The Committee was established in 2018, with the purpose of providing advice and recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing. More recently, the World Health Organisation (WHO) Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing handed down a set of three reports on the governance of genome editing: Governance Framework, Recommendations and Position Paper ( Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, 2021a Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, 2021b Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, 2021c). Rather, public involvement should be extended to embrace more active forms of consultation and participation in policy setting and development. The Report emphasises that public involvement must go further than mere information sharing (National Academies of Sciences, Engineering, and Medicine, 2017, 167). A 2017 Report by the US-based National Academies of Sciences, Engineering, and Medicine similarly recognised the need for public participation in the context of genome editing, calling for meaningful public input into the policy-making process.
The numerous examinations of the complex policy issues associated with human genome editing are a case in point, routinely ending with a call for some form of public engagement, as demonstrated in a report by the International Commission on the Clinical Use of Human Germline Genome Editing ( International Commission on the Clinical Use of Human Germline Genome Editing, 2020). In the context of new technologies, particularly those with uncertain risks and benefits, calls for greater public participation, in one form or another, have become de rigeur. Appropriate attention to these three pillars of good governance should lead to higher levels of public trust and confidence, both in the subject matter being governed and in the governance regime itself. Public participation is increasingly expected as a core pillar of good governance, along with transparency and accountability, in such diverse contexts as international development assistance ( Carothers and Brechenmacher, 2014), human rights ( United Nations, 2007), and genome editing ( Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, 2021a). 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. 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. 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. 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.
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 focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an individual’s genome. 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. Public participation, transparency and accountability are three of the pillars of good governance. 2Sydney Health Law, Law Faculty, University of Sydney, Sydney, NSW, Australia.
1Centre for Law and Genetics, Law Faculty, University of Tasmania, Hobart, TAS, Australia.Jane Nielsen 1*, Lisa Eckstein 1, Dianne Nicol 1 and Cameron Stewart 2
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