By Tobias Luppe
In November 2001, WTO members at a ministerial conference in Doha signed up to a 'Declaration on the TRIPS Agreement and Public Health' which explicitly endorses the right of poorer countries to issue compulsory licences for the manufacture of patent-protected drugs in the face of a threat to public health.
Also at the Doha conference, the TRIPS Council was told to find out, by the end of 2002, how a country can get access to generic drugs if it cannot manufacture them itself. At the end of November, talks on this question broke down, primarily because of the unbridgeable gap between the positions of the United States and the developing countries. Negotiations did resume shortly afterwards.
The problem is Article 31(f) of the TRIPS Agreement, which effectively bans the export of patent-protected products manufactured under compulsory licence. The Americans propose a waiver, whereby all WTO members would refrain, in certain pre-defined cases, from invoking Article 31(f). Because a waiver can be revoked at any time, however, the US solution offers little legal security. In effect, poorer countries would continue to be dependent on the goodwill of the rich WTO members.
The Commission of the European Union (EU) went a step further in the negotiations, but still not far enough. Its proposal was that Art. 31(f) should simply be deleted. Generic drugs could then be freely exported but there would still be a requirement for two compulsory licences - one issued by the country wishing to import the drugs, the other by the country that would manufacture them.
Issuing a compulsory licence is a time-consuming business, however, involving lots of red tape. What is more, experience has shown that poor countries wishing to issue a compulsory licence face intense pressure from pharmaceutical companies seeking to deflect them from their purpose.
Hence the joint call of developing countries and NGOs such as Medecins Sans Frontieres (MSF), who want to see patent protection rolled back in cases where generic drugs are manufactured for export to a third country on grounds of public health.
Because a compulsory licence would only need to be issued by the country wishing to import the drugs, this would greatly simplify licensing procedures. And there would be no absurd situation where the exporting country has to issue a compulsory licence and appraise the health situation in the recipient country to justify it. Moreover, because licence fees would still be paid - although only once and not twice as in the case of the EU proposal - this solution would also safeguard the rights of patent owners.
So it is a good compromise proposal, taking account of both the need for poor countries to get uncomplicated access to essential medicines and the pharmaceutical industry's interest in maximising patent protection. But there is adamant opposition to the proposal at present - especially from the Germans, who point to 'existing material constraints' and insist on acceptance of the EU proposal.
And after some successful backstage manoeuvring by the US pharmaceutical industry, this was watered down even more at the last TRIPS Council meeting. The modified version now proposes freedom of export for only certain pharmaceutical products - and also restricts their manufacture to specific countries. But because there are no such restrictions on countries with the capacity to make generic drugs themselves, this would mean - even under WTO rules - inadmissible discrimination against all other countries.
The Doha 'Declaration on the TRIPS Agreement and Public Health' calls for the Agreement to be interpreted in a way that promotes progress towards the goal of 'medicines for all'. It remains to be hoped that the industrialised nations will take this call to heart and heed it more fully in future negotiations within the TRIPS Council.
As for the German government, it should remember its pledge set out in the coalition agreement: to promote reform of the TRIPS Agreement as a means of improving poor countries' access to essential medicines. - Third World Network Features
About the writer: Tobias Luppe heads the Medicines campaign of Medecins Sans Frontieres. Tobias.luppe@berlin.msf.org
The above article first appeared in D+C (Development and Cooperation) (Vol. 30 No. 1, January 2003).
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