Commission or, where appropriate, by the competent authorities of the Member States, taking into account product-specific characteristics, market conditions, and risk-related considerations. This approach will ensure that the Union retains the capacity to respond effectively to public health needs and future crises.

Amendment 10

Proposal for a regulation

~~Recital 30~~

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for outpatient sector where they are often not purchased through public procurement, these programmes may also encompass measures to strengthen supply chain resilience and sustainability through measures related to pricing and reimbursement, where appropriate. The programmes should be shared with the Commission and the Critical Medicines Coordination Group, established by this Regulation, to facilitate the exchange of best practices and coordination between the Member States. This cooperation should enhance the overall effectiveness of the various measures put forward to secure the supply of critical medicinal products, while respecting the principles of subsidiarity and proportionality.

(30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for the 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 and non-discriminatory. 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.

(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, yield improvements or other chemistry or biotechnology process that contribute to increasing the level of security, energy efficiency and environmental performance of the production, Artificial Intelligence, platform techniques, 3D manufacturing and sustainable manufacturing methods;

Amendment 11

Proposal for a regulation

~~Recital 35~~

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;

(35) To ensure that the collaborative procurement initiatives contribute to the achievement of the objectives of this Regulation, while fully respecting the principle of subsidiarity, the Commission’s involvement in joint procurement and procurement on behalf, or in the name of the Member States, should be limited to defined cases with defined timelines. For this reason, the Commission should assess the proportionality of any collaborative procurement request, taking into account factors such as the necessity and scale of the procurement, the ability of Member States to act individually or collectively, and the potential impact on the internal market, and derogations from Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council12 should be provided. The Commission should ensure sufficient resources are allocated to joint procurement procedures in order to guarantee an efficient and robust process.

(b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater environmental sustainability, overall sustainability or increased efficiency, such as innovative processes that improve production quality, resilience, or reliability;

~~__________________~~

12 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Amendment 12

Proposal for a regulation

~~Recital 37~~

Article 7 – paragraph 2

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.

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.

(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 Critical Medicines Group may invite representatives from relevant industry associations, patient, consumer and professional healthcare organisations to participate as observers or provide input on specific issues within the group's remit. 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 13

Proposal for a regulation

~~Recital 37 a (new)~~

Article 12 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

(37a) Ensuring a reliable supply of critical medicinal products requires coherent coordination between pharmaceutical policy and Union policies on environmental protection and climate change. The Critical Medicines Group may provide opinions and recommendations to the Commission concerning the potential impact of relevant environmental, climate or sustainability legislation on the availability and security of supply of critical medicines in the Union, including with regard to manufacturing sites, supply chains and market availability.

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.

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. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.

_________________

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 14

Proposal for a regulation

~~Recital 39~~

Article 12 – paragraph 2

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. During accession negotiations, it is important that the Commission promote the gradual harmonisation of candidate countries with the Union acquis in the field of medicinal products, with a view to facilitating their integration into the internal market and to reinforcing the resilience of supply chains for critical medicines. 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.

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 15

Proposal for a regulation

Article 312 – paragraph ~~1 – point 18~~5 a (new)

Text proposed by the Commission

Amendment

(18a) 'significant proportion' means that the Commission or, where appropriate, the competent authority of the Member States concerned, has assessed that at least 30% of the annual production volume of a critical medicinal product, a medicinal product of common interest, or their active pharmaceutical ingredient (API), intended for the Union market, is manufactured within the Union;

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 16

Proposal for a regulation

Article 413 – 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. 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.

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

Amendment 17

Proposal for a regulation

Article 413 – 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.

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, while reflecting the principles of solidarity and coordination between Member States and safeguarding the free movement of goods.

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. The fact that assessments are combined pursuant to this paragraph shall not affect their content or quality or robustness of the assessment.

