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From: Art McGee <[log in to unmask]>
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Subject: [BRC-NEWS] Third World Battles for AIDS Drugs
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Chicago Tribune

April 28, 1999


By Merrill Goozner (mailto:[log in to unmask])
Washington Bureau

WASHINGTON -- Though the AIDS epidemic is taking its steepest toll in some
of the poorest regions of the world, the U.S. government and the nation's
pharmaceuticals industry are fighting efforts to make the latest
life-saving drugs more widely available there.

The battle pits the drug firms and their desire to maintain exclusive
control of the manufacture and marketing of their patented medicines
against the intentions of some countries to issue licenses for those drugs
to local firms, allowing them to make generic versions that are more

Last year, for instance, President Nelson Mandela raised hopes among South
Africa's burgeoning AIDS population when he signed into law a measure
designed to make more affordable some of the new miracle drugs that slow
progression of the disease.

Under the law, the South African government could begin issuing licenses
to local firms to manufacture low-cost generic versions of patented
anti-AIDS drugs.

While the World Trade Organization jealously guards intellectual property
rights among its member nations, its global rules of trade do allow for
what is known as "compulsory licensing" if it is done to combat a national

In a country with more than 3 million HIV cases, where one-quarter of
pregnant mothers in the poorest provinces are HIV-positive, the new South
African compulsory licensing law would seem to meet the WTO's
national-emergency guidelines.

The South African law was designed to "ensure through either global market
forces or local market forces that medicines become affordable for the
people of South Africa," said Ian Roberts, special assistant to the
government's health minister.

But the law angered the U.S. pharmaceuticals industry, which fears that
widespread licensing of its products will lead to a global "gray market"
in low-priced drugs and undermine its profits and incentive to spend on
costly research.

It pressed its allies in the U.S. government to swing into action against
the South African law.

They quickly complied. In Congress, Rep. Rodney Frelinghuysen (R-N.J.)
inserted a rider in last October's appropriations bill that temporarily
cut off foreign aid to South Africa as a way of pressuring the State
Department to take more forceful action against the law.

U.S. Trade Representative Charlene Barshefsky, saying the South African
law was too broad and might be applied to other medicines, denied South
Africa special tariff breaks on its exports to the U.S., a move designed
to pressure the government to repeal the law. Vice President Al Gore also
raised the issue when he visited Mandela earlier this year.

So far, South Africa has refused to back down. That has prompted dozens of
American and European pharmaceuticals giants to challenge the law in a
South African court, where they recently won a temporary injunction.

"In the West, companies are killing themselves to come up with the next
Viagra (Pfizer Inc.'s erectile dysfunction treatment) while the developing
world doesn't have access to basic medicines," said Nathan Ford, who works
in the London office of the international physicians aid group, Doctors
Without Borders. "In many of these countries, tuberculosis and AIDS drugs
are priced at Western market levels."

The pharmaceuticals industry considers compulsory licensing "a form of
patent piracy," said Thomas Bombelles, of the Pharmaceutical Research and
Manufacturers Association, the industry trade group. "It's stealing."

Joe Papovich, assistant U.S. trade representative for intellectual
property issues, said: "We're negative toward compulsory licensing. We
think companies that have the rights to new inventions should have the
right to market them the way they want."

Physicians with not-for-profit groups who labor in poor countries where
clinics have been inundated with AIDS patients are using the compulsory
licensing issue to pressure the global pharmaceuticals industry to come up
with ways of making its high-priced wonder drugs available where needed

These groups say the issues surrounding the affordability of AIDS drugs
apply equally to treatments for malaria, tuberculosis and meningitis,
which kill millions of people each year in the less developed world.

The exotic double- and triple-drug therapies that keep HIV-positive people
from developing full-blown AIDS cost more than $10,000 a year per patient
in the advanced industrial world and are virtually unheard of in poor
countries. Drugs for treating the chronic infections that kill AIDS
sufferers can cost $100 to $150 a month in developing countries--more than
the average worker's monthly salary.

For example, AZT, a drug made by Glaxo-Wellcome that has been proven
effective in inhibiting transmission of HIV from pregnant women to their
fetuses, costs about $240 a month in South Africa. Indian drug firms
manufacture a generic version of the drug that costs $48 a month.

