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Parliamentary questions
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15 February 2018
E-007698/2017(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-007698/2017

While the organisation of health systems and pricing of medicines are Member States' responsibilities, the Commission supports the generation of evidence-based information and cooperation mechanisms to facilitate accessibility to medicines: for example, the EURIPID project(1), related work from the Organisation for Economic Cooperation and Development(2) and the expert panel on effective ways of investing in health(3). Under the European Semester, the Commission encourages Member States to pursue healthcare reforms to enhance cost-effectiveness, ensure fiscal sustainability and ensure quality, affordable access(4).

Concerning shortages of medicines, the Commission collaborates with Member States, Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) to share best practices to assure continuous supply of medicines through effective implementation of the pharmaceutical legislation(5). Shortages are discussed in the Human Pharmaceutical Committee(6) and HMA-EMA task force on availability.

In addition, as the Commission pointed out in its reply to Written Question E-001508/17, ‘the Member States are also responsible for ensuring the marketing authorisation holders and wholesale distributors' obligations of continuous supply of medicines to cover the needs of patients. Moreover, a Member State can authorise the placing on the market of a medicine from another Member State or use an unauthorised medicine for the treatment of patients. In addition, Member States may adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions. It should be noted that some Member States have already taken national measures to prevent shortages of medicines arising from parallel trade.’

(1)http://ec.europa.eu/chafea/news/news492.html
(2)http://www.oecd.org/els/health-systems/pharmaceuticals.htm
(3).https://ec.europa.eu/health/expert_panel/home_en
(4)2018 European Semester: Annual Growth Survey, https://ec.europa.eu/info/sites/info/files/2017-comm-690_en_0.pdf
(5)Article 81 of Directive 2001/83/EC
(6)https://ec.europa.eu/health/documents/pharmaceutical-committee/human-meeting_en

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