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Adriana Mitsue Ivama Medicines, Vaccines and Health Technologies Sub Regional Advisor

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.

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Adriana Mitsue Ivama Medicines, Vaccines and Health Technologies Sub Regional Advisor

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  1. 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 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) 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 Monitoring/Evaluation Implementation Through the 5 Strategic Objectives of Organizational Change Pan American Health Organization

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

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  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”. 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. Pan American Health Organization

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  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”. Pan American Health Organization

  10. EU/ACP/WHO Partnership on “Pharmaceutical Policies” Strategic Objectives • Pharmaceutical Policy: To provide evidence basis and to support the development and the monitoring of pharmaceutical policies • Access and Innovation: To support the strengthening of integrated supply systems • Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework • Rational Use of Medicines: to support the strengthening of core-function Pan American Health Organization

  11. Medicines Strategy in the Caribbean • 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 Pan American Health Organization

  12. 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; Pan American Health Organization

  13. 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 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; Pan American Health Organization

  14. 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); Pan American Health Organization

  15. 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); Pan American Health Organization

  16. Medicines Strategy in the Caribbean 4) Rational Use of Medicines: to support thestrengthening 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; Pan American Health Organization

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  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. Pan American Health Organization

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  20. National Medicines Policiesin 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 Pan American Health Organization

  21. Medicines Regulatory Authority (MRA), 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 Pan American Health Organization

  22. Medicines Registration, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  23. Licensing of Facilities and Professionals, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  24. Regulatory Inspections, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  25. Quality Control, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  26. Pharmacovigilance, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  27. Prevention and Combat of Counterfeit Medicines, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  28. Legislation on Generics Medicines, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  29. Policies on Medicines Prices, 2007 Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  30. Public sector procurement and distributionin 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 Pan American Health Organization

  31. Availability and status of Essential Medicines List (EML) Pan American Health Organization Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007

  32. Total and per capita public expenditure for medicines (TPE) in $US, 2007 Source: PAHO/WHO. The Pharmaceutical Situation in the Caribbean, 2007 Pan American Health Organization

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

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

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

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

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