Changes from report parliamentary committee draft to plenary report

RemovedRecital 39: (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. Those partnerships should be identified through a structured methodology, distinguishing between those reinforcing existing cooperation and those aiming to reduce strategic dependencies. They should also address trade and regulatory barriers, promote regulatory cooperation, and facilitate cross-border movement of critical medicinal products or medicinal products of common interest, in compliance with international obligations.

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

RemovedRecital 41: (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. The Commission should continuously monitor the application of this Regulation and assess its impact on competition and the functioning of the internal market. Where such monitoring or a comprehensive evaluation reveals that the application of this Regulation leads to significant distortions of competition or serious disruptions to the internal market, the Commission should take appropriate correc…

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

RemovedRecital 41 a (new): (41a) In order to supplement this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the specification and harmonisation of the conditions applicable to Member States’ contingency stock requirements, as well as the determination of the categories, types and quantities of critical medicinal products and medicinal products of common interest to be included in the Union Stockpile, the determination of the specific arrangements for storage and maintenance of such Stockpile, and the criteria and procedures for the deployment of the stockpiled products. In order to amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distorsions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making* . In particular, to ensure equal participation in the preparation of deleg…

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

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

AddedRecital 39: (39) The Union should further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union should, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. As part of these partnerships, the Commission should promote a collaborative innovation ecosystem that integrates small and medium-sized enterprises, start-ups and deep-tech innovators alongside established pharmaceutical companies in order to enhance resilience, foster technological advancement and boost the competitiveness of the Union’s pharmaceutical sector. The Commission should specifically consider the inclusion of access to active pharmaceutical ingredients (API) and their starting materials in the scope of international partnerships.

RemovedArticle 1 – paragraph 1 a (new): 1a. It is also an objective of this Regulation to support the competitiveness of the Union’s pharmaceutical sector as a strategic asset and to promote targeted, evidence-based measures that avoid unintended consequences for the continuity of supply of critical medicinal products and for the accessibility of medicinal products of common interest to patients.

AddedRecital 41: (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. When an evaluation reveals a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission should conduct a coordinated, evidence-based assessment and, where appropriate, propose proportionate mitigating measures in consultation with Member States and relevant stakeholders to safeguard continuous supply.

RemovedArticle 1 – paragraph 2 – point c: (c) leverage the aggregated demand of participating Member States through collaborative procurement procedures,

AddedRecital 42 a (new): (42a) In order to supplement this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the specification and harmonisation of the conditions applicable to the determination of the categories, types and quantities of critical medicinal products to be included in the Union Stockpile, the determination of the specific arrangements for storage and maintenance of such Stockpile, and the criteria and procedures for the deployment of the stockpiled products. The exercise of these delegated powers should fully respect the principles of subsidiarity and proportionality. In order to amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distortions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparatio…

RemovedArticle 1 – paragraph 2 – point d: (d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships,

AddedArticle 1 – paragraph 1: 1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby reducing its dependency on third countries and thereby ensuring a high level of public health protection, maintaining patient safety and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the accessibility and affordability of medicinal products.

RemovedArticle 3 – paragraph 1 – introductory part: For the purposes of this Regulation, the definitions laid down in Article 4 of Directive (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] and in Article 2 of Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall apply. For the purpose of this Regulation, the following definitions shall apply:

AddedArticle 1 – paragraph 2 – point c: (c) leverage the aggregated demand of participating Member States through collaborative procurement procedures;

AddedArticle 1 – paragraph 2 – point d: (d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain;

AddedArticle 1 – paragraph 2 – point d a (new): (da) facilitate investments in critical distribution infrastructure capacity for critical medicinal products ensuring security of supply, availability and accessibility in the Union; and

AddedArticle 1 – paragraph 2 – point d b (new): (db) strengthen the resilience of supply chains and promote the sustainable access to and supply of active substances of critical medicinal products, their API starting materials, and other key inputs within the Union insofar as they are used for the manufacture of critical medicinal products.

AddedArticle 2 – paragraph 1: 1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product’s supply chain.

AddedArticle 2 – paragraph 1 a (new): 1a. Chapter III also applies to active substances of critical medicinal products, their starting materials, and other key inputs within the Union, insofar as they are used for the manufacture of critical medicinal products.

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

AddedArticle 3 – paragraph 1 – introductory part: For the purposes of this Regulation, relevant definitions laid down in Article 4 of Directive (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] and in Article 2 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall apply mutatis mutandis. The following definitions shall also apply:

AddedArticle 3 – paragraph 1 – point 11 a (new): (11a) ‘economic operator’ means an economic operator as defined in Directive 2014/24/EU;

AddedArticle 3 – paragraph 1 – point 12: (12) ‘permit granting process’ means a process covering all relevant permits to build, expand, convert and operate a strategic project, including building, chemical and grid connection permits and environmental assessments and authorisations where those are required and encompassing all applications and procedures;

RemovedArticle 5 – paragraph 1 a (new): Notwithstanding the first paragraph, a project shall not be considered strategic if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs within the Union, unless such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

AddedArticle 6 – paragraph 1 – subparagraph 2: A promoter may request the designated authority to assess whether a project constitutes a strategic project.

AddedArticle 6 – paragraph 5 c (new): 5c. The Commission shall act as a coordinator for cross-border strategic projects and shall ensure effective cooperation between the designated authorities of the Member States concerned, to avoid duplication of efforts in bordering Member States and to promote complementarity and efficiency in the implementation of such projects.

AddedArticle 6 – paragraph 5 d (new): 5d. Prior to the determination of a project as strategic, the designated authority shall notify the Critical Medicines Coordination Group of its intention to make such a determination. Within one month of receipt of such notification, the Critical Medicines Coordination Group shall assess whether the project would result in a significant duplication of existing or planned manufacturing capacities within the Union. Where the Critical Medicines Coordination Group does not complete the assessment within that period, the project shall be presumed not to result in significant duplication. / Where the Critical Medicines Coordination Group considers that the project would result in a significant duplication of existing or planned manufacturing capacities within the Union, it shall inform the designated authority thereof. Such projects shall not be eligible to receive financial support from the Union pursuant to Article 16.

