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This research paper from the DFID Health Systems Resource Centre shows that the laws on Trade-Related Aspects of Intellectual Property (TRIPS) are having a negative effect on health systems in developing countries.

The report brings together findings from seven studies commissioned by DFID on the public health implications of TRIPS for developing countries and the effect it has on access to drugs for poor people. In particular, the studies focus on the policy implications for those developing countries which produce cheap generic versions of drugs, particularly India and China, and those countries whose health systems depend on the supply of these cheap drugs.

The findings include the following:

• TRIPS-related legislation is already having, and will continue to have, a negative effect on public health by increasing prices and decreasing availability of newer drugs.
• India and China have been major suppliers of cheap generic drugs to developing countries. In January 2005 India incorporated TRIPS laws into its patent legislation. Indian generic drugs companies will no longer be able to produce generic version of any new drugs unless compulsory licences or government-use orders are issued.
• There is a risk that companies in India and China will now focus on developing products for conditions affecting richer populations rather than on the neglected diseases which mainly affect the poor.
• A significant degree of flexibility on the application of TRIPS law to pharmaceuticals has been established for developing countries by the 2001 Doha Declaration on the TRIPS Agreement and Public Health and the subsequent decision by the World Trade Organisation (WTO) in 2003. However there are substantial legal and administrative obstacles to implementing these complex procedures in many poor countries. There is in particular a widespread lack of clarity on the options available for lawfully importing generic medicines.
• The existing intellectual property protection laws in many developing countries, such as Kenya and Malawi, is stronger than the minimum required by TRIPS and would preclude these countries from taking advantage of the flexibilities. Moreover, many developing countries are under economic pressure from richer nations to introduce such so-called TRIPS-plus legislation as part of bilateral trade agreements.
• There are some prospects for expanded local production of generic drugs in developing countries focused on supplying regional markets. However this would involve substantial improvements in manufacturing capacity and in the capacity of governments to regulate the quality and safety of new drugs.

The paper argues that action is needed in three broad areas to respond to the challenges posed by the TRIPS legislation and to improve access to medicines. These are information, technical support and advocacy. In particular the paper recommends that:

• Developing nation governments and regional organisations be provided with technical advice on the legislative changes and procedures required for the legal use of TRIPS flexibilities.
• Governments be given assistance to understand the implications of free trade agreements and that TRIPS-plus provisions which are detrimental to public health be discouraged.
• Patent banks and regional collaboration be used to improve information about patents and drug registration.
• The development of efficient, accurate and corruption-free drug regulation be supported and regional harmonisation on medicine regulation be strengthened.
• Advocacy work be carried out with pharmaceutical companies to encourage further investment in low-cost production, non-registration of patents in poor countries, transfer of technology to developing countries and more research into neglected diseases.

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