TRIPS and the WHO's revised drug strategy

by Someshwar Singh

Geneva, May 19 -- The fifty-second World Health Assembly, currently in session, is to consider a draft resolution that will establish the primacy of the World Health Organization (WHO) in monitoring the pharmaceutical and public health implications of the Trade Related Intellectual Property Rights (TRIPS).

The draft resolution on the 'revised drug strategy' has been a contentious issue - particularly because of international trade agreements such as TRIPS place obligations (in big-industry interests) on countries, particularly those in the developing world, which may actually conflict with WHO's revised drug strategy, which also places obligations (in public interest) on the member states.

While seeking to provide a clear role for the WHO to monitor the consequences of international trade agreements for public health, the new draft resolution also gives the WHO a mandate to assist countries in their efforts to safeguard public health while implementing these agreements.

The draft resolution clearly urges member states of the WHO 'to ensure that public health interests are paramount in pharmaceutical and health policies.'

The WHO revised drug strategy was designed to ensure equitable access to quality, essential drugs and to promote their rational use.

One third's of the world population has no guaranteed access to essential drugs, an poor quality pharmaceutical raw materials and finished products continue to move in international trade.

Inappropriate drug donations, such as donations of expired, mislabelled, unessential products, continue to be common. This is despite the fact that a number of states have adopted guidelines for drug donations that are based on the interagency guidelines issued by WHO.

Last year, in order to address specific constraints on access to drugs, rational use of drugs, and drug quality, the Executive Board of the WHO a resolution (EB 101.R24) on the revised drug strategy. The last World Health Assembly, in May 1998, was invited to consider the resolution.

However, as a result of heavy lobbying by the transnational pharmaceutical industry, backed by the US government, the Health Assembly agreed to establish a drafting group. This drafting group, chaired by Professor J. F. Girard of France, had long discussions but failed to reach a consensus on language for the resolution.

The Executive Board then decided on a two-tier approach - an ad hoc working group was established, open to all member states wishing to participate, with a subgroup to assist WHO in its contact with 'relevant interested partners.'

Both these groups met together 12 to 16 October, 1998. In order to assist them in exploring the complex issues raised by the resolution, a technical briefing was organized, in which relevant interested partners were invited to participate.

The technical briefing covered globalization and pharmaceutical, including the question of how trade agreements could interfere with or support public health, and strategies for ensuring access to pharmaceutical.

Presentations on globalization and pharmaceutical were made by representatives of WIPO, WTO, The South Centre, Health Action International, the International Federation of Pharmaceutical Manufacturers' Associations, and the International Pharmaceutical Generic Alliance. The WHO secretariat made a presentation on the strategies for ensuring access to pharmaceutical.

The ad hoc working group identified a number of new topics not covered by the resolution, which it felt should be the subject of further work by the WHO secretariat, in particular on access to drugs, transfer of technology and local production, new drugs, counterfeit drugs, human resources, and gender issues.

Issues discussed under the topic of access to drugs included supply systems, drug financing, drug insurance, price information and pricing policies, generic drugs, procurement methods, and related matters.

However, 'in order to conclude on the issues in the resolution on which there had been diverging views at the Health Assembly, the ad hoc group decided to concentrate on those topics currently included in the resolution.'

"MSF, together with health Action International and the Consumer Project on technology wholeheartedly support the passage of the resolution on the revised drug strategy," said Dr. Bernard Pecoul of Medicines Sans Frontiers (MSF). "We believe that the resolution helps to address the negative consequences of trade agreements on access to medicines.

Specific concerns about the implications of trade agreements on access to medicines relate to the new global system of regulations on intellectual property contained in the TRIPS agreement, part of the new international trade system administered by the World Trade Organization.

intellectual property is an important mechanism for stimulating research and development, but many NGOs, including those mentioned above, do not consider that these rights should be absolute, especially when a large part of the world's population does not have access to life-saving essential drugs.

"What is the use of having new, effective essential drugs if most people do not have access to them?" says Ellen t Hoen of the HAI team present at the WHA meeting.

"Africa is facing a mind boggling crisis and the world community needs to respond. We need to embrace global rules for sharing the burden of essential medical research and development that explicitly facilitate equitable access to new scientific discoveries. The WHA is showing needed leadership on this issue," said James Love, Director of Consumer Project on Technology.

Meanwhile, in a press statement issued today, seven NGOs have sent a protest letter to the WHO Director General, questioning WHO's increasingly close contact with industry and objecting to the conflict of interest it may cause. The organisations doubt whether WHO will be able to focus on its public health mandate when industry is directly involved in an increasing number of programmes.

Two recent examples of WHO partnership with specific companies are given to illustrate the pharmaceutical industry's possible influence on WHO's priorities. The most recent involves the 'secondment' by Merck, Sharp and Dohme (MSD) to the staff of WHO's Tobacco Free Initiative. An internal MSD announcement portrays the employee as an "effective Ambassador."

The letter also criticizes the process by which controversial guidelines on hypertension were developed by WHO and an international working group. The recommendations, reportedly, conflict with the current evidence-based guidelines on treating hypertension and inappropriately expand the potential market for anti-hypertension drugs.

The NGOs that have endorsed the letter to Dr. Gro Harlem Bruntland have called for 'greater transparency and accountability by WHO in all of its decision-making involving industry partnerships. They have also called for guidelines for co-operation with the commercial sector and said that secondment be excluded as an option for partnership arrangement between WHO and the industry.

Other NGO groups have privately assessed that under Mrs.Bruntland and her "management style", the entire WHO and its programmes have been "hijacked" by the World Bank and the Harvard University groups, and the focus is being shifted to "softer" issues (including tobacco and using a consumer approach) which the US administration of Bill Clinton is promoting. They note that while in cases like tobacco the emphasis is one tackling the problem at consumption end, the US on drug problems wants it to be tackled at the producers end.

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