Disgraced fertility doctor's clinic broke federal rules as far back as 1999, inspection reports reveal
Class action against Norman Barwin now claims 77 children conceived using the wrong sperm or his own sperm
Federal inspections of the clinic run by the now-disgraced fertility doctor Norman Barwin found "troubling" problems with the clinic dating back to 1999, raising concerns about whether the oversight system is failing to protect Canadian patients.
Barwin's medical licence was revoked in June by the College of Physicians and Surgeons of Ontario, after determining he had used his own sperm or the wrong sperm in helping families conceive more than 70 children at his clinic since he began offering fertility services in the 1970s.
Health Canada is responsible for inspecting the safety of donor eggs and sperm.
Health Canada inspection records obtained through an Access to Information request suggest Barwin's clinic repeatedly violated federal regulations including the mishandling of donor sperm, missing sperm, missing proof of safety checks, mislabelling and missing patient consent forms.
1999 all sperm quarantined
In the first inspection in 1999, all of the donated sperm stored at the clinic — foreign and domestic — had to be quarantined because the clinic could provide none of the necessary paperwork required by the law, including whether the sperm had passed safety assessments for diseases like HIV and chlamydia.
"You must immediately quarantine all non-compliant semen currently in stock and cease distribution," said the letter to Barwin following the inspection on June 25, 1999.
No follow-up document was shared with CBC on whether he complied with the order, and the incident was not mentioned in the following inspection in 2001.
In 2002, an inspection in July found similar problems in the handling of donor sperm.
None of the donor sperm files reviewed included the necessary paperwork assessing the safety of donor sperm. Inspectors noted missing sperm from the recorded inventory. In a couple of instances, sperm vials were found no longer viable after falling to the bottom of the holding canister. Patient consent forms necessary to use sperm were also missing.
And yet in both 1999 and 2002, Barwin passed the inspection as "compliant."
He finally failed a September 2010 inspection, which came weeks after news two families were suing Barwin for using the wrong sperm used to conceive their children. Barwin denied the allegations at the time and was asking the court to dismiss the cases.
Inspectors made six "observations" that required "corrective actions" from Barwin — with three featuring a risk rating of "critical."
Once again, problems included missing evidence of testing for infectious diseases, missing consent forms, missing donor-sperm vials and labelling problems.
At follow-up inspection in late 2011, inspectors noted that Barwin's clinic continued to see patients.
When the College of Physicians and Surgeons began investigating complaints against Barwin, he volunteered in February 2012 to stop offering IVF and artificial insemination services at his Ottawa clinic, and his medical licence was suspended by the college in 2013, though not revoked until last year.
Over the years, at no time did Health Canada share its inspection information with the college.
"What we see is a lack of compliance dating back," said Dr. Arthur Leader, a fertility expert who sat on the Canadian Standards Association committee developing updated rules for assisted human reproduction that come into effect next month.
Leader reviewed the documents obtained by CBC and noted that no "punitive measures," and no efforts to restrict Dr. Barwin's practice were ever considered.
Could Health Canada shut violators down?
"What was also troubling was the fact that the inspectors did a very superficial assessment of what was going on," said Leader, though even it was found, "the [Barwin] records are very sloppy, in that it's very difficult to follow where the sperm went and to which person. And potentially they could have said — given that — that the operation should cease."
Leader said Health Canada did have the ability to shut Barwin's clinic down if he did not comply with the regulations, however, he said the inspection process was in its very early stages, and inspectors may not have had the confidence to use that power.
Health Canada did not provide a response to our report in time for this publication.
However, new legislation affecting "compliance and enforcement" that goes into effect next month recognizes "the need to strengthen the rules for assisted human reproduction."
Families of 77 children sue
To date, a class action lawsuit by families against Barwin claims he used the wrong sperm, including his own sperm, in the conception of now 77 children, according to Peter Cronyn, the lawyer representing families.
None of the allegations have been proven in court.
Cronyn said the failings of oversight have left families with no choice but to sue to find a remedy.
He notes the Barwin victims fall into a regulatory gap, with moral and ethical harms beyond whether donor sperm is "safe."
He describes how fathers — after DNA testing — have had to tell their children that they are not their biological dad. He said there are parents who still don't know who their father is because of mix-ups. And there are 11 children who have tested to find Norman Barwin himself is the father.
"The problems that I've seen now... It's mind boggling," said Cronyn, "I think that we kind of just started doing this without thinking about the implications, the possibilities of something like this happening. And so it was, in my view, a regulatory failing."
Role of the province overdue
One of the things aimed at closing the gap will be provincial oversight suggested by the College of Physicians and Surgeons of Ontario two years ago.
It would mean someone would be inspecting the fertility clinic for more than just how it handles the safety of donated sperm and eggs. Quebec already has a similar inspection system in place.
Arthur Leader sat on the CPSO committee that contributed to the new rules.
"But unfortunately it's now been two years since the regulations were developed by the college and no effort to introduce legislation in Ontario that would complete the oversight," he said.
Leader said a more robust federal inspection system, along with a provincial regulation for clinics, could have made a difference in the case of Norman Barwin.
"I think if these two things had been in place 20 years ago, we may have been able to avoid some of the horrible impacts that occurred with the lack of oversight."
The Ministry of Health and Long Term Care of Ontario said in a statement to CBC the new system would include "a site visit by the inspection team, a review of records, examination of the physical premises, and observation of the procedures performed by physicians."
The statement said the ministry "expects to finalize its review of the proposal in the coming months."