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National Medicines Policies & Access to Medicines Index

National Medicines Policies & Access to Medicines Index. Richard Laing EMP/MIE. Department of Essential Medicines & Pharmaceutical Policy. Objectives. Review the history of NDPs Discuss the background to NDP’s List the Components of a NDP Review actors involved in the NDP process

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National Medicines Policies & Access to Medicines Index

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  1. National Medicines Policies& Access to Medicines Index Richard Laing EMP/MIE Department of Essential Medicines & Pharmaceutical Policy

  2. Objectives • Review the history of NDPs • Discuss the background to NDP’s • List the Components of a NDP • Review actors involved in the NDP process • Discuss the Global Pharmaceutical Market • Discuss the Access to Medicines Index

  3. History of National Drug Policies • 1985 Nairobi Conference of Experts on rational Use of Drugs • 1987 Working group of Experts to draft guidelines for NDP’s • 1988 Guidelines for NDP’s released • 1995 Expert Committee on NDPs met report issued • 2002 New Guidelines published

  4. Background to NDP’s • Need for common framework to coordinate many different actors in the pharmaceutical field: • These include regulators (quality, safety and efficacy), producers (local & international), users (prescribers & consumers), health planners & managers, health finance authorities and researchers. • Each have valid interests in the field which may be contradictory or supportive • Involves both public & private sectors

  5. Components of a NDP • Legislation, Regulation and Guidelines • Selection of Drugs • Supply (incl. procurement & production issues) • Quality Assurance • Rational Drug Use • Economic Strategies for Drugs • Monitoring & Evaluation of NDP’s • Research • Human Resources Development • Technical Cooperation among Countries

  6. Overview of Components • Each component has a crucial part in the overall policy! • Emphasizing one component at the expense of others, weakens the entire policy • Many different actors are involved. Some are outside MoH, some outside government, some outside country • Means that NDP planners need to be aware, though not expert, in all areas!

  7. Many Actors Involved! Some pro, some against! • Doctors, specialists, public/private • Pharmacists retail and manufacturing • Local and international producers, importers • Consumers/Patients • Media • Regulators • Insurance Companies • Etc, Etc,

  8. Characteristics of a National Medicines Policy • Essential part of health policy, must fit within the framework of a particular health care system. • Goals should be consistent with broader health objectives • Health policy and the level of service provision in a particular country are important determinants of drug policy and define the range of choices and options. • Implementation of an effective drug policy promotes confidence in and use of health services.

  9. The Global Pharmaceutical Market • Scale of Global market • By Value • By Volume • Generic market by Value • The Access to Medicines Index

  10. Distribution of total pharmaceutical expenditures by income level2005/06 TPE (Millions US$) Pop (000s) $4,123 (0.5%) $81,235 (9.9%) 782,194 (14.4%) 983,493 (18.0%) $76,857 (9.3%) 577,565 (10.6%) 3,106,247 (57.0%) $660,609 (80.3%) Data Source NHA 2005/6

  11. Source IMS Health 2008

  12. Consumption by Volume Volume measured by IMS Health Standard Units

  13. 2008 Generic Uptake after Patent Expiry in 2000 Data Source IMS Health 2009

  14. The 2010 Access to Medicine Index: methodology and indicators 28 June 2010 Afshin Mehrpouya RiskMetrics Group (MCSI Inc.) WHO, Geneva

  15. Geographical Scope: Index 2010 focuses on the Low and Medium Human Development Countries based on the UN Human Development Index (UN HDI) 2006. Countries classified as ‘medium-high’ and ‘high’ according to the World Bank Country Classifications, are excluded Disease Scope: Index 2010 covers a total of 33 diseases, consisting of acombination of the WHO Neglected Tropical Diseases, the top-10 non communicable diseases and the top-10 communicable diseases based onDisability Adjusted Life Years (DALY) Increased company coverage to 27 (from 20 in Index I) 20 Originator (19+1) and 7 Generics Manufacturers Highlights of Changes from Index 2008 to Index 2010 Scope 15

  16. The New Structure Index 2008 Index 2010 30% 30% 30% 10% ATM Management Public Policy& Advocacy R&D Patents &Licensing Equitable Pricing Capacity Donations Philanthropy 16

  17. The New Structure 17

  18. Index 2010 Rankings

  19. Highlight of Findings - Generics Ranbaxy, Cipla and Mylan undertaking adaptive R&D Ranbaxy, Cipla and Mylan collaborate with international programs such as PEPFAR, AMFm, UNITAID-CHAI etc. Only Ranbaxy and Cipla undertaking non-exclusive voluntary licensing Cipla has been innovative in capacity building Apotex under CAMR has been the first company to benefit from the 31f clause of TRIPS Reporting is very weak across the sector Authorized generics is a fast growing trend Teva and Sunpharma have no strategies or disclosure on access related issues

  20. THANK YOU

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