1. The Coordination Group shall carry out joint clinical assessments on health technologies on the basis of its annual work programme.
2. The Coordination Group shall initiate joint clinical assessments of health technologies by designating the subgroup on joint clinical assessments to oversee the conduct of the joint clinical assessment on behalf of the Coordination Group.
3. The joint clinical assessment shall be conducted in accordance with the procedure established by the Coordination Group according to the requirements set out in this Article, in Article 3(7), point (e), and in Articles 4, 9, 10, 11 and 12, as well as the requirements to be established pursuant to Articles 15, 25 and 26.
4. The designated subgroup shall appoint, from among its members, an assessor and a co-assessor from different Member States to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment. If the health technology has been the subject of a joint scientific consultation in accordance with Articles 16 to 21, the assessor and the co-assessor shall be different from those appointed pursuant to Article 18(3) for the preparation of the joint scientific consultation outcome document.
5. Notwithstanding paragraph 4, where, in exceptional circumstances, the necessary specific expertise is otherwise not available, the same assessor or co-assessor, or both, involved in the joint scientific consultation may be appointed to conduct the joint clinical assessment. Such an appointment shall be justified and subject to approval by the Coordination Group and shall be documented in the joint clinical assessment report.
6. The designated subgroup shall initiate a scoping process in which it identifies the relevant parameters for the assessment scope. The assessment scope shall be inclusive and reflect Member States’ needs in terms of parameters and of the information, data, analysis and other evidence to be submitted by the health technology developer. The assessment scope shall include in particular all relevant parameters for the assessment in terms of:
(a)
the patient population;
(b)
the intervention or interventions;
(c)
the comparator or comparators;
(d)
the health outcomes.
The scoping process shall also take into account information provided by the health technology developer and input received from patients, clinical experts and other relevant experts.
7. The Coordination Group shall inform the Commission of the assessment scope of the joint clinical assessment.