Round Table presentation on Implementation of PANDRH Guidelines in CARICOM countries

CARICOM comprises 15 Full Members, and 5 Associate Members: Composition of CARICOM

The Caribbean Community and Common Market (CARICOM) was established in 1972; The Principal Organs are The Conference of Heads of Government (and its Bureau) and The Community Council of Ministers (The Community Council), assisted by four 'Organs', one of which is the Council for Human and Social Development (COHSOD). COHSOD - responsible for the promotion of human and social development in the Community.” (Article 12 of the Revised Treaty of Chaguaramas). The mandate of COHSOD includes: “to promote the improvement of health, including the development and organisation of efficient and affordable health services in the Community”. Establishment of CARICOM

Antigua & Barbuda, JamaicaAntigua & Barbuda, The Bahamas, Montserrat,The Bahamas, Montserrat, Barbados, Saint Lucia,Barbados, Saint Lucia, Belize, St. Kitts & NevisBelize, St. Kitts & Nevis Dominica, St Vincent & theDominica, Grenada, GrenadinesGrenada, Guyana SurinameGuyana Haiti Trinidad &Tobago CARICOM MEMBERS

Anguilla, Bermuda, Bermuda, British Virgin Islands, Cayman Islands andCayman Islands Turks and Caicos Islands.Turks and Caicos Islands CARICOM Associate Members

There are seven observers: Aruba Colombia Dominican Republic Mexico Netherlands Antilles Puerto Rico Venezuela CARICOM Observers

Good Laboratory Practice Biotechnological Products Pharmacovilance Drug Promotion Medicines Registration Combating Counterfeit Medicines Vaccines Medicinal Plants Medicines Promotion Good Clinical Practice WG’s Represented on PANDRH

 Development of a National Drug policy  Strengthening the Drug Inspectorate for Regulatory functions  Moving to Drug registration using PANDRH guidelines  General attempt to incorporate PANDRH guidelines into regulatory functions Challenges, mainly delays and the capacity and political will to effect and implement changes Use of guidelines by Belize

 Improvement in Good Laboratory Practice  Improved communication and dissemination of test results to countries  Monthly reports of all drugs tested to CMOs and DRAs  Technical assistance to agencies requiring help  Supporting DRAs in other areas as a member of the Technical Advisory Group Use of guidelines by CRDTL

 Improvement in Good Laboratory Practice Inspection  Improved Drug Evaluation, Promotion, EML, Registration  etc. Use of guidelines by Haiti

 Improvement in Good Laboratory Practice by implementing rapid testing in HIV  Improvement of practices in the registration of Biologicals from experiences with biosimilars  Carrying out Country Pharmaceutical Profile assessment  Strengthening Pharmacovigilance Use of guidelines by Trinidad & Tobago

 Strengthening of Pharmacovigilance  Use of WHO guidelines in the registration of herbal products  Strengthening of registration of Biologicals  Improvement in Good Laboratory Practice  WHO Level II Pharmaceutical Assessment  Pharmaceutical Country Profile Assessment  Providing Technical Assistance in the development of CPP Use of guidelines by Jamaica

 Development of new regulations to facilitate the Pharmacy Act recently enacted  Adaptation in Drug Promotion  Adaptation in Drug Registration  Adaptation in Pharmacovigilance  Development of a National Pharmaceutical Policy Use of guidelines by the Bahamas

 To incorporate the BIO WG guideline into the policy of a Biotechnology Steering Group recently approved by Cabinet, (help from FIFARMA {Panama})  Strengthen Pharmacovigilance  Adopt the guidelines provided by the Drug registration WG  Adopt the guidelines provided by the Drug Promotion WG Use of guidelines by Barbados

PANDRH Steering Committe PANDRH WG Meetings Elluminate Meetings Share Points PANDRH Conferences Meetings Participated

T&T Jamaica Belize Bahamas Barbados Suriname Haiti Members Participating in VI PANDRH

Caribbean Pharmaceutical Policy (CPP) Improvements on some national policies (NPP) Sub regional Pharmacovigilance (VigiCarib) WHO Level II Surveys in several countries Two Studies by HERA with collaboration from CARICOM and the WHO/EU/ACP Partneship on Pharmaceutical Policies Pharmaceutical Country Profile Achievements of CARICOM Countries

Major Regional and International Guidelines/Mandates The Nassau Declaration: “Health of the region is the Wealth of the region” Declaration of Port of Spain: “Comprehensive and Integrated Approach to the Control of CNCD” Report of the Caribbean Commission on Health and Development. Caribbean Cooperation in Health Phase III (CCH III) “Investing in Health for Sustainable Development” – 2009

Techincal support Development of the WHO/EU ACP Partnershio on Pharmaceutical Policies in the Caribbean – Phase II Pharmaceutical Policy; Quality and Regulation; Access; Rational Use US $1,215,203

Achievements of CARICOM Countries Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework Outcomes: Support to the Caribbean Regional Drug Test Laboratory (CRDTL); Establishment of Pharmacovigilance Network – VIGICARIB: 2 full members of WHO Network (BAR, SUR) 1 associated member (OECS/PPS) - focus on HIV/Aids related medicines – Suriname is the focal coordinator Prevention and Combat of Counterfeit Medicines in the Caribbean: diagnosis; multisectoral workshops (OECS); Two Caribbean Workshops on Medicines Regulation (2006 and 2009)

The Caribbean Community and Common Market (CARICOM) was established in 1972; The Principal Organs are The Conference of Heads of Government (and its Bureau) and The Community Council of Ministers (The Community Council), assisted by four 'Organs', one of which is the Council for Human and Social Development (COHSOD). COHSOD - responsible for the promotion of human and social development in the Community.” (Article 12 of the Revised Treaty of Chaguaramas). The mandate of COHSOD includes: “to promote the improvement of health, including the development and organisation of efficient and affordable health services in the Community”. Establishment of CARICOM

Quality and Regulation: To support the strengthening of core functions of NRAs and sub-regional regulatory framework Outcomes: CARICOM Regional Assessment of Drug Regulatory and Registration Systems and CARICOM Regional Assessment on Patent and Related Issues and Access to Medicines (2009) PAHO/WHO Pharmaceutical Situation in the Caribbean (2009); Development of the proposal for the Caribbean Network on Medicines Regulation to work in close collaboration with PANDRH. Presentation of the outcomes of the DRA Survey to the CAUCUS of Ministries of Health in September Achievements of CARICOM Countries

2010. Development of a concept paper and a proposal for the Caribbean Pharmaceutical Policy based on the outcomes of the surveys conducted; 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 Accomplishments and Challenges to date

Implement the CPP and national Policies; Strengthen participation on the PANDRH SC and WGs and adapting and incorporating PANDRH guidelines, 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 CARICOM representatives on WG; Accreditation for CRDTL, the reference Lab Complete Country Pharmaceutical Profiles Work Plan 2011 to 2013

Thank you for your attention.