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National Medicines Policies Process, World Medicines Situation Report and Access to Medicines Index. Richard Laing EMP/WHO TBS 2011. Department of Essential Medicines & Pharmaceutical Policy. Objectives. Review the history of NMPs Discuss the background to NMP’s List the Components of a NMP
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National Medicines Policies Process, World Medicines Situation Report and Access to Medicines Index Richard Laing EMP/WHO TBS 2011 Department of Essential Medicines & Pharmaceutical Policy
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
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
Consumption by Volume Volume measured by IMS Health Standard Units
2008 Generic Uptake after Patent Expiry in 2000 Data Source IMS Health 2009