The U.S. government is threatening to obstruct low-income countries’ access to generic HIV/AIDS drugs approved by the World Health Organization (WHO), Human Rights Watch said today. The United States will convene a conference in Botswana on Monday that may challenge the WHO’s approval of generic copies of patented AIDS drugs.
The drugs in question meet the stringent standards of the WHO’s technical review for generic drugs but have not been approved by the U.S. Food and Drug Administration. The United States, under pressure from pharmaceutical companies selling the brand-name equivalents, claims instead that “there are no uniform principles, guidelines or international standards addressing the development” of generic drugs — an assertion that calls into question the WHO’s widely accepted review process.
“WHO has made enormous headway in verifying the quality of generic AIDS drugs that are the only hope for millions of low-income people with AIDS,” said Joanne Csete, director of the HIV/AIDS Program at Human Rights Watch. “But to protect brand-name pharmaceutical interests, the United States may dash that hope.”
The generic drugs opposed by the United States allow people with HIV/AIDS to take only two pills a day, and they are much cheaper than the equivalent brand-name drugs. The cheapest generic regimen, also endorsed by Doctors Without Borders and other health practitioners, costs $140 per year per patient as opposed to the brand-name equivalent of six pills a day costing at least $600 per year. Numerous U.N. bodies, including the Commission on Human Rights, have recognized that access to affordable medicines for HIV/AIDS is essential to the right to health.
Generic drugs are an integral part of the WHO’s recently announced “3 by 5” initiative — a plan to ensure access to HIV/AIDS medicines for at least 3 million persons with AIDS by end-2005. In spite of WHO approval, Randall Tobias, the U.S. Global AIDS Coordinator, told the press that the United States is unsure that generic drugs meet the “principles and standards” necessary to qualify for U.S. support for their use. President Bush praised the development of cheaper AIDS drugs in his State of the Union Address in January 2003. But since then, the U.S. government’s “presidential emergency program” on HIV/AIDS has not purchased or promoted the use of generic drugs.
“The United States stands alone in opposing these safe, inexpensive and WHO-certified generic medicines,” said Csete. “The Bush administration should dispel all accusations that it is protecting the interests of brand-name drug companies, and instead it should endorse and purchase these cheaper drugs, which would maximize the return on its investment in fighting AIDS.”
The United States agreed to a November 2001 World Trade Organization resolution permitting expanded access to generic drugs in countries fighting epidemics such as HIV/AIDS.