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Parliamentary questions
10 January 2013
E-000199-13
Question for written answer
to the Commission
Rule 117
Marc Tarabella (S&D)

 Subject:  Wonder drug for rare disease sabotaged?
 Answer(s) 

For three years now, the Commission has fought tooth and nail against issuing a marketing authorisation for Orphacol, a drug manufactured by CTRS, which prevents certain death (unless they have a liver transplant, a taxing and expensive operation) for the people affected by the rare disease it is intended to treat. What is striking about this case is that scientists and the 27 Member States have all issued favourable opinions on this drug.

1. The European Medicines Agency (EMA) gave Orphacol the go ahead in 2010 and then again in 2011, the Standing Committee on Medicinal Products for Human Use (Member States) did so in October 2011 and lastly the EU Governments gave it the green light in November 2011. Why, therefore, has the Commission rejected this drug?

2. How does the Commission justify its refusal?

3. Why is the Commission challenging, and denigrating, the positive opinions given by EMA which exists precisely to give expert opinions on matters of this kind?

4. During the past three years, in what percentage of cases has the Commission not followed the opinion given by the EMA?

5. Apparently Asklepion Pharmaceuticals sent a letter to the EU executive arguing against granting Orphacol authorisation. Is it normal practice for one firm to attempt to lobby officially the direct or indirect decision‐makers at the Commission against another firm?

6. Given the number of grey areas and discussions provoked by the question of authorising or rejecting this drug, would it not be in the interest of the EU institutions, the firms mentioned and, in the end, the patient, to refer the whole matter to the European Anti-Fraud Office (OLAF)?

Original language of question: FROJ C 346 E, 27/11/2013
Zadnja posodobitev: 17. januar 2013Pravno obvestilo