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Issue 8, May 2002
Innovation vs. Access:
Two Epidemics Transform the Pharmaceutical Patent Law Debate into an International Controversy
Shawna Williams
Biochemistry, Colorado College
williams@jyi.org
It
looked like a clear-cut case of arrogance, even hypocrisy. The United
States government, which for years had defended the patent rights
of pharmaceutical companies from South African efforts to obtain
affordable anti-retroviral drugs for its many HIV-infected citizens,
seemed to execute a shameless about-face when it encountered a national
crisis of its own: anthrax.
The facts are these: In 1997 South Africa, faced with a mounting
death toll from its AIDS epidemic, passed a law allowing it to manufacture
or import generic drugs from countries such as India and Thailand,
which do not have drug patent laws, as long as it paid the patent
holder a "wholesale" fee. PHARMA, a U.S. trade association
of the pharmaceutical industry, quickly jumped into action, hiring
lobbyists who helped persuade the Clinton administration that the
act was a violation of international trade and patent agreements,
and to put pressure on South Africa to revoke its new legislation.
In 1998 the United States put South Africa on a watch list, a warning
that trade sanctions could follow. Then the 39 pharmaceutical companies
of PHARMA filed suit against the South African government, even
naming its highly popular then-leader, Nelson Mandela, as the "First
Responder." Two years later, in what many saw as a bid to avoid
creating more of the bad publicity that resulted from these actions,
the companies dropped their suit, claiming they were willing to
work with the South African government to develop affordable solutions
to its drug shortages.
Months later, when a spate of anthrax mailings in the United States
prompted the U.S. government to create a stockpile of the anthrax
antibiotic Cipro, President Bush spoke of overriding Bayer's patent
on the drug in order to obtain cheap, generic alternatives. He explained
that this action was justified by a provision in World Trade Organization
(WTO) guidelines that allows governments to override patents in
times of national emergency. Ultimately, Bayer was to strike a deal
with the American government to provide Cipro at a lower cost in
return for the continued integrity of its patent, but this did not
prevent the incident from receiving international attention. In
November of last year, weeks after striking its deal with Bayer,
the U.S. government supported a change in WTO policy to allow countries
to seek a patent waiver from the WTO when public health reasons
compel it.
To many, this about-face was an instance of the United States putting
its own and corporate interests above those of poorer countries.
The answer to why fewer than 20 anthrax infections in the United
States constitutes an emergency, while millions of HIV-infected
South Africans does not, appears simple to many: power.
"To me, [then-Vice President] Al Gore … never in his life bucked
corporate interest. He hasn't shown any character by bucking big
money," said James Love, director of the Consumer Project on
Technology in 2000. Love was referring to Gore's role in applying
diplomatic pressure on South Africa to reverse its 1997 law and
preserve the drug giants' patents. Activists like Love allege that
as far as developing countries are concerned, pharmaceutical companies
callously value profits above human life, pricing anti-retrovirals
and other medications far out of reach while doing everything in
their power to ensure that other labs are not permitted to manufacture
and sell the drugs at lower cost.
Supporters of the pharmaceutical industry argue an economic position
that lacks the emotional appeal of 5 million dying men, women, and
children. They claim that selling their products at far above the
cost of manufacturing them is the only way to recoup the enormous
costs of years of research and development, and continue to fund
research.
Frank Kane, a business editor for the British newspaper The Observer,
criticizes the popular view of South Africa's dispute with the drug
companies as a battle of "good versus evil." He explains,
"Without present profits, the stream of future drugs dries
up, plain and simple. The only assets drugs companies have are their
patents, which ensure this revenue stream."
Pharmaceutical companies and many economists claim that if a company's
patents, which award it sole rights to market its products for 20
years, are not adhered to, then investment in research and development
will dwindle. New drugs will cease to be created, and everyone will
suffer the consequences.
The real situation, though, is more complicated than either of these
two viewpoints. South Africa's AIDS problem goes far beyond the
prohibitive expense of anti-retrovirals. The widespread myth that
sex with a virgin will cure a man of AIDS has contributed to a rise
in the number of reported cases of child rape, including a recent
notorious trial of a handful of men for the rape of a baby just
nine months old.
The obvious first step in stopping the AIDS epidemic is education,
as Secretary of State Colin Powell pointed out while in Africa last
year. "We don't want to lose focus on prevention," he
said, adding, "The great humanitarian necessity is to get the
young generation to protect themselves."
Prevention, though, is of no help to those millions already infected.
According to South Africa's director-general, Ayanda Ntsaluba, even
if the government obtained cheap AIDS drugs, it lacks the health
care infrastructure to monitor the administration of them to all
who need treatment. And this is a big "if," since the
state might not be able to afford all the anti-retrovirals its population
needs, even at manufacturing cost.
If the world needed a clear indication of the high hurdles that
must be overcome in South Africa's battle against AIDS, it came
with the government's recent announcement that it will distribute
the drug Nevirapine only in some pilot hospitals, despite the fact
that the drug's maker, Boehringer-Ingelheim, has offered to provide
it free for the next four years.
Nevirapine has been shown to prevent the transmission of HIV from
mother to child in about 50% of cases if administered at birth,
but the South African state asserts that more studies must be done
before it can be provided universally. Western scientists are coming
to realize that such use of Nevirapine can result in the virus mutating
resistance to the drug in a significant portion of women. Such resistance
severely limits their options for successful treatment in the future.
