E-DRUG: Global Fund procurement rules and WHO PQ
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Dear all,
As you know, the procurement rules of the Global fund included that after 31st December 2004, for a single or limited-source medicine (that is, a medicinal product for which there are not publicly available quality assurance standards, analytic methods, and reference standards), to be eligible for purchase with Fund resources, 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).
[Until 31 December 2004, there was also a 3rd category:
(c) authorized by the national regulatory authority in the Recipient's country]
Finally, in their last Board Meeting in November, they have decided to request further information on the impact of such a rule. The decision to extend the transition period or not is, hence, further delayed until the Tenth Board meeting (April 2005).
Until a new decision is taken, besides (a) and (b) categories of products above described, also other products (c) authorized by the national regulatory authority in the Recipient's country can be purchased with the Fund resources.
Thanks,
Carmen
Carmen Perez Casas, MsCPharm
Access to Essential Medicines Campaign
Medecins sans Frontieres
carmen.perez@paris.msf.org
[The Global Fund Board papers are available at:
http://www.theglobalfund.org/en/about/board/ninth/
WB]