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Parliamentary questions
PDF 5kWORD 19k
6 December 2018
E-006153-18
Question for written answer E-006153-18
to the Commission
Rule 130
Ivo Belet (PPE)

 Subject:  Abuse in the manufacturing of orphan drugs

Regulation (EC) No 141/2000(1) lays down rules for what is known as orphan medicinal products. The purpose of the regulation is to encourage the manufacturing of medicinal products for rare diseases.

Pharmaceutical companies may obtain a 10-year monopoly on the manufacturing of a specific orphan drug, to offset the high costs of research, inter alia. The regulation, however, allows existing medicinal products to be used for the treatment of rare diseases, and therefore to be recognised as orphan medicinal products.

This means that manufacturers are free to push up the price of existing drugs. This is, for instance, what happened with CDCA, a drug that is used for treating the metabolic disease CTX.

CDCA has been considered as an orphan drug since 2016. Due to the monopoly that was granted for the production of this drug, the price is 500 times more expensive in a few years, making it unaffordable for many patients.

Is the Commission aware of such practices?

Does the Commission agree that this practice is not in accordance with the purpose of Regulation (EC) No 141/2000?

Will the Commission take action to stop this situation in the short term, and does it intend to take steps to amend the existing legislation?

(1)Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).

Original language of question: NL 
Last updated: 19 December 2018Legal notice