Some CRISPR research is illegal in Canada

Using CRISPR on human germ cells in Canada could criminalize scientists and land them in jail. Now a team of lawyers and bioethicists steps up to defend scientists, urging for reconsideration of a thirteen-year-old law.

While the rest of the research world is buzzing with the possibilities of CRISPR research for healthcare, Canadian scientists could actually face jail time or a hefty fine for using the technology for basic research on human germ cells. CRISPR research on human germ cells in Canada is legally prohibited by the Assisted Human Reproduction Act (AHRA). Recently, in the Nature partner journal npj Regenerative Medicine, a team of Canadian lawyers and bioethicists argued that the thirteen-year-old act must be reconsidered (1).

“The problem with the law is that the way the prohibition is actually written leads to, in our opinion, an interpretive grey area,” said Erika Kleiderman, an academic associate and lawyer with the Centre of Genomics and Policy and one of the authors of the recent editorial. According to the AHRA, “No person shall knowingly alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants” (section 5.1.f), herein referred to as the “germline prohibition” (2). According to Kleiderman and her colleagues, it is not clear whether the act encompasses both research and clinical applications of human germline gene editing or if it would be more permissive towards research and prohibitive towards only clinical applications.

Zubin Master, a Canadian bioethicist at the Mayo Clinic, recently published an unrelated article in the Journal of Obstetrics and Gynaecology Canada claiming that the AHRA could be interpreted to permit basic research (3). “At first glance, it does sound like it actually prohibits it, but we felt like it hinged on the word ‘capable,’” said Master. “Even though [the alteration] may be capable of being transmitted to descendants, the fact that you’re not going to put that human embryo inside a woman such that the woman would become pregnant and a child would result means that genetic change is actually not going to be transmitted to a descendent.” He argues that this interpretation may also be consistent with the intent of the lawmakers at the time, who were concerned about preventing designer babies.

However, violating the AHRA is a criminal offense that carries a hefty fine and the possibility of up to ten years in prison—a risk that most researchers are unwilling to take. Both Kleiderman and Master hope that the criminal aspect will be removed from the law since this makes it rigid and difficult to adapt for the continual emergence of new technologies and their research applications.

“I would like these prohibitions to disappear. I would like to see some other type of governance mechanism be developed for scientific research on gene editing—something that is more dynamic,” said Master.

As a solution, Kleiderman’s group proposes a regulatory approach. They previously reviewed human germline editing laws and policies in 16 different countries and found the United Kingdom’s regulatory approach to be most appealing (4). The approach involves submitting an application to a regulatory body that grants a research license if the work is deemed permissible. The proposed research must also undergo ethics reviews.

“We do realize that reopening the act and fully revising it might be a bit much for us to expect. A simpler approach that we feel would be acceptable would be to at least put forward some guidance as to the interpretation of the Act so that we can know whether scientists, interested in conducting research using human germ cells can legally move forward or not,” said Kleiderman. According to Master, Health Canada could help by offering clarifications to aid in interpreting the law.

So far, scientists have generally responded positively to Kleiderman’s editorial. “From direct interactions that I’ve had, and our group has had with different researchers in the field of stem cell research, they’re eager for this to move forward,” said Kleiderman. A lot of Canadian researchers have gone as far as they can with embryo research to better understand miscarriage and embryo development. “Other countries will be doing that research and as a result, Canada may remain behind,” concluded Kleiderman.