12 September 2016
Université de Montréal; McGill University; University of Alberta; University of Miami; the Ottawa Hospital Research Institute; and the Stem Cell Network, OntarioAppeared in BioNews 868
Gene editing, in particular CRISPR/Cas9 technology, is sweeping the scientific world and has been receiving ample attention from policymakers worldwide. Policy statements and academic papers regarding responsible ways of moving forward with gene editing have already been published, such as the Hinxton Group's Statement on Genome Editing Technologies and Human Germline Genetic Modification or a recent Science paper titled 'Editing policy to fit the genome'. To date, Canada has remained silent on this matter.
To address this gap, Canada's Stem Cell Network asked McGill University's Centre of Genomics and Policy to convene a workshop to discuss the Canadian context. On 31 August 2016, 21 experts on science, ethics, law and policy, as well as government observers, gathered to provide insights regarding ways to move policy forward in this complex area.
The workshop was launched with four key presentations to inform the discussion. Professor Michael Rudnicki, scientific director of the Stem Cell Network and director of the Regenerative Medicine Program at the Ottawa Hospital Research Institute, presented the science behind gene editing and CRISPR/Cas9, characterising it as a disruptive technology that creates disruptive policy circumstances. He discussed cancer treatment and somatic treatment for genetic diseases as two areas where the clinical application of gene editing appears to be the most promising. He also described current advances in germline gene editing in animals, and clarified that this research is not permissible in many countries and has not yet been done successfully in human embryos.
Professor Tim Caulfield, Canada Research Chair in Health Law and Policy and a professor in the Faculty of Law at the University of Alberta, discussed the Canadian legal landscape. He reminded participants that the environment that drove the policy debate in Canada in the past was imbued with concerns regarding human cloning, and reflected a polarised debate that was prevalent at the time, dividing people between utopian and dystopian visions of genomics research. This led to the federal Assisted Human Reproduction Act of 2004, which includes a very broad ban on any germline genetic alteration that may be passed on to future generations. He noted that while the current debate surrounding gene editing is not as polarised as the human reproductive cloning debate was in the 1990s, there is still a growing focus on the more controversial potential uses of this technology, such as so-called 'designer babies' and concerns related to eugenics.
Dr Rosario Isasi, research assistant professor at the Department of Human Genetics and at the Institute for Bioethics and Health Policy at the University of Miami, presented the international policy landscape. She highlighted policy trends regarding gene editing and discussed lessons to be learned from the regulation of genetics research around the world. She emphasised the importance of remaining sensitive to the broader context of how policy governs research, including human biomedical research and assisted reproductive technologies. She also noted the importance of careful choice of appropriate policy tools (i.e. bans, moratoria, regulation, limitations on public funding). While laws are in effect long-term and more difficult to modify when science advances, funding moratoria are temporary in nature and easier to lift when the time is right. In many cases, any type of prohibition might be ill-suited and a more nuanced regulatory approach would be better. She thus called for attention to relevant distinctions: between different cell types (somatic, germline, stem cells); between various stages of research (pre-clinical, clinical, applied); between research objectives (medical innovation, disease prevention, modification of disease risk, therapy); and between types of risks that are being addressed (uncertainty, specific outcomes).
Prior to the policy workshop, participants were surveyed by McGill's Centre of Genomics and Policy regarding their views on key ethical and policy questions. First, whether the current Canadian bans on 1) all germline alterations, and 2) the creation of embryos and/or gametes for research purposes, are appropriate. If not, what they would propose for Canada? Second, whether future regulation of gene editing should make distinctions between cell types, purpose or use of the technology, and types of research. In addition, whether distinctions should also encompass the types of policy instruments used and establish thresholds for the application of germline alterations (e.g. prevention of serious incurable disease versus enhancement).
Dr Bartha Knoppers, Canada Research Chair in Law and Medicine and director of the Centre of Genomics and Policy at McGill University, presented the aggregate results of the survey, which demonstrated wide agreement among participants that current Canadian policy needs to be revisited, and that future policy should be sensitive to all the distinctions mentioned above. The rest of the workshop was consequently dedicated to a discussion of the best way forward for Canada, which raised the following points:
- The necessity for Canada to revisit its current policies and consider different approaches and policy tools to address the challenges and promises of gene editing. This would allow Canadians to potentially 'enjoy the benefits of scientific progress and its applications' (article 15b of the International Covenant on Economic, Social and Cultural Rights and article 27 of the Universal Declaration of Human Rights). It would also allow Canadian researchers to remain engaged in the evolution and progress of this area of research.
- The crucial importance of promoting a scientifically and ethically informed policy debate. Choice of policy approach should be principled and not driven by over-estimated clinical benefits (hype), uninformed reliance on scientific alternatives that lack promise, or an exaggerated focus on risk.
- The importance of scientific freedom as a core principle of liberal democracies. Science should not be limited by policy without compelling reasons. Regulation, when appropriate, should remain nuanced, sensitive to relevant distinctions, as flexible as possible, and not overly prohibitive.
- The importance of informing and engaging the public. While a diversity of voices should be recognised and an inclusive approach to policymaking is preferable, policymakers should remain cautious regarding the use of data about public perception of emerging technologies. Evidence-based policy should not be based on surveys, but rather on an informed debate that incorporates societal and cultural values, to ensure a good fit with the broader Canadian social context.
In conclusion, participants drafted together a series of insights and suggestions for policymakers on how to move forward in the Canadian context that will soon be published in a workshop report.