Over the summer, we at Health Canada developed a plan that will allow the agency to begin its licensing and enforcement activities as soon as possible. I'll address this strategy in a few minutes, but first I'd like to make a few other comments.
This standing committee has played a significant role in shaping the legislation we now have in place. Over the next few years, as we work toward the full implementation of the act, this role will continue, especially with regard to regulations under the act.
As you know, the act received royal assent in March 2004. Since then, the department continues to work toward the full implementation of the act, which essentially consists of developing a regulatory system and establishing the agency, Assisted Human Reproduction Canada.
I would now like to present a brief overview of the activities of the implementation office to support this implementation.
We have drafted proposed regulations to address section 8 of the act related to the issue of informed consent. The draft regulations were pre-published in the Canada Gazette in September 2005 for comments by stakeholders. The act requires that the minister table the regulations in Parliament with this committee, as well as with the Senate committee. We have now tabled these regulations and we're looking forward to the review.
[Translation]
We also organized workshops and are currently carrying out consultations with interested parties to examine certain issues, such as consent, counselling, health reporting information, and clinical and laboratory practices.
We are focussing our consultations to seek policy advice on various clinical activities and laboratory activities carried out in clinics, as these are complex issues requiring a detailed and in-depth knowledge of procedures before regulations can be developed. We must also include the opinions of those affected by these activities, especially parents and the children of these technologies, along with donors.
We are also looking at other ways of obtaining additional information and expert opinions, including on-line consultations, so as to speed up the regulation development process.
[English]
We have now secured temporary office space for Assisted Human Reproduction Canada in Vancouver, B.C., and have done extensive work to develop the necessary governance and accountability structures, business plans, processes, and management tools. We are continuing to work toward the setup of the information systems for the agency, including the personal health information registry.
Another important step we have taken has been the development of a memorandum of understanding with Health Canada's inspectorate. This MOU has been concluded on behalf of the agency to provide compliance and enforcement support through in-house inspection staff. Twenty-three inspectors have been designated, and eleven are currently concluding outreach activities to encourage compliance by improving awareness of the act, providing information regarding the provisions of the act, and educating the stakeholders about their responsibilities under the act. We began these outreach activities in the fall of this year.
As you heard from the Minister of Health when he appeared before the committee in late November, the government anticipates it will soon be making an announcement on the president and other members of the agency's board of directors.
I would now like to go back to the regulatory development and share with you Health Canada's approach.
In the AHR field, very little currently exists as far as established Canadian guidelines or standards. Following a rigorous planning exercise earlier this year, a new approach to the development of regulations was devised. A refocused set of priorities was identified that will deliver on key regulations within a shorter timeframe. We will concentrate on a core set of regulations covering the licensing of in vitro fertilization activities with people using their own gametes. This will enable the agency to begin its licensing activities sooner.
[Translation]
In vitro fertilization is the main authorized activity of the clinics. We have reached the last stage of a consultation in three cities that began in Montreal on November 24, continued last week in Toronto and will wind up in Vancouver tomorrow and Saturday of this week, during which we discuss documentation on the 10 activities governed by the IVF legislation.
We are also taking this opportunity to discuss the licensing framework and health reporting information with the sector we will be regulating. These discussions will help us better understand the problems, issues and concerns with respect to the development of regulations. Barring any unexpected circumstances, the regulations should be put in place in the next 18 to 24 months.
[English]
I do, however, want to reassure this committee that while our goal is to get the regulations in place that will allow the agency to begin its licensing activities sooner, by focusing on IVF regulation, work is continuing on other regulations necessary to fully implement the act. It is my sincere belief that this new approach will produce the expected results.
In a moment, I will turn to Kata, who can elaborate further on the proposed consent regulations under section 8.
As you know, the proposed section 8 regulations deal with consent issues as they relate to the use of human reproductive material and in vitro embryos.
It should be noted that the act addresses consent in a number of provisions and in different contexts. For example, section 14 requires that licensees make counselling services available to any person donating human reproductive material or an in vitro embryo, or anyone providing health reporting information. Licensees must also ensure that these counselling services are received.
Section 14 of the act also requires that donors of human reproductive material and in vitro embryos, and persons providing health reporting information, provide written consent indicating they were informed of the requirements of the act respecting the retention, use, provision to other persons, and destruction of the human reproductive material or in vitro embryos, as well as the retention, use, disclosure, and destruction of health reporting information.
However, this section--section 14--and the accompanying regulations are dependent on the licensing framework being in place. Regulations respecting licensing are the ones we are currently developing.
I will now turn it over to Kata, who can elaborate further on the proposed consent regulations.
