CITY - Carmina Garcia rises before the sun each morning, taking pleasure in the
first yellow rays of dawn. But it's the pink and white tablets that keep her
Found to be HIV-positive shortly before her husband died of
AIDS-related complications last fall, an ailing Garcia was convinced of her own
death sentence. But generic drugs have kept the virus in check and restored 60
lost pounds to her frame.
"I now have hope," said the 52-year-old
grandmother and flower vendor, who gets her medicine free from a nonprofit
Public health experts fear that hope might fade for Garcia and
thousands of the region's chronically ill if the Dominican Republic-Central
American Free Trade Agreement, known as CAFTA, is approved this
Under the pact American pharmaceutical giants would gain a
five-year edge on the development of new drugs by low-cost competitors. Generic
versions of name-brand drugs are the main weapon for battling the AIDS pandemic
in the developing world.
Healthcare activists say those intellectual
property protections would drive up the cost of treating chronic conditions,
particularly HIV/AIDS, sufferers of which routinely develop resistance to old
medications. About 40 million people worldwide are infected with HIV, the virus
that causes AIDS, and more than 275,000 of them live in the six Latin American
CAFTA nations, according to United Nations statistics.
The prospect of
less-affordable medicines has fueled opposition to CAFTA in Central America,
particularly in Guatemala, where public opinion has turned overwhelmingly
against the trade pact despite its passage by legislators here in
Similar concerns have been raised in other parts of the region,
where three countries - Nicaragua, Costa Rica and the Dominican Republic - have
yet to ratify the pact. In addition to Guatemala, it has been approved in
Honduras and El Salvador.
Though CAFTA supporters hope to win U.S.
approval of the pact before Memorial Day, they are still far short of the votes
needed for passage. Critics in the U.S. - including many Democrats and labor
unions - say the pact doesn't contain tough enough protections for labor and the
With opposition mounting on both sides of the border,
President Bush went to bat Wednesday for the controversial agreement, saying it
was needed to "create jobs and to strengthen democracy in our hemisphere."
Though Central America isn't a huge market, the Bush administration considers
the pact key to building a free trade zone from Alaska to the tip of South
America. U.S. supporters fear that a high-profile setback would weaken that
effort and others around the globe.
The trade-off between protecting drug
companies' intellectual property rights and providing low-cost drugs to poor
nations is being grappled with by governments and health activists around the
U.S. trade officials readily acknowledge that they are trying to
strengthen intellectual property laws worldwide to protect drug companies and
other U.S. interests whose innovations are under constant attack by
Similar provisions protecting big drug companies are part
of U.S. trade pacts with Morocco, Jordan and Singapore - and are expected to be
included in many future U.S. deals.
The Bush administration insists CAFTA
will not endanger a Central American government's ability to import or
manufacture generic drugs it needs to "protect public health" against epidemics
such as HIV/AIDS or in cases of "extreme urgency or national
For many Guatemalans, this is far more than an arcane trade
dispute. Competition from generics has helped drive down prices for some
antiviral drugs by as much as 98% in Guatemala, where 78,000 people are infected
with HIV. That has allowed relief agencies to stretch their budgets to treat
more people like Garcia. Even so, it's estimated that as many as 80% of
Guatemalans who need these medicines still lack them.
But like makers of
toys, software and designer clothing, big drug firms say they need help in
fending off copycats who swipe their innovations and then siphon off profits by
selling illegally copied drugs in their most lucrative markets. Through reverse
engineering, generic makers can quickly duplicate drugs that took U.S. firms
years, even decades, to bring to market.
U.S. pharmaceutical companies,
which spent more than $38 billion on research in 2004, are also worried about
the safety of copycat drugs.
"The amount of innovation and risk that goes
into the development of compounds is enormous," said Steve Schnittman, vice
president of global clinical research for Bristol-Myers Squibb Co. "You need to
reward that innovation and risk taking."
He said his company spent five
years developing Reyataz, or atazanavir sulfate, a new HIV and AIDS drug that
activists are eager to get in a low-cost generic version.
