1. Quality Assurance for pharmaceutical products in international procurement Approach 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. 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. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 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” contribution to the achievement of the Millennium Development Goals” Since 2002: 579 active grants in 144 countries (June 2010)

4. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 4 Disease Components Distribution Rounds 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

5. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 5 Rapid scaling up of results Intervention mid 2007mid 2008July 2009June 2010 HIV: People on ARV treatment 1.1 million1.75 m2.3 m2.8m TB: People treated under DOTS 2.8 million3,9 m5.4 m7m Malaria: Insecticide-treated nets malaria treatment 30 million59 m88 m122m 142m Global Fund Top 3 result indicators (2010)

6. 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

7. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 7 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 or SRA approved Or - ERP recommended 2010 Interim exception for some live saving anti malarial and anti TB

8. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 8 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 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, 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 + +

9. 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

10. 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)

11. 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

12. 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.

13. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 13 Products reviewed by the Expert Review Panel since 2009 NumberTotalARVAnti- Malarials Anti-TB Products permitted for use based on ERP advice – pre qualified by WHO (feb10) – approved by SRA (USFDA) (Feb 10) 38 9 5 17 7 5 4 1 NA 18 1 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

14. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 14 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”

15. WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 15 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 /

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

17. 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

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

19. 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

20. 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

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

22. 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

23. 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 - 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

24. 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

25. 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