WRITTEN QUESTION No. 3195/98 by Heidi HAUTALA to the Commission. Rules in the EU governing substitute medicinal products and forms of treatment used to help patients overcome drug addiction
Date: 1998-10-27
Institutions: European Parliament, HAUTALA
Subjects: European Monitoring Centre for Drugs and Drug Addiction, World Health Organisation, drug addiction, drug surveillance, health policy, medicinal product, narcotic, psychology, substitute product, therapeutics

C 142/104

Official Journal of the European Communities

EN

21.5.1999

(1999/C 142/128)

WRITTEN QUESTION E-3195/98

by Heidi Hautala (V) to the Commission

(27 October 1998)

Subject: Rules in the EU governing substitute medicinal products and forms of treatment used to help

patients overcome drug addiction

In the European Union there are two almost completely different approaches to helping people overcome
drug addiction.

The first is the officially approved model, which focuses on hospitals and includes monitoring by the
authorities and the controlled prescription of medicinal products.

The second model is based on interaction: it focuses on the patient and places emphasis on the freer
provision of medicinal products and open discussions. In addition, the patient has the right to choose the
doctor and place of treatment.

There are also substantial differences with regard to the availability of the medicinal products used for the
treatment. For example, Buprenorphin (Subutex), the medicinal product used in withdrawal treatment for
out-patients in France, cannot be obtained on prescription in Finland because the authorities regard it as a
drug almost equivalent to heroin and stipulate that it may be prescribed to drug addicts only in certain
places and subject to strict monitoring of the patients and medicinal products. At least 80 drug addicts
therefore travel each month from Finland to France in order to obtain prescriptions for this medicinal
product.

Is the Commission preparing legal provisions to cover the medicinal products used in withdrawal

1.
treatment and in the treatment of drug addicts?

Is the Commission planning to launch investigations into the effectiveness of the various withdrawal

2.
treatments and medicinal products used to help drug addicts in the various stages of their illness?

3. Will the Commission take steps to bring an end to the situation whereby drug addicts receiving
private treatment in many Member States are forced to travel to another Member State in order to obtain
Buprenorphin/Subutex for their withdrawal treatment?

Answer given by Mr Flynn on behalf of the Commission

(11 December 1998)

1. and 3.
Buprenorphin is, together with methadone, one of the medicines used in the treatment of
serious opiate dependence. The placing on the market, indications, rules and procedures for the
prescription of these ‘substitution’ drugs falls within the competence of the national authorities, and
the Commission does not intend to introduce legislation in this connection.

The evaluation of treatments for drug dependence is a priority of the European Monitoring Centre
2.
for Drugs and Drug Addiction which, in collaboration with the organisers of the World Health
Organisation (WHO) programme to combat drug abuse and the COST A-6 programme, organised a
workshop on this subject in March 1997 at which the terms of reference were laid down for the medium
term. In the same connection, the Community action programme on the prevention of drug dependence (1)
sets out the minimum assessment criteria for medical treatment of a psychological or socio-educative
nature.

(1) Decision No 102/97/EC, OJ L 19, 22.1.1997.