V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) 17 – 19...
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V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) 17 – 19 November 2008
Buenos Aires Argentina
Beverly ReynoldsCARICOM Secretariat
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
CARIBBEAN COMMMUNITY MEMBER STATES
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.
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
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).
Governing Structure of CARICOM
Executive Body
Legislative Body
Supporting Organs
Supporting Bodies
Judiuciary
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
Mandate and Supporting Structures/Mechanisms
MandateNassau Declaration
COHSOD
Trinidad Declaration
Existing Mechanism
CCH Initiative CRDTL
TAG – Access to Medicines
CSME
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
Regional Initiatives: Past and Present Undertaking
OECS/PPS - Pooled ProcurementEstablished 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
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
9 OECS COUNTRIES
550 K people550 K people
Activities
Development of Model National Drug Policy
Standardization of Pharmacy Qualification
Drug TestingCaribbean Procurement and Supply
Management Authority (CARIPROSUM)Caribbean Network for Pharmacovigilence
(Vigicarib)Training/sensitization Workshops on TRIPSRegional Assessment of Patent Legislation
and related issues
Regional Assessment of Drug Registration and Regulatory Systems
OBJECTIVESAdequacy 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
Next Steps
Follow up on regional drug harmonization meeting in Barbados, 2006
Implement assessmentsImplementation of recommendations from
assessmentsExplore region-wide application of OECS
pooled procurement processStrengthen capacity of institutions to address
drug regulation issues
THANK YOU