As South African Health Minister Manto Tshalbalala-Msimang points
out, "We, as a government, cannot say we've now provided Nevirapine
so we can go home." Without a broader AIDS treatment program,
the best that could result from widespread use of Nevirapine would
be an even greater number of orphans.
Weakening the pharmaceutical companies' argument, on the other hand,
is the fact that free market forces are not solely responsible for
the development of new drugs. The U.S. government has spent billions
of public dollars on the research and development of AIDS drugs,
contributing to the development of most of those on the market today.
One group that vocally supported South Africa's stance in the pharmaceutical
dispute was composed of students and professors at Yale University.
It was at Yale that d4T, the main component in the popular anti-retroviral
Zerit, was developed. Although Yale, a non-profit organization,
received millions of dollars in royalties for its role in formulating
Zerit, some members of the university's community felt its distributor's
actions in South Africa were unacceptable. So while pharmaceutical
stock prices have been shown to drop when patents are threatened,
reflecting a drop in investor confidence, private investments do
not alone provide the impetus for new discoveries.
Often overlooked in this dispute of "people versus profit,"
as some have termed it, is a crucial question. Pharmaceutical companies,
whose AIDS treatments may run to tens of thousands of dollars per
year, could not have hoped to sell them at this price in impoverished
sub-Saharan Africa. So why didn't they sell them at the cost of
production, or allow other companies to do so? These other companies
wouldn't have profited, but the larger pharmaceutical companies
would certainly have saved money on lawyers and lobbyists.
One fear is that South Africa's law might set a precedent for policies
in wealthier countries, such as the United States, Canada, and European
nations, where the industry makes most of its profits.
Another is that drugs sold at reduced cost in the Third World will
find their way back to markets in North America and Europe, re-imported
through the so-called "gray market" as a way to save money.
History offers numerous examples of corrupt officials in developing
countries who have sold drugs donated to help those nations, and
sent the proceeds to private Swiss bank accounts. The high cost
of anti-retrovirals would present an even greater incentive for
Westerners to find ways of procuring them from developing countries,
should they become available there at reduced rates. This would,
indeed, cut into pharmaceutical companies' profits, and, by extension,
their ability to fund innovation.
Hidden in the heated debates over patents and profits, public funding
versus private, is a question that has no easy answer: Are the world's
rich to be the only beneficiaries of the latest advances? And if
not, if rich countries wish to make the latest miracle drugs available
to as many people as possible, then how should they go about it?
This story of two nations and their respective epidemics is just
one high-profile instance of the problems associated with the seemingly
ever-rising costs of health care.
Last May, Kofi Annan, the secretary general of the United Nations,
called for a $7 to $10 billion global fund to be set up to combat
the AIDS epidemic, only to receive a discouragingly small starting
donation of $200 million from the United States. To effectively
treat not only AIDS, but also other diseases common in the developing
world, would require a massive infusion of money from richer countries,
many of which face looming health care crises of their own. Clearly,
whatever stance one takes with regard to the morality of patenting
drugs, the bottom line in saving Africa from disease and famine
is money.
Suggested Reading
Borger, Julian. "Gore Accused of Working Against Cheap Aids Drugs."
Guardian. 10 Aug 1999. 3 April 2001. http://www.guardian.co.uk/Archive/Article/0,4273,3891133,00.html
Clark, A. and J. Borger. "Cheaper drugs for Africa." Guardian.
15 March 2001. 3 April 2001. http://www.guardian.co.uk/Archive/Article/0,4273,4152510,00.html
Crossette, B. and D. Sanger. "Annan in Washington to Seek AIDS
Funds." New York Times. 10 May 2001: A16
Denny, Charlotte. "WTO relaxes rule on drug patents." Guardian.
13 Nov 2001. 3 April 2002 http://www.guardian.co.uk/Archive/Article/0,4273,4297889,00.html
Kane, Frank. "Victory? This outcome will harm us all." Observer.
22 April 2001. 3 April 2002. http://www.observer.co.uk/business/story/0,6903,476407,00.html
Levings, B. and P. Kahn. "Phase I DNA vaccine trial begins in
Nairobi." Biotechnology and Development Monitor. 46 (2001):
8.
Lewis, Anthony. "Abroad at Home; Africa On the Agenda."
New York Times. 19 May 2001: A13
Mathiason, Nick. "Drugs: Round One to Africa." Observer.
22 April 2001. 3 April 2002 http://www.guardian.co.uk/Archive/Article/0,4273,4173653,00.html
Pollack, Andrew. "Defensive Drug Industry: Fueling Clash Over
Patents." New York Times. 20 April 2001: A6
"S. Africa Won't Give Nevirapine to All HIV+ Moms." Reuters.
21 February 2002.
South African Press Association (SAPA). "Drugs Case Over, AIDS
Patients to Wait." Financial Times. 19 April 2001. 15
April 2002. http://www.sapa.org.za/secure/login.cfm?CFID=101879&CFTOKEN=1831
Swarns, Rachel. "Child Rape Increasing at Alarming Rate in South
Africa." New York Times. 29 January 2002: A6.
Vulliamy, Ed. "How drug giants let millions die of AIDS."
Observer 19 December1999. 3 April 2001 http://www.guardian.co.uk/Archive/Article/0,4273,3943293,00.html
Journal
of Young Investigators. 2002. Volume Five.
Copyright © 2002 by Shawna Williams and JYI. All rights reserved.
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