[Ip-health] IFPMA on WHO list of drugs

[Mike Palmedo]

I thought the report pretty much discredited this phrma line...

http://biz.yahoo.com/ap/020321/un_aids_drugs_6.html

Drug manufacturers: approving generic AIDS drugs could reduce quality
By NAOMI KOPPEL
Associated Press Writer

GENEVA (AP) -- United Nations approval of generic HIV/AIDS drugs could
reduce quality of treatment in poor countries and might lead to
widespread drug resistance, the federation that represents international
pharmaceutical companies said Thursday. 

The World Health Organization on Wednesday produced a list of 41 drugs
by eight manufacturers that met its criteria for quality. It includes
products made by the Indian generic manufacturer Cipla as well as by big
research companies like Bristol Myers Squibb and Roche. 

"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. 

"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 such issues as good use and
preventing resistance are handled within a country's own health system. 

Cipla Chairman and Managing Director Yusuf K. Hamied said the U.N.
decision removes the doubts in the minds of consumers that the generic
versions of drugs may not be as good as the product of the companies
that hold the 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
different techniques from those of the patent-holding companies. It is
legal in India, which recognizes patents on drug-making processes and
not the products. 

The medical aid group Medecins Sans Frontieres said it was pleased that
the list included generic manufacturers of patented drugs. 

"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. 

Of the world's 40 million people who are HIV-positive, 28 million are 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 cost more than $10,000 per
patient per year. 

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 low 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. Another 13
suppliers and 100 products are being reviewed.