[e-med] DES TRITHERAPIES A MOINS D'UN DOLLAR PAR JOUR

[press@paris.msf.org]

E-MED: DES TRITHERAPIES A MOINS D'UN DOLLAR PAR JOUR
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[ci-joint le communiqué de presse de MSF et les réactions de Cipla. CB]

 Communiqué de presse de Médecins Sans Frontières

 DES TRITHERAPIES A MOINS D'UN DOLLAR PAR JOUR

 MSF défie l'industrie pharmaceutique de concurrencer les prix des
médicaments génériques

 Paris, le 7 février 2001 - Médecins Sans Frontières (MSF) a accueilli
positivement l'annonce faite par CIPLA, un producteur indien de médicaments
génériques, de lui vendre son traitement contre le SIDA (trithérapie) pour
350$ par an et par patient et aux gouvernements pour un prix de 600$. Les
détails de cette offre précisent que les achats effectués par les
gouvernements doivent être " garantis " par MSF, ce qui n'est ni pratique ni
nécessaire. MSF demande donc que CIPLA offre directement ce prix aux
gouvernements et aux agences des Nations Unies.

 Cette offre illustre le fait que le prix de 200$ par année pour une
trithérapie, présenté comme un objectif majeur par MSF à la conférence sur
le SIDA de Durban en juillet passé, est presque atteint. Ce prix de 350$
représente une baisse de 96,6% par rapport au prix de la même combinaison de
médicaments aux Etats-Unis, qui coûterait environ 10'400$.

 A court terme, MSF invite les cinq compagnies pharmaceutiques impliquées
dans l'initiative d'ONUSIDA (UNAIDS Accelerating Access Initiative)
d'aligner leur offre sur celle de CIPLA, de rendre leurs prix publics et
d'accélérer la mise en place de mesures concrètes, de manière à ce que des
médicaments soient rapidement fournis aux patients. L'offre de CIPLA
démontre que les grandes compagnies pharmaceutiques peuvent encore réduire
leurs prix. Lors de la journée mondiale du SIDA, MSF avait demandé sans
succès aux cinq compagnies partie prenante à l'initiative d'ONUSIDA
d'abaisser leurs prix  pratiqués aux Etats-Unis de 95%.

 Toujours dans le cadre de cette initiative, le Sénégal paye actuellement
entre 1008 et 1821$ par traitement par an - presque le triple d'un
traitement générique - et les grandes compagnies ont  refusé de révéler
leurs prix pour l'Ouganda et le Rwanda.

 L'engagement politique et l'amélioration de l'accès au soin sont des
éléments fondamentaux dans la lutte contre le SIDA. Au Brésil l'engagement
politique du gouvernement a permis de limiter de moitié les décès dus au
SIDA, en grande partie grâce à la production de médicaments génériques. De
gros producteurs, y compris le gouvernement du Brésil, peuvent à la fois
approvisionner en médicaments d'autres pays en voie de développement et
appuyer le lancement de production nationale dans de nouveaux pays.

 Les pays en voie de développement devraient pouvoir bénéficier pleinement
de leurs droits de produire ou importer des médicaments génériques contre le
SIDA comme mentionnés dans les accords ADPIC  conclus à l'Organisation
Mondiale du Commerce.

 Le défi dans l'immédiat est de pratiquer réellement ce prix générique. La
communauté internationale doit pour cela fournir un soutien politique,
pratique et financier. Un appui politique est nécessaire pour permettre aux
pays en voie de développement de surmonter les barrières liées aux brevets.
Le système onusien peut prendre en charge les aspects pratiques de la
distribution. Les donateurs peuvent apporter l'appui financier nécessaire en
allouant suffisamment de fonds pour l'achat de médicaments et la mise en
place de programmes de traitement aux antirétroviraux. Une réunion
internationale devrait immédiatement rassembler pays en voie de
développement, agences de l'O.N.U., fabricants de médicaments et bailleurs
de fonds pour déterminer la meilleure stratégie à mettre en place.

 Pour plus d'information, vous pouvez contacter
Cécile Guthmann au 01 40 21 29 17.
press@paris.msf.org


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E-DRUG: Reactions on Cipla's ARV price reduction offer
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[crossposted from Pharm-Policy with thanks. Sources:
http://www.cipla.com/whatsnew/ciplanews.htm
http://interactive.wsj.com/articles/SB981583719750566041.htm
AP, The Times of India, UNAIDS, Wall Street Journal.
All copied as fair use. WB]

Cipla offers cheap AIDS drugs

New Delhi, Thursday 8 February 2001: Indian drug company Cipla Ltd. has
offered to sell an AIDS cocktail that costs $10,000 a year per patient
to an international aid agency for only $350, the company's chairman Dr
Yusuf Hamied said on Wednesday.

The decision by the Mumbai based company could revolutionise the
treatment of HIV patients in developing countries, where the virus is
most rampant.

Cipla will sell the three drug, anti-retroviral cocktail to 'Doctors
without Borders', a Paris-based medical aid agency, at the discounted
price as long as they agree to distribute the drug for free, said Dr
Hamied. Similar drug cocktails often sell for between $10,000 and
$15,000 per patient, per year in the United States and Europe.

