Emergency Task Force

1. The Emergency Task Force (‘ETF’) is hereby established within the Agency.

The ETF shall be convened in preparation for and during public health emergencies, either in person or remotely.

The Agency shall provide the secretariat of the ETF.

2. During public health emergencies, the ETF shall undertake the following tasks:

in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific advice and reviewing the available scientific data on medicinal products that have the potential to address the public health emergency, including requesting data from developers and engaging with them in preliminary discussions;

providing advice on the main aspects of clinical trial protocols, and providing advice to developers on clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency, in accordance with Article 16 of this Regulation without prejudice to the tasks of the Member States as regards the assessment of submitted clinical trial applications to be conducted within their territories in accordance with Regulation (EU) No 536/2014;

providing scientific support to facilitate clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency;

contributing to the work of the scientific committees, working parties and scientific advisory groups of the Agency;

in liaison with the scientific committees, working parties, and scientific advisory groups of the Agency, providing scientific recommendations with regard to the use of any medicinal product which have the potential to address public health emergencies, in accordance with Article 18;

cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations, on scientific and technical issues that relate to the public health emergency and to medicinal products which have the potential to address public health emergencies, as necessary.

The support referred to in the first subparagraph, point (c), shall include advice to sponsors of similar or linked planned clinical trials on the establishment of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with Article 2(2), point (14), and Article 72 of Regulation (EU) No 536/2014.

3. The members of the ETF shall consist of:

chairs or vice chairs, or both, of the scientific committees of the Agency, and other representatives of those committees;

representatives of the working parties of the Agency, including representatives of the PCWP and representatives of the HCPWP;

staff members of the Agency;

representatives of the coordination group established in accordance with Article 27 of Directive 2001/83/EC;

representatives of the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) No 536/2014; and

other clinical trial experts who represent national competent authorities for medicinal products.

The members of the ETF shall be nominated by the entities they represent.

External experts may be appointed to the ETF on an ad hoc basis, as necessary, especially in the cases referred to in Article 5(3).

Representatives of other Union bodies and agencies shall be invited on an ad hoc basis, as necessary, to participate in the work of the ETF, especially in the cases referred to in Article 5(3).

The ETF shall be chaired by the representative of the Agency and co-chaired by the chair or vice-chair of the CHMP.

4. The composition of the ETF shall be approved by the Management Board of the Agency, taking into account specific expertise relevant to the therapeutic response to the public health emergency.

The Executive Director of the Agency or the representative of the Executive Director, as well as representatives of the Commission and of the Management Board of the Agency, shall be entitled to attend all meetings of the ETF.

The composition of the ETF shall be made publicly available.

5. The co-chairs of the ETF may invite other representatives of Member States, members of scientific committees and working parties of the Agency, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and representatives of healthcare professionals and of patients to attend its meetings.

6. The ETF shall establish its rules of procedure, including rules on the adoption of recommendations.

The rules of procedure referred to in the first subparagraph shall enter into force once the ETF has received a favourable opinion from the Commission and the Management Board of the Agency.

7. The ETF shall perform its tasks as an advisory and support body separate from, and without prejudice to, the tasks of the scientific committees of the Agency as regards the authorisation, supervision and pharmacovigilance of the medicinal products concerned and related regulatory actions to ensure the quality, safety and efficacy of those medicinal products.

The CHMP and other relevant scientific committees of the Agency shall take the ETF recommendations into consideration when adopting their opinions.

The ETF shall take account of any scientific opinion issued by the committees referred to in the second subparagraph of this paragraph in accordance with Regulation (EC) No 726/2004 and Directive 2001/83/EC.

8. Article 63 of Regulation (EC) No 726/2004 applies to the ETF as regards transparency and the independence of its members.

9. The Agency shall publish information regarding the medicinal products that the ETF considers to have the potential to address public health emergencies and any updates on its web portal. The Agency shall inform Member States and the HSC, as appropriate, of any such publication without undue delay and, in any case, prior to such publication.

REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices