• Access to medicines and international issues

Access to medicines and international issues

The special declaration on issues relating to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) represents an unprecedented step for the World Trade Organisation (WTO), but what are its implications? This paper, commissioned by Essential Drugs and Medicines (EDM) in the World Health Organisation (WHO), examines the implications of the Doha Declaration for developing countries and the provision of public health.

A background to the Declaration is provided, followed by interpretation and treatment of the Declaration’s provisions. Included in this is an analysis of how Members lacking sufficient manufacturing capacity can make use of compulsory licensing and a presentation of other possible solutions. Other issues coming out of the Declaration are discussed, its legal status is defined and related issues not covered in the Declaration are outlined.

The provisions of the Declaration makes clear the following:

• It applies to all products, methods and technology for health care, not only medicines, as well as all areas of intellectual property covered by the TRIPS Agreement.
• The high price of medicines caused by patent protection is a contributory problem that afflicts developing countries and needs addressing.
• The realisation of public health is a purpose of the TRIPS Agreement and the Agreement can and should be implemented in a manner supportive of the Members’ right to protect public health.
• A public health crisis can represent a national emergency allowing for the granting of compulsory licences, which may continue as long as the underlying situation persists. If contested, the burden of proof lies with the complaining member.
• Effective incentives should be granted in developed countries to foster the transfer of health related technologies to Less Developed Countries (LDCs) including pharmaceutical technologies.
• Grounds for an extension of the transitional period for LDCs applies to pharmaceutical patents only, and in fact in Africa, would only benefit two LDCs.

Implications of the Declaration, and recommendations made include the following:

• Public health-related patents, in particular pharmaceuticals, require different treatment from other patents.
• The Declaration can make it easier for developing countries to adopt measures necessary to ensure access to health care. Whilst it has no specific legal status, it can be argued that it has the same effects as an authoritative interpretation of TRIPS agreement.
• The relationship between the TRIPS agreement and public health policies of Member countries is clarified, and the right of Members to take measures necessary to protect public health is reaffirmed.
• Many countries lack sufficient capacity to manufacture medicines of their own and therefore cannot make effective use of compulsory licensing. In addressing this problem, as the Declaration instructs the Council for TRIPS to do, an effective solution must create the right economic conditions for these countries to obtain pharmaceutical products at low cost.
• A possible solution for countries with insufficient pharmaceutical manufacturing capacity may be to pool their buying power of certain drugs to allow potential suppliers to realise economies of scale.
• The problems faced by LDCs to gain access to needed pharmaceuticals require further consideration.

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