E-DRUG: MSF/CIPLA ARV offer update
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[2 messages in 1: first a WallStreet Journal article asking where all the
buyers are. Secondly, a joint MSF/Cipla statement on how to access the ARVs.
Accessing generic ARVs is indeed not easy: there are patent, registration,
management and financial barriers:
In countries with pre-TRIPS patent protection, a compulsory license will be
needed to avoid patent infringement. WTO (Moore) has admitted they are
permissable under TRIPS, so developing countries should make sure they enable
these permitted "public health safeguards" in their national legislation.
In countries without pre-TRIPS product patent protection, generic ARVs can
probably be imported without infringement, as the patents for AZT, 3TC and
NVP were internationally filed before 1995, and thus they are not covered under
TRIPS (which only covers newly filed patents from 1 January 1996 for countries
without previous patent protection). Most African countries fall in this
category: they could import or start production without problems.
All countries will, however, need to register the CIPLA drugs for quality,
safety and efficacy; this will some time and money.
However, most Drug Regulatory Agencies allow an "exemption" system for
small-scale projects or emergencies.
Individual AIDS patients can legally bring in unregistered medication into
most countries provided it is for their own use and they have a legal prescription.
Any E-drugger who wants to report on small scale pilot projects where "triple treatment"
is being introduced in developing countries? Like the WHO advice on MTCT
(start small pilot projects, then scale up), ARV introduction requires substantial
training of health workers and patients, access to laboratory systems and other
managerial issues. This is, however, not so impossible as the industry sometimes
thinks!
Finally: USD 600 per year is a 94% reduction of the current cost of USD 10,000
per person per year, but it is still a lot of money. One would expect the private
sector, insurance companies and companies with AIDS programmes to take up these
cheaper drugs first. At USD 600 per year, it is probably cost-effective to
treat your skilled workforce as they then live many years longer, and fewer
people have to be trained.
For the public sector, developing countries would need substantial financial support
(grants rather than loans!) as the sheer volume of HIV+ people in Africa will make
it impossible to provide "triple treatment" in an equitable manner to all AIDS
patients.
The message is clear: Ministries of Health should start considering ARV policies
similar to Brazil, and prepare for a future where ARVs are available at USD 200 pp/year
or so (MSF prediction by end 2002). There is no excuse anymore for writing ARVs off as
"impossible, unaffordable" treatments in developing countries.
Let's discuss the practicalities of (slow but steady) implementation...
WSJ article copied as fair use. NN]
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February 23, 2001
Offer to Sell Cut-Rate AIDS Drugs
Failing to Draw Any Major Buyers
By ALIX M. FREEDMAN, RACHEL ZIMMERMAN and DANIEL PEARL
Staff Reporters of THE WALL STREET JOURNAL
An offer to sell AIDS drugs at an extreme discount in Africa has yet to
find a major buyer, largely because international relief agencies are
still wrestling over how to provide the life-saving medicines on a vast
scale.
Two weeks ago, Cipla Ltd. of Bombay, India, jolted the drug industry and
the public-health community with its surprise offer to sell a
combination of three AIDS drugs at the much-reduced price of $600 per
patient per year to governments that want to buy the therapy. Cipla said
it 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 of about $10,000
for the AIDS-drug cocktails in the U.S. and Europe, and also less than a
discounted price that big drug makers began offering in Africa last
year. But Cipla has yet to receive any orders. "We thought, in our
naivete, we'd have people calling us and saying 'fantastic,' " says Amar
Lulla, Cipla's joint managing director. "It was stupid naivete."
Indeed, as the initial euphoria over the offer has died down, the
potential buyers of Cipla's drugs say they are deeply frustrated by the
complexity of buying and distributing the medicines where they are
desperately needed.
For instance, there is uncertainty over the role Doctors Without Borders
will play. In an interview this week, Bernard Pecoul, a top official at
the group, stressed that it has no intention of becoming a global
distributor of AIDS drugs; it plans to place a limited order with Cipla
(as well as with other drug firms) for its pilot programs involving no
more than 6,000 AIDS patients in 20 countries.
"It is not at all part of our mandate to cover the world and be in
charge of distributing AIDS drugs -- that's much more the mandate of
U.N. agencies," said Dr. Pecoul, who directs the group's campaign to
increase access to essential medicines, such as lower-cost antibiotics.
Mark Stirling, an adviser on AIDS issues in New York for Unicef, met
with Doctors Without Borders on Wednesday to talk about the possibility
of distributing drugs from Unicef's central warehouse in Copenhagen. But
Mr. Stirling cautioned that Unicef will need, among other things, to get
"stronger commitments" from developing nations that AIDS is a top
priority. "There is still great reluctance from countries to address
this," he said, noting that his agency would need a sharp increase in
funding to buy and distribute the drugs, even at the price offered by
Cipla.
