Changes from report parliamentary committee draft to plenary report

RemovedArticle 180 – paragraph 13: deleted

AddedArticle 147 – paragraph 2 c (new): 2c. The Agency shall make available the rules of procedure, agendas, minutes and the members of the Management Board, committees, working parties and advisory committees on its website.

RemovedAnnex I – point 3: 3. Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding herbal medicinal products, which shall in any case not be authorised by the Union.

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

RemovedAnnex II – point 25 a (new): (25a) the obligation to notify the competent authority of the Member State and, where relevant, the Agency about cessation, withdrawal, temporary suspension or temporary disruption in accordance with the deadlines provided for in Article 116;

AddedArticle 150 – paragraph 2 – subparagraph 3: The Committee shall establish an ad hoc Environmental Risk Assessment working party and other scientific working parties, as necessary.

RemovedAnnex II – point 25 b (new): (25b) the obligation to have in place and keep up to date a shortage prevention plan as provided for in Article 117;

AddedArticle 150 – paragraph 3 – subparagraph 1 – point b a (new): (ba) fulfilment of conflict of interest requirements referred to in Article 147

RemovedAnnex II – point 25 c (new): (25c) the obligation to comply with the recommendations and measures taken in case of a critical shortage as provided for in Article 125;

AddedArticle 150 – paragraph 3 a (new): 3a. Representatives of patients, caregivers, clinicians and academia shall be included as members of the working parties as appropriate.

RemovedAnnex II – point 25 d (new): (25d) the obligation to comply with the recommendations and measures taken in relation to critical medicinal products as provided for in Article 133.

AddedArticle 150 – paragraph 5 a (new): 5a. The Agency shall establish the following ad hoc working groups: / (a) an ad hoc working group on advanced therapy medicinal products; / (b) an ad hoc working group on orphan medicinal products; / (c) an ad hoc working group on paediatric medicinal products

RemovedAnnex IV – Part V a (new): Part Va / For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: / 1. Product availability information: / Product availabilities shall be reported per wholesale warehouse and shall be indexed as yes/no. / 2. Service level information: / Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.

AddedArticle 151 – paragraph 3 – subparagraph 1: Where necessary, for the nomination of other experts the Agency shall publish a call for expression of interest after endorsement by the Management Board of the necessary criteria and fields of expertise, in particular to ensure a high level of public health and animal protection.

AddedArticle 152 – paragraph 2 – subparagraph 2: The person concerned, or their employer, shall be remunerated in accordance with [a scale of fees to be included in the financial arrangements established by Regulation (EU) 2024/568 of the European Parliament and of the Council1a. / 1a Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).

AddedArticle 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. The Agency shall, in collaboration with patient organisations and healthcare professionals, draw up guidelines for the determination of added therapeutic value.

AddedArticle 154 – paragraph 4: 4. Activities relating to the assessment of marketing authorisation applications, subsequent variations, pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. This shall not preclude the Agency from charging fees to marketing authorisation holders for performing these activities by the Agency on the condition that its independence is strictly guaranteed in accordance with Article 147.

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

AddedArticle 163 – paragraph 1: The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the healthcare professions, including through the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

AddedArticle 164 – paragraph 5: 5. For not-for-profit entities the Commission shall adopt specific provisions clarifying the definitions, establishing waivers, reductions or deferrals of fees, as appropriate, in accordance with the procedure referred to in Article 10 and Article 12 of and Annex V to [revised Regulation (EC) No 297/95].

AddedArticle 165 – paragraph 3 a (new): Sufficient resources shall be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments.

AddedArticle 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 real world data 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. The Agency shall put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulations (EU) 2016/679 and (EU) 2018/1725, including but not limited to clear and targeted data minimisation policies, state-of-the-art anonymisation and pseudonymisation requirements.

AddedArticle 166 – paragraph 1 – subparagraph 1 a (new): Such data shall in particular include personal electronic health data as defined in Regulation (EU) .../... [EHDS Regulation 2022/0140(COD)], data from the Eudravigilance database, clinical data and, where applicable, 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.

AddedArticle 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. Marketing authorisation applicants and marketing authorisation holders shall have the opportunity to respond within a reasonable timeline set by the Agency. Marketing authorisation applicants and marketing authorisation holders may submit to the Agency questions and shall be offered the opportunity of an explanation to any proposed update to the summary of product characteristics as appropriate. The reasons for the conclusions reached shall be included in the final opinion.

AddedArticle 167 – paragraph 2: For the purposes of the first subparagraph, the Agency shall actively take measures to ensure its compliance with a high common level of cybersecurity adopted within Union institutions, bodies, offices and agencies, identify and implement up-to-date cybersecurity best practices for preventing, detecting, mitigating, and responding to cyber attacks.

AddedArticle 168 – paragraph 1: 1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 and Directive (EU) 2019/1937 of the European Parliament and of the Council85 , and existing national provisions on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council86 , including intellectual property rights.

