Richard Laing WHO/PAU TBS 2013 National Medicines Policies Process, World Medicines Situation Report and Access to Medicines Index Richard Laing WHO/PAU TBS 2013 Department of Essential Medicines & Health Products

Objectives Review the history of NMPs Discuss the background to NMP’s List the Components of a NMP Review actors involved in the NMP process Discuss the Global Pharmaceutical Market Discuss the Access to Medicines Index

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

Background to NMP’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

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

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 NMP planners need to be aware, though not expert, in all areas!

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.

The Global Pharmaceutical Market Scale of Global market By Value By Volume Generic market by Value

TPE (Millions US$) Pop (000s) Distribution of total pharmaceutical expenditures by income level 2005/06 $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

Source IMS Health 2008

Consumption by Volume 2000 2008 Country Income Group Volume per capita (SU) % of total High (33) 895 58.2% 1024 55% Upper Mid (16) 376 24.4% 513 27% Lower Mid (15) 163 10.6% 202 11% Low (3) 105 6.8% 140 8% Total (67) 1539 100% 1878 Volume measured by IMS Health Standard Units

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

The 2012 Access to Medicine Index was published in November 2012 See http://www.accesstomedicineindex.org/ and http://www.accesstomedicineindex.org/new-england-journal-medicine-publishes-index-perspective-article 14

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