_________________

23 Directive 2014/89/EU of the European Parliament and of the Council of 23 ELI: http://data.europa.eu/eli/dir/2014/89/oj 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 18

Proposal for a regulation

Article 1814 – paragraph 12

Text proposed by the Commission

Amendment

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

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, security and diversification of supply in the Union and shall base the award of public contracts on the most economically advantageous tender. The procurement requirements shall be defined in accordance with Directive 2014/24/EU and may relate to stockholding obligations, volume or value of manufacturing of the final product or availability of the key ingredients and components within the Union, monitoring of supply chains for potential supply bottlenecks, their transparency, including final contract value, upon request to the contracting authority and, subject to safeguarding the confidentiality of trade secrets, contract performance clauses on timely delivery or the number of diversified suppliers. Contracting authorities shall also allow for multi-winner procurements, where appropriate.

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.

Contracting authorities may take into account the views of economic operators and other relevant stakeholders when defining procurement requirements as set out in the first subparagraph. In particular with regard to supplier diversification, procurement requirements shall be proportionate and adapted to the specific characteristics of the relevant market segment. Where diversification of supply chains is demonstrably not technically possible or not economically feasible, targeted exemptions from certain criteria may be granted, so as not to jeopardise the availability of critical medicinal products on the market.

Amendment 19

Proposal for a regulation

Article 18 – paragraph 21

Text proposed by the Commission

Amendment

2.1. ~~With~~For ~~regard~~award toprocedures of critical medicinal products ~~for~~falling ~~which~~within athe ~~vulnerability~~scope inof ~~the~~Directive ~~supply~~2014/24/EU ~~chains~~of ~~has~~the ~~been~~European ~~confirmed~~Parliament ~~through~~and aof ~~vulnerability~~the ~~evaluation~~Council, ~~pointing~~contracting toauthorities in the ~~high~~Member ~~level~~States ofshall ~~dependency~~apply onprocurement arequirements ~~single~~other orthan aprice-only ~~limited~~award ~~number~~criteria ofsuch ~~third~~as ~~countries,~~procurement requirements that promote the ~~contracting~~resilience ~~authorities~~of ~~shall,~~supply ~~where~~in ~~justified,~~the ~~apply~~Union. Those procurement requirements ~~that~~shall ~~favour~~be ~~suppliers~~defined ~~that~~in ~~manufacture~~accordance awith ~~significant~~Directive ~~proportion~~2014/24/EU ofand ~~these~~may ~~critical~~relate ~~medicinal~~to ~~products~~stockholding inobligations, the ~~Union.~~number ~~These~~of ~~requirements~~diversified ~~shall~~suppliers, bemonitoring ~~applied~~of insupply ~~compliance~~chains, ~~with~~their transparency to the ~~Union’s~~contracting ~~international~~authority ~~commitments.~~and contract performance clauses on timely delivery.

2. Contracting authorities shall apply procurement requirements, for critical medicinal products that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, the European Economic Area (EEA) or the European Free Trade Association (EFTA) area, in order to ensure security of supply, and, when feasible, shall apply multi-winner procurements. These requirements shall be applied in compliance with the Union’s international commitments.

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 wherever feasible implement multi-winner procurements, which scope is designed based on clinical needs in consultation with healthcare professionals and relevant experts, with predictable procurement timelines. 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 shall include several qualitative criteria, such as patient impact and clinical value, environmental sustainability, innovation, diversity and robustness of supply chain, may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority, and contract performance clauses on timely delivery.

Amendment 20

Proposal for a regulation

Article 18 – paragraph ~~2 a (new)~~4

Text proposed by the Commission

Amendment

2a. The Commission shall, by ... [18 months from the date of entry into force of this Regulation], adopt guidelines to support public procurement practices in the field of medicinal products covered by this Regulation. The guidelines adopted by the Commission shall illustrate the effective application of the criteria for the most economically advantageous tender, in particular on the application of non-price criteria, ensuring that such criteria shall be allocated a significant weighting in order to promote resilience and diversification of the supply in the Union. The guidelines shall also provide guidance on the assessment and practical application of the concept of significant proportion as defined in Article 3 of this Regulation including its implementation in specific market situations and the methodology for verifying compliance. They shall ensure a common understanding and legal certainty, while balancing the promotion of Union production with the need to avoid protectionism and weakened competition.

