Abstract

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints that recognize political and practical challenges in keeping oversight of this research under Federal jurisdiction, whether conducted in academic or private sectors. The proposed nuanced regulatory scheme should be overseen by a new national Agency, modeled on a blend of the Canadian Stem Cell Oversight Committee and Assisted Human Reproduction Canada.

Highlights

  • Robust regulation of novel health biotechnologies in morally contentious domains is central to the ethical conduct of research and clinical applications

  • We focused our discussion on reforms to the Assisted Human Reproduction Act (AHRA) concomitant with the development of regulations and a regulatory agency that would enable unified Federal oversight of research, whether conducted in academic or private sectors

  • assisted reproductive technologies (ARTs) research would be overseen by a regulatory agency, modeled on a blend of the national Stem Cell Oversight Committee (SCOC) and Assisted Human Reproduction Canada

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Summary

Introduction

Robust regulation of novel health biotechnologies in morally contentious domains is central to the ethical conduct of research and clinical applications. The aim of the workshop was to inform proportionate and responsive regulation of research using human reproductive materials and clinical application of ARTs. Workshop participants included 20 experts in law, ethics, science, and reproductive medicine, as well as five representatives and observers from departments and agencies of the Canadian government. In enacting the AHRA, the Government of Canada employed its criminal law power to prohibit some areas of research and clinical practice that raised societal concerns in the 1990s and early 2000s.

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