National Medicines Policies & Access to Medicines Index

National Medicines Policies& Access to Medicines Index

Richard Laing EMP/MIE

Department of Essential Medicines & Pharmaceutical Policy

http://www.accesstomedicineindex.org/


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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

processDiscuss the Global Pharmaceutical

MarketDiscuss the Access to Medicines Index


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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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The Global Pharmaceutical Market

Scale of Global market By Value By Volume

Generic market by ValueThe Access to Medicines Index


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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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The 2010 Access to Medicine Index: methodology and indicators

28 June 2010

Afshin Mehrpouya

RiskMetrics Group (MCSI Inc.)

WHO, Geneva


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Geographical Scope: Index 2010 focuses on the Low and Medium Human Development

Countries based on the UN Human Development Index (UN HDI) 2006. Countries classified as ‘medium-high’ and ‘high’ according to the World Bank Country Classifications, are excluded

Disease Scope: Index 2010 covers a total of 33 diseases, consisting of a

combination of the WHO Neglected Tropical Diseases, the top-10 non communicable diseases and the top-10 communicable diseases based onDisability Adjusted Life Years (DALY)

Increased company coverage to 27 (from 20 in Index I) 20 Originator (19+1) and 7 Generics Manufacturers

15

Highlights of Changes from Index 2008 to Index 2010 Scope


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Index 2008 Index 2010

Strategic Pillars

Commitments

Transparency

Performance

Innovation

Technical Areas

General Access to Medicine Management

Public Policy and Market Influence

Research & Development

Equitable Pricing, Manufacturing & Distribution

Patents & Licensing

Capability Advancement Advancement in Product Development and Distribution

Product Donations & Philanthropic Activities

16

The New Structure

30% 30% 30% 10%


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17

The New Structure


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Index 2010 Rankings


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Highlight of Findings - Generics

Ranbaxy, Cipla and Mylan undertaking adaptive R&D Ranbaxy, Cipla and Mylan collaborate with international

programs such as PEPFAR, AMFm, UNITAID-CHAI etc. Only Ranbaxy and Cipla undertaking non-exclusive

voluntary licensing Cipla has been innovative in capacity building Apotex under CAMR has been the first company to

benefit from the 31f clause of TRIPS Reporting is very weak across the sector Authorized generics is a fast growing trend Teva and Sunpharma have no strategies or disclosure on

access related issues


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THANK YOU

Documents

National Medicines Policies & Access to Medicines Index