92001E2001

WRITTEN QUESTION E-2001/01

by Concepció Ferrer (PPE-DE) to the Commission

(6 July 2001)

Subject: Distribution of pharmaceutical products in the Third World

Reports have recently appeared in the media to the effect that almost 50 % of pharmaceutical products sent to the Third World are counterfeit or are in a very poor condition.

The reports mention two studies carried out in Nigeria and South-east Asia and coordinated by Aberdeen's Robert Gordon University. According to the studies' findings, 48 % of the pharmaceutical products intended to combat malaria, bacteria and tuberculosis have levels of active ingredients which are either higher or lower than the recommended levels.

The pharmaceutical products analysed in Nigeria come from 12 different countries.

An earlier report by the World Health Organisation found that the quality of 31 % of pharmaceutical products imported into Burma and Vietnam and 46 % of pharmaceutical products produced locally were substandard.

Has the Commission any information regarding these statistics? If so, what action is being taken in the European Union in order to prevent substandard pharmaceutical products from being exported to third-world countries?

Answer given by Mr Nielson on behalf of the Commission

(13 September 2001)

The Commission is aware that the quality of pharmaceutical products on the market in many countries remains a major public health concern and recognises that even if pharmaceutical products are available, weak regulation may mean that they are substandard or counterfeit. Irrational use of pharmaceutical products and globalisation of the pharmaceutical industry are also bringing other safety issues to the fore.

In this regard, it has to be highlighted that all proprietary medicinal products manufactured and used in the Community or manufactured and imported from third countries are subject to tight regulations before marketing authorisations can be delivered. Provisions are laid down in Community directives(1) and guarantee the quality and safety of products. These regulations also apply to medicines exported to third countries.

The Commission's recent Communication on accelerated action on human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), malaria and tuberculosis in the context of poverty reduction(2), also stipulates that the Community will support the development of local production capacity in developing countries and the strengthening of pharmaceutical policy and practice through national and regional co-operation, capacity building and financial and technical assistance. Particular efforts will inter alia be made to improve quality assurance, distribution and optimal use of pharmaceuticals.

The development worldwide of norms, standards and guidelines to promote quality assurance and quality control for the key pharmaceuticals and medicines is an integral part of World Health Organisation's Constitution and mandate.

(1) Second Council Directive 75/319/EEC OJ L 147, 9.6.1975, p. 13.

(2) COM(2001) 96 final.