Strategies Promoting Access to Medicines: The role of supply management

1. . . Strategies Promoting Access to Medicines: The role of supply management Unit of Essential Medicines, Vaccines and Health Technologies, Nov 2004.

2. Policy Development Process • Sep 2003: Governing bodies request PAHO to develop policy options for countries • March 2004: Strategic lines presented to the Sub-Committee of Planning and Programming • June 2004: Working Group (WHO, UNDP, MSH, MSF, countries and Collaborating Centers) develops strategic lines • June 2004: Executive Committee endorse policy options and drafts resolution • Sep 2004: Directing Council adopts policy options and resolution

3. A Framework for Access Selection POLICY ACCESS REGULATION Financing Pricing RATIONAL USE QUALITY Supply Management

4. Data on Pharmaceutical Expenditures (IMS) Data on Pharmaceutical Expenditures (IMS) 1994 1994 2001 2001 • Global Expenditure: • Global Expenditure: • US$ 364 billion • Latin America: • 5% or US$ 18.2 billion • Global Expenditure: • US$ 246 billion • Latin America: • 7% or US$ 18.5 billion • Lack of access to health care for large segments of the population • Increasing role of the public sector in health care provision • Intensification of cost containment in the pharmaceutical sector IMS DEC 2003

5. Share of Household Health Expenditure by Type Source: Table A.6 (III) PAHO Health Accounts and National Health Accounts, 2003

6. Strategic Lines for PAHO and Access WHO Medicines Strategy 2007 • Policy • Quality and Safety • Rational Use PAHO and • Coherent Generic Medicines Policy • Cost Containment Strategies • Commodity Supply Systems • Procurement Mechanisms Access

7. 1. Developing Coherent Generic Policy • Understanding differences in definition • Reviewing legislation, regulations and policy • Examining incentives promoting generics: (production, registration, distribution, prescription, dispensing, and use) • Assessing impact • Providing Options

8. 1. Developing Coherent Generic Policy

9. 222% Armenia Brazil Ghana Kenya Peru Philippines S. Africa Sri Lanka (n=7) (n=8) (n=5) (n=10) (n=14) (n=9) (n=15) (n=10) Savings to Consumers and Governments from Buying Generic Brand median MPS Most sold generic median MPS 33% Generic savings 33% 108% 21% 423% 176% 186% 271% Source: WHO-HAI Medicine Prices, 2003

10. Strategies to Achieve a Mature Generics Market National strategies for generics 1. Supportive legislation & regulation 2. Reliable quality assurance 3. Professional, public acceptance 4. Economic incentives Percent of new prescriptions, U.S.A. Source: WHO Rockefeller

11. Strategic Lines for PAHO and Access WHO Medicines Strategy 2007 • Policy • Quality and Safety • Rational Use PAHO and • Coherent Generic Medicines Policy • Cost Containment Strategies • Commodity Supply Systems • Procurement Mechanisms Access

12. 2. Cost Containment Approaches • Understanding Pricing • Tender Options • Negotiations • Price Controls • IP Regulatory Options provided for by TRIPS • Voluntary / Compulsory Licensing • Parallel Imports • Data Protection • Global, Regional and Bilateral Trade Agreements: Monitoring Access and Pricing

13. Cost Containment for ARVs in Andean Countries Regional Price Negotiation for ARVs, REMSAA, June 2003, ORAS/PAHO

14. 2. IP and Access • Meeting of the Working Group on IP (Nicaragua 2004) • Meeting of MOHs and Ministries of Trade and Commerce, Ecuador, Colombia and Peru, July 2004. • Methodologies to assess impact of trade agreements • Training materials for health professionals

15. 2. Monitoring TRIPS Implementation in Latin America • Assessment in 11 countries, recently published in the Bulletin of the World Health Organization1 • Methodology: Analysis of IP legislation in 11 countries focusing on tersm of patents issued; patentable subject matter; transition periods; burden of proof of patent infringement; exhaustion rights, compulsory licensing; and early working. • Results: • By 2000 all countries had reformed legislation • 10 of 11 made use of TRIPS safeguards and flexibilities • Andean countries, DOR and Panama made use of parallel importing • Early working exception in two countries (DOR and Brazil) • Oliveira MA, Bermudez JAZ, Chaves GC, Velasquez G. • Bulletin of the World Health Organization. November 2004, 82 (11). Pp 815-820.

16. Strategic Lines for PAHO and Access WHO Medicines Strategy 2007 • Policy • Quality and Safety • Rational Use PAHO and • Coherent Generic Medicines Policy • Cost Containment Strategies • Commodity Supply Systems • Procurement Mechanisms Access

17. 3. Access and Supply Management • To ensure continuous availability of essential medicines and public health supplies • of quality • coherent with the needs of the public health system • focusing on priority public health programs • maximizing resource utilization • using efficient and dynamic administrative and management processes • promoting rational use of pharmaceutical products

18. An Overview of the System

19. Characteristics of a Supply Management System • Pharmaceutical Management Framework • Product Selection • Acquisition • Inventory Management and Distribution • Rational Use • Monitoring and Evaluation

20. The Pharmaceutical Supply Management Framework A:National / Regional Pharmaceutical Policy

21. 1. The Pharmaceutical Supply Management Framework B:Definition of the Supply System • MOH / Drug Regulatory Authority • MOH / Dept. Pharmacy Services • MOH / Procurement Service • MOH / Priority Programs • Ministry of Finance • Central Medical Stores • Social Security System • Therapeutic Committees • Drug Selection Committees • Tendering Committees • Reference Hospitals • Primary Health Care Pharmacies • Community Pharmacies • National QC Laboratories • MOH / Pharmaco-surveillance Rational Use Acquisition

