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:
(a)
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;
(b)
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;
(c)
providing scientific support to facilitate clinical trials for medicinal products intended to treat, prevent or diagnose the disease causing the public health emergency;
(d)
contributing to the work of the scientific committees, working parties and scientific advisory groups of the Agency;
(e)
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;
(f)
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:
(a)
chairs or vice chairs, or both, of the scientific committees of the Agency, and other representatives of those committees;
(b)
representatives of the working parties of the Agency, including representatives of the PCWP and representatives of the HCPWP;
(c)
staff members of the Agency;
(d)
representatives of the coordination group established in accordance with Article 27 of Directive 2001/83/EC;
(e)
representatives of the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) No 536/2014; and
(f)
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.
Advice on clinical trials
1. During a public health emergency, the ETF shall provide advice on the main aspects of clinical trials and clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers as part of an accelerated scientific advice process, without prejudice of the responsibility of the Member State or States concerned under Regulation (EU) No 536/2014.
2. Where a developer engages in an accelerated scientific advice process, the ETF shall provide the advice referred to in paragraph 1 free of charge at the latest 20 days after the developer submits a complete set of the requested information and data to the Agency. The advice shall be endorsed by the CHMP.
3. The ETF shall establish procedures and guidance for requesting and submitting of the set of information and data required, including information on the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted.
4. The ETF shall involve representatives of the Member States with clinical trial expertise in the preparation of the scientific advice, in particular in cases where an application for authorisation of a clinical trial is submitted or is intended to be submitted.
5. When authorising a clinical trial application for which the ETF has provided scientific advice, Member States shall take that advice into consideration. The scientific advice provided by the ETF shall be without prejudice to the ethical review provided for in Regulation (EU) No 536/2014.
6. Where a developer is the recipient of the scientific advice referred to in paragraph 5 of this Article, that developer shall subsequently submit the data resulting from clinical trials to the Agency if the Agency makes a request for those data pursuant to Article 18.
7. Without prejudice to paragraphs 1 to 6 of this Article, the scientific advice referred to in paragraph 5 of this Article shall otherwise be provided in accordance with the procedures established pursuant to Article 57 of Regulation (EC) No 726/2004.
Public information regarding clinical trials and marketing authorisation decisions
1. For the duration of a public health emergency, the sponsors of clinical trials conducted in the Union shall, in particular, make the following information publicly available through the EU portal and EU database established respectively by Articles 80 and 81 of Regulation (EU) No 536/2014:
(a)
the clinical trial protocol, at the start of each trial for all trials authorised under Regulation (EU) No 536/2014 that examine medicinal products which have the potential to address the public health emergency;
(b)
the summary of the results, within a timeline set by the Agency that is shorter than the timeline laid down in Article 37 of Regulation (EU) No 536/2014.
2. Where a medicinal product of relevance to the public health emergency receives a marketing authorisation, the Agency shall publish, in particular:
(a)
the product information with details of the conditions of use at the time of the marketing authorisation;
(b)
the European Public Assessment Reports as soon as possible and, where possible, within seven days of the marketing authorisation;
(c)
the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation by the Commission;
(d)
the entire risk management plan referred to in Article 1, point 28c, of Directive 2001/83/EC, and any updated versions thereof.
For the purposes of the first subparagraph, point (c), the Agency shall anonymise all personal data and redact commercially confidential information.
Review of medicinal products and recommendations on their use
1. Following the recognition of a public health emergency, the ETF shall undertake a review of the available scientific data on medicinal products which have the potential to be used to address the public health emergency. That review shall be updated whenever needed during the public health emergency, including where the ETF and the CHMP agree on the preparation of the assessment of a marketing authorisation application.
2. In the preparation of the review referred to in paragraph 1, the ETF may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The ETF may also make use of health data generated outside of clinical studies, where available, taking into account the reliability of those data.
The ETF may liaise with the third country agencies for medicinal products with respect to additional information and data exchanges.
3. Following a request from one or more Member States, or the Commission, the ETF shall provide recommendations to the CHMP for an opinion in accordance with paragraph 4 on:
(a)
the compassionate use of medicinal products falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004; or
(b)
the use and distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.
4. Following receipt of a recommendation provided pursuant to paragraph 3, the CHMP shall adopt its opinion on the conditions to be imposed on the use and distribution of the medicinal product concerned and on the patients targeted. That opinion shall be updated where necessary.
5. Member States shall take account of the opinions referred to in paragraph 4 of this Article. Article 5(3) and (4) of Directive 2001/83/EC applies to the use of such an opinion.
6. In the preparation of its recommendations provided pursuant to paragraphs 3, the ETF may consult the Member State concerned and request it to provide any available information or data that the Member State used for its decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the requested information and data.
Communication regarding the ETF
The Agency shall provide information to the public and relevant interest groups with regard to the work of the ETF in a timely manner and shall respond to disinformation targeting the work of the ETF, as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.
The Agency shall regularly publish on its web portal the list of the members of the ETF, the rules of procedure referred to in Article 15(6) and the list of medicinal products under review, as well as the opinions adopted pursuant to Article 18(4).
IT tools and data
In preparation for and to support the work of the ETF during public health emergencies, the Agency shall:
(a)
develop and maintain IT tools, including an interoperable IT platform, for the submission of information and data, including electronic health data generated outside of clinical studies, that facilitate interoperability with other existing IT tools and with IT tools under development, and provide adequate support to national competent authorities;
(b)
coordinate independent monitoring studies on the use, effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health emergency, using relevant data, including, where relevant, data held by public authorities;
(c)
as part of its regulatory tasks, make use of digital infrastructures or IT tools in order to facilitate rapid access to or analysis of available electronic health data generated outside of clinical studies and to facilitate the exchange of such data between Member States, the Agency and other Union bodies;
(d)
provide the ETF with access to external sources of electronic health data to which the Agency has access, including health data generated outside of clinical studies.
For the purposes of the first paragraph, point (b), coordination as regards vaccines shall be conducted in conjunction with the ECDC, in particular, through a new vaccine monitoring IT platform.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
