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1. No later than 13 January 2028, the Commission shall present a report to the European Parliament and to the Council on the application of this Regulation. The report shall focus on reviewing:

(a) the added value for Member States of the joint work carried out pursuant to Chapter II and, in particular, whether the health technologies subject to joint clinical assessments in accordance with Article 7 and the quality of those joint clinical assessments correspond to the needs of Member States;

(b) the non-duplication of the request of information, data, analyses and other evidence for joint clinical assessment in terms of reducing the administrative burden for Member States and health technology developers;

(c) the functioning of the support framework set out in this Chapter and, in particular, whether there is a need to introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint scientific consultations.

2. No later than 13 January 2027, Member States shall report to the Commission on the application of this Regulation and, in particular, on the consideration of joint work pursuant to Chapter II in their national HTA processes, including the way joint clinical assessment reports have been considered when carrying out national HTAs pursuant to Article 13(2), and the workload of the Coordination Group. Member States shall also report on whether they have considered methodological guidance developed pursuant to Article 3(7), point (d), for the purpose of national assessments, as referred to in Article 23(6).

3. In the preparation of its report, the Commission shall consult the Coordination Group and use:

(a) the information provided by Member States in accordance with paragraph 2;

(b) the reports on emerging health technologies prepared in accordance with Article 22;

(c) the information provided by Member States in accordance with Articles 13(2) and 14(4).

4. The Commission shall, if appropriate, present a legislative proposal based on that report in order to update this Regulation.