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5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Achievements and Impacts of prequalification to date
The Global Fund Perspective
5th Consultative Stakeholder meeting UN prequalification of diagnostics,
medicines & vaccines11 February 2010
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Presentation Outline
1. The Global Fund Principles
2. The Global Fund Quality Assurance Policy for Pharmaceuticals
• Main principles
• QSM and Global Fund : areas for collaboration
3. The Global Fund Quality Assurance Policy for Diagnostics
• Board request
• DLT and Global Fund : areas for collaboration
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
The Global Fund
The Global Fund is an international financing organization, not an implementing organization
The Global Fund objectives include: to allow access to and continued availability of quality assured medicines and health products to fight AIDS, Malaria and TB
About 45% of grant funds are spent on commodities and health products procurement.
Principal Recipients are responsible for procurement and for ensuring adherence to Global Fund QA Policy requirements
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Rapid scaling up of results
Intervention mid 2007 mid 2008 December 2009
HIV: People on ARV treatment
1.1 million 1.75 m 2.5 million
TB: People treated under
DOTS2.8 million 3,9 m 6.0 million
Malaria: Insecticide-treated nets
distributed30 million 59 m 104 million
Malaria treatments .. .. 108 million
Global Fund Top 3 result indicators (2009)
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Global Resources DistributionRounds 1-8, (July 2009)
OP/140709/2
Administration7%
Human Resources
21%
Commodities, Products, Drugs
45%
Monitoring and Evaluation
4%
Infrastructure and Equipment
9%
Other14%
Expenditure Component (July 2009)
Estimates from Rounds 2-8 proposals
100% = $8.2 billion USD
Overview of procurement of medicines by value
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Global Fund Policies for pharmaceuticals and other health productsThe Global Fund Approach for procurement
• Principles and minimum standards, not detailed procedures • On international best practices• Build upon existing systems
GF Quality Assurance Policy for pharmaceuticals:• revised policy effective from 1 July 2009 • amended at the 20th Board, November 2009, to respond to
challenges faced for the procurement of certain FPPs• defines:
1: quality criteria requirements2: selection products process3: monitoring quality
GF Quality Assurance Policy for diagnostics: under development
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
QSM and Global Fund areas for collaboration
• Prequalification Programs and Implementation of the GF Quality Assurance Policy
• QSM: Reference Technical Partner for The Global Fund
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
1 - Authorization of the FPPS in Country of use
• GF requirements for all FPPSs
• “NDRAs are encouraged to expedite registration by accepting WHO pre-qualification inspection and supporting dossiers in lieu of national requirements.”
2 - Selection of products :
• GF requirements for all ARVs ,anti-TB and antimalarial FPPs be:
– Priority 1: Prequalified by WHO (Option A), or authorized for use by SRA (Option B)
– Priority 2: Permitted for use based on the advice of the Expert Review Panel (ERP)
Prequalification Programs and Implementation of the GF Quality Assurance Policy
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
WHO Prequalified products purchases
Number of Purchases Reported to the PRM/PQR by Quality Level
783
1126
1521 15901696
371
285
288
499
576
28
41
78
50
58
193
185
138
61
58
66
169
141
202
380
0
500
1000
1500
2000
2500
3000
2005 2006 2007 2008 2009
Nu
mb
er o
f P
urch
ases
GLC
C2
C1
B
A
WHO Prequalified products:• priority 1, with SRA approved products, unless no availability of enough number of FPPs in the WHO PQ list (eg. Certain ACTs or TB medicines)• currently, more than 95% of ARVs purchases by PRs are WHO PQ
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Expert Review Panel reviewed productsPermitted for use based on the advice of the Expert Review
Panel (ERP): Priority 2
Expert Review Panel (ERP):• An independent technical body,
– Composed of external technical experts (mainly SRA experts)– Hosted by WHO
• Purposes: – To review the potential risks/benefits associated with the use of FPPs
that are not yet WHO-prequalified or SRA-authorized.– To advise the Global Fund in its decision on whether to allow grant
funds to be used to procure those FPPs
• ERP recommendations time limited: 12 months