"This is my contribution to fighting AIDS," Hamied said, adding that the
inspiration for his decision came from the January 26 earthquake in
Gujarat, where more than 17,000 people have been confirmed dead, and the
outpouring of aid for the 1 million people left homeless.

"AIDS is going to be a bigger holocaust in India than the earthquake,"
Hamied said.

The key to the program, Hamied said, is a three-tiered pricing scheme
where wholesalers pay $1,200 for enough drugs to treat one patient for a
year; governments would pay $600 for the same amount of drugs; and
'Doctors without Borders' would pay $350.

"We're not making money, but we are not going to lose money either,"
Hamied said. "With the average of the three prices, we should break
even."

The cocktail consists of two 40 milligramme tablets of stavudrine, two
150 milligramme tablets of lamivudine and two 200 milligramme tablets of
nevirapine.

Hamied said Cipla was able to manufacture the drugs so cheaply because
his company makes the raw materials and production costs in India are
low.

One stumbling block may be the patents on the drugs held by Western
pharmaceutical companies and whether governments of poor countries would
be willing to waive local patent laws by issuing compulsory licenses,
possibly angering the big drug companies.

Bristol-Meyers Squibb holds the patent on stavudrine under the brand
name Zerit; GlaxoSmithKlein of Britain developed lamivudine, also known
as Heptovir; and Boerhinger Ingelheim of Germany holds the rights to
nevirapine under the name Viramune.

A spokesman for GlaxoSmithKlein in London, Phil Tompson, said the
company was not consulted about Cipla's offer and was waiting to see the
details.

"It would appear that the offer is partially one of donation. As a
consequence of that, questions have to be raised about the
sustainability of the offer. Certainly questions need to be answered,"
Thompson said.

Officials from 'Doctors without Borders', Bristol-Meyers Squibb and
Boerhinger Ingelheim were not immediately available for comment.

Hamied said Cipla cannot be sued in India and that it was up to 'Doctors
without Borders' to work out the legalities of importing the drugs into
the countries where they work.

"Any government that wants to buy and distribute the drug is welcome,"
Hamied said. "(Doctors without Borders) can take it anywhere they want,
but they must give it away for free."

'Doctors without Borders' has campaigned for two years to convince
Western pharmaceutical companies to cut drug prices.

The aid agency operates 40 AIDS projects worldwide, about half of them
in sub-Saharan Africa, home to 70 per cent of the world's 36 million
AIDS cases. Some African countries spend only $5 a year per capita on
health care.

Hamied said he hoped his offer would "wake up" the government in India,
where doctors say 3,500 people a day are infected with HIV, the virus
that causes AIDS. More than 50 million Indians will be infected by 2005,
Hameid said.

GlaxoSmithKlein, Bristol-Meyers Squibb and Boerhinger Ingelheim have all
agreed to participate in the International Partnership Against AIDS in
Africa initiative, which will supply drugs at a discounted price to the
governments of developing countries, but the prices are still about
$1,100 per patient, per year.

Critics of the cheaper drugs argue that patients taking the drugs must
be closely monitored in a well-equipped clinic, something that is rare
in developing countries. AIDS activists, though, say that Western
doctors are too cautious and that the problem is to large to deny those
with HIV access to the drugs. (AP)

- The Times Of India

http://interactive.wsj.com/articles/SB981583719750566041.htm

February 8, 2001

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Drug Industry, AIDS Community
Is Jolted by Cipla AIDS-Drug Offer
By RACHEL ZIMMERMAN and JESSE PESTA
Staff Reporters of THE WALL STREET JOURNAL

The sudden offer by an Indian drug manufacturer to sell lower-priced
AIDS drugs in Africa has sent a jolt through the drug industry and the
international AIDS community, but many questions remain about whether or
how poor countries could take advantage of it.

Dr. Y.K. Hamied, chairman and managing director of Cipla Ltd., Bombay,
India, the generic-drug maker, said he will sell a combination of three
AIDS drugs for $600 per patient per year to governments that want to buy
the therapy. Dr. Hamied said he would lower the annual price even more,
to $350 a patient, to Doctors Without Borders, an international
nonprofit organization that provides medical services in the developing
world. Both prices are much lower than the typical annual cost for the
AIDS-drug cocktails in the U.S. and Europe, where the average cost is
$10,000 to $12,000. The Cipla offer was first reported by The New York
Times this week.

Abbott AIDS Drug Didn't Make Patients Resistant to Other Drugs

More HIV Strains That Resist Drugs Are Being Spread

Dr. Hamied's offer is only a gesture at this time and in many ways is
limited by a number of political and logistical factors. It isn't clear
whether countries will accept the particular combination of drugs the
company is offering; whether the price is low enough; who will
distribute the drugs; who will provide support and testing that usually
accompany such complex treatment; and how difficult cultural and
political barriers to treatment will be overcome.

But Cipla's offer is still expected to shake up negotiations taking
place between some African countries and the group of five big
pharmaceutical companies. What is especially significant about Cipla's
action is that its price appears to be even lower than a
sharply-discounted price a group of drug makers is offering to nations
in Africa.

