World Health Organization Strategy for working with countries Work in progress Dr Gilles Forte Essential Medicines and Pharmaceutical Policies WHO Geneva Technical Briefing Seminar Geneva, 20 November.

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Transcript World Health Organization Strategy for working with countries Work in progress Dr Gilles Forte Essential Medicines and Pharmaceutical Policies WHO Geneva Technical Briefing Seminar Geneva, 20 November.

World Health Organization
Strategy for working with countries
Work in progress
Dr Gilles Forte
Essential Medicines and Pharmaceutical Policies
WHO Geneva
Technical Briefing Seminar
Geneva, 20 November 2008
Better access to medicines through health systems
Strengthening
Quality health service delivery
Well performing
health workforce
Robust information systems
and evidence
Leadership and
Governance
OBJECTIVE
Support countries for
strengthening systems and capacity
to achieve
sustainable
availability of affordable,
quality, safe, efficacious medicines
and their appropriate use
Based on
country needs
strategy & plans
Enhanced capacity
in regions
and countries
Multi stakeholders
approach
Sustainable health financing
Coordinated efforts within WHO for
efficient and sustainable collaboration with Countries
AFRO
Other
WHO
Clusters
AMRO
NPO
NPO
EMRO
Country Offices
HSS
EURO
EMP
NPO
SEARO
NPO
WPRO
Roles and responsibilities for supporting
implementation of WHO Medicine Strategy
Strategy, policy guidance,
support and collaborations
Planning, implementation, monitoring
Headquarters:
Regional Offices:
Country Offices:
Ministries of Health:
•Strategy and
• Oversee country
• Assess needs and
• Identify needs &
policy making
operations
•Planning & monitoring
• Planning and
•Partnerships and
Collaboration
•Resource Mobilisation
•Provide specific
technical
& policy support
• Support in HR
development & training
monitoring of
country support
• Technical, policy
and management
support to countries
• Human resources
development &
training
• Partnerships and
collaborations
at regional level
identify priorities for
technical support
• Plan & implement
priorities
• Plan, implement and
monitor action
WHO work
• Coordinate with other
•Provide technical
and policy support
to countries
• Assist in coordination
•Partnerships &
collaborations
in countries
•Feedback and report
Ministries and national
bilateral and
multilateral agencies
and CSO's.
Economic Country Groupings in the EMR
Low income
countries
US $ 765 or less
1.
2.
3.
4.
5.
Afghanistan
Pakistan
Somalia
Sudan
Yemen
Lower middle
income countries
Upper middle
income countries
from $ 3036 to 9385
from US $ 765 to 3035
1.
2.
3.
4.
5.
6.
7.
8.
Djibouti
Egypt
Iran
Iraq
Jordan
Morocco
Syria
Tunisia
World Bank list of economies, July 2004
1.
2.
3.
4.
Lebanon
Libya
Oman
Saudi Arabia
High income
countries
$ 9385 or more
1.
2.
3.
4.
Bahrain
Kuwait
Qatar
UAE
Country Groupings in the EMR
Countries in
emergencies
1. Afghanistan
2. Iraq
3. Pakistan
4. Somalia
5. Sudan
6. oPt
Big countries with
sizable pharma
industry
1. Egypt
2. Iran
3. Pakistan
Non-Arabic
countries
•
1.
2.
3.
Afghanistan
Iran
Pakistan
GCC
countries
1.
2.
3.
4.
5.
6.
Bahrain
Kuwait
Oman
Qatar
Saudi Arabia
UAE
Arab League
•
20 / 22 countries
of the League are
in the EMR
OIC
22 / 57 countries are
in the EMR
Franchophone
countries
1. Morocco
2. Tunisia
3. Djibouti
Out of 22 EMR countries 14 are in Asia and 8 are in Africa
Enhanced expertise in countries &
sub regional economic blocks in Africa
WHO Medicines advisers in 16
countries, in sub regional
economic blocks to assist in:
UEMOA
Burundi
Cameroon
Central African Rep.
