WRITTEN QUESTION E-0410/98 by Giacomo Leopardi (PPE), Guido Viceconte (PPE) and Elena Marinucci (PSE) to the Commission (24 February 1998)

Subject: Sale of medicines over the Internet

In the USA and several EU Member States, such as the Netherlands, Portugal and the UK, suppliers have emerged who sell medicines over the Internet.

The 50th General Assembly of the WHO adopted a resolution stating that the uncontrolled sale of medicines over the Internet poses a danger to public health and a real risk to patients. An ad-hoc working party is closely following developments in this area.

The following points have been noted in connection with purchases of medicines via the Internet:

1. prescription medicines are dispatched without medical prescriptions having been obtained;

2. products for which prescriptions are not required in the country of origin but are required in the country of destination are supplied;

3 dosage and indication notes are missing;

4. notes are incomplete and make no or inadequate reference to contra-indications and side effects;

5. notes contain incorrect therapeutic indications;

6. products are dispatched after their use-by dates.

Does the European Union already have specific legislation prohibiting such practices?

What action can the Commission take in this area?

Answer given by Mr Bangemann on behalf of the Commission (27 March 1998)

The Internet is a rapidly expanding means of communication in Europe and throughout the world and there is considerable interest in the Community in electronic commerce.

However, because of their nature and the likely risks associated with them, medicines are subject to very strict Community regulations, in particular as regards the marketing authorisation procedure and advertising. The problem of the sale of medicines via the Internet, which is an act of distance selling, must therefore be considered in the light of existing Community regulations.

In accordance with Council Directive 65/65/EEC of 26 January 1965 ((OJ 22, 9.2.1965. )) on the harmonisation of provisions laid down by law, regulation or administrative action relating to medicinal products, a medicine, whether it is produced in the Community or imported, may not be placed on the market of a Member State before the completion of a very strict procedure to guarantee its quality, safety and effectiveness. Any medicine that does not have a national or Community marketing authorisation but is nevertheless on sale within the Community is therefore being sold unlawfully.

Articles 2 and 3 of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use ((OJ L 113, 30.4.1992. )) stipulates that the Member States shall prohibit any advertising to the general public especially of medicinal products which are available on prescription only or for which marketing authorisation has not been granted in accordance with Community law. Since the sale of medicines via the Internet is by definition impossible without 'advertising to the general public' within the meaning of Article 1 of the Directive, the sale via the Internet of medicinal products available on prescription only, products for which marketing authorisation in accordance with Community law has not been granted and products containing psychotropic or narcotic substances is therefore illegal within the Community.

European Parliament and Council Directive 97/7/EC of 20 May 1997 on the protection of consumers in respect of distance contracts ((OJ L 144, 4.6.1997. )) was introduced to strengthen these two texts and Article 14 enables the Member States to prohibit, in the general interest, the marketing of medicinal products by means of distance contracts within their territory.

Furthermore, there is the need to respect the monopoly position enjoyed by pharmacies in some Member States as regards the distribution of medicinal products to the general public, which the Court of Justice ((Case C-369/88, Delattre, [1991] ECR I-1487. )) has ruled to be compatible with Community law.

It is therefore up to Member States which wish to prohibit the sale of medicines via the Internet to take appropriate action within their territory to ensure that the relevant Community legislation is fully applied. Nonetheless, given the global nature of the Internet, the Commission does realise that this problem extends well beyond the Community's frontiers and can therefore only be effectively resolved by means of increased international cooperation. Against this background, the Commission did notably take part in the meetings at which the Member States contributed to the draft resolution now approved by the 50th General Assembly of the World Health Organisation (WHO).