eCite Digital Repository

Integrating public participation, transparency and accountability into governance of marketing authorisation for genome editing products


Nielsen, J and Eckstein, L and Nicol, D and Stewart, C, Integrating public participation, transparency and accountability into governance of marketing authorisation for genome editing products, Frontiers in Political Science, 3 Article 747838. ISSN 2673-3145 (2021) [Refereed Article]

PDF (Published version)

Copyright Statement

Copyright © 2021 Nielsen, Eckstein, Nicol and Stewart. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International (CC BY 4.0) License ( The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

DOI: doi:10.3389/fpos.2021.747838


Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies to raise distinct scientific, ethical, legal and social issues. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an individual’s genome. This article focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Although clinical trials for genome edited products are only just underway, lessons can be drawn from the marketing approvals pathways for related gene therapy products. This article provides a broad overview of the regulatory pathways that have been adopted by the US Food and Drugs Administration, the European Medicines Authority, and the Australian Therapeutic Goods Administration for reviewing gene therapy products for marketing approval. This analysis focuses on the extent to which public participation processes and transparency and accountability of review pathways are incorporated into marketing approval policy and practice. Following this review, the article proposes the application of Sheila Jasanoff’s "technologies of humility" as a foundation for meaningfully incorporating these pillars of good governance into regulatory processes for the review of products of genome editing. We conclude by articulating clear mechanisms for operationalising technologies of humility in the context of public participation, transparency and accountability, providing a blueprint for future policy development.

Item Details

Item Type:Refereed Article
Keywords:personalised medicine, health, gene editing, regulation, translation, safety
Research Division:Law and Legal Studies
Research Group:Law in context
Research Field:Law, science and technology
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Law reform
UTAS Author:Nielsen, J (Associate Professor Jane Nielsen)
UTAS Author:Eckstein, L (Dr Lisa Eckstein)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:147778
Year Published:2021
Funding Support:Australian Research Council (DP180101262)
Deposited By:Law
Deposited On:2021-11-15
Last Modified:2021-12-02
Downloads:19 View Download Statistics

Repository Staff Only: item control page