:
My understanding is that committee members have already received the deck on section 8, so I won't presume to go over it. We can respond to questions following this.
I want to give a few highlights of the deck. Section 8 regulations were developed first, because section 8 is the only prohibition not yet in force. You'll probably be hearing that story over and over again this afternoon. While section 8 is not the only section in the AHR Act that addresses the issue of consent, it provides the essential minimal requirements for consent to protect users of AHR services.
As Hélène said, section 14, once in force, will require, among other things, that licensees inform a person in writing of the requirements of the act respecting the retention, use, provision to other persons, and destruction of the human reproductive material or in vitro embryos. Licensees will also be required to obtain written consent to the application of these requirements, and they must ensure that counselling services are received.
[Translation]
Additional regulations will be developed to deal with issues related to the conservation, transportation and destruction of human reproductive material and in vitro embryos.
Section 8 deals with the issue of written consent for the use of human reproductive material and in vitro embryos and the posthumous removal of human reproductive material.
[English]
The proposed regulations require that donors be informed of the allowable uses for their human reproductive material and in vitro embryos and of the conditions for withdrawal of consent. They also require that donors provide a written consent that is attested to by a witness.
The section 8 regulations conform to the provisions of the 2002 CIHR “Human Pluripotent Stem Cell Research Guidelines”, as required by section 3 of the AHR Act, notably with respect to the following issues: the reiteration of consent, the withdrawal of consent, and obtaining the consent of the original gamete provider if they are not the same as the in vitro embryo donor. The regulations include transitional provisions for human reproductive material and in vitro embryos that were obtained prior to the regulations coming into force. They can still be used as long as written consent was obtained.
That concludes my remarks.
:
Thank you, Mr. Merrifield.
My name is Burleigh Trevor-Deutsch. I am the director of the Ethics Office at CIHR. With me here is Dr. Pierre Chartrand, who is the vice-president of research.
First of all, let me thank you for inviting us here today.
[Translation]
Canadian Institutes of Health Research (CIHR) is the major federal agency responsible for funding health research in Canada. It aims to excel in the creation of new health knowledge, and to translate that knowledge from the research setting into real world applications. The results are improved health for Canadians, more effective health services and products, and a strengthened Canadian health care system.
[English]
CIHR carries out its mission in collaboration with a wide cross-section of partners, including our colleagues in the health portfolio, and these, of course, include Health Canada and the Public Health Agency of Canada, other federal departments, such as Industry Canada, CIDA, and Environment Canada, and we also collaborate with provincial health research agencies, charities, and other non-profit organizations, as well as industry.
Today, with an annual budget of $737 million, CIHR is supporting over 10,000 health researchers in universities, research institutes, and teaching hospitals across the country.
CIHR takes a problem-based and multidisciplinary research approach to health challenges facing Canadians. We bring together all the disciplines of health research under one umbrella, and these include biomedical, clinical, health systems and services, and population and public health. These are the so-called four pillars of CIHR.
Stem cell research is one of the areas funded. Stem cell research can potentially lead to effective therapies in the treatment of a number of health care conditions and diseases, including Alzheimer's, Parkinson's, diabetes, kidney failure, heart disease, spinal cord injury, and most recently—you may have read in the Globe and Mail—cancer.
CIHR is committed to funding health research that meets the highest standards of science, excellence, and ethical conduct. A number of systems have been put into place to uphold these standards for the research that CIHR funds.
In the area of stem cell research, a number of oversight mechanisms are in place. Of course, CIHR complies with the Assisted Human Reproduction Act, which, as you know very well, provides a legislative framework within which all public and private human embryo research can be undertaken. Complementing this legislative framework, CIHR's stem cell guidelines set out conditions under which CIHR will and will not fund human pluripotent stem cell research.
The guidelines operate within the legal framework created by the act, and it's also worth mentioning that the consent provisions of our stem cell guidelines are incorporated by reference into the act itself.
[Translation]
CIHR is currently working closely with Health Canada to ensure that guidelines on stem cells are completely harmonized with the implementing regulations of the Assisted Human Reproduction Act now under preparation.
As the federal agency responding for funding health research in Canada, CIHR will continue to support, in cooperation with all its partners, the Canadian research community. This is a community based on excellence, once that respects ethical standards and that definitely will help to improve the health of Canadians.
[English]
These are my introductory comments.
My colleague, Dr. Chartrand, and I will of course be pleased to answer your questions.
The whole issue of consent is one where all of us feel we ought to be able to do better. What people think they consented to sometimes isn't what is really on offer, and people aren't necessarily told in detail about the real risk-benefit ratio or some of the stories.