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

4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability, and social rights. In order to safeguard the integrity of the Single Market, the Commission shall support coordination and the exchange of best practices between Member States.

Amendment 21

Proposal for a regulation

Article 1819 – paragraph 31 – subparagraph 1 a (new)

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.

Member States shall aim to ensure that the design and periodic review of such programmes involve health professionals and patient organisations, as well as environmental expertise, to balance public health needs, affordability and sustainability.

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

Amendment 22

Proposal for a regulation

Article 1820 – paragraph 42 a (new)

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.~~

Stockpiling management system shall apply a “first in, first out” principle and promote the use of shelf-life extension studies, in order to reduce expiry-related waste. The Commission, in cooperation with the Member States and the relevant agencies, shall adopt guidelines on sustainable stockpiling, including measures to reduce emissions, improve packaging, manage expiry dates, and ensure the environmentally sound disposal of unused or obsolete medicinal products.

4. This Article shall not preclude contracting authorities from using additional qualitative requirements, in accordance with Directive 2014/24/EU, that aim to contribute to improving supply chain security and the availability of critical medicinal products or medicinal products of common interest, which may take into account, where relevant, considerations related to sustainability and social factors.

Amendment 23

Proposal for a regulation

Article 1826 – paragraph 52 – point d a (new)

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.~~

(da) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of procurement programmes, ensuring proportionality and avoiding duplication.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3, market analysis where they can demonstrate that the application of these provisions would lead to a disproportionately high price in the procurement concerned or impact negatively affordability of critical medical products for patients. That derogation shall be clearly justified in writing and specify the circumstances relied upon. It shall be subject to ex-post review by the supervisory authority designated by the Member State.

Amendment 24

Proposal for a regulation

Article 2027 – 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.

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.

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

Amendment 25

Proposal for a regulation

Article 2030 – paragraph 1 ~~a (new)~~

Text proposed by the Commission

Amendment

1a. To facilitate a coordinated approach between Union and national authorities as well as marketing authorisation holders, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as part of its work to ensure Union coordination on the availability of medicines, shall contribute to the strengthening and effective implementation of the Solidary Mechanism framework, in particular the communication between Member States, marketing authorisation holders on the movement of stocks including, where appropriate, for medicinal products other than critical medicines, in cases of identified or imminent risk of shortage.

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. 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 26

Proposal for a regulation

Article 2030 – paragraph 2 a (new)

~~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 requirements they impose on public or private entities in the supply chain to hold contingency stocks, or any restrictions they establish on the free movement of medicines, are proportionate and respect the principles of transparency and solidarity. Member States shall, in cases where such requirements may have an impact on other Member States, without undue delay, notify the European Medicines Agency and inform other Member States of their intentions in the Critical Medicines Group, as specified in Article 26, using a common notification mechanism established for this purpose.

~~Amendment 27~~

~~Proposal for a regulation~~

~~Article 20 – paragraph 2 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

2a. The European Medicines Agency shall assess the notified measures in light of their potential impact on the availability of medicinal products in other Member States and on the functioning of the internal market and shall report its findings to the Commission and the Critical Medicines Coordination Group.

~~Amendment 28~~

~~Proposal for a regulation~~

~~Article 20 – paragraph 2 b (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

2b. Any Member State that considers itself negatively affected by measures adopted by another Member State may submit an opinion describing the negative impacts to the Critical Medicines Group and the Commission. The Commission shall, without delay, engage with the Member State concerned and other affected Member States to promote coordinated solutions.

~~Amendment 29~~

~~Proposal for a regulation~~

~~Article 21 – paragraph 2~~

~~Text proposed by the Commission~~

~~Amendment~~

2. Having received the request, the Commission shall inform all other Member States of the initiative and set an appropriate deadline for them to declare interest. Such a deadline shall not exceed three weeks.

2. Having received the request, the Commission shall inform all other Member States of the initiative and set an appropriate deadline for them to declare interest, provided the product qualifies as a medicinal product of common interest in their jurisdiction. Such a deadline shall not exceed three weeks.

