Changes from plenary report to adopted text

Recital 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.

Recital 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…

Article 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.

Article 1 – paragraph 1 a (new): 1a. Strengthening manufacturing capacities and the resilience of supply chains, as well as competitiveness, strategic autonomy and innovation in the Union’s pharmaceutical sector, is also an objective of this Regulation.

Article 1 – paragraph 2 – introductory part: 2. To achieve the objectives set out in paragraphs 1 and 1a, the Regulation sets out a framework to:

Article 1 – paragraph 2 – point a: (a) facilitate, support and incentivise investments in new manufacturing capacity and strengthen existing manufacturing capacity for critical medicinal products and, where applicable, medicinal products of common interest, their active substances and other key inputs in the Union with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain, by making available any accelerated permit granting processes related to the strategic projects that exist in applicable Union and national law;

Article 1 – paragraph 2 – point b a (new): (ba) prevent shortages and strengthen availability of medicinal products by facilitating the adoption of common standards governing contingency stocks and national stockpiles of critical medicinal products and medicinal products of common interest, and by enhancing transparency and coordination among Member States in this regard;

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

Article 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;

Article 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

Article 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.

Article 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.

Article 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.

Article 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.

Article 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:

Article 3 – paragraph 1 – point 1: deleted

Article 3 – paragraph 1 – point 2: (2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including primary packaging materials, excipients, solvents and reagents, raw materials, feedstock and starting materials;

Article 3 – paragraph 1 – point 3: deleted

Article 3 – paragraph 1 – point 4: deleted

Article 3 – paragraph 1 – point 6: (6) ‘vulnerability in the supply chains’ means structural and non-structural risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, and the specific features of the supply chains of each product, that compromise the continuous supply of such medicinal products to patients in the Union;

Article 3 – paragraph 1 – point 10: (10) ‘strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation;

Article 3 – paragraph 1 – point 10 a (new): (10a) ‘cross-border strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation, which may be carried out by a minimum of two Member States;

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

Article 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;

Article 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, automation, yield improvements or other chemistry or biotechnology process that contribute to increase the level of security, energy and environmental performance of the production, and use of Artificial Intelligence, platform technologies or 3D technologies in manufacturing;

Article 3 – paragraph 1 – point 13 a (new): (13a) ‘contingency stock’ means the quantity of critical medicinal products or, where applicable, medicinal products of common interest that manufacturers and wholesalers might be required to hold under national law in order to have a buffer when shortages or supply disruptions occur, including because of fluctuations in demand or supply;

Article 3 – paragraph 1 – point 13 b (new): (13b) ‘contingency stock requirement’ means an obligation imposed by a Member State law on manufacturers and wholesalers in the supply chain to establish buffer stocks of certain medicinal products to mitigate the risk of shortages or supply disruptions;

Article 3 – paragraph 1 – point 13 c (new): (13c) ‘national stockpile’ means the reserves of a quantity of critical medicinal products or medicinal products of common interest established under national law by a Member State for a public health use, such as national strategic reserves;

Article 3 – paragraph 1 – point 13 d (new): (13d) ‘redistribution’ means the transfer of critical medicinal products from a contingency stock or national stockpile from one or several Member States to other Member States following a decision of the Commission in response to shortages or supply disruptions in one or more Member States;

Article 3 – paragraph 1 – point 18: (18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products or its supply chain, their active substances and key inputs that is established through a non-binding instrument and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation;

Article 3 – paragraph 1 – point 18 a (new): (18a) 'resilience of supply chains' means the ability of the supply chain to maintain a continuous and demand-oriented supply of medicinal products, active substances, API starting materials, and key inputs in the Union, even during disruptions or external shocks;

Article 3 – paragraph 1 – point 18 b (new): (18b) 'diversification of supply chains' means the existence of several independent sources or production sites, so that the supply of a medicinal product, active substances, API starting materials, and key inputs does not depend on a single supplier or third country of supply.

Article 4 – paragraph 1: 1. The security of supply, availability and affordability of critical medicinal products and, where applicable, medicinal products of common interest, for patients shall be considered a strategic objective of the Union. In order to achieve such an objective, the determination of strategic projects that meet the criteria laid down in Article 5 shall be made in accordance with Article 6.

Article 4 – paragraph 2: 2. The Member States and the Commission shall work together to achieve the strategic objective of the Union referred to in paragraph 1 including by gathering information from healthcare professional organisations, patient organisations and economic operators including marketing authorisation holders, to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures provided for in Sections II and III of this Chapter that take full advantage of the potential of the internal market, reflecting the principles of solidarity and coordination between Member States and reducing dependencies on third countries, while ensuring predictability for project promoters.

Article 4 – paragraph 3: 3. The Commission shall support the coordinated efforts of the Members States and foster a secure cross-border exchange of relevant information and facilitate the distribution of critical medicinal products throughout the Union.

Article 5 – paragraph 1 – introductory part: 1. A project located in the Union and related to creating, modernising, increasing or improving manufacturing capacity, as well as decreasing Union dependency in relation to key inputs or otherwise contributing to the security of supply or availability of medicinal products, shall be considered as a strategic project if it meets at least one of the following criteria:

Article 5 – paragraph 1 – point a: (a) it creates or increases manufacturing capacity, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or, where applicable, medicinal products of common interest, or for collecting or manufacturing their active substances, or it creates capacity for compounding techniques within pharmacies or hospitals;

Article 5 – paragraph 1 – point b: (b) it modernises an existing manufacturing site, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or where applicable, medicinal products of common interest, their active substances or key inputs to strengthen supply chain resilience, to ensure greater sustainability or increased efficiency;

Article 5 – paragraph 1 – point c: (c) it creates, increases or modernises manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or, where applicable, medicinal products of common interest, their active substances or key inputs;

Article 5 – paragraph 1 – point d: (d) it contributes to the roll-out or transfer of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products, or, where applicable, medicinal products of common interest, their active substances or key inputs;

Article 5 – paragraph 1 a (new): Notwithstanding paragraph 1, a project shall not receive financial support from the Union pursuant to Article 16 if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances or key inputs within the Union, unless the Critical Medicines Group has assessed the need and such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

Article 6 – title: Determination of Strategic Projects

Article 6 – paragraph 1 – subparagraph 1: Within three months of the entry into force of this Regulation, each Member State shall designate an authority (‘the designated authority’) to be in charge of assessing and verifying whether or not a project meets at least one of the criteria set out in Article 5 and is therefore to be considered a strategic project.

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

Article 6 – paragraph 1 – subparagraph 3: Any Member State authority may request the designated authority to verify its determination of a project as a strategic project.

Article 6 – paragraph 3: 3. The Commission shall provide a simple, accessible, and user-friendly webpage serving as the central hub for project promoters on which at least the following elements shall be clearly listed:

Article 6 – paragraph 3 – point a (new): (a) the contact details and other relevant information on the Member States’ designated authorities;

Article 6 – paragraph 3 – point b (new): (b) information on available administrative or financial support from the Union; and

Article 6 – paragraph 3 – point c (new): (c) a standard template for the project promoter’s request available in all official languages of the Union.

Article 6 – paragraph 3 – subparagraph 1 a (new): The Commission shall adopt implementing acts to provide for a standard template for the project promoter’s request referred to in point (c) of the first subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20e(2).

Article 6 – paragraph 3 a (new): 3a. The designated authority shall assess the project promoter’s request referred to in paragraph 1, second subparagraph, within three months of that submitted request.

Article 6 – paragraph 5: 5. Where the verification whether a project constitutes a strategic project has been performed by a designated authority in accordance with this Article, any other authority shall rely on that verification.