Changes from report parliamentary committee draft to plenary report

AddedArticle 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.

AddedArticle 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.

AddedArticle 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

Change 59

ChangedArticle 28 – paragraph 1 – point b,a, Article 2 – paragraph 31 – subparagraph 3point a (new): By way of derogation– frompoint theiii: first(iii) subparagraphbiotechnologies, ofand thisdirectly paragraph,related theenabling valuetechnologies chainnecessary for the development or manufacturing of medicinal products that fall within the scope of the [Critical Medicines Act] and that are referred to in paragraph 1, point (a)(iii) of this Article, relates to finished dosage forms,critical asmedicinal wellproducts, asincluding totheir active pharmaceutical ingredients, raw materials, feedstocksubstances and other key inputs necessary for the production of the finished dosage forms of critical medicinal productsinputs, as defined in theCritical Regulation.Medicines Act*;

Change 60

ChangedArticle 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 and adhering to the principles of the Better Regulation framework and subject to safeguarding the confidentiality of trade secrets.Regulation.

Change 61

ChangedArticle 29 – paragraph 2: 2. The Commission, the Agency and national authorities of the Member States shall aimtake all appropriate measures to avoid duplication of the information requested and submitted, by maximisingmaking thefull use of datainformation already available to them under Union pharmaceutical legislation, including data submitted byin the context of marketing authorisation holdersprocedures, (e.g.variations, duringinspections, registrationand process)other asregulatory wellfilings, so as existingto tools,minimise suchadditional asadministrative theburden Europeanon Medicineseconomic Verificationoperators. SystemRequests (EMVS)for andsupplementary theinformation Europeanshall Shortagesbe Monitoringlimited Platformto (ESMP).what is necessary to ensure effective monitoring, analysis and assessment.

Change 62

ChangedArticle 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, and shall protect any information that is commercially confidential against unjustified disclosure.disclosure, Theyand shall ensurerestrict thataccess commerciallyto confidentialsuch information strictly to staff responsible for applying this Regulation. The Commission and tradethe secretsnational areauthorities, dulytheir protectedofficials, inemployees fulland respectother persons working under the supervision of Unionthose law,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 restrictalso accessapply to suchall informationrepresentatives strictlyof toMember staffStates, responsibleobservers, experts and other participants attending meetings of the Critical Medicines Group. In addition, they shall also ensure that digital systems used for applyingdata thiscollection Regulation.and analysis include appropriate cybersecurity measures.

Change 63

RemovedArticle 30 – paragraph 1: 1. The Commission shall continuously 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 evaluate 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.

AddedArticle 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.

Change 64

ChangedArticle 30 – paragraph 2:1: 2.1. The Commission shall inregularly monitor the implementation of this Regulation and its evaluationimpact assesson the impactfunctioning of thisthe Regulationinternal market, competition, and tothe whatsecurity extentof itssupply objectivesof asmedicinal establishedproducts in Articlethe 1Union. haveIn beenaddition, achieved.by The[OP evaluationplease shallinsert paythe particulardate attentionof:] tofive anyyears unintendedafter effectsthe ondate marketof concentration,application competition,of innovationthis incentives,Regulation orand barriersevery tofive entry,years andthereafter, the Commission shall within its evaluation assess whetherthe impact of other relevant Union legislation on this Regulation remainsand proportionatepresent a report on the main findings to the European Parliament, the Council, the European Economic and effective.Social Committee, and the Committee of the Regions.

Change 65

RemovedArticle 30 – paragraph 3 a (new): 3a. If, on the basis of its continuous monitoring or the comprehensive evaluation, the Commission identifies that the application of this Regulation leads to significant distortions of competition or serious disruptions of the functioning of the internal market, it shall take the necessary corrective measures, including by proposing amendments to this Regulation. In the case of urgent and significant distortions, the Commission may adopt a delegated act in accordance with Article 30a in order to temporarily suspend specific provisions of this Regulation until appropriate corrective measures are adopted.

AddedArticle 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:

RemovedArticle 30 a (new): Article 30a / Exercise of the delegation / The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. / The power to adopt delegated acts referred to in Articles 20a, 20g and 30(3a) shall be conferred on the Commission for an indeterminate period from … [date of application of this Regulation]. / The delegation of power referred to in Articles 20a, 20g and 30(3a) 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. / 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. / As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. / A delegated act adopted pursuant to Articles 20a, 20g and 30(3a) 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 that period,…

AddedArticle 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;

AddedArticle 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;

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

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

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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…