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Parliamentary questions
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20 April 2018
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-000831/2018

1. The EU adopted new Regulations(1) on medical devices and in vitro diagnostic medical devices in 2017. Although they do not contain special provisions with regard to rare diseases, they foresee harmonisation of the legal framework across the Member States, enhancement of patient safety and strengthening of cooperation between Member States, which is expected to improve the availability and quality of all medical devices, including those for rare diseases.

2. The EU introduced new legislation(2) in 2000 with the aim of providing incentives for the research, development and marketing of medicines for rare diseases (so-called orphan medicinal products). These incentives include EU-wide authorisation, fee waivers, 10-year market exclusivity and protocol assistance. To date, the Commission has already authorised 145 orphan medicines and has designated 1 540 products as orphan medicinal products.

The setting of prices for medicines or their inclusion in the scope of national health insurance schemes falls outside the competence of the EU; it is a Member State responsibility. However, the Commission promotes the exchange of information on pricing policies between Member States in order to support them in their decision-making(3).

(1)Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic medical devices — http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC
(2)Regulation (EC) No 141/2000 on orphan medicinal products, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF

Last updated: 20 April 2018Legal notice