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Global pharmaceutical regulation: the challenge of integration for developing states
BACKGROUND: This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, includi...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5175325/ https://www.ncbi.nlm.nih.gov/pubmed/27998293 http://dx.doi.org/10.1186/s12992-016-0208-2 |
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author | Pezzola, Anthony Sweet, Cassandra M. |
author_facet | Pezzola, Anthony Sweet, Cassandra M. |
author_sort | Pezzola, Anthony |
collection | PubMed |
description | BACKGROUND: This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state’s institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. RESULTS: This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in regulatory infrastructure. Human capacity across many developing countries remains limited. Most notably, variation among states is stark. Countries that have been leaders in establishing global norms do not appear to have influenced their neighbors in establishing regional patterns. Finally, in contrast to traditional theories of international norms diffusion, global standard-setters such as the United States or European Union appear to have surprisingly little influence on standard setting across our survey. CONCLUSIONS: Our research has implications for the framing of technical support on public health initiatives aimed at strengthening local public institutions in medicine and offers a new methodological approach for analyzing drug regulation systems in developing countries. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12992-016-0208-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5175325 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51753252016-12-28 Global pharmaceutical regulation: the challenge of integration for developing states Pezzola, Anthony Sweet, Cassandra M. Global Health Research BACKGROUND: This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state’s institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. RESULTS: This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in regulatory infrastructure. Human capacity across many developing countries remains limited. Most notably, variation among states is stark. Countries that have been leaders in establishing global norms do not appear to have influenced their neighbors in establishing regional patterns. Finally, in contrast to traditional theories of international norms diffusion, global standard-setters such as the United States or European Union appear to have surprisingly little influence on standard setting across our survey. CONCLUSIONS: Our research has implications for the framing of technical support on public health initiatives aimed at strengthening local public institutions in medicine and offers a new methodological approach for analyzing drug regulation systems in developing countries. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12992-016-0208-2) contains supplementary material, which is available to authorized users. BioMed Central 2016-12-20 /pmc/articles/PMC5175325/ /pubmed/27998293 http://dx.doi.org/10.1186/s12992-016-0208-2 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Pezzola, Anthony Sweet, Cassandra M. Global pharmaceutical regulation: the challenge of integration for developing states |
title | Global pharmaceutical regulation: the challenge of integration for developing states |
title_full | Global pharmaceutical regulation: the challenge of integration for developing states |
title_fullStr | Global pharmaceutical regulation: the challenge of integration for developing states |
title_full_unstemmed | Global pharmaceutical regulation: the challenge of integration for developing states |
title_short | Global pharmaceutical regulation: the challenge of integration for developing states |
title_sort | global pharmaceutical regulation: the challenge of integration for developing states |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5175325/ https://www.ncbi.nlm.nih.gov/pubmed/27998293 http://dx.doi.org/10.1186/s12992-016-0208-2 |
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