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1. The Member State Coordination Group on Health Technology Assessment (the ‘Coordination Group’) is hereby established.

2. Member States shall designate their members of the Coordination Group and inform the Commission thereof and of any subsequent changes. The members of the Coordination Group shall appoint their representatives in the Coordination Group on an ad hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes.

3. The members of the Coordination Group shall designate their national or regional authorities and bodies as members of subgroups of the Coordination Group. The members of the Coordination Group may designate more than one member to a subgroup, including the member of the Coordination Group, without prejudice to the rule that each Member State shall have one vote. The members of the subgroup shall appoint their representatives, who shall have the appropriate HTA expertise, in the subgroups on an ad hoc or permanent basis and inform the Commission of their appointment and any subsequent changes. Where there is a need for specific knowledge, members of the subgroup may appoint more than one representative.

4. The Coordination Group shall, in principle, act by consensus. Where consensus cannot be reached, the adoption of a decision shall require the support of members representing a simple majority of the Member States. Each Member State shall have one vote. The results of the votes shall be recorded in the minutes of the Coordination Group’s meetings. Where a vote takes place, members may ask for divergent opinions to be recorded in the minutes of the meeting in which the vote took place.

5. By way of derogation from paragraph 4 of this Article, where consensus cannot be reached, the Coordination Group shall adopt, by a qualified majority as defined in Article 16(4) TEU and Article 238(3), point (a), TFEU, its annual work programme, its annual report and the strategic direction referred to in paragraph 7, points (b) and (c), of this Article.

6. Meetings of the Coordination Group shall be chaired and co-chaired by two elected members from the Coordination Group, from different Member States, for a limited term to be determined by its rules of procedure. The chair and the co-chair shall be impartial and independent. The Commission shall act as the secretariat of the Coordination Group and support its work in accordance with Article 28.

7. The Coordination Group shall:

(a) adopt its rules of procedure and update those rules where necessary;

(b) adopt its annual work programme and annual report pursuant to Article 6;

(c) provide strategic direction for the work of its subgroups;

(d) adopt methodological guidance on joint work following international standards of evidence-based medicine;

(e) adopt detailed procedural steps and the timeframe for the conduct of joint clinical assessments and for updates thereof;

(f) adopt detailed procedural steps and the timeframe for the conduct of joint scientific consultations, including submissions of requests from health technology developers;

(g) adopt guidance on the appointment of assessors and co-assessors for joint clinical assessments and joint scientific consultations, including on the scientific expertise required;

(h) coordinate and approve the work of its subgroups;

(i) ensure cooperation with relevant Union level bodies established pursuant to Regulations (EC) No 726/2004, (EU) 2017/745 and (EU) 2017/746 to facilitate the generation of additional evidence necessary for its work;

(j) ensure appropriate involvement of stakeholder organisations and experts in its work;

(k) establish subgroups, in particular for the following:

(i) joint clinical assessments;

(ii) joint scientific consultations;

(iii) identification of emerging health technologies;

(iv) development of methodological and procedural guidance.

8. The Coordination Group and its subgroups may meet in different configurations, in particular for the following categories of health technology: medicinal products, medical devices, in vitro diagnostic medical devices and other health technologies.