Bubela Tania, Kleiderman Erika, Master Zubin, Ogbogu Ubaka, Ravitsky Vardit, Zarzeczny Amy, Knoppers Bartha Maria
Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada.
Centre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, Canada.
Front Med (Lausanne). 2019 Jul 10;6:157. doi: 10.3389/fmed.2019.00157. eCollection 2019.
Canada's 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 research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental 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.
加拿大早就应该进行议会审查了。我们认为，目前对使用人类生殖材料的研究的监管不成比例，没有应对对人类和环境健康与安全构成的不确定威胁，也没有考虑到民主社会中的多元价值观。我们提议针对目前被禁止的活动（如基因编辑）的研究以及部长就加拿大人获取目前被禁止的实验性干预措施（如线粒体替代疗法）行使自由裁量权制定量身定制的监管豁免。我们的建议受到宪法限制的约束，这些限制认识到在联邦管辖下对这项研究进行监督所面临的政治和实际挑战，无论该研究是在学术部门还是私营部门进行。拟议的细致入微的监管方案应由一个新的国家机构监督，该机构以加拿大干细胞监督委员会和加拿大辅助人类生殖机构为蓝本。
