Newmarket sperm importer failed safety inspection 3 times

The company received “non-compliant” ratings on its inspections this year, in 2011 and 2009. Fourteen of 19 violations, formally known as “observations,” are considered “critical” and “major.”

Many relate to incomplete screening questionnaires.

“Certain health and behaviour criteria such as drug use, exposure to foreign blood or body fluids were not adequately assessed as part of the donor screening process,” Health Canada spokesperson Rebecca Gilman says.

On a number of occasions, Outreach promised Ottawa it would not distribute non-compliant semen to fertility clinics and doctors until foreign sperm banks “re-qualified” respective donors with new questionnaires.

But not only did Outreach fail to ensure the donors were re-qualified, it went ahead and distributed their semen anyway, Health Canada documents show.

The federal government says it has received no reports of infection transmission related to the breaches.

Outreach is the same importer named in lawsuits from three Ontario women for selling them sperm from Chris Aggeles, a U.S. donor advertised as a healthy, highly educated genius but who turned out to be a college dropout with a criminal past and serious mental health problems. His sperm was used to create at least 36 children around the world, including 10 in Canada.

Outreach declined to comment for this article. It hasn’t yet filed a statement of defence in the lawsuits, though it has filed a notice of intent to defend.

The company has told Health Canada it is taking steps to address the violations and ensure future imports meet Canadian regulatory requirements.

The federal government does not require sperm importers to be licensed and, as a result, its authority over the industry is limited.

In an acknowledgement that more needs to be done to protect the increasing number of Canadians turning to assisted reproduction to expand their families — including same-sex couples and single parents — Ottawa recently announced plans to strengthen and clarify the regulatory framework governing assisted reproduction. Plans call for a review of compliance tools to minimize risks associated with donor semen.

But many observers say Canada needs to go further and argue that government licensing of the industry is long overdue.

Many are also calling for changes to the 2004 Assisted Human Reproduction Act, which they consider to be woefully outdated and inadequate.

They blame the legislation, which made it illegal to compensate sperm donors, for Canada’s reliance on foreign sperm banks for most of the semen used for assisted reproduction in this country. While there are no official statistics on this, many in the industry estimate 95 per cent comes from jurisdictions outside Canada where donors are paid.

But the idea of compensating donors has opponents who say this would not only commodify sperm but would also open the doors to compensating organ and tissue donors.

Opening up discussion about assisted reproduction is a political hot potato, one the former federal government avoided.

It’s becoming increasingly difficult for Ottawa to ignore concerns. More headlines are appearing about the ethical, legal and health problems associated with assisted reproduction — not just with sperm donation, but surrogacy and egg donation as well.

Undertaking regulatory changes is viewed by many as the government’s cautious way of starting a national discussion about what needs to be done.

Outreach Health Services president and founder Heather Brooks declined to answer any questions for this story. She will not comment because of the lawsuits involving Aggeles, her lawyer says

Health Canada says that, to date, it has received no reports of transmission of infectious disease due to insemination with semen from Outreach or any importer over the past decade.

Current regulations leave it to “processors,” or sperm banks, to report investigations into potential disease transmission to Health Canada. Yet Canada has no authority over foreign sperm banks from which most of the semen used in this country originates. Canadian physicians who suspect patients have been exposed to or infected by an infectious agent are required to notify the banks.

The dearth of oversight and transparency in the industry is reflected in Health Canada’s inability to answer many questions posed by the Star.

The federal department says it does not collect data on how much sperm is imported into the country, the number of inseminations performed, the amount of sperm distributed by importers, the number of Canadians using donor sperm, and the number of donor-conceived children. Health Canada does say that “more and more” Canadians are turning to assisted reproduction to help build their families, but again does not collect data on exact numbers.

On questions about the amount of problematic semen distributed by Outreach and the number of women inseminated with it, Health Canada advised this reporter to ask the importer.

It’s unclear that these women have even been made aware there was a problem. There are no requirements that they be told they received non-compliant sperm or that they be screened to determine if they contracted infectious disease from it. Outreach has advised physicians and clinics to whom it had distributed the insufficiently screened sperm to stop using it, according to the federal department.

Outreach is the only Canadian importer to have failed an annual safety inspection over the last decade, according to Health Canada. (There are currently four Canadian importers, including Outreach, all based in Ontario.)

