The safety regulations covering fertility clinics and sperm and egg banks must be more rigorous, with regular inspections and enforcement mechanisms.

The much-maligned, often-studied Assisted Human Reproduction Act is a sweeping piece of legislation that governs the regulation of reproductive technologies and embryo research in Canada. Although it was passed in 2004, regulatory inertia and battles over jurisdiction have meant that very few of its provisions have come into force. That may soon change, but not enough to adequately protect the health and safety of Canadian families.

After the 2015 election of Prime Minister Justin Trudeau’s government, Health Canada announced its intention to fill this regulatory void and, following several more years of drafts and consultations, regulations are expected to come into force in the near future. However, the regulations apply only within Canada, even though assisted reproduction is increasingly transnational. Bodies and tissues move between countries in ways that require coordination and a regulatory regime that more substantially recognizes that the safety of gametes (sperm cells and eggs) does not end at the border.

Intended parents in Canada have long sought, and continue to seek, assisted reproductive services abroad for many reasons, including lower costs in certain jurisdictions, marketing of high success rates by some international clinics, and relatively relaxed legislative regimes (although some countries where Canadians have travelled for surrogacy, such as India, Thailand, and Mexico, have recently become more restrictive). As well, the movement of people and gametes occurs in both directions, as foreign intended parents increasingly view Canada as a surrogacy “destination.”

Sperm and eggs, however, tend to move north from the United States to Canada. Much of the sperm used by Canadian intended parents originates in the US, a function of the rigorous testing standards for Canadian sperm and sperm donors, which makes the cost of collecting and processing sperm in Canada relatively high. Frozen eggs are also imported into Canada, as economies of scale enable large American egg banks to provide catalogues full of images of young egg providers from whom Canadian intended parents can choose. The so-called “shortage” of Canadian gamete donors may be a problem in and of itself, but in the meantime, as Canada strives for self-sufficiency in the provision of eggs and sperm, importation of gametes from foreign donors continues and must meet rigorous safety standards.

To rely on Canadian sperm and egg banks and fertility clinics to self-monitor and self-report errors is optimistic, given the history of failures in self-regulation.

Health Canada’s new regulations aim to improve how sperm and eggs from donors are screened for safety before use. According to  the impact analysis that accompanied the draft regulations, Health Canada intends to “place the most regulatory oversight and administrative burden” on those responsible for the activities that involve the biggest health risk: the commercial sperm and egg banks that provide the sperm and eggs to fertility clinics.

In some ways, this approach makes sense. Significant concerns have been raised about the safety of sperm and eggs used in Canada. Our already strict regulations on sperm were implemented following cases in the late 1990s of chlamydia and HIV contracted from semen samples that were inadequately tested and quarantined. More recently, in 2015 the records of a sperm donor were proven to be fraudulent. As a result, at least 36 children known to be conceived with his sperm may have a higher risk of mental health disorders than their parents anticipated. Canada’s new regulations aim to address these concerns at the source, to ensure that the safety of sperm and eggs will be addressed prior to arriving in fertility clinics.

While its goals are sound, the proposed regulatory regime does not go far enough, focusing on the top of an international supply chain over which it has little control. Health Canada does recognize that donor sperm and eggs used in Canada largely come from processors in the US and aims to address longstanding concerns that the federal government has had to work through Canadian importers to influence the actions of foreign processors. The new regulations suggest that Canadian companies importing gametes are responsible for ensuring that these sperm or eggs are “processed in accordance with the regulations.”

Yet it is unclear how fertility clinics and processors are expected to prove compliance, beyond signing paperwork to that effect. There are no clear mechanisms that would trigger legislative safeguards (apart from failure to file the annual attestation) and, while stronger measures to protect the health and safety of Canadians using assisted reproductive services are on the books, under the new regulations these measures remain very difficult to use.

Allowing the fertility industry to self-regulate has, to date, not adequately protected the health and safety of gametes in Canada. Further, given that Health Canada has made clear that its reading of the Assisted Human Reproduction Act does not include extraterritorial application (and has budgeted for only “four inspectors, one regulatory compliance and enforcement advisor and a registration officer” to oversee all aspects of the legislation), it is unlikely that inspections of international sperm and egg banks or processors can or will occur.

Improving safety is still possible. Health Canada could impose more rigorous safety requirements on individual fertility clinics, with regular inspections and clear enforcement mechanisms; although, given the combined resistance of the fertility industry and historic struggles over federal-provincial jurisdiction, the federal government seems to be reluctant to do so.

Alternatively, Health Canada could create a rigorous international approach to inspections, or go beyond attestation to demand proof of the safety of gametes by requiring “all establishments that process, import, or distribute donor sperm or ova [eggs]” to register with Health Canada. This approach had been considered but rejected because of the perceived administrative costs to fertility clinics. If Health Canada is committed to the health and safety of sperm and eggs, it is imperative that these regulations be strengthened and clarified.

The new regulatory regime is still a much-needed improvement over the status quo. The use of reproductive technologies has changed substantially since the Assisted Human Reproduction Act was passed in 2004, and the new regulations will allow Health Canada to address some of these changes. These include guidelines for the reimbursement of expenses to surrogates and gamete donors; and clearing up longstanding confusion about the limits of the law, as more and more Canadians engage with surrogates and/or gamete donors to build their families. Further, the new regime includes long-awaited federal regulations governing eggs, which will improve safety. (Until this round of regulations, the health and safety of eggs were not included in the legislation.)

However, we are concerned that the regulations lack sufficient regularized inspections and clear enforcement mechanisms to ensure that imported gametes comply with the regulations. Reliance on Canadian sperm and egg banks, and on fertility clinics, to self-monitor and self-report errors is overly optimistic, given the history of failures in self-regulation. The health and safety of Canadian families is at stake.

This article is part of the Addressing the Gaps in Canada’s Assisted Reproduction Policy special feature.

Photo: Shutterstock by Nonnakrit


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