Global Fund ’s procurement principles

1. Study on Quality Assurance for Essential Medicines other than ARVs, Antimalarial and Antituberculosis Medicines Joëlle Daviaud1, Jean-Michel Caudron2, Corinne Pouget2, Monika Zweygarth1, Abu Saleh1, Carmen Perez Casas1, Sophie Logez1 1 The Global Fund to Fight AIDS, Tuberculosis and Malaria, Switzerland; 2 Quamed, Institute of Tropical Medicine, Antwerp, Belgium

2. Global Fund’s procurement principles • Procure quality assured products • Conduct procurement processes in a transparent and competitive manner • In the most adequate form to support adherence (Fixed dose combinations, children forms) • At the lowest price • Adhere to National and • International Laws On average, 40 % percent of funds are used for medicines and health products procurement

3. Overview of the Global Fund’s QA policy(issued 1 July 2009, last amended 14 December 2010): + • Quality Monitoring • Grant recipients must organize: • Monitoring quality all along the supply chain (storage, distribution) • Systematic random quality control testing Quality Criteria All medicines must be authorized for use in recipient countries + Additional stringent criteria for all ARVs, anti-TB products and antimalarials • Clinical Criteria • Medicines must be listed in WHO or national or institutional Standard Treatment Guidelines (or appropriate technical justification) + • 2008: Decision to phase in stringent criteria for other Global Fund-financed medicines

4. Quality criteria for grant-funded medicines

5. Monitoring compliance with quality criteria • Grant recipients report all purchases of ARVs, anti-TB medicines and antiretrovirals, Bednets, Condoms and RDTS, received in the online PQR database (requirement of the grant agreement) • Local Fund Agents verify all entries are verified against source documentation prior to each disbursement and at grant review for extension (“Phase 2” / periodic review) • The Global Fund Secretariat detects and follows up non-compliances based on PQR data • Procedures are in place to deal with: • Failure to obtain Global Fund agreement before procuring ERP-reviewed products • Non-compliance with the requirements of the Global Fund QA policy Less than 1% of Non Compliance purchase have been identified

6. Procurement since July 2009, classified as per Global Fund QA Policy First-line TB incl.streptomycin: US$ 48 million, 68% “A” or “B” Second-line TB: USD 30 million B: SRA-autho-rized* GLC/GDF A: WHO-prequalified A and B Source: PQR data as at 31/10/2011

7. Study on QA status of donor-funded essential medicines Aim To identify areas for improvement to inform policy development • Method: • Desk review and survey: • Publications and assessment reports • Questionnaire on QA criteria for the procurement of essential medicines, focusing on opportunistic medicines • Completed by 27 of 53 donors, implementers and organizations with procurement activities • Five one-week country visits: Armenia, Burkina Faso, Cambodia, Nepal, Nicaragua • Key informant interviews: representatives of facilities across levels of health care, regulatory authorities, local manufacturers, recipients of Global Fund grants, WHO country offices, disease programmes, procurement agents

8. Main Outcome • The global pharmaceutical market for non ATM medicines is at high-risk • Poor regulations = weak protection of patients • Predominance of price in purchase procedures, not linked with clear quality requirements • More than 80% of Non ATM medicines purchased with Global Fund resources in 2010 are anti-infective, live saving medicines

9. Challenges with QA of donor-funded essential medicines National medicines regulatory authorities (NMRAs) Legally responsible in country of use, but weak capacity Complex procurement channels Small market share No clear QA criteria Over-reliance on QC MQAS principles: difficult to apply Fast-tracked registration (International) procurement agents Diverse capacity for QA  Competition on price and overall efficiency Donors Small market share, special requirements  Limited choice for some products Delegation of QA

10. Weaknesses at regulatory level In many grant recipient countries (developing countries): Lack of human, financial and technical resources: Post-marketing surveillance • Poor capacity for medicines control Assessment of manufacturing sites Insufficient capacity to assess domestic sites Rarely done for foreign sites • Authorization for medicines use: • Weak requirements • Difficulties to properly assess the quality of generic medicines • Waivers, fast-tracking • In developed countries: • Resources and independent technical expertise for global pharmaceutical QA are becoming increasingly scarce • Trend towards harmonized, risk-based approaches for maximum impact • Less stringent requirements for products for export

11. Weaknesses at procurement level • Product selection and prequalification • Poor knowledge and understanding of norms and standards • Difficult access to technical references (pharmacopoeias, WHO technical report) • Poor quality of information submitted by suppliers; challenge to verify the veracity of the information Quality monitoring • Difficulty to confirm the identity of the product supplied (e.g. WHO prequalified) • Confusion between quality assurance and quality control • Inappropriate QC protocols (costly and not necessarily efficient) • Lack of internationally recognized standards and/or manufacturers’ specifications

12. Key stakeholders’ comments All medicines should meet appropriate quality standards.Many implementers call for an appropriate and global answer to the problem. No double standards: Logistic and ethical dilemma to maintain multiple QA systems Advocate for a harmonization of QA policies among donors who have the capacity to influence the market Critical responsibility: check, control and audit delegated activities Need more efficient procurement and supply systems Situation will not change as long as drug regulatory authorities have not strengthened their capacity and responsibilities of all actors are better defined and respected Policy implementation should include resource mobilization to promote quality assurance

13. Towards a harmonized approach with partners WHO and Global Fund joint meeting on Quality Assurance for Essential Medicines 30-31 August 2011 Participants from16 International Organizations: CentraleHumanitaireMédico-Pharmaceutique (CHMP) Crown Agents European Commission, DG Humanitarian Aid and Civil Protection Global Fund IDA Foundation International Committee of the Red Cross (ICRC) Institute of Tropical Medicine ( QUAMED) Management Sciences for Health (MSH) Médecins sans Frontières (MSF) Partnership for Supply Chain Management (PFSCM) UNICEF Supply Division United Nations Office for Project Services (UNOPS) United Nations Population Fund (UNFPA) USAID, Bureau for Global Health World Health Organization (WHO) World Bank

14. Possible approaches for QA of essential medicinesWhich standards to apply to which products? Step-wise, risk-based?

15. Joint Global Fund-WHO meeting on QA of essential medicines • A common approach with harmonized criteria is needed and was agreed by all participants: • Efficient use of scarce, technical resources • Maximum market impact (even if still limited – market niche) • Avoiding confusion and double standards • Specific criteria can be established once a risk classification is finalized • Consider medicines in each class and associated risks • Define appropriate mechanisms to mitigate these risks • Recipient countries must be involved • Responsibility of NMRAs remains • Avoid double standards (donor-funded vs. other medicines)

16. Next steps • Donors and procurement agencies will continue to work towards common quality requirements for non-ATM medicines • Risk categorization of essential medicines by WHO in 2012 • Towards Qualification of Procurement Agencies: • A working group of donors and procurement agencies, facilitated by Global Fund, will develop a common tool for assessment of procurement agencies, based on the WHO Model Quality Assurance System (Q3 2012) • WHO will formalize the tool, ultimately to serve for independent qualification of procurement agents (Q4 2012)

17. THANK YOU