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SF Chronicle on trade policy and access to HIV/AIDS drugs
This ran on page 1 of the San Francisco Chronicle on Monday, May 24, 1999
jl
www.sfgate.com
New Crusade To Lower AIDS Drug Costs
Africa's needs at odds with firms' profit motive
Sabin Russell, Chronicle Staff Writer
Monday, May 24, 1999
c1999 San Francisco Chronicle
URL: http://www.sfgate.com/cgi-
bin/article.cgi?file=/chronicle/archive/1999/05/24/MN104738.
DTL
In the 18 years since he first showed symptoms of AIDS,
Eric Sawyer has been a fighter, battling his own disease
while agitating on the streets and in the halls of Congress
for more research and better drugs.
The payoff is an array of costly new pills that since
1996 have helped slash the American AIDS death rate in half,
and restored vigor and good health to Sawyer and tens of
thousands like him.
Now a new cause is tapping the fresh energy and
political instincts of American AIDS veterans, whose work
succeeded in changing U.S. drug approval policy. They are
helping in an international movement to let Third World
nations make cut-rate copies of the life-saving drugs.
''When you are no longer burying your friends, you have
the luxury of time to try to save people in more remote
areas,'' said Sawyer, a co-founder of ACT UP/New York.
''There is a tremendous sense of survivor guilt, which gives
us inspiration to fight harder.''
The problem is this: At Western market prices of $1,000
a month, the multidrug therapies are hopelessly out of reach
in the very countries hit hardest by the epidemic -- in
African and other developing nations where 90 percent of
AIDS cases occur.
Activists such as Sawyer, director of a new group
called the HIV/AIDS and Human Rights Project, think they
have found a solution:
By declaring health emergencies, impoverished countries
could sidestep patent laws and produce or import these drugs
at a fraction of the cost, making them available to
millions of destitute AIDS victims -- a market that big drug
companies would never touch.
But the quest to flood Africa with cheap AIDS drugs has
run headlong into conflict with American trade policy. High
level Clinton administration officials are blocking attempts
to tamper with AIDS drug patents, saying that they undermine
the entire system of intellectual property protection that
encourages businesses to find new drugs.
One of the best examples of this new front in the
battle over AIDS drugs is South Africa, where a recently
enacted law would override pharmaceutical company patents
and allow ''gray market'' imports of cheap drugs from other
countries.
Prescription drug prices vary dramatically from country
to country, based on deals cut by the manufacturer. The
antibiotic Amoxicillin, for example, costs 50 cents a pill
in Johannesburg, 4 cents in Zimbabwe. The South African law
would let the country pursue the lowest cost drugs on the
world market.
But court challenges have delayed the law's being put
into effect. Also, U.S. officials are threatening trade
sanctions. One State Department memo to Congress boasted of
a ''full court press'' involving the Vice President Al Gore,
Commerce Secretary William Daley and four U.S. agencies to
change the ''offending'' law.
''The U.S. government has . . . made it clear that it
will defend the legitimate interests and rights of U.S.
pharmaceutical firms,'' wrote State Department assistant
secretary Barbara Larkin in her letter to Congress.
Veteran AIDS activists are angry. The Clinton
administration, they charge, seems content to let
multinational drug companies set American trade policy --
which is threatening access to life-saving medicines, not
only in South Africa, but also in Thailand, India and poor
countries around the world.
''Pharmacy companies are making U.S. government policy
with essentially no other voices. That has to change,'' said
John James, editor of the respected San Francisco
newsletter AIDS Treatment News.
Drug companies have all but ignored markets in Africa.
Less than 1 percent of AIDS drugs are sold in African
nations south of the Sahara Desert, where 70 percent of new
HIV infections and 90 percent of all AIDS deaths occur. Some
11.5 million people in sub-Saharan Africa have died of AIDS
since the epidemic began.
Dr. Ian Roberts, special adviser to the South African
Health Ministry, said the United States is showing little
understanding of his country's public health catastrophe.