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Evolution of FPPs reviewed by ERP
Total ARV Malaria TB
Number of products recommended by ERP
– currently pre qualified by WHO– currently approved by SRA (USFDA)
28
9
5
15
7
5
3
1
NA
11
1
NA
Number of products NOT recommended by ERP
– currently pre qualified by WHO– currently approved by SRA (USFDA)
43
0
1
12
0
1
19
0
NA
12
0
NA
Two ERP reviews (in May 2009 and October 2009)
78 FPPs dossiers submitted to ERP for review, 71 reviewed:
• 28 products permitted for use
• 43 not permitted for use
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Global Fund requirements:
• GF Secretariat responsible for “Random” quality control testing of ERP products
• PRs responsible at country level to monitor the quality of products all along the supply chain, including systematic random quality control testing
• Selection of the QC laboratory:a NDRA laboratory of the recipient country, or a laboratory
recognized by the NDRA, andcompliant to the following criteria :
1.WHO prequalified or,2.ISO/IEC 17025 certified for the required scope of drug
testing
Prequalification Programs and Quality monitoring
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Prequalification Programs and Quality monitoring Critical role of WHO Prequalification program for Quality
Control Laboratory :
• Selection of a QC laboratory contracted by the GF Secretariat, including :
• preparation of the request for proposal published in July 2009• technical evaluation committee for awarding the laboratory, in
November 2009
• Selection of laboratory by the PRs in country :• Safer and Easier process where there is access to WHO
Prequalified QC laboratories
• Sharing testing results with QSM • Database of testing results published by GF in Q1 2010• Immediate alert for sub-standards products
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
QSM: Technical Partner for The Global Fund
• Technical expertise– Global Fund technical partner and reference in case of
concerns related to the quality of products
– Member of the expert Technical Advisory Group who reviewed the GF QA policy (2008) and proposed an update policy
– Participation as experts to the Global Fund Portfolio committees: amendment to revised QA policy ( 2009)
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
QSM: QSM: Technical Partner for The Global Fund Partner for The Global Fund
• Development and Publication of finished product monographs in the International Pharmacopoeia
Direct impact
– on the methods and specifications used by the Laboratory contracted by the GF
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
• At its 18th Meeting, the Board requested the Secretariat, with the oversight of the PC, to “review the current status of quality assurance for diagnostic products and to make recommendations”
• Objective: to provide recommendation on the feasibility of establishing a QA policy for diagnostics
GF Quality Assurance Policy for diagnostics
Background
DLT and Global Fund : areas for collaboration
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Quality Assurance Policy for Diagnostics
• On 2009, Phase I : review of the current status of quality assurance for diagnostic products– the Board signaled to Secretariat the importance of
inclusion of WHO in such review
– WHO Diagnostics and Laboratory Technology = key partner
– Providing timely technical information and expertise, and preparation of background analysis and reports
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Quality Assurance Policy for Diagnostics
• GF Board MDC committee endorsed the approach and the continuation of the Technical Advisory Group
• On 2010, Phase II: recommendations and options for a GF QA Policy for Diagnostics– Need for the expertise and support of technical partners – WHO Diagnostics and Laboratory Technology key
participant
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Global Fund challenges• Increasing demands for
– Malarial ,TB, and OI medicines of assured quality– Quality Control Laboratories compliant with GF
requirements– Rapid diagnostic tests prequalified
• Lack of NRA capacity
• Lack of consistent Quality assurance systemof Procurement Agents
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
Conclusion
GF gratefully acknowledges the assistance, help and guidance provided in 2009 by WHO prequalification programs for Medicines Quality Control Laboratory and Diagnostics which was a key element to assure access of assured quality medicines to people in need
5th Consultative Stakeholder meetingUN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010
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