Withholding the Cure (AIDS)
by N A Siegal
The Progressive magazine.
Bill Haddad helped create the U.S. Peace
Corps and now works as a volunteer for a generic drug manufacturer,
Cipla Ltd., based in India. Haddad's mission is to bring inexpensive
medication to dying populations in the Third World. Wherever he
goes, he carries an eyedropper filled with a drug called Neverapine,
which is known to reduce the risk of transmitting HIV/AIDS from
an HIV-positive pregnant woman to her unborn child.
The bottle of Neverapine costs Cipla less
than forty cents to produce, Haddad says, and each one contains
about 200 doses. The mother is given one drop when she goes into
labor, the baby is delivered by Caesarian section, and the newborn
is given a single drop within forty-eight hours of birth. Using
this method, the risk of infecting the newborn is reduced by 90
percent, says Haddad.
Haddad gives away his eyedroppers to pediatric
hospitals at no cost and donates them to physicians in small villages
in sub-Saharan Africa where AIDS has so devastated the population
that only the very old and the very young survive. Yet many countries,
such as Kenya, Ghana, and South Africa, won't let him.
"Because of alleged patent laws or
other political barriers, I can't do it in most of the sub-Saharan
countries and in half the Latin American countries," he says.
"We produce the drugs legally, and the international law
says we can do it. The companies have public statements that say,
'We won't prevent you.' But then, some piece of paper arrives
and stops you.
The piece of paper is usually a legal
notice informing him of an injunction by one of the major brandname
pharmaceutical companies in the United States or other countries
that develop and patent new medications, Haddad says. The notice
usually states that his life-saving efforts violate intellectual
To Haddad, each one is a death certificate
for scores of infants.
"Every trip I'm on, I run into 100
people who die," he says. "I don't have the words to
describe what's really happening. It's Dickensian: children who
are under five dying without one dose of medications that we could
give them for free. You send the drugs for free and they don't
get distributed. Frustrating would be the mild word for it."
It wasn't supposed to be this way. Less
than two years ago, the nations of the world assembled at the
World Trade Organization's 2001 meeting in Doha, Qatar, seemed
to agree that treating poor people in the world's indigent nations
was a higher priority than maintaining the intellectual property
claims of multinational corporations. At Doha that November, 142
nations signed a historic agreement that allowed governments to
override international patent protections and produce generic
versions of medicines for a small fraction of the price charged
by brand-name drug makers.
The pact, known as the Doha Declaration,
was good news for the more than thirty million Africans living
with HIV and AIDS, and millions more people in developing countries
dying of illnesses that are treatable or curable in the West (such
as measles, influenza, asthma, various types of cancer, and digestive
diseases). But since it was signed, the United States, the European
Union, Canada, Japan, and other wealthy countries have attempted
to undermine that agreement, say nongovernmental organizations
such as Medecins Sans Frontieres (Doctors Without Borders), Oxfam,
and Africa Action.
"They're seeking about four types
of restrictions," says Asia Russell, who directs international
policy at Health GAP, an activist organization founded in 1999
to campaign for increased access to affordable medication in developing
countries. These restrictions "would significantly compromise"
the ability of poor countries to provide urgent health care to
their people, she says.
U.S. trade negotiators have suggested
limiting the list of illnesses covered under the Doha pact to
AIDS, tuberculosis, malaria, and future equivalent pandemics.
The United States and other countries, such as Japan and Switzerland,
have also suggested restricting the number of countries that could
benefit from the pact by strictly defining what constitutes a
poor country. Western nations have also proposed a series of economic
"tests" that would determine which countries could legally
import or export generics. And finally, pharmaceutical companies
and Western countries want to ensure that generic versions of
brand-name drugs are not diverted to rich countries, where they
could undercut potential profits.
"If you want new medicines, you have
to have intellectual property protections," says Mark Grayson,
a spokesman for the Pharmaceutical Research and Manufacturers
of America, the trade group for the leading U.S. drug and biotechnology
companies. "Right now, many people believe that Doha has
to be applicable to all diseases. If it's all diseases, then you
have to limit the countries."
The Pharmaceutical Research and Manufacturers
of America, the twenty-fourth most powerful lobbying group in
the country, according to Fortune magazine, agrees that the process
of getting cheap medications to the world's dying populations
has stalled. But Grayson argues that Haddad and nongovernmental
organizations (NGOs) are the ones to blame.
Grayson's members don't want companies
like Cipla in India and other generic drug makers in Brazil and
China to be able to profit by producing cheap versions of drugs
that cost U.S. pharmaceutical companies as much as $800 million
to develop, he says. Instead of focusing on getting the drugs
to the poorest of the poor, he argues, Haddad and the NGOs are
trying to give manufacturers of generics the power to expand their
reach into the global market.
