EN Official Journal of the European Union CE 78/893

(2004/C 78 E/0944)

WRITTEN QUESTION E-4016/03

by Salvador Garriga Polledo (PPE-DE) to the Commission

(9 January 2004)

Subject: Free movement of pharmaceutical products in the EU

Freedom of movement for the Union's citizens has enabled numerous citizens of Member States to settle in Member States other than their country of origin, in order to enjoy a more comfortable lifestyle and higher living standards.

This has, however, led to a considerable number of problems. One of these concerns the variations in medicines as between one Member States and another, which means many non-nationals cannot take their usual medicines in their host country for the treatment of physical illnesses, above all those of a chronic nature.

Can the Commission state what possibilities exist for an EU citizen resident in a Member State other than his country of origin to be supplied with his usual medicines in his new host country, via the relevant pharmaceutical establishments?

Answer given by Mr Bolkestein on behalf of the Commission

(20 February 2004)

As a matter of fact, an EU citizen resident in a Member State other than his country of origin may find his usual medicines in his new host country provided those medicines have received marketing authorisation in that Member State or have received a Community marketing authorisation.

In the case of distance selling where the EU citizen concerned would like to have his usual medicines supplied by a pharmacist established in his country of origin, the following must be noted:

— Article 14 of Directive 97/7/EC (1), provides that Member States, in order to ensure a higher level of consumer protection, may introduce or maintain restrictions on the marketing of certain goods or services, particularly medicinal products, within their territory by means of distance contracts, with due regard for the EC Treaty.

— In its recent judgement of 11 December 2003 on Case C-322/01, the European Court of Justice ruled that a national prohibition on the sale by mail order of medicinal products, the sale of which is restricted to pharmacies in the Member State concerned, may be considered as a restriction to the free movement of goods (Article 28 of the EC Treaty). That measure may, nevertheless, be justified by one of the grounds foreseen in Article 30 of the EC Treaty, in particular the protection of the health and life of humans provided that the measure in question is necessary for the effective protection of health and life of humans and that there are no other measures available which are less restrictive of intra-Community trade.

— According to the Court prescription medicines must, for these purposes, be distinguished from nonprescription medicines. Thus, a national prohibition on the sale by mail order of medicinal products, the sale of which is restricted to pharmacies in the Member State concerned may be justified in so far as the prohibition covers medicinal products subject to prescription. However, an absolute prohibition on the sale by mail order of medicinal products which are not subject to prescription in the Member State concerned cannot be justified on the basis of Article 30 of the EC Treaty.

(1) Directive 97/7/EC of the Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts — Statement by the Council and the Parliament re Article 6(1) — Statement by the Commission re Article 3(1), first indent, OJ L 144, 4.6.1997.