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Parliamentary questions
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16 March 2018
E-007787/2017(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-007787/2017

Kymriah has not yet been authorised in the European Union. A decision on the marketing authorisation thereof will be taken by the Commission on the basis of the opinion of the European Medicines Agency — which is currently assessing the quality, safety and efficacy of this product — and after consultation with the Member States.

The pricing of medicines remains a national competence and the Commission has no role in the setting of prices for the medicinal products that it authorises. Specifically, it is noted that Article 168 of the Treaty on the Functioning of the European Union(1) does not empower the Commission to take decisions on the prices of medicines. Likewise, Article 81 of Directive 2001/83/EC(2) empowers Member States to take actions to ensure appropriate and continued supplies of medicines to pharmacies and authorised distributors under certain conditions but it does not foresee any role for the Commission in this regard.

The case law referred by the Honourable Members refers to the application of the competition rules. The Commission remains vigilant as regards potential breaches of EU competition law and will of course continue to monitor the developments in the pharmaceutical markets. It is also worth noting that the competition authorities of the Member States and the national courts are also competent to apply EU competition rules and depending on the specific circumstances, they may be well placed to tackle a given problem.

(1)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN
(2)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0083&from=EN

Last updated: 7 June 2018Legal notice