91997E2230(01)

WRITTEN QUESTION E-2230/97 by Alexandros Alavanos (GUE/NGL) to the Commission (2 July 1997)

Subject: Effects of the substance ephedrine on public health

The American Food and Drugs Administration has called for checks on all products containing ephedrine since use of the substance has been shown to be responsible for the deaths of 17 people over recent months in the USA and for serious health problems in a further 800. Checks carried out by the Greek Drugs Organization have detected 31 products in Greece which contain ephedrine in quantities that pose a danger.

1. In what circumstances is it permissible to import and use drugs containing ephedrine?

2. Given that scientists differ on this point, at what level is the use of ephedrine dangerous?

3. How does the Commission intend to tackle the problem?

Supplementary answer given by Mr Bangemann on behalf of the Commission (10 November 1997)

Ephedrine, related to the amphetamine family, is an alkaloid of vegetable origin which can be used either to supplement certain diets or as a medicinal product with a wide range of therapeutic indications. As such, it is a stimulant of the cardio-vascular and nervous systems, with known side effects. The American Food and Drugs Administration's checks on products containing ephedrine, following the appearance of health problems related to their consumption, relate solely to food and not medicines.

To date, ephedrine-based medicinal products available in the Community have only received national marketing authorisations, in accordance with the provisions on the quality, safety and efficacy of medicinal products laid down in Council Directive 65/65/EEC of 26 January 1965, as amended, on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products ((OJ 22, 9.2.1965. )). Marketing authorisations must be sought for medicinal products containing ephedrine; they are granted for prescriptions which must observe the constant principle in human medicine of striking a balance between the health benefits/drawbacks of taking the medicinal product.

The importation into Community territory of medicinal products from non-member countries must meet the requirements of Chapter IV of the second Council Directive 75/319/EEC of 20 May 1975, as amended, on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ((OJ L 147, 9.6.1975. )). Use of these products is subject to the provisions on monitoring and pharmacovigilance laid down in that Directive.

Given that, to date, no medicinal product containing ephedrine has been authorised under the new Community procedures, centralised or decentralised, the Commission has not had to pronounce on the concentrations of ephedrine considered dangerous for human consumption.