Directive 2011/24/EU of the European Parliament and of the CouncilShow full title

Article 15 Cooperation on health technology assessment

1. The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States. The Member States shall communicate their names and contact details to the Commission. The members of such a health technology assessment network shall participate in, and contribute to, the network’s activities in accordance with the legislation of the Member State where they are established. That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations.

2. The objectives of the health technology assessment network shall be to:

(a) support cooperation between national authorities or bodies;

(b) support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short- and long-term effectiveness, when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies;

(c) support the analysis of the nature and type of information that can be exchanged;

(d) avoid duplication of assessments.

3. In order to fulfil the objectives set out in paragraph 2, the network on health technology assessment may receive Union aid. Aid may be granted in order to:

(a) contribute to the financing of administrative and technical support;

(b) support collaboration between Member States in developing and sharing methodologies for health technology assessment including relative effectiveness assessment;

(c) contribute to the financing of the provision of transferable scientific information for use in national reporting and case studies commissioned by the network;

(d) facilitate cooperation between the network and other relevant institutions and bodies of the Union;

(e) facilitate the consultation of stakeholders on the work of the network.

4. The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the establishment, management and transparent functioning of this network.

5. Arrangements for granting the aid, the conditions to which it may be subject and the amount of the aid, shall be adopted in accordance with the regulatory procedure referred to in Article 16(2). Only those authorities and bodies in the network designated as beneficiaries by the participating Member States shall be eligible for Union aid.

6. The appropriations required for measures provided for in this Article shall be decided each year as part of the budgetary procedure.

7. Measures adopted pursuant to this Article shall not interfere with Member States’ competences in deciding on the implementation of health technology assessment conclusions and shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.