5 th consultative stakeholder meeting un prequalification of diagnostics, medicines and vaccines 11...

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


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


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


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)


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


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


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


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


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


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


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


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


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


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)


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


• 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


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


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


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


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

5 th consultative stakeholder meeting un prequalification of diagnostics, medicines and vaccines 11...

Documents

global fund slide

medicines vaccines

global fund principles

global fund areas

global fund approach

global fund perspective

global fund policies

global fund objectives