The World Trade Organization (WTO) held a "mini-ministerial" meeting in Sydney, Australia, last week, to resolve by the end of the year how poor nations can get access to cheap drugs. The meeting focused on the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), which governs the content of domestic patent law and how it influences access to pharmaceuticals.
Last year in Doha, Qatar, the WTO softened the impact of TRIPs with the "Doha Declaration", which states that during a national emergency - such as "HIV/AIDS, tuberculosis, malaria and other epidemics" - it is permissible for a country to grant a compulsory license to a local "third party" manufacturer to supply a drug for domestic use despite the drug being under patent.
However at Doha it was recognised that countries without manufacturing capacity would face difficulties in making any use of compulsory licensing provisions. The WTO has set itself the task of cracking this problem by the end of the year.
Oxfam and MSF have called for a further Declaration that would expand TRIPS's article 30, which allows countries to provide limited exceptions to the rights conferred by a patent. This would permit generic drug manufacturers to produce drugs solely for export to countries that had issued a compulsory license. Production for export conditions would be defined under national law as an exception to the rights of patent holders. This plan is supported by India and Brazil.
The European Parliament has similarly recently amended a directive issued in 2001 to state that manufacturing should be allowed if the medicinal product is intended for export to a third country that has issued a compulsory license for that product, or where a patent is not in force and if there is a request to that effect of the competent public health authorities of that third country.
However, the USA has instead proposed that there simply be a long-term waiver against bringing disputes to the WTO for breach of TRIPs in these circumstances. However, waivers are inherently unreliable and on this basis drug firms are unlikely to produce drugs in large supplies.
A third option is a short-term waiver and an amendment to one of the numerous conditions of a compulsory license prescribed under article 31 of TRIPs. Article 31(f) requires that any compulsory license authorise the supply of drugs mainly for the domestic market of the country issuing the license. The amendment would allow the export of drugs to countries without a manufacturing base. Critics say that this would continue to make countries in need of drugs reliant upon the exporting country. Also case-by-case approval would be necessary, as would the satisfaction of the other bureaucratic and complex requirements of article 31.
Inside US Trade, a trade newsletter, has reported that the USA had favoured the exclusion of advanced developing countries from qualifying as importing countries and had originally advocated that developing countries alone be eligible as producers.
Whatever option is settled upon, the TRIPs Council must reach a solution during their meeting in Geneva on Nov 25-27.
Oxfam and MSF have called for a further Declaration that would expand TRIPS's article 30, which allows countries to provide limited exceptions to the rights conferred by a patent. This would permit generic drug manufacturers to produce drugs solely for export to countries that had issued a compulsory license.