Changes from report parliamentary committee draft to plenary report

AddedArticle 132 – paragraph 1 b (new): 1b. Following the update of the Union list of critical medicinal products, the MSSG shall assess the shortage prevention plan of the medicinal products present on the list.

Article 134 – paragraph 1 – introductory part: 1. The Commission shall:

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RemovedArticle 134 – paragraph 2: 2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt an implementing act to improve security of supply and other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors and other relevant entities.

AddedArticle 134 – paragraph 1 – point -a (new): (-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products;

RemovedArticle 134 a (new): Article 134a / General provisions / 1. Member States may introduce or maintain more robust provisions than those provided for in this Regulation with regard to the security of supply of and the availability of medicinal products. / 2. The implementation of this Regulation shall in no circumstances constitute grounds for a reduction of the level of safeguards already afforded by Member States with regard to the security and availability of supply of medicinal products. Where Member States detect infringements of measures in relation to Chapter X, penalties in accordance with Article 171(1) shall be imposed without undue delay.

AddedArticle 134 – paragraph 1 – point c a (new): (ca) develop guidelines to ensure that national initiatives on stockpiling are proportionate to the needs and do not create undesirable consequences, such as supply shortages, in other Member States;

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point a: (a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures; the Agency, after consulting with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 and the health technology coordination group established by Article 3 of Regulation (EU) 2021/2282, shall set out binding uniform standards for the design of scientific studies.

AddedArticle 134 – paragraph 1 – point c b (new): (cb) develop, within the framework of Directive 2014/24/EU, guidelines to support public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the most economically advantageous tender (MEAT) criteria in order to establish remedies against single-winner, price-only tenders.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point n: (n) creating a user-friendly database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

AddedArticle 134 – paragraph 1 a (new): 1a. The Commission shall work with the ECDC on producing reliable forecasts of potential threats and potential shortages.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point zl: (zl) drawing up scientific guidelines to facilitate the implementation of the definitions established in this Regulation and in [revised Directive 2001/83], and for the environmental risk assessment of medicinal products for human use, in consultation with the Commission and the Member States and relevant stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations.

AddedArticle 134 – paragraph 2: 2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, is empowered to adopt delegated acts in accordance with Article 175 supplementing this Regulation to improve security of supply, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against shortages of medicinal products, in respect of the commitments taken in the framework of the Voluntary Solidarity Mechanism. The delegated acts may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point zl a (new): (zla) where scientific guidelines are provided, the Agency shall ensure that such guidelines are always kept up-to-date and based on the latest scientific developments.

AddedArticle 134 – paragraph 3: deleted

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ChangedArticle 138 – paragraph 21 – subparagraph 1: The database provided for in paragraph 1, point (n),Agency shall include allprovide medicinalthe productsMember forStates humanand usethe authorisedinstitutions inof the Union together with the summariesbest ofpossible productscientific characteristics,opinion theon packageany leafletquestion andrelating theto informationthe shownevaluation onof the labelling, asquality, wellsafety, asefficacy Memberand Statesenvironmental whererisk theof medicinal product is placed on theproducts market.for Wherehuman relevant,use, itveterinary shallmedicinal includeproducts, thewhich electronicis linksreferred to theit dedicatedin webpagesaccordance wherewith the marketing authorisation holders have reportedUnion thelegal informationacts pursuantrelating to Article 40(4), pointmedicinal (b),products andfor Articlehuman 57use ofor [revisedveterinary Directivemedicinal 2001/83/EC].products.

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RemovedArticle 138 – paragraph 2 – subparagraph 3: The database shall also include references to clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 81 of Regulation (EU) No 536/2014.

AddedArticle 138 – paragraph 1 – subparagraph 2 – introductory part: The Agency, acting particularly through its Committees and working groups, shall carry out the following tasks:

RemovedArticle 142 – paragraph 1 – point j a (new): (ja) an ad hoc working group on Advanced Therapy Medicinal Products ;

AddedArticle 138 – paragraph 1 – subparagraph 2 – point a: (a) coordinating the scientific evaluation of the quality, safety, efficacy and environmental risk of medicinal products for human use, which are subject to Union marketing authorisation procedures;

RemovedArticle 142 – paragraph 1 – point j b (new): (jb) an ad hoc working group on Orphan Medicinal Products ;

AddedArticle 138 – paragraph 1 – subparagraph 2 – point a a (new): (aa) develop, after consulting with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 of this Regulation and the Member State Coordination Group on Health Technology Assessment established by Article 3 of Regulation (EU) 2021/2282, harmonised standards for the design of scientific studies for marketing authorisation holders;

