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Parliamentary questions
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22 March 2019
P-000817/2019(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: P-000817/2019

The main objective of the EU Regulation on orphan medicinal products(1) is to provide incentives for research, development and placing on the market of orphan medicines to ensure that patients suffering from rare conditions have the same quality of treatment.

The Commission is currently evaluating(2) the functioning of the EU Orphan Regulation, which will provide insight in how the various incentives (including market exclusivity(3)) have been used in practice and the financial consequences this has resulted in.

Pricing policies for medicinal products are outside the EU remit and fall under the Member States’ competences. However, the Commission is promoting the exchange of information among Member States on their pricing policies. This can enhance price competition for medicines and help minimise potential negative effects on accessibility.

The Commission also facilitates the exchange of best practices and knowledge and supports the strengthening of cooperation on a voluntary basis, in particular through tools such as a European medicine price database(4).

As part of its competition policy, the Commission also monitors pharmaceutical markets and investigates, where appropriate, possible breaches of EU competition rules that may entail high prices. Article 102 of the Treaty on the Functioning of the EU also applies to abusive practices in the context of medicines benefitting from patent protection and regulatory exclusivity. That said, competition law enforcement has to take due account of the efforts and incentives to innovate.

The Commission supports national competition authorities in Europe that can investigate possible breaches of EU competition rules, including excessive pricing.

(1)https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF
(2)https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6059807_en
(3)https://www.ema.europa.eu/en/human-regulatory/post-authorisation/orphan-medicines/market-exclusivity-orphan-medicines
(4)https://www.euripid.eu/aboutus

Last updated: 3 April 2019Legal notice