Transcript Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean

The Pharmaceutical Situation in the
Caribbean Countries
Adriana Mitsue Ivama
Medicines, Vaccines and Health Technologies Sub Regional Advisor
PAHO/WHO – Office of Caribbean Programme Coordination
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(1) Medicines and Biologicals in the
Global and Regional Health Agenda
Global and Regional Mandates
WHO / PAHO Resolutions (selected)
1.
Millennium Development Goals
2.
XI WHO Medium Term Strategic
Plan (2008-2015);
•
•
3.
Health Agenda for the Americas
(2008 – 2017)
4.
PAHO Strategic Plan (2008-2012);
5.
WHO Core Functions
6.
PAHO 5 Organizational Change
Objectives
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•
•
•
WHO Medicines Strategy (WHA54.11)
Ensuring accessibility of essential
medicines (WHA55.14)
Global strategy and plan of action on
public health, innovation and
intellectual property (WHA 61.21)
Access to Medicines (CD45.R7)
Public Health, Health Research,
Production, and Access to Essential
Medicines (CD47.R7)
Public Health, Innovation and
Intellectual Property (WHA61.21): a
regional perspective (CD48.R15)
2
Goals and Objectives: PAHO Project in
Medicines and Biologicals 2008 - 2012
• Goal:
– Equitable Access to essential medical products and technologies of
assured quality, safety and efficacy, and cost effectiveness, and on their
sound and cost-effective use.
• Objectives:
– RER12.1 Comprehensive national policies on access, quality and
rational use
– RER12.2 Implementation of international norms, standards and
guidelines for safety, quality, efficacy and cost effectiveness
– RER12.3 Evidence base for cost effective use
Implementation
Monitoring/Evaluation
Through the 5 Strategic Objectives of Organizational Change
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A Comprehensive Approach
Responding to
Country Needs
Strategic
Management
Using Knowledge
and Evidence
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Equitable
Access to
Medicines and
Biologicals
(SO12)
Innovative
Modalities of
Cooperation
Strengthening
Regional Fora
4
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Priorities in the Caribbean
Port of Spain Declaration (2007):
• “Our Ministries of Health, in collaboration with other
sectors, will establish by mid-2008 comprehensive
plans for the screening and management of chronic
diseases and risk factors so that by 2012, 80% of
people with NCDs would receive quality care and
have access to preventive education based on
regional guidelines. It means it is necessary to
consider an inter-programatic approach for
guarantee access to quality and safety medicines
and to promote their rational use”.
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Caricom
• Single Market and Economy (CSME);
• Caribbean Cooperation in Health Phase III (CCH III)
“Investing in Health for Sustainable Development”
purpose is “Access to safe, affordable and efficacious
medicines improved”. The expected results are:
– Caribbean Pharmaceutical Policy designed and implemented
– Strengthened regulation of medicines including legislation and drug
registration
– Harmonized medicines supply systems and sub-regional negotiation
mechanism
– Caribbean Strategy for rational use of medicines approved and
implemented.
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EU/ACP/WHO Partnership on
“Pharmaceutical Policies”
• The agreement for the EU/ACP/WHO Partnership on
Pharmaceutical Policies was signed on 7 March
2004 - Africa, the Caribbean and the Pacific.
• The overall objective is “to close the huge gap
between the potential that essential medicines
have to offer and the reality that for millions of
people, particularly the poor and disadvantaged,
medicines are unavailable, unaffordable, unsafe or
improperly used”.
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EU/ACP/WHO Partnership on
“Pharmaceutical Policies”
Strategic Objectives
1.
Pharmaceutical Policy: To provide evidence basis and to
support
the
development
and
the
monitoring
of
pharmaceutical policies
2.
Access and Innovation: To support the strengthening of
integrated supply systems
3.
Quality and Regulation: To support the strengthening of core
functions of NRAs and sub-regional regulatory framework
4.
Rational Use of Medicines: to support the strengthening of corefunction
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Medicines Strategy in the Caribbean
1)
Pharmaceutical Policy: To provide evidence basis and to
development and the monitoring of pharmaceutical policies
support the
Outcomes:
•
Pharmaceutical Situation Assessment: to provide evidence for decision makers Level I (structure and process): 13 countries - publication and Level II (Outcomes):
training.
