Rules are part of reproductive technology act that some say leaves confusion
March 16, 2004
The Canadian Parliament on Friday (March 12) passed legislation permitting research on stem cells from embryos under specific conditions. The law bans human cloning and prohibits the sale of sperm and payments to egg donors and surrogate mothers. Because of overlaps with existing regulations and potential delays in implementing parts of the new law, however, researchers say there is an element of confusion as to exactly what research can be undertaken, by whom and when.
Bill C-6: An Act Respecting Assisted Human Reproduction and Related Research still requires Royal Assent, expected within a matter of weeks. After that, it is unclear when the provisions will come into force.
The new law will affect postdocs considering getting into the field and “may apply to existing researchers as well,” according to Ron Worton, the chief executive officer and scientific director of Molecular Medicine at the Ottawa Health Research Institute and scientific director of the Stem Cell Network.
The government makes clear in a release accompanying the passage of C-6 by the Senate that “by no means does the [assisted human reproduction] legislation promote embryo research.” The intention, it says, is to ensure that embryonic research is carefully regulated.
The legislation does not address research involving existing derived embryonic cell lines, simply because Canadian scientists have not yet derived lines of their own. There is separate legislation already in place that deals with importation of existing cell lines being used across the country. Stem cell research is, and may continue to be, addressed by existing oversight mechanisms such as the Canadian Institutes of Health Research (CIHR) and its Stem Cell Oversight Committee. The new legislation does make clear, however, that “an embryo cannot be specifically created for research purposes.”
The legislation also establishes an agency, the Assisted Human Reproduction Agency of Canada, to be separate from Health Canada but reporting to Parliament through the Minister of Health, to oversee licenses for assisted human reproduction procedures or research using in vitro embryos and to ensure peer and ethics review of any proposed project. The agency cannot issue a license for embryonic stem cell research aimed at deriving new lines unless it receives the written consent of the original gamete providers and the embryo provider, in accordance with the CIHR's March 2002 Human Pluripotent Stem Cell Research Guidelines.
Francine Manseau, a senior Health Canada policy analyst, said in a broadcast interview over the weekend that the new agency wouldn't be created for another few years. In the meantime, Manseau said, police would be responsible for enforcing the law.
“I would have expected 6 months to a year,” said Worton, “but nothing that long. The legislation is supposed to be enabling, not disabling. If they don't set it up, then the regulated activities become banned activities.”
Worton suggested that the rule of thumb to be applied is that the new legislation is concerned with embryos and “once embryonic stem cells are taken, this law won't generally apply; the CIHR guidelines will click in.”
“What we have,” according to Francoise Baylis, professor of medicine and philosophy in the departments of bioethics and philosophy at Dalhousie University in Halifax, “is like a Zen circle. We have two attempts at regulation—CIHR and the new legislation—and there's an area of overlap. But one whole part of the circle, to do with stem cells, is outside the part of the circle which deals with assisted human reproduction.”
The new legislation includes a grandfather clause that exempts from the licensing requirements anyone who has performed stem cell research in the year before the laws come into force. “Some people have done some experiments just to be able to say that they've undertaken the work,” Worton told The Scientist.
“What this should mean for scientists,” Baylis told The Scientist, “is that anybody doing this work in the private sector [or funded by a medical charity but not connected with a university or other publicly funded body] could be creating, or have been creating, stem cell lines up until the act comes into force, and that would be perfectly legal. In the public sector, that research has been covered since 2002 by the CIHR guidelines. And, if the Stem Cell Oversight Committee—which met for the first time in January—approves any projects, then that work too should be able to be grandfathered.”
As a result, added Worton, “[potentially], it's a tight window [of opportunity] if the legislation becomes law and comes into force too quickly.”
The actual application of the law could be quite limited. According
to a study headed by Baylis that appeared in December 2003 in the Journal
of Obstetrics and Gynaecology Canada, although there are thousands of frozen
embryos in storage at infertility clinics across the country, only about
2% have been donated for research. Baylis said that the available embryos
would provide raw material for as few as seven and no more than 36 stem
cell lines of the kind needed for research.
Copyright © 2004, The Scientist Inc.