Hope, hype and the case for fertility oversight

Calls for assisted reproductive technology continue to grow as more Canadians delay parenthood, confront infertility or seek greater reproductive choice. For many, fertility treatment offers something invaluable: hope. It can provide options that once did not exist during one of life’s most uncertain experiences.

But Canada’s fertility sector has also become one of the country’s fastest-growing areas of healthcare and one of its least supervised.

Patients are increasingly asked to make complex medical and financial decisions in a system where clinical evidence, commercial incentives and deeply personal aspirations intersect. Information can be inconsistent, treatment options difficult to compare, and expensive tests or add-on procedures are often presented with claims that outpace the underlying science. Persistent inequities in access and growing concerns about adherence to evidence-based medical practice only deepen those concerns.

"Fertility medicine has made extraordinary advances, but the commercial industry surrounding it has grown faster than the framework designed to oversee it,” says Jan Marin, senior associate at Gluckstein Lawyers. “We regulate physicians and their clinical decisions, but there is far less scrutiny of the products, technologies and commercial claims being marketed to patients. The concern isn't innovation. It's that we're increasingly relying on litigation to provide accountability after something has already gone wrong.”

Why is fertility care regulated differently?

As class actions over preimplantation genetic testing move through courts in the United States and Canada, Canadian courts will be asked to make determinations in an evolving area of law. Judges will be asked to address issues that regulation has largely left unresolved. In many respects, litigation is testing whether consumer protection and tort law can fill gaps that health oversight has not.

When Parliament enacted the Assisted Human Reproduction Act in 2004, it envisioned a far more comprehensive national oversight regime. But in Reference re Assisted Human Reproduction Act (2010), the Supreme Court of Canada significantly narrowed the federal government’s authority, finding that many of the Act’s regulatory provisions encroached on provincial jurisdiction over healthcare. Unfortunately, to date, the provinces have not stepped up to fill this gap.

The fragmented approach has consequences. While the federal regime continues to prohibit practices such as human cloning and the commercial sale of reproductive material, responsibility for overseeing clinical practice largely shifted to the provinces. Yet provincial oversight remains uneven and inadequate.

"We need to distinguish between a physician exercising clinical judgment and a company marketing a product,” Marin explains. A doctor may reasonably recommend different treatments for different patients, but when a test is commercially marketed as improving someone's chance of having a child, those claims should be supported by reliable scientific evidence.

“The fact that a product is being sold in a medical setting shouldn't exempt it from meaningful scrutiny.”

In Ontario, for example, fertility clinics are primarily privately operated, embryologists are not subject to mandatory professional licensing, and there is no standardized public reporting that allows patients to compare clinic performance or treatment outcomes.

Wrongful pregnancy claims continue to produce inconsistent outcomes across Canada, with judges differing on whether damages should be limited to pregnancy-related losses or extend to the costs associated with raising a child. While these cases raise difficult questions about reproductive autonomy and negligence, they also illustrate a broader reality: litigation is increasingly being relied upon to resolve issues that clearer regulatory standards might have prevented from arising in the first place.

Innovation has outpaced accountability

Fertility medicine has become increasingly sophisticated, with clinics offering a growing range of tests and technologies aimed at improving treatment outcomes. But the evidence supporting some of those interventions remains the subject of ongoing scientific debate, even as they become more widely available.

Preimplantation genetic testing for aneuploidy (PGT-A) illustrates the point. Designed to identify embryos with abnormalities before transfer, the test is frequently marketed as a way to improve IVF success rates. Yet its routine use for many patients remains the subject of ongoing scientific debate, with professional bodies continuing to refine recommendations as new evidence emerges.

In the U.S. and Canada, class actions allege that patients were misled and encouraged to purchase expensive genetic testing without adequate disclosure of its limitations, leading to embryos being discarded that may have otherwise resulted in healthy pregnancies. While these legal claims have yet to be determined, they have raised questions about whether the commercial representations aligned with the underlying science.

Marin points out that fertility patients are often making extraordinarily difficult decisions under enormous emotional and financial pressure. Many have already experienced years of disappointment, and they may feel that time is running out.

“When they're told that an additional test or procedure could improve their chances of having a baby, it's understandable that they would want to pursue it,” she says. “That makes it all the more important that they're given clear, balanced information about what the science actually supports.”

Oversight should not begin with litigation

None of this suggests that fertility medicine is failing patients or that clinicians are acting in bad faith. The great majority are not. But the current arrangement asks a great deal of individual practitioners and patients while providing neither with the infrastructure that comparable areas of medicine take for granted. Increasing corporate ownership of clinics may also impact patient care.

Unlike many other areas of healthcare, fertility treatment sits at the intersection of medicine and a largely private marketplace. Patients often pay substantial sums out of pocket for testing and treatment, including add-on services that may carry varying levels of clinical evidence. At the same time, there is little standardized public reporting of clinic outcomes, no professional licensing framework for embryologists and no independent body responsible for evaluating how emerging technologies and commercial claims are presented to patients.

"We need to move beyond simply regulating the physicians who provide fertility care; there should be mandatory professional standards for embryologists, meaningful independent oversight of fertility laboratories, and comprehensive reporting of errors and adverse events,” Marin says. “Patients should also have access to reliable information about clinic outcomes and the evidence supporting the additional treatments they're being asked to purchase. None of that should be controversial. These are basic elements of patient protection.”

Innovation should not be slowed nor clinical judgment second-guessed, but patients should be able to make decisions with access to consistent information about outcomes, the strength of the evidence supporting a particular intervention and the limitations of newer technologies. Those are functions regulation is designed to serve long before a dispute reaches the courts.

While negligence claims will always have a role where standards of care fall short, many of the disputes now emerging over embryo testing, informed consent and commercial representations raise broader questions than individual lawsuits can answer.

Courts cannot be expected to establish the consistent standards, transparency and accountability that patients should be able to expect before treatment begins. Litigation, after all, is inherently retrospective: it can provide compensation when someone has suffered a loss, Marin says, but it cannot restore an embryo that has been destroyed or give someone back a lost opportunity to have a child.

“We shouldn't have to wait for patients to suffer harm and pursue lawsuits before identifying problems in the system,” Marin states. “The purpose of effective regulation is to protect patients before those losses occur, not simply provide a remedy afterward.”

This article was produced in partnership with Gluckstein Lawyers