Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states

ABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and econo...

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Main Authors: Charles Preston, Harinder S. Chahal, Analia Porrás, Lucette Cargill, Maryam Hinds, Babatunde Olowokure, Rudolph Cummings, James Hospedales
Format: Article
Language:English
Published: Pan American Health Organization
Series:Revista Panamericana de Salud Pública
Subjects:
Online Access:http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=en
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author Charles Preston
Harinder S. Chahal
Analia Porrás
Lucette Cargill
Maryam Hinds
Babatunde Olowokure
Rudolph Cummings
James Hospedales
author_facet Charles Preston
Harinder S. Chahal
Analia Porrás
Lucette Cargill
Maryam Hinds
Babatunde Olowokure
Rudolph Cummings
James Hospedales
author_sort Charles Preston
collection DOAJ
description ABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems—may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative’s concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.
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spelling doaj.art-d6b27901d33a4187a0f06834951326862022-12-22T00:30:40ZengPan American Health OrganizationRevista Panamericana de Salud Pública1680-5348395262268S1020-49892016000500262Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member statesCharles PrestonHarinder S. ChahalAnalia PorrásLucette CargillMaryam HindsBabatunde OlowokureRudolph CummingsJames HospedalesABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems—may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative’s concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=enCooperación internacionallegislación farmacéuticaBarbadosGuyanaJamaicaTrinidad y TobagoIndias Occidentales
spellingShingle Charles Preston
Harinder S. Chahal
Analia Porrás
Lucette Cargill
Maryam Hinds
Babatunde Olowokure
Rudolph Cummings
James Hospedales
Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
Revista Panamericana de Salud Pública
Cooperación internacional
legislación farmacéutica
Barbados
Guyana
Jamaica
Trinidad y Tobago
Indias Occidentales
title Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
title_full Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
title_fullStr Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
title_full_unstemmed Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
title_short Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
title_sort regionalization as an approach to regulatory systems strengthening a case study in caricom member states
topic Cooperación internacional
legislación farmacéutica
Barbados
Guyana
Jamaica
Trinidad y Tobago
Indias Occidentales
url http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=en
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