Health Canada 'required' 2-year wait between blood ban policy changes: documents

First at Five: Moving the Needle There's an upcoming recommendation from Canadian Blood Services that could end the ban on gay and bisexual men form donating blood

OTTAWA — Amid ongoing questions about why the policy that prohibits sexually active gay men as well as some other folks in the LGBTQ2S+ community from donating blood has been slow to evolve, documents indicate that Health Canada “required” two-year intervals between when the donor screening criteria could be updated.

This request from the federal health agency—which regulates Canada’s blood donor agencies Canadian Blood Services (CBS) and Hema-Quebec—was made in order to monitor potential blood safety impacts of the updated donor screening criteria. It was detailed in court submissions from both Health Canada and Canadian Blood Services.

Between 2013 and 2019, Canada’s blood donation policy as it pertains to donations from gay and bisexual men as well as certain trans folks who have sex with men has changed three times, gradually evolving from a five-year ban on giving blood to the current three-month deferral period. In each instance, at least two years passed between updates.

The policy started in 1992 as an outright lifetime ban following the tainted blood scandal that played out in the 1980s and 1990s and saw thousands of Canadians infected with HIV after receiving donor blood.

According to CBS, in “each of” the three instances where it submitted to Health Canada approval to change its blood donation policy -- 2013, 2016, and 2019 -- the agency “required” CBS to collect two years’ worth of data before it could make any further changes.

However, Health Canada denies that minimum monitoring periods were a condition of its authorizations, telling CTVNews.ca in an email days after the story was initially published, that the two-year wait between when the donor screening criteria could be updated was only asked for in the 2013 instance, and not as part of subsequent submissions, despite what the documents indicate.

In reference to the 2013 change that saw the then-lifetime ban knocked down to a five-year deferral period, CBS said in its submission that following that update, Health Canada “required a minimum of two years of post-implementation monitoring before it would consider further changes” to the blood donation policy.

In its own “Statement of Particulars” in the case, Health Canada stated that after the 2013 change the agency imposed the requirement for two years of post-implementation monitoring “before it could consider further changes” to the policy.

Further, Health Canada confirmed that it asked CBS to do two years of monitoring for the rate of HIV and other transmissible pathogens in donors prior to filing further submissions for changing the deferral policy. “This request was made to ensure that sufficient safety data could be collected prior to considering further changes to the deferral policy,” said Health Canada spokesperson Andre Gagnon in a statement.

While Health Canada’s documents show that post-implementation monitoring was also done following the 2016 and 2019 updates to the blood ban, the agency said that annual monitoring was a condition of its authorizations, but “the request to monitor the safety of the blood supply for two years prior to filing subsequent submissions was not made.”

“As the regulatory authority, Health Canada is always open to receiving new scientific data in support of changes to the blood donation policy,” said Gagnon.

In 2016, CBS sought and was granted regulatory approval to drop the deferral period from five years to one year in 2016.

Pointing to the 2019 policy change—the latest evolution putting the deferral period at three months—CBS said that as was the case before, the non-profit blood donation organization had to continue monitoring the data for “at least two years” before presenting a further request to update the blood donor screening criteria.

“As before, when Health Canada approved the change in the deferral period, it required mandatory post-implementation monitoring to continue for at least two years after the change to assess the impact of the shorter deferral on the safety of the blood supply, and to be reported to Health Canada on an annual basis,” said CBS in what’s called a “Statement of Particulars.”

The documents were presented in court as part of an ongoing Canadian Human Rights Commission court battle over the blood ban. The submissions were filed by the Canadian Human Rights Commission as an intervener in the federal government’s fight to halt a tribunal from probing a human rights complaint alleging Health Canada discriminated against Christopher Karas on basis of sexual orientation by prohibiting him from donating blood.

The Canadian Human Rights Commission’s statement of particulars also makes reference to what CBS has stated in the matter, stating that: “Upon Health Canada’s approval of each of these policy changes, CBS states that Health Canada required it to monitor any impacts of the policy change and collect two years’ worth of data prior to making any further incremental reduction to the deferral period.”

Asked to comment on Health Canada denying CBS’ claims that the mandatory two-year interval between donor screening updates was in place in all three instances, CBS said in an email that it would not comment, as the documents in reference are “part of an ongoing court case.” Also citing the ongoing court matter, Health Canada did not comment on the contradiction between its and CBS’ statements.

