Home > IP Topics Index > The Policy and Legal Environment for Innovation > Developing Countries and TRIPS: What Next? > Editor's Summary, Implications and Best Practices

The Agreement on Trade Related Aspects of Intellectual Property (TRIPS) mandates minimum IP protections for patented pharmaceutical products. Its effects on innovation, research and development, and product availability in low- and middle-income countries is vigorously debated. Based on a meeting held in New Delhi, India, that was convened by the Indian Council for Medical Research and MIHR in December 2005, this chapter ponders whether TRIPS will positively or negatively affect health in developing countries. It concludes that this will largely depend on how countries respond to the new IP regime.

Measuring the impact of TRIPS on innovation is an unwieldy task because of the numerous variables in play. But the chapter does note that foreign investment increases when IP protection is strengthened. The most urgently asked question is whether TRIPS will increase prices and restrict access for patented drugs. The authors candidly observe that it is too early to tell, and they strongly urge that post-TRIPS drug prices be closely monitored. They also note that drug access for non-patented drugs is itself uneven—price does not seem to be the only determinant affecting access. Moreover, the kinds of drugs that are provided should also be considered when evaluating the impact of TRIPS. The availability of new, innovative medicines is part of the new IP regime’s promise.

IP management skills appear to be the crucial element for harnessing the power of TRIPS, and such skills will allow developing countries to gain access to emerging tools, technologies, and resources that can dramatically improve the health and welfare of their citizens. For example, private industry in India is not automatically channeling its resources into the research and development of drugs for diseases that dominate in developing countries; instead, it is focusing on robust markets for health conditions in developed countries. Therefore, in India the public sector should orchestrate health solutions for diseases that predominantly afflict the poor. Effective IP management can allow public research institutions to use their own research products to benefit the poor and to enter into public-private partnerships that can direct the power of industry to the needs of the poor. Without knowledge of sophisticated IP management techniques, however, such efforts—and their benefits—will be impossible.

Finally, the chapter discusses the possible role of compulsory licensing and parallel trade to ensure that the health needs of people in developing countries are met. These flexibilities in TRIPS are valuable but complicated and should be considered in the context of all of the options available to TRIPS member countries for ensuring health security.

Overall, the chapter contends that countries have considerable freedom to control the effects of TRIPS on the availability of new health technologies by building capacity for IP management and by formulating policies and practices for courts, patent offices, and other institutions that will be pro-poor.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Countries have considerable freedom to control the effects of TRIPS on the availability of new health technologies. This can be done most effectively by building capacity for IP management and by formulating policies and practices, for courts, patent offices, and other institutions, that favor the poor.
• Product development partnerships (PDPs), having forged effective strategies through which industry can invest and apply its expertise to address the needs of the poor, are now driving the drug development pipeline in neglected disease R&D. PDPs represent a pioneering new institutional structure, and may become increasingly prevalent for developing products for less viable markets.
• National governments should promote policies and capacities that facilitate these innovative partnerships, which include effective clinical trials and ethical review capacities, appropriate regulatory bodies for clinical research and product approval, and national and institutional IP policies that stimulate health and agricultural R&D for national benefit.

For Senior Management (university president, R&D manager, etc)

• Product development partnerships (PDPs) have mobilized substantive new resources into R&D for global health. They are a significant source of potential R&D support for non-profit R&D and academic institutions, both in industrialized and developing economies.
• R&D institutions in disease endemic countries can contribute critically to health and agricultural innovation through public-private partnerships at the local and international level, both through their scientific expertise and their unique research resources.

For Scientists

• To become viable partners, scientists should be able to understand, recognize and protect IP assets.
• Links between product development partnerships (PDPs) and scientific communities in disease endemic countries should be strengthened. These communities can provide essential contributions to the drug development pipeline, from pre-clinical and clinical development through operational research to preparing for access and patient adoption.
• It is important to increase international awareness of the research capacities within disease endemic countries and their unique resources (for example, patient cohorts, traditional medicinal plants) through active dissemination and outreach. Scientists can provide critical input for this process.

For Technology Transfer Officers

• Technology transfer offices can take proactive steps to facilitate locally-based and international public-private partnerships or engage product development partnerships (PDPs). These include: collectively organizing inventories of IP rights held and licensing status in key global health fields, instituting training programs and personnel exchanges to build IP competencies and partnerships (including skills in technology valuation and brokering with the commercial sector), creating information policies to assist the identification of partners for potential collaboration in neglected diseases and encouraging strategic market analysis, such as estimates of need.