American Journal of Law & Medicine

Foreword--global access to health: legal, business, and policy obstacles.

INTRODUCTION

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. (1) 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." (2)

Jefferson's philosophy offers a glimpse of the solution to our global struggle to address the diseases of the poor. Despite improved health and reduced mortality globally in the last half-century, (3) too many people are still not being treated for these diseases. (4) Millions of people in developing countries--most of them children--die every year from diseases that are preventable and treatable. A measles vaccine costs 15 cents, yet nearly 675 infants die of measles every day. (5) Some 26 million children per year under the age of five are not immunized with simple, inexpensive vaccines most of us take for granted. (6) The number of women at risk of death during childbirth in low-income countries compared with wealthy ones is 500 to one. (7) Tuberculosis, HIV/AIDS, diarrheal diseases and childhood pneumonia, complications of pregnancy and neonatal deaths--each partially preventable with vaccines or treatable or manageable with therapeutics available in rich nations--cause 29% of all deaths in low- and middle-income countries. Every year, HIV/AIDS, malaria, and TB together kill six million people, mostly in sub-Saharan Africa and Asia. (8) This is the equivalent of everyone in Los Angeles and Houston (9) dying from these diseases each and every year.

These tragedies persist, despite the many billions of dollars (10) spent annually to develop new products to enhance and extend human life. New health solutions--drugs, vaccines, diagnostics, monitoring tools, and related platforms--are clearly needed. However, due in part to an historical lack of market incentives for the pharmaceutical industry, only 21 of the 1,556 new drugs put on the market in the three decades prior to 2004 specifically targeted neglected diseases, meaning those that disproportionately affect developing countries. (11) Even when these interventions are appropriate, they quickly run into the many legal, policy and infrastructure challenges that make delivery in resource-poor countries enormously difficult.

UNRIVALLED OPPORTUNITY

Nevertheless, there is reason for optimism. We live in a time of unprecedented opportunity when it comes to tackling neglected diseases. This reflects a broader movement in global health that has engaged academia (including the creation of numerous global health institutes or divisions), government (including the creation of the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative), as well as the developing countries themselves. The net result of this surge in resources and political will can be witnessed in the successes of the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the GAVI Alliance. Mechanisms are being created to incentivize product development and ensure that the right ones will be purchased and used, and lives will be saved.

The science is moving ahead as well. A growing number of universities, for-profit companies and not-for-profit research and development (R&D) initiatives house life-sciences projects that are focused on developing global health solutions. They include a broad array of health technologies, products, approaches and strategies for the prevention, diagnosis or treatment of neglected diseases. For example, in comparison to a decade ago, when the pipelines for malaria and TB drugs were virtually non-existent, today there are more than 20 malaria drug candidates and six TB drug candidates under development. (12)

At the same time, there are still far too many legal and policy hurdles that stand in the way of delivering the emerging global health solutions. It is not enough to design these interventions to be effective in the communities where they are needed. …

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