[afro-nets] Africa: Governments rejects USA approved HIV/Aids drugs

[A. Odutola <chpss_abo2@yahoo.com>]

Africa: Governments rejects USA approved HIV/Aids drugs
-------------------------------------------------------

A row has reportedly 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.

Health officials in Uganda, Tanzania, Nigeria and Ethiopia in-
sist that FDA approval for ARV drugs had no standing in their
regulatory reviews of medicine and that the World Health Organi-
sation (WHO) and their national drug authorities must first
clear the drugs before their citizens register to use them.

US officials however say their own approval was sufficient and
the WHO system was "not stringent enough". "What is Nigeria,
Ethiopia, Uganda, and Tanzania, or the WHO going to do that is
better than the FDA?" South Africa's Aspen Pharmacare senior ex-
ecutive in charge of strategic trade development Stavros, is
quoted by the Bostonn Globe to have asked. The pertinent ques-
tion to ask is: Should registration of a drug by the US Food and
Drug Administration automatically confer registration status in
other nations especially in "resource-poor" African countries?

Read full report below and offer your own opinion.

A. Odutola
mailto:chpss_abo2@yahoo.com


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Uganda govt rejects USA approved HIV/Aids drugs

By: Kakaire A. Kirunda & Peter Nyanzi

The Monitor
Source: http://www.monitor.co.ug/news/news06223.php


Copied as "fair use"
====================

UGANDA, June 22, 2005 - 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, Af-
rican 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 suffi-
cient 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 Ma-
kumbi, 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 bol-
ster 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.