What changed between the plenary report and the adopted text

Article 6 – paragraph 5 a (new): 5a. In order to promote a consistent and coordinated approach across the Union and to ensure legal certainty for project promoters, the Commission shall adopt guidelines setting out common criteria and procedural principles for the assessment and determination of projects as strategic projects for critical medicinal products and, where applicable, medicinal products of common interest. Designated authorities shall take into consideration those guidelines, as appropriate, when assessing and determining projects as strategic

Article 6 – paragraph 5 b (new): 5b. The guidelines referred to in paragraph 5a shall, in particular, specify: / (a) measurable criteria for the assessment of strategic relevance, including the project's potential to address supply vulnerabilities, enhance manufacturing capacity or resilience, ensure security of supply, or contribute to Union-wide public health preparedness; / (b) indicative timelines for operational readiness, transparency requirements, and steps for submission and assessment of requests; / (c) available mechanisms for cooperation and exchange of information between the Commission and the designated authority to allow for consistent application of the guidelines.

Article 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.

Article 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.

Article 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.

Article 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.

Article 8 – title: Administrative and technical support

Article 8 – paragraph 1 – point b: (b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project and, where relevant, facilitating required consultations of local communities, organisations and social partners;

Article 8 – paragraph 2: 2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs), small mid-cap enterprises (SMCs), as well as to entities not engaged in an economic activity and, where appropriate, establish a dedicated channel for communication with them to provide guidance and respond to queries related to the implementation of this Regulation.

Article 8 – paragraph 2 a (new): 2a. Member States shall ensure that a strategic project located within its territory is provided with the administrative and technical support necessary to prevent or mitigate unplanned interruptions in the supply of energy, gas or heat required for the establishment or expansion of manufacturing capacity, including facilitating timely access to relevant network connections and capacity, and coordinating with the competent network operators to ensure the stability and continuity of supply.

Article 8 – paragraph 2 b (new): 2b. Member States shall ensure that their authorities providing administrative support and authorities involved in the permit-granting process have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary for the effective performance of their tasks under this Regulation.

Article 11 – paragraph 1: 1. Upon request of a project promoter, a Member State, with support of the Agency as necessary and through a single point of contact, shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing and Good Distribution Practices inspections for approval of new or extended manufacturing sites or modernisation of the manufacturing sites modernised in the context of the concerned strategic project.

Article 11 – paragraph 2: 2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall, where appropriate, with the support of national competent authorities for medicinal products, provide dedicated advice to assist project promoters, including those developing projects relying on innovative manufacturing processes.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 13 – paragraph 2 a (new): 2a. Where the development of Strategic Projects or their related infrastructure has potential cross-border implications, the Member States concerned shall coordinate their planning and assessment procedures, with the support of the Commission, in order to avoid duplication of efforts, ensure complementarity, and reflect the principles of solidarity and cooperation between Member States.

Article 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.

Article 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, and, where applicable, medicinal products of common interest, 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). Financial support shall be proportionate to the financing needs of the strategic project and shall be subject to transparency requirements.

Article 15 – paragraph 1 a (new): 1a. Member States may, at the request of the Critical Medicines Group, establish contractual arrangements with economic operators on strategic projects to dedicate a portion of their manufacturing capacity to produce specific medicinal products, their pharmaceutical forms, their active substances and key inputs or technologies, or categories thereof, in order to address current, emerging or potential shortages within a fixed timeframe, determined by the Critical Medicines Group.

Article 15 – paragraph 1 b (new): 1b. The Commission shall facilitate the consistent application of this Article by providing sufficient guidance to Member States on the possibilities offered under existing State aid rules for the granting of State aid to strategic projects that meet the criteria of Article 5. This guidance shall in particular facilitate the financing of strategic projects that are aimed to improve the security of supply of medicinal products in the Union, both in terms of manufacturing capacity and in terms of innovative manufacturing processes.

Article 15 – paragraph 2: 2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, a project promoter that has benefitted from financial support by a Member State for a strategic project shall prioritise appropriate and continued supply to the Union market so that the needs of patients in the Member State in question are covered and ensure that the critical medicinal product remains available in the Member States where it is being marketed. This paragraph applies mutatis mutandis to medicinal products of common interest.

