(2004/C 65 E/016)

WRITTEN QUESTION E-3539/02

by Chris Davies (ELDR) to the Commission

(11 December 2002)

Subject:   Preferential-priced medicines illegally reimported into the EU

Is the Commission aware that significant quantities of not-for-profit medicines destined for African countries are being illegally reimported back to the EU for sale at a higher price? If so, what measures are in place to ensure that current customs controls at EU borders are being effectively implemented, and does the Commission intend to introduce further additional measures to address this growing problem?

Answer given by Mr Lamy on behalf of the Commission

(17 January 2003)

The Commission is indeed aware of the problem of low priced medicines destined for developing country markets that are being imported into the Community.

Importation of medicines coming from third countries into a Member State is subject to the holding of an authorisation as laid down in Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1).

Action against unauthorised importation of low priced medicines is currently only possible for products protected by intellectual property rights. If goods covered by either trademark or patent protection on a Community market are appearing without permission of the right holder, he/she may take action in the national courts against the importer and ensure that the goods are removed from circulation.

The Commission has in the context of the Community Programme for action on communicable diseases and poverty reduction proposed a Council Regulation (2), adopted by the Commission on 30 October 2002, to prevent tiered priced medicines sold to developing countries from entering the Community market. This Regulation, once in force, will enable the customs authorities to detain goods suspected to be tiered priced medicines (whether covered by intellectual property protection or not) at the Community borders until the national authorities issue a decision on the character of the merchandise and the use that can be given to these goods.

The Commission firmly believes that improved means to prevent import of low priced pharmaceuticals to be traded on Community markets, as outlined above, will encourage the pharmaceutical industry and exporters to supply sufficient volumes of essential medicines to poor countries at affordable prices.

(1)  OJ L 311, 28.11.2001.

(2)  COM(2002) 592 final.