RemovedArticle 142 – paragraph 1 – point j c (new): (jc) an ad hoc working group on Paediatric Committee ;

AddedArticle 138 – paragraph 1 – subparagraph 2 – point b: (b) coordinating the scientific evaluation of the quality, safety and efficacy of veterinary medicinal products, which are subject to Union marketing authorisation procedures in accordance with Regulation (EU) 2019/6 , providing advice on methodological aspects relating to the trials for such products and the use of clinical trial results affected for regulatory purposes and coordinating the performance of other tasks set out in Regulation (EU) 2019/6 and Regulation (EC) 470/2009;

RemovedArticle 142 – paragraph 1 – point k a (new): (ka) create a pool of experts from Member States and relevant stakeholders to work in the ad hoc working groups; the members shall be selected based on relevant experience in relation to the different ad hoc working groups, so they can contribute to the regulatory support and scientific advice procedures, and they shall be free of any conflicts of interest.

AddedArticle 138 – paragraph 1 – subparagraph 2 – point c: (c) transmitting on request and making publicly available assessment reports, summaries of product characteristics, periodic safety update reports, labels, package leaflets and AMR awareness cards, where applicable, for the medicinal products for human use;

RemovedArticle 147 – title: Transparency and conflict of interest

AddedArticle 138 – paragraph 1 – subparagraph 2 – point n: (n) creating a user-friendly database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflet, and for other documents deemed relevant by the Agency; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

RemovedArticle 147 – paragraph 1 – subparagraph 1: Members of the Management Board, members of the committees, rapporteurs and experts shall carry out their activities in an independent, impartial and transparent manner. They shall not have financial or other interests in the pharmaceutical industry which could affect their independence or impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial and other interests and update it 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 138 – paragraph 1 – subparagraph 2 – point zc: (zc) establishing a mechanism of consultation of authorities or bodies active along the life cycle of medicinal products for human use for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency, notably with the SoHO Coordination Board, Medical Devices Coordination Group, the Member State Coordination Group on Health Technology Assessment and national pricing and reimbursement authorities;

RemovedArticle 147 – paragraph 1 – subparagraph 2: deleted

AddedArticle 138 – paragraph 1 – subparagraph 2 – point ze: (ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and, where possible, prioritising replacement strategies such as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products;

RemovedArticle 147 – paragraph 2: 2. Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda. These declarations shall be made available to the public. Where the Agency decides that a declared interest constitutes a conflict of interest, that representative shall not take part in any discussions or decision-making, or obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.

AddedArticle 138 – paragraph 1 – subparagraph 2 – point zl a (new): (zla) where scientific guidelines are provided, the Agency shall ensure that such guidelines are kept up-to-date and based on the latest scientific developments.

RemovedArticle 147 – paragraph 2 a (new): 2a. Patients, clinical experts and other relevant experts shall declare any financial and other interests relevant to the joint work in which they are due to participate. Such declarations and any actions taken as a result shall be recorded in the summary minutes of the meeting and in the outcome documents of the joint work in question.

AddedArticle 138 – paragraph 2 – subparagraph 1: The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, European product assessment reports, periodic safety update reports, where applicable documentation related to scientific advice received, environmental risk assessment reports, the package leaflet, the information shown on the labelling, awareness cards in the case of antimicrobials, post-marketing obligations related to the medicinal product, shortage prevention and, where relevant, mitigation plans, and information as to in which Member States the medicinal product is placed on the market and other documents deemed relevant by the Agency. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to 40(4), point (b) and Article 57 [revised Directive 2001/83/EC].

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ChangedArticle 147138 – paragraph 2 b (new):– 2b.subparagraph All2 indirect– interestspoint whichb coulda relate(new): to(ba) themarketing pharmaceuticalauthorisation industryholders shall be entered in a registerelectronically heldsubmit byto the Agency which isinformation accessibleconcerning toin thewhich public.Member /States Thethe Agency'smedical codeproducts offor conducthuman shalluse provideauthorised forin the implementation of this ArticleUnion withhave particularbeen referenceplaced toon the acceptance of gifts.market.

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RemovedArticle 148 – paragraph 3 – point a a (new): (aa) four co-opted members chosen by the Committee among experts proposed by Member States or the Agency on the basis of their specific scientific competence and expertise, with a view to ensuring that the relevant expertise is available within the Committee for the purpose of working groups and ad-hoc working groups in the field of advanced therapy medicinal products, paediatric medicinal products, herbal medicinal products and orphan medicinal products.

