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