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The US president's international emergency plan for AIDS relief (PEPFAR), announced in President Bush's state of the union address in 2003, has made a good start to meeting its ambitious goals, a report by the independent Institute of Medicine said last week.
But the report criticises the Congress's specification of how the money must be spent, with 55% to be spent on medical treatment and 20% on prevention, a third of which must be spent on abstinence-only programmes.
“Having the same budget allocation formula for 15 countries with very different kinds of epidemics is not useful,” said Jaime Sepulveda, chairman of the committee that conducted the evaluation and former director of the National Institutes of Health of Mexico. “Having a one size fits all kind of approach is not helping the countries to handle the resources for their local epidemic.”
The targets set in the 2003 legislation that created the plan included preventing seven million new HIV infections; providing antiretroviral treatment to two million people; and caring for 10 million people affected by HIV, including orphans. It committed $15bn (£7.6bn; €11.2bn) over the five year life of the programme (BMJ 2003;326:1233, doi: 10.1136/bmj.326.7401.1233-b).
The programme's key challenge is “the transition from emergency response to sustainability,” said Dr Sepulveda. That would require “an emphasis on long term strategic planning and capacity building that are necessary for sustainable long term response,” he added.
The programme may buy drugs only if they are approved by the US Food and Drug Administration. Initially this requirement precluded the use of cheap generic versions that had been approved by the World Health Organization for use by host countries. But the FDA has since agreed to approve applications for generic drugs, and the programme has increased its purchase of these cheaper alternatives.
Charles Carpenter, a member of the committee and head of the AIDS Center at Brown University in Providence, Rhode Island, said that the committee's report recommends study of whether the more rapid and less burdensome WHO approval process should be sufficient to allow the programme to buy a drug without waiting for FDA approval.
Mark Dybul, the administrator of the president's plan, was encouraged by the overall tenor of the report and its recommendations. He said that its conclusions were similar to the programme's own internal evaluations and recommendations.
He agreed in principle that there should not be congressional guidelines as to how money should be spent but said that he had not found them to be overly restrictive. He said that the rules were for the programme as a whole and allowed for variation within individual countries to respond to the local epidemic.
“Without some congressional directive saying you must move rapidly toward increasing treatment, I'm not sure we would have moved as quickly.” The same applies to programmes for orphans, Dr Dybul said. He said that organisations tended to continue to do what they had done before and changed slowly.
The issue of generic drugs was a problem two years ago, Dr Dybul acknowledged, but had largely been resolved over the last year. He noted that the FDA has approved additional generic drugs for HIV in the six months since the committee stopped gathering data for its report.
All individual HIV drugs and combinations are now available. Manufacturers of generic drugs worldwide had overcome their initial resistance and had submitted their paperwork to the FDA for approval, he said.
PEPFAR Implementation: Progress and Promise is available at http://books.nap.edu/catalog.php?record_id=11905.