Among its most serious transgressions is the failure to follow through on commitments to Health Canada to ensure that some donors, found in previous inspections to have been insufficiently screened, were “re-qualified” with new medical questionnaires. Outreach distributed their sperm to physicians and/or fertility clinics for use in inseminating patients, despite assurances it would not, government documents show.

“An establishment’s compliance history is always considered when preparing an inspection plan. In situations where inspectors find that an establishment has not met previous commitments, the inspector may change the focus of his/her inspection and elevate risk levels on specific inspection observations,” an email from Health Canada’s communications branch states.

Francoise Baylis, a Dalhousie University professor and Canada Research Chair in bioethics and philosophy, says the repeated inspection failures are cause for alarm.

“If a company has repeated notices of non-compliance, what confidence can the average Canadian woman have in the safety of the sperm she is using?” she asks.

Brooks, a registered nurse, was formally notified of the most recent failure in an April letter from Health Canada. An inspection, completed a month earlier, involved a review of a sample of files on imports from the Denmark-based European Sperm Bank and the U.S.-based Seattle Sperm Bank.

Health Canada was especially concerned about the European imports.

“This is the third non-compliant rating that Health Canada has issued to Outreach Health Services for its importation activities related to donor semen processed by the European Sperm Bank since 2009,” reads the letter.

“Even with all the corrective actions implemented by the European Sperm Bank, donor semen is still being supplied to the Canadian market that is not compliant with the semen regulations,” it continues.

Different jurisdictions have their own screening requirements for donor semen. Canadian directives require donors to undergo lab tests and complete questionnaires when they donate, and again after their semen has been quarantined for 180 days.

The questionnaires are used to assess donors’ medical information and are “vital” to minimizing risk of infectious disease transmission, according to Health Canada. The quarantine period provides a window to see if they carry the viruses or develop antibodies to infection.

These directives are supposed to apply, even if the semen comes from other countries.

An importer that fails an inspection is responsible for taking timely corrective action to achieve regulatory compliance. If it doesn’t, Health Canada has the authority to request a recall, issue a public advisory or undertake and administrative seizure. (Under the latter, frozen sperm would remain on site at the affected facility, but Health Canada would have legal control over it.)

An eight-page “exit notice” that accompanied the April letter to Outreach president Brooks from Health Canada points out where her company breached the regulations in its latest inspection.

Of nine observations cited, one references the Seattle Sperm Bank while all others relate to the European Sperm Bank.

The critical observation cited problems with four European donors whose files were studied, including one who tested positive for Hepatitis C. Subsequent testing came back negative, but Canadian regulations do not allow repeat tests.

The critical observation also noted some European donors were not completely assessed in questionnaires for whether they were at high risk for HIV, hepatitis or HTLV.

The single observation for the Seattle Sperm Bank, rated Risk 2, pointed out shortcomings with questionnaires and microbiological testing.

Among problems found in the failed 2011 and 2009 inspections:

• Some European donors did not get required lab tests for syphilis.

• A European donor answered “yes” to a question asking if he had “knowingly been exposed to, diagnosed with, or treated for any sexually transmitted diseases including . . . HPV, herpes or genital warts.”

• Some donors to both banks were not completely assessed in questionnaires for whether they were at high risk for HIV, hepatitis or HTLV.

Asked what sanctions Outreach has faced for the repeat violations, Health Canada’s email states:

“As per Health Canada’s inspection strategy, importers of donor semen are inspected annually to verify compliance with semen regulations. In the past 10 years, (Outreach) has been subject to 15 inspections, re-inspections and compliance verifications and has had to cease distribution of non-complaint semen on multiple occasions.”

The Seattle Sperm Bank also received a warning letter from the U.S.-Food and Drug Administration in 2011 because “significant deviations” from American regulations were discovered during an inspection. Again, concerns related to inadequate screening of donors for communicable diseases.

Annemette Arndal-Lauritzen, CEO of Nordic Cryobank Group ApS, of which the European Sperm Bank is a part, says she believes there has been some sort of misunderstanding about the inspection outcomes and she is endeavoring to get to the bottom of it. Donors are tested for communicable diseases according to internationally accepted standards, she says, adding that there has never been a single case of transmission.

Seattle spokesperson Fredrik Andreasson says there was no health risk posed by sperm from his company: “We do more donor screening and testing than any other sperm bank in the U.S. and the rest of the world. Health Canada has a different set of regulations from the FDA, which we adhere to.”