AddedArticle 7 – paragraph 1: Strategic projects shall be considered as contributing to the security of supply of critical medicinal products, or where applicable, medicinal products of common interest, in the Union and, therefore, to be in the public interest as serving the objectives of public health, safety and the protection of patients’ interests.

AddedArticle 7 – paragraph 2: The Member States’ authorities shall ensure that the relevant permit granting processes and corresponding certification and inspection processes related to strategic projects are fast tracked, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring the quality and robustness of assessments and upholding the relevant environmental, health and work safety standards.

RemovedArticle 12 a (new): Article 12a / Coordination with environmental and chemical legislation / The Commission and Member States shall ensure that the application of this Regulation is coordinated with the application of environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products or medicinal products of common interest. / Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products or medicinal products of common interest, the Commission shall conduct a coordinated impact assessment and consult with the Critical Medicines Group to propose mitigating actions including, where appropriate, legislative proposals.

AddedArticle 12 – paragraph 1 – subparagraph 1: 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 is applied. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.

RemovedArticle 14: deleted / (deleted) / (deleted) / (deleted)

AddedArticle 12 – paragraph 2: 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.

RemovedArticle 15 – paragraph 1: 1. Without prejudice to Articles 107 and 108 TFEU, Member States shall prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

AddedArticle 12 – paragraph 5 a (new): 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.

RemovedArticle 15 – paragraph 1 a (new): 1a. Member States may establish contractual arrangements on strategic projects to dedicate a portion of their manufacturing capacity for the production of specific critical medicinal products, their active substances and key inputs or technologies, or categories thereof, in order to address potential or emerging shortages at the request of the Critical Medicines Group within a fixed timeframe.

AddedArticle 13 – paragraph 1: 1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data are available and accessible, including online.

RemovedArticle 15 – paragraph 1 b (new): 1b. The Commission shall adopt guidelines to facilitate the consistent application of this Article by Member States and the granting of State aid to strategic projects that meet the criteria of Article 5. Those State aid guidelines should include specific provisions for financing strategic projects that are aimed to improve the security of supply of medicinal products in the Union, both in terms of capacity (increased manufacturing of medicinal products in the Union) as well as in terms of innovative manufacturing process (improved manufacturing of medicinal products in the Union).

AddedArticle 13 – paragraph 2: 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.

RemovedArticle 18 – paragraph 2: 2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. Where these requirements are introduced, the contracting authority shall apply multi-winner approaches and shall ensure that significant quantities are purchased from suppliers that manufacture a significant proportion in the Union. Those requirements shall be applied in compliance with the Union’s international commitments.

AddedArticle 15 – paragraph 3 c (new): 3c. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

RemovedArticle 18 – paragraph 2 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50% of the active pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; / (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation.

AddedArticle 16 – paragraph 1: 1. All the Union funding under the current and future Multiannual Financial Frameworks, including regional policy funding programmes, may support strategic projects unless explicitly excluded by the legal basis or the scope of relevant programmes and provided that such support is in line with the objectives set out in the regulations establishing those programmes. / (deleted) / (deleted) / (deleted) / (deleted)

RemovedArticle 18 – paragraph 3: 3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

AddedArticle 16 – paragraph 1 – subparagraph 1 a (new): Subject to a Council regulation laying down the multiannual financial framework for the years 2028 to 2034 (MFF 2028–2034), strategic projects may be supported by Union funding, including any relevant Union instrument financed within the limits of the ceilings established in the MFF 2028–2034, provided that such support is in line with the objectives set out in the regulations establishing any such relevant instrument. A critical medicines security fund shall be established within the framework of MFF 2028–2034, in coordination with other relevant Union instruments, to support the achievement of the objectives of this Regulation.

RemovedArticle 18 – paragraph 3 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a medicinal product of common interest shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50 % of the active pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a s…

AddedArticle 16 – paragraph 1 – subparagraph 1 b (new): If a project promoter has received financial support for a strategic project from Union funding, it shall prioritise supply to the Union market and shall ensure that the critical medicinal product or, where applicable, medicinal product of common interest, remains available in the Member States where it is being marketed.

RemovedArticle 18 – paragraph 4: 4. Procurement procedures under this Chapter may include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights, insofar as they are linked to the subject-matter of the contract.

AddedArticle 16 – paragraph 2 a (new): 2a. A project promoter receiving Union financial support under this Article shall comply with any obligations linked to such support including any reporting obligations pursuant to Article 57 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final]. Where a project promoter fails to comply with those obligations, the Commission may suspend, revoke or recover the funding, in whole or in part, in accordance with the applicable rules. In addition, the Commission may impose a financial penalty or exclusion from future funding that is proportionate to the impact of the non-compliance, time-limited, and targeted to safeguard public health within the Union.

RemovedArticle 18 – paragraph 5: 5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where such a decision is duly justified on the basis of a documented market analysis, or where application of those provisions would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be supported by a written justification outlining the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

AddedArticle 16 – paragraph 2 b (new): 2b. Where there is a substantiated risk that export of a critical medicinal product would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the project promoter benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited, and targeted to safeguard public health within the Union.