Chad
Congo
Democratic Rep. of the Congo
Ethiopia
Ghana
Kenya
Mali
Nigeria
Rwanda
Senegal
Uganda
United Rep. of Tanzania
Zambia
EAC
• Assessment of needs and priorities
• Support planning, implementation
and monitoring of medicines policies
• Coordination of stakeholders
involved in pharmaceuticals
WHO CC Drug Policies
Regional Office
Subregional post
Central America
WHO CC Drug Supply
Subregional post Intl
Caribbean
WHO CC Drug Supply
Sub-regional offices for
the Program of Essential
Medicines, in the
Americas
Subregional post Intl
MERCOSUR
WHO CC Drug Policies
Subregional post
National Officer
WHO CC Rational Use
Pacific island countries
1. Cook Islands
2. Fiji
3. Kiribati
4. Marshall Islands
5. Micronesia
6. Nauru
7. Niue
8. Palau
9. Papua New Guinea
10. Samoa
11. Solomon Islands
12. Tonga
13. Tuvalu
14. Vanuatu
Support to policy changes based on
evidence
WHO developed Level I, Level II, level III indicators & tools
to assess & monitor pharmaceutical sector in countries
(structures, process & outcomes)
Regional/country plans
implemented in
coordination with all
partners: bilateral and
multilateral agencies,
NGOs, and other
stakeholders
1. Assess and Monitor
3. Implement
2. Plan
data used to identify
gaps - set objectives
& priority
interventions –
develop work plans
and estimate resource
needed
Activities Driven by Country Needs & Priorities
Activities are identified in conjunction with countries and responsive to country needs
Activities are also based on WHA & EB Resolutions
Type A:
Situation analysis &
Monitoring
Type B:
Specific technical
support
Type C:
Comprehensive
programme support
Type IC:
Inter-country
• Assessment of
•
• Time frame may
• Ad hoc or regular
cover one or more
biennia
• Usually involves a
full-time national
programme officer
• Covers most or all
of the EMS areas:
policy; access,
quality, safety
& efficacy,
and rational use
support involving
two or more
countries often in
the same region
• Usually focused on
specific areas:
policy; access;
quality, safety &
efficacy;
and rational use
pharmaceutical
situation, identify
priority needs –
recommendations
for interventions
Ad hoc or regular
support usually
focused on
specific areas:
policy; access:
quality, safety &
efficacy; and
rational use
Seeking evidence for transparency and
policy making in countries
Collaborate with countries & build capacity to:
•
Level I
Questionnaire
(Health officials)
Systematic
surveys
(facilities, HH)
Core structure &
process indicators
Level II
Core outcome/impact indicators:
access to, rational use of medicines
•
•
Level III
In-depth assessment of specific components
of the pharmaceutical sector
. Pricing
. Supply chain
Medicines for children
Assessing regulatory capacity
•
Establish evidence on strengths &
weaknesses of country pharmaceutical sector,
prioritize policy and advocacy interventions for
improving efficiency of pharmaceutical
systems (policy makers, donors)
Measure trends of pharmaceutical sector over
time and among countries
Make information available for increased
transparency & accountability and improving
governance
Household survey
– Cost, availability, affordability
– Patients attitudes
– Rational use for acute and chronic
conditions
Assessing pharmaceutical situations in 2008
At global level: 2007 Level 1 survey completed and
analysed – WMS 2009; Level 2 package
finalised and published
At Regional level:
Training on monitoring in St Vincent and Accra
At country level: Level 2 & House Hold piloted in 9
countries (Gambia, Ghana, Kenya, Uganda,
Nigeria, Jamaica, The Philippines, Trinidad &
Tobago, Tonga)
2007 Level 1 survey in the African Region
NMP
Comparison 2003 - 2007
Countries with NMPs in 2003-2007a
 Among the low income
countries an increase
in countries with NMP
can clearly be noted
Countries with NMP by
income level
 In all middle income
countries a NMP has
been available in both
2003 and 2007
8
Middle income
8
2003
30
Low income
25
50.0%
a
aFor
2007
countries with data on both years .
