Under the mandate of the WHO medicines strategy (resolution WHA54.11) and the Revised Drug Strategy (resolution WHA52.19), the World Health Organization (WHO) cooperates with its Member States, at their request, and with relevant organizations to: (1) assist Member States to develop pharmaceutical and health policies related to international agreements; and (2) monitor, analyze, study and report on existing and future health implications of international trade agreements.

WHO policy perspectives on access to drugs

(See above-noted resolutions and Globalization, TRIPS and access to pharmaceuticals, WHO Policy Perspectives on Medicines, No. 3, March 2001)

1. Basic principles and values - The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, as defined in the Constitution of the World Health Organization. Progressive realization of that right involves access to health facilities, prevention, care, treatment and support, including access to medicines. Access to essential drugs depends on: (1) rational selection and use of medicines; (2) sustainable adequate financing; (3) affordable prices; and (4) reliable health and supply systems.

2. Patent protection has been an effective incentive for research and development for new drugs - Protection of intellectual property rights, including patent rights, has supported research and development for new pharmaceuticals. But questions remain as to whether the patent system is sufficient to ensure investment in medicines needed largely by the poor. Strong public involvement and investment is needed to ensure development of needed new drugs for priority health problems of the poor.

3. Affordability of essential drugs is a public health priority - WHO considers it a priority to assess the impact of trade agreements on the affordability of essential drugs, particularly those still on patent. Poorer populations in developing countries cannot afford to pay the same price for newer essential drugs as do the wealthy for newer essential drugs. Differential pricing is now recognised as a means through which prices can be adapted to the purchasing power of governments and households. An April 2001 WHO-WTO workshop observed that differential pricing could be achieved through a combination of factors, which may include market mechanisms, negotiation, bulk purchasing, voluntary licensing, compulsory licensing, and establishment of a flexible global differential pricing system. In addition, WHO supports other measures to improve access to essential drugs, including mechanisms to promote competition, such as: price information; generic policies; reduced duties, taxes, and mark ups; and the application of safeguards contained within the WTO/TRIPS Agreement.

4. Essential drugs are not simply another commodity - TRIPS safeguards are crucial - Patents for pharmaceuticals should be managed in an impartial way, protecting the interest of the patent holder and safeguarding the basic public health principles. Hence, WHO supports WTO/TRIPS-related safeguards, to be applied where justified in accordance with the provisions of TRIPS, to enhance affordability and availability of existing medicines, while not discouraging the development of needed new medicines. These safeguards include setting standards of patentability which reflect public health concerns, legislative provision for compulsory licensing, exceptions to exclusive rights and other measures which promote generic competition, as well as extension of the transitional period. Parallel importation of a patented drug from countries where it is sold more cheaply is widely understood as being a matter of national discretion. WHO recommends that countries assess the public health impacts of the TRIPS Agreement before introducing TRIPS-plus requirements or extending TRIPS requirements to non-WTO Members.

5. Informed country approaches to health and trade - Countries with the least capacity for implementing international trade agreements are most at risk in terms of access to medicines. WHO will continue to provide independent data and technical assistance to countries to help them develop informed approaches to addressing the health implications of trade issues at national, sub-regional and regional levels. WHO advises countries to monitor - carefully - the implementation of the TRIPS Agreement. A network of legal experts who have specialized knowledge and understanding of the public health and pharmaceutical impact of international trade agreements is being developed as a resource for developing countries.