RemovedArticle 20 a (new): Article 20a / Safeguards relating to national contingency stock requirements and Union-level coordination measures to ensure security of supply / 1. Measures adopted by Member States to safeguard the security of supply of critical medicinal products and medicinal products of common interest shall not adversely affect the availability of such products in other Member States or compromise the functioning of the internal market. / In particular, Member States shall: / (a) refrain from introducing or maintaining requirements on economic operators in relation to the holding of contingency stocks that could result in disproportionate or discriminatory effects on the supply of such products in other Member States; / (b) ensure that any obligations they impose on economic operators in relation to the holding of contingency stocks are proportionate, non-discriminatory, and consistent with the principles of transparency and solidarity; / (c) take due account of any guidelines on improving the security of supply to and avoiding supply shortages that have been issued by the Commission pursuant to Article 134 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final], including those on facilitating the fulfilment of Member State’s obligations pursuant to points (a) and (b) of this subparagraph; (d) take due account of the guidelines referred to in point (c) of this subparagraph when establishing national programmes in accordance with Article 19 of this Regulatio…

AddedArticle 17 – paragraph 2 – subparagraph 2: The Commission shall inform the Critical Medicines Group of its intention to propose the establishment of funding possibilities to support strategic projects. It shall also inform the Critical Medicines Group of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

RemovedChapter IV – Section I a (new): SECTION Ia / UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS AND MEDICINAL PRODUCTS OF COMMON INTEREST

AddedArticle 18 – paragraph 1: 1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs and the size of the patient population in consultation with healthcare professionals, with predictable procurement timelines and predictable mix and weighting of qualitative criteria, and shall apply procurement requirements other than price-only award criteria. Those requirements shall include award criteria that promote the resilience of supply in the Union, support the diversification of supply sources, and take into account the distance between manufacturing sites and points of delivery within the Union. Such criteria shall form the main basis for award decisions and shall, in any case, be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and may also include innovation, supply chain robustness, the number of diversified suppliers, obligations on the monitoring of supply chains, transparency of supply chains upon request of the contracting authority and contract performance clauses on timely delivery.

RemovedArticle 20 b (new): Article 20b / Establishment of a Union coordination mechanism for critical medicinal products and medicinal products of common interest / A Union coordination mechanism for critical medicinal products and medicinal products of common interest is hereby established. It shall be operated by the Commission. Through that coordination mechanism the Commission shall: / (a) monitor the availability and distribution of critical medicinal products and medicinal products of common interest across the Union; / (b) ensure effective and equitable redistribution in cases of shortage or supply disruption in one or more Member States having a negative impact in the internal market or in other Member States.

AddedArticle 18 – paragraph 1 a (new): 1a. In contracts which provide for the possibility of unilateral prolongation by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

RemovedArticle 20 c (new): Article20c / Redistribution decisions / Where, for a critical medicinal product or medicinal product of common interest, a shortage or supply disruption is identified in one or more Member States, the Commission shall, upon request of the Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring a redistribution from a national stockpile or a contingency stock. Such a decision shall: / (a) be based on an objective risk assessment and real-time data establishing both the shortage or supply disruption resulting in serious harm or risk of serious harm to patients and the negative impact in the internal market or in other Member States; / (b) specify the quantities to be transferred, the timeframe for delivery, and any logistical arrangements; / (c) ensure that the transferring Member States retain adequate minimum levels of the relevant medicinal product.

AddedArticle 18 – paragraph 2: 2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicinal products. Those requirements shall be applied in compliance with the Union’s international commitments.

RemovedArticle 20 d (new): Article20d / Stockpile information and reporting obligations / The Commission shall establish and maintain a digital reporting system that enables real-time updates on the status of national stockpiles and contingency stocks where they are established under national law. / Each Member State shall report to the Commission at least once per month, and immediately upon any significant change in stock levels. The Member States’ reports shall contain, at a minimum, the following information: / (a) a list of medicinal products for which contingency stocks or a national stockpile are held; / (b) the quantities of such stocks; / (c) the measures in place to ensure proper stock management, including rotation and the prevention of expiry. / For the purposes of this Article, the Commission shall make use of existing Union data infrastructures and reporting mechanisms, including but not limited to the Technical Regulation Information System (TRIS), the European Medicines Verification System (EMVS), the European Shortages Monitoring Platform (ESMP), EudraGMDP, the Industry Single Point of Contact (iSPOC) network, and relevant instruments established under the Union Civil Protection Mechanism. The Commission shall be granted timely access to data held by the Agency, and by the competent authorities of the Member States, to the extent necessary to support its mandate in the areas of situational awareness, risk assessment, and the coordination under this Chapter. / The Commission may adopt i…

AddedArticle 18 – paragraph 2 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50% of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EFTA countries; / (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EFTA countries.

RemovedArticle 20 e (new): Article 20e / Obligations of Member States / Member States shall: / (a) comply with binding redistribution decisions adopted pursuant to Article 20c; / (b) cooperate fully with the Commission in the implementation of this Regulation. / The Commission may initiate an infringement procedure against a Member State in the event of non-compliance with the obligations laid down in this Regulation.

AddedArticle 18 – paragraph 3: 3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union and shall take into account the distinctive characteristics of the supply chains of different medicinal products. These requirements shall be applied in compliance with the Union’s international commitments.

RemovedArticle 20 f (new): Article 20f / Reimbursement and replacement / Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20c, it shall be entitled to full reimbursement from the receiving Member State for the value of the medicinal products transferred and the costs of transport and a reasonable mark-up. / The value of the medicinal products transferred shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned or, in the absence of agreement, as determined by the Commission. / The transferring Member State shall be entitled to reimbursement of the determined value within a period not exceeding [60] calendar days from the date of receipt of the critical medicinal products by the receiving Member State. / The Commission shall adopt implementing acts specifying procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 20h(2). / In duly justified circumstances, and in the interest of solidarity, the Commission may authorise the use of Union financial instruments or emergency health funds to support or partially offset the cost borne by the receiving Member State, in accordance with applicable Union law.

