WRITTEN QUESTION E-2618/01 by Alexandros Alavanos (GUE/NGL) to the Commission. Dangers associated with anti-cholesterol drug.
Date: 2001-09-27
Institutions: European Parliament, Provisional data
Subjects: European Medicines Agency, Greece, dangerous substance, marketing, medicinal product, pharmaceutical industry, withdrawal from the market

C 81 E/196

Official Journal of the European Communities

EN

4.4.2002

Answer given by Mr Bolkestein on behalf of the Commission

(17 October 2001)

The Commission(cid:146)s view is that the exemption provided for in Article 13(A)(1)(c) of the Sixth VAT Directive
(Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States
relating to turnover taxes (cid:129) Common system of value added tax: uniform basis of assessment (1)) for the
provision of medical care in the exercise of medical professions applies to both natural and legal persons.

The Commission would point out that the Court of Justice is currently considering an application for a
preliminary ruling on this issue (Case C-141/2000).

(1) OJ L 145, 13.6.1977.

(2002/C 81 E/230)

WRITTEN QUESTION E-2618/01

by Alexandros Alavanos (GUE/NGL) to the Commission

Subject: Dangers associated with anti-cholesterol drug

(27 September 2001)

A number of fatalities have occurred in Greece recently as a result of the side effects of an anti-cholesterol
drug, Cerivastin, sold under the trade name of Lipobay. The press reports that the European Agency for
the Evaluation of Medicinal Products had details of the drug in its possession since April following
notification by the working parties concerned in the Member States.

Did Greece supply the relevant information and did the European Agency inform that country of the
dangers associated with the drug?

Answer given by Mr Liikanen on behalf of the Commission

(7 November 2001)

Information about possible rare but potentially fatal side effects of the anti-cholesterol medicinal product
cerivastatin, sold under the name of Libobay has been available in all Member States for some time. New
concerns about the implications of the available information were raised in April 2001 at a meeting in the
European Medicines Evaluation Agency which was attended by all Member States. This led to a new
analysis of the situation, a detailed discussion with all Member States in June 2001 and a subsequent
decision by all Member States to contraindicate the use of this medicinal product with another medicinal
product, gemfibrozil. The decision, which was expected to substantially reduce the risk of fatalities, came
into effect at the end of June 2001. This was prior to the company(cid:146)s decision to withdraw the product
worldwide.

As far as the Commission is aware, Greece supplied all necessary and relevant information and was fully
involved in the discussions at a European level concerning this medicinal product.

(2002/C 81 E/231)

WRITTEN QUESTION E-2620/01

by Christopher Huhne (ELDR) to the Commission

(27 September 2001)

Subject: Council meeting of 25/26 June 2001

Will the Commission state whether any votes were taken in the General Affairs Council on 25/26 June
2001 and if so, how many and on what matters?

Will it further record the votes of all those who voted on each issue during the meeting?