Changes from report parliamentary committee draft to plenary report

AddedArticle 22 – paragraph 4: 4. The Commission shall assess the utility, necessity and proportionality of the joint request referred to in paragraph 1 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 22 – paragraph 5: 5. The Commission shall communicate to the requesting Member States its decision within one month of the request of its decision and state its reasons in case of a refusal. It shall inform the European Parliament thereof.

AddedArticle 22 – 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 22 – paragraph 5 b (new): 5b. The Commission shall conduct a procurement on behalf or in the name of Member States 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 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 22 – paragraph 5 c (new): 5c. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procurement procedure established herein and with which the Union has concluded a bilateral agreement providing for such a participation, 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 requirement of a minimum of five participating Member States in accordance with paragraph 1.

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;

Article 26 – paragraph 2 – point d: (d) provide recommendations to the MSSG on order of priority of critical medicinal products for vulnerability evaluation, and propose a review or an update of existing evaluations where necessary;

Change 55

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Change 56

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Change 57

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Change 58

RemovedArticle 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, raw materials and feedstock 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. However, such partnership shall fulfil the same requirements in terms of safety, quality, and effectiveness.

AddedArticle 26 – paragraph 2 – point d d (new): (dd) assess Union needs to determine whether specific projects concerning medicinal products of common interest should qualify as strategic projects;

RemovedArticle 27 – paragraph 1 a (new): The Commission shall endeavour to incorporate health security provisions into free trade agreements and other relevant international agreements and instruments. Such provisions 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.

AddedArticle 26 – paragraph 2 – point d e (new): (de) assess Union needs to reserve a defined portion of manufacturing capacity, within a fixed timeframe, for the production of specific medicinal products, including their pharmaceutical forms, active substances, key inputs, or enabling technologies;

RemovedArticle 27 – paragraph 1 b (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 26 – paragraph 2 – point d f (new): (df) assess, in accordance with Article 6, whether a proposed strategic project would result in a significant duplication of existing or planned manufacturing capacities within the Union;

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.