Article 15 – paragraph 3 – subparagraph 1: The Member State that provided financial support to a strategic project may request such project promoter to prioritise and provide the necessary supplies of a critical medicinal product, or, where applicable, medicinal product of common interest, active substance or key inputs, as applicable, to the Union market as a priority to avoid shortages in one or several Member States.

Article 15 – paragraph 3 – subparagraph 2: Any Member State that encounters a threat of shortages of the critical medicinal product or medicinal product of common interest in question may demand the Member State that provided financial support to submit a request on its behalf. The project promoter shall undertake its very best efforts to supply such products in the requesting Member State.

Article 15 – paragraph 3 a (new): 3a. Where a project promoter that receives financial support fails to comply with the obligations in paragraphs 2 and 3, the financial support granted to the strategic project may be suspended, revoked or recovered, in whole or in part, by the Member State concerned. In addition, the project promoter may be subject to an effective, proportionate and dissuasive financial penalty in accordance with national law of the Member State concerned or an exclusion from funding proportionate to the impact and severity of non-compliance.

Article 15 – paragraph 3 b (new): 3b. Where there is a substantiated risk that export of a critical medicinal product or, where applicable, medicinal product of common interest, 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.

Article 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.

Article 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)

Article 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.

Article 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.

Article 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.

Article 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.

Article 16 – paragraph 2 c (new): 2c. The Commission shall establish a ‘one-stop-shop’ to coordinate the award of Union funds pursuant to this Article and to support Member States’ authorities with the prioritisation of financial support to strategic projects pursuant to Article 15.

Article 16 – paragraph 2 d (new): 2d. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

Article 17 – paragraph 1: 1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical Medicines Group’) referred to in Article 25 of the intention to provide financial support to strategic projects sufficiently in advance to allow the group to carry out its coordination task as set out in Article 26. This information shall include a description of how the project meets one or more of the criteria listed in Article 5.

Article 17 – paragraph 2 – subparagraph 1: The Commission shall regularly inform the Critical Medicines Group of the strategic projects that benefited from financial support from the Union including information on how these projects meet the criteria listed in Article 5.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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].

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 20 – paragraph 2 d (new): During health emergencies and crises, Member States authorities and Union preparedness authorities shall closely coordinate the distribution of critical medicinal products, in particular with systemic wholesalers, in order to ensure equitable and fair distribution. Member States may also undertake the distribution of critical medicinal products via their civil preparedness authorities or military authorities if deemed necessary in accordance with national law.

Chapter IV – Section I a (new): Ia UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS

Article 20 a (new): Article 20a / Establishment of a Union coordination mechanism for critical medicinal products / A Union coordination mechanism for national stockpiles and contingency stocks of critical medicinal products is hereby established. It shall be operated by the Commission in collaboration with the Agency and the Critical Medicines Coordination Group. Through that coordination mechanism, the Commission shall: / (a) monitor the availability and distribution of critical medicinal products across the Union; (b) enable effective and equitable redistribution in cases of a shortage or a supply disruption in one or more Member States that has a negative impact on the internal market or on other Member States.

Article 20 b (new): Article20b / Redistribution decisions / 1. Where a shortage or a supply disruption of a critical medicinal product is identified in one or more Member States, the Commission shall, as a last resort and only after all other measures have been exhausted, including the voluntary mechanisms provided for in Union legislation, and upon a justified and substantiated request of one or more Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring redistribution from a national stockpile or a contingency stock. / 2. Any distribution decision as referred to in the first paragraph shall: / (a) be based on an objective risk assessment and regularly updated 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; / (b) specify the quantities to be transferred, the timeframe for delivery, and any other necessary logistical arrangements; / (c) ensure that transferring Member States retain adequate minimum levels of the relevant medicinal product. / 3. A distribution decision adopted pursuant to this Article shall specify the date at which it takes effect and shall be notified by the Commission to the Member States concerned without delay/within ... [and at least 20 days before its date of application].