For years advocates have questioned why the federal government has been incrementally shortening and not outright eliminating the deferral period preventing men who had sex with men, or the “MSM” community as some have coined it, from donating blood unless they’ve been abstinent for a certain period of time.

There is research ongoing that both Health Canada and CBS have said will inform future policy changes, with a moving target for this work’s completion sometime this year.

The evolutions to the policy over the last several years were the result of Health Canada approving regulatory submissions from CBS and Hema-Quebec, which included risk modelling showing it would be safe to change the blood donor screening criteria, narrowing the window of time that has to pass between a sexual encounter and donating blood.

According to CBS as of last month, in the nearly two years since the waiting period went from one year to three months, based on its monitoring, the agency has “not seen an increase in the risk of transmissible disease.”

As has been the case for some time, every blood donation in Canada is tested for HIV.

Under current testing capabilities, HIV can be detected in a “window period” of approximately nine days after infection. Advocates have suggested updated lifestyle-focused screening questions and eligibility would be determined based on behaviour, rather than outright eliminating certain LGBTQ2S+ donors who are sexually active.

“The rate of HIV in our donors remains extremely low, and Canada continues to have one of the safest blood supplies in the world,” said Canadian Blood Services spokesperson Delphine Denis in a May comment to CTVNews.ca.

At the heart of the contention over the current policy is what appears to be a struggle over who has the power to change it. It’s this debate that is currently playing out in court as part of Karas’ case, which his lawyer said has been further bolstered by these submissions.

“It goes to show that the inquiry at the Human Rights Tribunal is having its intended effect: that is to reveal further evidence of how Health Canada is implicated in the process of developing donor selection criteria that excludes gay men. We anticipate that if the Tribunal is allowed to continue in its inquiry, more evidence will emerge showing how Health Canada is a critical and necessary actor in the development of the gay blood ban,” said Gregory Ko, a partner with Toronto firm Kastner Lam, in an email to CTVNews.ca.

Calls for the federal government to step in and force a change to Canada’s Blood Regulations, which are under the purview of Health Minister Patty Hajdu, have been met by a Health Canada argument that the agency has a “limited role” to intervene in Canadian Blood Services’ work unless it’s a pressing matter of blood safety.

The Liberals’ position as of late—after vowing without condition that their government would eradicate the ban—is that it’s waiting on the blood donation organizations to request a further blood policy change. If CBS was waiting two years from the 2019 implementation of the three-month deferral period to propose a subsequent policy update, it could propose a further change at some point this month.

OPPOSITION PUSHBACK

In addition to advocacy groups continuing to call for the blood ban to be ended, the Liberals are facing increasing pressure from both sides of the political spectrum to make good on their two-time campaign commitment.

Opposition MPs have pointed to the fact that more than a dozen other countries currently have no deferral period for donations from men who have sex with men, in calling for Canada to make the change to a behaviour-based screening process.

On Tuesday, to mark the beginning of Pride month, Conservative MPs Eric Duncan and Michelle Rempel Garner called for Health Minister Patty Hajdu to take action to remove the “blatantly discriminatory” ban by the end of the month.

“It is long past due for the federal government to put an end to the stigma and discrimination that men who have sex with men face in this country,” said Duncan. “It’s nothing short of virtue signalling to go out during an election campaign, twice, and promise men that you would end it, and now claim it's out of your hands and you can't make that change. If you couldn't make the change, why did you promise it in the first place?”

The MPs presented a draft order they suggested could be enacted by Hajdu today to “start the process of removing the ban,” by updating the Food and Drug Act to impose a ministerial authorization outlawing the restrictive policy.

“We believe that there is enough room for the minister to act on this within the existing regulatory structure,” Rempel Garner said. This is a position Hajdu has previously pushed back on.

“If she does not believe it's adequate, she has an obligation to explain what gaps in the legislation exist, and take immediate action to rectify that. The federal government cannot be allowed to skate by on thin talking points, suggesting that they can't make the change,” said Rempel Garner. “The federal government is the regulator on this issue, they have the power to introduce legislation if they have to, to make changes.”

In an email, Cole Davidson, a spokesperson for the minister, said that “Hajdu has asked blood operators about their timeline for submission and has offered to discuss any additional supports that may be required for CBS and Hema Quebec to develop a behaviour-based donation model.”