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Globalization and Health
Published in: Globalization and Health 1/2018

Open Access 01-12-2018 | Research

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

Authors: Mary Wiktorowicz, Kathy Moscou, Joel Lexchin

Published in: Globalization and Health | Issue 1/2018

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Abstract

Background

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 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.

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.
Appendix
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Footnotes
1
The areas where the ICH develops harmonized standards include: quality guidelines (e.g., conduct of stability studies), efficacy guidelines (e.g., design, conduct, safety and reporting of clinical trials), safety guidelines (uncover potential risks such as cardio-toxicity) and multidisciplinary guidelines (e.g., the ICH medical terminology). See: http://​www.​ich.​org/​products/​guidelines.​html. Accessed 3 Aug 2018.
 
2
Each member forms a contact network of experts within their organization from which their representative is drawn to ensure Expert Working Group discussions reflect members’ views and policies.
 
3
For example, the US took action on biological product safety issues three times more frequently than the EU from 1995 to 2007 [58].
 
4
Related initiatives of the common committee included enhanced quality assurance systems, Eudra Vigilance (a European-wide electronic ADR database), transparent communications on product safety, coordinated resources for pharmacoepidemiologic studies and advancing research methods in the field of pharmacovigilance.
 
5
The FDA attained the authority to require manufacturers to undertake Risk Evaluation and Mitigation Strategies (REMS) and develop Risk MAPs that exclude active surveillance. REMs and RiskMAPs consist of updated medication guides, healthcare provider education to support safer use, risk communication strategies, a prescriber agreement and a patient-physician agreement [138].
 
6
The PAFSC is comprised of 16 committees and 21 subcommittees. The PAFSC members include experts in such fields as medicine, pharmacy, biology, dentistry, nursing and social science based in universities, hospitals and research institutes; there are 55 permanent members and about 400 temporary members. Areas addressed by the PAFSC include the determination of regulatory standards for drugs, review of new applications, re-examination and re-evaluation drug applications, and judgments concerning relief funds payment under the provisions of the ADR Relief and Research Promotion Fund Law [80].
 
7
The British Government’s 1987 review of the agency, prompted by industry’s complaints of slow reviews, was co-chaired by a former ABPI chair and led to several changes including industry fees to fund the new product authorization process. The government also agreed to consult industry on the agency’s management performance [94].
 
8
The government ignored most of the Committee’s recommendations [95].
 
9
The FDA’s relative transparency reflects its adherence to the Administrative Procedures Act (1946) and the Freedom of Information Act (1967) that require agencies to record how decisions have been made, and in the case of pharmaceuticals to make those records public following marketing authorization.
 
10
A pilot project in 2016 involved patients in the Committee for Human Medicinal Products (CHMP) benefit-risk evaluation of medicines meetings. Patient representatives are in some cases funded by pharmaceutical companies [113]. In contrast, consumers are users of health services overall who may be more objective [114].
 
11
Individuals are not eligible to become members or observers of the ICH. Articles of Association 17 and 18 allow the ICH Management Committee to invite organizations as ad hoc observers to the Assembly, while Article 19 makes provisions for the termination of observer status [139].
 
12
Although the FDA approach to pharmacovigilance entails greater independence from industry, the FDA has not always acted on the safety signals detected. In the case of rosiglitazone (Avandia®) for example, while the FDA had internal analyses of an increase in cardiac events as an adverse drug effect, it did not issue a safety warning until an independent study was used to criticize the FDA for not acting on the information [140].
 
13
Patients harmed by rofecoxib (Vioxx®) filed a class-action lawsuit against Merck. The company settled the product-liability lawsuits for $US4.85 billion. Related litigation, including a multi-district class action lawsuit against Merck in New Jersey federal court alleged it concealed safety information from company-sponsored trials from investors. Merck settled the lawsuit by paying $US830 million to investors who bought Merck stock [141].
 
14
The EU developed a regulation mandating that Clinical Study Reports be published following marketing authorization and launched a proactive publication policy (Policy 0070) to upload clinical reports submitted for marketing authorizations on a publicly available website in 2014. Despite legal action by companies against the EU to annul the EMA’s decision to release clinical trial data, the policy stands. The clinical data are available to download and re-use by academics and for non-commercial research. Commercially confidential information may however be redacted before the data are released [132].
 
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Metadata
Title
Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence
Authors
Mary Wiktorowicz
Kathy Moscou
Joel Lexchin
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Globalization and Health / Issue 1/2018
Electronic ISSN: 1744-8603
DOI
https://doi.org/10.1186/s12992-018-0402-5

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