South Africa's health minister, Nkosazana Zuma, admires the generic-drugs policy in the U.S. so much that when she drafted her health care reform proposal, she called on the Food and Drug Administration for advice. But now Zuma has a bitter pill to swallow: Her efforts to make generic drugs widely available in her country are being blocked by the United States' brand-name pharmaceuticals industry, Commerce Secretary William Daley, and even Vice President Al Gore.
At a meeting of U.S. and South African officials in Washington, D.C., in July, both Daley and Gore warned that South Africa could face trade sanctions and be held in violation of the World Trade Organization's intellectual property agreement if it implements Zuma's reform proposal. The policy would give South African pharmacists the ability to suggest generic substitutions to customers whose doctors don't object, and would require that public health care facilities use only generics whenever they are available. Her opponents say that by discriminating against brand-name drugs, her proposal may pose "unjustified encumbrances" on trademarks, a violation of intellectual property rights.
According to Stephen W. Schondelmeyer of the University of Minnesota College of Pharmacy, Zuma's proposed policy essentially matches what Medicaid does here in the U.S.Medicaid pays for brand-name drugs only when generics are unavailable. But in South Africa, close to 70 percent of the population depends on publicly provided health care. That's a huge market for American drug companies to be shut out of, and they have acted swiftly to enlist the help of Washington's most powerful players in their fight against the reform. "Political leverage in the Commerce Department is being used to represent the interests of the pharmaceutical companies," says Gordon Johnston of the FDA's division of generics.
The drug companies, represented by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the U.S.-South Africa Business Council (conveniently chaired by Johnson & Johnson exec Aldrage Cooper Jr.), have also reacted swiftly on their own, freezing all pharmaceutical investment in South Africa and threatening divestiture. South Africa's Pharmaceutical Manufacturing Association, which has close ties to PhRMA, has even launched a scare advertising campaign featuring full-page newspaper ads (left) that read: "Health Warning! Remain Silent and the Unsafe Control of Medicine Could Cost You Forever," complete with a photograph of a wailing baby.
"It's not fair to mischaracterize our generics policy," says Dr. Ian Roberts, Zuma's special assistant. "But if they want to use those tactics, it's their democratic right.... We aren't backing down. People are living in squalor here; we're trying to change that."