1. TBS Meeting Geneva, November 2011 Global Fund Policies and Reporting on Procurement of Health Products WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 1 st November 2011 Carmen Perez Casas Pharmaceutical Management Unit

2. Geneva, November 2011 Contents Areas of risk General principles Quality Assurance policies Competitive procurement Price and quality reporting mechanism

3. Geneva, November 2011 Use of the Global Fund Grant Funding On average, 37% percent of funds are used for medicines and health products procurement

4. Geneva, November 2011 Procurement and Supply Management : highest areas of risk Extract from Final Report of the High-Level Independent Review Panel on Fiduciary Controls and Oversight Mechanisms of the Global Fund (September 2011), Annex E: Procurement, Construction and Supply-chain Management (PCSCM) weaknesses

5. Geneva, November 2011 Procurement and Supply Management : highest areas of risk Extract from Final Report of the High-Level Independent Review Panel on Fiduciary Controls and Oversight Mechanisms of the Global Fund (September 2011), Annex E: Procurement, Construction and Supply-chain Management (PCSCM) weaknesses

6. Geneva, November 2011 Global Fund Policies on Procurement of Pharmaceuticals and other Health Products –Principal Recipients responsible for all PSM activities –Principles and minimum standards, not detailed procedures –Build upon existing systems –Transparent, fair and competitive procurement –Value for money –Aim to ensure that the Recipient selects: among quality assured products, at the lowest possible price, in the most adequate formulations (fixed-dose combinations, children formulations)

7. Geneva, November 2011 Principal Recipients must procure all products in accordance with principles set out in the interagency guidelines Interagency Guidelines on Good Pharmaceutical Procurement (WHO 1999) A Model Quality Assurance System for Procurement Agencies (WHO, 2007) Global Fund Policies on Procurement of Pharmaceuticals and other Health Products : principles

8. Geneva, November 2011 Quality Assurance for Health Products

9. Geneva, November 2011 Quality Assurance for Health Products Global Fund quality criteria Pharmaceuticals: QA Policy Diagnostics: QA policy Insecticides and Nets: WHOPES Condoms: WHO/UNPFA guidance To ensure safe, effective and acceptable health products to end users.

10. Geneva, November 2011 Partnerships in Quality Assurance Collaboration with –WHO prequalification –WHO Disease Programs Collaboration/information sharing with other donors and suppliers, such as UNITAID, UNICEF, UNDP,… Policy harmonization with partners (GDF, UNITAID) Regular communication with manufacturers: annual meeting Transparency. Monitoring QA activities and publication of results

11. Geneva, November 2011 Publication of QC Results

12. Geneva, November 2011 Competitive procurement In accordance with good procurement practices, the Fund request Recipients to perform competitive purchasing from qualified manufacturers/products. Regulatory issues: -Authorization by local authorities (fast-track registration)

13. Geneva, November 2011 Competitive procurement Regulatory issues cont.: -Intellectual property at country level

14. Geneva, November 2011 DOHA declaration on TRIPS and Public Health “TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use to the full the provisions in the TRIPS Agreement, which provide flexibility for this purpose” (WTO, Doha, 9-14 November 2001)

15. Geneva, November 2011 How can we anticipate future problems earlier in the grant cycle? Technical assistance and support can be requested for management of patent issues in agreement with provisions in national laws and international agreements : –to prepare PSM plans to avoid future procurement bottlenecks, –during implementation. Technical Partners (WHO, UNDP) and other organizations are available for Technical Assistance –possible with Global Fund grants but not often requested Need for more accessible information on the domestic patent status of medicines to better anticipate options for procurement public health oriented licenses (UNITAID-funded Medicines Patent Pool)

16. Geneva, November 2011 Evolution of prices (example with LPV/r for HIV grants in Lower Middle Income Countries) 16

17. Geneva, November 2011 Reporting prices and quality

18. Geneva, November 2011 PQR Goals Share Communicate market information to Principal Recipients Monitor Improve transparency Benchmark prices and monitor QA compliance Analyze Influence policy and decision-making “Disclosure of information on prices paid for purchases by Fund Recipients is a matter of principle and will facilitate a process leading to lower prices” October 2002, 3rd Board Meeting

19. Transparency and Responsibility PRs must report to the on-line Reporting system the information concerning quality and price (PQR) with data for all procurement performed for certain categories of products Antiretrovirals Antimalarial medicines Antituberculosis medicines Mosquito Nets Condoms Rapid Diagnostic Tests 600 users in 125 countries More than 1,800 million USD reported since 2009 Grant reviews

20. Geneva, November 2011 How can you use the comparative data? Available online Reports – View Best Prices in your Region, in your tier, ….. 1.Informing budgets 2.Monitoring efficiencies

21. Geneva, November 2011 PQR pricing reports

22. Geneva, November 2011 BACK UP

23. Geneva, November 2011 Quality Assurance Policy for Pharmaceutical Products Clinical Criteria Medicines listed in WHO or national or institutional Standard Treatment Guidelines Quality Criteria For all products: Authorized for use in recipient countries For ARVs, anti-TB and anti-malarial products: WHO Prequalified or authorized by a Stringent Regulatory Authorities; OR Recommended for use by Expert Review Panel Monitoring Quality Monitoring quality of products all along the supply chain Systematic random quality control testing Recipients report testing results to Global Fund + +

24. Geneva, November 2011 Non ATM Medicines Working towards harmonized, risk- based criteria for essential medicines OTHER THAN ATM (ARVs, anti-TB products and anti- malarials)

25. Geneva, November 2011 CLINICAL CRITERIA Product types must be selected in compliance with: National guidelines WHO guidance CLINICAL CRITERIA Product types must be selected in compliance with: National guidelines WHO guidance QUALITY STANDARDS All products: manufacturing site compliant with ISO 13485 (or ISO 9000 series for products to which ISO 13485 does not apply : microscopes) Malaria RDTs : approved by WHO after technical assessment HIV RDTs, ELISA and WB : -Assessed according to requirements of authorities member of GHTF; or -Approved by WHO after technical assessment QUALITY STANDARDS All products: manufacturing site compliant with ISO 13485 (or ISO 9000 series for products to which ISO 13485 does not apply : microscopes) Malaria RDTs : approved by WHO after technical assessment HIV RDTs, ELISA and WB : -Assessed according to requirements of authorities member of GHTF; or -Approved by WHO after technical assessment + Quality Assurance Policy for Diagnostic Products Monitoring quality and ensuring adequate use

26. Geneva, November 2011 Challenges at country level on IP Bottlenecks in procurement are common among recipients –weakness in forecasting, storage, distribution, etc. Management of patent matters as a procurement bottleneck –Procurement plans are usually prepared without taking into account patent situation. Problems arise only late in the cycle. –May leads to emergency procurement to avoid treatment disruption/stocks outs –Delays in clarifying situation and potential options due to lack of expertise of procurement offices –Disconnect between Ministry of Health and other authorities –Lack of up-to-date domestic patent information and knowledge about voluntarily licenses –Patents might impact procurement of improved formulations (fixed-dose combinations and children forms)