~~Amendment 30~~

~~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 necessity and proportionality of the request in light of the actual access hurdles in the Member States and in light of the objectives of this Regulation, taking into account, where necessary, the views of relevant stakeholders, including market authorisation holders.

~~Amendment 31~~

~~Proposal for a regulation~~

~~Article 21 – paragraph 4~~

~~Text proposed by the Commission~~

~~Amendment~~

~~4. If the Commission declines the request, it shall provide reasons for the refusal.~~

4. 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. Where the Commission declines the request, it shall provide reasons for the refusal.

~~Amendment 32~~

~~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.

~~Amendment 33~~

~~Proposal for a regulation~~

~~Article 22~~

~~Text proposed by the Commission~~

~~Amendment~~

~~[...]~~

~~deleted~~

~~Amendment 34~~

~~Proposal for a regulation~~

~~Article 23 – title~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Joint Procurement~~

~~Joint Procurement and procurement on behalf of Member States~~

~~Amendment 35~~

~~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 the conditions laid down in this Article and by way of derogation from Article 168(2) and (3) 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, or the Commission may procure, on behalf of, or in the name of nine or more Member States, in accordance with paragraphs 2 to 8 of this Article.

~~Amendment 36~~

~~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 procurement procedure as referred to in paragraph 1 may be organised following a request by the Member States or at the Commission’s initiative, provided that, when the procurement relates to medicinal products belonging to one of the categories below:

~~Amendment 37~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 2 – point b~~

~~Text proposed by the Commission~~

~~Amendment~~

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) of Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation, where such products have been identified as being subject to clearly defined supply risks under the mechanisms set out in this Regulation; procurement procedures shall be designed with the objective of facilitating timely patient access to such products.

~~__________________~~

31 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI: http://data.europa.eu/eli/reg/2021/2282/oj)

~~Amendment 38~~

~~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 shall assess the necessity and proportionality of the procurement procedure referred to in paragraph 1. It shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition and only launch it if it assesses that the procedure contributes to improving the security of supply and availability of critical medicinal products in the Union or ensuring the availability and accessibility of medicinal products of common interest, as applicable. That assessment shall be based on objective criteria, including market conditions, risk assessments, and product-specific characteristics, and may also be conducted on the basis of a consultation with the marketing authorisation holder and relevant stakeholders.

~~Amendment 39~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 4 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

4a. The procurement procedure set out in this Article shall be preceded by a joint procurement agreement between the Commission and the participating Member States in order to determine the practical arrangements governing the procurement, the duration of the procedure and the award criteria, in accordance with relevant Union law.

~~Amendment 40~~

~~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.

~~deleted~~

~~Amendment 41~~

~~Proposal for a regulation~~

~~Article 23 – 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.

6. If, in light of the Commission assessments referred to in paragraph 3, it is necessary, in order to achieve the objectives of this Regulation, the procurement procedure may be conditional upon interested Member States accepting specific requirements, including conducting the procurement as exclusive to those Member States or agreeing to minimum binding quantities.

~~Amendment 42~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 7 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

7a. In order to promote the resilience, availability, and diversification of the supply chain, the Commission shall ensure that any procurement procedure under this Article applies the award criteria and requirements referred to in Article 18.

~~Amendment 43~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 8~~

~~Text proposed by the Commission~~

~~Amendment~~

8. Except for the derogations provided for in this Regulation, the joint procurement procedure shall be carried out by the Commission in accordance with Article 168 (2) of Regulation (EU, Euratom) 2024/2509.

8. Except for the derogations provided for in this Regulation, the joint procurement procedure shall be carried out by the Commission in accordance with Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509.

~~Amendment 44~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 8 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

8a. The Commission shall inform the European Parliament about any procurement procedures conducted in accordance with this Article and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of commercially sensitive information, including business secrets, commercial relations and the interests of the Union.

~~Amendment 45~~

~~Proposal for a regulation~~

~~Article 23 – paragraph 8 b (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

8b. Where the Commission cancels the procurement procedure in accordance with Article 174 of Regulation (EU, Euratom) 2024/2509, it shall immediately inform the participating Member States thereof, so that they can initiate their own procurement procedures without delay.