for countries with data on both years
75.0%
Percentage
100.0%
2007 Level 1 survey in the African Region
Hospital STGs
Countries with hospital
STGs by income level
STGs
Comparison 2003 - 2007
Both middle and low income country show an
increase of all STGs
5
Middle
income
2
0.0%
2007
2003
7
Low income
13
25.0%
50.0%
75.0%
100.0%
Percentage
a
for countries with data on both
years
a
Primary Health Care STGs
Countries with PHC STGs
by income level
National STGs
Countries with national
STG by income level

a
7
Middle income
6
2007
2003
25
Low income
0.0%
19
25.0%
50.0%
75.0%
100.0%
a
for countri es wi th da ta on both
4
14
25.0%
50.0%
Percentage
for countri es wi th da ta on both
2007
2003
15
Low income
0.0%
a
7
Middle
income
Percentage
a
75.0%
100.0%
Level 2 surveys for setting targets
% availability of key drugs in public sector
Ministry
Target =
90%
100%
78%
80%
60%
40%
73% 75%
72%
55%
Health Facility
Warehouse
46%
25%
15%
20%
0%
Rural 1
Rural 2
Rural 3
Kampala
House hold surveys indicators of
geographic access
Procurement prices – public sector
Lowest Priced Generic
6
75th percentile
25th percentile
Median
4
Procurement prices – public sector
of Lowest Priced Generic
Price (MPR)
n= number of medicines
3.29
2
1.69
1.3
0.95
0.8
0.88
0.66
0.61
0.57
0.71
0
da
an
Ug
)
33
)
32
n=
(n=
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nza
Ta
l
ga
ne
Se
)
18
n=
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Nig
)
33
n=
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Ma
)
24
n=
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Ke
)
26
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22
(n =
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Gh
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12
n=
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)
17
n=
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Ch
roo
me
Ca
Patient price vs procurement price in the
public and private sector (LPG) - matched
pairs of same medicines
16
P rivate
14.9
P ublic
P ric e (MP R )
12
n = number of medicines
9.3
7.3
8
5.3
4.0
3.5
4
4.0
3.3
3.1
2.0
2.4
1.8
1.3
2.9
2.1
3.9 3.5
2.9
2.6
2.0
1.3
0
0
C ameroon
(n=17)
C had
(n=5)
Mali
(n=30)
Tanzania
(n=28)
S enegal
(n=20)
G hana
(n=30)
E thiopia
(n=36)
K enya
(n=28)
Zimbabwe
(n=25)
Nigeria
(n=19)
Uganda
(n=38) (*)
Components of medicines prices
Component
Kenya*
Uganda**
Manufacturer’s
selling price (MSP)
43-59%
24-77%
Landed costs
2-4%
5-14%
Wholesale
1-43%
3-23%
Retail
17-50%
0-68%
0%
0%
Dispensed (final)
price: VAT, GST
Price components and essential medicines in Kenya. WHO 2006
**Levison L. Investigating price components, WHO 2006
Affordability of medicines in the private sector
for a family* : Originator Brand
It would take more
than 2 weeks
wages in 6 out of 7
countries for a
month treatment
(where Originator
brands were found)
Senegal: 18 days
Nigeria: 30 days
Ghana: 107 Cameroon 47 days
days
Ethiopia: 71 days
Kenya: 24 days
South Africa: 9 days
* an asthmatic child with a respiratory infection, an adult with diabetes and hypertension and
another adult with a peptic ulcer
Affordability and financing in 2008
• At global level: update of the medicines prices surveys methodology
and tools
• At regional level: UEMOA, EAC
• At country level:
Support provided to monitor and disclose medicines prices: Ghana,
Uganda, Tanzania, Kenya
Support for establishing sustainable financing including through health
insurance: Burundi, Ghana, Kenya, Nigeria, Tanzania, Uganda
Surveys on patients prices and & components: Zambia, Malawi,
Mauritius, Rwanda; Barbados, Bahamas, Trinidad & Tobago
Sub regional collaboration - expected
benefits
and opportunities
• Sharing information and experience on medicines policy
• Sharing information on medicines quality & suppliers performance
• Promoting transparency and good governance
• Efficient pooling of resources & expertise – financial, technical and
human
• Stronger negotiating & purchasing power – economies of scale
• Joint assessments, inspections, dossier evaluation
• Alignment of policies and regulations for improving access
• Harmonize standard treatment guidelines and medicines lists
Pre requisites for efficient sub regional
collaboration
•
•
•
•
•
•
•
•
•
Shared political commitment from countries
Regional structures and capacity
Coordination mechanisms among countries
Human resources available in countries
Countries medicines policies and guidelines
developed and endorsed e.g. PSM; EML Legal and regulatory framework - disparities
Information sharing mechanisms e.g. regulation,
pricing & patents
Sustainable financing mechanisms
Capacity building plan
Collaboration with sub regional groups
• CEMAC, Caribbean, PIC: medicines policy
assessments (Level 1 & 2) & alignment
• EAC, SADC, Caribbean, PIC: procurement &
regulations
• UEMOA: medicines policies & regulations
Links with partners at global, regional
& country level
HQ
WHO
Regional Offices
WHO operational
partners
UN agencies e.g.