Health Canada says that in updating the regulations it will look at what more it can do to ensure importers follow the rules.

The federal government has invited public commentary on a new regulatory framework until the end of the month and is getting much advice.

The Canadian Standards Association (CSA) has drafted new standards for health professionals who work in the field. The proposed standards, which are subject to change pending ongoing public consultation, call for improved screening of donors, including extensive genetic testing. Ottawa has said it will consider incorporating these standards into the updated regulations.

Dr. Arthur Leader, chair of a CSA subcommittee on assisted reproduction, says there is a potential for such tests to detect genetically linked mental illnesses and identify ineligible donors such as Aggeles.

The draft standards also require that potential donors’ medical questionnaires be checked against their medical records, another measure with the potential to identify ineligible donors.

The CSA is proposing that screening questionnaires be amended to detect emerging new diseases like Zika.

As well, the organization is proposing that some questions about infection risks be dropped from medical questionnaires because advanced laboratory testing for both viruses and bacteria is so reliable.

Liberal MP Anthony Housefather, chair of the Justice Committee, hopes his government will go further than updating the regulations and will overhaul the Act itself. Specifically, he wants to see it made legal again in Canada for men to be compensated for their sperm, giving them an incentive to donate and making the country less reliant on imports.

“The Assisted Human Reproduction Act is totally outdated and is totally wrong in concept. What we have done is closed the industry in Canada and that’s forcing us to import sperm that doesn’t meet Canadian standards,” he remarks.

Housefather expects that during the public commentary on the regulatory changes, the government will hear from many people like himself who want it to go further by undertaking a broad review of the legislation.

Port Hope mother Angie Collins — one of at least seven Canadian women known to have had babies with Aggeles’ sperm, imported by Outreach — plans to participate in the public commentary.

“There are more and more Canadian children like my son who are the products of sperm donation and we could be doing so much more to ensure they are healthy,” argues Collins, 46, who fears her 9-year-old boy is genetically predisposed to mental illness.

(Given that the semen regulations deal only with infectious disease, Outreach did not violate them when it imported Aggeles’ sperm.)

Collins is in favour of legalizing paid donation, but it is a contentious topic with many opponents who warn it’s a slippery slope. They note that Ottawa and provinces like Ontario have seen fit not to commodify blood, organ and plasma donation.

“One of the guiding principles of the Canadian legislation is that ‘trade in the reproductive capabilities of women and men’ should be prohibited. In other words, in Canada we don’t want Canadians to sell their body bits. We understand that this can result in exploitation,” Baylis argues.

She would rather see Ottawa do more to encourage Canadian men to donate altruistically by removing disincentives. This could be done, for example, by addressing uncertainties created by outdated family law, which leave donors unsure of whether they will have parental obligations — including financial obligations — to children created from their sperm.

Baylis argues that licensing of the industry would go a long way toward protecting Canadians by giving government more enforcement clout.

It should have been done long ago, she explains, noting that the 2004 Assisted Human Reproduction Act initially included licensing provisions, but much of the legislation was declared unconstitutional in 2010 and repealed two years later.

“One of the clear benefits of a licensing system is that if a company like Outreach Health Services failed to meet health and safety criteria its licence could be revoked. What better way to protect the health and safety of Canadians?” she says.

Prompted by its most recent failed inspection, Outreach issued “halt usage and quarantine” notices to all fertility clinics and physicians to whom it had distributed insufficiently screened sperm, according to Health Canada.

It also quarantined its inventory of semen from the European and Seattle banks: a total of about 1,381 units from 181 donors.

Outreach has told the federal government it plans to work with the Seattle bank to re-qualify donors using a new questionnaire that addresses deficiencies in initial screening questionnaires. It’s also creating and revising standard operating procedures.

As for the European bank, Outreach is giving up on trying to get it to meet Canadian screening standards, according to Health Canada. Outreach has advised Ottawa that it is returning its imports from European and no longer plans to do business with it.

As an added safeguard, the Canada Border Services Agency will be on the lookout for imports from the European bank, Health Canada says.

As well, even though the federal government has no authority over foreign sperm banks, it has sent letters to the five remaining ones selling semen to Canada — they all happen to be American — reminding them of our regulations.

Lastly, Health Canada says it plans to re-inspect Outreach later this month to ensure corrective actions are being taken.

Meantime, the importer’s “non-compliance” status remains.

Theresa Boyle can be reached at tboyle@thestar.ca or 416-869-4915