U.S. Rule on AIDS Drugs Criticized

Ban on Using Aid to Buy Foreign Generics Hinders Treatment, Experts Say

BANGKOK, July 13 -- The Bush administration's prohibition against using money from its $15 billion global AIDS plan to buy foreign-produced generic drugs is complicating the delivery of medicine to some of the millions of poor people who badly need it, according to AIDS experts at an international conference here.

In an effort to sidestep the policy, some countries have been using U.S. money to train AIDS clinicians and buy lab equipment, while employing money from other sources to buy the medicines.

U.S. officials at the conference said Tuesday that they would go along with such an approach. They have also said a fast-track plan announced in May would allow some of the generics to receive rapid approval from the Food and Drug Administration, which would make them eligible for U.S. funding.

Specified in the giant President's Emergency Plan for AIDS Relief, the restrictions against unapproved generics, which for now include all foreign-made generics, have added to the already long list of obstacles to bringing antiretroviral (ARV) therapy to poor countries, experts attending the 15th International AIDS Conference here say.

"It was very confusing. You're trying to figure out who can buy what with what money," said Joia Mukherjee, medical director for Partners in Health, a Boston-based organization that has run an AIDS treatment program in Haiti for seven years and is developing others in Latin America.

The policy "slows the coordination" between the Bush plan and the people running treatment programs in the countries, Mukherjee said in an interview at the conference.

The U.S. Government Accountability Office reached similar conclusions in a report issued this week.

The GAO interviewed 28 U.S. government employees involved in the plan in the 15 countries where it is starting to operate. "Twenty-one respondents indicated that they had not received adequate guidance on the procurement of ARV drugs, which makes it difficult for the U.S. missions" to support country programs.

The State Department, which runs the plan, has not specified which activities the program "can fund and support in national treatment programs that use ARV drugs not approved for purchase by the office," the authors wrote.

Partners in Health is expecting to receive at least $1 million in fiscal 2005 from the U.S. program. Mukherjee said she first began about nine months ago to inquire about whether it could be used to buy generic drugs. She -- and others -- were told no several months ago. But last week, she said, she was advised unofficially to use money from another source to buy generics and use the U.S. money for such things as salaries for health care workers, lab tests and a van.