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Agencies urge end to global trade restrictions on essential medicines

Gavin Yamey , BMJ

Intellectual property rights that protect drug patents, enforced by the World Trade Organisation, are preventing access of essential medicines to the developing world, warned an international coalition of health and legal professionals at a conference in Amsterdam last week.

Groups including the medical relief organisation Médecins Sans Frontiàres are calling on the World Trade Organisation to strengthen its provisions to help developing countries in bypassing patent law.

Patent protection of drugs can prevent poor countries from producing cheaper local versions, speakers warned delegates. In Thailand, for example, Pfizer used to be the sole supplier of fluconazole, used in treating cryptococcal meningitis, an opportunistic infection affecting 1 in 5 of the country's patients with AIDS. The company charged a daily price of £8.75 ($14), making the drug largely unaffordable. The market exclusivity on the drug expired in 1998, leading to its local production at 5%of the 1998 price (Lancet 1999;354:1893-5).

The conference examined the impact of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreements on access to medicines. Member states of the World Trade Organisation must abide by these multilateral agreements in trade negotiations. The agreements cover patent law and set minimum standards, such as 20 year patent protection for pharmaceuticals.

Representatives of Médecins Sans Frontiàres argued that there are two major provisions within the TRIPS agreements that could be used by the developing world to obtain cheaper essential drugs. Firstly, TRIPS allows for compulsory licensing, the right for local companies to produce patented medicines in exchange for a royalty payment to the patent holder. Secondly, it allows parallel imports, the legal right to import patented drugs sold more cheaply elsewhere.

Some wealthy countries, however, have attempted to prohibit poor countries from adopting these legal measures, as documented by the Consumer Project on Technology on its website (www.cptech.org). One example occurred when the United States unsuccessfully exerted trade pressure on the South African government to prevent its use of compulsory licensing and parallel imports. The Dutch minister for development, Eveline Herfkens, said: "We cannot accept the kind of bilateral dealings in which one country puts pressure on another. What the Netherlands wants is an open, transparent, multilateral system."

Director general of the World Health Organisation, Dr Gro Harlem Brundtland, said: "Recourse to compulsory licensing is a legitimate measure consistent with the TRIPS agreement."

Candidate drugs for compulsory licensingsuggested by Médecins Sans Frontières Generic drug Public health drug Azithromycin Tachoma Ceftriaxone Bacterial meningitis Ciprofloxacin Shigella (Sd1) dysentery Didanosine (ddI) HIV infection Fluconazole Opportunistic infections Indinavir HIV infection Lamivudine HIV infection, hepatitis B Nevirapine HIV infection Ofloxacin Multidrug resistant tuberculosis Zidovudine HIV infection