Fertility clinics need improved oversight
The journey of infertility is emotional and our regulatory system in Ontario makes it worse. This industry’s growth has outpaced the development of fitting legislative action.
Ontario is exercising a laissezfaire approach in regard to fertility clinics with very limited oversight on their operations. They’re essentially being treated as private businesses rather than health care providers. Consequently, clinics are operating in a regulatory blind-spot starting from when they obtain patient consent, through the handling and storage of genetic material and extending beyond.
This is causing tangible harm. Consider the notorious Barwin case, where an Ontario fertility doctor intentionally inseminated women with the wrong sperm, including his own. The class action involved over 200 plaintiffs and settled for $13.3 million, a sum not paid by Barwin but rather by the Canadian Medical Protective Association (CMPA). The CMPA is funded by doctors, then doctors are reimbursed by the province. Essentially, Ontario taxpayers end up paying for Barwin’s actions.
Let’s go back to the beginning. The Assisted Human Reproduction Act was Canada’s first attempt at regulating fertility treatments, but it lost its effect when multiple sections were declared unconstitutional, thereby transferring the duty of regulation to provinces.
The conversation gets interesting when discussing private fertility clinics as they operate in this regulatory void. They often escape rigorous scrutiny, subject only to a program that audits procedures using anesthesia. Thus, treatments not involving anesthesia face even less regulation.
Truthfully, the industry has been commercialized. Private clinics have the freedom to slap on hefty price tags on procedures. A single IVF cycle will cost between $9,000 to $15,000 and the medication required will range between $5,000 and $15,000.
Fertility clinics have now standardized “add-on” procedures, such as intracytoplasmic sperm injection (ICSI), adding approximately $3,000 to the treatment. ICSI’s efficacy and necessity are not nearly as well studied as they should be, yet it’s frequently recommended, thereby raising costs without guaranteed improvement in outcomes. OHIP covers one cycle of IVF; however, generally, one cycle is not enough.
Additionally, in order to receive informed consent, doctors must disclose to patients the risks, benefits, and alternatives associated with any treatment. But how can fertility doctors obtain true informed consent for procedures like ICSI when doctors themselves lack comprehensive knowledge of the risks and benefits, given the procedure is not well studied?
The repercussions of these regulatory shortcomings aren’t just about money; the emotional and mental toll on patients when treatments fail can be brutal. Even more so when these issues could have been prevented or stem from unethical practices.
To illustrate, I recently worked on a case where clients informed my superior that the fertility clinic they had been patients at had simply lost their embryos. As we spoke about the potential legal avenues to pursue, we asked ourselves, “how do we even begin legal proceedings for this issue?”
The sad reality is that stories of mix-ups with genetic material or losing embryos due to equipment failures are common. A stark example came about in 2018 where a woman in Toronto lost 65 frozen eggs due to the malfunction of a cryogenic storage tank. Such incidents would be significantly less common if the industry was stringently regulated.
The current state of this industry is treating private for-profit clinics as a “buyer beware” situation. The Assisted Human Reproduction Act must undergo amendments to rectify existing deficiencies.
We need to introduce mandatory licensing enforced by a new regulatory body overseeing staff qualifications and operational standards, alongside transparent disclosure of success rates, safety data and adverse events for industry accountability and transparency. Ontario must adopt legislation to protect and empower patients.