Changes from plenary report to adopted text

Added2. The membership of the scientific committees shall be made public. When each appointment is published, the professional qualifications of each member shall be specified.

Added3. The Executive Director of the Agency or their representative and representatives of the Commission shall be entitled to attend all meetings of the scientific committees referred to in Article 142, working parties and scientific advisory groups and all other meetings convened by the Agency or its scientific committees.

Added4. Members of the scientific committees and experts responsible for evaluating medicinal products and nominated by Member States shall rely on the scientific evaluation and resources available to national competent authorities responsible for marketing authorisation, and on external experts proposed by Member States or selected by the Agency. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated members of the Committees and experts. Member States shall refrain from giving those members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.

Added5. The members of the scientific committees may be accompanied by experts in specific scientific or technical fields.

Added6. When preparing any opinion or recommendation, the scientific committees shall use their best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.

Added7. The Committee for Medicinal Products for Human Use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.

Added8. 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. [Am. 321]

AddedRapporteurs appointed by the scientific committees may, on an advisory basis, establish contacts with representatives of patient organisations and healthcare professionals’ associations relevant to the therapeutic indication of the medicinal product for human use.

Added9. The Committee for Veterinary Medicinal Products shall operate in accordance with Regulation (EU) No 2019/6 and paragraphs 1, 2 and 3.

AddedArticle 147 Independence and conflict of interest [Am. 322]

Added1. Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

AddedThe Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts. [Am. 323]

Added2. 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. [Am. 324]

Added2a. 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. [Am. 325]

Added2b. 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. [Am. 326]

Added2c. 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. [Am. 327]

AddedArticle 148 Committee for Medicinal Products for Human Use activities

Added1. The Committee for Medicinal Products for Human Use shall be responsible for drawing up the opinion of the Agency on any matter concerning the admissibility of the files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market in accordance with the provisions of this Chapter, and pharmacovigilance. For the fulfilment of its pharmacovigilance tasks, including the approval of risk management systems and monitoring their effectiveness provided for under this Regulation, the Committee for Medicinal Products for Human Use shall rely on the scientific assessment and recommendations of the Pharmacovigilance Risk Assessment Committee referred to in Article 142, point (e).

Added2. In addition to their task of providing objective scientific opinions to the Union and Member States on the questions which are referred to them, the members of the Committee for Medicinal Products for Human Use shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation.

Added3. The Committee for Medicinal Products for Human Use shall be composed of the following:

Added(a) one member and one alternate member appointed by each Member State, in accordance with paragraph 6;

Added(b) four members and one alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

Added(c) four members and four alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

Added4. The Committee for Medicinal Products for Human Use may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.

AddedWith a view to the co-opting of such members, the Committee for Medicinal Products for Human Use shall identify the specific complementary scientific competence of the additional member or members. Co-opted members shall be chosen among experts nominated by Member States or the Agency.

Added5. The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs in accordance with Article 152.

AddedMembers and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human use as appropriate and shall represent the competent authorities of the Member States.

Added6. The members and alternate members of the Committee for Medicinal Products for Human Use shall be appointed on the basis of their relevant expertise in the assessment of medicinal products which should cover all types of medicinal products covered by [revised Directive 2001/83/EC] and this Regulation and which include medicinal products for rare and paediatric diseases, advance therapy medicinal products, biological and biotechnological products, in order to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. The Member States shall cooperate in order to ensure that the final composition of the Committee for Medicinal Products for Human Use provides appropriate and balanced coverage of all scientific areas relevant to its tasks taking into account scientific developments and new types of medicinal products. For this purpose, Member States shall liaise with the Management Board and the Commission.

Added7. The members and alternate members of the Committee for Medicinal Products for Human Use shall be appointed for a term of three years, which may be renewed following the procedures referred to in paragraph 6. The Committee shall elect its chairperson and vice-chairperson from among its members for a term of 3 years, which may be prolonged once.

Added8. The Committee for Medicinal Products for Human Use shall establish its own rules of procedure.

AddedThese rules shall, in particular, lay down:

Added(a) procedures for appointing and replacing the chairperson;

Added(b) procedures relating to working parties and scientific advisory groups; and

Added(c) a procedure for the urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance.

AddedThey shall enter into force after receiving a favourable opinion from the Commission and the Management Board.

AddedArticle 149 Pharmacovigilance Risk Assessment Committee activities

Added1. The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

Added2. The Pharmacovigilance Risk Assessment Committee shall be composed of the following:

Added(a) one member and one alternate member appointed by each Member State, in accordance with paragraph 3;

Added(b) six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;

Added(c) two members and two alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

Added(d) two members and two alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

AddedThe alternate members shall represent and vote for the members in their absence. The alternate members referred to in point (a) may be appointed to act as rapporteurs in accordance with Article 152.

Added3. A Member State may delegate its tasks in the Pharmacovigilance Risk Assessment Committee to another Member State. Each Member State may represent no more than one other Member State.

Added4. The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed on the basis of their relevant expertise in pharmacovigilance matters and risk assessment of medicinal products for human use, in order to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. For this purpose, Member States shall liaise with the Management Board and the Commission in order to ensure that the final composition of the Committee covers the scientific areas relevant to its tasks.

Added5. The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed for a term of 3 years, which may be renewed following the procedures referred to in paragraph 1. The Committee shall elect its chairperson and vice-chairperson from among its members for a term of three years, which may be prolonged once.

AddedArticle 150 Scientific working parties, ad hoc working groups and scientific advisory groups [Am. 328]

Added1. The scientific committees referred to in Article 146 may establish scientific working parties and scientific advisory groups in connection with the performance of their tasks.

AddedThe scientific committees may rely on scientific working parties for the performance of certain tasks. The scientific committees shall retain the final responsibility for the assessment or any scientific opinion related to these tasks.

AddedWorking parties established by the Committee for Veterinary Medicinal Products are governed by Regulation (EU) 2019/6.

Added2. The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations.

AddedFor the provision of scientific advice the Committee for Human Medicinal Products shall establish a scientific advice working party.

AddedThe Committee mayshall establish an ad hoc Environmental Risk Assessment working party and other scientific working parties, as necessary. [Am. 329]

Added3. The composition of the working party and the selection of members shall be based on the following criteria:

Added(a) a high level of scientific expertise;

Added(b) meeting the needs for the specific multi-disciplinary expertise of the working party to which they will be appointed.

Added(ba) fulfilment of conflict of interest requirements referred to in Article 147. [Am. 330]

AddedThe majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. 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.

Added3a. Representatives of patients, caregivers, clinicians and academia shall be included as members of the working parties as appropriate. [Am. 331]

Added4. Competent authorities of the Member States that are not represented in a working party may request to attend meetings of working parties as an observer.