Canada Passes Cloning Law
Rules are part of reproductive technology act that some say leaves confusion
By Doug Payne

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.

Links for this article:

House of Commons of Canada, Bill C-6: An Act Respecting Assisted Human Reproduction and Related Research, February 11,
2004.
http://www.parl.gc.ca/PDF/37/3/parlbus/chambus/house/bills/gove rnment/C-6_3.pdf

Ronald G. Worton
http://www.ohri.ca/profiles/worton.asp

Stem Cell Network
http://www.stemcellnetwork.ca/index.en.php

“Research involving the use of the in vitro human embryo,” Canadian Institutes of Health Research press release, March
2004.
http://www.hc-sc.gc.ca/english/media/releases/2004/2004_10bk3.h tm

Stem Cell Oversight Committee
http://www.cihr-irsc.gc.ca/e/about/19312.shtml

“Information: The Assisted Human Reproduction Agency of Canada,” Canadian Institutes of Health Research press release,
March 2004.
http://www.hc-sc.gc.ca/english/media/releases/2004/2004_10bk1.h tm

“Human pluripotent stem cell research: Guidelines for CIHR-funded research,” Canadian Institutes of Health Research,
March 4, 2002.
http://www.cihr-irsc.gc.ca/e/publications/1487.shtml

Francoise Baylis
http://bioethics.medicine.dal.ca/WhoWeAre/Baylis.htm

F. Baylis et al., “Cryopreserved human embryos in Canada and their availability for research,” Journal of Obstetrics
and Gynaecology Canada, 25:1026-1031, December 2003.
[PubMed Abstract]
http://www.biomedcentral.com/pubmed/14663537

SOURCE: BioMed Central
http://www.biomedcentral.com/news/20040316/03

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