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Parliamentary questions
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22 March 2018
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-000141/2018

The mission of the European Medicines Agency (EMA) is the scientific evaluation, supervision and safety monitoring of medicines in the EU. The evaluation of medicines by EMA, and their authorisation by the Commission, is based on the objective scientific criteria of quality, safety and efficacy of the medicine concerned, to the exclusion of economic and other considerations.

The organisation of health systems and the pricing of medicines are Member States' competence. Some Member States have concluded bilateral agreements with the pharmaceutical industry to ensure the entry of new products in to their market and according to their national laws.

The Commission supports the generation of evidence based information and cooperation mechanisms on access to medicines such as the EURIPID project(1) and projects by the Organisation for Economic Cooperation and Development(2).

The legislative proposal on strengthening the EU cooperation on Health Technology Assessment includes provisions on joint clinical assessments of centrally authorised medicinal products. The proposal is expected to facilitate faster, reliable and more transparent processes for Member States, including for orphan medicines.


Last updated: 23 March 2018Legal notice