The 2016 class action lawsuit filed against former fertility specialist Dr. Norman Barwin represents at least 50 individuals conceived via artificial insemination at his Ottawa- based clinic.

Their common feature — none were conceived with the sperm samples their parents had intended to be used — whether from the fathers who raised them or from selected donors.

Shockingly, at least 11 children were conceived with Dr. Barwin’s own sperm. Others, children of unknown sperm, do not know the identities of their true biological fathers and are left with potentially unanswerable questions about their lineage and medical histories.

But this legal action against Dr. Barwin, though awaiting court certification, is not the first of its kind. Individual lawsuits filed in 1995, 2009 and 2010 alleging sperm mix-ups were quietly settled out of court.

All that time, Dr. Barwin continued to conduct procedures in Ottawa — until 2012 — when he voluntarily stopped performing fertility treatments in the aftermath of media attention from two of those lawsuits.

It took until 2013 for the Ontario College of Physicians and Surgeons to sanction Dr. Barwin for sperm mix-ups — suspending his license for two months.

After more than 40 years of practising medicine in Canada, Dr. Barwin quit the profession altogether in 2014.

So how was this fertility doctor, with a history of lawsuits, able to continue to practice, free of prosecution or significant repercussions?

The answer may lie in the fact there was a confusing hodgepodge of laws and guidelines that continue to pass as a regulatory framework for fertility issues in Canada.

Since 1996, Health Canada has been authorized under the Food and Drugs Act to inspect establishments that distribute semen for assisted conception. Primarily, this is to help minimize the risk of disease transmission. A search of Health Canada’s database indicates 144 such inspections since 2012.

Hopes for nationally regulated oversight surrounding fertility issues were dashed in 2010 when the Supreme Court of Canada struck down, on constitutional grounds, most of the Assisted Human Reproduction (AHR) Act.

That Act had been passed in 2004, with a system of guidelines including rules for the licensing, monitoring and inspection of clinics. The Assisted Human Reproduction Canada agency, tasked with enforcing the Act, was rendered obsolete by the Court’s decision.

Though Health Canada has taken over responsibility for the remaining federal functions related to fertility treatment, each province and territory has since been individually tasked with regulating, accrediting, licensing and inspecting clinics and physicians.

In Quebec, provincial law now governs all clinical and research activities related to assisted reproduction. And in other jurisdictions like Alberta, British Columbia and Ontario — where Dr. Barwin practiced — provincial responsibility has been assigned to each of those province’s Colleges of Physicians and Surgeons.

But in its 2015 report on assisted reproduction in Canada, the Canadian Medical Association stated that there was a “need for the elaboration of national” ethical and legal standards. Though the CMA’s report supported provincial and territorial jurisdiction, it did suggest that treatment and standards of care have been inconsistent from province to province.

The good news is that the regulatory landscape appears to be changing.

Health Canada has announced plans to bring in rules that would ensure sperm and ova intended for the use in assisted human reproduction are obtained, prepared, preserved, quarantined, identified, labelled and stored properly, and that their quality is assessed. Other regulations will support administration and enforcement of these standards. Though those rules are still forthcoming, draft regulations are anticipated this fall.

In Ontario, the College of Physicians and Surgeons has also proposed an amendment to the Out-of-Hospital Premises Inspection Program that would allow inspections of premises that perform in-vitro fertilization and artificial insemination.

And, in September 2017, the Ontario government passed omnibus Health Bill 160 to streamline oversight for health facilities — but these laws are still not in force.

Many of those in the class-action lawsuit against Dr. Barwin have spoken out about the need for stricter controls of how fertility clinics operate. Some have raised the prospect of criminal charges.

W5 approached both the Ottawa Police and the Office of the Attorney General to determine whether Dr. Barwin had ever been charged or investigated for criminal acts like assault or fraud.

Ottawa police say no formal complaints have been made against Dr. Barwin and the Office of the Attorney General had no record of any criminal proceedings against him.

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