E-drug: Amir, IIPI and Boston Globe on patents in Africa
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Amir and Lee Gillespie-White long promissed study on patents in
Africa is out. The earlier version presented in London indicated that
37 countries in Africa have patents on Combivir, probably the single
most important HIV combination, but few have patents on protease
inhibitors, drugs that are most costly to manufacture, and to which
patents are not the binding constraint in Africa. Amir and White
basically ignore the price differences between the patented and
unpatented versions of various drugs, particular the nuke and
non-nuke combinations, and are drawing the conclusion that
patents are not important in determining access to medicines,
which is fairly twisted reading of the data on prices. IIPI is an
industry funded NGO, and Amir's work on this has been peddled by
Merck for months as evidence that patents aren't an issue, and was
used by the US government in the TRIPS council discussion to say
the same thing. Of course the big price competition from the
generic sector for AV drugs is very new, less than one budget cycle
away, so it's early to predict what the bottom following of the
non-nuke cocktail market will mean.
I'm in South Africa today working on a compulsory licensing case,
and my immediate reaction was while it is nice of course to publish
some data on patents in Africa, what is the point of drawing such
stupid conclusions in the paper, and making such stupid quotes in
the press. Every country in Africa with any bit of a market has
quite a few patents on nuke and non-nuke products, certainly
enough to make a program of treat problematic. In South Africa he
reports patents on 10 products, in Botswana, Gambia, Kenya,
Sudan, Uganda, Zambia and Zimbabwe six products, in Ghana,
Lesogtho and Swaziland 5, and in Malawi, Seychelles and Tanzania
4. Taken together, that's a lot of HIV cases. And the smaller the
remaining market, the harder for the generic entrants to obtain the
economies of scale to do much.
The lack of patents on the PIs is of course interesting and important
info, but there are also probably the only class of drugs that can't
be manufactured at very low prices right now, and I'm not sure
what the lesson is here.
Of course African countries face lots of problems, a point made by
lots of people much better than in this paper, and more money is of
course needed. But if Amir and IIPI are saying that the IPR issues
aren't important in Africa, they have a funny agenda, and of
course, Merck, IFPMA and others have what they are looking for,
so welcome to the IFPMA PR team.... I guess. I went over this
paper with Amir earlier this summer, and spent some time
explaining that while the data was interesting, the conclusions were
stupid, and it ignored the evidence of how generic competition has
pushed down prices for these products over the past 3 years, the
fact that you need particular combinations of drugs for treatment so
barriers in one product affect access to other products, the
relationship between generic entry in big markets and smaller
markets (Brazil fueling the decline in global raw materials prices),
the inability to look realistically at the brief period after the CIPLA
offer, the other regulatory barriers to generic entry, the dynamic
benefits from competition, the future of patent protection under
AGOA and TRIPS, how the treat of compulsory license in the case
of fluconazole lead to the Pfizer donation, and anything else that
would make Merck unhappy with the study. It was about as
one-sided of an arguement that one could imagine, and I'm still not
sure what the point of this is. It has been well known for some
time that historically patent filings are uneven in the Africa market.
If anything, the fact that combivir, an important product, is under
patent in 37 African countries, is much more than most of us
thought.
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036, USA
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030 fax 1.202.234.5176
mobile 1.202.361.3040
<SNIP>
The survey of patents is being done by Amir Attaran, a health
specialist at the Center for International Development at Harvard,
and Lee Gillespie-White of the International Intellectual Property
Institute, a Washington-based nonprofit group. Attaran said
yesterday that the survey shows that the lack of anti-retroviral
drugs for people with HIV or AIDS "has little to do with patents."
"That's the point," he said. "It's kind of amazing, considering how
much has been made of it" by AIDS activists, pharmaceutical
companies, and the media.
<SNIP>
"There's a very small number of drugs patented in Africa," Jeffrey
P. Kemprecos, director of public relations for Merck & Co.'s Europe,
Middle East, and Africa division, said at a meeting for congressional
staff in July on Capitol Hill. "This study finds that 16 percent of the
drugs are patented. That means 84 percent of Africa is a free-fire
zone for generic drugs."
<SNIP>
Asia Russell, an activist at ACT UP-Philadelphia, said that
GlaxoSmithKline's drug combivir, a double-combination AIDS
medication now used in some developing countries, has patent
protection in a majority of African countries.
Eric Sawyer, a longtime AIDS activist and founder of ACT UP, also
said drug companies in the past have threatened lawsuits for drug
sales not covered by patents, forcing countries and generic makers
to back away from deals.
