Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence

dc.contributor.authorWiktorowicz, Mary
dc.contributor.authorMoscou, Kathy
dc.contributor.authorLexchin, Joel
dc.date.accessioned2020-03-09T19:55:43Z
dc.date.available2020-03-09T19:55:43Z
dc.date.issued2018-08-22
dc.description.abstractBackground: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United States and Japan. In this paper we explore the manner in which state interdependence fosters the conditions for regulatory harmonization by tracing the underlying parallels between ICH and member state pharmacogovernance to clarify emergent patterns in regulatory policy convergence. Results: A shift to the life cycle approach to pharmaceutical regulation corresponded with international convergence in pre-market standards as emphasis shifted to post-market standards where convergence remains unresolved. Transnational pharmacogovernance was found to concentrate regulatory authority within a coregulatory model of bilateral negotiation with pharmaceutical trade associations in defining safety and efficacy standards. Given a context of state interdependence, parallels were found between transnational and ICH member pharmacogovernance modes that guide policy development. Divergent modes of state regulatory governance that re-calibrate perceptions of risk and risk mitigation were found to coincide with post-market policy dissonance. Conclusion: Although interdependence fostered harmonization in pre-market standards and aligned with increased focus on post-market approaches, the confluence of divergent state governance modes and perceptions of risk may inspire improvisation in post-market standards. As the ICH expands to an ensemble with a greater global reach, further research is needed to clarify the manner in which interdependence shapes transnational pharmacogovernance and the conditions that foster policy convergence in the public interest. Keywords: Pharmaceutical regulation, Medicines policy, Transnational governance, Transnational regulation, Pharmacogovernance, Policy network, Policy convergence, Drug safety, Pharmacovigilanceen_US
dc.description.sponsorshipYork University Librariesen_US
dc.identifier.citationGlobalization and Health 14 (2018): 86.en_US
dc.identifier.urihttps://doi.org/10.1186/s12992-018-0402-5en_US
dc.identifier.urihttps://hdl.handle.net/10315/37079
dc.language.isoenen_US
dc.publisherBiomed Centralen_US
dc.rightsAttribution 2.5 Canada*
dc.rights.articlehttps://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-018-0402-5en_US
dc.rights.journalhttps://globalizationandhealth.biomedcentral.com/en_US
dc.rights.publisherhttps://www.biomedcentral.com/en_US
dc.rights.urihttp://creativecommons.org/licenses/by/2.5/ca/*
dc.subjectPharmaceutical regulationen_US
dc.subjectMedicines policyen_US
dc.subjectTransnational governanceen_US
dc.subjectTransnational regulationen_US
dc.subjectPharmacogovernanceen_US
dc.subjectPolicy networken_US
dc.subjectPolicy convergenceen_US
dc.subjectDrug safetyen_US
dc.subjectPharmacovigilanceen_US
dc.titleTransnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergenceen_US
dc.typeArticleen_US

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