USA: Drug Patents Draw Scrutiny as Bush Goes to Africa

Laws to Protect Interests of Pharmaceuticals Companies May Be at Odds With Continent's Public-Health Dilemma
Publisher Name: 
The Wall Street Journal

In a five-Nation African tour this week, President Bush
is trumpeting his $15 billion program to fight the continent's AIDS
epidemic. But that program's gains could be undercut by a separate U.S.
effort to impose strict drug-patent protections that make AIDS drugs
more expensive and harder to obtain. The Commerce Department is helping
shape patent laws in developing countries such as Nigeria -- where Mr.
Bush will visit Saturday -- that go beyond global standards in
protecting drug makers. The U.S. Trade Representative's office is
seeking similarly strict protections in developing nations world-wide.

While President Bush is flaunting his program to help pay for drugs to
treat AIDS in the near term in Africa, "there are many ways that the
Bush administration has contravened the letter and spirit" of other
global efforts to give needy countries better drug access, says Asia
Russell, international policy coordinator at the Health Global Access
Project, a nongovernmental activist group.

The issue shows the difficult balance Mr. Bush is trying to strike as
he tries to please two very different groups: the African nations that
badly need American help, and the large pharmaceuticals companies that
play a major role in the U.S. economy. The drug companies also are major
bankrollers of his re- election effort and his party's crusade to
strengthen its control of Congress.

U.S. officials say the goals of fighting epidemics and defending U.S.
patents aren't at odds. Richard Mills, spokesman for the trade
representative, says the U.S. has taken measures to assure developing
countries can take advantage of special rules allowing use of generics
to treat serious epidemics, such as AIDS, malaria and tuberculosis. But
in Nigeria, U.S. officials involved in helping to craft strict
intellectual property laws have been generating controversy with rules
that opponents say go too far in favor of drug companies.

In 2000, the U.S. Agency for International Development started funding
a $1.2 million technical-assistance program administered by the Commerce
Department. It was aimed at helping Nigeria improve oversight of
publicly financed projects, rework its regulatory functions -- and
rewrite patent laws.

The U.S. said it was helping a nation update its decades-old law
governing intellectual-property rights to keep up with new international
standards to curb the sale of counterfeit goods, from medicine to music
compact discs.

As part of the program, the Commerce Department sponsored some Nigerian
officials and lawyers to attend two patent-law writing conferences in

April and November 2002. Commerce Department letters and reports
indicate 100 government officials and trade-group representatives were
invited, with the U.S. picking up the airfare tab and total expenses of
$940 each for about 20 attendees -- the equivalent of three times
Nigeria's annual per capita income.

Nongovernment public-health representatives weren't invited, though
after protests, they were allowed to attend. Olayide Akanni a
representative of the Treatment Action Group, an activist umbrella
organization, presented an analysis of draft legislation saying its
intellectual-property protections exceeded those required by the World
Trade Organization. Her points: The bill mandates a complex Nigerian
court process to license cheaper generic-drug copies to treat serious
diseases, instead of the simpler government administrative procedure
allowed by global rules. It adds a four-year waiting period for issuing
drug licenses, when WTO rules in general have no waiting period. The
bill would block nongovernment civil health organizations from applying
for licenses and would punish violators with criminal sanctions, instead
of the more common civil sanctions.

Nnamdi Ezera, the Commerce Department's commercial-development-program
manager for Africa, says his group "did not influence the process," and
Nigerian officials and intellectual protection lawyers made the
decisions about writing the legislation.

Activists disagree, and question whether the U.S. can provide neutral
technical assistance when powerful U.S. companies have a stake in the
outcome. "Technical assistance on this matter from the U.S. will always
be a case of the fox guarding the hen house," said Ms. Russell of the
Health Global Access Project.

Suspicions about American motives in Nigeria have been heightened by
its stance in international patent protection negotiations during the
past two years. WTO trade ministers agreed in late 2001 in Doha, Qatar,
that poor countries should be able to override patent protections and
use cheaper generic copies of drugs to attack mass health problems.

But the U.S. drug industry expressed concerns that relaxing patents
beyond those for a limited list of epidemics would set a precedent
leading to much broader erosion of intellectual-property rights. The
industry fears that could spark an open season on lucrative drugs of
little relevance to African public- health crises, citing Pfizer Inc.'s
impotence remedy, Viagra, and products designed to prevent baldness.

On Dec. 20, 2002, at the urging of big drug companies the U.S. -- alone
among the 144-member World Trade Organization -- blocked a proposal for
distributing patented medicines to less-developed nations. The U.S. also
agreed not to file any complaints with the WTO against countries that
use the agreement to access drugs to treat serious diseases until after
the dispute is resolved, says Mr. Mills, the U.S. trade representative

AMP Section Name:Pharmaceuticals