''Medicines to treat HIV/AIDS are far too highly priced
for the mass of our people,'' he said. ''With up to 16
percent of our people already HIV positive, this can be seen
as a national disaster.''
Despite South Africa's gold and diamond mines, most of
its people remain poor, with an average annual income of
$2,600. ''Clearly, we cannot afford retrovirals at a cost of
$1,000 per month,'' said Roberts.
South Africa has emerged from the shadow of apartheid
only to become a major center of the AIDS epidemic. An
estimated 3.2 million South Africans are infected by the
virus, including 45 percent of the nation's military
personnel. Most of those infected are poor and black.
Consumer advocate Ralph Nader, who was drawn to the
issue because of his long-standing interest in
pharmaceutical regulation, called the Clinton position on
South Africa ''an affront to the sovereignty of Third World
nations.''
In a sharply worded letter to Gore, who chairs a
commission on South African trade, Nader accused the United
States of abusing its superpower status: ''You have engaged
in an astonishing array of bullying tactics to prevent South
Africa from implementing policies . . . designed to expand
access to HIV/AIDS drugs.''
Nader's Consumer Project on Technology advocates two
steps -- both of them legal under international law -- by
which poor countries can slash the cost of AIDS drugs.
The first is for poor countries to issue ''compulsory
licenses,'' granting rights to make copies of patented drugs
without the approval of the patent holder. Compulsory
licenses are permitted in health emergencies under
international trade agreements.
The second step is to allow countries to shop around on
the international market for AIDS drugs and import the
cheapest available. Forbidden in the United States, such
''parallel market'' or ''gray market'' purchases are
routinely permitted in Europe.
''Compulsory licensing will have huge effects on price,
leading to decreases of 50 to 90 percent,'' said James Love,
director of the Consumer Project on Technology.
But the pharmaceutical industry and the Clinton
administration take the view that compulsory licenses and
gray markets pose a threat to the entire system of
intellectual property protection. Access to AIDS drugs, they
say, can be solved without destroying the patent system.
''Patents are the lifeblood of our industry,'' said
David Warr, associate director of tax and trade policy at
Bristol-Myers Squibb, the New York-based maker of an array
of drugs to treat AIDS and AIDS-related infections.
''Compulsory licensing and parallel imports expropriate our
patent rights.''
The only beneficiary of an erosion of patent rights,
said Warr, is the generic drug industry, which does not
subsidize through its sales the costly process of research -
-
research that makes new top-of-the- line therapies
available. ''There is a need not to fight the
firefighters,'' he said.
Drug makers stress that even if AIDS medications were
magically made cheaper for the African market, the lack of
an infrastructure to distribute the drugs and monitor
patients means that few would benefit.
Tom Bombelles, a spokesman for the Pharmaceutical
Research and Manufacturers Association, said patents are not
the problem. Access to AIDS drugs remains a desperate
problem in India, which does not recognize international
drug patents and where manufacturers make low-cost generic
versions of AIDS drugs.
Experts in the international AIDS crisis agree that
merely lowering the price of AIDS drugs will not solve the
problem, and potentially could make the epidemic worse.
''If you spread anti-HIV drugs in a population, but not
in sufficient quantities, you are establishing a recipe for
disaster. You could make people sicker, rather than better,
and increase the possibility for development of drug-
resistant HIV strains,'' said Tom Coates, executive director
of the University of California at San Francisco AIDS
Research Institute.
Coates said the limited money available to fight AIDS
in Africa would save the most lives if it were directed at
prevention first. Most African nations do not even have
funds to pay for testing of the blood supply, and in 1997,
only $650 million was spent on all African AIDS programs.
''If, as UNAIDS (the Joint United Nations Programme on
HIV/AIDS) has suggested, we raised spending to $2.5 billion,
we could prevent half the HIV infections from occurring,''
Coates said.
