quality assurance for pharmaceutical products in international procurement approach of major donors...

Quality Assurancefor pharmaceutical products in

international procurement

Approach of major donors and procurers

Core presentation prepared by Sophie LogezThe Global Fund to fight AIDS, TB and Malaria

Presented by Milan Smid, PQP

WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

2

Trends applied by major international donors and

procurers

• Focus on quality• Harmonization of quality policies and standards• Quality is prerequisite for successful tenders• The Global Fund to fight AIDS, TB and Malaria sets up

an example• Similar criteria applied by others, e.g. UNITAID, GDF

and UNFPA


3

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”

Since 2002: 579 active grants in 144 countries (June 2010) Since 2002: 579 active grants in 144 countries (June 2010)


4

Disease Components DistributionRounds 1-8, (July 2009)

Global Fund Resources by Disease Component

100% = US$ 15.9 billion Percentages of total funds approved by the Board

OP/140709/3

Malaria29%

HIV/AIDS57%

TB14%


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Rapid scaling up of results

Intervention mid 2007 mid 2008 July 2009 June 2010

HIV: People on ARV treatment 1.1 million 1.75 m 2.3 m 2.8m

TB: People treated under DOTS 2.8 million 3,9 m 5.4 m 7m

Malaria: Insecticide-treated nets malaria treatment

30 million 59 m 88 m 122m142m

Global Fund Top 3 result indicators (2010)


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The Global Fund PSM Policy and Principles

• Quality-assured products – Quality Assurance Policy for Pharmaceutical Products

• Lowest possible price• Transparent, fair and competitive procurement

– “Operational principles for Good Pharmaceutical Procurement”

• National laws and international agreements• Build on existing systems

Recipients of grants are responsible for health products management


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Development of the Global Fund QA Policy for Pharmaceutical

Products 2002

For limited and single source:

- WHO PQ- SRA approved

Or - GMP

manufacturing site

2005

For limited and single source:

- WHO PQ- SRA 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


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QA Policy for Pharmaceutical Products (as of 2009)

Clinical Criteria

Medicines listed in WHO or national or institutional Standard Treatment Guidelines

Quality Criteria

For all productsAuthorization for use in the recipient countriesFor ARVs, anti-TB and anti-malarial products

WHO PQed or authorized by a SRA;orRecommended 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

+ +


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The Expert Review Panel

• A technical panel hosted by PQP• Coordinated by Head of PQ Assessment• 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 and GDF in its decision making


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How ERP works

• Review of product documentation:– at the request of the Global Fund/GDF, or – in response to GF/GDF invitation for EoI to

submit dossiers.• A product is eligible for review by the ERP if:

– Application to WHO Prequalification or application for marketing authorization to an SRA is accepted for assessment, and

– Manufacturing site is GMP compliant (WHO/SRA/PICs)


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How ERP works

• ERP provides advice only, decision is made by the procurer

• Time limited use (12 months)– Possibility of extending under certain

circumstances

• Not an alternative to PQ, but provides limited assurance of quality when there is no other option


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Categorization of products reviewed by ERP

• Products in Categories 1 and 2 can be considered, in principle, for time-limited procurement.

• Products in Category 3 can be considered only if there is no other option and the risk of not treating the disease is considered to be higher than the risk of using the product

• Products in Category 4 should not be considered for procurement under any circumstances.


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Products reviewed by the Expert Review Panel since 2009

Number Total ARV Anti-Malarials

Anti-TB

Products permitted for use based on ERP advice

– pre qualified by WHO (feb10)– approved by SRA (USFDA) (Feb 10)

3895

1775

41

NA

181

NA

• Hosted by WHO at the request of the Board• Review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized and make recommendations to the Global Fund• 3 ERP set of reviews of dossiers based on an invitation for expression of interest to submit product dossiers• 98 product dossiers reviewed by ERP• 38 products permitted for use for a one year period


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The Price and Quality Reporting system for key health products: Element of the Market Dynamics Strategy

– Make publicly available price and quality information • Transparency and accountability• Informed procurement decisions• demand forecasts

– Monitor price and quality information • market conditions• Supplier performance• QA Policy compliance

– Analyze procurement information for policy and decision-making purposes

Monitoring Quality and Pricing

“Essential foundation of sound market dynamics and procurement practices”


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Recipients of grants are required to report procurement data of key health products:

Monitoring Quality and Pricing

Health Products reported

- Antiretrovirals - Antimalarial medicines- Antituberculosis medicines

- Bednets- Condoms- Rapid diagnostics tests

http://www.theglobalfund.org/en/procurement/


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Accomplishments as of July 2010

*As of July 2010

Reporting into PQR since Feb 2009Major product categories reported into the PQR

8%

41%

4%

32%

2%

13%

Anti-malaria medication

Anti-retroviral medication

Anti-TB medication

Bednet

Condom

RDTs and Other

Since

February 2009

- over 700 million* US reported - 712 registered users in 128 countries- 6,111 invoices - over 11,000 product purchases


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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


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Publication of QC Results


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Partnerships

• Close collaboration with WHO Prequalification Programme

– Expert advice– QA Policy implementation: ERP management

• WHO disease programs: HIV, Malaria, TB• Collaboration/information sharing with other donors and suppliers, such

as UNITAID, PMI, UNICEF, UNDP• Working toward QA policy harmonization (eg. Global Drug Facility)• Regular communication with manufacturers


20

Challenges

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

requirements

• Strengthening National Regulatory Authority capacity and regulatory networking and harmonization


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22

UNITAID

• Strategically deployed funds in time-limited interventions

• Innovative health financing mechanism raises money through air ticket levy from high and low income countries

• Targeted interventions in global markets to improve patient access to health products

• Works with and funds Partners to implement projects

• Leverage investments to produce global public goods that generate positive externalities


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93 countries already receive UNITAID support…

HIV / AIDS49 recipient countries

Malaria29 recipient countries Tuberculosis

72 recipient countries

- Paediatric ARV- Second line ARV-PMTCT

US$476 m

- ACT- LLIN- AMFm

US$318 m

- First line TB- Paediatric TB- MDR-TB- Diagnostics

US$211 m- Cross cutting programs: US$109 m for PQ of drugs & diagnostics and transversal programs


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Quality Assurance Standard(under construction)

• Medicines are prequalified by WHO Pre qualification Programme or a Stringent Regulatory Authority (SRA)

• For single or no prequalified source: GMP compliant and complete dossier submitted to WHO PQP or a SRA = technical evaluation of the product


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With thanks to Sophie Logez and Lorenzo Witherspoon for agreeing to use their presentations

Thank you for the attention

E-mail for correspondence: [email protected]

quality assurance for pharmaceutical products in international procurement approach of major donors...

Documents

global fund resources

results global fund

global fund qa policy

global fund psm policy

global fundgdf

sophie logezthe global

boardop1407093qsm tbs13

unfpaqsm tbs13