Article 6 · Commission Implementing Regulation (EU) 2024/1381

Contents

Article 6Selection of patients, clinical experts and other relevant experts#

1.The JCA subgroup shall specify, for each particular joint clinical assessment, the disease, the therapeutic area concerned and other specific expertise, based on which the HTA secretariat shall identify patients, clinical experts and other relevant experts to be consulted during that joint clinical assessment.

2.The HTA secretariat shall compile a list of relevant patients, clinical experts and, where necessary, other relevant experts, in consultation with the JCA Subgroup and the appointed assessor and co-assessor. When compiling the list, the HTA secretariat may consult:

(a)the members of the HTA stakeholder network;

(b)the European reference networks for rare and complex diseases and their respective European patient advocacy groups;

(c)the portal for rare diseases and orphan drugs (‘Orphanet’);

(d)the national contact points designated in accordance with Article 83 of Regulation (EU) No 536/2014 of the European Parliament and of the Council^note;

(e)the European Medicines Agency.

3.Where the consultation of the sources referred to in paragraph 2 has not allowed to identify a sufficient number of relevant patients, clinical experts and other relevant experts, the HTA secretariat may consult other existing databases or directories or contact members of the Coordination Group, its subgroups and relevant European Union and international agencies and organisations.

4.The HTA secretariat shall provide the JCA Subgroup with a list of available patients, clinical experts and, where necessary, other relevant experts, after the Commission has concluded on their conflicts of interest, in accordance with the rules set out in Article 5 of Regulation (EU) 2021/2282 and with the general procedural rules adopted under Article 25(1), point (a), of that Regulation.

5.The JCA Subgroup shall make the final selection of patients, clinical experts and, where necessary, other relevant experts to be consulted during the joint clinical assessment. In making the final selection, the JCA Subgroup shall give priority to patients, clinical experts and other relevant experts who have expertise, covering several Member States, in the therapeutic area of the joint clinical assessment.