Officials at other U.N. agencies also are proceeding cautiously, saying
they need more information about the viability of Cipla's proposal.
Their questions include whether Cipla will maintain the price and
availability of its product, as well as the patent implications of using
a generic drug in various African countries.
A further difficulty is that Cipla has indicated it is prepared to offer
its government price of $600 only to those countries that have "the
backing of Doctors Without Borders." But the doctors' group says this
approach is impractical; it wants Cipla to make its "humanitarian" price
of $350 directly available to governments in the developing world.
"We aren't looking for a humanitarian price, but a global price for
governments," Dr. Pecoul said. He said that his "target price" for AIDS
drugs is even lower than what Cipla has proposed. At $200 per patient
per year, he believes the drug combinations become affordable for a
significant number of people in poor nations.
Even at $350, it isn't clear whether governments will embrace the Cipla
offer. For instance, in India, where some 3.7 million people are
infected with HIV, Prasada Rao, head of the National AIDS Control
Organization, said that it is unlikely his government could even afford
a $350-a-year price.
Despite widespread agreement that subsidies for AIDS drugs need to come
from rich countries and philanthropic foundations, interest remains
negligible. The World Bank is now weighing whether to make loans
available to countries to buy AIDS drugs. But Debrework Zewdie, the
bank's top AIDS official, said that loans alone aren't the answer. A key
part of the solution: "Rich countries need to get involved," she said.
Still, according to the World Health Organization, AIDS drugs are
unlikely to win funding subsidies from foundations and wealthy nations
until prices fall even further. Five large drug makers in May 2000
pledged to cut the price of AIDS drugs in poor nations. But so far, only
a tiny fraction of people infected with HIV in Senegal, Rwanda and
Uganda have benefited from this effort, largely because the African
nations say they don't have the money to buy drugs even at reduced
prices.
Now, in the wake of the Cipla offer, the pharmaceutical giants are under
even more intense pressure to cut costs and waive patent restrictions
that block their generic rivals -- and they too, have begun clamoring
for a coordinated political response. "Massive increases in donor
funding are the missing element when it comes to having a significant
impact on this pandemic," said Robert Laverty, a spokesman for AIDS-drug
maker Bristol-Myers Squibb Co.
Write to Alix M. Freedman at alix.freedman@wsj.com, Rachel Zimmerman at
rachel.zimmerman@wsj.com and Daniel Pearl at danny.pearl@wsj.com
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[2nd message]
E-DRUG: MSF/CIPLA statement on ARVs
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Joint Statement M�decins Sans Fronti�res & Cipla
Progress Reported on Implementation of Offer for
More Affordable Anti-AIDS Drugs
23 February 2001,Mumbai, India* Two days of discussions between M�decins
Sans Fronti�res (MSF) and Cipla Limited have resulted in clarification
of how the Cipla offer for affordable anti-AIDS drugs will be
implemented.
Governments of developing countries can immediately take advantage of
the offer for its triple-combination anti-retroviral drugs for $600 per
patient per year by contacting Cipla directly. This offer is available
without restrictions in time, geography or quantity. This is the first
time that across-the-board price reductions have been made available
without restrictions. The company will also provide similar level of
prices for its other antiretroviral drugs. Cipla cooperates with drug
regulatory authorities to provide all necessary documentation for
registration as required in individual countries.
MSF will integrate some of these drugs into existing protocols where
these drugs are already registered by national health authorities. The
organization is beginning antiretroviral pilot programs in approximately
10 countries. Sources of drug supply will vary according to
availability, registration and affordability.
To expand the offer of a humanitarian price ($350 per patient per year)
which has been made to MSF, Cipla agrees to examine several additional
possibilities, including working with third parties to increase the
number of patients that could be reached and treated.
Cipla is also open to have a dialogue with the relevant UN agencies. The
company also agrees to participate in meaningful discussions on
potential international procurement of antiretrovirals for developing
countries, along with developing country representatives, donors and
relevant members of the UN system.
A sample of Cipla's prices offered to governments:
A combination of stavudine (d4T) 40 mg tablets, lamivudine (3TC) 150 mg
tablets and nevirapine (NVP) 200 mg tablets, twice daily: $600 per
patient per year.
A breakdown of the above price offer for the individual drugs is as
follows:
d4T 40 mg : $70; 3TC 150 mg : $190; NVP 200 mg: $340.
Contacts:
M�decins Sans Fronti�res Cipla Limited
Daniel Berman corporate@cipla.com
Phone : 0041 79 286 9649 www.cipla.com
access-com@geneva.msf.org Phone : 0091 22 3082891/
www.accessmed-msf.org 0091 22 3095521
Fax : 0091 22 3070385
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