2. V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) 17 – 19 November 2008 Buenos Aires Argentina Beverly Reynolds CARICOM Secretariat

3. 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

4. CARIBBEAN COMMMUNITY MEMBER STATES

5. Regional Integration Caribbean Free Trade Area (CARIFTA) (1968) The Caribbean Community established under the Treaty of Chaguaramas 1 st 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.

6. Regional Integration Integration process deepened under the Revised Treaty (5 th July 2001). CARICOM Single Market and Economy (CSME) established CSME agreement was effected 1 st 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

7. Regional integration CSME f acilitates: 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).

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

9. 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

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

11. 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

12. 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

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

14. 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

15. 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

16. 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

17. THANK YOU