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Parliamentary questions
PDF 27kWORD 24k
7 March 2019
E-000090/2019(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-000090/2019

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 this regulation. The evaluation will include an assessment of measures at national and EU level ensuring accessibility to affordable medicines and will provide insight into the use of various incentives in practice and its financial consequences.

Pricing policies for medicinal products are Member States’ competence. However, the Commission promotes the exchange of information among Member States on their pricing policies, for example through the Euripid database(3). It also facilitates the exchange of best practices and knowledge among Member States through a network of competent authorities(4).

As part of its competition policy, the Commission 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(5) also applies to abusive practices in the context of medicines benefitting from exclusivity, like the one resulting from patent law and orphan medicines regulation.

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 as regards 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.euripid.eu/aboutus
(4)Known as CAPR
(5)https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN

Last updated: 7 March 2019Legal notice