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

Mary Wiktorowicz,Kathy Moscou,Joel Lexchin

doi:10.1186/s12992-018-0402-5

Abstract

BackgroundAs 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.ResultsA 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 co-regulatory 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.ConclusionAlthough 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.

Highlights

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
Pharmacogovernance guiding the interdependence shapes the transnational network (ICH) was compared to that of six member jurisdictions including the European Union, United Kingdom, France, United States, Canada and Japan given their relative similarity as developed nations and regions with established regulatory frameworks to allow generalizability, yet sufficient range to cover a spectrum of regulatory approaches [36]
Transnational network governance - Co-decision-making As a transnational network, the ICH is a governance forum whose decisions culminate in a set of harmonized regulatory standards to which its members agree

Summary

Introduction

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. 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. Case studies exploring the links between globalization and policy convergence may cast states as independent actors with the capacity to assume completely different policy instruments, the approach neglects their economic interdependence, highlighting the need for more nuanced analyses exploring the underlying strategic political dimension [4, 5]. Factors that affect interdependence include the symmetry of states’ economic power and influence, the type of political strategy that states pursue, and the degree to which one state depends on others [6]

Objectives

Methods

Results

Discussion

Conclusion