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

2. 2 |2 | Objectives zReview the history of NDPs zDiscuss the background to NDP’s zList the Components of a NDP zReview actors involved in the NDP process zDiscuss the Global Pharmaceutical Market zDiscuss the Access to Medicines Index

3. Department of Essential Medicines & Pharmaceutical Policy 3 |3 | History of National Drug Policies z1985 Nairobi Conference of Experts on rational Use of Drugs z1987 Working group of Experts to draft guidelines for NDP’s z1988 Guidelines for NDP’s released  1995 Expert Committee on NDPs met report issued z2002 New Guidelines published

4. Department of Essential Medicines & Pharmaceutical Policy 4 |4 | Background to NDP’s zNeed for common framework to coordinate many different actors in the pharmaceutical field: zThese include regulators (quality, safety and efficacy), producers (local & international), users (prescribers & consumers), health planners & managers, health finance authorities and researchers. zEach have valid interests in the field which may be contradictory or supportive zInvolves both public & private sectors

5. Department of Essential Medicines & Pharmaceutical Policy 5 |5 | Components of a NDP zLegislation, Regulation and Guidelines zSelection of Drugs zSupply (incl. procurement & production issues) zQuality Assurance zRational Drug Use zEconomic Strategies for Drugs zMonitoring & Evaluation of NDP’s zResearch zHuman Resources Development zTechnical Cooperation among Countries

6. Department of Essential Medicines & Pharmaceutical Policy 6 |6 | Overview of Components zEach component has a crucial part in the overall policy! zEmphasizing one component at the expense of others, weakens the entire policy zMany different actors are involved. Some are outside MoH, some outside government, some outside country zMeans that NDP planners need to be aware, though not expert, in all areas!

7. Department of Essential Medicines & Pharmaceutical Policy 7 |7 | Many Actors Involved! Some pro, some against! zDoctors, specialists, public/private zPharmacists retail and manufacturing zLocal and international producers, importers zConsumers/Patients zMedia zRegulators zInsurance Companies zEtc, Etc,

8. Department of Essential Medicines & Pharmaceutical Policy 8 |8 | Characteristics of a National Medicines Policy z Essential part of health policy, must fit within the framework of a particular health care system. z Goals should be consistent with broader health objectives z 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. z Implementation of an effective drug policy promotes confidence in and use of health services.

9. Department of Essential Medicines & Pharmaceutical Policy 9 |9 | The Global Pharmaceutical Market zScale of Global market yBy Value yBy Volume zGeneric market by Value zThe Access to Medicines Index

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

11. Department of Essential Medicines & Pharmaceutical Policy 11 | Source IMS Health 2008

12. Department of Essential Medicines & Pharmaceutical Policy 12 | Consumption by Volume 20002008 Country Income Group Volume per capita % of totalVolume per capita % of total High (33)89558.2%102455% Upper Mid (16)37624.4%51327% Lower Mid (15) 16310.6%20211% Low (3)1056.8%1408% Total (67)1539100%1878100% Volume measured by IMS Health Standard Units

13. Department of Essential Medicines & Pharmaceutical Policy 13 | 2008 Generic Uptake after Patent Expiry in 2000 Data Source IMS Health 2009

14. Department of Essential Medicines & Pharmaceutical Policy 14 | The 2010 Access to Medicine Index: methodology and indicators 28 June 2010 Afshin Mehrpouya RiskMetrics Group (MCSI Inc.) WHO, Geneva

15. Department of Essential Medicines & Pharmaceutical Policy 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 a combination of the WHO Neglected Tropical Diseases, the top-10 non communicable diseases and the top-10 communicable diseases based on Disability Adjusted Life Years (DALY)  Increased company coverage to 27 (from 20 in Index I)  20 Originator (19+1) and 7 Generics Manufacturers 15 Highlights of Changes from Index 2008 to Index 2010 Scope

16. Department of Essential Medicines & Pharmaceutical Policy 16 | Index 2008 Public Policy & Advocacy R&D Patents &Licensing Capacity Equitable Pricing Donations Philanthropy ATM Management Index 2010 Strategic Pillars Commitment s Transparenc y Performanc e Innovatio n Technica l Areas General Access to Medicine Management Public Policy and Market Influence Research & Development Equitable Pricing, Manufacturing & Distribution Patents & Licensing Capability Advancement Advancement in Product Development and Distribution Product Donations & Philanthropic Activities 16 The New Structure 30% 10%

17. Department of Essential Medicines & Pharmaceutical Policy 17 | 17 The New Structure Strategic Pillars Commitments 30% Transparency 30% Performance 30% Innovation 10% Technical Areas A. General Access to Medicine Management ATM Governance ATM Management System Stakeholder Engagement B. Public Policy and Market Influence Advocacy and Lobbying Competition Behavior Marketing Behavior C. Research and Development Innovative R&D Adaptive R&D Intellectual Property Sharing D. Equitable Pricing, Manufacturing and Distribution Marketing Approval (Registration) Equitable Pricing Manufacturing & Distribution E. Patents & Licensing Patents Non-Exclusive Voluntary Licensing F. Capability Advancement in Product Development and Distribution Capacity Building in Research and Development Capacity Building in Quality Management and Distribution G. Product Donations and Philanthropic Activities Donations Philanthropy

18. Department of Essential Medicines & Pharmaceutical Policy 18 | Index 2010 Rankings

19. Department of Essential Medicines & Pharmaceutical Policy 19 | Highlight of Findings - Generics zRanbaxy, Cipla and Mylan undertaking adaptive R&D zRanbaxy, Cipla and Mylan collaborate with international programs such as PEPFAR, AMFm, UNITAID-CHAI etc. zOnly Ranbaxy and Cipla undertaking non-exclusive voluntary licensing zCipla has been innovative in capacity building zApotex under CAMR has been the first company to benefit from the 31f clause of TRIPS zReporting is very weak across the sector zAuthorized generics is a fast growing trend zTeva and Sunpharma have no strategies or disclosure on access related issues

20. Department of Essential Medicines & Pharmaceutical Policy 20 | z THANK YOU