Canada's Assisted Human Reproduction Act: Pragmatic Reforms in Support of Research

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.

The need for regulation in the practice of human assisted reproduction in Mexico. An overview of the regulations in the rest of the world

“…In 2018, a workshop entitled Consensus Statement: gene editing, genetic testing, and reproductive medicine in Canada was held in Ottawa, Canada (Consensus Statement: Gene Editing, Genetic Testing, and Reproductive Medicine in Canada). It aimed to propose a restructuring of the AHR Act (amended in 2013) [ 35 , 37 ], in order to take into account the interests of physicians and researchers for the promotion of medical and scientific innovation through the adaptation of in vitro and in vivo research that is prohibited, such as gene editing research for the correction of genetic mutations, somatic cell nuclear transfer (SCNT), the use of embryos produced in vitro that will be discarded and that could later be used for research to expand the knowledge of processes such as early embryonic development and developmental disorders, as well as research on mitochondrial replacement therapy (through genome alteration), research on the development of human organs, the origin of human diseases and the study of human primordial germ cells (through the creation of chimeras) [ 35 , 37 ].…”

National Human Embryo and Embryoid Research Policies: A Survey of 22 Top Research-Intensive Countries

“…Australia, Canada, Japan, the Netherlands, Spain, South Korea and Taiwan allow human embryo research, but only on embryos created for IVF and donated for research [64,65]. Australia (Human Embryos Act), Canada (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) and Taiwan (Human Embryo and Embryonic Stem Cell Act) have a 14-day limit within their laws and national guidelines [66][67][68][69][70][71][72][73][74][75]. Japan's Act on Regulation of Human Cloning Techniques does not include a 14-day limit, but the national guidelines from the Ministry of Education, Culture, Sports, Science and Technology do [76,77].…”

“…Several nations have laws or guidelines allowing embryoid research. Canada's definition of an embryo explicitly prohibits reproductive cloning alone and allows for hESC research and, therefore, embryoid research [69,70,74,75]. India, Spain, South Korea and Taiwan mention fertilization as part of their definition.…”

The Regulation of Mitochondrial Replacement Techniques Around the World

“…Since in Canada the fundamental barrier to change does not seem to be pro-life political agendas that demand respect for in vitro human embryos, but rather an absence of political will, a group of Canadian experts was formed to explore the challenges of revising the AHRA. This resulted in the publication of a consensus statement, based on several academic publications (12,53,54,73,84), recommending that "basic and pre-clinical research on human germ cells and embryos in the earliest stages of development should be allowed" and that "mitochondrial replacement therapy to prevent the transmission of serious mitochondrial diseases should be permitted when demonstrated to be safe and effective" (55, p. 1). The group also stated that "MRT is a novel, promising intervention" and that "Canada should not curtail scientific exploration that might lead to its safe and effective clinical application" (54, p. 917).…”