WRITTEN QUESTION E-2908/00

by Giuseppe Nisticò (PPE-DE) and Francesco Fiori (PPE-DE) to the Commission

(14 September 2000)

Subject: e-commerce and medicinal products

The Commission's attention is drawn to an extremely delicate subject which the authors have already had the opportunity of discussing directly, albeit informally, with Commissioner Byrne: the sale of medicinal products via the Internet.

This type of commerce is covered by the following European legislation:

- Directive 97/7/EC(1) on the sale of goods by means of distance contracts: Article 14 of this directive offers Member States the option of prohibiting the sale of medicinal products by means of such contracts;

- Directive 97/36/EC(2) on teleshopping, Article 14 of which prohibits teleshopping for medicinal products;

- Directive 92/28/EEC(3) on the advertising of medicinal products.

This directive prohibits the advertising of medicinal products which are available only on medical prescription.

- Medicinal products are not mere consumer products, but substances which affect the health of European citizens, having the power to save lives or improve their quality, but also to produce toxic side-effects which may sometimes even be fatal.

- The public is concerned about the various types of medicinal products that can be purchased electronically, in that no guarantee or certainty is provided with regard to the correct dosage or absence of contaminants; moreover, it is highly unlikely that potentially dangerous interactions with other medicines taken simultaneously by the patient are taken into account.

- The EU has developed its own system for the marketing of medicinal products including the establishment of the EMEA to guarantee their safety, quality and efficacy.

- The global nature of the Internet eliminates national and/or European borders, enabling people to buy not only over-the-counter medicines, powerful and potentially dangerous psychotropics, cardiovascular medicines and hormones, etc. but also medicinal products which have not been approved in the EU, bypassing the safeguards provided by both national and centralised EMEA authorisations.

- Given the above, and that in over 100 countries there are no laws to regulate the marketing of medicinal products, with obvious consequences on the safety, quality and efficacy of such products,

what measures does the Commission intend to take to tackle the problem of the electronic sale of medicinal products? This is particularly important with a view to protecting the health of European citizens and safeguarding the system of marketing authorisations, which guarantees that in Europe only medicines which meet certain criteria of safety, quality and efficacy may be marketed.

(1) OJ L 144, 4.6.1997, p. 19.

(2) OJ L 202, 30.7.1997, p. 60.

(3) OJ L 113, 30.4.1992, p. 13.

Answer given by Mr Liikanen on behalf of the Commission

(23 November 2000)

The Commission is aware of a possible threat to the health of European citizens resulting from the sale of medicinal products over the internet by companies established outside Europe.

Within Europe, a high level of protection is achieved by a number of specific Community directives and national practices governing the authorisation, the advertising and the distribution and sale of pharmaceuticals. 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 and efficient control in the Member State where the online service provider is established, and administrative co-operation among Member States.

However, the global nature of the internet increases the possibility of 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 drugs 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' authorities to address this problem. In this context, the Commission recommends inter alia the promotion of codes of conduct and the possible use of awareness campaigns for consumers.

In summary, therefore, whilst there is no restriction in Community legislation which prevents 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. 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). Such provisions would be the minimum requirements to which an electronic pharmacy operating in the Community would be subject.

(1) OJ L 178, 17.7.2000.