National Medicines Policies & Access to Medicines Index Richard Laing EMP/MIE Department of Essential Medicines & Pharmaceutical Policy
Dec 28, 2015
National Medicines Policies& Access to Medicines Index
Richard Laing EMP/MIE
Department of Essential Medicines & Pharmaceutical Policy
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
processDiscuss the Global Pharmaceutical
MarketDiscuss the Access to Medicines Index
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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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!
Department of Essential Medicines & Pharmaceutical Policy
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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,
Department of Essential Medicines & Pharmaceutical Policy
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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.
Department of Essential Medicines & Pharmaceutical Policy
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The Global Pharmaceutical Market
Scale of Global market By Value By Volume
Generic market by ValueThe Access to Medicines Index
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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The 2010 Access to Medicine Index: methodology and indicators
28 June 2010
Afshin Mehrpouya
RiskMetrics Group (MCSI Inc.)
WHO, Geneva
Department of Essential Medicines & Pharmaceutical Policy
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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
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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
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The New Structure
30% 30% 30% 10%
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The New Structure
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Index 2010 Rankings
Department of Essential Medicines & Pharmaceutical Policy
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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
Department of Essential Medicines & Pharmaceutical Policy
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THANK YOU