--------------------------------
http://www.boston.com/dailyglobe2/237/nation/Africa_may_skirt_p
atent_to_get_drugs+.shtml
Africa may skirt patent to get drugs
By John Donnelly, Globe Staff, 8/25/2001
WASHINGTON - Lost amid the noisy fighting over access to AIDS
drugs in the poor world lies a startling fact: The vast majority of the
medicines are not protected by patents in Africa, leaving no legal
barrier for most cheap knockoff drugs to enter the markets. A
survey now underway of multinational pharmaceutical companies
has found that 84 percent of AIDS drugs are not under patent
protection in Africa. One exception is South Africa, where 11 of 15
most commonly used drugs are under patent, according to the
survey. The news does not mean that a flood of AIDS medication
will be unleashed into Africa. Other hurdles remain, notably
affordability, political commitment from heads of state in the rich
and poor worlds, and developing health services needed to oversee
proper use of the medication. Still, at a time when drug makers
have brought lawsuits or threatened legal action against countries
and against generic drug makers who plan to distribute copycat
medication, the survey's findings are likely to give producers and
African health ministers more confidence about entering into
agreements. The urgency of getting the drugs to the poor world
was underscored this week when Brazil announced that it was
giving a local manufacturing plant the license to make an anti-AIDS
drug that is under a patent held by the Swiss drug giant Roche.
Brazil acted under laws that allow it to sidestep patent protection
by invoking a national emergency or saying the public sector will
distribute the product for no profit. The issue of access also is the
subject of a private meeting on Monday and Tuesday at Harvard,
called by Barry R. Bloom, the school's dean of public health. About
30 specialists will talk about setting up a so-called AIDS drugstore,
which would buy drugs in bulk, drive down the prices, and
distribute the medication only to countries or programs employing
proper oversight. Among those expected to attend are Richard
Holbrooke, the former US ambassador to the UN who is now
leading an effort to get corporations more involved in the AIDS
fight; several pharmaceutical company representatives; senior World
Health Organization officials, including J.W. Lee and Jonathan
Quick; and Henk den Besten, head of the International Dispensary
Association, a nonprofit generic drug maker and procurement agent.
More than 25 million Africans are now estimated to have HIV or
AIDS. Six countries report that more than a quarter of their adults
age 18 to 49 are infected, with scant hope that many would soon
receive life-extending medication now readily available in the West.
The survey of patents is being done by Amir Attaran, a health
specialist at the Center for International Development at Harvard,
and Lee Gillespie-White of the International Intellectual Property
Institute, a Washington-based nonprofit group. Attaran said
yesterday that the survey shows that the lack of anti-retroviral
drugs for people with HIV or AIDS "has little to do with patents."
"That's the point," he said. "It's kind of amazing, considering how
much has been made of it" by AIDS activists, pharmaceutical
companies, and the media. "What's impeding access? Money," he
said. "Even in the case of Namibia, which has a decent health care
system, a hell of a national AIDS program, there are zero
anti-retroviral drugs. Why is that? Because they are broke."
Jim Yong Kim, an infectious disease specialist at Harvard, said he
hoped the survey would "make the case in a very public way that
it's OK for generic manufacturers and generic procurement agents
to move these drugs to African countries." "If pharmaceutical
companies try to put a stop to it, there would be a public outcry,"
he said. Drug company representatives are well aware of the
patent matter. "There's a very small number of drugs patented in
Africa," Jeffrey P. Kemprecos, director of public relations for Merck
& Co.'s Europe, Middle East, and Africa division, said at a meeting
for congressional staff in July on Capitol Hill. "This study finds that
16 percent of the drugs are patented. That means 84 percent of
Africa is a free-fire zone for generic drugs." Kemprecos said most
drug companies declined to seek patents for their medication
because there "wasn't a commercial reason to do so." "Until there
are drastically discounted prices of drugs, we face the same issue
Cipla faces: There isn't a sufficient amount of money to buy drugs
on a massive level needed," he said. Cipla, an Indian generic drug
manufacturer, started a freefall in prices for AIDS medication in
February by agreeing to sell a combination of AIDS drugs for $350
a year per patient in the poor world. Since then, the price for some
generic combinations has dipped below $300, while the large
pharmaceutical companies are offering $1,000 combinations to the
developing world. In the United States, such medication costs
$10,000 and $15,000 per year. Some health care analysts,
however, say patents still will play a role in preventing wider
distribution of drugs in Africa. Asia Russell, an activist at ACT
UP-Philadelphia, said that GlaxoSmithKline's drug combivir, a
double-combination AIDS medication now used in some developing
countries, has patent protection in a majority of African countries.
Eric Sawyer, a longtime AIDS activist and founder of ACT UP, also
said drug companies in the past have threatened lawsuits for drug
sales not covered by patents, forcing countries and generic makers
to back away from deals. Last year, Pfizer helped stop a planned
sale of the drug fluconazole from a Thailand generic manufacturer
to Kenya, even though no patents existed on the drug in either
country. If patents were not an issue, other factors stand in the
way of distributing the drugs, said Julian Fleet, a senior policy
adviser at UNAIDS in Geneva. "One is affordability, and there are a
number of factors that go into making a drug high-priced to the
consumer, including import duties or taxes.
Another is sustainable financing. And not least important is an
adequate health system to ensure that drugs are properly prescribed
and that patient compliance is properly monitored," he said. He
said the ultimate solution is likely to involve giving drug companies
enough intellectual property rights protection to ensure profit and
stimulate new research into AIDS drugs and vaccine. That needs to
be balanced, he said, by making sure that "intellectual property
rules are not an obstacle to providing the medicine to people."
John Donnelly may be reached by email at donnelly@globe.com
<mailto:donnelly@globe.com>.
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