by Aileen Kwa

GENEVA - As the 61st annual World Health Assembly gathers in Geneva this week, a major issue that the world's governments are struggling with is patents on medicines, and whether the option to digress from a strict patent system should be endorsed by the United Nations World Health Organisation (WHO).

The United States is the sole country obstructing the ability of the WHO to push for a more flexible intellectual property system, according to several sources. This issue is being negotiated at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).

According to the WHO's website, "developing countries remain largely excluded from the benefits of modern science." IGWG's mandate is "to prepare a global strategy and plan of action on essential health research to address conditions affecting developing countries disproportionately."

IGWG was to have already agreed on its plan of action. However, the controversial issue of intellectual property has prevented consensus, and negotiations remain ongoing. At issue for the U.S. is the further dilution of its desired strict intellectual property system and the interests of its pharmaceutical industry.

"We have some sort of consensus that the WHO should step in and work in the area of intellectual property (in terms of helping countries push for a more flexible intellectual property system)," Thailand's lead negotiator, Dr. Shripen Tantives, said at a panel on Access to Medicines organised by Oxfam Tuesday.

"We think this is a key moment that many countries either developed and developing agree that WHO should do something to improve health in the area of IP (intellectual property). We have these principles in the draft (plan of action). Unfortunately, (complete) consensus is pending because of only one member. Only one member disagrees with the new role of the WHO."

Tantives, who said she was speaking in her personal capacity, noted that since the IGWG process began in 2006, "member states had to make compromises which resulted in some diluted text which will have consequences for the provisions and implementation in the future."

Noting her dissatisfaction with the current text, Tantives said, "(With) what we have now in the IGWG (plan of action) we are not satisfied because if we go into the details, we have to compromise, to delete some very substantive elements."

Ellen 't Hoen of Médecins Sans Frontières (Doctors Without Borders) who spoke at the same panel, said "companies today charge high prices because they have patents. There are two consequences of this patent system. One, R&D (research and development) is directed only where there is a market. Two, access (to drugs) is horribly expensive."

Patents provide companies a monopoly over their knowledge. "If we finance research and development independently from access, we may be getting somewhere."

She described the current system as the "blockbuster model", where pharmaceutical companies build their operations around a few blockbuster drugs or drugs that command very high sales. The result is neglect of the diseases that developing countries' populations suffer from.

"We don't get out of bed if we can't make 1.5 billion dollars per product (per annum). The blockbuster model is not necessarily the way to go."

'T Hoen also said that the Trade Related Aspects of Intellectual Property Rights (TRIPS) and the Public Health Declaration of 2001, where the World Trade Organisation (WTO) declared that TRIPS should not compromise governments' public health objectives, "put access firmly on the political agenda."

Since then, she said, the prices of first generation anti-retrovirals for HIV have come down dramatically. Countries have started issuing compulsory licences (for production of generic versions of patented drugs), as in Thailand and Brazil.

However, "progress is confined (largely) to AIDS-related treatments. What about other diseases and products? Success is on a case-by-case, drug-by-drug basis, and is highly dependent on civil society actions."

In the last two years, she said, Thailand issued compulsory licences for anti-retovirals, and for drugs to fight cancer and heart disease, and the country came under considerable political and economic pressure from the United States.

Speaking at the same panel, Nicoletta Dentico from the Drugs for Neglected Diseases Initiative (DNDi), a non-profit drug development organisation, noted that despite some success stories, the general situation remains bleak. "The 10/90 gap still remains." The 10/90 gap refers to the developed countries accounting for 90 percent of global pharmaceutical sales, whilst accounting for only 10 percent of the 14 million plus global deaths occurring annually due to infectious diseases. Developing countries represent 90 percent of the 14 million deaths but only 10 percent of pharmaceutical sales.

Said Dentico, "When you have nothing except death as the alternative, you may want to use common sense if a drug should be registered (patented) or not. It is important to talk about patents, but look at least at the transition phase at what is lacking in terms of needs."

Can the WHO be a major player in correcting the crisis of the current system? Speaking to IPS on the sidelines of the panel, Oxfam America's Rohit Malpani said that "the WHO is an effective counterweight. It provides advice to developing countries to use safeguards, and it can use its voice to prevent governments from signing up to higher levels of IP. It can assist developing countries by providing studies on the public health consequences of data exclusivity, for example. However, there is resistance from the U.S."

Malpani added, "WTO has already guaranteed countries the ability to override patents in certain circumstances. WHO should be able to provide the advice and technical support. All countries should be able to attain this support. We should not even have this discussion to begin with."
© 2008 Inter Press Service