Tussle Over Generic AIDS Drugs

The World Health Organization has produced a list of companies making safe AIDS drugs, a move that could bring down the price of treatment in poor countries.

But the organization representing big international drug companies said Thursday the move could reduce the quality of treatment and lead to widespread drug resistance.

The WHO list, released Wednesday, named 41 drugs by eight manufacturers that met its criteria for quality. It included products by the Indian generic manufacturer Cipla as well as by big drug makers such as Bristol-Myers Squibb Company, GlaxoSmithKline, Abbott Laboratories and Roche Holding.

"This U.N. initiative marks an important step in increasing the number of qualified suppliers of HIV medicines and improving the procurement of these drugs for people living with HIV/AIDS in developing countries," said Peter Piot, executive director of the U.N. AIDS agency.

But the International Federation of Pharmaceutical Manufacturers Associations said it did not think that some generic suppliers met acceptable standards.

"Under no circumstances do companies based in some countries that have poor regulatory and quality standards match the standards of quality, service, and innovation on a sustainable basis that international research companies provide," said Harvey Bale, the federation's director-general.

Eric Noehrenberg, the federation's director of intellectual property and trade issues, said generic producers like Cipla also failed to provide after-sales service, which could lead to the drugs being misused and a buildup of resistance to their effectiveness.

"We could get back to a situation like in the early 1980s when there was no treatment at all," he told The Associated Press.

Jonathan Quick, director of essential drugs and medicines policy at WHO, denied the claims.

"The process we used was according to international standards with an international team and with guidelines that were reviewed by the WHO Expert Committee," he said.

He said the investigation had not looked at what happened after the drugs were sold, but in many cases issues such as good use and preventing resistance were handled within a country's own health system.

Cipla Chairman and Managing Director Yusuf K. Hamied said the U.N. decision should remove doubts in the minds of consumers about the quality of generic versions of drugs as compared with those made by companies holding the drug patent.

"What we've been saying all these years has been vindicated," he said.

Cipla is among a dozen companies in India that produce AIDS drugs using techniques different from those of the companies who hold the patent. India recognizes patents on drug-making processes but not the products, making it legal to reproduce a patented drugs if the manufacturing process used is slightly different.

The Nobel Prize-winning aid group Medecins Sans Frontieres welcomed the inclusion of generic manufacturers.

"In our experience, competition is really the driving force for having a good level of price for developing countries. We cannot only rely on charity," said Dr. Bernard Pecoul, director of the group's medical access campaign.

Although many developing countries have patent laws that would normally prevent governments from buying cheaper generic drugs, many insist that they should have more leeway when dealing with public health.

Members of the World Trade Organization agreed last year that governments should have the flexibility to override patent laws under certain circumstances when dealing with crises in public health.

HIV/AIDS is a major problem for many developing countries, especially in sub-Saharan Africa. Of the 40 million people who are HIV positive in the world, 28 million live in Africa. The disease is also spreading rapidly in Asia and the Pacific region, and in parts of the former Soviet Union.

In rich countries, AIDS treatments can often cost more than $10,000 a patient each year. Although the prices are much lower in developing countries, aid groups and governments claim the drugs are still beyond the reach of most people.

Last year Cipla said it would sell a three-drug, anti-retroviral cocktail to Medecins Sans Frontieres — also known as Doctors Without Borders — for $350 a year per patient and would also make the low-cost offers to governments of poor countries.

WHO says its list provides guidance for governments and medical staff purchasing drugs who would be unable to make their own quality checks.

It lists products that have been made according to "good manufacturing practices" and up to WHO recommended standards of quality. The list includes 11 anti-retroviral drugs and five drugs to treat infections that take advantage of the body's weakened defenses. Thirteen suppliers and 100 products are being reviewed.

"We expect that the list will grow steadily as more companies take an interest in participating and countries expand their HIV/AIDS programs," the WHO's Quick said.