WRITTEN QUESTION E-3075/00

by Cristiana Muscardini (UEN) to the Commission

(2 October 2000)

Subject: Electronic sales of drugs

The development of telematics networks has increased the volume of e-commerce. The commodities sold over the internet include drugs, the purchase of which is regulated in every Member State by laws designed to avoid the dangers associated with the use of drugs obtained without a prescription.

1. Who regulates electronic sales of drugs?

2. Who formulates pricing policy in respect of drugs?

3. What impact could this system have on distributors' and pharmacists' turnover?

4. Does the Commission intend to assess the situation and, if necessary, propose measures to reduce the risks connected with using drugs that have not been prescribed by a doctor?

Answer given by Mr Liikanen on behalf of the Commission

(23 November 2000)

The Commission is aware of the possible risk to the health of European citizens resulting from the internet sale of medicinal products especially where those products might be obtained without a prescription.

The authorisation, advertising and sale of pharmaceutical products within Europe is regulated by specific Community directives which apply to the sale of those products by electronic means just as they do to their sale by more conventional means. In addition, the recently adopted Directive 2000/31/EC of the Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce in the Internal Market (Directive on electronic commerce)(1) provides for transparency requirements, efficient control in the country where the online service provider is established and administrative co-operation amongst Member States. Accordingly, an electronic pharmacy established in the Community would be subject to the requirements set out in the legislation described above. Moreover, in the case of provision of pharmaceuticals by pharmacists, the latter are, of course, subject to the rules of conduct of their own professional bodies.

Consequently, whilst Community legislation does not prevent the establishment of electronic pharmacies, such developments in Europe must if they are permitted by Member States meet the terms of European legislation in this area. In particular, these provisions require that patients have access to approved information only; that prescription-only medicines are delivered to patients who can provide a prescription that reflects a meaningful contact with a qualified medical professional and that a qualified pharmacist is responsible for oversight of the dispensing process (when and as foreseen by national legislation).

However, the global nature of the internet increases the potential for the advertising and sale of pharmaceuticals to European consumers by operators from third countries bypassing the protection provided by these Community directives. A considerable amount of work has been taken forward at the international level led in particular by the World Health Organisation with the participation of the Commission and the American Food and drug administration (FDA) to ensure that patients are aware of the risks in using unregulated internet sites. In addition, the Commission has launched work with the Member States to address this problem and also to examine the potential benefits of such systems, in terms of better value for money and a more convenient service to patients. In this context, the Commission recommends the promotion of codes of conduct and the possible use of awareness campaigns for consumers.

Pricing and reimbursement negotiations are the responsibility of the Member States concerned. The procedures adopted for these negotiations need to respect the terms of the Transparency Directive, Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems(2) and to bear in mind the single market dimension of the European pharmaceutical market.

(1) OJ L 178, 17.7.2000.

(2) OJ L 40, 11.2.1989.