1. Pan American Health Organization 1 Adriana Mitsue Ivama Medicines, Vaccines and Health Technologies Sub Regional Advisor PAHO/WHO – Office of Caribbean Programme Coordination The Pharmaceutical Situation in the Caribbean Countries

2. Pan American Health Organization 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)

3. Pan American Health Organization 3 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

4. Pan American Health Organization 4 A Comprehensive Approach Equitable Access to Medicines and Biologicals (SO12) Responding to Country Needs Innovative Modalities of Cooperation Strengthening Regional Fora Using Knowledge and Evidence Strategic Management

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6. Pan American Health Organization 6 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”.

7. Pan American Health Organization 7 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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9. Pan American Health Organization 9 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”.

10. Pan American Health Organization 10 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

11. Pan American Health Organization 11 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

12. Pan American Health Organization 12 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

13. Pan American Health Organization 13 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

14. Pan American Health Organization 14 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

15. Pan American Health Organization 15 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

16. Pan American Health Organization 16 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 – 2 nd edition and Rational Use of Antibiotics; To continue with Information Bulletins; Medicines Strategy in the Caribbean

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18. Pan American Health Organization 18 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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20. Pan American Health Organization 20 National Medicines Policies in 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of % % NMP status countries NMP document7 53.8% 2271.0% NMP Official 4 57.1% 1672.7% Official document updated < 5 years2 50.0% 960.0% Official document updated < 10years3 75.0% 1386.7% NMP implementation plan5 55.6% 1356.5% updated within 5 years4 80.0% 1083.3% NMP integrated in NHP 444.4%1666.7%

21. Pan American Health Organization 21 Medicines Regulatory Authority (MRA), 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Policy area covered Number of% % countries Legal provision for establishment of MRA 1184.6%2890.3% Existing formal MRA 969.2%2787.1% Legal provision requiring transparency 545.5%2071.4% MRA involved in harmonization initiative 1083.3%2893.3% Publicly accessible MRA website 325.0%1963.3% Sources of funding for MRA Government budget 1191.7%2996.7% Medicines registration fees 114.3%1466.7% Other 120.0%753.8%

22. Pan American Health Organization 22 Medicines Registration, 2007 CARIBBEANAMERICAS Number of% % Policy areas coveredcountries Provision for marketing authorization 646.2% 2477.4% Marketing authorization list publicly available 430.8%1858.1% Computerized system for registered products 218.2% 2069.0% WHO Certification Scheme part of MA 430.8%1651.6% INN used in registration of medicines* 646.2% 2477.4% Official registration committee 430.8%1655.2% Median [25 th, 75 th percentile] Total no. of products with MA 7,175 11,571 4,7639,588 6,49916,849 N=2 N=19 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

23. Pan American Health Organization 23 Licensing of Facilities and Professionals, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Legal provision for licensing Number of% % Countries Manufacturers 1292.3%2993.5% Distributors/wholesalers 1292.3%2993.5% Importers or exporters of medicines 1191.7%2793.1% Prescribers 1292.3%3096.8% Pharmacy 13100.0%31100.0%

24. Pan American Health Organization 24 Regulatory Inspections, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % Legal provision to inspect premisesCountries Manufacturers Facilities inspected 650.0%2480.0% Written national guidelines 457.1%1986.4% Wholesalers/ distributors Facilities inspected 861.5%2477.4% Written national guidelines 457.1%1777.3% Importers/ exporters Facilities inspected 861.5%2275.9% Written national guidelines 466.7%1578.9% Retail distributors/ pharmacies Facilities inspected 866.7%2482.8% Written national guidelines 571.4%1885.7%

25. Pan American Health Organization 25 Quality Control, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countriesCountries Quality management system in place 753.8%2172.4% Samples tested for Medicines registration 541.7%1862.1% Post-marketing surveillance 654.5%2074.1% Samples tested in Government quality control laboratory 555.6%1979.2% Local academic institutions 116.7%842.1% Private laboratory 350.0%741.2% Mini laboratories (district, regional) 233.3%318.8% Quality control laboratory in another country 787.5%947.4% Quality control procedures for imported medicines 1076.9%2686.7% Legal procedures to recall/ dispose defective products 861.5%2376.7%

26. Pan American Health Organization 26 Quality Control, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Average Quality testing in 2006[25 th, 75 th percentile] Number of samples tested 113.5 812 17261.8 1831,713 N=6 N=17 Number of samples that failed 3 45 215 1291 N=5 N=16

27. Pan American Health Organization 27 Pharmacovigilance, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % Countriescountries Monitoring of ADRs 538.5%1858.1% Local level 240.0%1164.7% Regional level 120.0%850.0% Central level 466.7%1688.9% International reporting of ADRs 323.1%1448.3%

28. Pan American Health Organization 28 Prevention and Combat of Counterfeit Medicines, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Countr ies Laws or regulations on counterfeit medicines 753.8 % 2064.5 % Sources used to detect counterfeit medicines national authorities 1083.3 % 2284.6 % specific / ad hoc studies 981.8 % 2187.5 % pharmaceutical sector 12100.0 % 2796.4 % Civil society/NGOs 9100.0 % 1986.4 %

