The marketing authorisations of those medicinal products were harmonised by a Commission decision of 1996 following the opinion of the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products. In that decision, the Commission, concurring with the CPMP opinion, stipulated in particular that the duration of treatment with those products was not to exceed three months owing to the serious risks associated with their prolonged use. It considered that, within that limit, those medicinal products had sufficient efficacy and a favourable benefit/risk balance.

On 9 March 2000, the Commission ordered the withdrawal of marketing authorisations of medicinal products for human use containing, inter alia, the anorectic agents referred to above. It based its decision on the scientific conclusions issued by the CPMP in 1999, following a reevaluation of those substances: they are now considered to lack efficacy according to the new scientific criterion of long-term efficacy of anti-obesity drugs.

The Community code relating to medicinal products for human use reproduces the provisions of the directives governing the decentralised Community authorisation procedure. In particular, that code:

*    provides that the marketing of a medicinal product in a Member State is conditional upon the issue by the competent authority of that Member State of a marketing authorisation, which is valid for five years and renewable;

*    lays down the conditions of efficacy and safety according to which the competent authority can grant, suspend or withdraw a marketing authorisation;

*    establishes a mutual recognition procedure for national marketing authorisations which has been mandatory since 1 January 1998, together with Community arbitration procedures;

The Court of First Instance first addressed the Commission's competence in the matter. It found that, as regards national marketing authorisations, consultation of the CPMP is purely optional.

The principle that the Community is to act within the limits of the powers conferred upon it implies that the Member States are not deprived of their competence _ in respect of any subsequent decision to withdraw the national marketing authorisations of a medicinal product, where those authorisations have been harmonised _ following a non-binding CPMP opinion. Therefore, the Commission was not competent to adopt the contested decisions.

The Court of First Instance also considers that even if the Commission had been competent to adopt the decisions, they would nevertheless have had to be annulled because the condition for withdrawal of a marketing authorisation on the ground of lack of efficacy of the substances in question, on which the decisions are based, has not been met. The general principle that precedence must be given to the protection of public health requires:

*    the taking account exclusively of considerations relating to health protection;

*    the reevaluation of the benefit/risk balance of a medicinal product where new data give rise to doubts as to its efficacy or safety, and

*    in cases of scientific uncertainty, the application of the rules of evidence in accordance with the precautionary principle

On the benefit/risk balance, the Court of First Instance points out that if the therapeutic effects which justified a marketing authorisation, despite certain undesirable effects, cease to exist, the marketing authorisation must be withdrawn.

Third, the precautionary principle requires the competent authority to suspend or withdraw a marketing authorisation where there are serious doubts as to the safety or the efficacy of the medicinal product.

The CPMP and the Commission have expressly acknowledged that the CPMP opinions of 1999 and the Commission decisions of 2000 were based on medical and scientific data which were strictly identical to those taken into consideration in the CPMP opinion of 1996 and the Commission decision of the same year. In addition, the assessment of the acceptable risks has not changed.

In those circumstances, the Court of First Instance finds that the Commission decisions on anorectic agents must be annulled.