E-DRUG: Brazil Makes Name for Itself Pumping Out Cheap AIDS Drugs
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[crossposted from Pharm-Policy with thanks. Copied as fair use.
http://interactive.wsj.com/articles/SB988318940250231621.htm
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Brazil Makes a Name for Itself Pumping Out Cheap AIDS Drugs
By MIRIAM JORDAN
Staff Reporter of THE WALL STREET JOURNAL
RIO DE JANEIRO -- A small drug factory on a tropical campus sandwiched
between two slums is giving big multinational pharmaceutical makers a
headache.
For more than 40 years, the assembly lines of this Brazilian government
laboratory, Far-Manguinhos, have spewed out dozens of drugs, most of
them for malaria, leprosy and other illnesses that have largely
disappeared from developed countries.
"We call these 'orphan drugs,' " says Hilbert Ferreira, industrial
director of Far-Manguinhos. "Multinationals are not interested in
producing them because they fight diseases of the Third World." So the
lab developed and produced treatment for "diseases of the poor," says
Mr. Ferreira. No one noticed Far-Manguinhos.
Then AIDS began to afflict Brazilians by the thousands, and the
government devised a dual program of prevention and treatment to tackle
the disease. The government made a commitment to supply its infected
population with free medication.
But burdened by the steep cost of imported AIDS medications, Brazil in
1998 gave Far-Manguinhos's director, Eloan Pinheiro, a mandate: analyze
brand-name drugs and develop generic forms of them. The decision has put
Far-Manguinhos under the international spotlight and set a new standard
for excellence in the developing world. Brazil is the only country in
Latin America whose public institutions manufacture AIDS drugs on a
large scale.
With ingredients imported from Asia, the laboratory now produces eight
out of 12 medications that make AIDS manageable for 200,000 Brazilians
and that have helped Brazil contain the spread of the immunodeficiency
disease better than any other Third World country. After completing an
expansion this year, Far-Manguinhos is expected to start supplying other
developing countries with competitively priced AIDS medications.
"Our role is social," says Ms. Pinheiro, who spent about half of her
30-year career at international pharmaceutical companies. "The price of
a drug cannot determine whether one lives or dies. We will do all the
research necessary to ensure drug prices are fair."
Despite an international outcry over the price of AIDS drugs, Brazil may
not have been able to secure a lower price for two AIDS drugs produced
by Merck & Co. without the pressure supplied by Far-Manguinhos. Brazil's
epidemic has not reached the proportions of sub-Saharan countries, nor
is it as poor. "Far-Manguinhos is our instrument of price regulation,"
says Platao Puhler, the Health Ministry official who negotiates with
pharmaceutical firms. "It plays a critical role."
Confident of the laboratory's ability, Brazil threatened to invoke a law
that would justify copying a patented drug called Stocrin unless Merck
substantially lowered its price. The U.S. drug maker did in the end
reduce by two-thirds the cost of Stocrin and another drug that
Far-Manguinhos already produces, Crixivan.
Brazil is currently talking with Roche Holding AG of Switzerland about
the cost of its patented AIDS drug, Viracept. The Roche drug alone
accounted for 28% of Brazil's total expenditure on AIDS medications last
year, or $85 million. A Roche spokesman said the company is likely to
announce a new price within two weeks. Despite getting lower prices,
Brazil remains determined to develop a generic form of Stocrin, called
efavirenz, as well as a copy of Viracept, or nelfinavir. "Even if we
don't actually produce the drugs, we want to make sure we have the
know-how to manufacture them should it be necessary," says Ms. Pinheiro.
"What if a multinational reneges on its price agreement?"
A small, energetic 56-year-old chemist, Ms. Pinheiro grew up in Niteroi,
the city across the bay from Rio. The daughter of a typist and a
housewife, she worked her way through college by doing accounting work
for a TV repair shop. After graduating, she honed her skills as a
drug-formula specialist at the Brazilian units of two multinationals.
"Eloan has tenacity, competence and dedication the likes of which one
rarely sees," says Pedro Chequer, U.N. AIDS chief in South America, who
worked with Ms. Pinheiro during his tenure as coordinator of Brazil's
AIDS program.
Even during Ms. Pinheiro's 14 years at international companies, she
expressed concern over their "monopoly of patents," she says. She
declines to disclose her current political sympathies, but in the '80s
she was a leader of the chemists' union affiliated with Brazil's leftist
Working Party. In a 1981 union pamphlet, she wrote that "automatic
acceptance of [drug] patents amounts to submission" to the U.S.
Twenty years later, she sits in her office above the Far-Manguinhos
production unit that has more than doubled its capacity in the past two
years. Thanks to its huge role in Brazil's AIDS program, Far-Manguinhos
has boosted its research team to 33 members from two in two years. A $4
million modernization and expansion is currently under way, a first for
the institute. In 2000, the manufacturing unit began operating in three
shifts to meet demand for AIDS drugs.
Health officials from several African and Caribbean countries have
visited Far-Manguinhos, and Ms. Pinheiro has pledged to give them
support in setting up their own local production. In the meantime, a
decision by leading pharmaceutical firms not to try to stop South Africa
from importing cheap AIDS drugs paves the way for Brazil to export to
that country and others.