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US choke point for WHO

By Aileen Kwa

May 23, 2008 - GENEVA - Developing countries desperate to secure cheaper medicines for their populations, particularly for those suffering infectious diseases, will do battle in Geneva this week with the United States as the sole holdout against developing a more flexible global patent system.

The US is obstructing the ability of the World Health Organization to push for a more flexible intellectual property system, according to several sources. The issue is being negotiated this week at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) at the 61st annual United National World Health Assembly in Geneva.

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."

The general situation remains bleak despite some success stories, Nicoletta Dentico, from the Drugs for Neglected Diseases Initiative (DNDi), a non-profit drug development organization, said at a panel on Access to Medicines organized by Oxfam on Tuesday.

"The 10/90 gap still remains," she said. The 10/90 gap refers to the developed countries accounting for 90% of global pharmaceutical sales, whilst accounting for only 10% of the 14 million plus global deaths occurring annually due to infectious diseases.

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."

IGWG was to have already agreed on its plan of action but a consensus has yet to be achieved on the controversial issue of intellectual property. At issue for the US 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, Shripen Tantives, said at the Access to Medicines panel.

"We think this is a key moment when many countries, 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 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, that with "we are not satisfied" with what was now in the IGWG plan of action "because if we go into the details, we have to compromise, to delete some very substantive elements."

Ellen 't Hoen of Medecins Sans Frontieres, 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, 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 US$1.5 billion 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 Organization declared that TRIPS should not compromise governments' public health objectives, "put access firmly on the political agenda". TRIPS is an international agreement reached in 1994 that sets minimum standards for many forms of intellectual property regulation.

Since 2001, she said, the prices of first generation anti-retrovirals for HIV, for example, have come down dramatically. Countries have started issuing compulsory licenses 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 past two years, she said, Thailand had come under considerable political and economic pressure from the United States after the Southeast Asia country had issued compulsory licenses for anti-retovirals, and for drugs to fight cancer and heart disease.

Can the WHO be a major player in correcting the crisis of the current system? Speaking to Inter Press Service 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 US."

Malpani said the 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."


Reproduced with permission - Asia Times Online ("

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