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Canada: The Assisted Human Reproduction Act

Canadian Parliament Approves the "Assisted Human Reproduction Act," A Model of Responsible Policy

Canada's new Assisted Human Reproduction Act (AHRA) is one of the most significant pieces of legislation addressing human genetic and reproductive technologies enacted to date. Many Canadian constituencies played key roles in building consensus for the AHRA, notably including the women's health community. Canada now joins the United Kingdom, Germany and Australia as countries that have adopted comprehensive, responsible policies addressing human genetic and reproductive technologies. These policies embody differing social and political values but agree on core principles. Successful passage of the AHRA stands in stark contrast to the situation in the United States, where these issues have become entangled with the politics of abortion, the "culture wars," and the Presidential election.

Introduction

Provisions of the Assisted Human Reproduction Act

Wider Context: A Menu of Policy Models

Comparative Politics: Canada and the United States

What You Can Do

Introduction

On March 11, 2004, the Canadian Senate approved the Assisted Human Reproduction Act (AHRA), one of the most significant pieces of legislation addressing human genetic and reproductive technologies enacted to date. The legislation was earlier approved by the House of Commons and will become law shortly.

The new legislation draws clear lines prohibiting unacceptable applications of new human genetic and reproductive technologies while allowing beneficial applications to proceed in a socially accountable manner.

Successful passage of the AHRA is a tribute to the hard work and political sophistication of key constituencies, and to Canada's tradition of consensus politics. Canadian feminists supported the measure's core values of protecting the health and well-being of women and children, and preventing the commercial exploitation of reproduction. Supporters of embryonic stem cell research recognized that if they were to receive public funding they needed to work within a publicly acceptable framework. Although key anti-abortion groups opposed the AHRA, other groups usually associated with anti-choice positions, including the Canadian Conference of Catholic Bishops, explicitly declined to oppose the measure.

Provisions of the Assisted Human Reproduction Act

The AHRA distinguishes between practices that are prohibited and those that are permitted but regulated. The prohibited practices include:

The creation of human embryos solely for research;

germline engineering (i.e., inheritable genetic modification);

the creation of human/non-human hybrids and chimeras;

all use of somatic cell nuclear transfer (cloning), whether for research or reproduction;

sex selection except to prevent, diagnose or treat a sex-linked disorder or disease;

commercial surrogate motherhood contracts and the sale of sperm, eggs and embryos.

Research involving human embryos, including embryonic stem cell research, is permitted, using embryos created but not used during in vitro fertilization procedures. The AHRA establishes the Assisted Human Reproduction Agency of Canada (AHRAC) to develop and oversee regulations covering these and other permitted activities. The AHRAC is to license and monitor all private and public fertility clinics, research facilities and other institutions whose research or commercial activity involves human gametes or embryos.

The AHRAC will be governed by a 13-member Board and chief executive officer, both appointed by the federal Cabinet and operating within the Ministry of Health. Board members serve 3-year terms. Senators voting for the bill recommended that at least 50% of the members be women.

Portions of the new law are still contested. Some organizations representing infertile couples and fertility clinic physicians objected to the ban on payments (beyond reasonable expenses incurred by donors) for women's eggs. Some disability rights leaders called for tighter restrictions on pre-implantation genetic testing, to avoid promoting a medical model of disability in place of a more inclusive social model. Some scientists argued that criminal sanctions for the measure's prohibited activities are excessive. Some pro-life groups want to extend the prohibitions to include all embryo research.

The AHRA provides for a legislative review after three years. This provision enabled many who were not completely satisfied with the measure to support it nonetheless.

There is no reason to expect that passage of the AHRA means the end of controversy over human genetic and reproductive technologies in Canada. But the measure considerably narrows the range of controversies and establishes a democratically accountable structure for addressing them.

Wider Context: A Menu of Policy Models

Many in the United States and elsewhere are skeptical that comprehensive policies to govern human genetic and reproductive technologies can be developed, given the wide range of conflicting positions held by engaged constituencies. But legislation adopted in the United Kingdom, Germany, Australia, and now Canada shows that this skepticism is premature. Policies adopted in these countries embody differing social and political values but agree on core principles.

In general, German policies are more restrictive, British policies are more permissive, and Australian and Canadian policies are in-between. [1]

German laws ban a wide range of activities involving human genes, gametes or embryos. As a consequence no regulatory bodies were needed to oversee these activities.

The British law established a Human Fertilization and Embryological Authority (HFEA), whose 18-member Board decides what is permitted and what is not. The HFEA requires that private and public institutions working with human gametes and embryos be licensed, and can suspend or revoke the license of non-complying institutions.

The Australian and Canadian laws legislatively ban a number of widely condemned activities, leaving a more limited but still significant set of issues open for further consideration by regulatory bodies. The Australian regulatory body is the National Health and Medical Research Council Licensing Committee and the Canadian body, as noted, will be the Assisted Human Reproduction Agency of Canada (AHRAC).

The different ways in which the four sets of policies have addressed the issue of research cloning is instructive. The German law prohibits research cloning. The United Kingdom's HFEA has agreed to entertain specific research cloning proposals. These require public hearings, and any approved research would be subject to regulatory oversight. The Australian law established a three-year moratorium on research cloning. The new Canadian law prohibits research cloning, but this provision, along with the rest of the law, will be subject to review after three years.

