Concern has been mounting for some time now in developing countries over the potential impact of new global trade agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), on access to essential medicines. The passing of a resolution on WHO's Revised Drug Strategy at this year’s World Health Assembly was therefore very timely. “When trade agreements affect health, WHO must be involved from the very beginning”, Director-General Dr Gro Harlem Brundtland told delegates. Rather than allowing trade agreements to limit health care, “we need to analyse and monitor how international agreements can support health,” she stated.
When originally proposed at last year’s World Health Assembly, the resolution caused much debate and was referred hack to WHO’s Executive Board. Lengthy discussion and high-level negotiations involving a working group of 59 countries finally produced a consensus text.
Adoption of the resolution gives WHO the go-ahead to expand its work on a range of issues that affect access, quality, and rational use of drugs.
Fighting inequity in health care
Despite improved global availability, at least one-third of the world’s population still lacks access to essential drugs. In the most impoverished parts of Africa and Asia, this proportion rises to over half.
The inequities are striking. In developed countries, a course of antibiotics can be bought for the equivalent of two or three hours’ wages and one-year’s treatment for HIV infection for the equivalent of four to six months’ salary. And most drug costs are reimbursed. But in developing countries -where drugs costs must often come from the patient’s pocket and are not reimbursed - a full course of antibiotics to cure simple pneumonia can swallow up one month’s wages. Treatment may even be totally out of reach. One year’s HIV treatment, for instance, would consume around 30 years’ income.
Health implications of new trade agreements
In the light of such disparity, the possible impact of international trade agreements on access to pharmaceuticals is understandably a source of much heated debate. Some Member States fear that TRIPS requirements for intellectual property rights protection could lead to a higher cost burden for newer, patent-protected essential drugs, in particular, reducing access to health care yet further. Others argue that TRIPS will stimulate research for needed new drugs.
The 1999 Human Development Report of the United Nations Development Programme points out that before the TRIPS Agreement, countries such as China, Egypt and India allowed patents on pharmaceutical processes but not final products. This had facilitated development of domestic industries using different methods to produce mainly generic drugs, similar to but far cheaper than the original brand names. Denied such flexibility, many developing countries might now find meeting essential drugs needs even harder.
The resolution means, however, that WHO can now act on trade issues. Indeed, it charges WHO with “monitoring and analysing the pharmaceutical and public health implications” of trade agreements. WHO will undertake this work jointly with Member States, the World Intellectual Property Organization, the World Trade Organization, the United Nations Conference on Trade and Development, public interest nongovernmental organizations and industry.
Combating poor-quality and counterfeit medicines
Quality of medicines is also at risk following development of recent alarming trends. Growing numbers of substandard and counterfeit drugs are finding their way onto international markets and local markets. Although global standards for drugs are becoming more demanding, 10-20% of sampled drugs in developing countries fail quality control tests.
In response to these problems, the resolution calls on countries and WHO to expand efforts to ensure effective drug regulation and to promote quality assurance.
Confronting unethical drug promotion
The resolution also highlights unethical drug promotion as an area requiring investigation and action. WHO consultations with stakeholders, and recent research, reveal continuing unethical promotion worldwide. But a comprehensive strategy to implement WHO's Ethical Criteria for Medicinal Drug Promotion can now move rapidly forward.
Further needs identified by the resolution include the provision of price information for pharmaceutical starting materials, tackling inappropriate drug donations, and promoting rational use through independent drug information and consumer education.
A full copy of the resolution can be found at: http://www.who.int/wha-1998/WHA99/PDF99/e_reso.pdf or requested from: Department of Essential Drugs and Other Medicines, World Health Organization, 1211 Geneva 27, Switzerland.