June 21, 2005
by Kakaire A. Kirunda and Peter Nyanzi
Uganda is among four African countries that are rejecting US Food and Drug Administration approval of generic AIDS drugs.
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.
A row has erupted between the US government and four African countries over the refusal to accept the FDA approval of generic Aids drugs manufactured in South Africa.
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, Professor Francis Omaswa, described Uganda's position "as normal" and that "there was no other way around it."
Ugandan Health Director: Giving-in to cynicism, or pressure from the regime?
"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.
Urbane Analysis: An inartfully written piece of news, to be sure, but telling on the issue of the Ugandan regime's smarting over increased instances of U.S. asserted hegemony on geo-political issues. And the cynical inability of Ugandan health authorities to rush - in placing one more finger in the dike of a leaky-and-broken AIDS policy. This is a "just over the horizon" issue: getting Pharma into the affected populations - and allowing Africans to actually become patients for the first time (rather than recipients of hospice care at best), is the challenge. Not only in affecting survival rates, but also in impacting the hardened, cynical mindset regarding AIDS in Africa.
George W. Bush (shown here meeting with HIV-positive Ugandans during his visit to Uganda in 2003) has done more than any human to qualitatively improve the care for (and provision of medicine to) those affected by AIDS in the world's poorest countries. The effort being thwarted now by the Ugandan government is part of Bush's five year, $15 billion outreach effort announced during his 2004 State of the Union Address. Mainstream media ignores this accomplishment - and the motivation behind it. Kudos to the Bush Administration for not kowtowing to the inept WHO, by the way. When will the Gates Foundation wake up to their enabling behavior toward the WHO - and find more efficient channels for delivering health care to the poorest of the poor? I'm sure World Vision would not mind chatting on that topic...
1 comment:
Scott, Thanks for keeping up on the situation in Uganda. It's a tragedy that Museveni doesn't understand that he was not elected president for life. And the foolishness over AIDS medications.
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