Priorities:
•
To support the Level II surveys (outcomes): SAL, JAM, SUR (in progress), DOM,
SVG, TRT, BAR (proposals) and price survey;
•
To prepare the pharmaceutical situation in the Caribbean – Level II;
•
To support the development of a Caribbean Pharmaceutical Policy (TAG/Caricom)
with an interprogrammatic/intersectoral approach, in the CCH III framework;
•
To support development/updating and implementation of National Medicines
Policies
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Medicines Strategy in the Caribbean
2) Access and Innovation: To support the strengthening of
integrated supply systems
Drug Supply Management
Outcomes:
• Establishment of CARIPROSUM (Caribbean Network for
Procurement and Supply Management);
• Members of the PAHO/WHO Strategic Fund: BAR, BLZ, JAM,
SUR, TRT;
Priorities:
• To continue supporting the CARIPROSUM: indicators; Good
Practices of Supply System (including pre-qualification);
• To continue promoting PAHO/WHO Strategic Fund
• To support development of cost-containment and pool
negotiation mechanisms;
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Medicines Strategy in the Caribbean
2) Access and Innovation: To support the strengthening of integrated
supply systems
Intellectual Property Rights
Outcomes:
•
Active participation of Caribbean countries in the InterGovernmental Working Group on Public Health and Intellectual
Property Rights (IGWI);
•
Assessment of Intellectual Property Rights and access – as
part of Technical Advisory Group of Medicines of Caricom (in
progress)
Priority:
•
To support the development of a sub-regional strategy for
Intellectual Property Rights and Public Health and a work plan with
Caricom based on the results of the Survey conducted and in the
WHO Global Strategy – advocacy and training;
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Medicines Strategy in the Caribbean
3) Quality and Regulation: To support the strengthening of core
functions of NRAs and sub-regional regulatory framework
Outcomes:
• Assessment of Drug Regulation in the Caribbean with
Caricom;
• Support to the Caribbean Regional Drug Test Laboratory
(CRDTL);
• Establishment of Pharmacovigilance Network – VIGICARIB: 2
full members of WHO Network (BAR, SUR) 1 associated
member (OECS/PPS) - focus on HIV/Aids related medicines –
Suriname is the focal coordinator
• Prevention and Combat of Counterfeit Medicines in the
Caribbean: diagnosis; multisectoral workshops (OECS);
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Medicines Strategy in the Caribbean
3) Quality and Regulation: To support the strengthening of core
functions of NRAs and sub-regional regulatory framework
Priorities
• To support the strengthening of National Regulatory Authorities;
• To support implementation of the recommendations of the Pan American
Network of Drug Regulatory Harmonization (PANDRH)
• To support the development of a sub-regional regulatory framework
based on the results of the Survey conducted within the TAG/Caricom;
• To continue supporting CRDTL and the national laboratories of quality
control;
• To continue supporting Vigicarib integrated into Public Health
Programmes and NRA;
• To support an inter-sectoral response for prevention and combat of
counterfeit medicines (Caribbean, OECS, DOR);
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Medicines Strategy in the Caribbean
4) Rational Use of Medicines: to support the strengthening of corefunction
Outcomes:
•
Training for selection of medicines/therapeutics committees
•
Distance Learning course on ARV – in progress;
•
Information Bulletins;
Priorities
•
To support the development of a Caribbean Strategy of Promotion of
Rational Use of Medicines
•
To support the strengthening of Pharmacy Education and the
introduction of core elements of RUM into the health courses;
•
Distance Learning courses on ARV – 2nd edition and Rational Use of
Antibiotics;
•
To continue with Information Bulletins;
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The Pharmaceutical Situation in
the Caribbean
13 participants: Antigua and Barbuda, Bahamas,
Barbados, Belize, Dominican Republic, Grenada,
Guyana, Jamaica, Saint Kitts and Nevis, Saint Lucia,
Saint Vincent and the Grenadines, Suriname,
Trinidad and Tobago
It was possible due to the collaboration of the National
Authorities who provided the data answering the Level I
Questionnaire of the Pharmaceutical Situation.
