Canada’s Prohibition on Altering the Human Genome

Françoise Baylis and Alana Cattapan defend the current prohibition in Canada on making genetic alterations that can be passed on to future generations.

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With the development of CRISPR-Cas9 for genome editing, scientists can more safely and more easily insert, delete, or replace DNA.  Should this new genome editing tool be used to make changes that will be passed on to future generations?

In Canada, the law currently prohibits altering “the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants.” Some people advocate removing this prohibition.

This past summer, Health Canada invited Canadians to comment on its plans to introduce regulations in support of the 2004 Assisted Human Reproduction (AHR) Act. A discussion paper titled Toward a Strengthened Assisted Human Reproduction Act: A Consultation with Canadians on Key Policy Proposals was published. In the discussion paper, Health Canada indicated that amending the prohibition on altering the human genome was beyond the scope of the regulations currently being developed, but that this issue might be addressed at some future time.

In light of this comment by Health Canada suggesting that the legal prohibition on altering the genome of human gametes and embryos may be revisited, we consider it important to explain why this should not happen – at least not now.

First, the current prohibition on the modification of the human germline is in line with legislative objectives. When the AHR Act was passed, Health Canada officials were clear about the fact that the purpose of the AHR Act was not to facilitate research, but rather to “fill a [regulatory] void so that inappropriate things do not happen.” With limited information available about the potential uses and long-term effects of the new genetic technologies, the prevention of “inappropriate things” is most likely to be achieved by maintaining the current prohibition.

Sculpture “Bootstrap DNA” in Kew Gardens
Sculpture by Charles Jencks (2003). Photo Credit: Françoise Baylis 2017

Second, the prohibition on editing the human genome is consistent with international standards. In 2015, both UNESCO  and the Council of Europe called for a moratorium on germline genome editing. The UNESCO International Bioethics Committee published a report to this end entitled “Updating its Reflection on the Human Genome and Human Rights.” The Council of Europe Committee on Bioethics adopted a “Statement on Genome Editing Technologies” in which it reminded everyone of the commitments in the “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine” (also known as the Oviedo Convention).

Article 13 of the Convention stipulates that: “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”

At present, the only country that explicitly permits any kind of genetic modification of human gametes and embryos is the United Kingdom (although there are countries with no legislation on the matter at all). In 2015, the United Kingdom made it legal to create three-parent embryos. The United Kingdom, however, has considerable regulatory oversight through the Human Fertilisation and Embryology Authority. Canada currently has no institutional equivalent that has the capacity or expertise to do similar work.

Third, even if international standards were different, the new possibilities for heritable modification require ongoing, meaningful public dialogue about a wide range of ethical and social issues. At the close of the 2015 International Summit on Human Gene Editing – sponsored by the U.S. National Academy of Sciences, the U.S. National Academy of Medicine, the Chinese Academy of Sciences, and the Royal Society – the Organizing Committee issued a statement which affirmed that it would be irresponsible to proceed with germline gene editing without ‘broad societal consensus’.  And, at the 2017 Annual meeting of the American Association for the Advancement of Science, the President of the Royal Society (of the U.K. and the Commonwealth), Venki Ramakrishnan, insisted that the future use of genetic technologies “is not something that should be decided by a small group of people in a small group of nations because new technologies will affect us all.” These kinds of consultations and public dialogue are only just beginning.

In light of recent scientific developments, it may well be time for broad, considered, and careful discussion of the various challenges raised by human germline gene editing. Right now, however, we are a very long way away from being ready to amend the AHR Act to remove the prohibition of making genetic alterations that can be passed on to future generations.

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Françoise Baylis is a Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University @FrancoiseBaylis

Alana Cattapan is an Assistant Professor at the Johnson Shoyama Graduate School of Public Policy at the University of Saskatchewan @arcattapan

Also published today with The Conversation is another blog by Françoise Baylis on the recent genome editing research in the United Kingdom focused on early human embryonic development.