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Back Issues and Articles

Table of Contents
Table of Contents
AJLM - [PDF] (Free Download)
American Journal of Law & Medicine Volume 34, Number 2 & 3 * 2008 Articles: 97 Foreword - Global Access to Health: Legal, Business and Policy Obstacles - Erik Iverson and Regina Rabinovich. 107 Delivering Drugs to the Poor: Will the TRIPS Amendment Help? - Graham Dutfield. 125 Think Globally, Prescribe Locally: How Rational Pharmaceutical Policy in the U.S. Can Improve Global Access to Essential Medicines - Aaron S. Kesselheim. 141 When You Reach a Fork in the Road, Take It: Science and Product Development as Linked Paths - Gerald T. Keusch. 151 "Trust Me": Patent Offices in Developing Countries - Peter Drahos. 175 Strategic Patent Licensing for Public Research Organizations: Deploying Restriction and Reservation Clauses to Promote Medical R&D in Developing Countries - Gail E. Evans. 225 Demand Forecasting for Essential Medical Technologies - Ruth Levine, Jessica Pickett, Neelam Sekhri and Prashant Yadav. 257 Intellectual Property and Development at WHO and WIPO - Jack Lerner. 279 Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases? - Kevin Outterson. 303 Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage - Brook K. Baker. 345 Access to Medicines, BRICS Alliances, and Collective Action - Peter K. Yu - Notes and Comments: 395 Are Developing Countries Going Too Far on TRIPS? A Closer Look at the New Laws in India - Radhika Bhattacharya
Symposium Articles
Are Developing Countries Going Too Far on TRIPS? A Closer Look at the New Laws in India
Radhika Bhattacharya - [PDF]

The goal of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is to harmonize the intellectual property rights of World Trade Organization (WTO) member countries to a certain minimum standard. As a WTO member, the organization required India to enact legislation that enforces TRIPS by 2005. Part of India's motivation to pass its 2005 Patents Act stemmed from its obligations as a WTO member nation, as well as the government's desire to stimulate greater foreign investment, innovative research and economic growth.
Articles
Foreword - Global Access to Health: Legal, Business, and Policy Obstacles
Erik Iverson and Regina Rabinovich - [PDF]

Thomas Jefferson - scientist, philosopher, and United States president - firmly believed in the power of innovation. A bit of a tinkerer himself, he devoured new applications while serving as America's first patent examiner and often engaged in enthusiastic correspondence with hopeful inventors. He was a pioneer in the development of American patent law and shaped its attention to the utility, novelty, and non obviousness of inventions. But Jefferson also believed that inventions were only meaningful if they were used to benefit the quality of life in society as a whole. In a letter to Robert Morris written in 1794, he told the inventor of waterproof cloth that his valuable discovery "will be truly great if the process be so cheap as it will admit to be used for the laboring part of mankind. The rich have so many resources already for taking care of themselves, that an advantage the more, if confined to them, would not excite our interest; but if it can be introduced commonly for laborers, then it becomes valuable indeed."
Delivering Drugs to the Poor: Will the TRIPS Amendment Help?
Graham Dutfield - [PDF]

Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people's lives. High-profile pandemics like HIV/AIDS understandably attract considerable attention. Millions of people have died of this terrible disease - 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively. As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.
Think Globally, Prescribe Locally: How Rational Pharmaceutical Policy in the U.S. Can Improve Global Access to Essential Medicines
Aaron S. Kesselheim - [PDF]

Improving access to essential medicines in low and middle-income countries (LMICs) has become a critical health policy issue. Millions more people die each year in poorer countries from diseases that are treated by pharmaceutical agents currently available in higher income nations. Recent medical innovation has tended to focus on problems affecting populations in developed countries and avoid those found exclusively or predominantly in LMICs. The etiology of these disparities is multifactorial, and can include high costs of products, inadequate cooperation between governments and aid agencies, rigid protection of intellectual property rights, and poor local health leadership regarding dissemination of products.
When You Reach a Fork in The Road, Take It: Science and Product Development as Linked Paths
Gerald T. Keusch - [PDF]

