June 2006: Health Canada Delay Endangers Women

Agency to regulate Human Reproduction Act still not set up
June 1, 2006

March 29, 2006 was the second anniversary of the passage into law of Canada’s Assisted Human Reproduction (AHR) Act, an Act marking the culmination of years of hard work by many thoughtful Canadians of diverse perspectives.

What should have been a time for celebration, however, remained instead a time for concern, if not dismay, at the continuing failure of real implementation of this Act. After well over a decade of waiting for legislation that would protect the physical, emotional, and social health of the women and children who use--or result from the use of--the expanding range of reproductive technologies, we are still waiting for the setting up of the Assisted Human Reproduction Agency, the regulations, and the enforcing mechanisms the Act mandates.

When the AHR Act was passed in March 2004, Canada was seen by many as a world leader in woman- and child-centered regulation of reproductive medicine, with many groups in the United States and elsewhere looking here for a model of leadership and principled governance. As time passes, however, Health Canada is increasingly being perceived as having good intentions, but failing in its commitments to the women and children whose health and safety were promised protection. Indeed, many of us who have worked over the last two decades with the federal government toward regulation of reproductive and genetic technologies are concerned that the AHR Act is merely a “paper dragon.” And with the government of Quebec contesting 27 articles in the federal law in court as it pushes for passage of its own legislation, it seems fair to wonder if even this image overestimates current protections for women and children.

Granted that putting in place an operating agency and on-the-ground regulations, as the AHR Act requires, is complex. Granted, too, that negotiating federal/provincial jurisdictions and relationships in the domain of health is complicated. But the slow movement forward from an Act on paper to a functioning program contrasts starkly with the rapid, uncontrolled proliferation of reproductive technologies and their applications in an increasingly commercialized area of medicine, one that some already call an “industry.”

In the face of this delay with regard to both the regulations and the formation of the Agency, and despite applicants for positions on the Agency having been solicited and vetted, we must ask if Health Canada has the necessary resources to permit timely implementation—and if the federal government (present and past) has or had the political will do to so.

Given the rapid dissemination and increased marketing of reproductive and genetic technologies--what Deborah Spar refers to as “The Baby Business” in the title of her recent book about this area--as well as reports of potential violations of the prohibitions in the Act, this extended delay in putting in place the oversight called for by the legislation threatens the health and safety of Canadian women undergoing assisted reproduction and the children who may result.

Advertisements in Canadian college and university newspapers, as well as on Internet websites, continue to recruit young women who will be given potentially harmful drugs, and experience the risks of surgery, to extract their “donated” eggs to be used by physicians in profit-making in vitro fertilization (IVF) programs for wealthy patients. These ads raise the question of whether financial inducements (illegal under the AHR Act) are involved, and what Health Canada is doing about them. Further, the continuing absence of the legislated national monitoring registry that would achieve consistency in quality of care, including prevention of multiple pregnancies and monitoring for subsequent health problems in the children born of these pregnancies and their mothers, remains problematic.

Then, too, there are the persistent pressures from researchers to ease the current limits on what is permissible regarding human embryonic stem cell research, with these also raising serious concerns about the protection of women’s health.

We strongly support citizen input to policy development, which Health Canada has been undertaking in various in-person and on-line activities, but feel just as strongly that calls for consultation should not delay government action.

However, to ensure that consultations are representative of the full range of Canadians and of all the approaches to deal with infertility, we encourage not just workshops in Toronto and elsewhere, but also the inclusion of a public education component in the regulation development process. Only this kind of measure can help prevent the domination of future consultations of Health Canada by those with financial interests in the outcomes and also broaden the health promotion and protection elements the AHR Act should also address.

When it was passed, the AHR Act gave hope to many that a just approach to regulation was at hand. Most knew that the complexities in this area would become no simpler, the debates no less heated nor more easily resolved. And certainly time has shown this to be the case. But most hoped, as we did, that we would have, well before the Act’s second anniversary, regulation, monitoring, evaluation, and enforcement mechanisms with teeth, not merely words on paper.

It is imperative that Health Canada take action to explore what seem to be potential violations of the existing law and also accelerates the speed with which the Assisted Human Reproduction Agency is created and regulations established. It would be unconscionable to have to wait yet another year before we can celebrate more than words on paper.

(Abby Lippman is a professor of epidemiology at McGill University and chair of the board of the Canadian Women’s Health Network. Jeff Nisker, MD, PhD, is a professor of obstetrics-gynecology and coordinator of health ethics and humanities in the Schulich School of Medicine and Dentistry at the University of Western Ontario.)