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by Marcy DarnovskyGenetic Crossroads
October 2nd, 2003

The fate of Canadian legislation that would provide one of the world's most comprehensive regulatory frameworks for assisted reproduction and human embryo research is hanging in the balance as the country's Parliament begins its fall session.

The pending legislation, known as the Human Reproduction Bill, or C-13, is based on an extensive process of feminist advocacy, public consultation, and democratic deliberation going back more than fifteen years. Its key provisions-including bans on human reproductive and research cloning, inheritable genetic modification, commercial surrogacy, and "non-medical" sex selection-enjoy broad public approval, the official backing of major Canadian scientific organizations, and strong support among lawmakers.

But C-13 may nonetheless fail to come to a vote. Its future is uncertain because the right-wing Canadian Alliance and some MPs from the ruling Liberal Party object to the part of the bill that allows regulated research on embryos that were created in the course of fertility procedures. Canadian Prime Minister Jean Chrétien and Health Minister Anne McLellan, themselves Liberals, support C-13. But the Government has been reluctant to bring it to a vote unless its passage is assured, and the "revolt" by the "pro-life Liberal caucus" (as it is described in Canadian media reports) threatens to prevent this. If no Parliamentary vote takes place, C-13 will effectively die. (See Dennis Bueckert, "Speculation growing that anti-cloning bill in Parliament likely to die," http://cnews.canoe.ca/CNEWS/Canada/2003/09/18/196370-cp.html)

On September 25, however, the Toronto Star reported that the democratic socialist New Democratic Party (NDP) had agreed to support C-13, and that this would likely give the Liberal government enough votes to get it through the House of Commons. The NDP had initially opposed the legislation because, among other things, it does not explicitly guarantee that women will make up at least half the members of the regulatory agency that the bill would establish. But after Health Minister McLellan made what NDP MP Judy Wasylycia-Leis called a "personal commitment" to do everything possible to ensure gender parity, the NDP changed its position. (See Valerie Lawton, "Anti-clone bill edges closer to a vote," Toronto Starhttp://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/

From the perspective of the United States, where regulatory oversight of assisted reproduction is minimal and efforts to prohibit even those procedures that are overwhelmingly opposed, such as reproductive cloning, have failed, Bill C-13 appears a remarkable piece of legislation. A number of the practices that C-13 addresses, including cloning, stem cell research, surrogacy, and regulation of the fertility industry, have been the subjects of high-profile media attention here. But the US media have almost completely ignored the legislation. In Canada, C-13 recently has been overshadowed by debate about legalizing same-sex marriage (which the Chrétien government supports), but has nonetheless attracted considerable public attention and debate.

The failure of C-13 would be a setback not just for Canada, but for efforts worldwide to bring reproductive technologies under responsible societal governance. If it is enacted, Canada will become one of the very few countries with a comprehensive approach to the array of existing and emerging reproductive genetic technologies.

Provisions and Principles

Bill C-13 specifies those reproductive and embryo research practices that would be forbidden entirely, and those that would be allowed with regulation. It prohibits research on embryos created solely for the purposes of research, but explicitly allows research involving human embryos that were created in the course of fertility procedures, not used to initiate a pregnancy, and donated according to principles of informed consent.

C-13 prohibits payments for surrogate pregnancies and for embryos and gametes, but allows regulated noncommercial surrogacy, and egg and sperm donation. It also prohibits reproductive cloning, "social" sex selection, inheritable genetic modification, and the production of human-animal chimeras.

Regulated activities would be monitored by a new federal authority, the Assisted Human Reproduction Agency, which would license and oversee fertility clinics and biomedical research that involves human embryos, whether the research is funded publicly or privately.

The legislation explicitly states its core values, which include:

preventing the commercial exploitation of reproduction,

protecting the health and well-being of women and children, and

protecting "human individuality and diversity, and the integrity of the human genome."

Bill C-13 also specifically addresses concerns about discrimination in the provision of reproductive technologies that are judged safe and beneficial: "[P]ersons who seek to undergo AHR [assisted human reproduction] procedures must not be discriminated against, including on the basis of sexual orientation or marital status."