Rules on drug
copying are tightening all over the globe. By year-end, the World Trade
Organization will require most of its 148 members to begin honoring
pharmaceutical patents for 20 years. But healthcare advocates are particularly
alarmed at what they see as a U.S. effort to use smaller trade pacts such as
CAFTA to throw up even higher barriers to generic drug makers.
example, WTO rules permit member countries to override patents and authorize
generic production of name-brand medicines that are needed to protect the public
health. The mere threat of this so-called compulsory licensing has helped keep
drug prices down. However, if CAFTA is approved, experts say, the ability of
Central American nations to use that leverage would be severely
In addition, under CAFTA, generic-drug manufacturers seeking
government approval to produce a drug would be required - for the first five
years after a drug is registered - to conduct their own clinical trials rather
than piggyback on originators' work. That would add considerable time and
expense, critics say, making it much less attractive for generic makers to
pursue the Central American market, which represents less than 1% of drug sales
"It's especially disgraceful to impose these kinds of
obligations on very poor countries for the purpose of some broader business plan
when the consequences in these countries are life and death," said Robert
Weissman, director of Essential Action, a Washington corporate accountability
On a recent morning in a gritty section of Guatemala City,
elderly women waited alongside middle-aged laborers and young mothers cradling
babies at an AIDS clinic operated by the relief group Doctors Without
Discrimination against infected people is rampant in Guatemala.
Those who reveal their illness risk losing their jobs and being shunned by
family and friends. Those at rallies to demand more AIDS funding here typically
wear paper bags over their heads so that they won't be recognized on
Sandra, a 32-year-old former prostitute who did not want her
last name published, didn't know she was infected with the deadly disease until
her preschool-age son died of AIDS complications two years ago. She contemplated
suicide, but credits the clinic's counseling and antiviral medication for
bringing her back from the edge.
"I'd be dead without those pills," she
Doctors Without Borders pioneered the use of generic AIDS drugs in
Guatemala, where it treats 1,700 patients. The agency's most widely used
medication is a generic version of the antiviral cocktail AZT/3TC, which it
purchases from a supplier in India for $216 per patient per year. Guatemala's
social security system last year paid $4,818 per patient for the original made
by GlaxoSmithKline, according to Doctors Without Borders figures.
administrators say that price differential is a big reason the agency now runs
the country's largest treatment program. Still, a small but growing number of
its clients need expensive new medications such as lopinavir, marketed by Abbott
Laboratories under the name Kaletra.
The $480-a-bottle antiviral is so
coveted on the black market here that staffers at the Guatemala City clinic keep
it in a locked refrigerator inside a secure storage room. A generic version does
not exist, and probably won't anytime soon in Central America if CAFTA is
approved, AIDS activists said.
Pharmaceutical firms are responding to the
heat. Under the United Nations-sponsored Accelerated Access Initiative, five
leading companies - GlaxoSmithKline, Bristol-Myers Squibb, F.Hoffman-La Roche,
Boehringer Ingelheim and Merck & Co. - are offering cut-rate AIDS medicines
to poor countries. But at $1,100 to $1,600 per year per person, those prices are
still well above what some generic manufacturers are charging for similar
medications in Central America, activists say.
Most governments would
prefer to let the free market set prices by letting generic manufacturers in and
forcing pharmaceutical companies to compete.
But countries such as
Guatemala are finding that's not so easy. In 2003, the nation revised its
intellectual property laws to conform to CAFTA. Pressured by an angry public,
legislators repealed the law late last year and replaced it with a new one meant
to promote more generic competition in pharmaceuticals.
After the U.S.
accused Guatemala of reneging on its CAFTA commitments, the legislators
flip-flopped again. In early March the Guatemalan Congress restored the
data-exclusivity provision and quickly voted to approve CAFTA. The nation
erupted with protests in which scores were injured and at least one demonstrator
"I'm doing a lot of things now that I never thought I would,"
said Garcia, the HIV-positive grandmother, after she participated in an
anti-CAFTA protest without the customary paper bag mask. "I'm fighting for my
life, their lives."
- 116 Human Rights
- 182 Health