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National Medicines Policies in
2007
CARIBBEAN
AMERICAS
Number of
Number
of
%
countries
%
countries
NMP status
NMP document
7
53.8%
22
71.0%
NMP Official
4
57.1%
16
72.7%
Official document updated < 5 years
2
50.0%
9
60.0%
Official document updated < 10years
3
75.0%
13
86.7%
5
55.6%
13
56.5%
4
80.0%
10
83.3%
4
44.4%
16
66.7%
NMP implementation plan
updated within 5 years
NMP integrated in NHP
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Source: PAHO/WHO. The Pharmaceutical Situation in the
Caribbean, 2007
20
Medicines Regulatory Authority
(MRA), 2007
CARIBBEAN
Number of
AMERICAS
%
countries
Number of
%
countries
Policy area covered
Legal provision for establishment of MRA
11
84.6%
28
90.3%
Existing formal MRA
9
69.2%
27
87.1%
Legal provision requiring transparency
5
45.5%
20
71.4%
MRA involved in harmonization initiative
10
83.3%
28
93.3%
Publicly accessible MRA website
3
25.0%
19
63.3%
Government budget
11
91.7%
29
96.7%
Medicines registration fees
1
14.3%
14
66.7%
Other
1
20.0%
7
53.8%
Sources of funding for MRA
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Health
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Source: PAHO/WHO. The Pharmaceutical Situation in the
Caribbean, 2007
21
Medicines Registration, 2007
CARIBBEAN
Number of
Policy areas covered
AMERICAS
%
countries
Number of
%
countries
Provision for marketing authorization
6
46.2%
Marketing authorization list publicly available
4
30.8%
18
58.1%
Computerized system for registered products
2
18.2%
20
69.0%
WHO Certification Scheme part of MA
4
30.8%
16
51.6%
INN used in registration of medicines*
6
46.2%
24
77.4%
Official registration committee
4
30.8%
16
55.2%
Total no. of products with MA
77.4%
Median
Median
[25th, 75th percentile]
[25th, 75th percentile]
7,175
11,571
4,763
9,588
N=2
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Health
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6,499
16,849
N=19
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
22
Licensing of Facilities and
Professionals, 2007
CARIBBEAN
Number of
AMERICAS
%
Countries
Number of
%
Countries
Legal provision for licensing
Manufacturers
Distributors/wholesalers
Importers or exporters of medicines
Prescribers
Pharmacy
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12
92.3%
29
93.5%
12
92.3%
29
93.5%
11
91.7%
27
93.1%
12
92.3%
30
96.8%
13
100.0%
31
100.0%
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
23
Regulatory Inspections, 2007
CARIBBEAN
Number of
Legal provision to inspect premises
AMERICAS
%
Countries
Number of
%
Countries
Facilities inspected
6
50.0%
24
80.0%
Written national guidelines
4
57.1%
19
86.4%
Facilities inspected
8
61.5%
24
77.4%
Written national guidelines
4
57.1%
17
77.3%
Facilities inspected
8
61.5%
22
75.9%
Written national guidelines
4
66.7%
15
78.9%
Facilities inspected
8
66.7%
24
82.8%
Written national guidelines
5
71.4%
18
85.7%
Manufacturers
Wholesalers/ distributors
Importers/ exporters
Retail distributors/ pharmacies
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Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
24
Quality Control, 2007
CARIBBEAN
Number of
AMERICAS
%
countries
Quality management system in place
Number of
%
Countries
7
53.8%
21
72.4%
Medicines registration
5
41.7%
18
62.1%
Post-marketing surveillance
6
54.5%
20
74.1%
Government quality control laboratory
5
55.6%
19
79.2%
Local academic institutions
1
16.7%
8
42.1%
Private laboratory
3
50.0%
7
41.2%
Mini laboratories (district, regional)
2
33.3%
3
18.8%
Quality control laboratory in another country
7
87.5%
9
47.4%
Quality control procedures for imported medicines
10
76.9%
26
86.7%
Legal procedures to recall/ dispose defective products
8
61.5%
23
76.7%
Samples tested for
Samples tested in
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Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
25
Pharmacovigilance, 2007
CARIBBEAN
Number of
AMERICAS
%
Countries
Monitoring of ADRs
Local level
Regional level
Central level
International reporting of ADRs
Pan American
Health
Organization
Number of
%
countries
5
38.5%
18
58.1%
2
40.0%
11
64.7%
1
20.0%
8
50.0%
4
66.7%
16
88.9%
3
23.1%
14
48.3%
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
27
Prevention and Combat of Counterfeit