AddedArticle 18 – paragraph 3 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a medicinal product of common interest shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50 % of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (c) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of thi…

RemovedArticle 20 g (new): Article 20g / Union Stockpile / In order to ensure the timely and effective availability of critical medicinal products or medicinal products of common interest with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism. / The Commission is empowered to adopt delegated acts in accordance with Article 30a, to determine: / (a) the categories and specific types of critical medicinal products and medicinal products of common interest to be included in the Stockpile; / (b) the minimum quantities to be stocked for each product, taking into account Union-level risk assessments, supply vulnerabilities, and public health needs; / (c) the logistical, technical and operational arrangements for storage and maintenance of the stockpile; / (d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States. / Should the Commission decide to establish the Union Stockpile, it shall coordinate with national competent authorities to ensure that it does not duplicate national stockpiles or contingency stocks arrangements. The establishment of the Union Stockpile shall be designed and implemented in a way that does not result in any negative impact on availability of medicinal products in other Member States. / The Commission shall further ensure that packaging, labelling, and storage conditions are such as to enable the rapid and safe distribution and use of the medicinal products across th…

AddedArticle 18 – paragraph 4: 4. Procurement procedures under this Chapter shall, include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights.

RemovedArticle 20 h (new): Article 20h / Committee procedure / 1. The Commission shall be assisted by the Standing Committee on medicinal products for human use established by Article 214 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. / 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

AddedArticle 18 – paragraph 5: 5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where such a decision is duly justified on the basis of a documented market analysis, or where the application of those paragraphs would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be accompanied by a written justification specifying the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

RemovedArticle 20 i (new): Article 20i / Removal of obstacles to implementation / Where Member States identify obstacles to the effective implementation of Section Ia of this Chapter, they shall take all necessary measures to remove such obstacles within one year from the date of application of this Regulation. / To that end, Member States shall, where appropriate, amend or repeal national legislative, regulatory or administrative provisions that are incompatible with the requirements laid down in Section Ia of this Chapter.

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

RemovedArticle 21 – paragraph 1: 1. Upon a reasoned request of three or more Member States (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EU28 for medicinal products of common interest.

AddedArticle 19 – paragraph 1: 1. By 6 months after entry into force of this Regulation each Member State shall establish, after having consulted patient and consumer organisations and healthcare professional organisations, a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. National programmes shall include measures to promote the use of procurement award criteria relating to supply chain resilience and diversification of supply sources in accordance with Article 18. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis and shall align reporting and shortage signals with mechanisms operated by MSSG to avoid duplication. Such programmes shall also, where appropriate, include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures as well as review any price freezes, cost containment measures or stockholding obligations applicable. Member States may involve their national pricing and reimbursement authorities in the planning and evaluation of such programmes.

RemovedArticle 21 – paragraph 5: 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, including on the use of award criteria as set out in Article 18 and on regulatory matters related to medicinal products.

AddedArticle 19 – paragraph 2: 2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate a discussion, involving representatives of marketing authorisation holders, patient and consumer organisations and healthcare professional organisations, and other relevant actors in the supply chain, aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

RemovedArticle 21 – paragraph 6: 6. The facilitation offered by the Commission shall be limited in time and end at the latest upon delivery of the medicinal products of common interest.

AddedArticle 20 – paragraph 1: Measures relating to security of supply applied in one or more Member States shall not result in any negative impact on the availability of critical medicinal products and medicinal products of common interest in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for economic operators to hold contingency stocks.

RemovedArticle 21 – paragraph 6 a (new): 6a. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements: / (a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions; / (b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such; / (c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product; / (d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

AddedArticle 20 – paragraph 2: Member States shall ensure that any national measures or requirements they impose on economic operators in the supply chain to hold contingency stocks are proportionate, targeted, evidence-based and respect the principles of transparency, solidarity and non-discrimination.

RemovedArticle 22: deleted

AddedArticle 20 – paragraph 2 a (new): Where Member Stats impose contingency stock requirements on economic operators, they shall notify the Commission and the Agency. Member States shall also encourage the implementation of rolling stockpiling systems amongst manufactures.

RemovedArticle 23 – title: Joint Procurement and procurement on behalf of Member States

AddedArticle 20 – paragraph 2 b (new): All contingency stock requirements and other security of supply measures shall be implemented in a manner that minimises waste and environmental impact, including through effective stock rotation based on the ‘first expired, first out’ system to prevent the destruction of medicinal products.

RemovedArticle 23 – paragraph 1: deleted

AddedArticle 20 – paragraph 2 c (new): The Commission shall, following a consultation with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers, and marketing authorisation holders, issue Union guidelines recommending the establishment of common standards for contingency stocks and national stockpiles to support Member State activities, ensuring predictability for economic operators. Those common standards may include: / (a) the establishment of maximum quantitative thresholds for contingency stocks at both national and aggregated Union level, to be determined in cooperation with economic operators and reviewed periodically in light of evolving risk assessments; / (b) provisions allowing for the holding of contingency stocks in the form of white-label semi-finished or bulk products, where appropriate to ensure flexibility and timely deployment; / (c) the use of harmonised packaging formats, including multi-language or Union-wide packs, with a view to facilitating cross-border supply and reducing relabelling burdens; / (d) practices on sustainable stockpiling, including practices to reduce emissions, improve packing, including leaflet, manager expiry dates, and ensure responsible disposal of unused or obsolete medicinal products.

RemovedArticle 23 – paragraph 2 b (new): 2b. At the Commission’s initiative, the Commission and at least nine Member States with a similar epidemiological or economic situation may engage, as contracting parties, in a joint procurement procedure as provided for in Article 168(2) of Regulation (EU, Euratom) 2024/2509, if the requirements laid down in paragraph 2 of this Article are fulfilled. Such a joint procurement procedure shall be conducted in accordance with paragraphs 4 to 7 of this Article.

