[e-drug] NYT on WHO prequalification of Drugs

[EHOEN@paris.msf.org (Ellen T HOEN)]

E-drug: NYT on WHO prequalification of Drugs
---------------------------------------------

March 21, 2002
New List of Safe AIDS Drugs, Despite Industry Lobby
By DONALD G. McNEIL Jr.

PARIS, March 20 ó 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."

===============================================
Ellen 't Hoen, LL.M.
MSF- Access to Essential Medicines Campaign
8, rue Saint-Sabin, 75544 Paris Cedex 11
tel: + 33 (0) 1 40212836
fax: + 33 (0) 1 48066868
e-mail: ellen.t.hoen@paris.msf.org
Web-site: www.accessmed-msf.org
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