~~Amendment 46~~

~~Proposal for a regulation~~

~~Article 24 – title~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Agreement concerning procedures under Articles 22 and 23~~

~~Agreement concerning procedures under Article 23~~

~~Amendment 47~~

~~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.

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

~~Amendment 48~~

~~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. It shall, where appropriate, also include safeguards to ensure transparency of award criteria and the prevention of discriminatory practices.

~~Amendment 49~~

~~Proposal for a regulation~~

~~Article 24 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Article 24a~~

During accession negotiations, the Commission shall promote the gradual harmonisation of candidate countries with the Union acquis in the field of medicinal products, with a view to facilitating their integration into the internal market and to reinforcing the resilience of supply chains for critical medicines.

~~Amendment 50~~

~~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, including with regard to the assessment of the impact of other Union legal acts on the availability of critical medicines and the development of appropriate countermeasures, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

~~Amendment 51~~

~~Proposal for a regulation~~

~~Article 26 – paragraph 1 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

1a. To ensure the views of relevant stakeholders are taken into account, the Critical Medicines Group may invite representatives from relevant industry associations, pharmaceutical organisations, manufacturers, patient, consumer and professional healthcare organisations or market authorisation holders to participate as observers or provide input on specific issues within the group's remit.

~~Amendment 52~~

~~Proposal for a regulation~~

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

~~Text proposed by the Commission~~

~~Amendment~~

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

~~Amendment 53~~

~~Proposal for a regulation~~

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

~~Text proposed by the Commission~~

~~Amendment~~

~~(da) issue guidelines and exchange best practices on the use of resilience criteria in the framework of public procurement and on the use of qualitative criteria in the context of public procurement;~~

~~Amendment 54~~

~~Proposal for a regulation~~

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

~~Text proposed by the Commission~~

~~Amendment~~

(db) support the Commission in its dialogue with Member States on national security of supply measures, where relevant and feasible, with the aim of identifying coordinated solutions that make full use of, and protect, the proper functioning of the internal market.

~~Amendment 55~~

~~Proposal for a regulation~~

~~Article 26 – paragraph 5 a (new)~~

Text proposed by the Commission

Amendment

~~5a. The Critical Medicines Group may provide recommendations~~2a. toWhere the ~~Commission on regulatory exemptions that are necessary for the~~evaluation ~~short-term~~referred ~~redistribution~~to ofin ~~critical~~paragraph ~~medicinal~~1 ~~products,~~identifies ~~such~~a aspotential ~~modifications~~risk to ~~packaging,~~the ~~language~~availability or ~~labelling requirements. The~~security ~~Critical~~of ~~Medicines~~supply ~~Group~~of ~~may~~a ~~also~~critical ~~provide~~medicinal ~~opinions~~product ~~and~~in ~~recommendations~~the toUnion, the Commission ~~concerning~~shall ~~the~~carry ~~potential~~out ~~impact~~a ofcoordinated, ~~relevant~~evidence-based ~~legislation~~impact onassessment ~~the~~and, ~~availability~~where ~~and~~appropriate, ~~security~~propose ofproportionate ~~supply~~and ofappropriate ~~critical~~mitigating ~~medicines~~measures in ~~the Union, including~~consultation with ~~regard to manufacturing sites,~~the ~~supply~~Member ~~chains~~States and ~~market~~relevant ~~availability.~~stakeholders.

ANNEX: DECLARATION OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that ~~she~~he included in ~~her~~his opinion input on matters pertaining to the subject of the file that ~~she~~he received, in the preparation of the opinion, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register

~~European Commission, Directorate-General for Health and Food Safety~~

Federchimica

~~Bundesärztekammer~~

Farmindustria

~~CSL Behring~~

Menarini

~~European Federation of Pharmaceutical Industries and Associations (EFPIA)~~

~~Medicines for Europe~~

~~Kassenärztliche Bundesvereinigung~~

~~Pharma Deutschland e.V.~~

~~Permanent Representation of Germany to the EU~~

~~Deutsche Sozialversicherung~~

~~Merck~~

~~Bristol-Myers Squibb Company~~

~~Johnson & Johnson~~

~~Pfizer Inc.~~

~~Pharmaceutical Group of the European Union (PGEU)~~

~~Viatris~~

~~GSK~~

~~Bundesverband Medizintechnologie e.V.~~

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

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

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur for opinion declares that ~~she~~he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Date announced in plenary

