Health Committee on Dec. 12th, 2006

[Dr. Françoise Baylis]

That's my understanding. It would be specified, because you actually have to have a written statement that you've been told about these five possible uses and that you understand these specific rules for withdrawal. It would be a separate consent. It wouldn't be what you sign on the back of your driver's licence, such that it would pick up your gametes.

[Penny Priddy, NDP, Surrey North, BC]

Thank you.

Lastly, who makes the determination, and how would the determination be made, or by how many people, that an embryo is not feasible for either freezing or implanting, but that perhaps it is suitable for research? I'm trying to look at what the backups are for that to ensure that it's used properly.

[Dr. William Buckett]

That decision would be made primarily by the embryologist, who studies the quality of an embryo in a laboratory to determine whether it would be able to survive being frozen and thawed. The embryologist, in consultation with the clinician and the couple whose embryo it is, will then make a decision as to whether that embryo should be frozen, if that's what they really want, even though they're aware that it might not survive being frozen and thawed, or whether it should be destroyed or be considered for research.

[Penny Priddy, NDP, Surrey North, BC]

The professional recommendation comes from the clinician and the embryologist.

[Dr. William Buckett]

Yes.

[Penny Priddy, NDP, Surrey North, BC]

Thank you.

[Dr. Françoise Baylis]

If I can add to that, one of the things that's absolutely true—and there are a number of us funded to do research around the concept of the healthy embryo, what constitutes a healthy embryo, and what is an embryo that is or is not suitable for freezing or transfer—is that we find that because it is too much dependent on the expertise of the clinician or the embryologist, etc., you do get variety in terms of how you go about thinking and scoring when you're not looking at a genetic anomaly but are looking at some metabolic or other considerations.

One other important thing is that there was a study done by Tekpetey, presented in 2003. If I'm not mistaken—and you might know this—I think he won the prize that year, showing that what would be described as ugly embryos—morphologically, they're not very nice—turn out to make beautiful babies. He actually showed that some of the criteria that are used to make those determinations may not be as tight as we might have thought.

[Penny Priddy, NDP, Surrey North, BC]

That's the part I was worried about.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mr. Batters for five minutes.

[Dave Batters, Conservative, Palliser, SK]

Thank you very much, Mr. Chair. I want to thank all the witnesses for being here today to shed some light on this important, amazing, and somewhat controversial topic. We certainly appreciate all their expertise.

I have two questions, Mr. Chair. One is fairly short, and one is a little lengthier. I'm going to ask both my questions and give all the witnesses a chance to respond if they so wish.

First, at this time, how is consent obtained from gamete and embryo donors? Is there a standard procedure in place across the country?

The second one is a multi-part question. Are you satisfied that you were given an opportunity to comment on the proposed regulations under section 8? Were your comments or concerns addressed?

I'd like you to use the five minutes. For those of you who feel changes need to be made to section 8 of the assisted human reproduction regulations, this is an opportunity for you to reiterate the need for certain changes.

Thank you, Mr. Chair.

[Timothy Caulfield]

We're actually in the process of doing a study on how consent is obtained in the context of embryonic stem cell research. I can't speak to how it's obtained more broadly, but we tried to explore exactly how consent has been obtained in the past for those researchers and those clinics that are actually involved in embryonic stem cell research. Generally, what has happened—I know Françoise can speak to this too—has been relatively ad hoc. In part, that's because the regulatory environment has been in flux and the regulations have been in flux, and I think a lot of the research community is still learning about what's going on.

Having said that, it's a relatively small research community. This is a small, qualitative study that we've been doing, and we were actually surprised how few researchers are actually involved in embryonic stem cell research in Canada. Counting principal investigators, you're looking at three or four individuals. You're not talking about a big community. Those individuals are very closely tied with the entire process, and they seem to be relatively sensitive to, particularly now, the consent processes.

Though we have variation in what has been going on, it's our impression from what is very preliminary data—and I probably shouldn't be referring to stuff that hasn't been published yet, so I put that major caveat on it—that the consent obtained to date has been done to a high ethical standard. Having said that, there's variation; therefore, one of the benefits of a regime like this is that it will create a standard.

[Dave Batters, Conservative, Palliser, SK]

So this section 8 will create this standard procedure across Canada for consent?

[Timothy Caulfield]

As I said earlier, and as is recognized in some of the Health Canada background documents, there are a lot of consent norms out there. The consent norms in the context of research are tremendously high. Justice Picard has said it's the most onerous duty imaginable. Having said that, I think these guidelines will help to ensure and also create a form of monitoring that will allow us to know what is going on in the—

[Dave Batters, Conservative, Palliser, SK]

Thank you, Mr. Caulfield. I just want to give everyone an opportunity with the time that's left.

What changes need to be made to section 8?

[The Chair, Conservative, Rob Merrifield]

Ms. Baylis wanted to answer as well, so let's do that.

[Dr. Françoise Baylis]

I did just want to say that we had completed a study. It's referenced in number 5. It was published in 2005 and it looked at the consent process for embryos for research. We found only two clinics that did the same thing, and that was because they used the same form and were partnered clinics. In other words, every clinic does its own thing, and there is a wide degree of variation that hopefully will be reconciled by this.

[Dr. William Buckett]

I would just quickly concur. From a clinical point of view, I would say the same thing. In other words, there is a wide variation in the way we obtain consent for all parts of the AHR. However, in principle, this is the right sort of thing that most people do, and this will help to standardize it across the country.

[Dave Batters, Conservative, Palliser, SK]

On changes that need to be made, for any of you who have any big objections, this is your opportunity.

[Dr. Françoise Baylis]

I have said that we need clarity with respect to whether or not you can get consent—because that's what we're talking about—for the research use of fresh and frozen embryos. It does need to be addressed, because there are references to the timing of withdrawal having to do with the thawing of the frozen embryos. This suggests that you're imagining that you're going to be thawing embryos.

Given that there is inconsistency with respect to that view, and given that Canada's first two stem cell lines come from fresh and not previously frozen embryos, this is something that needs to be really clear. My understanding is that it needs to be consistent with the 2002 guidelines, which presume that they are cryopreserved—something the regulations seem to presume as well—but it will be contested, and it needs to be clear.

[Dave Batters, Conservative, Palliser, SK]

Thank you for that, Madam Baylis. That was an excellent summary.

Are any other changes needed, though?

[Dr. André Lalonde]

No, I think we're satisfied with the general intent of this. As someone mentioned awhile ago, it's supposed to be a living document. There are going to be changes every two or three years. It's in the law that you have to come back in front of this committee every two to three years. The more we try to be precise now, the more we're going to have delays. So we're happy. It's a good start.

[Dave Batters, Conservative, Palliser, SK]

Do I have time for one more?

[The Chair, Conservative, Rob Merrifield]

Your time is gone. Actually, you're over.

I do want to follow up, just for the committee's information.

Françoise, you said the two stem cell lines that were created in Canada were from fresh, not frozen. Is that through CIHR?

[Dr. Françoise Baylis]

That's correct, but it depends on what you mean by “through CIHR”.

[The Chair, Conservative, Rob Merrifield]

That's right.