Round Table: Future challenges for PANDRH CARICOM Perspective

2 The Caribbean Universe: Political Associations and Dependence Note: CARICOM Members indicated in BLUE and Associate Members in RED Type of stateCountry / Territory Sovereign states associated to the British Commonwealth Antigua, Barbados, Dominica, Grenada, Saint Lucia, Saint Kitts and Nevis, Saint Vincent, The Bahamas, Belize, Guyana, Jamaica, Trinidad and Tobago Other sovereign states (Republics)Haiti, Suriname, Cuba, Dominican Republic UK Overseas TerritoriesAnguilla, British Virgin Islands, Montserrat, Bermuda, Cayman Islands, Turks and Caicos Islands Autonomous islands of the Kingdom of the Netherlands Aruba and the Netherlands Antilles (5 islands) French Overseas Territories Martinique, Guadeloupe, and French Guyana

3 CARICOM/HERA Assessment Drug Regulatory Authority (2009) Major Gaps identified: Absence of a Pharmaceutical Policy for the Region/countries Medicines regulation is constrained by – limited human & financial resources – inadequate legislative & institutional frameworks (s/t) – market factors (SIDS) Main Recommendations Formally adopt a regional pharmaceutical policy, including a quality assurance and intellectual property component Medicines regulation is required to protect & promote public health Establishing an efficient regional negotiation platform for medicines

2011. Approval of the CPP by the CARICOM Council for Human and Social Development: Develop a sub-regional regulatory framework and Strengthen collaboration among Caribbean countries to ensure the essential components of medicines regulation; Proposal to implement the Policy with collaboration of PANDRH members and other development partners Caribbean Pharmaceutical Policy (2011)

5 Caribbean Pharmaceutical Policy (CPP) AccessQualityRational Use CPP Goal: Guide Caribbean Countries to: Intersectoral approach

Implement the regulatory component of the CPP; More active participation on the PANDRH activities, specially the SC and WGs Implement the Caribbean Network on Medicines Regulation integrated with existing initiatives such as VIGICARIB and WG for adapting harmonization proposals to the context of CARICOM Develop strategies for improving Communication and participation of country’s representatives; Work Plan 2011 to 2013

7 Implement the regulatory component of the CPP Medicines Regulatory Framework: Develop a harmonized sub-regional regulatory framework (in collaboration with Pan American Drug Regulatory Harmonization) Strengthen collaboration among Caribbean countries to ensure the essential components of medicines regulation (11 Countries with legal provisions for a Medicines Regulatory Authority (MRA), none of them can perform all the functions)

8 Strengthen participation on the PANDRH activities, specially the SC and WGs Sub-regional and national approaches; Strengthening participation in the Steering Committee and Working Groups; Adaptation and Implementation of Guidelines with PAHO/WHO support; Development of Assessment of National Regulatory Authorities

9 Caribbean Network on Medicines Regulation Proposed during the II Caribbean Workshops on Medicines Regulation (2009) General Objective: Support the strengthening of medicines regulation and surveillance in the Caribbean to facilitate access to and rational use of safe and effective medicines of good quality. Specific Objectives  To propose, monitor and evaluate the implementation of the sub-regional framework and policy orientation regarding medicines regulation in the Caribbean;  To develop proposals for harmonization of medicines regulation in the Caribbean based on the PANDRH and CARICOM recommendations;  To support strengthening of communication and experience-exchange among Caribbean Medicines NRA and other related National Authorities;

10 Caribbean Network on Medicines Regulation The participants shall be:  National Medicines Regulatory Authorities (MRA) or National Authorities;  Educational Institutions;  Professional bodies;  Civil society organizations;  PAHO/WHO; and  CARICOM secretariat.

11 Caribbean Network on Medicines Regulation Priority areas of action for the network: 1. In a short term (1-2 years): a. The network will allow for the rapid information and experience exchange; and sharing information regarding National Medicines Regulatory Authorities’ structure and contact; and b. The main task of the network will be to address the priority areas identified during the second Workshop on Medicines Regulation (registration, inspection and licensing and marketing surveillance) and to promote harmonization of legal framework, guidelines and procedures among member countries.

12 Caribbean Network on Medicines Regulation 1. In the medium term (3-5 years): a. To establish a continuous program of human resources development geared towards capacity building in regulatory matters; and b. To develop and to implement a proposal for a medicines regulation framework for the Caribbean, including the establishment of a permanent Secretariat. The first task for this secretariat is to implement a Caribbean Committee for common registration.

Challenges Constraints Human and financial resources Geographical locations Cultural diversity Different languages (English, Spanish, French, Dutch…) Time for implement proposals/strategies 13

Challenges The cooperation among: CARICOM countries Countries from the Americas through PANDRA It is very important to have: Technical and financial support Political will. 14