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Advances in Harmonization of Drug Regulatory Systems in CARICOM Member States

Advances in Harmonization of Drug Regulatory Systems in CARICOM Member States. V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) 17 – 19 November 2008 Buenos Aires Argentina. Beverly Reynolds CARICOM Secretariat. Overview of Presentation.

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Advances in Harmonization of Drug Regulatory Systems in CARICOM Member States

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  1. Advances in Harmonization of Drug Regulatory Systems in CARICOM Member States V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) 17 – 19 November 2008 Buenos Aires Argentina Beverly Reynolds CARICOM Secretariat

  2. Overview of Presentation • Highlights of Regional Integration Process • Governing Structure of CARICOM • Regional Drug Harmonization Challenges • Mandates and Supporting Structures/Mechanisms • Regional Harmonization Initiatives: Past and Present • Activities • Next Steps

  3. CARIBBEAN COMMMUNITY MEMBER STATES

  4. Regional Integration • Caribbean Free Trade Area (CARIFTA) (1968) • The Caribbean Community established under the Treaty of Chaguaramas 1st August 1973 to: • to promote economic integration and cooperation among its members; • ensure that the benefits of integration are equitably shared; • coordinate foreign policy; • Facilitate the provision of common services and cooperation in social sector development.

  5. Regional Integration • Integration process deepened under the Revised Treaty (5th July 2001). CARICOM Single Market and Economy (CSME) established • CSME agreement was effected 1st January 2006 with Barbados, Belize, Jamaica, Guyana, Suriname and Trinidad and Tobago as the first full members • Membership increased to 12 by July - Antigua and Barbuda, Dominica, Grenada, St. Kitts and Nevis, Saint Lucia and St. Vincent and the Grenadines

  6. Regional integration CSME facilitates: • Free movement of goods • Free movement of services • Free movement of skills • Free movement of capital • Right of establishment (free exercise of the right to set up businesses in any Member State).

  7. Governing Structure of CARICOM • Executive Body • Legislative Body • Supporting Organs • Supporting Bodies • Judiuciary

  8. Regional Drug Harmonization: Challenges • Size of countries, magnitude of task cost associated with regulatory systems • Limited human and financial resources /institutional capacity • Lack of supportive environment – no policy framework, antiquated or no legislation • Establishing Region-wide Pooled Procurement system • Ensuring safety and efficacy of drugs moving through the Region

  9. Mandate and Supporting Structures/Mechanisms Mandate • Nassau Declaration • COHSOD • Trinidad Declaration Existing Mechanism • CCH Initiative • CRDTL • TAG – Access to Medicines • CSME

  10. Regional Initiatives: Past and Present Undertaking • Regional Advisory Body on Drugs and Therapeutics (RABDAT) • Caribbean Regional Drug Testing Laboratories (CRDTL) • Technical Advisory Group – TRIPS • Regional Assessment of the Regulation of Pharmaceuticals • Access to medicines: Regional assessment of patents and related issues

  11. Regional Initiatives: Past and Present Undertaking • OECS/PPS - Pooled Procurement • Established in 1986 – self financing pooled procurement agency for OECS countries • ‘An excellent example of economic and functional cooperation to improve access to medicines that are safe, effective and affordable (WHO/PAHO, UNAIDS) • Work involves: • Harmonized drug formulary • Technical assistance • Common pharmaceutical policy • Donated goods policy • Pharmacovigilance • Strategies to combat counterfeit medicines • Drug utilization studies

  12. Anguilla Antigua and Barbuda British Virgin Islands Dominica 550 K people Grenada Montserrat St. Kitts and Nevis St. Lucia St. Vincent and the Grenadines 9 OECS COUNTRIES Source: Francis Burnett, Managing Director, PPS

  13. Activities • Development of Model National Drug Policy • Standardization of Pharmacy Qualification • Drug Testing • Caribbean Procurement and Supply Management Authority (CARIPROSUM) • Caribbean Network for Pharmacovigilence (Vigicarib) • Training/sensitization Workshops on TRIPS • Regional Assessment of Patent Legislation and related issues

  14. Regional Assessment of Drug Registration and Regulatory Systems   OBJECTIVES • Adequacy of the systems in Member States for regulation of the pharmaceutical market to ensure the timely supply of safe, effective and quality medicines • To explore the possibilities and identify the requirements and process for establishing a harmonized, pro-public health regional (Caribbean) drug regulation policy (to include generic drugs) and registration system • To identify mechanisms for the development of regional country coalition for joint procurement strategies

  15. Next Steps • Follow up on regional drug harmonization meeting in Barbados, 2006 • Implement assessments • Implementation of recommendations from assessments • Explore region-wide application of OECS pooled procurement process • Strengthen capacity of institutions to address drug regulation issues

  16. THANK YOU

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