In 1999, a small South Africa study revealed disturbing news about a medicine used in first line directly observed therapy for tuberculosis: it contained the right amount of the most essential ingredient but testing showed it was not being absorbed into patients’ systems. If the small study was representative of what was happening on a wide scale, an article in the Journal of Public Health Policy notes, it suggested the possibility that more than half the world’s TB patients were receiving faulty, inadequate drugs that could leave them sick while increasing resistance to treatment.
A few years later as the Global Fund to Fight AIDS Tuberculosis and Malaria formed, stories like that one raised a disquieting spectre: The entire endeavor would be threatened if the new charity sank its resources into substandard treatments. At the same time, branded medicines to treat HIV cost thousands of dollars per patient per year. These events make up part of the surprisingly riveting story of how the World Health Organization’s Prequalification of Medicines Programme came to do what regulatory authorities in resource poor countries could not do, by setting and holding standards for generic medicines that could then be administered and save lives on a mass scale. The article, A quiet revolution in global public health: The World Health Organizations Prequalifications of Medicines Programme, tells the story of what the program has accomplished, and why its future, for all of the acceptance its achievements have gained, is far from secure. One of its vulnerabilities: it relies on exactly two donors, the Bill and Melinda Gates Foundation, and UNITAID for its budget of $15 million.
The story told in the article is not intended to be detached or a disinterested look. its lead author is a regular consultant to the WHO medicines program, and a former director of policy and advocacy at Médecins Sans Frontières, which both scrutinized the program’s work and praised the “rigour” of its controversial decision to delist a product when inspectors could not find sufficient evidence that the generic was the equivalent of the brand drug on which it was based. But it does tell the story of what a Lancet article called “a little known part of WHO” in a way that is narrative and nuanced. It includes development of the first generic triple fixed dose combination antiretroviral drug available at $140 per patient per year, the WHO’s prequalification of the drug, and how then President’s Emergency Plan For AIDS Relief head Randall Tobias, a former CEO of Eli Lilly, questioned the program’s standards. It also tells how a General Accounting Office report helped the U.S. change its tune on using generic antiretroviral medicines. And it tells how in the 13 years since it was conceived, the program has put its stamp of approval on more than 200 medicines to treat HIV, conferring confidence in affordable medicines taken by more than 75 percent of the people on antiretroviral treatment in 2012.
Perhaps most importantly, it tells of the gap the program filled. In the short but epic story of how medicines to treat HIV were developed, became affordable and were distributed around the world, keeping people alive, and slowing the spread of the virus, the article indicates, the role of the World Health Organization’s Prequalification Programme is likely the least recognized.