AddedArticle 20 c (new): Article 20c / Appeal mechanism / 1. A Member State concerned by a redistribution decision adopted and notified pursuant to Article 20b may submit a reasoned request for a review of the decision referred to in that Article. Such a request shall be submitted to the Commission within 10 days of the notification referred to in that Article and shall state in detail the reasons for which that Member State considers that the decision does not comply with the conditions laid down in that Article or that its application would pose a disproportionate risk to public health. / 2. Following consultation of the Critical Medicines Coordination Group, the Commission shall adopt a review decision within 10 days of receipt of the reasoned request referred to in paragraph 1. That decision shall confirm, amend or revoke the distribution decision adopted and notified pursuant to Article 20b and shall state the reasons on which it is based. / 3.The submission of a request for review shall not suspend the application of the distribution decision adopted and notified pursuant to Article 20b, unless the Commission, on duly justified grounds, decides to grant a suspension pending the outcome of the review.

RemovedArticle 23 – paragraph 2 c (new): 2c. Where nine or more Member States consider it appropriate to mandate the Commission to act as a central purchasing body, those Member States may jointly request the Commission to procure on their behalf, or in their name, as a mandated contracting authority, in a procurement procedure on behalf of Member States as provided for in Article 168(3) of Regulation (EU, Euratom) 2024/2509. If the requirements laid down in paragraph 2 of this Article are fulfilled, the Commission may initiate such a procurement procedure in accordance with paragraphs 4 to 7 of this Article.

AddedArticle 20 d (new): Article 20d / Stockpile information and reporting obligations / 1. The Commission shall establish and maintain a digital reporting system that enables real-time updates on the status of national stockpiles and contingency stocks where such national stockpiles or contingency stocks are established under national law. Each Member State shall report to the European Commission at least quarterly on the status of their national stockpiles and contingency stocks, and immediately upon any significant change in stock levels. / 2. The report referred to in paragraph 1 shall include the following information: / (a) a list of critical medicinal products for which contingency stocks or a national stockpile are held; / (b) the quantities of such stocks; / (c) the measures in place to ensure proper stock management, including rotation and the prevention of expiry. / 3. For the purposes of this Article, the Commission shall make use of existing Union data infrastructures and reporting mechanisms, including but not limited to the Technical Regulation Information System (TRIS), the European Medicines Verification System (EMVS), the European Shortages Monitoring Platform (ESMP), EudraGMDP, the Industry Single Point of Contact (iSPOC) network, and relevant instruments established under the Union Civil Protection Mechanism. The Commission shall be granted timely access to data held by the Agency, and by the competent authorities of the Member States in accordance with national law, to the extent…

RemovedArticle 23 – paragraph 3: deleted

AddedArticle 20 e (new): Article 20e / Committee procedure / 1. The Commission shall be assisted by the Standing Committee on medicinal products for human use established by Article 214 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. / 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

RemovedArticle 23 – paragraph 4: 4. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request referred to in paragraph 2c, through the Critical Medicines Group, and invite them to join the procedure.

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

RemovedArticle 23 – paragraph 5: 5. The Commission shall assess the utility, the necessity and proportionality of the request referred to in paragraphs 2b and 2c 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.

AddedArticle 20 g (new): Article 20g / Reimbursement and replacement / 1. Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20b, it shall be entitled to full reimbursement from the receiving Member State for the value of the critical medicinal products transferred and the costs of transport and a reasonable mark-up. / 2. The value of the medicinal products shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned. / The transferring Member State or economic operator shall be entitled to reimbursement of the determined value as soon as possible, but not later than 30 day from the date of receipt of concerned medicinal product by receiving Member State. / The Commission is empowered to adopt delegated acts in accordance with Article 30a, to supplement this Regulation by laying down procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate.

RemovedArticle 23 – paragraph 8: deleted

AddedArticle 20 h (new): Article 20h / Union Stockpile / 1. In order to ensure the timely and effective availability of critical medicinal products with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism to be activated in situations where the Union coordination mechanism for critical medicinal products indicates the existence of a recurrent or persistent shortage in national stockpiles and contingency stocks. / 2. The Commission is empowered to adopt delegated acts in accordance with Article 30a to supplement this Regulation by establishing: / (a) the categories and specific types of critical medicinal products to be included in the Union Stockpile; / (b) the minimum quantities to be stocked for each product, taking into account Union-level risk assessments, supply vulnerabilities, and public health needs; / (c) the logistical, technical and operational arrangements for storage and maintenance of the Union stockpile; / (d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States. / 3. In the event that the Commission decides to establish a Union Stockpile for critical medicinal products with identified vulnerabilities in accordance with paragraphs 1 and 2, it shall: / (a) coordinate with national competent authorities to ensure alignment and ensure that the Union stockpile does not duplicate national contingency stock arrangements: / (b) design and implement the measures to be taken in…

RemovedArticle 23 – paragraph 8 a (new): 8a. The Commission shall ensure that any procurement procedure under this Article applies, to the greatest extent possible, the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

AddedArticle 21 – paragraph 1: 1. Upon a reasoned request of three or more Member States (‘the request’), the Commission shall act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive 2014/24/EC of the European Parliament and of the Council for medicinal products of common interest. / (deleted)

RemovedArticle 23 – paragraph 8 b (new): 8b. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements: / (a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions; / (b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such; / (c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product; / (d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

AddedArticle 21 – paragraph 3: 3. The Commission shall assess the request in light of the objectives of this Regulation. The Commission shall communicate to the requesting Member States its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request. It shall inform the European Parliament thereof.

RemovedArticle 24 – title: Agreement concerning procedures under Article 23

AddedArticle 21 – paragraph 5: 5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the interested Member States and provide advice on applicable Union public procurement rules, including on the use of award criteria as set out in Article 18 and on regulatory matters related to medicinal products.

RemovedArticle 25 – paragraph 2: 2. The Member States, the Agency and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed national permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of the MSSG as permanent representatives. The Critical Medicines Group shall appoint two permanent representatives from patient organisations.

AddedArticle 21 – paragraph 6: 6. The facilitation offered by the Commission shall be limited in time and end, unless otherwise requested by the requesting Member States, upon signature of the procurement contract by the participating contracting authorities. Where requested by requesting Member States, the facilitation offered by the Commission shall end upon delivery of the medicinal products of common interest.

