- The rise of generics has made treating millions of patients possible, and probably saved hundreds of thousands of lives
- The FDA requires evidence of bioequivalence before a drug is sold in the U.S., but many aid groups do not.
- Developing countries, including Uganda, have ineffectual or outdated drug quality laws--some dating back 60 years
Health advocates have worked tirelessly to increase access to drugs by encouraging companies to supply generic versions of originator products. Because generics companies do not have to recoup research and development costs, they can offer their products for lower prices, which all things being equal, encourages innovator companies to slash their prices.
The rise of generics (along with the commitment of wealthiest countries to spend billions of dollars in health aid for poorest ones) has made treating millions of patients possible, and probably saved hundreds of thousands of lives. Assuming, of course, that all generic drugs are bioequivalent to originator products--identical in dose, strength, safety, efficacy, and work in exactly the same way in humans.
"America has dramatically increased its investment in humanitarian relief to fulfill needs all around the globe. But isn't it time we properly tested the drugs we buy for them?" The FDA requires evidence of bioequivalence before a drug is sold in the U.S., as do other stringent drug regulatory authorities. But many aid groups, who purchase huge amounts of drugs for developing countries, do not. According to World Health Organization data, the Clinton Health Initiative, the Global Fund, Mission Pharma and UNITAID have together spent millions of dollars over the past two years on drugs that have yet to be proven bioequivalent.
Mission Pharma describes its vision as providing "generic medicines" to "economically disadvantaged populations." It is one of the world's leading suppliers of generic pharmaceuticals and medical devices to governments, United Nations agencies and NGOs in developing countries. The Clinton Health Initiative, founded by former U.S. President Bill Clinton, exists to negotiate pricing and procure drugs from India for developing nations, among other things. The Global Fund, an independent body aligned closely with the UN, procures drugs for TB, AIDS, and malaria for developing nations, and also provides grants for these countries to do so directly. A third of its budget is financed by U.S. taxpayers. UNITAID, founded by the French and Brazilian governments, has a similar aim, which it accomplishes by negotiating price reductions and providing funding to countries via a "solidarity" tax on airline tickets sold in participating donor countries.
Buying drugs that have not undergone rigorous bioequivalence testing, as these groups do, is often justified along the lines that they are less expensive, which enables more patients to be treated. Many organizations claim to do limited testing to ensure that the active ingredient is present in the correct proportion, although this does not necessarily mean that the drug will become available in the patients' bloodstream in the same way. These groups may be right, but it's a heroic and dangerous assumption, particularly when the lives of current and future patients are at stake.
In September 2008, President Bush's Emergency Plan for AIDS Relief announced that it was suspending procurement of drugs produced by two manufacturing plants of the Indian drug company Ranbaxy, on fears that they were not bioequivalent (in this case, owing to alleged shortcomings in manufacturing practices). PEPFAR operated on the "principle" of only purchasing antiretroviral "drugs that meet standards equal to those established for patients in the United States."
Versions of drugs that contain the right active ingredients but that do not enable the ingredients to become available in the bloodstream at the correct time encourage resistance, a particular concern for tuberculosis and HIV/AIDS drugs, which patients must take for several months or for a lifetime.
In addition to encouraging the purchase of drugs that have not yet been proven bioequivalent, the rigid belief "generic: cheap and therefore good; originator: expensive and therefore bad" has led some aid organizations to actively encourage developing countries to promote their own locally produced drugs, even when this amounts to little more than industry protectionism. Earlier this week the Ugandan press discussed the "mixed blessing" of a new children's version of a Swiss malaria drug: "Launch of child malaria drug threatens local industry," the New Vision, Uganda's daily newspaper warned. The "local industry," or Quality Chemicals, Inc., is well connected to President Museveni; rumors abound that once it produces enough HIV and malaria drugs it will be awarded all government drug tenders, regardless of cost.
Many developing countries, including Uganda, either have ineffectual or outdated drug quality laws--some dating back over 60 years. The oldest I'm aware of is Chile, which is operating with a drug quality law from 1942. Fortunately, Chile is one of the more open economies of Latin America, receiving good drugs from US and elsewhere--but patients in many other countries of poor regions are not so lucky. Brazil's health minister announced last week that the country would be able to domestically produce far more of its HIV drug requirement needs in the near future, even as anecdotal evidence points to increasing drug resistance rates among native Brazilians.
One has to hope that the increasing number of generic drugs hitting the market work are bioequivalent, and that local production is at par. If they are not, drug resistance will increase, making future treatment more expensive and eliminating currently useful drugs from the global medicine chest.
America has dramatically increased its investment in humanitarian relief to fulfill needs all around the globe. But isn't it time we properly tested the drugs we buy for them?
Roger Bate is a resident fellow at AEI.