Doubts over generic drug scheme

Series Title
Series Details Vol.12, No.7, 23.2.06
Publication Date 23/02/2006
Content Type

Date: 23/02/06

Drugs companies have cast doubts on whether an EU scheme designed to boost access to life-saving medicines in poor countries will attain its objective.

EU governments are expected to approve within the next few weeks a regulation allowing copies of patented medicines to be exported under compulsory licence if they are needed to deal with epidemics or other health crises in certain countries.

The regulation would give effect to a 2003 decision by the World Trade Organization (WTO) providing a waiver from its trade-related intellectual property rights (TRIPS) agreement so that countries with limited manufacturing capacity could import generic versions of certain drugs. Shortly before its Hong Kong ministerial conference in December, the WTO agreed to replace the temporary waiver with an amendment to the TRIPS accord.

But manufacturers of generic drugs and patent-holders are sceptical about what difference the regulation will make.

A spokesman for GlaxoSmithKline said that poor access to healthcare and the emigration of doctors and nurses to earn higher salaries in Europe were bigger problems in Africa than intellectual property issues. According to the spokesman, intellectual property provides no barrier to accessing 95% of the 325 'essential medicines' designated by the World Health Organization.

A generic industry source said that firms in the sector did not seem very excited by the regulation and were only likely to use it if it was commercially viable. The source said that generic firms regard the regulation as cumbersome, though some improvements have been made to it at the request of the European Parliament.

Belgian Liberal MEP Johan Van Hecke, the rapporteur on the dossier, acknowledged that "this regulation will not provide the whole solution" but said that compulsory licensing could help in ensuring a supply of cheap medicines in such humanitarian emergencies as natural disasters.

Seco Gerard from relief agency Médecins Sans Frontières urged the European Commission closely to monitor how the new system was applied. "If it doesn't work, the EU will have to find other ways to ensure access to affordable medicines," she added.

A Commission spokesman referred to a statement made by Peter Mandelson, the trade commissioner, in December, saying compulsory licences for export "will make an important contribution to bring down drug prices in the Third World".

Brendan Barnes from the European Federation of Pharmaceutical Industries and Associations said that since developing countries would "look for suppliers globally in order to get the best price", "the question of whether EU generic firms will participate will depend on whether they are competitive enough to offer better prices than Chinese or Indian firms, for example".

Article reports on negative reactions from the pharmaceutical industry as to whether an EU scheme designed to boost access to life-saving medicines in poor countries could attain its objective.

Source Link Link to Main Source http://www.european-voice.com/
Related Links
European Commission: DG Trade: Trade Issues: Harnessing Globalisation: Access to essential medicines http://ec.europa.eu/comm/trade/issues/global/medecine/index_en.htm
WTO: Trade Topics: Intellectual Property: TRIPS and Public Health: TRIPS and pharmaceuticals - fact sheet http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm

Subject Categories , , ,
Countries / Regions