"People want to use this for industrial
policy," Grayson said. "They want to put generic versions
of drugs on the market everywhere, including in the United States,
and make money that way, rather than providing drugs to the poorest
The pharmaceutical patent debate is expected
to be a central issue during the next round of international trade
negotiations at the World Trade Organization in Cancun, Mexico,
from September 10 to September 14.
"They [the pharmaceuticals] are trying
to figure out how to do the absolute minimum you can do to keep
to the basic premise of this agreement but not provide the needed
medicines," says James Love, director of the Consumer Project
on Technology, a nonprofit group based at Ralph Nader's Center
for the Study of Responsive Law in Washington, D.C. "It's
all about making it hard to do, to make it burdensome-whatever
they can do to slow the process."
Access to medicines and other life-saving
technologies has become, in the last few years, one of the most
explosive issues in the debate over globalization. Before 1994,
there were no uniform international trade barriers to manufacturing
or distributing generic versions of drugs invented in the West.
The World Trade Organization that year created a set of laws governing
intellectual property protections, known as the Trade-Related
Aspects of Intellectual Property Rights, or TRIPS. It gave twenty-year
patent protection for "all inventions, whether of products
or processes, in almost all fields of technology"-including
That means that if a U.S. company were
to develop a cure for cancer today, for example, a generic version
wouldn't be available for twenty years. This provision would allow
the company that develops the cure the opportunity to recoup its
investment. Anyone who couldn't afford the brand-name medication,
priced for maximum profit, would be out of luck.
Under TRIPS, there was relief for developing
nations, however: A country could break a patent monopoly if it
followed strict guidelines allowing them to issue what's known
as a "compulsory license." Article 31 of the agreement
listed seven ways a country could grant such a license, one of
which was to declare a national public health emergency.
On the African continent, where 2.2 million
people died of AIDS in 2001, according to the World Health Organization,
it made sense to override patent protections. With such a compulsory
license, African nations could get a triple combination "cocktail"
from India's Cipla for $300 a year, or from other generic companies
in Brazil and Thailand for as little as $250 annually per patient
instead of buying the medicine from U.S. drug makers that charge
about $12,000 to $15,000 each year per patient.
And yet, in 1997, when South African President
Nelson Mandela signed into law a measure to issue a compulsory
license for his country. thirty-nine of the world's largest pharmaceutical
companies, including Bristol-Myers Squibb, GlaxoSmithKline, and
Merck, sought and received an injunction to block it. The same
companies later filed lawsuits against the South African government,
charging it with patent violations. Their stance created enormous
negative publicity, so the companies dropped their suit.
But no country was willing to take the
political risk of attempting to issue a compulsory license after
South Africa, says Rachel Cohen, U.S. director of the Campaign
for Access to Essential Medicines, a project of Doctors Without
Borders. "They wanted assurance that they wouldn't face political
consequences if they tried to issue a compulsory license,"
she says. That explains why Haddad has had such a hard time distributing
his AIDS medicine.
The South Africa case helped put the conflict
over international property law and public health concerns on
the front burner for the next round of international trade negotiations
that November in Doha.
"It was because of the fallout from
that South Africa case that so much momentum was gained to support
the victory at Doha," says Health GAP's Russell.
At Doha, trade officials crafted language
to clarify TRIPS and to reassert the rights of poor nations to
issue compulsory licenses. The text said that TRIPS "can
and should be interpreted in a matter of WTO members' rights to
protect public health and in particular to ensure access to medicines
"This was a landmark moment,"
says Cohen. "For the first time in WTO history, all of the
participants said public health takes priority over these other
commercial interests. This was a huge, huge victory for developing
Yet many issues were still unresolved
as the trade negotiators departed Qatar. For one thing, it was
unclear how countries would be able to make effective use of compulsory
licenses if they didn't have the infrastructure or resources to
manufacture generics at home. Nor was it clear whether they could
Paragraph six of the Doha Declaration
instructed participating countries to "find an expeditious
solution to the problem and report to the General Council before
the end of 2002." For the last twenty months, trade negotiators
have been trying to do just that, even as they missed the 2002
In the meantime, the United States announced
an interim moratorium plan, pledging not to challenge any WTO
members that broke trade rules to export drugs to a country in
Robert Zoellick, the U.S. trade representative,
and the U.S. pharmaceutical giants said they wanted to make it
possible for India, Brazil, and other countries with some manufacturing
capacity to export, as long as there were limits set. Zoellick
proposed a "disease list" to define the types of medications
that could be included in compulsory licenses.
To activist groups, the list was laughable.