RemovedArticle 25 – paragraph 3: 3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the relevant marketing authorisation holders and other relevant stakeholders and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group and the MSSG may organise joint meetings. For discussions where input from the industry perspective is necessary, the Critical Medicines Group shall consult the relevant marketing authorisation holders and/or trade associations including through the organisation of structured joint meetings as required.

AddedArticle 21 – paragraph 6 a (new): 6a. The Commission shall act as a facilitator under this Article subject to the acceptance of the following conditions by the requesting Member States: / (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patients needs in their territory; / (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; / (c) participating Member States, for the duration of the contract, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract; / (d) regulatory flexibilities available under applicable Union law are applied to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

RemovedArticle 25 – paragraph 4: 4. The Commission shall organise regular meetings and coordinate the work of the Critical Medicines Group by means of the Secretariat.

AddedArticle 21 – paragraph 7 a (new): 7a. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein and with which the Union has entered into a bilateral agreement governing the facilitation of cross-border procurement, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the need for three or more Member States to initiate the procedure.

RemovedArticle 25 – paragraph 6 a (new): 6a. The Critical Medicines Group shall have biannual meetings, and additional meetings when needed, to consult with the Critical Medicines Alliance.

AddedArticle 22 – paragraph 1 – introductory part: 1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where five Member States jointly request the Commission to procure on their behalf, or in their name, the Commission shall initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below:

RemovedArticle 26 – paragraph 1: 1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission and inform the relevant marketing authorisation holder, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

AddedArticle 22 – paragraph 2: 2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply, availability and affordability of critical medicinal products in the Union or to ensure the availability, accessibility and affordability of medicinal products of common interest, as applicable.

AddedArticle 22 – paragraph 6: deleted

AddedArticle 23 – paragraph 1: 1. Under conditions laid down in this Article and by way of derogation from Article 168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least five Member States may engage, as contracting parties, in a joint procurement procedure.

AddedArticle 23 – paragraph 2 – introductory part: 2. A joint procurement procedure shall be organised following a request by the Member States or may be organised at the Commission’s initiative when the procurement relates to medicinal products belonging to one of the categories below:

AddedArticle 23 – paragraph 3: 3. The Commission may decide to conduct the joint procurement procedure if the procurement procedure helps to improve the security of supply, availability and affordability of critical medicinal products in the Union or to ensure the availability, accessibility and affordability of medicinal products of common interest, as applicable.

AddedArticle 23 – paragraph 4: 4. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request through the Critical Medicines Group and invite them to join the procedure. It shall inform the European Parliament thereof.

AddedArticle 23 – paragraph 5: 5. The Commission shall assess the necessity of a joint action and whether the request referred in paragraph 2 is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

AddedArticle 23 – paragraph 5 a (new): 5a. The Commission shall ensure that any procurement procedure under this Article applies to the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

AddedArticle 23 – paragraph 5 b (new): 5b. The Commission shall conduct a joint procurement under this Article subject to the acceptance of the following conditions by requesting Member States: / (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their territory; / (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; / (c) participating Member States, for the duration of the contract, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract; / (d) regulatory flexibilities available under applicable Union law are applied to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

AddedArticle 23 – paragraph 5 c (new): 5c. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein and with which the Union has entered into a bilateral agreement governing the procurement activities referenced in this Article, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the need for five Member States to engage in the procedure.

AddedArticle 23 – paragraph 6: deleted

AddedArticle 23 – paragraph 7: 7. The Commission shall communicate to the requesting Member States its decision within one month of the request, and state its reasons in case of a refusal.

AddedArticle 24 – paragraph 1: 1. Member States participating in the procurement procedures covered by Articles 22 and 23 shall share with the Commission any information relevant for the procurement procedure. Member States shall provide resources necessary for the successful conclusion of the procedure, in particular through involvement of staff with expertise and knowledge. Procurement procedures shall ensure that smaller Member States and SMEs can participate effectively, avoiding market distortion and ensuring equitable access to critical medicinal products.

AddedArticle 24 – paragraph 2: 2. An agreement between the Member States and the Commission shall determine the practical arrangements governing the procurement procedure, liabilities to be assumed and the decision-making process. Those practical arrangements shall also cover, where appropriate, the designation of the contracting authority, the distribution of procured stocks, and the identification of storage locations. Regulatory flexibilities may be granted with regard to packaging and labelling requirements, including the use of electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

AddedArticle 24 – paragraph 2 a (new): 2a. The Commission shall, following a consultation with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers, and marketing authorisation holders, issue Union guidelines recommending common standards for procurement activities under Articles 22 and 23 of this Regulation, ensuring predictability for companies.

AddedArticle 25 – paragraph 2: 2. The Member States, the Agency, the Commission and representatives from patient organisations and healthcare professional organisations shall be Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed national representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of the MSSG as representatives. The Critical Medicines Group shall appoint two representatives from patient organisations and two permanent representatives from healthcare professional organisations. The European Parliament shall have observer status and shall be represented by two Members of the European Parliament. The European Parliament shall be entitled to receive meeting agendas, documents, reports, and any other materials circulated to members of the Critical Medicines Group, and to participate in debates. The European Parliament shall not have voting rights and shall not be counted for the purpose of determining the quorum.

AddedArticle 25 – paragraph 2 a (new): 2a. The representatives appointed to the Critical Medicines Group and its working group or working groups shall make a declaration of their financial and other interests and update it annually and whenever necessary. They shall disclose any other facts of which they become aware that might in good faith reasonably be expected to involve, or give rise to, a conflict of interest.

AddedArticle 25 – paragraph 3: 3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the Commission and national authorities responsible for medicinal products. For discussions where input from the national regulatory authorities’ responsible for medicinal products' perspective is necessary, the Critical Medicines Group and the MSSG shall organise joint meetings. The Group shall also cooperate closely with patient and consumer organisations, healthcare professional organisations, and relevant marketing authorisation holders to fulfil its tasks, consulting them and other stakeholders as needed, including through structured joint meetings.

