E-DRUG: Global Fund procurement rules and WHO PQ (2)
----------------------------------------------------
[Andy Gray of DRUGINFO added the actual text of the Global Fund Board decision. Crossposted with thanks from Druginfo. WB]
Hi all
I'd previously posted a mention of the potential change in the Global
Fund medicine procurement rules (the rule that local registration would
not be sufficient after 31 December 2004 unless the local MRA was
regarded as "stringent"), to be debated at the Arusha Board meeting (see
http://www.theglobalfund.org/en/about/board/ninth/) - here's an update
from E-DRUG, cross-posted with thanks.
It appears that the Portfolio Management and Procurement Committee
(PMPC) recommended extension to December 2005 and a review of the issue
by the secretariat before the 10th Board meeting in April 2005. The MSF
posting below suggests a subtly different interpretation - that a
decision on whether or not to extend the deadline be made at the 10th
Board meeting. In any event, it seems the 2004 deadline will not be
applied.
The relevant section of the report from the PMPC (which served before
the Board)
(http://www.theglobalfund.org/en/files/boardmeeting9/gfb909.pdf)
is copied below
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
--------
Part 10: Quality Assurance of Single- and Limited-Source Pharmaceutical
Products
1. At the Third Board Meeting, in October 2002, the Board established
quality assurance standards for pharmaceutical products. In so doing,
the Board distinguished between standards for single- and limited-source
products and multi-source products. For the latter, quality assurance is
easier to determine as there are public reference standards of quality
and a longer history of manufacture and use of the product, so the Board
decided that quality assurance should be "in accordance with the
existing national procedures."
2. However, for single- and limited-source products, quality assurance
is more complicated and some National Drug Regulatory Authorities
(NDRAs) do not have the technical capacity to carry out all required
steps in assuring the quality of products. To address these concerns,
the Board adopted
the following quality assurance standard:
"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 UN Procurement Quality and
Sourcing Project (also known as the WHO Prequalification Project)1; or
b) Have been authorized for consumption in their country by a stringent
regulatory authority2; or
c) Have been authorized by the national regulatory authority in the
recipient's country.
* Option c) is applicable only until 31 December 2004, after which
suppliers must comply with at least one of the two standards set out in
a) and b). (GF/B4/2, p. 23)"
3. The transition period created by Option c) was included in the Board
policy to recognize both that it could be disruptive to programs should
they be required to change suppliers immediately, and that the WHO
Prequalification Project was relatively new at the time the Board
approved the policy (October 2002) and might need time to be fully
functional.
4. The PMPC discussed the potential impact of the expiry of the
transition period, with members raising concerns that the impending
change would result in reduced supply, higher prices, and additional
difficulties in adherence (by virtue of patients having to change
formulations, including
moving from fixed-dose formulations to non-coformulated products).
Additionally, members questioned whether the quality assurance standard
established under Option c) had resulted in any quality problems.
5. Concerned about these possible implications, the committee agreed
that it would be preferable to extend the transition period while
gathering more information about the impact of the expiry of the
transition period. The committee therefore recommended that the
transition period be extended by
one year, while asking WHO and the Secretariat to provide information
on five topics to the next PMPC meeting:
a. The experience using products that have been procured under Option
c) of the Third Board Meeting policy, particularly with regard to
quality assurance;
b. The impact on the supply of single- and limited-source products;
c. The impact on the price of single- and limited-source products;
d. The impact on adherence to single- and limited-source products; and
e. The budgetary and programmatic impact for the WHO Prequalification
Project.
6. This was a near-unanimous rather than consensus recommendation, with
one constituency noting that the deadline in the current Board policy
was already a negotiated compromise, and arguing that the committee
could review the topics listed above without having to extend the
deadline. There is no alternate recommendation as this constituency
agreed with Board policy as it currently reads.
7. The committee noted with appreciation that under recently adopted
European Union (EU) legislation, the European Medicines Agency is now
entitled to give scientific opinions (upon request of WHO) for the
evaluation of certain medical products manufactured in the EU intended
for markets
outside the EU, as well as to give regulatory assistance to developing
countries. The European Commission further noted the possible benefits
that these moves may have in accelerating market approval procedures in
recipient countries.
Decision Point 9:
9. The Board replaces the phrase "Option (c) is applicable only until
December 31, 2004" in the Board decision on quality assurance
(compliance with quality standards) from the Third Board Meeting
(GF/B4/2, p. 23) with "Option (c) is applicable only until December 31,
2005."
1 This project is managed by the Essential Medicines and Policy
Department of WHO.
2 For the purposes of this policy a stringent drug regulatory authority
is defined as a regulatory authority in one of the members of the
Pharmaceutical Inspection Cooperation Scheme (PIC/S) and/or the
International Conference on Harmonization (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use. See
Annex 2 for a list of these countries.