The Indonesian government aggravated the World Health Organization (WHO) three years ago by refusing to hand over samples of the deadly H5N1 "bird flu" virus. The Indonesians argued that the samples would be used to produce medicines priced beyond the means of its poorer citizens. Jakarta's stance raised concerns that countries with confirmed cases of SARS might abstain in a similar fashion.
Such global recalcitrance never materialized, and last year Indonesia relented by handing over 12 samples to the WHO after being assured of access to medicines in the event of a pandemic. According to a GlaxoSmithKline press release, H5N1 virus samples from Vietnam have been used to produce a viable pre-pandemic vaccine. Bird flu made its way back into the news after a recent death from the illness in China.
But Indonesia's fears were legitimate. Affordable drugs are often unavailable to the people who need them at the times they need them most, and access problems apply both to potential pandemics and to chronic and endemic diseases such as AIDS. Nine out of ten children with HIV do not have access to antiretroviral drugs, according to Doctors Without Borders.
The Patent Problem
Some activists blame the patent system for inadequate and unequal access, and thus their advocacy campaigns focus on reducing prices and relaxing patent restrictions on essential drugs. This strategy has often put human rights groups at odds with the major pharmaceutical companies.
Meanwhile, pharmaceutical companies contend that the profits generated from patented drugs provide the incentives for the private sector to innovate and invest in research. Critics such as Oxfam America counter that little private sector research has actually gone into neglected diseases in poor countries, and that many drugs have been developed using U.S. federal funding rather than private sector investment.
The WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement gives developing countries some flexibility to balance claims of intellectual property against their requirements for health and development. The TRIPS agreement provides developing countries with safeguards such as the issuance of compulsory licenses for patented medicines during health emergencies or in cases of public noncommercial usage.
But at a discussion of health as a human right at the Carnegie Council in New York City last month, Oxfam America's campaigner for access to medicines, Rohit Malpani, noted that pharmaceutical companies have filed lawsuits against developing-country governments to prevent them from exercising the safeguards.
To avoid this impasse, a number of new initiatives aim to work around the current patent regime, not against it, hoping to strike a balance between innovation and access.
The Yale-affiliated organization Incentives for Global Health has suggested an alternative patent regime that rewards drug companies based on the health impact of their innovations. Their proposal, called the Health Impact Fund, would provide a financial incentive for drug companies to pursue research and development while selling low-cost drugs to treat diseases that afflict people in poor countries. According to philosopher Christian Barry, an affiliate of the fund, the project offers "a complement to the existing system of patent protection that would create greater access to medicines for those who most need them, and yet at the same time protect innovation."
A similar market-based initiative was launched recently to stimulate the production of vaccines for the world's poorest. The GAVI Alliance is testing the idea of Advance Market Commitments (AMC) for vaccine development, where donors commit money in advance to guarantee low, long-term prices for developing countries. Manufacturers that participate sign legally binding commitments to "supply their vaccine for 10 years at a predetermined low price." In return, they receive a higher "AMC price" during the initial years of their commitment to help them recoup research costs. So far the project has received pledges totaling $1.5 billion from Italy, the United Kingdom, Canada, Russia, Norway, and the Bill & Melinda Gates Foundation.
Last summer, the board of directors of UNITAID, an international drug purchase facility formed by 44 countries, approved the establishment of a patent pool to provide a "one-stop shop for companies producing pharmaceuticals for low-income countries and global health buyers." The details of the patent pool are still being worked out by a task force, but it will focus initially on pediatric antiretroviral drugs.
While in the experimental phase, these innovative initiatives run the risk of working at cross-purposes or competing for financing. The Health Impact Fund alone requires governments of industrialized countries to commit at least $6 billion, the estimated yearly amount required to provide sufficient incentives to the private sector to register their drugs with the Fund. But with the world in a crippling financial crisis, political will and dollars may be hard to come by.
Some critics contend that market-based initiatives offer too much in the way of profits for pharmaceutical companies, and too little in the way of timely delivery of vaccines or choice for recipient countries. Doctors Without Borders has questioned the size of the initial investment in the AMC pilot program along these lines.
The Domestic Component
Although these international initiatives demonstrate increased global concern over health in the developing world, the most effective tactics may lie closer to home.
Despite the threat of drug company lawsuits, more governments are exercising TRIPS-sanctioned legal flexibilities such as compulsory licenses to produce or import affordably priced drugs for infectious diseases and other conditions. Thailand and Abbott Laboratories have been locked in a legal battle over Bangkok's 2007 decision to issue a compulsory license for an Abbott AIDS drug. In retaliation, Abbot blocked Thailand's access to its new drugs, including some that are vital to the treatment of AIDS.
The story in India, meanwhile, illustrates the significance of a long-term vision, robust domestic policy, strict legislation, and active civil society engagement around access to medicines. India combines price controls on essential drugs with investment in the local generic drug industry and a strict patent law. It has successfully blocked patent applications for a number of essential drugs and has held its ground despite threats and lawsuits from drug companies.
India's policy and legislation on the drug industry is, however, mismatched with its chronic under-investment in health services. "It's inexcusable for India to only spend 2 to 3 percent of its GDP on healthcare," Malpani said.
Increased access to medicines is but one part of a broad struggle to make health a universal human right. Some barriers to health may be overcome through indirect and low-tech solutions such as providing soap and clean water to poor communities, or paving roads to remote localities. But where the macroeconomic factors of poverty, inequality, and weak governance persist, they will inevitably hinder proper investment in global public health.