Jamie Love, director of the Washington-based Consumer Project on
Technology, estimates the price of most AIDS-related drugs could be
reduced 50 percent to 90 percent if local firms were allowed to produce
generic versions to counter national health emergencies.

AIDS activists, not-for-profit clinics and some health ministers from
developing countries have pressed the World Health Organization to take up
the licensing issue. A draft of a resolution that will be considered by
world health ministers next month in Geneva commands developing countries
"to explore their options under relevant international agreements,
including trade agreements, to safeguard access to essential drugs."

As part of its campaign to forestall widespread compulsory licensing, the
drug industry is raising concerns that poorly monitored use of the latest
HIV inhibitors might create resistant strains of the virus. Patients
taking these drugs must follow a complex daily regimen, and the pills can
have unpleasant side effects such as nausea and diarrhea.

"If you just parachute in and give medicines that make them feel sick when
they're not sick yet, they won't take them regularly and that can do more
harm than good," said Bombelles, of the Pharmaceutical Research and
Manufacturers Association.

But physicians who work in these countries call those complaints a false
issue. Mark Biot, a Belgium-based physician who oversees Doctors Without
Borders' worldwide AIDS efforts, said clinics in most of the larger cities
of the developing world would be fully equipped to handle AIDS patients if
they had access to affordable tests and drugs.

Biot recently returned from Thailand, where people begin lining up outside
Bamrasnaradura Hospital in central Bangkok at 3 a.m. for the weekly AIDS
clinic run by his group.

"This is not an undeveloped country," he said. "They have labs and the
real opportunity to treat people who are HIV-positive or have
opportunistic infections."

The clinic is seeing an increasing number of people who have recently
stopped using the combination of AZT and Videx or didanosine (ddI), a
reverse transcriptase inhibitor made by Bristol-Myers Squibb. The two
drugs taken in combination slow the onset of AIDS.

Because of the Asian financial crisis, those drugs were removed from the
government's essential medicines list and are no longer distributed at
subsidized prices, according to Biot.

A spokeswoman for Bristol-Myers said the company still supplied the
government with Videx but refused to discuss negotiations over its price.

Nearly two-thirds of the world's 33 million HIV-infected people live in
the impoverished countries of sub-Saharan Africa. About 6 million live in
the poor countries of Asia.

"We have an obligation on life-saving drugs," said Joseph Saba, a director
at the United Nations AIDS program (UNAIDS). "If we're going to bind these
countries to comply with global trading treaties, then we have to figure
out how to provide drugs needed for public health and life-saving drugs at
an affordable price."

UNAIDS has set up pilot programs to bring AIDS-fighting drugs to four
countries--Uganda, Ivory Coast, Chile and Vietnam. But the $1 million
program, which does receive free drugs from the pharmaceuticals firms,
barely scratches the surface in these countries.

What the pilot programs have taught UNAIDS officials is that access to
cheaper drugs is only the first step in developing a successful strategy
to treat AIDS. In Uganda, for instance, which has 1 million people with
HIV, the virus that causes AIDS, "there are no hospitals, no pharmacists,
no trained doctors. We have to improve the entire system," Saba said.

But many developing countries do have health-delivery systems capable of
treating HIV-infected people. In Thailand, where nearly a million Thais
are infected with HIV, a coalition of local not-for-profit groups last
fall began pressuring the Thai government to license local firms to
manufacture the drugs that hinder the virus' ability to multiply inside
the body.

The activists claim the U.S. government pressured the Thai government to
abandon its efforts to license the drugs to local manufacturers.

Papovich, who oversees intellectual property issues at the U.S. Trade
Representative's office, said he could not recall discussions about
compulsory licensing of drugs. He said the U.S. threatened Thailand's
special tariff breaks because it failed to curb piracy of copyrighted
goods like CDs and software.

But the U.S. trade representative's recently published annual report on
Foreign Trade Barriers tells a different story. The report said U.S.
businesses were upset that a new Thai pharmaceuticals law might allow
compulsory licensing of drugs.

"It's painfully clear U.S. trade representatives are not used to community
groups questioning what they do," said Ron McGinnis, director of AIDS
programs at the Global Health Council, in Washington. "People now want to
know how trade policies affect access to care."

(c) 1999 Chicago Tribune Company

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