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AAAS Science and Human Rights Coalition Explores Right to Access Live-Saving Medicines
About 10 million people, primarily in the developing world, die each year because they lack access to medicines that already exist, according to Ethan Guillen, executive director of Universities Allied for Essential Medicines.
Many more suffer because they don’t receive adequate treatment for neglected diseases, he said.
While science has brought progress and prosperity to many, access to essential medicines, potable water, basic sanitation and other benefits remains elusive for vulnerable and marginalized populations, Guillen and others said at a meeting of the AAAS Science and Human Rights Coalition.
The right to enjoy the benefits of scientific progress and its applications was first internationally recognized as a basic human right in the Universal Declaration of Human Rights, adopted by the United Nations General Assembly in 1948. It also is a key provision of the International Covenant on Economic, Social and Cultural Rights adopted by the Assembly in 1966 and ratified by more than 160 nations.
In April, the AAAS Board of Directors adopted a statement urging scientists to become more involved in the ongoing global effort to clarify the meaning of the human right to the benefits of science and its practical application.
Such discussion is part of the mission of the AAAS Science and Human Rights Program and also is a key initiative of the AAAS Science and Human Rights Coalition, which was launched in January 2009 and now consists of 44 scientific membership organizations and more than 50 individual scientists. The coalition had its fourth meeting on 26-27 July at the AAAS headquarters.
Progress toward more equitable access to the benefits of science has been fitful. In the case of essential medicines, Guillen said at the opening plenary of the coalition meeting, “the system we have set up for medical innovation does not take adequate account of human rights.”
Patents help universities and corporations protect their innovation and realize financial gain for beneficial research. But patents also limit the ability of generic drug companies to produce lower-cost alternatives in a timely fashion, particularly in developing countries.
More than a third of the recently approved drugs to combat HIV/AIDS have had university patents associated with them, Guillen said. His group has been pressing schools to adopt “global access licensing” by which they agree that any medicines discovered as a result of their research will be licensed “with a concrete and transparent strategy to ensure affordable access in developing countries.”
Gregg Alton, executive vice president for corporate and medical affairs at Gilead Sciences—a pharmaceutical company with 4000 employees in 25 offices on four continents—described his company’s efforts to provide wider access to crucial medicines. The Gilead program has a particular focus on countries hardest hit by the HIV/AIDS epidemic, including all of Africa.
Through pricing based on a nation’s economic status and HIV prevalence, Gilead has been providing Viread, an anti-retroviral drug, to the lowest income countries at a “no-profit price” of about 57 cents a day per patient. For the next tier of countries, with per capita incomes of less than $3000 per year, the price is $1 per day for each patient. The wholesale acquisition cost of the drug in the United States is $21.43 per pill per day, Alton said, a price that supports the company’s research and development efforts while also helping to sustain its global access program.
Even at the low “no profit” cost, Alton said, it still is difficult for some nations to pay for the drug. They rely on contributions from donors such as the U.S. President’s Emergency Fund for AIDS Relief; the Global Fund, a public/private partnership to fight AIDS, malaria and tuberculosis; and UNITAID, an international program founded in 2006 to purchase drugs against HIV/AIDS, malaria and tuberculosis. UNITAID is funded by airline ticket taxes and budget contributions by participating nations.
As an additional help, Gilead has been reaching out to generic drug manufacturers in India and South Africa, granting them non-exclusive licenses that allows them to make generic equivalents of Viread and distribute the drug in 95 countries.
Gilead’s access program now provides Viread to about 703,000 patients worldwide at a lowest generic price of $7.25 per month, Alton said, compared to 31,000 patients at a cost of $17 per month in 2006, shortly after the program began.
Programs such as Gilead’s recognize that the standard commercial model of drug distribution does not apply in developing regions, particularly in Africa, where large numbers of patients often cannot afford even standard medications, much less cutting-edge drugs. Alton said Gilead welcomed new efforts such as UNITAID’s “patent pool,” a means to facilitate voluntary licensing and technology transfer to the developing world.
James Love, director of Knowledge Ecology International—a nonprofit that seeks better use of knowledge to address social needs—discussed proposals for providing broader access to life-saving medications that will “de-link” R&D incentives from the prices of products. Love said intellectual property, as an incentive to recover R&D costs through pricing, serves to limit access by people who cannot afford to pay the high prices. Under such circumstances, he said, the system produces poor health results and does not encourage needs-driven innovation.
There has been talk of alternatives. Love noted that Aventis, a large pharmaceutical manufacturer, held a three-day planning session in 2002 to consider scenarios for drastic changes in business models for new drug development. One proposal was to eliminate patent-driven marketing monopolies in return for a system of large cash prizes.
The use of prizes to stimulate innovation has a long history in aerospace and other technologies. They now are drawing interest as a possible mechanism to spur biomedical innovation as well. As Love and co-author Tim Hubbard wrote in a Chicago-Kent Law Review article in 2007: “Reforming the way we pay for R&D on new medicines involves a simple but powerful idea. Rather than give drug developers the exclusive rights to sell products, the government would award innovators money: large monetary ‘prizes’ tied to the actual impact of the invention on improvements in health care outcomes that successful products actually deliver.”
Such a system of prizes would de-link the costs of research and development from the price of the resulting drugs, Love said, and would help more effectively address diseases that disproportionately affect the developing world. The prize idea has been drawing some attention, he said. The World Health Assembly (WHA), the decision-making body of the United Nations’ World Health Organization, adopted a global strategy in 2008 on public health, innovation and intellectual property that included exploring a range of R&D incentives, including the award of prizes. The most recent WHA in May 2010 agreed to create a working group that will examine some of these proposals.
The X Prize Foundation, with a planning grant from the Bill & Melinda Gates Foundation, has been working to develop a prize for effective diagnosis of tuberculosis in the developing world. The nonprofit Doctors Without Borders also has been urging creation of a prize fund to spur more effective tools for tuberculosis diagnosis. The governments of Bangladesh, Barbados, Bolivia and Suriname also have asked a working group of the World Health Organization to consider a prize fund for low-cost, rapid diagnostic tests for TB.
In the United States, U.S. Representative Bernie Sanders (I-Vermont) introduced a Medical Innovation Prize Act in the House in 2005 and again in 2007. The legislation, which was not acted upon, would have created a prize fund for products that provide new therapeutic benefits to consumers. A fixed proportion of the fund would have been used to reward innovations aimed at neglected diseases and global public health problems.
James Love also presented the concept of “open source” dividends, incentive mechanisms that could form part of the prize system or a stand alone tool to promote more sharing and collaboration within the scientific community.
Whatever the approach, science needs to be conducted in a way that is consistent with existing human rights regimes, said Audrey Chapman, professor of medical humanities and bioethics at the University of Connecticut and a former director of the AAAS Science and Human Rights Program. “The benefits of scientific initiatives need to be broadly diffused within and across countries,” she said.
“That is a very different standard than the way science is normally judged,” Chapman said. Universities, corporations and nations often see science as conferring a competitive economic advantage. But she argued for a type of compensatory action in which science and technology are pursued “with the intent that the groups who are the most disadvantaged also will receive their benefit.”
3 August 2010