AddedArticle 138 – paragraph 2 – subparagraph 3: Where applicable, the database shall also include references to clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 81 of Regulation (EU) No 536/2014.

RemovedArticle 150 – title: Scientific working parties, ad-hoc working groups and scientific advisory groups

AddedArticle 142 – paragraph 1 – point l: (l) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the Agency and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] and ensure appropriate coordination between it and the Committees. It shall also ensure the implementation of all transparency commitments and undertake the work required of the Agency under the procedures for the assessment and preparations of decisions for paediatric investigation plans, waivers, deferrals or orphan designations.

RemovedArticle 150 – paragraph 3 – subparagraph 2: The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. Patient representatives shall also be included as members of the working parties. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

AddedArticle 143 – paragraph 1 – subparagraph 2: In addition, two representatives of patients' organisations, one representative of doctors' organisations, one representative of pharmacists’ organisations and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

RemovedArticle 153 – paragraph 1: At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. Guidelines for the determination of added therapeutic value shall be drawn up in collaboration with patient organisations.

AddedArticle 143 – paragraph 2 – subparagraph 2: All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a gender balanced representation on the Management Board.

RemovedArticle 162 – paragraph 2: 2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders.

AddedArticle 143 – paragraph 4: 4. The term of office for members and their alternates shall be four years. That term shall be extendable once consecutively.

RemovedArticle 166 – paragraph 1: 1. To support its public health tasks and in particular the evaluation and monitoring medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space, for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product.

AddedArticle 143 – paragraph 4 a (new): 4a. Representatives from patients' organisations serving as members or alternate members on scientific committees shall be eligible for reimbursement of expenses incurred in the execution of their duties as representatives, financed through the Agency budget, in accordance with the financial rules applicable to the Agency.

RemovedArticle 166 – paragraph 1 – subparagraph 1 a (new): Such data shall in particular include personal electronic health data as defined in Regulation (EU) .../... [draft EHDS Regulation 2022/0140(COD)] and where relevant, data from monitoring studies on the use, effectiveness and safety of medicinal products intended for treatment, prevention, or the diagnosis of disease, including health data provided by public authorities and data as referred to in Article 20, first paragraph, point (b), of Regulation (EU) 2022/123.

AddedArticle 146 – paragraph 8 – subparagraph 1: The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations, including paediatric representatives, and healthcare professionals’ associations. For that purpose working groups of patient and consumer organisations and healthcare professionals’ associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

RemovedArticle 166 – paragraph 2: 2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product. Such update shall only take place after the consultation with the marketing authorisation applicant or marketing authorisation holder concerned.

AddedArticle 147 – title: Independence and conflict of interest

RemovedArticle 169 – paragraph 1 – subparagraph 2 – point b: (b) as regards special categories of personal data, is strictly necessary and subject to appropriate safeguards, which may include anonymisation and pseudonymisation requirements and techniques, data minimisation and retention measures, specific organisational measures and access controls on a ‘need to know’ basis and other appropriate measures, confidentiality requirements, and fundamental rights of data subjects as set out in Regulations (EU) 2016/679 and (EU) 2018/1725.

AddedArticle 147 – paragraph 1 – subparagraph 2: The Agency's code of conduct shall provide for the implementation of this Article.

RemovedArticle 169 – paragraph 3: deleted

AddedArticle 147 – paragraph 2: 2. Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda. These declarations shall be made available to the public. Where the Agency decides that a declared interest for a representative constitutes a conflict of interest, that representative shall not take part in any discussions or decision-making, or obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.

RemovedArticle 171 – paragraph 1: 1. By ... [six months after the date of entry into force of this Regulation], Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

AddedArticle 147 – paragraph 2 a (new): 2a. The Executive Director shall after leaving the service continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits and if intending to engage in an occupational activity, whether gainful or not, within two years of leaving the service shall inform the Management Board for approval. The Management Board shall, in principle, prohibit them, for 12 months after leaving the service, from engaging in lobbying or advocacy vis-à-vis staff of the Union’s institutions, bodies, offices and agencies for their business, clients or employers on matters for which they were responsible during their last three years in the service.

RemovedArticle 172 – paragraph 1: 1. The Commission shall impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations. The penalties imposed by the Commission shall be effective, proportionate and dissuasive.

AddedArticle 147 – paragraph 2 b (new): 2b. Patients, clinical experts and other relevant experts shall declare any financial and other interests relevant to the joint work in which they are due to participate. Such declarations and any actions taken as a result shall be recorded in the summary minutes of the meeting and in the outcome documents of the joint work in question.