Increasingly, health is recognized as a major force for economic development; and because economic development is central to political and social stability, health is being looked at as the great hope for the future of the world, as population sizes and disparities among them increase. This perspective has been growing ever since the 1993 World Development Report was released by the World Bank, and it has fueled an intensive scrutiny of health care around the world, focusing on systems and health care delivery on the one hand, and equitable access to the products of research on the other hand. In the middle of all of is this is a concern about how health care (which must include both the training of personnel from the basic low level health care worker to the physician), and research and development (which must include the financing of research in academia and the development of products primarily in the private sector) are organized, and how they do or do not address inequities between and within populations and nations. The purpose of this paper is to provide a perspective from the vantage point of a physician researcher, and to make the case that inclusion of the education and career development pathways of health researchers within the ongoing discussions on the health care and research "system" is essential to achieving future outcomes that, at present, can only be dreamed of. In essence, the argument will be that the education and research system must ensure that the scientific workforce will understand public health needs, that the public health workforce will understand the contributions of science, and that the financial and organizational mechanisms that create the private good of products for better health care.
"Trust Me": Patent Offices in Developing Countries
Peter Drahos - [PDF]

Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.
Strategic Patent Licensing for Public Research Organizations: Deploying Restriction and Reservation Clauses to Promote Medical R&D in Developing Countries
Peter Drahos - [PDF]

Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.
Demand Forecasting for Essential Medical Technologies
Ruth Levine, Jessica Pickett, Neelam Sekhri and Prashant Yadav - [PDF]

Today's global health programs will attain their objectives only if products appropriate to the health problems in low- and middle-income countries are developed, manufactured and made available when and where they are needed. Achieving this requires mobilizing public and charitable money for more and better products to diagnose, prevent and treat HIV/AIDS, tuberculosis, malaria, reproductive health problems and childhood killers. But more money is only one part of the story. Weak links in the global health value chain-from research and development through service delivery-are constraining on-the-ground access to essential products. The consequences of those weak links are many: supply shortages, inefficient use of scarce funding, reluctance to invest in R&D for developing country needs and, most importantly, the loss of life among those who need essential products.
Intellectual Property and Development at WHO and WIPO
Jack Lerner - [PDF]

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization ("WIPO") recently approved a historic "Development Agenda" - a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization ("WHO") has launched its own development agenda of sorts - an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property ("IGWG") that is tasked with preparing "a global strategy and plan of action" aimed at "securing an enhanced and sustainable basis for needs driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area." Several other IGOs have implemented programs designed to help developing countries build capacity to meet their intellectual property obligations in a way that fosters public health and access to medicines in those countries.
Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases?
Kevin Outterson - [PDF]

The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies.
Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage
Brook K. Baker - [PDF]

The pharmaceutical industry's dependence on intellectual property rights (IPRs), especially patents, to exclude competitors and thereby recoup past expenditures, incentivize future investments in research and development (R&D), and maximize profits is well known. Although initially content to solidify patent rights in the rich-country markets of North America, Europe, and Japan, in the last quarter of the 20th century the industry has increasingly turned its attention to emerging markets in Latin America, Asia, and even Africa as sites of future market expansion. Big middle-income countries like Brazil, India, China, and Indonesia have growing middle classes that increasingly favor allopathic medicine over the more traditional medicines of their elders. Obtaining monopoly rights in these growing markets could help the pharmaceutical industry weather the storm of increased consumer, business, and government blow-back against supra-competitive drug prices charged in rich country markets.
Access to Medicines, BRICS Alliances, and Collective Action
Peter K. Yu - [PDF]

On December 6, 2005, shortly before the World Trade Organization ("WTO") Ministerial Conference in Hong Kong, WTO member states agreed to accept a protocol of amendment 1 to the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPs Agreement"). This amendment sought to provide a permanent solution to implement paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health ("Doha Declaration"). If ratified, the new article 31bis of the TRIPs Agreement will allow countries with insufficient or no manufacturing capacity to import generic versions of on-patent pharmaceuticals.