From The New York Times Thursday, March 20, 2002
By Donald G. McNeil Jr.
PARIS. In a move that could help bring down the price of AIDS medicines for poor countries, the World Health Organization today released its first list of manufacturers of safe AIDS drugs, which included a large Indian producer of generics and three smaller European ones.
The decision represents a setback for the pharmaceutical multinationals who want only patent-holders to decide what discounts to offer on their most expensive and profitable products. The medicines on the list are approved for United Nations purchase, and it will encourage price competition in poor nations by telling health officials which of hundreds of generics suppliers make safe drugs. "This is a breakthrough," said William F. Haddad, a generics maker who helped create the cheaper off-brand industry in the United States in the 1980's. He said it was the first time the World Health Organization "has had the nerve to challenge the multinationals by listing generic versions of drugs that are still on patent." Dr. Peter Piot, director of the United Nations AIDS agency, said he hoped the list would help patients "gain greater access to affordable H.I.V. medicines of good quality."
The list includes 41 different formulations of drugs, among them 11 antiretroviral drugs and five drugs for infections that often accompany AIDS. Of the total, 26 come from major manufacturers: GlaxoSmithKline, Bristol-Myers Squibb Company, Roche Holding, and Abbott Laboratories. But 10 were from Cipla Ltd., the generic drug maker based in Bombay, India, that was the first to try breaking Western patent monopolies in February 2001 by offering AIDS therapy for $350 a year to charities and African governments. Before that, AIDS treatment in Africa generally cost the same as it did in the West, $10,000 or more. Only a handful of countries had negotiated prices in the range of $1,000 a year after lengthy negotiations with the patent-holders, who sometimes required them to keep the lower prices a secret. "I am delighted," said Dr. Yusuf K. Hamied, the chairman of Cipla. "This proves that we adhere to good manufacturing practices on a par with other companies. It says Cipla is kosher, so now the multinationals can't throw at us what they have said: `They're Indian, they're Third World, the quality might be iffy.' " Cipla products that the World Health Organization accepted include the antiretrovirals nevirapine, zidovudine, better known as AZT, and lamivudine, better known as 3TC. These three drugs make up one common AIDS cocktail. The health organization also accepted Cipla's acyclovir for shingles infections, ciprofloxacin for bacterial infections, and vinblastine and vincristine sulfate for Kaposi's sarcoma, a skin cancer. India recognizes patents on drug-making processes, not on products, so Cipla has a legal right there to make hundreds of chemicals made in the West as long as it makes them using slightly different steps.
The International Federation of Pharmaceutical Manufacturers in Geneva, which lobbies on behalf of the multinational drug companies, issued a statement saying "it would be unfortunate if the current plague of substandard and counterfeit medicines spread" because generics makers were on the health organization's list. Asked if the industry group was questioning the performance of the World Health Organization inspectors, Eric Noerenberg, the federation's director of intellectual property, said it was not. But he said he thought approved factories had been asked only to meet their own countries' standards. When told that the health organization said it was applying international standards, Mr. Noerenberg said, "It remains to be seen what will be supplied. We're interested." Poor countries and medical charities, like Doctors Without Borders, are always searching for cheaper drugs, but often lack the money and expertise to inspect distant foreign factories. Mr. Haddad said Latin American and African nations often ask him for help. He said he would write to their ambassadors immediately about the new list. The health organization began accepting applications for the list a year ago, and teams of United Nations inspectors spent up to two weeks at each factory, said Dr. Jonathan D. Quick, the health organization's director of essential drugs policy. Dr. Hamied of Cipla said his factories have passed 22 United States Food and Drug Administration inspections for generics made for the American market, so he was not surprised that he passed the United Nations scrutiny. An Indian competitor, Ranbaxy Laboratories Ltd., did not make the list. It makes a three-antiretroviral combination that it offers for as little $295 a year to customers with 5,000 or more AIDS patients. A spokesman for Ranbaxy, Paresh Chaudhary, said the company is not yet ready to export, but hopes its factory in Dewas will pass muster in a World Health Organization inspection in April. The Dewas antibiotic production lines have already passed inspections by the United States drug agency, he said. Up to 100 more applications are awaiting approval.
The World Health Organization asked for applications for 16 antiretrovirals that attack the AIDS virus itself and 24 drugs for other conditions that attack the weakened immune systems of AIDS patients. Dr. Bernard Pecoul, director of a campaign by Doctors Without Borders to lower drug prices, said he was "totally supportive" of inspections by the health organization. Of the list he said, "Theoretically, it's excellent because it creates competition." But he expressed frustration that some important drugs were missing. There was not a single approved supplier for fluconazole or other antifungals that suppress cryptococcal meningitis, which kills AIDS patients after agonizing headaches, and thrush, which makes eating so painful that patients can starve to death. Several antiretrovirals were missing from the World Health Organization list, "and for others, there is only one source, the patent manufacturer," Dr. Pecoul said. "But, hopefully, W.H.O. will go on." For other drugs, multiple suppliers are listed.
Approved makers of AZT included GlaxoSmithKline, the world's largest pharmaceutical company, which holds the patent in most Western countries. Also listed were Cipla and Combino Pharm, a six-year-old Spanish generics maker that supplies AZT to Gabon, the Ivory Coast and Tunisia and has a contract with Doctors Without Borders. "I won't say we don't mind that. We always defend our patents," a GlaxoSmithKline spokesman, Adam Chandler, said. "But in this case, the W.H.O. made the decision and we've got to abide by it. We believe the way to do this is to negotiate arrangements with governments and employers in the developing world, and in poorer countries we've said we will supply at cost." For ciprofloxacin, the antibiotic whose patent status and high price became an issue during last year's anthrax scare, the patent owner, Bayer, is not on the list as a safe supplier for AIDS-related infections. But Cipla and a Spanish generics company, Laboratorios Cinfa S.A., are.
Dr. Quick of the health organization declined to say why any particular company was not on the initial list, but said they might simply not have applied yet. He said that whether a drug was a patented or generic version was "never a question." In soliciting applications, the health organization had decided to inspect "any company that was legally registered in its own country."