Changes from plenary report to adopted text

Added1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Article 214 of [revised Directive 2001/83/EC]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Added2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Added3. Where the opinion of the Committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time-limit for delivery of the opinion, the chair of the Committee so decides.

Added4. The Standing Committee on Medicinal Products for Human Use shall ensure that its rules of procedure are adapted to the need to make medicinal products swiftly available to patients.

AddedArticle 174 Implementing measures related to authorisation and pharmacovigilance activities

Added1. In order to harmonise electronic transmissions provided for in this Regulation, the Commission may adopt implementing measures covering the format and content of electronic transmissions by marketing authorisation holders.

AddedThose measures shall take account of the work on international harmonisation carried out in the area and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Added2. In order to harmonise the performance of the pharmacovigilance activities provided for in this Regulation, the Commission shall adopt implementing measures as provided for in Article 214 of [revised Directive 2001/83/EC] covering the following areas:

Added(a) the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;

Added(b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency;

Added(c) the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

Added(d) the minimum requirements for the monitoring of data included in the Eudravigilance database to determine whether there are new risks or whether risks have changed;

Added(e) the format and content of electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders;

Added(f) the format and content of electronic periodic safety update reports and risk management plans;

Added(g) the format of protocols, abstracts and final study reports of the post-authorisation safety studies.

AddedThose measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the examination procedure referred to in Article 173(2).

AddedArticle 175 Exercise of the delegation

Added1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Added2. The power to adopt delegated acts referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) shall be conferred on the Commission for a period of five years from [date of entry into force]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Added3. The delegation of power referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) may be revoked at any time by the European Parliament or by 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.

Added4. 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.

Added5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Added6. A delegated act adopted pursuant to Articles 21, 19(8), 47(4), 49(2) and 175 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 to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

AddedCHAPTER XIV AMENDMENTS TO OTHER LEGAL ACTS

AddedArticle 175a Amendments to Regulation (EC) No 851/2004

AddedRegulation (EC) No 851/2004 is amended as follows:

Added(1) the following articles are inserted:

Added‘Article 11aa European Health Emergency Preparedness and Response Authority

Added1. 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’).

Added2. 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.

Added3. The Authority is represented by the Director of the ECDC.

AddedArticle 11ab Objectives and tasks of the Authority

Added1. 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.

AddedThe Authority shall carry out the following tasks:

Added(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’);

Added(b) setting up and supporting biomedical R&D projects addressing at least the following areas:

Added(i) the development of priority antimicrobials as defined in Article 40a of [Pharma Regulation];

Added(ii) the development of medical countermeasures and related technologies;

Added(c) setting up and management of collaboration with third-party research centres at national and European level, not-for profit entities, academia and industry;

Added(d) providing strategic advice to the Commission on the allocation of relevant Union grants and other financial sources to ensure appropriate resource allocation for biomedical R&D;

Added(e) detecting biological and other health threats soon after they emerge, evaluating their impacts and identifying potential countermeasures;

Added(f) assessing and addressing vulnerabilities in global supply chains and strategic dependencies related to availability of medical countermeasures and medicinal products in the Union, in coordination with the Medicine Shortages Steering Group and Medical Device Shortages Steering Group, established by Regulation (EU) 2022/123;

Added(g) addressing market challenges by identifying and ensuring the availability of production sites for priority products in the Union;

Added(h) facilitating joint procurement and distribution of medical products in Member States;

Added(i) monitoring compliance with funding and procurement agreements;

Added(j) establishing a mechanism of consultation and cooperation, in line with the One Health approach, internally within the ECDC and with other Union bodies and agencies, in particular the EMA, the European Food Safety Authority and the European Environment Agency;

Added(k) contributing to reinforcing the global health emergency preparedness and response architecture.

Added2. The Commission is empowered to adopt delegated acts to supplement this Regulation by expanding the priority research agenda set out in paragraph 1, second subparagraph, point (b), in order to address other areas of unmet medical need.’ [Am. 356]

Added(2) in Article 13, the following point is inserted:

Added‘(ba) the HERA Board;’ [Am. 357]

Added(3) in Article 16(2), the following point is inserted:

Added‘(da) ensuring that appropriate scientific, technical and administrative support are provided to the HERA Board;’ [Am. 358]

Added(4) the following articles are inserted:

Added‘Article 17a HERA Board

Added1. 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.

Added2. 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.

Added3. 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.

Added4. The term of office for members and their alternates shall be four years. That term may be extendable once consecutively.

Added5. 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 relevant Union bodies and agencies may be invited to attend as observers, where relevant.

Added6. The co-Chairs of the HERA Board may invite relevant stakeholders to attend the HERA Board meetings as observers. Observers shall declare their interests ahead of each meeting.