By raising the patent issue, however, activists believe
they are already nudging the international pharmaceutical
industry to pay more attention to Africa. This month,
Bristol-Myers Squibb announced a five-year, $100 million
project to test AIDS drugs and improve physician training in
five African nations, including South Africa.
But angry South African officials have dismissed the
drug company program as misplaced. The country does not have
doctors to spare for training in the United States, said
Roberts, the adviser to the South African Health Ministry.
And critics consider the offer a public relations ploy.
''They are getting billions more than they should with their
monopoly, so they send back a tip,'' sniffed Nader.
The size of the Bristol-Myers grant has nevertheless
upped the ante in the international response to the AIDS
catastrophe in Africa.
The controversies swirling around U.S. trade policies
indicates that a new front has been opened in the global war
on AIDS. Even as new AIDS medicines save lives in the United
States, they serve to underscore the appalling medical gap
between rich nations and poor.
Daniel Zingale, executive director of the AIDS Action
Council, the nation's largest lobby on HIV issues, said the
trade issues raised by Nader are looming larger. ''In my
view, on this issue, Ralph Nader is right,'' he said. ''It's
clear to us the pricing of AIDS drugs is not fair or serving
the interests of most people infected by HIV.''
The effect of American trade policy on the availability
of AIDS drugs has already struck a chord on Capitol Hill.
Representative Jesse Jackson Jr., D-Ill., has introduced an
African trade bill that bars U.S. trade sanctions against
countries that use compulsory licensing or parallel imports.
And Representative Marion Berry, an Arkansas Democrat
and the only licensed pharmacist in Congress -- who has long
been a thorn in the side of U.S. drugmakers -- is winning
support with his criticism of the Clinton administration
stand.
Last week, he introduced a bill, with Republican Jo Ann
Emerson of Missouri as co-author, that would allow American
wholesalers to import drugs sold in Mexico or Canada at
lower prices than those set by pharmaceutical companies for
the U.S. market.
''We're in favor of these companies making a profit,''
Berry said in a recent telephone interview. ''We all want
them to make as much money as possibly can. But when they
make money at the expense of someone dying, because they
can't afford to buy the medicine -- well, then it becomes a
moral issue.''
CHART:
THE WORLDWIDE TOLL OF THE AIDS
EPIDEMIC CONTINUES TO RISE
.
Here are the latest U.N. estimates of new cases of
infection and disease in 1998, the numbers of people living
with the disease or infected by the AIDS virus, and the
cumulative totals since the epidemic was first detected.
.
Global estimates of HIV/AIDS
Estimates as of end of 1998
.
People newly infected with HIV in 1998 5.8
million
.
Number of people living with HIV/AIDS 33.5
million
AIDS deaths in 1998 2.5
million
Number of AIDS deaths since the beginning
of the epidemic 13.9
million
.
KEY
People living with AIDS (a)
Newly infected with HIV
(infected during 1998) (b)
.
EASTERN EUROPE AND CENTRAL ASIA
270,000 (a)
80,000 (b)
.
EAST ASIA AND PACIFIC
560,000 (a)
200,000 (b)
.
WESTERN EUROPE
500,000 (a)
30,000 (b)
.
NORTH AMERICA
890,000 (a)
44,000 (b)
.
CARIBBEAN
320,000 (a)
45,000 (b)
.
NORTH AFRICA
AND MIDDLE EAST
210,000 (a)
19,000 (b)
.
SOUTH AND
SOUTHEAST ASIA
6.7 Mil. (a)
1.2 Mil. (b)
.
LATIN AMERICA
1.4 Mil. (a)
160,000 (b)
.
SUB-SAHARA AFRICA
22.5 Mil. (a)
4 Mil. (b)
.
AUSTRALIA AND
NEW ZEALAND
12,000 (a)
600 (b)
.
Source: UNAIDS
STEVE KEARSLEY/THE CHRONICLE
c1999 San Francisco Chronicle Page A1
-------------------------------
James Love
Center for Study of Responsive Law | Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org
Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org