The drugs deal

Print edition : September 26, 2003

JUST prior to the Doha Ministerial Conference, World Trade Organisation Director-General Mike Moore identified the contentious issue of access to essential medicines as a potential deal breaker. It took days of heated debate at Doha and lobbying efforts by diverse advocacy groups, to obtain a declaration that did little more than state an obvious ethical verity: that nothing in the trade-related aspects of intellectual property rights (TRIPS) agreement enshrined in the WTO should be interpreted as a barrier to the right of the needy to essential medical treatment.

In principle, it was agreed that the WTO would not impede the right of any member-country to license domestic production of any drug to meet a health emergency. The problem arose with countries that lacked the manufacturing capacity and faced serious medical care demands. On August 30, close to two years since the Doha declaration seemingly signalled that the WTO was about to acquire a kinder and gentler face, negotiators in Geneva agreed on a deal that would govern the scope of this relaxation of intellectual property rules.

The agreement is closely modelled on a text circulated in December by the Mexican Ambassador to the WTO and TRIPS Council Chair Eduardo Perez Motta. It comes with a clarification and an introductory statement by the Chair of the General Council Carlos Perez del Castillo, which is intended to provide the requisite degree of comfort to the United States and the various drug companies that it was fronting for at the WTO.

On the positive side, the mass of the WTO membership has been able to hold firm against the U.S. insistence on limiting the scope of the new agreement to cover only specific diseases, like HIV/AIDS, malaria and tuberculosis. It has also refused to take on board the high-level thresholds like "infectious epidemics" or "emergencies" that the U.S. was urging should be the sole circumstances that could be construed as triggers for the use of the special licensing provisions.

Where the WTO membership has been unable to hold off U.S. pressure has been in the procedures that would be adopted in licensing the manufacture of essential drugs and the strict supervision under which the distribution and application of these medicines would be conducted. Eligibility is restricted in the first instance to the least developed countries. Other developing countries would also be able to avail themselves of the special provisions, but only after notifying the TRIPS Council and explaining the special exigencies that compel such recourse.

Once eligibility is established, each import of essential medicines - its quantity and duration - would have to be notified to the TRIPS Council. Both the importing and exporting member would be under binding legal obligations to ensure that there is no diversion of the material produced under special provisions to any other use. And the medicines so produced should be colour-coded and each unit shaped in a manner that distinguishes it from the ordinarily available patented variant.

Much of this amounts to imposing a cost penalty on generic drug manufacturers, who depend upon large volumes and standardised dosages to attain their economies. Unsurprisingly, many of the advocacy groups that led the global campaign for access to essential medicines, reacted to the deal at Geneva with dismay. The deal was "designed to offer comfort to the U.S. and Western pharmaceutical industry", said Ellen t'Hoen of the Nobel Prize-winning group Medecins Sans Frontieres. "It poses so many hurdles and hoops to jump through that we are really worried it may not work at all." The U.K.-based charity Oxfam was equally dismissive: "What members do not seem to take into account is that the burdensome system being put in place does nothing to ensure that generic production will happen in the future."

In their last phase, the negotiations on TRIPS and public health were conducted among the U.S., which spoke for the drug companies, Brazil and India, which represented the promise of generic drug manufacturing, and South Africa and Zambia, which put forward the case of the intended beneficiaries. On its presentation to the full WTO membership, the Philippines and Thailand demanded certain further clarifications. It seemed that a last-minute glitch could hold up the deal. But the stakes were clearly too high and the WTO membership realised that a failure to agree on this area would cast a long shadow over Cancun. Agreement was quickly sealed and the world trade body set at liberty to move on to other equally contentious arguments.

This article is closed for comments.
Please Email the Editor