In contrast, consider the "wild west" regulatory environment in the United States. In 1999 the University of California at San Francisco began secret experiments to clone human embryos, and did not acknowledge this until 2002 when reporters using the California Public Information Act forced disclosure of lab reports. In 2000 Advanced Cell Technologies in Massachusetts began creating clonal embryos under wraps of corporate secrecy, with no prior review except by an internal "ethics advisory board" known in advance to support research cloning. In 2001 the Jones Institute for Reproductive Medicine in Virginia broke a widely-observed ethical restraint and harvested 162 eggs from 12 women to create 40 viable embryos to be used exclusively for research purposes, again without going through any process of public review and approval.

The important point is that the United Kingdom, Germany, Australia and now Canada all have laws on the books that prohibit unacceptable activities, require public oversight of acceptable activities, and establish socially accountable structures for revising policies or setting new ones. Nothing of this sort exists in the United States, or in most other countries, at this time.

Comparative Politics: Canada and the United States

In the United States the development of policy on human genetic and reproductive technologies has become deeply entangled with the politics of abortion, the "culture wars," and the Presidential election. Creative political work will be needed to prevent this situation from further distorting the development of needed policies.

Several factors have allowed Canadians holding different opinions about genetic technologies to agree on a legislative package, while their counterparts in the U.S. have been at loggerheads.

Abortion rights and access to abortion services are not hotly contested issues in Canada. As a consequence, policies concerning embryo research, cloning and related topics can be evaluated more easily on their own merits rather than with regard to their bearing on abortion politics.

The Canadian Institutes of Health Research (CIHR) and other bodies provide public funding for human embryo research. The existence of this support makes it easier for biomedical researchers to accept public oversight and control.

A third factor is simply the greater sense of social solidarity among Canadians, whose culture wars are often fought with styrofoam bats rather than with sharpened knives.

Also important is the fact that Canadians have been discussing the need for assisted reproduction policies since the early 1990's, when the Canadian Royal Commission on New Reproductive Technologies launched an ambitious series of public meetings and hearings that involved thousands of Canadians from all walks of life.

The situation in the U.S., by contrast, is highly polarized. The major constituencies politically active on these issues - the religious conservatives who want bans on all embryo research and the biotech/biomedical researchers who want a free hand to do pretty much whatever they wish - are sharply opposed. Although surveys suggest that Americans prefer a middle position, one that supports embryo research but wants it subject to strong social controls, at present this position does not have an organized constituency advocating for it.

In the absence of any effective countervailing forces, the biotech and biomedical interests are using this political moment to secure unprecedented corporate and professional control over the development and commercialization of human genetic and reproductive technologies. All-out efforts are underway in key states, including California, New York, New Jersey and Massachusetts, to legislatively affirm the acceptability of such research, secure public funding, and minimize public oversight.

The most troubling of these initiatives is the effort by stem cell researchers and patient advocates in California to put an initiative on the November ballot committing Californians to spend $3 billion on stem cell research, financed through taxpayer-supported bonds. The initiative would amend the state constitution to include a "right to conduct stem cell research," and vest control over these enormous funds in an independent Institute comprised largely of representatives of research institutions and patient advocacy groups. The leaders of the initiative are reportedly planning to raise $20 million for television ads and other campaign activities.

The problem here is not the fact that stem cell research is being supported and funded - we believe it should be - but that the initiative represents a move by wealthy interests to manipulate a compassionate public into supporting an earmarked fund for stem cell researchers far larger than any deliberative process of medical research priority-setting would allow. The initiative goes on to explicitly establish barriers to any effective public oversight of the use of these funds. This is precisely the opposite of what any responsible regulatory structure should be designed to do.

The U.S. Presidential campaign has the potential to exacerbate this perverse situation. In reaction to Republican calls for prohibitions on embryo research, some Democrats are responding by advocating not only that such technologies not be restricted but that they be given special dispensation from regulatory control. Under the polarizing pressures of partisan conflict, Democrats could find themselves unwittingly endorsing policies that further the corporate control of biomedical research and that open the door to an era of free-market eugenics.

What You Can Do

The Canadian Assisted Human Reproduction Act and the work of Canadian women's health leaders and others to ensure its passage demonstrate that effective social governance of reproductive and genetic technologies can be secured. All of us involved with professional or advocacy work in these areas can point to this hopeful development in the course of our academic, policy, communication and organizing efforts.

CGS is in touch with Canadian policy and activist leaders who were active in the campaign for passage of the AHRA and who are interested in meeting or talking with those interested in learning more about this legislation and the effort to get it approved. Please let us know if you would like to contact them.

Footnote

1. The British law is the 1991 Human Fertility and Embryological Act, the German law is the 1991 Embryo Protection Act (Embryonenschutzgesetz, or EmS), the Australian policies are specified in the 2003 Prohibition of Human Cloning Act and the 2002 Research Involving Human Embryos Act, and the Canadian law, as noted, is the 2004 Assisted Human Reproduction Act. In addition, thirty-one countries have signed the Council of Europe's 1997 Convention on Biomedicine and Human Rights, which commits them to policies concerning embryo research, cloning and genetic alteration roughly similar to those found in the Canadian legislation. It is important to note that none of these laws restrict access to abortion services. See the Resources section of this report for more information on these policies.


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