David Cronin
BRUSSELS, Oct 30 2007 (IPS) – The struggle to make medicines affordable to the world s poor, especially in Africa, is raging on at the highest levels. Last week the European Commission took a landmark decision on generic drugs and next week a high-level intergovernmental meeting will look at ways to prevent patents from blocking access to drugs.
In an agreement announced last week (on October 23), European Union (EU) governments were told that they are free to make available generic versions of patented drugs for export to poor countries which lack their own manufacturing facilities.
And next week, between November 5 and 10, a little-known group the intergovernmental working group (IGWG) on public health, innovation and intellectual property rights will meet in Geneva, Switzerland, to work on a plan of action.
This follows a 2006 World Health Organisation (WHO) report which found that unless there is greater clarity about some of the surrounding issues, patents will still be invoked by drug firms in a way that continues to deprive the poor of potentially life-saving medicines.
The humanitarian group Médecins Sans Frontières (Doctors Without Borders or MSF) is urging EU representatives to play an active role in framing this blueprint.
In last week s decision, the EU s executive, the European Commission, has undertaken not to hinder any of its 27 member states if they should decide to produce generic drugs as cheaper alternatives to patented drugs. The latter are normally too expensive for the vast majority of people in poor countries.
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The accord was reached between members of the European Parliament (MEPs) and representatives of EU governments and the Commission. It will allow the Union ratify a World Trade Organisation (WTO) decision officially designed to increase the supply of medicines to poor countries.
The decision will give permanent effect to a 2003 waiver from the WTO s Trade Related Intellectual Property Rights (TRIPS) agreement. The waiver was designed to allow poor countries which lack production capacity to address public health emergencies by importing cheap generic versions of patented drugs produced under a compulsory licence.
The EU decision was originally made in December 2005 but MEPs had declined to approve it until they won concessions from the other main EU bodies.
As part of the agreement, the Commission has also undertaken not to insert any intellectual property provisions specifically related to pharmaceuticals in the free trade deals known as economic partnership agreements (EPAs) which are currently being negotiated with the almost 80 African, Caribbean and Pacific (ACP) countries.
Yet, while campaigners for access to medicines have applauded the deal, they point out that other measures must ensue if the severe shortage of essential drugs in Africa is to be reduced.
The United Nations has estimated that 25.8 million people were HIV positive in sub-Saharan Africa in 2005. In Tanzania, Ethiopia, Ghana, Lesotho, Mozambique, Nigeria, Tanzania and Zimbabwe, 90 percent of those who needed the anti-retroviral drugs (ARVs) to treat AIDS could not obtain them.
Price is a major factor behind lack of access. Generic competition has helped to lower the price of a yearly supply of ARVs to 99 dollars per person down from 15,000 dollars six years ago. Yet the second-line treatments needed by people who have developed resistance to their previous prescription are often several times more expensive than the older drugs in Africa.
We won this battle, proving that it is crucial for the European Parliament to be united, said Italian Liberal Gianluca Susta, one of the MEPs who negotiated the deal.
However, the real struggle for access to medicines against HIV/AIDS is still not over. Bureaucracy and reluctance from developed countries are often a major impediment. I am sure there will be other occasions when we have to return to this and reaffirm our stance, said Susta.
Despite the assurances given by the European Commission that it will not insert provisions inimical to public health in the EPAs, concerns remain about other clauses related to intellectual property which are contained in draft EPAs prepared by EU officials.
Many African countries are not currently focused on intellectual property in the EPA talks, given that the Commission has revised a plan to have comprehensive deals finalised by the end of this year. On October 22, the Commission signalled that EPAs signed during 2007 will instead be mainly limited to trade in goods, leaving discussion on other issues to a later date.
Still, analysts have questioned why some of the intellectual property clauses suggested by the Commission for the EPAs are almost identical to provisions in EU law. Some argue that applying stringent rules in this area will not be conducive to industrial development in Africa.
It s really not necessary to include IP (intellectual property) provisions, said Fleur Claessens from the non-governmental organisation the International Centre for Trade and Sustainable Development in Geneva. We would like to keep them out of the EPA debate.
But an African diplomat involved in the negotiations said he believed that better copyright rules than those now applying are necessary. Nobody wants to flout intellectual property rules outright, said the diplomat, speaking on condition of anonymity.
If an inventor comes up with a telephone and sees a photocopy of it the following day, that s not good. The kind of intellectual property rights you have in Europe will not be good for us. What will be good for us is something we decide ourselves, the diplomat said.
Commenting on the two developments, MSF campaigner Alexandra Heumber told IPS that from a political point of view, it s really good that the European Parliament has accepted the deal. It shows that MEPs have been very committed to access to medicines.
On the other hand, the EU needs to change the system because we see that the patent system is insufficient in providing medicines to developing countries. The EU must adopt a pro-public health policy in the IGWG, Heumber said.
MSF is pushing for an international fund to finance research and development on neglected diseases. Just 1 percent of the nearly 1,400 new medicines approved between 1975 and 1999 were for treating tropical ailments and tuberculosis, despite these diseases comprising 10 percent of the world s disease burden .
Another idea being discussed is that of pooling patents, whereby drug firms would agree to combine their patents and license them to one another or to third parties. Such an approach to intellectual property is already common in the technology field, for example where common standards are required for DVDs or for audio and video files on the internet.
The WHO is exploring whether it could host an international patent pool system under which agreements would be negotiated between pharmaceutical firms and governments in poor countries.
