Merrill Goozner in Chicago Tribune THIRD WORLD BATTLES FOR AIDS DRUGS

[James Love <love@cptech.org>]

http://chicagotribune.com/news/printedition/article/0,1051,SAV-9904280067,00.html

THIRD WORLD BATTLES FOR AIDS DRUGS

By Merrill Goozner
Washington Bureau
April 28, 1999

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 affordable.

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 emergency.

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 most.

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."



-- 
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org