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.
That was "a compromise that wasn't acceptable before," said a person affiliated with one of the organizations that received a large Bush administration AIDS grant last winter. "We're still in the process of working out what drugs we will buy . . . in the countries we're in," said the official, who spoke on condition of anonymity.
Randall L. Tobias, the Bush administration's global AIDS coordinator, officially ratified that view in a statement Tuesday.
"We respect local governments' decisions as to how best to manage their HIV/AIDS programs," he said. "We will, however, not use U.S. tax dollars to purchase medications that have not passed the same consumer protection standards as those we use for our own patients in the United States.
"In the event that a country elects to use non-U.S. funding to purchase copy drugs that have not been approved for quality and safety by the U.S., the president's emergency plan will support non-pharmaceutical aspects of the country's care, treatment and prevention programs, and will do whatever is necessary to maintain integrated systems of care."
AIDS treatment that uses generic pills containing three antiretroviral drugs in one tablet -- known as fixed-dose combinations -- can cost as little as $200 a year. That is less than half the cut rates at which major pharmaceutical companies are offering brand-name drugs in poor countries.
Most organizations that are providing money for AIDS drugs in those countries -- notably, the two-year-old Global Fund to Fight AIDS, Tuberculosis and Malaria -- require that generics they purchase go through a process called pre-qualification that is run by the World Health Organization and is similar to FDA approval.
The U.S. program does not recognize pre-qualification and instead has specified that all drugs it pays for must be approved by the FDA. In May, the agency established a fast-track system by which it will rule on applications from generics makers in two to six weeks.
Anthony S. Fauci, the physician and AIDS researcher who heads the National Institute of Allergy and Infectious Diseases, acknowledged the controversy over generics at a news conference Tuesday.
"I know there's been criticism about that, but I think we should give a chance to the FDA to prove if they're able to do it or not," he said. "The only way to do that . . . is to submit the application for the approval process."
Progress in the effort to put 3 million poor AIDS patients on treatment by the end of next year has been a major topic of discussion at the conference, whose theme is "Access for All."
In Haiti, where 280,000 people are living with HIV, the virus that causes AIDS, Partners in Health had about 50 patients on antiretroviral drugs in 2001. Today, largely with Global Fund money, it is treating 1,500. The drugs are administered free through a community health clinic.
Cissy Kityo of the Joint Clinical Research Center in Uganda said that country's government cannot afford to pay for all the drugs it is providing patients, even with a price of about $300 per person per year for generics. Consequently, about 90 percent of the 20,000 people on treatment are paying for their drugs, she said.
Uganda's policy of making people pay for their drugs has allowed it to spend funds instead to hire and train health care workers, who are critical to prevention and treatment efforts, Kityo said. "We're just a small country trying to do our best," she said.
Chief among nongovernmental organizations providing antiretroviral drugs is Medecins Sans Frontieres, whose name in English is Doctors Without Borders. Today it has 13,000 patients in 56 projects in 25 countries in Africa, Asia, Eastern Europe and Latin America. About half are on fixed-dose combinations, which spokeswoman Rachel Cohen termed a "radically simplified" treatment.
The organization is spending $200 per person per year. The best available price worldwide for brand-name equivalents is $562 per person per year. "If you have the option of spending $200 per person per year or $600 per person per year, and you're electing to spend $600, that means you're treating one person when you could be treating three," Cohen said.
Brown reported from Washington.