National medicines policies process world medicines situation report and access to medicines index
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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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Richard Laing EMP/WHO TBS 2011

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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


Source IMS Health 2008


Consumption by Volume

Volume measured by IMS Health Standard Units


2008 Generic Uptake after Patent Expiry in 2000

Data Source IMS Health 2009


THANK YOU


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