Health Minister Allan Rock has unveiled legislation that would prohibit the cloning of humans in Canada, but some think it will be outdated before it becomes law in 2003. And others question whether criminal law is even the right way to approach the issue.
“This area is moving so quickly that before this bill is passed there'll be some new issue that we wish was covered,” says Tim Caulfield, research director at the University of Alberta's Health Law Institute.
Caulfield sat on the advisory group that drafted the Canadian Institutes of Health Research principles that until now have guided research in these areas. Rock's legislation has adopted many of those principles, but instead of placing moratoriums on human cloning and creating embryos for research purposes it would ban these and 10 other practices (see sidebar), and make offences punishable under the Criminal Code.
Rock also wants a new national regulatory body — he favours a stand-alone agency — to license the research and govern the use of assisted human reproduction activities. “This isn't legislation like any other,” Rock said, “and these are not issues like any other. These involve a human and an ethical dimension that surpasses technical or scientific matters.”
After public hearings this fall, an all-party committee has until January 2002 to make recommendations. Passage through Parliament should then take a year, and it will take an additional year before a new body to oversee the regulations is operational. The delays have prompted criticism from those who remember the fate of the Royal Commission on Reproductive Technologies, which called for strict regulations in 1993.
“It's very important that this move as fast as possible,” says Dr. Janet Rossant, a senior scientist at Toronto's Mount Sinai Hospital who conducts stem-cell research using mice. “It's been much too long, and we need [legislation] for everybody's protection.”
Dr. Jeffrey Nisker, who cochaired the committee that advised Rock on the legislation, says the chance of human cloning taking place in Canada in the near future is slight. “We have canvassed all the labs and people are saying they are not doing it,” says Nisker, a professor of obstetrics at the University of Western Ontario. “I don't think it will ever happen in Canada.”
But the lack of regulation for reproductive technologies means that Canadians have no way of knowing what is happening in private laboratories, Nisker acknowledged.
Canada's first animal clones were produced in 1999, when Montreal-based Nexia Biotechnologies announced that it had cloned triplet goats using the “Dolly technique.” That famous ewe was cloned by British scientists in 1997 using somatic cell nuclear transfer.
But there's a big difference between successfully cloning animals and cloning humans, says Nisker. “There's so much we don't know that cloning human beings at this time is inappropriate.”
And Dr. Kathleen Glass, director of bioethics at McGill University, says there is no reason to clone humans when there are many other ways for people to have children. Rock agrees. “Do we really need human cloning?” he said. “I would think not.” His draft proposals state that human cloning “would be banned because it treats human beings as though they were objects and does not respect individuality.”
However, Caulfield says an urgent need to clone human organs for transplantation purposes may eventually arise, and he worries that the criminal law is too cumbersome a tool to allow for changes like this. “Criminal law is our most permanent, the bluntest instrument that any government has,” Caulfield says.
He prefers a regulatory framework that imposes moratoriums, which could be lifted if science evolves to a point where practices now prohibited become justifiable. “The Brits have already accepted the argument for embryo cloning for research purposes. They've said that they will consider applications. France is considering amending its legislation.”
Rossant is adamant that any regulatory body be independent. She cites the success of Britain's Human Fertilisation and Embryology Authority (1991), which licenses and monitors clinics there. “That has turned out to be a pretty successful way of doing things,” says Rossant. “But it's only as good as the powers that it has and its arm's-length independence from any form of interference by either government, private clinics, university researchers, anybody.”
The British example also reinforces the concerns of those who believe legislation is too restrictive. The original British law permitted embryo research into the causes of birth defects, identifying new targets for contraception and infertility studies. However, it did not mention the use of spare embryos to treat Parkinson's and other degenerative diseases, says Dr. Roger Gosden, research director in the Department of Obstetrics and Gynecology at Montreal's Royal Victoria Hospital. Last December, the UK legislation was amended to permit researchers to use early-stage cloned embryos to create stems cells for research in these areas.
As debate surrounding this legislation begins, no one is speaking out against the general idea of regulation. What is being debated, however, are the form the regulatory body will take, and which practices it will prohibit and which it will merely control.
“The scientific community and medical communities in general have historically self-regulated, and there's always that reluctance to give that up,” says Glass. “But when you have issues that have wide social repercussions and impact, and that people have spiritual and moral questions about, I think it's a good thing to move it into the regulatory area.”