~~IMCO~~

ENVI

21.5.2025

Date appointed

~~Marion Walsmann~~

Michele Picaro

~~23.6.2025~~

18.6.2025

~~Discussed in committee~~

~~15.7.2025~~

~~25.9.2025~~

~~16.10.2025~~

Date adopted

~~11.11.2025~~

4.11.2025

Result of final vote

Members present for the final vote

Alex Agius Saliba, Pablo Arias Echeverría, Jeannette Baljeu, Arno Bausemer, Biljana Borzan, Anna Cavazzini, Stefano Cavedagna, David Cormand, Henrik Dahl, Dóra Dávid, Adnan Dibrani, Klara Dostalova, Hanna Gedin, Sandro Gozi, Maria Grapini, Elisabeth Grossmann, Maria Guzenina, Svenja Hahn, Anna-Maja Henriksson, Virginie Joron, Pierre Jouvet, Arba Kokalari, Nikola Minchev, Piotr Müller, Reinis Pozņaks, Christel Schaldemose, Andreas Schwab, Tomislav Sokol, Dimitris Tsiodras, Inese Vaidere, Adina Vălean, Kim Van Sparrentak, Marion Walsmann

Christine Anderson, Pascal Arimont, Bartosz Arłukowicz, Sakis Arnaoutoglou, Anja Arndt, Monika Beňová, Alexander Bernhuber, Barbara Bonte, Stine Bosse, Lynn Boylan, Jorge Buxadé Villalba, Laurent Castillo, Mohammed Chahim, Christophe Clergeau, Annalisa Corrado, Ivan David, Ondřej Dostál, Viktória Ferenc, Heléne Fritzon, Andreas Glück, Hanna Gronkiewicz-Waltz, Martin Günther, Roman Haider, Esther Herranz García, Radan Kanev, Ondřej Knotek, Stefan Köhler, András Tivadar Kulja, Peter Liese, Javi López, César Luena, Elżbieta Katarzyna Łukacijewska, Ignazio Roberto Marino, Catarina Martins, Tilly Metz, Dolors Montserrat, Jana Nagyová, Jutta Paulus, Michele Picaro, Nicola Procaccini, Massimiliano Salini, Silvia Sardone, Majdouline Sbai, Lena Schilling, Günther Sidl, Jonas Sjöstedt, Sander Smit, Antonín Staněk, Marta Temido, Ingeborg Ter Laak, Beatrice Timgren, Zala Tomašič, Dimitris Tsiodras, Ana Vasconcelos, Aurelijus Veryga, Kristian Vigenin, Emma Wiesner, Michal Wiezik, Tiemo Wölken

Substitutes present for the final vote

Marc Angel, José Cepeda, Veronika Cifrová Ostrihoňová, Salvatore De Meo, Dirk Gotink, Sophia Kircher, Alice Kuhnke, Marlena Maląg, Gaetano Pedulla’, Joanna Scheuring-Wielgus, Tomáš Zdechovský, Kosma Złotowski

Jeannette Baljeu, Biljana Borzan, Marie-Luce Brasier-Clain, Daniel Buda, Per Clausen, Raúl de la Hoz Quintano, Valérie Deloge, Sigrid Friis, Jens Gieseke, Michalis Hadjipantela, Martin Häusling, Paolo Inselvini, Sara Matthieu, Valentina Palmisano, Raffaele Topo, Laurence Trochu, Vlad Vasile-Voiculescu, Anders Vistisen

Members under Rule 216(7) present for the final vote

~~Siegbert Frank Droese, Pál Szekeres~~

Francesco Torselli

FINAL VOTE BY ROLL CALL BY THE COMMITTEE ASKED FOR OPINION