At first, it included only AIDS, tuberculosis, and malaria. Then,
the U.S. added nineteen other illnesses-all of them possible "pandemics."
A report prepared by Dr. Mary Moran of Doctors Without Borders
found that the listed illnesses didn't even "correlate with
the major causes of morbidity and mortality in Africa." Of
the twenty-two on the list, nine were diseases for which there
was no existing treatment-thus, there was no patent the countries
Also, the "approved list" was
restricted to infectious diseases such as yellow fever and dengue
fever, cholera, hepatitis, and the plague. Cardiovascular diseases
were excluded although, according to the World Health Organization,
they are the second biggest cause of death on the African continent,
taking about 985,000 lives a year. Some 544,000 Africans die of
various forms of cancer, and another 336,000 fall to respiratory
diseases, including pneumonia-neither of which was covered. Also
not included were digestive diseases and diabetes, which are treatable
with prescription medications but which cause some 434,000 deaths
in Africa annually.
Mouanodji Mbaissouroum, a cardiologist
in the central hospital at N'Djamena, Chad, told The Wall Street
Journal that he writes many prescriptions for medicines to relieve
hypertension that he knows will never be filled, either because
the medicine isn't sold in Chad or because it is priced way beyond
his patients' means.
"People in the developed world think
AIDS and malaria and communicable diseases are the biggest problems
in Africa," Dr. Mbaissouroum told the Journal. "But
we also suffer the same illnesses as rich people do."
James Love, of the Consumer Project on
Technology, says U.S. negotiators may be backing off from attempts
to limit the list of diseases and are now looking to keep a lid
on the number of countries that could import drugs to only the
most indigent. Those excluded could be developing nations such
as the Philippines and Malaysia, because they aren't considered
so poor that they would need such broad protections.
On the pharmaceutical side, the argument
is about property rights: Limiting the scope of the international
agreement to safeguard inventions is essential to keeping pharmaceutical
companies in business and to ensuring future research and development
for new life-saving drugs and medical technologies, the drug companies
"The profit is what has ended up
giving us these medicines we have now," says Grayson. "Without
profit, you won't have investment."
Grayson estimates that U.S. drug companies
put about 20 percent of their revenues into research and development.
Currently, he says, U.S. drug companies invest about $800 million
developing a single medication. In 2002, he says, they spent an
estimated $32 billion to discover and produce new medicines.
The pharmaceuticals industry was the most
profitable sector of the economy last year, according to the 2003
Fortune 500 list of the world's top companies. Pfizer alone made
$9.13 billion in profits, and Merck made $7.15 billion.
"The pharmaceutical industry is,
fairly stated, a profit-making group- and that doesn't mean price-gouging
or 'I don't care about the Third World,' " says Neil Sweig,
a financial analyst who tracks pharmaceutical companies for Fulcrum
Global Partners in New York. "If prices plunge or if prices
are too low or if drugs are given away at no charge, it represents
a very serious problem in the ability of global brand-name companies
to go forward with research and development that runs into the
billions for the companies.
In 2003 alone, the World Health Organization
predicts that there will be some ten million deaths in developing
countries from malaria, tuberculosis, acute respiratory infections,
and diarrhoeal diseases. There are safe, effective drugs to treat
these diseases-for people who can afford them. (While the United
States says it has agreed that malaria and tuberculosis should
be covered by the Doha accord, nothing formal has been agreed
to yet.) Millions more poor people are dying of treatable cancers,
diabetes, digestive diseases, and sleeping sicknesses. These people
could be served by the science and technologies that are now prolonging
lives in the West.
Bill Haddad has been involved in this,
the other drug war, for many years. A former investigative journalist
for the New York Herald Tribune, he exposed a tetracycline cartel
that prevented the drug from being distributed in Latin America
and became so interested in the subject that he quit journalism
to work as a generics' advocate. He became chairman and CEO of
the Generic Pharmaceutical Industry Association, and in 1994 created
his own company, the United States Research and Development Corporation.
In 1999, he founded Biogenerics, Inc., which produced generics,
and a year later he went to work for Cipla as a volunteer to reduce
the price of AIDS medications in Africa.
In April, he attended the European Commission
conference in Brussels and gave a presentation in which he listed
the casualties: 8,500 people are dying every day in Africa of
AIDS, and many more infected children are being born who, without
Neverapine, will die the same way.
"I can't go to some of these places
anymore, the places people want you to see with your own eyes.
It's horrendous," says Haddad. "Patents need to be protected,
but they're so exaggerated in what prices they need. They continue
to raise the prices because they have no conscience. It looks
like a snowball's chance in hell that these powerful forces will
back down and let anything happen."
N. A. Siegal is a New York-based reporter
who has contributed to The Progressive since 1997.