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Parliamentary questions
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9 January 2019
Question for written answer E-000090-19
to the Commission
Rule 130
Annie Schreijer-Pierik (PPE)

 Subject:  Abuse of the rules governing orphan medicinal products
 Answer in writing 

Regulation (EC) No 141/2000(1) lays down rules on orphan medicinal products. The purpose of the regulation is to encourage the manufacture of medicinal products to treat rare diseases.

In the Netherlands, gaps in the rules governing orphan medicinal products have been exploited by one pharmaceutical company to make an existing medicinal product almost six times more expensive than it used to be. The product is lutetium octreotate, which is used to treat cancer and which has possessed orphan medicinal product status since the end of 2017. In spring 2018, it was bought by a big pharmaceutical company, which then raised its price fivefold. Previously, hospitals had provided the treatment for around EUR 4 000 per infusion. The pharmaceutical company is now charging some EUR 23 000 per infusion for this medicine. A course of treatment consists of four infusions(2).

1. Is the Commission aware that pharmaceutical companies are abusing the rules governing orphan medicinal products in order to make an existing medicinal product significantly more expensive?

2. What measures are taken at national and European level to ensure access to affordable medicines for patients?

3. Can the Commission do anything to combat these excessive rises in prices of orphan medicinal products in the short term, and what action will the Commission take to stop the gaps in European legislation on orphan medicinal products?

(1)Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.

Original language of question: NL 
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