[Pharm-policy] WSJ on CIPLA CL request

[love@cptech.org]

This WSJ article on the CIPLA request, which ran on page b6 of the
journal today, has this quote:
jl

"Officials privately say they are worried that should Cipla win its bid
to supply the country with cheap AIDS drugs, the government will not
have the budget to buy them or distribute them. "We are in real danger
that Cipla could open the door on the AIDS drugs barrier in this country
and we will not be able to walk through," said one health-ministry
official."

http://interactive.wsj.com/articles/SB984084641877481987.htm

 March 9, 2001  
 

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Cipla Sidesteps South African Fight
With a Bid to Offer Generic Drugs
By ROBERT BLOCK 
Staff Reporter of THE WALL STREET JOURNAL


JOHANNESBURG, South Africa -- The South African government has been
tossed a hot potato by Indian drug maker Cipla, which asked Wednesday
for legal permission to supply the country with low-cost generic copies
of patented AIDS medicines.

The gambit by Cipla Chief Executive Yusuf Hamied for a "compulsory
license" for eight anti-retroviral drugs used to treat AIDS completely
sidesteps the landmark legal battle between South Africa and 39 leading
pharmaceutical companies over drug-patent rights. The lawsuit, which
opened this week, has been postponed until April 18 to give the drug
makers more time to challenge a 1997 law that allows the government wide
discretion to limit patent rights in order to import cheaper medicines.

AIDS Fighters Win Skirmish in South African Legal Fight (March 7)

Price War Breaks Out Over AIDS Drugs in Africa as Generics Present
Challenge (March 7)

AIDS Epidemic Puts Drug Firms in a Vise: Treatment vs. Profits (March 2)

Bush Won't Alter Clinton's AIDS Policy Despite Criticism From Drug Firms
(Feb. 21)

Drug Industry, AIDS Community Is Jolted by Cipla AIDS-Drug Offer (Feb.
8)
 
Cipla's request tests claims by the drug giants that the legislation
under dispute is unnecessary because patent law allows the government
more acceptable alternatives such as granting compulsory licenses in
emergencies to achieve the same goal. But the request could also prove
to be a trial of the government's assertions that the drug firms'
reluctance to provide affordable medicines is at the heart of its own
poor response to the AIDS epidemic sweeping the country. An estimated
four million South Africans are believed to be infected with the virus
that leads to the disease.

Some critics suggest that the government, which only a year ago was
pilloried for its policies questioning the link between HIV and AIDS and
dismissing AIDS drugs as "toxins" might be using the lawsuit and the
negative publicity it has focused against the drug companies to restore
its own tattered credibility. They warned that the government risked
slipping back into disrepute if the Cipla opportunity was squandered.

Officials privately say they are worried that should Cipla win its bid
to supply the country with cheap AIDS drugs, the government will not
have the budget to buy them or distribute them. "We are in real danger
that Cipla could open the door on the AIDS drugs barrier in this country
and we will not be able to walk through," said one health-ministry
official.

Mr. Hamied said so far neither the government nor any of the drug
companies that own the patents he plans to copy have tried to contact
him.

Mirryena Deeb, the head of the Pharmaceutical Manufacturers Association
of South Africa, a trade group party to the lawsuit against the
government, told a news conference Thursday that her organization had no
plans to challenge Cipla's request. "On the contrary, we welcome it
because it proves what we have been saying all along: that we are only
against [the 1997 law] and not access to cheaper drugs," she said.
However, she added that some PMA members, which include the large
international firms, might challenge the application in their individual
capacity.

Cipla told the Registrar of Patents at the Department of Trade and
Industry in a letter on Wednesday that it was eligible for a compulsory
license because the large pharmaceutical companies had abused their
patent rights by failing to meet demand "on reasonable terms." Now the
government must examine its argument and hear any challenges by patent
holders.

But according to Stephen Saad, Chief Executive of Aspen Pharmacare,
South Africa's largest generic-drug manufacturer, the government could
at any time declare AIDS a national emergency and grant compulsory
licenses to make generic AIDS drugs without a challenge. Prepared for
such an event, Aspen already has a contract with Cipla's Indian rival
Hetero to make three generic AIDS drugs in South Africa. "We're just
waiting for the government to give the word. It's just not coming," he
said.

Health Minister Manto Tshabalala Msimang says she ruled out the option
after a meeting of African Health ministers last year concluded that
national emergencies could only be called for a temporary period of
time, which is not sufficient to deal with the AIDS problem on the
continent.

Write to Robert Block at bobby.block@wsj.com