african governments reject usa approval of hiv/aids drugs

By Karaire Kirunda & Peter Nyanzi (The Monitor)

June 24, 2005: Health officials in Uganda, Tanzania, Nigeria and Ethiopia insist that the approval by the US government's Food and Drug Administration (FDA) of ARV drugs has no standing in their regulatory reviews of medicine. Instead they say that the World Health Organisation (WHO) and their national drug authorities must first clear the drugs before their citizens register to use them.

The move is apparently delaying the delivery of the low cost medicine to patients, according to the USA, United Nations, African and drug company officials.

But Ugandan health officials and their counterparts in Tanzania, Nigeria and Ethiopia, insist the World Health Organisation (WHO) and their national drug authorities must first clear the drugs before their citizens register to use them.

Uganda's Director General of Health Services, Prof. Francis Omaswa, described Uganda's position "as normal" and that "there was no other way around it."

"It is necessary that we follow the normal procedures we have in place for the management and administration of drugs. Every drug coming into the country must have
the approval of WHO and the National Drug Authority (NDA)," he said by telephone yesterday.

However, The Boston Globe reported on June 20 that the move was frustrating USA officials, who say their own approval was sufficient and the WHO system was "not
stringent enough."

But the four countries have told South African generic drug maker Aspen Pharmacare that its FDA approval for ARV drugs had no standing in their regulatory reviews of medicine. "After we got FDA approval, we thought all the red tape would be waived, and there would be a flurry of orders. It's baffling. You go to these countries, and
say, 'Here's FDA approval,' and they say, 'Sorry, we want WHO pre-qualification first,'"

The Boston Globe reported. "What is Nigeria, Ethiopia, Uganda, and Tanzania, or the WHO going to do that is better than the FDA?" the paper quoted Aspen's senior executive in charge of strategic trade development Stavros Nicolaou.

"I think our asking for WHO approval is partly historical and because of our membership in the organisation," Dr James Makumbi, chairman of the National Drug Authority in Uganda, told The Boston Globe in an interview.
"This is how we've been doing things for time immemorial. We don't ask for FDA
approval. I think this is basically a problem with the FDA interacting with the WHO, because the WHO can always endorse the US regulator's review."

According to the newspaper, the snag which was unanticipated by the US, has set off a flurry of discussions in recent weeks among USA, UN and African officials, including a phone call from US Global Aids coordinator Randall L. Tobias to WHO Director General, Dr Lee Jong-wook, requesting immediate approval of any FDA-tested drugs.

The WHO standards, the Americans argued, would not ensure the same quality and refused to send US scientists to Geneva to bolster the WHO staff.

Uganda is the leading beneficiary of President George Bush's Emergency Plan for Aids Relief. Statistics from the US Global Aids Coordinator's office at March 30, show Ugandans receiving US-supported treatment were 50,900.