National Medicines Policies

Richard Laing
PAR/PSM

Department of Medicines Policy and Standards

TBS 2005

Objectives
Review the history of NDPs
Discuss the background to NDPs
List the Components of a NDP
Review actors involved in the NDP
process
Debate characteristics of an NDP
Discuss the Global Pharmaceutical
Market

Department of Medicines Policy and Standards

TBS 2005

History of National Drug Policies

1985 Nairobi Conference of Experts on
rational Use of Drugs
1987 Working group of Experts to draft
guidelines for NDPs
1988 Guidelines for NDPs released
1995 Expert Committee on NDPs met
report issued
2002 New Guidelines published
3

Department of Medicines Policy and Standards

TBS 2005

Background to NDPs
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
4

Department of Medicines Policy and Standards

TBS 2005

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 NDPs
Research
Human Resources Development
Technical Cooperation among Countries

Department of Medicines Policy and Standards

TBS 2005

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!
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Department of Medicines Policy and Standards

TBS 2005

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,

Department of Medicines Policy and Standards

TBS 2005

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.
8

Department of Medicines Policy and Standards

TBS 2005

Global Pharmaceutical
Market 2002 $406 billion

US, Europe &

Japan 78%

5%
1.3%
Market
projected
to grow 7.8%
annually

Source
www.ims-global.com/insight/report/global/report.htm

Department of Medicines Policy and Standards

TBS 2005