UNDP, UNFPA,
UNICEF; NGOs,
CSOs
Country Offices
Partners in Country Support
WHO scientific
partners
WHO Collaborating
Centres in
pharmaceuticals,
universities, research
centres, international
health professional
associations
Countries
Ministries of Health
WHO strategic
partners
World Bank and
development banks,
Donor Agencies
e.g. EU, DFID,
pharmaceutical
industry, WTO,
WIPO, TGF,
UNITAID
WHO/HAI Africa Regional Collaboration
Goal
Improved policies and practices to increase ATM
Purpose
Improved collaboration among MOH, WHO and HAI
Africa/network of CSOs (to increase availability and affordability
of medicines in selected countries)
Output 1
Activities
Collaboration mechanisms operational at global and country level
Management mechanisms in place at global and country levels
Effective processes implemented for collaborative planning,
budgeting, management, implementation and monitoring
Output 2
Activities
Access to quality information and collaborative activities related
to affordability, availability and rational use increased
Research and data collection: Pricing surveys and medicines
price monitoring
Policy advocacy and communications: At least two
communication and advocacy activities per country; policy and
guidelines revision; rational drug use promotion; intellectual
property rights and public health safeguards in place/maintained.
WHO/HAI Africa Regional Collaboration
MOH
Pharmacy Division
EDP
Improved collaboration
for impact on better
policies and
practices for ATM
WHO
TCM – EDM AFRO
& national advisers
HAI Africa
CS members
WHO/HAI Africa Regional Collaborationqualitative analysis
Hypothesis: collaborative working enhances the
impact of diverse stakeholders on common
goals
The review found the Collaboration added value
as:
• a forum to generate synergies among stakeholders
with diverse interests and expertise
• an enabling mechanism for the MOH and civil
society to increase mutual trust and respect and to
engage as strategic partners in policy processes
• a dynamic process for consultative, policy-relevant
research to meet country needs and increase the
likelihood of policy implementation
The MeTA “model”
Goal: increased access to medicines
Purpose: promote a multi-stakeholder approach to
improve transparency, governance, efficiency and
accountability, and encourage responsible business
practices.
Objectives: establish multi-stakeholder process in 7
countries and internationally; encourage progressive
disclosure of data on availability, price, quality and
promotion of medicines; use the evidence to improve
policies and practice; design a sustainable approach
MeTA’s Focus
• MeTA’s focus will be on strengthening country
capacity to collect, analyse, disseminate and
use data on medicine quality, availability, pricing
and promotion/use.
• This will help improve transparency and
accountability around the way medicines are
selected, regulated, procured, distributed,
supplied and then sold to and used by patients.
Incentives for MeTA stakeholders
Pharmaceutical companies
(generic and patent)
•Access to more
information on medicines
needs
•Active role in national
policy agenda
•Visibility & concerned by
public health issues
•Address quality matters
Ministrie
s & Gov.
agencies
Civil
society
Private
Wholesales, distributors,
sector
retailers
•Access to more information
Opportunity for building
capacity & improve business
Int.
practices
•Active role in policy agenda
institutions
•Promote transparency &
good governance agenda
•Improve health systems
efficiency & access to
medicines
•Improve health systems
efficiency & access to medicines
•Commitment to good
governance & transparency
agenda
•Promote multi stakeholders
inclusive approach
DPs
•
Active role in
national policy
agenda
•Supportive environment
for advocacy
•Financial and other
support
•Improved dialogue with
public and private sectors
Good governance agenda
Tackle corruption
Increase access to medicines
Support responsible business
32