National Medicines Policies & Monitoring Implementation

National Medicines Policies& Monitoring Implementation

Richard Laing EMP/MIE

Department of Medicines Policy and Standards

Department of Essential Medicines & Pharmaceutical Policy

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Objectives

Review the history of NDPsDiscuss the background to NDP’sList the Components of a NDPReview actors involved in the NDP processDebate characteristics of an NDPDiscuss the Global Pharmaceutical MarketDiscuss Monitoring Implementation of

NMPs


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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 released1995 Expert Committee on NDPs met

report issued2002 New Guidelines published


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Background to NDP’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


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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 NDP’s Research Human Resources Development Technical Cooperation among Countries


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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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Many Actors Involved! Some pro, some against!

Doctors, specialists, public/privatePharmacists retail and manufacturingLocal and international producers, importersConsumers/PatientsMediaRegulators Insurance CompaniesEtc, Etc,


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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.


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High Low

Low-mid Up-mid

High Low

Low-mid Up-mid

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


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1999-2008 total country sales

J apan11%France

6%

Germany6%

US39%

Pharmerging

9%

ROW17%

Spain3%

Canada2%

UK3%

Italy4%

Source IMS Health 2008


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Consumption by Volume

2000 2008Country Income Group

Volume per capita

% of total Volume per capita

% 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 100%

Volume measured by IMS Health Standard Units


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2008 Generic Uptake after Patent Expiry in 2000

Unprotected market segmentation volume (SU) 2000

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

U.S.A

South A

frica

Canad

a

Denmark UK

Poland

German

y

Czech

Rep

.

New Z

ealan

d

Sweden

Slovak

ia

Finlan

d

Norway

Turke

y

Australi

a

Irelan

d

Austria

Switzerl

and

France

Spain

Belgium

Italy

Portugal

Greece

Japa

n

Vol

ume

mar

ket s

hare

% S

U

ORIGINAL & LICENSED OTHER BRANDS UNBRANDED

Data Source IMS Health 2009


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THANK YOU

Documents

National Medicines Policies & Monitoring Implementation