Changes from plenary report to adopted text

Article 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.

Article 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.

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

Article 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.

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

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

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

Regulation (EU) 2024/795

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

Article 29 – paragraph 1: 1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances or medicinal products of common interest shall upon request provide the Commission, the Agency or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Article 29 – paragraph 2: 2. The Commission, the Agency and national authorities of the Member States shall take all appropriate measures to avoid duplication of the information requested and submitted, making full use of information already available to them under Union pharmaceutical legislation, including data submitted in the context of marketing authorisation procedures, variations, inspections, and other regulatory filings, so as to minimise additional administrative burden on economic operators. Requests for supplementary information shall be limited to what is necessary to ensure effective monitoring, analysis and assessment.

Article 29 – paragraph 3: 3. The Commission, the Agency and the competent national authorities of the Member States shall assess the merits of duly substantiated confidentiality claims made by marketing authorisation holders and other economic operators, requested to provide information per paragraph 1, shall protect any information that is commercially confidential against unjustified disclosure, and shall restrict access to such information strictly to staff responsible for applying this Regulation. The Commission and the national authorities, their officials, employees and other persons working under the supervision of those authorities shall ensure the confidentiality of information obtained in carrying out their tasks and activities in accordance with relevant Union and national law. This paragraph shall also apply to all representatives of Member States, observers, experts and other participants attending meetings of the Critical Medicines Group. In addition, they shall also ensure that digital systems used for data collection and analysis include appropriate cybersecurity measures.

Article 29 a (new): Article 29a / Obligation of the Commission to collect information on medicinal products with no adequate Union substitute / 1. The Commission shall collect the necessary information from the Agency and national authorities of the Member States and establish, taking as a basis the list of critical shortages of medicinal products referred to in Chapter X of Regulation (EU) No …/… [reference to be added after adoption cf. COM(2023) 193 final], a list of critical medicinal products originating from third countries for which no adequate substitute produced within the Union is available. The Commission shall maintain and keep that list regularly updated. / 2. The list referred to in paragraph 1 shall serve to identify and monitor strategic dependencies and to support the adoption of appropriate measures under this Regulation aimed at ensuring the continuous supply and availability of such medicinal products within the Union. / 3. In developing and updating the list referred to in paragraph 1, the Commission shall take into account the public health relevance, therapeutic importance, and criticality of the medicinal products.

Article 30 – paragraph 1: 1. The Commission shall regularly monitor the implementation of this Regulation and its impact on the functioning of the internal market, competition, and the security of supply of medicinal products in the Union. In addition, by [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall within its evaluation assess the impact of other relevant Union legislation on this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.

Article 30 – paragraph 2: 2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. The evaluation shall in particular assess:

Article 30 – paragraph 2 – point a (new): (a) data on the number of new manufacturing sites opened or modernised within the Union and the number of existing manufacturing lines extended;

Article 30 – paragraph 2 – point b (new): (b) the number and nature of projects confirmed, supported, or recommended by the Critical Medicines Group under this Regulation;

Article 30 – paragraph 2 – point c (new): (c) progress made in diversifying sources of active substances, starting materials, and other key inputs;

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

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

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

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

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