Changes from plenary report to adopted text

Article 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.

Article 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…

Article 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.

Article 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.

Article 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.

Article 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…

Article 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)

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 22 – paragraph 3: 3. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the joint request referred to in paragraph 1, through the Critical Medicines Group, and invite them to join the procedure.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 22 – paragraph 6: deleted

Article 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.

Article 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:

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 23 – paragraph 6: deleted

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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.

Article 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:

Article 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;

Article 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;

Article 26 – paragraph 2 – point d b (new): (db) assess national stockpiling strategies, their proportionality, compatibility with the internal market, and feasibility for implementation by industry, and, where appropriate, issue recommendations on Union-wide minimum standards;

Article 26 – paragraph 2 – point d c (new): (dc) decide on whether to give to the Commission its prior approval to requests for the redistribution of critical medicinal products submitted by one or more Member States pursuant to Article 20b in the event of a shortage or supply disruption;

Article 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;

Article 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;

Article 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;

Article 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;

Article 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;

Article 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;

Article 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.

Article 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.

Article 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,…

Article 27 – title: International cooperation and strategic partnerships