This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter “SSA” or “Africa”). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime’s inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

The Agreement on Trade Related Aspects of Intellectual Property rights (TRIPS) requires all WTO members to adopt certain minimum standards for the protection of intellectual property rights including the rights of holders of patents for pharmaceutical products. The adoption of the standards delineated by the TRIPS Agreement appears to have resulted in significant loss of public health policy flexibilities for developing country members with respect to regulating the grant and use of pharmaceutical patents and controlling the cost of medicines. The Agreement, however, provides inherent flexibilities that are to enable member countries to take adequate measures to safeguard pubic health. This Study analyzes the extent to which countries in Sub-Saharan Africa have been able to utilize the flexibilities to improve access to HIV/Aids medicines. This is done primarily in relation to the two regional intellectual property organizations, the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Proprit Intellectuelle (OAPI), bearing in mind the close linkages between the legal instruments of these regional institutions and the domestic laws of their member countries. It has been observed that in spite of the availability of the flexibilities provided by the Agreement, obstacles to implementation in SSA center mainly on lack of awareness and political will and lack of efficient administrative structures and procedures for coordination and decision making. The Study also examines the option of local manufacture of HIV/Aids medicines, based on the experiences of four countries, evaluates challenges to the sustainability of this option in the SSA context andmakes recommendations based on key findings.

In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.

Some two decades will shortly have passed since the WTO's Trade Related Aspects of Intellectual Property Rights agreement came into force in 1995. This volume is the first cross-country analysis of how TRIPS has affected the capacity of 11 major low or medium income countries to produce generic drugs.

Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.