Patent protection versus public health

Abstract

On October 24, Tommy Thompson, Secretary of the US Department of Health and Human Services, and Helge Wehmeier, president of the Bayer Corporation, announced the federal purchase of 100 million tablets of ciprofloxacin (Bayer's Cipro) at half price. This emergency price cut was agreed after the US government threatened to override Bayer's patent on Cipro. The US government's action was sparked by the Canadian health ministry's decision to commission a local drug company to make ciprofloxacin, violating Bayer's patent rights. Bayer responded by donating a large amount of Cipro to Canada, and promising more in the event of an emergency, which led the Canadian government to agree to acquire ciprofloxacin exclusively from Bayer for the duration of the patent agreement. No new anthrax cases have been reported in Canada, yet the threat to public health was deemed enough for the Canadian government to challenge Bayer's patent rights. Events in the USA after September 11 have proven the bioterrorist threat to be real with documented cases of anthrax, but it is hard to justify the need for patent challenge on public-health emergency grounds, especially because the anthrax isolates seem to be sensitive to doxycycline. Bayer's patent for Cipro is protected by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which sets minimum standards of patent law for member states of the World Trade Organisation. Under TRIPS, patent protection lasts for 20 years, although compulsory licensing (production of medicines by companies other than the patent holder) is allowed in public-health emergencies or where there are unfair pricing practices. The US government's action on Cipro is in stark contrast to US trade pressure on less-developed countries to limit compulsory licensing and parallel importing (importing of medicines from countries other than the country of manufacture). Parallel importing is also allowed under TRIPS, and is, like compulsory licensing, widely practised by western countries. Even where there is clear evidence of a public-health emergency, such as the HIV crisis in Africa and many parts of Asia, the US government has used its might to limit those countries' options to provide affordable drugs. For example, in 1998, under threat from the USA to increase tariffs on imports of wood products and jewellery, the Thai government limited the right to issue compulsory licences for Pharmaceuticals. Last year, the US government filed a complaint with the World Trade Organisation over a law that enabled Brazil to produce cheap generic versions of antiretroviral drugs, stating that Brazil's patent law broke the TRIPS agreement. The number of AIDS-related deaths in Brazil has halved since 1995, partly due to the availability of cheap antiretroviral drugs. In June of this year, the US government retracted its complaint, after outcry from international aid agencies. In April, after a 3-year lawsuit, the Pharmaceutical Manufacturers Association of South Africa and 39 international drug companies dropped action to prevent the South African government from importing cheaper drugs for HIV and AIDS. TRIPS allows such imports but it took this case to prove that the AIDS epidemic, which has now affected more than 58 million people worldwide, killing 22 million, is of sufficient proportion to warrant recognition as a public-health emergency in TRIPS terms. Clarification of and changes to the TRIPS agreement to favour public-health needs over patent protection are urgently needed and have been called for by aid agencies and less-developed countries on the eve of the World Trade Organisation summit to take place in Qatar on November 9–13. So far, however, the US government, backed by Japan, Switzerland, and Canada, is opposing change. In June at the UN General Assembly Special Session on HIV/AIDS, the USA pledged $200 million for a global AIDS fund, which was judged by many as a paltry sum. A task force to ensure a “comprehensive and coordinated effort” by the USA to combat AIDS was announced, chaired by Secretary of State Colin Powell and Tommy Thompson. It is time that the US government recognised that a “comprehensive and coordinated effort” means that public-health needs may have to override trade profits, and that putting money into a fund while doing its utmost to prevent life-saving treatments reaching those who need them is duplicitous. The US government should apply the same standards abroad as at home in defining what is, or is not, a public-health emergency.