Medicines, 2007
CARIBBEAN
Number of
AMERICAS
%
%
Countr
ies
countries
Laws or regulations on counterfeit medicines
Numbe
r of
7
53.8
%
20
64.5
%
10
83.3
%
22
84.6
%
9
81.8
%
21
87.5
%
12
100.0
%
27
96.4
%
9
100.0
%
19
86.4
%
Sources used to detect counterfeit medicines
national authorities
specific / ad hoc studies
pharmaceutical sector
Civil society/NGOs
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Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
28
Legislation on Generics Medicines,
2007
CARIBBEAN
Number of
Policies on generic medicines
AMERICAS
%
countries
Number of
%
countries
Prescribing generics mandatory in
Public sector
7
53.8%
23
76.7%
Private sector
2
16.7%
10
37.0%
Public pharmacies
13
100.0%
27
90.0%
Private pharmacies
9
75.0%
21
77.8%
Public pharmacies
5
38.5%
8
26.7%
Private pharmacies
2
18.2%
6
22.2%
Permitting generic substitution in
Incentives to promote generics dispensing
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Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
29
Policies on Medicines Prices, 2007
CARIBBEAN
Number of
AMERICAS
%
countries
Policy covering medicine prices
Number of
%
countries
Public sector
6
50.0%
16
53.3%
Private Sector
4
33.3%
12
42.9%
NGO
1
11.1%
4
18.2%
Public sector
2
28.6%
8
53.3%
Private Sector
5
83.3%
8
66.7%
NGO
2
100.0%
4
50.0%
Public sector
2
28.6%
9
60.0%
Private Sector
6
75.0%
11
70.6%
NGO
2
66.7%
5
50.0%
Public sector
2
28.6%
5
33.3%
Private Sector
7
77.8%
10
62.5%
NGO
3
75.5%
4
44.4%
Public sector
2
28.6%
6
37.5%
Private Sector
8
88.9%
12
70.6%
NGO
3
75.0%
5
45.5%
If yes, which areas are covered?
Maximum wholesale
mark-up
Maximum retail mark-up
Duty on raw pharmaceutical
materials
Duty on finished pharmaceutical
materials
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Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
31
Public sector procurement and
distribution in 2007
CARIBBEAN
Number of
AMERICAS
%
countries
Number of
%
countries
13
100.0%
25
Procurement
12
92.3%
26
89.7%
Distribution
7
87.5%
18
85.7%
Procurement
2
28.6%
4
25.0%
Distribution
0
0%
2
20.0%
Procurement
2
28.6%
2
12.5%
Distribution
2
100%
3
27.3%
Procurement
0
0.0%
11
52.4%
Entire public sector procurement
pooled at national level
80.6%
Responsible agency for public procurement
Ministry of Health
NGOs
Private institution
Individual health institution
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Source: PAHO/WHO. The Pharmaceutical Situation in the
Caribbean, 2007
33
Availability and status of
Essential Medicines List (EML)
CARIBBEAN
Number of
AMERICAS
%
countries
Number of
%
countries
Existence of EML*
10
76.9%
25
80.6%
Last Update of EML < 5 years
9
100%
24
100.0%
No separate paediatric EML
9
100%
21
100.0%
Public sector procurement
10
90.9%
24
88.9%
Public insurance reimbursement
5
50.0%
9
40.9%
Private insurance reimbursement
2
22.2%
3
14.3%
Committee for EML medicines selection
10
90.9%
24
88.9%
Use of EML in different sectors
Median
Median
[25th, 75th percentile]
[25th, 75th percentile]
464
Number of medicines in EML
350
512
526
386
N=8
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Health
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Paediatric formulations in
National EML
N=22
40
30
58.5
50
N=2
598
29.5
263.5
N=10
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
35
Total and per capita public
expenditure for medicines (TPE) in
$US, 2007
CARIBBEAN
AMERICAS
Median
Median
[25th, 75th percentile]
[25th, 75th percentile]
$ 4,000,000
Median Total public expenditure for
medicines (TPE) in $US
815,000
13,000,000
N=9
Median Public medicines per capita in
$US
Pan American
Health
Organization
$ 20.90
$ 34,087,493
$ 3,750,000
$ 53,081,172
N=24
$ 11.50
Source: PAHO/WHO. The Pharmaceutical Situation in the
Caribbean, 2007
37
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Were we want to be/what goals
we want to achieve in…
• 2 years…
• 4 years…
• 10 years…
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What are the priorities?
• At Caribbean level
• Country level
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How can PAHO/WHO support
Caribbean countries to achieve those
goals?
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Thanks!
Contact: [email protected]
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