• Access to medicines and international issues

Access to medicines and international issues

This study from the South Centre outlines how regional co-operation provides a potential solution to the problems posed to the health systems of developing countries by the Trade-Related Aspects of Intellectual Property (TRIPS) agreement.

The Doha Declaration of 2001 established a degree of flexibility in the application of the TRIPS patenting laws to medicine. This was done to avoid a situation were developing countries would be unable to afford the drugs, particularly very expensive drugs such as anti-retrovirals (ARVs), which their populations needed. However, in practice many developing countries lack the capacity to make full use of this flexibility. The study outlines what these constraints are, and makes a number of recommendations on what can be done to overcome them.

The constraints which countries face include the following:

• Insufficient capacity in the domestic pharmaceutical industry to research, develop and manufacture the cheaper, generic versions of medicines allowed for by compulsory licensing.
• A lack of the technical expertise to incorporate the TRIPS flexibilities into national law and policy, which is a mandatory part of the TRIPS system. This is further exacerbated by the difficulty of gaining access to information on best practices in this area.
• Insufficient technical expertise and infrastructure for regulating medicines which leads to delays in new drugs becoming available for use and to breaches of the TRIPS regulations.
• Difficulties in establishing efficient pharmaceutical management and procurement systems which in turn affects the price, quality and availability of drugs.
• Political pressure from rich countries, particularly the United States, not to take advantage of the flexibilities. This includes bilateral trade agreements which have intellectual property components built in to them and the threat of a complaint being filed against them to the World Trade Organization (WTO).
• Problems tackling anti-competitive practices through which patents and intellectual property rights are abused by manufacturers to retain a monopoly in the market and keep drug prices high.

The study recommends a regional approach to overcoming these obstacles. Using the existing regional frameworks of co-operation between developing countries offers the best opportunity to improve access to essential medicines, services and facilities. This will help developing countries to maximise the use of TRIPS flexibilities through sharing resources and expertise.

The report recommends that the regional economic communities (RECs) in Africa, Asia, Latin America and the Caribbean:

• establish institutions for promoting medical research and innovation on a region-wide basis
• give serious consideration to the viability of developing regional pharmaceutical research and manufacturing capacity
• create region-wide mechanisms for the regulation and control of medicines
• develop suitable mechanisms for co-operation in pharmaceutical management and procurement, including, where possible, developing a procurement system where they would jointly tender and purchase medicine through a central agency
• create regional mechanisms for exchanging information and investigating breaches of competition rules
• use their regional institutions to resist pressure from rich nations and international organisations aimed at preventing them from using the TRIPS flexibilities.

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