MEPs ease access to generic drugs

October 25 2007

By Andrew Bounds in Strasbourg
Financial Times

More poor countries will gain access to cheap generic drugs to deal with epidemics after European lawmakers agreed to the ratification of a key world trade protocol, the European parliament said on Wednesday.

The European Union agreed to back full flexibility for poor countries to waive patents to deal with health emergencies such as HIV/Aids and malaria under a 2003 protocol to the trade-related intellectual property (Trips) agreement of the World Trade Organisation.
After months of talks between governments and MEPs, the EU also pledged to exclude protection of intellectual property rights for drugs from bilateral trade deals with poor countries, without defining which countries qualified.

The parliament also set up a €2m ($2.8m, £1.4m) a year fund for technology transfer and research.

“The European Union is not asking, and does not foresee asking, to negotiate pharmaceutical-related provisions, affecting public health and access to medicines,” said a statement agreed with MEPs.

MEPs said this would encourage more countries to follow Rwanda, which is the only country to have used the provision so far.
Gianluca Susta, the Italian Liberal MEP who led negotiations with member states, and Peter Mandelson, the trade commissioner, said: “We won this battle. However, the struggle for real access to medicines against HIV/Aids is still not over.
“Bureaucracy and reluctance from most developed countries are often a major impediment. I am sure there will be other opportunities to come back to this and strengthen our position even further.”

The EU has been embroiled in a high-profile dispute with Thailand, which has forced Sanofi-Aventis, the Franco-German drugmaker, to make a malaria treatment available at cheaper prices to patients of its public health system.
Mr Mandelson‘s spokesman said he would continue to “seek clarification” in such cases, adding that the Commission did not consider Thailand a poor country.

The US and many other developed countries have yet to ratify the protocol because they fear the impact on drug company profits.
The European pharmaceutical industry welcomed the ratification but said compulsory licensing was only part of the solution.
“The main problem of lack of access is not related to intellectual property, so an IP-based solution will not provide the answer,” said EFPIA, the drug companies’ lobby group.

It pointed out that 95 per cent of medicines are not patented. “Where some essential medicines do have patents, voluntary licences have been granted to generic companies in Africa,” it said.

It also said a 2001 industry initiative, the Accelerated Access Initiative, had provided anti-retrovirals to more than 800,000 people living with HIV in developing countries by May 2007.

It is thought to be the first time the parliament has extracted concessions from EU countries over an international agreement. “This is a historic victory,” said Erika Mann, a German Socialist MEP.

Copyright The Financial Times Limited 2007

© Copyright The Financial Times Ltd 2007.