The Cipla offer "changes everything," said Toby Kaspar, based in South
Africa as an official of Doctors Without Borders. "Every one of those
countries should use the Cipla offer to help them make a better deal
with the big drug makers."

Last May, under intense pressure to lower their prices in Africa and
other developing nations, five drug companies, including Merck & Co.,
Bristol-Myers Squibb Co., New York, and Britain's GlaxoSmithKline PLC,
offered to sharply reduce the prices for their AIDS medicine to nations
in sub-Saharan Africa, where the epidemic has become a human
catastrophe. Negotiations with those nations have moved slowly, but
three nations, Senegal, Uganda and Rwanda, have agreed with the drug
makers on a set of prices for various combinations of the drugs. Only
Senegal has released the negotiated prices. It has said that people in
that nation can buy the drug combination for between $1,008 and $1,821
per patient per year.

The Cipla offer of $600 appears to involve a combination of drugs
resembling the one priced at about $1,008 in Senegal. The higher price
quoted to Senegal includes a powerful protease-inhibitor drug, such as
Crixivan, sold by Merck. Cipla's offer involves three anti-AIDS
medicines, but doesn't include a protease inhibitor.

Commenting on the Cipla price, Peter Mugyenyi, director of the Joint
Clinical Research Centre in Kampala, Uganda said, "It's a good offer but
it's still not good enough." Dr. Mugyenyi, a leading African AIDS
physician and researcher, said the price of the drugs "is finally coming
into the reach of top government salaries," noting that in Uganda there
is no health insurance or government drug-buying program. As a result,
even at $600 very few Ugandans will benefit from the offer, he said.

AIDS: The Global Picture
2000 figures, for adults and children

People living with AIDS: 36.1 million

New HIV infection: 5.3 million

Deaths due to HIV infection: 3.0 million

Cumulative number of deaths: 21.8 million

Source: UNAIDS

Moreover, the Cipla offer carries numerous qualifications. Cipla is
offering to sell just three of the roughly 10 drugs commonly combined to
form the so-called AIDS cocktail therapy. Those drugs are Zerit, from
Bristol-Myers; Glaxo's 3TC, and the German company Boehringer-Ingelheim
Gmbh's Viramune. Spokespersons at several of the large drug makers said
their offer of price discounts involves more drugs and therefore
provides doctors the ability to prescribe different combinations for
different patients.

Guy Macdonald, a vice president at Merck, Whitehouse Station, N.J., said
there remain too many variables in the Cipla offer to fully estimate its
impact. "Are they going to provide it to 20 or 30 countries in Africa?
Are they going to provide sustainable products? And what about quality?"
Mr. Macdonald asked.

Peter Dolan, president of Bristol-Myers and soon to become chief
executive, said that cutting prices isn't necessarily the answer to AIDS
treatment. He noted that India hasn't solved its own burgeoning AIDS
problem even though its generic-drug industry regularly ignores
intellectual-property rights.

The drug makers' coalition, which also includes the World Health
Organization and the United Nations AIDS program called Unaids, is
offering a program of reduced prices and a promise of other support
services, such as testing and counseling. The companies say negotiations
have gone slowly because the deals are being forged with one country at
a time. These talks, the companies said, involve sensitive political and
economic issues, as well as what the drug makers may provide in
financial assistance.

"We're concerned about long-term sustainability, about building an
infrastructure in which patients are managed appropriately," said Nancy
Pekarek, a spokeswoman for GlaxoSmithKline, which has offered to sell
its combination of two drugs, AZT and 3TC, for $2 a day.

Those two drugs alone, however, still cost more than the three drugs
being offered by Cipla.

The Cipla offer comes at a sensitive moment in international-trade
relations involving the major drug makers. In March, 40 international
drug companies are expected to go to court in South Africa to block that
country from importing or making generic drugs. South Africa had passed
a law several years ago to make such action legal. While major drug
makers have patents for their products in some African nations, such as
South Africa, in many countries the companies' products aren't
patent-protected.

Several nations, including South Africa, have said they are seriously
thinking about importing generic drugs by applying for a special waiver
from the World Trade Organization that allows the countries, in the case
of national emergencies, to bypass drug-company patents. Indeed, Mr.
Hamied of Cipla said he isn't worried about violating patent law or of
drawing a legal challenge from the companies. Instead, he said each
country must deal with the legality of importing his products.

"I'm not a salesman, I'm not a scientist," he said. "I've made an offer.
It's up to individual countries to decide, that's the way I look at it."

Ben Plumley, a Unaids staffer working on drug-access issues, said none
of the agreements between the drug makers and the countries prevents the
nations from exploring other options, such as buying generic versions of
the AIDS drugs. "Where the legal situation allows, competition does
bring down prices," Mr. Plumley said.

-- Robert Block in Johannesburg, South Africa, and Gardiner Harris in
New York contributed to this article.

Write to Rachel Zimmerman at rachel.zimmerman@wsj.com and Jesse Pesta at
jesse.pesta@wsj.com

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