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[e-drug] WHO prequalifies artesunate for malaria (2)

E-DRUG: WHO prequalifies artesunate for malaria (2)

The message posted in e-drug requires clarification on one aspect related to
procurement of drugs with Global Fund Money. It was mentioned that "the
prequalification of artesunate tablets now opens Global Fund receivers to
order an alternative product from the previously registered Co-artem
(artemether + lumefantrine, made by Novartis)".

Actually, it is not only now that GF recipients can purchase Artesunate with
GF funds. They can do so since the beginning given the fact that

(1) there are various manufacturers of artesunate available in different
countries, and
(2) already on October 2002 the GF Board approved that procurement policy
including the following :

"Provided products are accepted by the national drug regulatory agency of
the Recipient country ... to be eligible for purchase with Fund resources
any single or limited source product (that is, a medicinal product for which
there are not publicly available quality assurance standards, analytic
methods, and reference standards) must
(a) have been found to be acceptable by the WHO-initiated UN Pilot
Procurement Quality and Sourcing Project, or
(b) have been authorized for consumption in their country by a stringent
regulatory authority (For the purposes of this policy a stringent drug
regulatory authority is defined as a regulatory authority in one of the 28
countries which is either a PIC/S and/or ICH member) or
(c) have been authorized by the national regulatory authority in the
Recipient?s country.

Option (c) is applicable only until December 31, 2004, after which suppliers
must comply with one of the two standards as set out in (a) and (b) ? and in
all cases are subject to monitoring product quality standards prescribed by
the Fund .......

In other words, until 31st December 2004, recipients of Fund grants are
allowed to purchase drugs that, being accepted by their National Drug
regulatory Agency, are still not pre-qualified.

It was already suggested in October 2002 that this decision needs to be
revised taking into account the availability within the Pre-qualification
project during this year 2004 of  (1) enough different medicines to cover
the protocol of AIDS, Malaria and TB,  and (2) enough different products of
those medicines to assure sufficient quantities in the different recipient
countries, in order to avoid any discontinuation of current procurement
plans in countries, and eventually, interrupting individuals treatment.

Carmen Pérez Casas

[Thanks for that correction; we are happy that E-drug is being spelled! WB]

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