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

Department of Essential Medicines & Health Products2 |

Objectives

Review the history of NMPsDiscuss the background to NMP’sList the Components of a NMPReview actors involved in the NMP

processDiscuss the Global Pharmaceutical

MarketDiscuss 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 released1995 Expert Committee on NDPs met

report issued2002 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


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


1999-2008 total country sales

J apan11%France

6%

Germany6%

US39%

Pharmerging

9%

ROW17%

Spain3%

Canada2%

UK3%

Italy4%

Source IMS Health 2008


Consumption by Volume

2000 2008Country Income Group

Volume per capita

(SU)

% of total 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 100%

Volume measured by IMS Health Standard Units


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


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


THANK YOU

Richard Laing WHO/PAU TBS 2013

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