Strategic Patent Licensing for Public Research Organizations: Deploying Restriction and Reservation Clauses to Promote Medical R&D in Developing Countries

Article excerpt

In May 2006, at the World Health Assembly, the governments of Kenya and Brazil called on fellow nations to promote the development of the public health tools necessary to build the research capacity of developing countries. That call was again made at the G8 Summit in June 2007,1 when the national science academies of the G8 nations and Brazil, China, India, Mexico and South Africa signed a statement on the promotion and protection of innovation. Highlighting the need to balance the protection of intellectual property with the need to foster access to knowledge and remove barriers to innovation, the statement calls on world leaders to:

Work with developing countries to build systems of science, technology and innovation for economic and social development, and to promote the education and training of their future leaders particularly in science, engineering, technology, and medicine.2

As to the means of working with developing countries to build innovative capacity, the Network of African Science Academies (NASAC), made the following recommendations to the leaders of the G8 countries:

That the G8 governments provide financial, scientific and technical support for the efforts of the African scientific community, including NASAC and the Association of African Universities (AAU), to work with the academies of science, engineering and medicine in G8 countries, to promote International cooperation in science and technology for the purposes of advancing the Millennium Development Goals (MDGs) in Africa.3

The prominence of public health within the internationally agreed framework of eight goals and eighteen targets provides an indication of the magnitude of the problem. Public health issues feature in no less than four of the eight millennium development goals. Goals Four, Five and Six speak respectively of reducing child mortality, improving maternal health, and combating epidemic diseases such as HIV/ AIDS and malaria. Over and above the goals specifically directed to public health, Goal Eight is especially relevant for the development of an indigenous supply of affordable medicines. The eighth MDG aspires to create a "Global Partnership for Development" that is, in turn, offset by Target Seventeen, entitled "Access to Medicines." This Target exhorts fellow Members of the United Nations, in cooperation with pharmaceutical companies, to provide access to affordable, essential drugs in developing countries.4

According to the World Health Organization (WHO), the principal causes of death in the developing world are respiratory infections, HIV/AIDS, infections at birth, diarrhoeal disease5 and tropical diseases such as malaria.6 Nevertheless, it is commonly claimed that only 10% of the world's medical research is devoted to conditions that account for 90% of the global disease burden.7 Irrespective of whether such estimates represent an accurate indication of the imbalance between R&D and the risks to public health, a sustainable supply of affordable medicines will require action to mobilize collaborations between public research organizations (PROs) for drug discovery and partnerships for drug development within the pharmaceutical industry.8 Thus, there remains a need to develop better drugs and vaccines for diseases that are largely confined to developing countries.

Many drugs for diseases prevalent in the developing world are antiquated or have serious side effects and many organisms that cause these diseases are developing resistance to treatment.9 Although effective medicines are available for many of the most prevalent diseases, ensuring access in resourcepoor countries is of major concern due to problems of cost, delivery, and healthcare support. The factors that are expected to catalyze the need for indigenous R&D in developing countries are epidemics, an aged population and the growing incidence of lifestyle-related diseases giving rise to increased healthcare expenditure. …