Seven things I learned at Health Canada's consultation
Last week was filled with fertility story gathering. On Monday, I sat in on a conference on fertility law. On Wednesday, I attended a public consultation put on by Health Canada regarding the new regulations. On Thursday, there was a great debate about whether the ban on payment for surrogacy and gametes should be repealed. Then, all day Friday, I attended a conference about how to regulate this fast-paced field with all its deep and far-reaching ripples. Each of these events has yielded excellent issues, narratives, and nuggets, which I look forward to sharing with you over the coming weeks.
Today, though, the Health Canada consultation.
Last week, Health Canada began its consultation on the new regulations for assisted reproduction. I am not reassured.
When Health Canada announced the rollout of regulations for the Assisted Human Reproduction Act, they also mentioned a consultation process. For those of us new to this, it wasn't clear what that even meant. I signed up for the Toronto meeting, scheduled for November 21 at 6pm.
Forty-eight hours in advance, all I'd been told was the address -- nothing about how the process would unfold. A few emails back and forth revealed only that we would be sitting at tables, we would be discussing three topics (they wouldn’t say which) and that there would be facilitators and record takers.
To no one's surprise, the three topics were 'safety of sperm and ova,' 'reimbursement' and 'administration and enforcement.' Officials summarized the regulations with slides, then asked us to discuss amongst ourselves, with Health Canada people circulating. (We were also asked to write our thoughts down on what they called "placemats" — cruel, really, given that we were there for three hours over the dinner hour and all we got to eat were brownies and Hershey's kisses).
Here are seven interesting things I gleaned:
1. The new regulations will be accompanied by an enforcement policy. So, when the regulations say something like "you can only reimburse if you have receipts," there will be a protocol for checking that people are collecting those receipts and that payment matches them. Or when they say "sperm has to be tested for the following infectious diseases," there will be an inspector who can verify that that is happening. The way in which compliance is going to be monitored has to be finalized by the time the regulations come into force, likely sometime next year. When I inquired of one of the Health Canada officials what those policies look like, he admitted that most of the details have yet to be worked out. Health Canada does not know yet how it will monitor compliance.
2. So how will they decide on those details — on what they need to do to ensure compliance? Who did he think would give Health Canada the information they needed to do this right? He said they will consult further, with "stakeholders" — fertility doctors, fertility lawyers and agencies. Then added: advocacy groups. Health Canada will be relying on the very people it will regulate to give advice on how they would like to be monitored for compliance.
3. There will only be 10 inspectors to monitor compliance throughout the entire country. According to the Health Canada official I spoke to, the same inspectors will be responsible for compliance regarding labs and reimbursements. So, scientist-accountants?
4. At least one of the inspectors was there at the consultation, according to Cindy Wasser, a Toronto fertility lawyer. Wasser was inquiring whether donors and surrogates could be reimbursed for something like kennelling a dog, in the event she had to be away for screening and cycling appointments. As written in the new regulations, the only categories that could capture a reimbursement like kennelling speak of "products or services... recommended in writing" but they have to be recommended by "a person authorized under the laws of a province to practise medicine." Physicians do not typically sign off on things like kennelling, housecleaning, and babysitting, nor do we want them to. Wasser was alarmed to learn that the inspector seemed to think they did.
5. Although they haven't worked out how routine compliance monitoring might work, Health Canada seems to have spent a lot of time thinking about the need to seize eggs, sperm or embryos in the event of a serious problem. We spent way too much time discussing this. Still, it was made clear that while they are prepared to seize reproductive material if necessary, they may not have thought through what that might mean in terms of maintaining the eggs, sperm and embryos that come into their possession. Heather Brooks, president of Outreach Health Group, a sperm distributor, asked: Do they have access to the right freezers? Do they have technicians who can keep the materials viable? Have they thought about how a woman might react if her last egg is united in an embryo with sperm that has been found in violation of the regulations?
6. I asked why ‘safety of sperm and ova’ didn't include continued follow-up and reporting, so that if diseases or traits are later discovered by donors, that information can be passed on to donor offspring. The Health Canada official at my table appeared never to have considered that idea before.
7. Alana Cattapan, at the University of Saskatchewan, was struck by the fact that these regulations may not ever be reviewed by a parliamentary committee. While it's true that most regulations don't go through that type of review, she says, section 66 of the Assisted Human Reproduction Act sets out a process for it. Cattapan reminds us that earlier regulations on consent were carefully considered by committee. "That is what that clause is there for," she says, "to make sure that Parliamentarians have a chance to think and debate any important regulations being made." The Health Canada official said the regulations have been put before parliament and are not expected to be scrutinized by a parliamentary committee.
You still have time to participate:
Montreal, November 29
Halifax, December 2
Winnipeg, December 6
Vancouver, December 8
If you like the HeyReprotech newsletter, please spread the word through your networks.
If you have something to share about any topic related to reproductive technology, please get in touch: firstname.lastname@example.org or 416-465-0497.
Follow @HeyReprotech on Twitter