By David Cronin for Intellectual Property Watch
The European Union has taken steps to ratify a 2005 decision by the World Trade Organization designed to ensure that intellectual property does not limit access to medicines in developing countries.

Peter Mandelson, the EU’s trade commissioner, announced on 30 November that the Union has formally told the WTO that it accepts a protocol amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This amendment, approved by the WTO in December 2005, is intended to ensure that generic versions of patented medicines can be secured by developing countries that need them for public health reasons, if necessary without the patent-holder’s permission.

Whereas current IP rules generally allow compulsory licensing for the supply of domestic markets, the new amendment should permit any WTO member to export a majority of drugs made under such a licence to a developing country without its own manufacturing capacity. The amendment will make permanent an August 2003 temporary waiver to the TRIPS provision that drugs produced under compulsory licence be predominantly for the domestic market.

“The EU has been at the forefront of the debate in the WTO on access to medicines for developing countries and played a leading role in the negotiations which led to the amendment of the TRIPS agreement,” said Mandelson. “By depositing its instrument of acceptance, the European Union confirms its commitment to help ensure effective access to medicines for developing countries.”

Two-thirds of the WTO’s 151 member countries are required to ratify the decision before it will have legal effect. Before the EU’s announcement, just 13 countries had officially approved the deal, with Hong Kong doing so on 27 November and China on 28 November, according to the WTO tracking of ratifications.

A spokesman for Mandelson said that the EU’s acceptance will count as 28 ratifications – those of its 27 member states, plus the European Union as a whole.

WTO members agreed in October to extend the deadline for two-thirds ratification until the end of 2009. Originally, the end-date for ratification was 1 December of this year.

The EU’s acceptance followed months of wrangling between its main institutions.

Members of the European Parliament (MEPs) had been reluctant to approve the decision, with some of them claiming it may be too complex for developing countries to use.

But the Parliament eventually gave its assent last month, after winning several assurances from the Commission and EU governments. These included a commitment that EU countries would not be prevented from exporting generic medicines to developing countries.

Swedish Green MEP Carl Schlyter said that making use of the 2005 decision to increase access to medicines is “bound to be complex.”

“This is a written exemption to a patent right, where the patent right has dominance,” he added.

Schlyter raised concern over indications that the EU wishes to limit the application of the 2005 deal to the world’s poorest countries. During the summer Mandelson wrote to Thailand, which is categorised by the United Nations as a middle-income country, arguing that the Bangkok government could damage the international patent system if it resorted systematically to compulsory licensing in cases where it deemed the price of a medicine to be too high. Thailand has issued compulsory licenses for three drugs used to treat AIDS and heart disease.

“Where I really disagree with the Commission is that it wants to limit this to least-developed countries,” said Schlyter. “Middle-income countries have serious health problems, too.”

The world’s 50 least-developed countries are not required to respect the provisions of TRIPS until 2011. But the same transition period does not apply to many slightly better-off developing countries.

Alexandra Heumber, an access to medicines campaigner with the humanitarian group Médecins Sans Frontières (MSF), said it is vital that the EU’s ratification will boost the supply of essential medicines to the poor. She called on the Union to support efforts at the World Health Organization (WHO) to introduce an international system which makes it easier for developing countries to import generic medicines.

Last year the WHO published a report suggesting that unless there is greater clarity around some of the surrounding issues, patents likely will still be used in a way that continues to deprive the poor of potentially life-saving medicines. Industry has been participating actively in the effort to help address the gap in the system.

The WHO has set up an intergovernmental working group (IGWG) on public health, innovation and intellectual property rights. IGWG is scheduled to present a plan of action during 2008 (IPW, WHO, 10 November 2007).

“If there is strong public support for the use of flexibilities under TRIPS, then access to medicines will become a reality,” said Heumber.

Earlier this month, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said that the international IP system should not be weakened as it could harm drug innovation.

“It is the same IP system that has produced most of the medicines that are now used to treat European patients,” said EFPIA’s Brian Auger. “Our challenge is to find ways to complement it so that global innovation efforts are more relevant to the needs of the developing world.”

Drug firms say that they are now conducting 50 research and development programmes for medicines destined for developing countries, compared to 43 at the end of last year.

In a new report, Oxfam accuses the pharmaceutical industry of being “narrow-minded” by seeking a high level of patent protection in developing countries. Oxfam was particularly critical of the unsuccessful legal challenge mounted by the multinational firm Novartis to a decision by the Indian Patent Office to reject its application for a patent on Glivec, a leukaemia treatment.

Oxfam also alleged that the pharmaceutical industry is pressuring the EU to insert clauses on intellectual property in free trade agreements it is negotiating with developing countries. “High levels of intellectual property protection have not resulted in new cures for diseases that affect poor people,” said Helena Vines-Fiestas, author of the Oxfam report, which cites UN estimates that nearly 2 billion people in developing countries are deprived of essential medicines.

David Cronin may be reached at info@ip-watch.ch.