RHSC Meeting Kampala, 27- 28 May 2010 Quality for Medicines The Global Fund approach Sophie Logez Manager, QA and Data Quality Pharmaceutical Management

RHSC Meeting Kampala, 27- 28 May 2010

Quality for MedicinesThe Global Fund approach

Sophie LogezManager, QA and Data Quality

Pharmaceutical Management Unit


The Global Fund

Guiding principles• Operate as a financial instrument • Make available and leverage additional financial resources • Support programs that evolve from national plans and

priorities

• Performance-based funding mechanism

“Making a “sustainable and significant” contributionto the achievement of the Millennium Development Goals”

Financing 700 grants in 144 countries (May 2010)Financing 700 grants in 144 countries (May 2010)


Global Resources DistributionRounds 1-8, (July 2009)

Procurement of medicines by value

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


The Global Fund PSM Policy Principles

• Quality-assured products • Lowest possible price

• Transparent, fair and competitive procurement • National laws and international agreements• Build on existing systems

Recipients are responsible for health products management


Development of the Global Fund QA Policy for Pharmaceutical Products

2002

For limited and single source:

- WHO PQSRA approved

Or - GMP

manufacturing site

2005

For limited and single source:

- WHO PQSRA approved

Or - GMP site

Or - GMP site and

submission to WHO PQ

2007

For limited and single source*:

- WHO PQ SRA approved

Or GMP site

Or GMP site and

submission to PQ

* New definition of Single and limited source

2008/2009

For all ARVs, anti-TB, anti malarials:

- WHO PQ orSRA approved

Or - ERP recommended

2010Interim exception for some live saving anti malarial and anti TB


QA Policy for Pharmaceutical Products

• Since 2002, medicines WHO PQed and or SRA authorized be a priority with a step approach to increase the number of formulations concerned:– Single and limited source ARVs and antimalarials (TB medicines

multisource)– More stringent definition of single and limited source– More stringent criteria for all ARVs, antimalarials and anti TB medicines

• the Expert Review Panel mechanism

Possibility of purchasing products authorized by an ERP on the basis of a risk/benefit assessment of products dossier not yet WHO PQed or SRA for a time-limited period (1 year)


QA Policy for Pharmaceutical Products (as of 2009)

Clinical Criteria

• Medicines listed in WHO or national or institutional Standard Treatment Guidelines

• Require applicants/ recipients to provide justification for selection of unlisted products in one of the STGs

Quality Criteria

For all productsAuthorization for use in the recipient countries

For ARVs, anti-TB and anti-malarial products

WHO Prequalified or authorized by a Stringent Regulatory Authority;or Recommended for use by an Expert Review Panel,Only If <2 WHO PQed or SRA authorized products available

Monitoring Quality

• Monitoring quality of products all along the supply chain

• Systematic random quality control testing

• Recipients report testing results to Global Fund

+ +


Establishment of the Price and Quality Reporting system for key health products, including ARVs, anti-malarial and anti TB medicines

– Make publicly available price and quality information • Transparency • Informed procurement decisions by countries• Basis to develop demand forecasts

– Monitor price and quality information – Analyze procurement information for policy purposes

Transparency and Accountability


Publication of QC Results


Distribution of Products by Quality Criteria

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 and SRA approved products are purchased in priority, if available.Currently, 95% (in units) of ARVs purchased by PRs are WHO PQed


Products reviewed by the Expert Review Panel since 2009

Number Total ARV Anti-Malarials

Anti-TB

Products permitted for use by ERP – pre qualified by WHO (feb10)– approved by SRA (USFDA) (Feb 10)

38

9

5

17

7

5

4

1

NA

18

1

NA

Products NOT permitted for use by ERP– currently pre qualified by WHO– currently approved by SRA (USFDA)

60

0

1

16

0

1

23

0

NA

21

0

NA

Three ERP set of reviews (May, October 2009 and April 2010) based on an invitation for expression of interest to submit product dossiers

98 product dossiers submitted and reviewed by ERP:

• 38 products permitted for use for a one year period


Partnerships in Quality Assurance

• Close collaboration with WHO PQ

– Expert advice– QA Policy implementation: ERP management

• WHO Disease Programs: HIV, Malaria, TB• Collaboration/information sharing with other donors and

suppliers, such as UNICEF, UNDP• Working toward policy harmonization with partners eg. GDF• Regular communication with manufacturers: annual meeting • Monitoring QA activities and publication of results


Challenges

• Increasing demands for – Malarial ,TB, and OI medicines of assured quality– Quality Control Laboratories compliant with GF requirements

• Strengthening National Regulatory Authority capacity and regulatory networking and harmonization

• Lack of consistent Quality Assurance system

of Procurement Agents

Documents

RHSC Meeting Kampala, 27- 28 May 2010 Quality for Medicines The Global Fund approach Sophie Logez Manager, QA and Data Quality Pharmaceutical Management