AddedArticle 25 – paragraph 4: 4. The Commission, acting as the Secretariat of the Critical Medicines Group, shall organise regular meetings and coordinate the work of the Critical Medicines Group.

AddedArticle 25 – paragraph 6: 6. The Critical Medicines Group, at the proposal of the Chair or any of its members, may, on a case-by-case basis, decide to establish one or more working groups.

AddedArticle 25 – paragraph 6 a (new): 6a. The Critical Medicines Group shall have biannual meetings, and additional meetings when needed, to consult with the Critical Medicines Alliance on vulnerabilities in supply chains and on mitigation measures to address structural risks and reinforce supply. The Critical Medicines Group shall take into account the findings from the Critical Medicines Alliance, where relevant. The Commission, as the Group’s secretariat, shall ensure regular and transparent communication with the Alliance.

AddedArticle 26 – paragraph 1: 1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market or on national healthcare systems.

AddedArticle 26 – paragraph 1 a (new): 1a. The Critical Medicines Group shall include in its rules of procedure provisions for the systematic consultation of Union and national patient organisations and other relevant stakeholder to encourage the exchange of information about the working group’s activities and promote transparency. It shall ensure alignment and data coherence with the EMA’s MSSG.

AddedArticle 26 – paragraph 2 – introductory part: 2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines Group shall perform the following tasks in compliance with the necessary guarantees of protection of commercial confidential information:

AddedArticle 26 – paragraph 2 – point a: (a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States, as well as critical distribution infrastructure capacity and facilitate discussion on the capacity needed in the Union to strengthen its supply security, availability and affordability of critical medicinal products, active substances and key inputs within the Union, as well as to ensure that the public health and patient safety implications are explicitly assessed and taken into account in all related decisions;

AddedArticle 26 – paragraph 2 – point c a (new): (ca) issue guidelines on measures to support availability and affordability in the Union market of critical medicinal products in the context of strategic projects that have received financial support;

RemovedArticle 27 – paragraph 1 c (new): Strategic partnerships shall be guided by a clear Union-level framework to ensure coherence with the Union’s exclusive competence on trade, avoid uncoordinated national initiatives, and support a unified and consistent external approach to Union health resilience.

AddedArticle 26 – paragraph 2 – point d g (new): (dg) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of national programmes referred to in Article 19, ensuring proportionality and avoiding duplication;

RemovedArticle 27 – paragraph 1 d (new): The Commission shall develop no later than ... [2 years from the entry into force of this Regulation] a structured methodology when identifying and prioritising such partnerships, distinguishing between: / (a) partnerships designed to leverage and strengthen existing cooperation frameworks and trade relations that contribute to security of supply and supply chain stability; and / (b) partnerships designed to develop new or intensified cooperation to reduce strategic dependencies and ensure geographical diversification of supply chains.

AddedArticle 26 – paragraph 2 – point d h (new): (dh) based on relevant financial expertise, examine the bottlenecks and Union wide financial needs of strategic projects, advise on ways of coordinating Union and national financing with regard to those financial needs, and share best practices;

RemovedArticle 27 – paragraph 1 e (new): Strategic partnerships shall also seek to address trade and regulatory barriers that impede supply chain resilience, promote regulatory cooperation to facilitate faster and more predictable market access, and support the smooth cross-border movement of medicinal products and critical components, while remaining fully consistent with the Union’s international obligations.

AddedArticle 26 – paragraph 2 – point d i (new): (di) establish the process for the strategic foresight report and prepare the annual strategic foresight report on strategic projects in accordance with Article 26a;

RemovedArticle 27 – paragraph 1 f (new): The Commission shall also build on existing forms of cooperation, where relevant, to reinforce efforts to strengthen the production and supply resilience of critical medicinal products, their active substances, key inputs, raw materials and feedstock in the Union and globally.

AddedArticle 26 – paragraph 2 – point d j (new): (dj) issue a recommendation concerning the applicability of any of the provisions referred to in Article 2 (2a) to medicinal products of common interest.

RemovedRegulation (EU) 2024/795

AddedArticle 26 – paragraph 2 a (new): 2a. In carrying out the task referred to in paragraph 2(dc) of this Article, only the representatives of the Member States within the Critical Medicines Group shall have the right to vote. The decision shall be adopted by a two-thirds majority of the Member States present and voting.

RemovedArticle 28 – paragraph 1 – point a, Article 2 – paragraph 1 – point a– subparagraph iii: biotechnologies, and directly related enabling technologies necessary for the development or manufacturing of critical medicinal products and medicinal products of common interest, including their active substances, key inputs, raw materials and feedstock, as defined in Critical Medicines Act *;

AddedArticle 26 – paragraph 5 a (new): 5a. The Critical Medicines Group shall assess the Union-wide financial needs of strategic projects and issue recommendations on how to ensure adequate financing, including through the Union budget, in order to support the achievement of the objectives of this Regulation; and advise on the coordination of financing by the Union, Member States, the European Investment Bank and the private sector.

AddedArticle 26 a (new): Article 26a / Strategic Foresight on Critical Medicinal Products / 1. In order to strengthen the Union’s preparedness and ensure a coordinated approach to future challenges in the supply of critical medicinal products, the Critical Medicines Group shall establish a strategic foresight process. / 2. The strategic foresight process shall be established after consultation with the Commission, the Agency, and the Critical Medicines Alliance. / 3. The strategic foresight process shall identify medicinal products of common interest that would advance the objectives of this Regulation if included in Chapter III. / 4. The strategic foresight process shall identify and assess potential strategic projects, taking into account long-term trends, vulnerabilities, opportunities for enhancing the resilience and sustainability of supply chains within the Union, and patients’ unmet medical needs. / 5. The Critical Medicines Group shall prepare the report and communicate it to the Commission, the Agency and the European Parliament. / 6. Following the preparation of the foresight report, the Critical Medicines Group shall make recommendations to the Commission and Member States on actions to be taken, including the identification and support of projects. Where there is a need to strategically reserve manufacturing capacity, recommendations shall specifically include proposals for strategic projects pursuant to Article 5(2), for the production of specific pharmaceutical forms, active substances,…

AddedArticle 27 – title: International cooperation and strategic partnerships

AddedArticle 27 – paragraph 1: Without prejudice to the prerogatives of the Council, the Commission, shall seek to conclude strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also aim to build on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union.