WHO programme of work on pharmaceuticals and trade

1. Policy guidance and information support

Critical among WHO policy guidance is the WHO medicines strategy (Resolutions WHA54.11 and WHA52.19). The Director General's speeches, WHO publications and related documents provide other WHO policy guidance and information support for Member States. The following examples, available upon request through the WHO Department of Essential Drugs and Medicines Policy (EDM) documentation centre, include:

• Globalization, TRIPS and Access to Pharmaceuticals. WHO Policy Perspectives on Medicines. No. 3, March 2001.
• Globalization, Patents and Drugs. An Annotated Bibliography, Second Edition. EDM/PAR/2001.1.
• Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, 2000 (cosponsored by The Rockefeller Foundation, the South Centre and WHO/EDM).
• The TRIPS Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPS Agreement and its impact on Pharmaceuticals. Jakarta, 2-4 May 2000.
• Mission conjointe MSF/OMS/ONUSIDA. Revue de la Politique pharmaceutique au Cameroun. Les Brevets de Médicaments dans les Pays d'Afrique francophone. February 2000, World Health Organization. · Essential drugs in the new international economic environment, Bulletin of the World Health Organization, Volume 77, Number 3, 1999. · Globalization and Access to Drugs - Perspectives on the WTO/TRIPS Agreement, WHO/DAP/98.9, Revised, January 1999.

2. Direct country support and regional awareness meetings

WHO provides direct country support on request, such as briefings on the TRIPS safeguards and advice on the revision of national pharmaceutical legislation. Recent examples include support to China, Iran, South Africa, and Thailand. WHO also sponsors or participates in interregional, regional and national awareness meetings (eg, Association of South-East Asian Nations (ASEAN), Southern African Development Community (SADC) countries, the WHO South-East Asia Region (SEARO) countries and the WHO African Region). Each country's strategy in regard to globalization in the field of the production, distribution and use of drugs will need to be incorporated into its National Pharmaceutical Policy, a component of the National Health Policy.

Examples of planned and completed country and regional support include:

• Intercountry meeting on the TRIPS Agreement and its impact on access and prices of pharmaceuticals in Eastern Europe (Warsaw, September 2001).
• Workshop on TRIPS and the implementation of its safeguards in relation to pharmaceuticals in the WHO African Region (Harare, August 2001).
• Briefing on WHO policy perspectives on globalization and access to medicines for the drug regulatory authorities of Ibero-America (Costa Rica, September 2000).
• Briefing on TRIPS to Ministers of Health of the Member States of the Southern African Development Community (South Africa, June 2000).
• Meeting on the impact of globalization and trade agreements on access to pharmaceuticals, organized by the Directorate General of Drug and Food Control, Ministry of Health, Indonesia, with EDM support (Jakarta, May 2000).
• Joint WHO/EDM-UNAIDS mission to Thailand to provide technical backup to the continuing debate in Thailand on HIV/AIDS-related drugs that are under patent protection (February 2000).
• Joint WHO/EDM-UNAIDS-MSF assessment of the patent situation of AIDS-related drugs in francophone African countries (February 2000).
• At the request of the Chinese Government, EDM mission to provide briefing to Ministry of Health and Ministry of Trade officials on TRIPS (January 2000).
• Continuation of ongoing EDM support to national comprehensive drug programmes (e.g. Bolivia, Brazil, South Africa).

3. Monitoring and analysing the effects of globalization on access to drugs

The public health impact of TRIPS requirements has yet to be fully assessed. Therefore, the WHO medicines strategy (resolution WHA54.11) provides WHO with a mandate to study and report on existing and future health implications of international trade agreements.

3.1 Expert Group: To define standard monitoring tools, methods, and selected indicators to be used periodically over the next five years.

• Experts from four WHO collaborating centres (Brazil, Spain, Thailand and the United Kingdom of Great Britain and Northern Ireland) and other members of the Expert Group met in Thailand in February, 2001. Dr Supachai Panitchpakdi, Director-General Designate of the World Trade Organization, made the opening remarks.
• The WHO collaborating centres' plans of action and the selected model indicators used in monitoring the impact of the TRIPS Agreement on access to essential drugs are guided by four questions:

  1. What is the impact, if any, to the prices of essential drugs under the new IPR regime?
  2. Has there been any impact on the speed with which generic drugs are being introduced?
  3. Are more new drugs for neglected diseases being developed?
  4. Are transfer of technology and direct foreign investment in developing countries increasing or decreasing?