29. Pan American Health Organization 29 Legislation on Generics Medicines, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % Policies on generic medicinescountries Prescribing generics mandatory in Public sector 753.8%2376.7% Private sector 216.7%1037.0% Permitting generic substitution in Public pharmacies 13100.0%2790.0% Private pharmacies 975.0%2177.8% Incentives to promote generics dispensing Public pharmacies 538.5%826.7% Private pharmacies 218.2%622.2%

30. Pan American Health Organization 30 Legislation on Medicines Promotion and Advertisement, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countriesCountries Legislation on promotion/advertising 861.5%2583.3% Responsible agency for regulating promotion/advertising: Industry 436.4%414.3% Government or national regulatory authority 654.5%2278.6% Co-regulation 19.1%27.1% Regulations of government include: Pre-approval for advertisement / promotion 342.9%1672.7% Prohibition of public advertising 675.0%2087.0% Guidelines on advertising of OTC medicines 342.9%1463.6% Civil society/NGOs taking part in monitoring advertising activities 220.0%1037.0%

31. Pan American Health Organization 31 Policies on Medicines Prices, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Policy covering medicine prices Public sector 6 50.0%1653.3% Private Sector433.3%1242.9% NGO111.1%418.2% If yes, which areas are covered? Maximum wholesale mark-up Public sector228.6%853.3% Private Sector583.3%866.7% NGO2100.0%450.0% Maximum retail mark-up Public sector228.6%960.0% Private Sector675.0%1170.6% NGO266.7%550.0% Duty on raw pharmaceutical materials Public sector228.6%533.3% Private Sector777.8%1062.5% NGO375.5%444.4% Duty on finished pharmaceutical materials Public sector228.6%637.5% Private Sector888.9%1270.6% NGO375.0%545.5%

32. Pan American Health Organization 32 Medicines prices monitoring and regulation, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Monitoring system for retail prices Public sector 216.7%1446.7% Private Sector 325.0%1139.3% NGO 218.2%626.1% Regulations on accessibility of retail medicine price information Public sector 433.3%931.0% Private Sector 433.3%519.2% NGO 327.3%313.0% Guidelines on medicine donations Public sector 1076.9%2477.4% Private Sector 450.0%1254.5% NGO 337.5%1361.9%

33. Pan American Health Organization 33 Public sector procurement and distribution in 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Entire public sector procurement pooled at national level 13100.0%2580.6% Responsible agency for public procurement Ministry of Health Procurement 1292.3%2689.7% Distribution 787.5%1885.7% NGOs Procurement 228.6%425.0% Distribution 00%220.0% Private institution Procurement 228.6%212.5% Distribution 2100%327.3% Individual health institutionProcurement 00.0%1152.4%

34. Pan American Health Organization 34 Essential Medicines List (EML) procurement and tender process in 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Public sector procurement limited to EML 4100.0%1191.7% If yes, are there provisions for purchasing medicines outside EML 541.7%1346.4% Country participation in pooled procurement scheme 541.7%1034.5% Tender board overseeing public sector procurement 1191.7%2382.1% If yes, are the key functions of the procurement office and tender committee clearly separated? 888.9%1990.5% Use of WHO Prequalification system 666.7%1150.0% Type of tender National competitive tender 450.0%1982.6% International competitive tender 981.8%1973.1% Negotiation/ direct purchasing 675.0%1982.6%

35. Pan American Health Organization 35 Availability and status of Essential Medicines List (EML) Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Existence of EML* 1076.9%2580.6% Last Update of EML < 5 years 9100%24100.0% No separate paediatric EML 9100%21100.0% Use of EML in different sectors Public sector procurement 1090.9%2488.9% Public insurance reimbursement 550.0%940.9% Private insurance reimbursement 222.2%314.3% Committee for EML medicines selection 1090.9%2488.9% Median [25 th, 75 th percentile] Number of medicines in EML 464 512 350526386598 N=8N=22 Paediatric formulations in National EML 40 58.5 3050 29.5263.5 N=2 N=10

36. Pan American Health Organization 36 Availability of standard treatment guidelines (STGs) and Medicines Formulary Manuals Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Number of% % countries Standard Treatment Guidelines National 975.0%2586.2% Hospital 758.3%1967.9% Primary care 866.7%2382.1% Last update of STG < 5 years National 583.3%1292.3% Hospital 3100.0%7 Primary care 4100.0%9 STGs for key paediatric illnesses 337.5% 1979.2% Medicines Formulary Manual* 975.0%2376.7% Last update < 5 years 562.5%1676.2% Covering only EML medicines 450.0%1361.9%

37. Pan American Health Organization 37 Total and per capita public expenditure for medicines (TPE) in $US, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 CARIBBEANAMERICAS Median [25 th, 75 th percentile] Median Total public expenditure for medicines (TPE) in $US $ 4,000,000 $ 34,087,493 815,00013,000,000$ 3,750,000$ 53,081,172 N=9N=24 Median Public medicines per capita in $US $ 20.90$ 11.50

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39. Pan American Health Organization 39 Were we want to be/what goals we want to achieve in… 2 years… 4 years… 10 years…

40. Pan American Health Organization 40 What are the priorities? At Caribbean level Country level

41. Pan American Health Organization 41 How can PAHO/WHO support Caribbean countries to achieve those goals?

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43. Pan American Health Organization 43 Thanks! Contact: ivamaadr@cpc.paho.org