Several commentators have noted that the principles are more than lofty phrases: According to an analysis of the bill by the Parliamentary Research Branch, "Because they are enshrined in a 'statutory declaration' as opposed to a preamble, these principles have greater legal force than if they were set out in a preamble." In other words, according to a new Hastings Center Report, these "guiding principles…. must be taken into account when interpreting or implementing a section of the act or its supplementing regulations." (See http://www.parl.gc.ca/37/2/parlbus/chambus/house/bills/summaries/c13-e.pdf and http://www.thehastingscenter.org/news/features/repro%20supplement.pdf)

C-13's motivating principles, as well as its comprehensiveness, make it an attractive policy model for the growing number of countries moving toward regulation of reproductive and genetic technologies.

History and Political Alignments

The origins of Bill C-13 lie in the work of a feminist alliance that began lobbying for regulation of reproductive technologies in the early- to mid-1980s. In 1989, the government created the Royal Commission on New Reproductive Technologies, which after four years of extensive public hearings and consultations published its recommendations. (For an account of this process by Commission Chair Patricia Baird, see http://www.bioethics.gov/transcripts/jun02/june20session1.html)

Two previous attempts to pass legislation based on the Commission's recommendations have failed in recent years. Bill C-13 attempts to resolve the dissatisfactions that doomed those efforts. For reasons connected in part to Prime Minister Chrétien's announced retirement, Bill C-13 must be passed soon, or probably not at all. Given this political reality, most of the groups and individuals with remaining reservations about the bill have decided that it is nonetheless crucial that it be passed.

The debate about Bill C-13 demonstrates some sharp differences between the Canadian and US political contexts. Perhaps most striking is that in spite of its prohibition of embryo cloning, C-13 is supported by major Canadian scientific and research bodies, and by patient advocacy organizations that champion embryonic stem cell research. Among the groups that have decided that the line C-13 draws is a reasonable and responsible one are Canadian Institutes for Health Research (the country's primary funding agency for medical research), Stem Cell Network (a government-funded association of 65 stem cell researchers), ALS Society of Canada, Muscular Dystrophy Association of Canada, Diabetes Research Foundation, and Parkinson Society Canada.

Canadian Feminists and Women's Health Advocates

Canadian feminists and women's health advocates are currently mounting a strong effort to pressure lawmakers to adopt C-13. Yet while they support the bill's guiding principles, its key prohibitions, and the main thrust of its regulatory approach, they have also voiced serious reservations about some provisions that they consider too weak, and pointed out components that are missing entirely.

One area of their concern is the make-up and functioning of the regulatory agency that the bill will establish. In addition to their insistence on gender parity on the agency's board, NDP and feminist commentators have raised concerns that the legislation's conflict-of-interest clauses are not explicit about disallowing representation by biotech and pharmaceutical companies.

A recent article by Abby Lippman, co-chair of the Canadian Women's Health Network, and Diane Allen, executive director of The Infertility Network, calls for a strong regulatory body "empowered to make additions to the current list of prohibited activities and to ensure that if there is no long-term information on a practice, it will be regulated as research." Lippman and Allen urge the regulatory agency to take on an active public education function: "We need mechanisms to address the questions raised by these technologies that insure public consultation, accountability, transparency, safety, and justice in their development, evaluation, and use." (See Abby Lippman and Diane Allen, "Time to Fill the Legal and Ethical Vacuum on Stem-Cell Research," The Hill Times, archived at http://www.stemcellnetwork.ca/news/articles.php?id=281)

Lippman and Allen also call for the regulatory agency to "scrupulously avoid discrimination against those with disabilities of any kind, before or after birth," and to "adhere to the precautionary principle." In a statement to a parliamentary Health Committee, Lippman linked the precautionary principle to preventative health care. She recommended an increased focus on the causes of infertility, including sexually transmitted diseases and social structures that make it difficult for women to have children "when they want, not when career advancement demands based on men's biographies require."

Lippman and Allen are particularly concerned about the commercialization of human reproduction and the risks this poses for the exploitation of women. "Assisted reproduction, and the genetic technologies that support it, constitute areas in which commercial forces increasingly rule," they write. "Too frequently, infertility is seen as a `business' and not as the social concern it really is. C-13 is an important first step to prohibit activities and practices that distress Canadians."

Their conclusion, which echoes that of Canadians of diverse political views, is this: "Bill C-13 is not perfect; no bill in this area could possibly be.... [But t]he women of this country have waited far too long for this bill. It is time to act on the regulation of reproductive and genetic technologies. Bill C-13 is a step in this direction, and we urge all Members of Parliament to pass this legislation."


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