AddedArticle 27 – paragraph 1 a (new): The Commission shall endeavour to incorporate health security aspects into strategic partnerships. Such aspects may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies and to foster regulatory convergence and cooperation in the pharmaceutical sector. The Commission shall endeavour the inclusion of access to active substances and API starting materials within strategic partnerships, in order to ensure timely availability of critical medicinal products under this mechanism.

AddedArticle 27 – paragraph 1 b (new): The Commission shall establish and regularly update a list of countries that meet Union regulatory standards for the quality and safety of medicinal products, including key inputs and active substances. It shall make that list available to contracting authorities and healthcare professionals involved in the selection, procurement, prescribing, management, dispensing, and monitoring of such products.

AddedArticle 27 – paragraph 1 c (new): In the context of accession negotiations, the Commission shall support the progressive alignment of candidate countries with the Union acquis in the field of pharmaceuticals, with a view to facilitating their gradual integration into the Union’s internal market and strengthening the resilience of the Union’s supply chains for critical medicinal products.

AddedArticle 27 – paragraph 1 d (new): The Commission shall inform the Critical Medicines Group about possible strategic partnerships on an annual basis.

AddedArticle 27 – paragraph 1 e (new): The Commission shall, within the framework of strategic partnerships, promote the harmonisation of Union quality, safety and environmental standards for pharmaceutical production between the Union and third countries.

AddedArticle 27 – paragraph 1 f (new): By ... [two years from the entry into force of this Regulation], the Commission shall develop a structured methodology when identifying and prioritising such partnerships, distinguishing between: / (a) partnerships designed to leverage and strengthen existing cooperation frameworks and trade relations that contribute to security of supply and supply chain stability; and / (b) partnerships designed to develop new or intensified cooperation to reduce strategic dependencies and ensure geographical diversification of supply chains.

AddedArticle 27 – paragraph 1 g (new): Strategic partnerships shall also seek to address trade and regulatory barriers that impede supply chain resilience, promote regulatory cooperation to facilitate faster and more predictable market access, and support the smooth cross-border movement of medicinal products and critical components, while remaining fully consistent with the Union’s international obligations.

AddedArticle 27 – paragraph 1 h (new): The Commission shall also build on existing forms of cooperation, where relevant, to reinforce efforts to strengthen the production and supply resilience of critical medicinal products, their active substances and key inputs in the Union and globally.

AddedArticle 30 – paragraph 2 – point d (new): (d) the effectiveness of measures adopted to mitigate structural risks and strengthen supply resilience;

AddedArticle 30 – paragraph 2 – point e (new): (e) unintended effects on market concentration, competition including impact on SMEs, innovation incentives, or barriers to entry, and assess whether the Regulation remains proportionate and effective.

AddedArticle 30 – paragraph 3: 3. The national authorities and the economic operators, patient and consumer organisations, as well as healthcare professional organisations shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1.

AddedArticle 30 – paragraph 3 a (new): 3a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.

AddedArticle 30 a (new): Article 30a / Exercise of the delegation / 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 20g(4) and 20h(2) shall be conferred on the Commission for an indeterminate period from … [date of application of this Regulation]. / 3. The delegation of power referred to in Articles 20g(4) and 20h(2) may be revoked at any time by the European Parliament or the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. / 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. / 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. / 6. A delegated act adopted pursuant to Articles 20g(4) and 20h(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act. to the European Parliament and the Council or if, before the expiry of th…

AddedSHORT JUSTIFICATION

AddedThe 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.

AddedTo 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.

AddedTo 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.

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

AddedAMENDMENTS

AddedThe Committee on the Environment, Climate and Food Safety submits the following to the Committee on Public Health, as the committee responsible:

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, 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.

AddedRecital 4 a (new): (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.

AddedRecital 17: (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.

AddedRecital 18 a (new): (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.

AddedRecital 19: (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.

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. 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.

AddedRecital 39: (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. Any such partnership should support a high level of safety, environmental protection, quality, and efficacy.

AddedRecital 41: (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.

AddedRecital 41 a (new): (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.

AddedArticle 3 – paragraph 1 – point 13: (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;

AddedArticle 5 – paragraph 1 – point b: (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;

AddedArticle 7 – paragraph 2: 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, while ensuring compliance with the highest social, health and environmental standards.

AddedArticle 12 – paragraph 1 – subparagraph 1: 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.

AddedArticle 12 – paragraph 2: 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.

AddedArticle 12 – paragraph 5 a (new): 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.

AddedArticle 13 – paragraph 1: 1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data is available and accessible, including online.

AddedArticle 13 – paragraph 2: 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.

AddedArticle 14 – paragraph 2: 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.

AddedArticle 18 – paragraph 1: 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.

AddedArticle 18 – paragraph 4: 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.

AddedArticle 19 – paragraph 1 – subparagraph 1 a (new): 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.

AddedArticle 20 – paragraph 2 a (new): 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.

AddedArticle 26 – paragraph 2 – point d a (new): (da) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of procurement programmes, ensuring proportionality and avoiding duplication.

AddedArticle 27 – paragraph 1: 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. Such partnership shall support a high level of safety, environmental protection, quality, and efficacy.

AddedArticle 30 – paragraph 1: 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.

AddedArticle 30 – paragraph 2 a (new): 2a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.