Transcript Characteristics of a National Medicines Policy

National Medicines Policies
& Monitoring Implementation
Richard
Laing
EMP/MIE
Department of Medicines Policy and Standards
Objectives
Review the history of NDPs
Discuss the background to NDP’s
List the Components of a NDP
Review actors involved in the NDP process
Debate characteristics of an NDP
Discuss the Global Pharmaceutical Market
Discuss Monitoring Implementation of NMPs
2
|
Department of Essential Medicines & Pharmaceutical
Policy
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 released
1995 Expert Committee on NDPs met
report issued
2002 New Guidelines published
3
|
Department of Essential Medicines & Pharmaceutical
Policy
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
4
|
Department of Essential Medicines & Pharmaceutical
Policy
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
5
|
Department of Essential Medicines & Pharmaceutical
Policy
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!
6
|
Department of Essential Medicines & Pharmaceutical
Policy
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,
7
|
Department of Essential Medicines & Pharmaceutical
Policy
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 Essential Medicines & Pharmaceutical
Policy
Distribution of total pharmaceutical expenditures by income level 2005/06
TPE (Millions US$)
Pop (000s)
$4,123
$81,235
(0.5%)
782,194
983,493
(14.4%)
(18.0%)
(9.9%)
$76,857
(9.3%)
577,565
(10.6%)
3,106,247 (57.0%)
High
9
|
$660,609 (80.3%)
Low
Department
of Essential Medicines
Low-mid
Up-mi&dPharmaceutical
Policy
High
Low
Low-mid
Up-mi d
1999-2008 total country sales
ROW
17%
Pharmergin
g
9%
US
39%
Canada
2%
Spain
3%
UK
3%
10
|
Italy
4%
Germany
France
6%
6%
Department of Essential Medicines & Pharmaceutical
Policy
Source IMS Health 2008
Japan
11%
Consumption by Volume
2000
Country
Income Group
2008
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%
11
|
Department of Essential Medicines & Pharmaceutical
Policy
Volume measured by IMS Health Standard Units
2008 Generic Uptake after
Patent Expiry in 2000
Unprotected market segmentation volume (SU) 2000
Volume market share % SU
100%
90%
80%
70%
60%
50%
40%
30%
20%
So U
ut . S
h .A
Af
r
Ca ica
De nad
nm a
ar
k
UK
Po
Ge lan
Cz rm d
Ne ech an
w R y
Ze ep
a .
Sw land
Sl ede
ov n
a
Fi kia
n
No land
rw
Tu ay
Au r ke
str y
a
Ir e lia
la
A
Sw us nd
itz tria
er
la
Fr nd
an
c
Sp e
Be ain
lg
iu
m
Po Ital
rtu y
g
Gr al
ee
Ja ce
pa
n
10%
0%
ORIGINAL & LICENSED
12
|
OTHER BRANDS
Department of Essential Medicines & Pharmaceutical
Policy
Data Source IMS Health 2009
UNBRANDED
THANK YOU

13
|
Department of Essential Medicines & Pharmaceutical
Policy