AddedArticle 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 pseudonymisation requirements and techniques, data minimisation 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 171 – paragraph 1: 1. By ... [12 months from 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 172 – paragraph 5 – point b a (new): (ba) the nature, gravity and duration of the infringement and of its consequences, taking into account the scope as well as the number of persons affected and the level of damage suffered by them;

AddedArticle 172 – paragraph 5 – point b b (new): (bb) the size and market share of the entity committing the infringement;

AddedArticle 172 – paragraph 5 – point b c (new): (bc) the intentional or negligent character of the infringement;

AddedArticle 172 – paragraph 5 – point b d (new): (bd) any action taken by the infringing party to mitigate the damage caused by the infringement;

AddedArticle 172 – paragraph 5 – point b e (new): (be) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

AddedArticle 172 – paragraph 5 – point b f (new): (bf) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

AddedArticle 172 – paragraph 5 – point b g (new): (bg) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

AddedArticle 172 – paragraph 5 – point b h (new): (bh) the risk to public health, including in the case of falsification of medicinal products.

AddedRegulation (EC) No 851/2004

AddedArticles 11a a (new) and 11a b (new)

AddedArticle 175 a (new) – paragraph 1 – point 1: Article 175a / Amendments to Regulation (EC) No 851/2004 / Regulation (EC) No 851/2004 is amended as follows: / (1) the following articles are inserted: / ‘Article 11aa / European Health Emergency Preparedness and Response Authority / 1. The Health Emergency Preparedness and Response Authority (‘HERA’ or the ‘Authority’) is hereby established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (‘ECDC’). / 2. The Authority shall be responsible for creating, coordinating and implementing the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats as well as the production, procurement, stockpiling and distribution capacity of medical countermeasures and other priority medical products in the Union. / 3. The Authority is represented by the Director of the ECDC. / Article 11ab / Objectives and tasks of the Authority / 1. The Authority shall provide the Member States and the Union institutions, bodies, offices and agencies, with the strategic direction and the resources to develop a robust biomedical R&D capacity to address major public health issues. / The Authority shall carry out the following tasks: / (a) setting out a long-term European portfolio of research and development projects in line with public health priorities set by the Commission in consultation with the World Health Organization (‘WHO’); / (b) setting up and s…

AddedRegulation (EC) No 851/2004

AddedArticle 175 a (new) – paragraph 1 – point 2, Article 13 – paragraph 1 – point b a (new): (2) in Article 13, the following point is inserted: / ‘(ba) the HERA Board;’

AddedRegulation (EC) No 851/2004

AddedArticle 175 a (new) – paragraph 1 – point 3, Article 16 – paragraph 2 – point d a (new): (3) in Article 16(2), the following point is inserted: / ‘(da) ensuring that appropriate scientific, technical and administrative support are provided to the HERA Board;’

AddedRegulation (EC) No 851/2004

AddedArticles 17 a (new) and 17 b (new)

AddedArticle 175 a (new) – paragraph 1 – point 4: (4) the following articles are inserted: / ‘Article 17a / HERA Board / 1. The HERA Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights. All HERA Board members shall be appointed for a two-year term, renewable once. / 2. In addition, two public health experts shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission. 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 those representatives to the HERA Board. / 3. The HERA Board shall be co-chaired by the director and an elected representative of a Member State. The members of the HERA Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise, and an absence of direct or indirect conflict of interest. / 4. The term of office for members and their alternates shall be four years. That term may be extendable once consecutively. / 5. A representative of the Health Security Committee and a representative of the EMA shall attend the meetings of the HERA Board, as permanent observers. Other rele…

AddedRegulation (EC) No 851/2004

AddedArticle 175 a (new) – paragraph 1 – point 5, Article 19: (5) Article 19 is replaced by the following: / ‘Article 19 / Transparency and conflicts of interest / 1. Members of the Management Board, members of the HERA Board, members of the scientific panels, members of the Advisory Forum, the director and the staff shall undertake to act in the public interest and in an independent manner. They shall not have any direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect their impartiality. They shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request. / 2. The ECDC's and Authority’s code of conduct shall provide for the implementation of this Article. / 3. The ECDC and the Authority shall make available the rules of procedure, meeting agendas and minutes, and the members of the structures referred to in paragraph 1 and their declarations of interest on their website. / 4. Stakeholders invited to meetings at the ECDC and the Authority shall declare their interests ahead of the meeting’.

AddedArticle 181 – paragraph 3 a (new): The provisions in Chapter III shall apply from ... [the date of entry into force of this Regulation].

AddedAnnex II – point 16: (16) the obligation to conduct post-marketing studies, including post-authorisation safety studies, post-authorisation efficacy studies and post-authorisation environmental risk assessment studies, and to submit them for review, as provided for in Article 20;

AddedAnnex II – point 25 a (new): (25a) the obligations related to the availability and supply of medicinal products as laid down in Chapter X;

AddedAnnex II – point 25 b (new): (25b) the obligations to report on financial support and research and development costs as laid down in Article 57 of [revised Directive 2001/83/EC].

AddedAnnex IV – Part III – paragraph 1 – point 2 – point e: (e) Reason for shortage providing, where applicable, information on: / (i) raw material disruption; / (ii ) API disruption; / (iii) excipient disruption; / (iv) production problems; / (v) quality problems; / (vi) production capacity; / (vii) logistics problems; / (viii) distribution problems; / (ix) inventory and storage practices; / (x) increase in demand; / (xi) commercial reasons; and / (xii) any other reasons;

AddedAnnex IV – Part V – paragraph 1 – point 2 – point d a (new): (da) methodology for establishing the demand forecast;

AddedAnnex IV – Part V a (new): Part Va / For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: / 1. Product availability information: / Product availabilities shall be reported per warehouse and shall be indexed as yes/no. / 2. Service level information: / Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.