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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. (1) Medicines and Biologicals in the Global and Regional Health Agenda. - PowerPoint PPT Presentation
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Pan AmericanHealthOrganization 1
Adriana Mitsue IvamaMedicines, Vaccines and Health Technologies Sub Regional Advisor
PAHO/WHO – Office of Caribbean Programme Coordination
The Pharmaceutical Situation in the Caribbean Countries
Pan AmericanHealthOrganization 2
(1) Medicines and Biologicals in the Global and Regional Health Agenda
Global and Regional Mandates
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
WHO / PAHO Resolutions (selected)
• 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)
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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
Through the 5 Strategic Objectives of Organizational Change
Implementation Monitoring/Evaluation
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A Comprehensive Approach
Equitable Access to
Medicines and Biologicals
(SO12)
Responding toCountry Needs
Innovative Modalities of Cooperation
StrengtheningRegional Fora
Using Knowledgeand Evidence
StrategicManagement
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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 core-function
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1) Pharmaceutical Policy: To provide evidence basis and to support the development and the monitoring of pharmaceutical policies
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
Medicines Strategy in the Caribbean
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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;
Medicines Strategy in the Caribbean
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2) Access and Innovation: To support the strengthening of integrated supply systems
Intellectual Property Rights
Outcomes:• Active participation of Caribbean countries in the Inter-Governmental
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;
Medicines Strategy in the Caribbean
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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);
Medicines Strategy in the Caribbean
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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);
Medicines Strategy in the Caribbean
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4) Rational Use of Medicines: to support the strengthening of core-function
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;
Medicines Strategy in the Caribbean
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The Pharmaceutical Situation in the Caribbean13 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
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of%
Number of%
NMP statuscountries countries
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%
NMP implementation plan 5 55.6% 13 56.5%
updated within 5 years 4 80.0% 10 83.3%
NMP integrated in NHP 4 44.4% 16 66.7%
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Medicines Regulatory Authority (MRA), 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Policy area covered
Number of % Number of %
countries countries
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%
Sources of funding for MRA
Government budget 11 91.7% 29 96.7%
Medicines registration fees 1 14.3% 14 66.7%
Other 1 20.0% 7 53.8%
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Medicines Registration, 2007
CARIBBEAN AMERICAS
Number of % Number of %
Policy areas covered countries countries
Provision for marketing authorization 6 46.2% 24 77.4%
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%
Median Median
[25th, 75th percentile] [25th, 75th percentile]
Total no. of products with MA 7,175 11,571
4,763 9,588 6,499 16,849
N=2 N=19
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
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Licensing of Facilities and Professionals, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Legal provision for licensing
Number of % Number of %
Countries Countries
Manufacturers 12 92.3% 29 93.5%
Distributors/wholesalers 12 92.3% 29 93.5%
Importers or exporters of medicines 11 91.7% 27 93.1%
Prescribers 12 92.3% 30 96.8%
Pharmacy 13 100.0% 31 100.0%
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Regulatory Inspections, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
Legal provision to inspect premises Countries Countries
ManufacturersFacilities inspected 6 50.0% 24 80.0%
Written national guidelines 4 57.1% 19 86.4%
Wholesalers/ distributorsFacilities inspected 8 61.5% 24 77.4%
Written national guidelines 4 57.1% 17 77.3%
Importers/ exportersFacilities inspected 8 61.5% 22 75.9%
Written national guidelines 4 66.7% 15 78.9%
Retail distributors/ pharmaciesFacilities inspected 8 66.7% 24 82.8%
Written national guidelines 5 71.4% 18 85.7%
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Quality Control, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
countries Countries
Quality management system in place 7 53.8% 21 72.4%
Samples tested for
Medicines registration 5 41.7% 18 62.1%
Post-marketing surveillance 6 54.5% 20 74.1%
Samples tested in
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%
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Pharmacovigilance, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
Countries countries
Monitoring of ADRs5 38.5% 18 58.1%
Local level2 40.0% 11 64.7%
Regional level1 20.0% 8 50.0%
Central level4 66.7% 16 88.9%
International reporting of ADRs3 23.1% 14 48.3%
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Prevention and Combat of Counterfeit Medicines, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
countries Countries
Laws or regulations on counterfeit medicines 7 53.8%
20 64.5%
Sources used to detect counterfeit medicines
national authorities 10 83.3%
22 84.6%
specific / ad hoc studies 9 81.8%
21 87.5%
pharmaceutical sector 12 100.0%
27 96.4%
Civil society/NGOs 9 100.0%
19 86.4%
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Legislation on Generics Medicines, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
Policies on generic medicines countries countries
Prescribing generics mandatory in
Public sector 7 53.8% 23 76.7%
Private sector 2 16.7% 10 37.0%
Permitting generic substitution in
Public pharmacies 13 100.0% 27 90.0%
Private pharmacies 9 75.0% 21 77.8%
Incentives to promote generics dispensing
Public pharmacies 5 38.5% 8 26.7%
Private pharmacies 2 18.2% 6 22.2%
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Policies on Medicines Prices, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
countries countries
Policy covering medicine prices
Public sector 6 50.0% 16 53.3%
Private Sector 4 33.3% 12 42.9%
NGO 1 11.1% 4 18.2%
If yes, which areas are covered?
Maximum wholesale mark-up
Public sector 2 28.6% 8 53.3%
Private Sector 5 83.3% 8 66.7%
NGO 2 100.0% 4 50.0%
Maximum retail mark-up
Public sector 2 28.6% 9 60.0%
Private Sector 6 75.0% 11 70.6%
NGO 2 66.7% 5 50.0%
Duty on raw pharmaceutical materials
Public sector 2 28.6% 5 33.3%
Private Sector 7 77.8% 10 62.5%
NGO 3 75.5% 4 44.4%
Duty on finished pharmaceutical materials
Public sector 2 28.6% 6 37.5%
Private Sector 8 88.9% 12 70.6%
NGO 3 75.0% 5 45.5%
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Public sector procurement and distribution in 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
countries countries
Entire public sector procurement pooled at national level 13 100.0% 25 80.6%
Responsible agency for public procurement
Ministry of Health
Procurement 12 92.3% 26 89.7%
Distribution 7 87.5% 18 85.7%
NGOsProcurement 2 28.6% 4 25.0%
Distribution 0 0% 2 20.0%
Private institutionProcurement 2 28.6% 2 12.5%
Distribution 2 100% 3 27.3%
Individual health institution Procurement 0 0.0% 11 52.4%
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Availability and status of Essential Medicines List (EML)
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Number of % Number of %
countries 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%
Use of EML in different sectors
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%
Median Median
[25th, 75th percentile] [25th, 75th percentile]
Number of medicines in EML
464 512
350 526 386 598
N=8 N=22
Paediatric formulations in National EML
40 58.5
30 50 29.5 263.5
N=2 N=10
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Total and per capita public expenditure for medicines (TPE) in $US, 2007
Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007
CARIBBEAN AMERICAS
Median Median
[25th, 75th percentile] [25th, 75th percentile]
Median Total public expenditure for medicines (TPE) in $US
$ 4,000,000 $ 34,087,493
815,000 13,000,000 $ 3,750,000 $ 53,081,172
N=9 N=24
Median Public medicines per capita in $US
$ 20.90 $ 11.50
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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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