Quality Assurance for pharmaceutical products in international procurement Approach of major donors and procurers

1. Quality Assurancefor pharmaceutical products in international procurementApproach of major donors and procurers Core presentation prepared by Sophie Logez The Global Fund to fight AIDS, TB and Malaria Presented by Milan Smid, PQP

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

3. The Global Fund “Making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals” 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 Since 2002: 579 active grants in 144 countries (June 2010) WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 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 WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 OP/140709/3

5. Rapid scaling up of results Global Fund Top 3 result indicators (2010) WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

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

7. Development of the Global Fund QA Policy for Pharmaceutical Products 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 or SRA approved Or - ERP recommended 2010 Interim exception for some live saving anti malarial and anti TB 2005 For limited and single source: - WHO PQ - SRA approved Or - GMP site Or - GMP site and submission to WHO PQ 2002 For limited and single source: - WHO PQ - SRA approved Or - GMP manufacturing site WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

8. QA Policy for Pharmaceutical Products (as of 2009) • Quality Criteria • For all products • Authorization for use in the recipient countries • For ARVs, anti-TB and anti-malarial products • WHO PQed or authorized by a SRA; • or • Recommended for use by an Expert Review Panel, • OnlyIf <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 • Clinical Criteria • Medicines listed in WHO or national or institutional Standard Treatment Guidelines + + WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

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

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

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

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

13. Products reviewed by the Expert Review Panel since 2009 • 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 WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

14. Monitoring Quality and Pricing 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 “Essential foundation of sound market dynamics and procurement practices” WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

15. Monitoring Quality and Pricing Recipients of grants are required to report procurement data of key health products: • - Antiretrovirals • - Antimalarial medicines • Antituberculosis medicines • - Bednets • - Condoms • - Rapid diagnostics tests Health Products reported http://www.theglobalfund.org/en/procurement/ WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

16. Accomplishments as of July 2010 • - over 700 million* US reported • - 712 registered users in 128 countries • 6,111 invoices • over 11,000 product purchases Since February 2009 Reporting into PQR since Feb 2009 *As of July 2010 WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

17. Distribution of Products by Quality Criteria WHO prequalified and SRA approved products are purchased in priority, if available. Currently, 95% (in units) of ARVs purchased by PRs are WHO PQed WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

18. Publication of QC Results WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

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

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

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

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

23. 93 countries already receive UNITAID support… HIV / AIDS 49 recipient countries Malaria 29 recipient countries Tuberculosis 72 recipient countries • ACT • LLIN • AMFm • US$318 m • - First line TB • - Paediatric TB • MDR-TB • Diagnostics • US$211 m • - Paediatric ARV • - Second line ARV • PMTCT • US$476 m - Cross cutting programs: US$109 m for PQ of drugs & diagnostics and transversal programs WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010

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

25. With thanks to Sophie Logez and Lorenzo Witherspoon for agreeing to use their presentations Thank you for the attention E-mail for correspondence: smidm@who.int WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010