22. 1. The Pharmaceutical Supply Management Framework B:Definition of the Supply System • .Definition of Responsibilities • Identification of Coordination • Mechanisms • Integration of Existing Institutions • & Programs Rational Use Acquisition

23. Operational Framework for Supply Management: COHAN, Colombia Coordination MOH Technology Transfer Research Supply System Training Selection & Needs Estimation Quantitative Approaches Qualitative Purchases Technical Support Marketing Stock Managememnt Sales Rational Use Source: COHAN 2004

24. Product Selection • National Therapeutic and Drug Selection Committees based on information provided in • Treatment Norms • National Essential Drug List • Cost v Therapeutic Class

25. Product Selection Financial Regulations And Admin. Procedures Health Regulations And Drug Registration • Requires understanding • of the • Public Health • Regulatory Framework Commercial and IP Regulations

26. Product Acquisition • Good Practices for Pharmaceutical Procurement, WHO 2002: presents basic principles for effective pharmaceutical procurement • Selection of reliable manufacturers and suppliers (Prequalification) • Lowest cost for products of quality • Appropriate delivery times • Transparent procurement procedures and management

27. Product Acquisition Compilation of Information Financial Quantity Market Intelligence Reference Prices Morbidity Data Treatment Norms Local / International Availability Historic Use Procedures Funding Patent Original/Brand INCOTERMS Taxes

28. Inventory Management & Distribution… means Information Management By: product, batch no, expiry date, budget line, health program, location etc Customs, Taxes, Registration, Quality & Order verification, Costing Product, Presentation, Qt Suppliers, Prequalification Pricing, Shipping, Delivery Times Institution information, Product picking, Invoicing & Accounting, Shipping & Transport, Usage Evaluation

29. Rational Use & Drug Supply Systems Monitoring Rational Use Adherence to Treatment Norms Registering Product Use Monitoring Clinical Response Surveillance for Adverse Reactions & Resistance Changes in Product In the Supply Chain Product Availability & Affordability

30. Monitoring an Evaluation • Pharmaceutical Management Framework • Product Selection • Acquisition • Inventory Management and Distribution • Rational Use Process Indicators + Result Indicators

31. The HR Factor

32. PAHO Program of Work 2004 Supply Management • Regional Workshops in HIV/AIDS to Assess the Gaps • Caribbean (February 2004) & Central America (August 2004) • Methodology: • Participation of HIV/AIDS Program Managers, HR Managers, Chief Pharmaceutical Officers, Strategic Planning Managers Country Reports • WG1: Assessment of Minimum Requirements for scaling up by country, focusing on Logistics, HR and Planning • WG2: Assessment of Min. Requirements, inter-country by area • WG3: Definition of priorities by country and TC requirements

33. Results of Workshop / Caribbean Total 5,417 6,656 1,239

34. TC Priorities for Caribbean • Processes of quantification, prequalification and procurement • IPR and Drug Regulation • Coordination Mechanisms in Supply Management • Training in Procurement and Supply Management (using WB materials) • Direct support to countries and CARICOM on IP and drug regulation assessment and options • Development of regional capacity in QC • Establishment of Caribbean Network of Procurement and Supply Management Agencies (CariPRO)

35. Results of Workshop / Central America

36. Priority Areas in Pharmaceutical Supply Management Identified by Central American Countries M&E Information / Communication Pharmaco.Vigil Rational Use GDP/GSP Distribution Planning Acquisition Management Procurement Regulation Knowledge of Reg. Frame. Selection Def. Responsibilities Coordination mechanisms Nacional Policy 0 10 20 30 40 50 60 70 80 % Priority by element Results of Workshop / Central America

37. TC Priorities for Central America • Monitoring and Evaluation: Performance Assessment of the Supply Chain • Good Storage and Distribution Practices • Coordination Mechanisms in Supply Management • Support in performance assessment • Good Storage and Distribution Practices • Networking / Intercountry cooperation • Assessments of Supply System in NIC and HON

38. Strategic Lines for PAHO and Access WHO Medicines Strategy 2007 • Policy • Quality and Safety • Rational Use PAHO and • Coherent Generic Medicines Policy • Cost Containment Strategies • Commodity Supply Systems • Procurement Mechanisms Access

39. 4. Procurement / PAHO Strategic Fund 2000 2004 • Established by the Director, with formal invitations to countries • A procurement mechanism to support countries in supply management of prequalified TB, HIV, and malaria public health supplies • 12 Countries with signed participation agreements • >US$ 14 million in purchase orders by three countries • Strategic review of Fund framework through SPP and PAHO Working Group

40. The Review Process – WHO Audit • Procurement Funds and Linkages to Technical Cooperation in the Americas, March - April 2004 • To assess the efficiency of the process and the effectiveness of activities in the achievement of stated objectives. • Methodology: reviewing planning, program design and implementation, reliability of information, communication and monitoring

41. Recommendations from the Audit • The Strategic Fund should be a fundamental component of the PAHO strategy to promote Access to priority public health supplies • Political impetus be provided through advocacy to Member States • The product mix be reviewed • Technical cooperation scope and mechanisms be developed specifically in demand forecasting, supply management and quality at the country level.

42. Strategic Fund Work Program 2005 • Focus on PAHO/AMRO priority countries and the Caribbean • Update technical framework document and product mix • Review of legal framework to facilitate participation of GFTAM projects • Commence training in focus countries

43. And Finally…. We´ve lots to do…. !!!! And we can do it together Thank You - Gracias

44. Next Steps • Modify TORs, prepare meeting report and disseminate • Modify Indicators and disseminate. Set date for collection • Establish the Sharepoint website • Organize next meeting (April 04 with PAHO/WB training?)