With the opportunity to set up a new agency, do you think we should go further in this particularly difficult area, where patients can be particularly vulnerable and particularly prone to charlatans and other things that have a very tiny risk of success, and take this opportunity to do a better job?
I think some of you have heard me say at committee before that I think the Toronto Medical-Legal Society looked at some American models, where people had to look at a CD of people who had the procedure and everything went well, and people had to look at a CD of people who had the procedure and things went terribly wrong. Until you actually understand both sides, you can't really give informed consent. Do you think this could or should be an opportunity for us to go further on this?
If you wouldn't mind, I would like you to describe what happened in the public consultation on this. In examining this, do you feel that the kinds of infertile couples who we didn't hear from enough at this committee were part of the consultation? Could you also describe the process for public consultation that brought you to this and whether or not you think it is sufficient?
I really believe public consultation isn't supposed to be only occupational therapy. They said we're supposed to have public consultations. Can we show the people who bothered to participate in this that changes were made to what you had on offer before the public consultation? How did it change after you'd listened to people? Are you comfortable that you listened to enough people and to people who are the most vulnerable in this file?
:
Most of the comments we heard through those processes were requesting.... It's not that the people were not in accord, I guess, with what was proposed, but that they sometimes required more clarification. That's what we did, I guess, with some of the modifications we made after the proposal was put in the
Canada Gazette, part I.
There was clarification as to the time of withdrawal of a consent. There was clarification also to ensure that the original gamete provider is donating for third parties. That person would also have to provide consent for research, because that person will be told that those in vitro embryos are created for third-party reproductive use. If they have surplus to the reproductive need of the couple for whom the embryo would be created, that couple could decide to give them to research. The original gamete provider will have to have given consent for research also. These are the types of clarification.
We also had a transitional period that was taken into consideration, knowing that there are already gametes that have been donated and are there waiting, I guess, to be used. We want to ensure that with the coming into force of the regulations, we would not allow the use of those unless there was a written consent, which would have been dated.
Also, there was a clarification, I would say, to the definition of an in vitro embryo donor, making it clear that it is the individual or the couple from whom the in vitro embryo was created.
I have several questions. Some of them are really easy, so I just need quick answers.
First, is there any restriction on who can be a witness to the consent?
Second, the education material that is to be created by the agency or is the responsibility of the agency, given that they have a fairly large budget and not an active board, but lots of money that we seem to have approved last week or the week before...I'm wondering if some of that work has been done currently and whether there's anything we could actually look at.
Third, I want to follow up Dr. Bennett's comment. It's one thing to have education and awareness material “available”. I don't know how I know it's available. If I've gone to a private clinic, are they going to say to me, here's the 1-800 number you call and there will be a trained, experienced person on the other end of that? And how many languages will this line be available in, because that's a major concern across this country these days?
I've come into this a bit late, and this may be a foolish question, but when somebody signs an organ transplant card, is there any way that sperm is included under organ transplant? I'm just curious. I'm wondering if under those circumstances, if the donor is dying and we talk about a donor who has died or is dying...I'm not sure how one actually goes about getting consent for how sperm can be used.
My last question, and I think the chairperson was getting at this point, is if you're going to run a stem line or create a stem line using the in vitro, does it say somewhere in the consent how far you can and cannot go with that stem line and with those stem cells in terms of research that will produce--and maybe it's covered off by the word “reproduce”--a human being? So is there something that says the research can only go this far if you're running a stem line and collecting stem cells?
Thank you, and maybe they weren't so easy.
I can see why you would have taken three years on this topic. This is really quite a fascinating and very difficult subject.
May I say, Ms. Priddy, I thought your questions were superb.
I have a very short question. It's a short question, but it's a very complicated question for the witnesses. First of all, thank you very much to all of you for being here today.
In Health Canada's presentation, there's a statement that says:
Violation of section 8 carries with it the consequence of criminal penalties, therefore:
the scope of the regulations must be clearly defined and focus only on the essential elements; and,
the regulations must be very clear to prevent inadvertent contravention of the law.
In my five minutes, I'd like each of you to talk to me and educate me about what types of contraventions we're talking about here. If you can, list as many under the sun as possible. What are the penalties? We're talking criminal penalties. What penalties are being contemplated? Where are we in that process? Is the justice department involved in this process? Are the penalties already defined? That's what I'd like you to talk about in the five minutes, please. Thank you.
A question just occurred to me. We're dealing with a very controversial subject, a very difficult subject, perhaps. I think about couples I know where one person has been tragically lost in an accident and the remaining spouse wishes with all—in this case—her heart that they had been able to have a baby. It was just a terrible tragedy that prevented it.
As I sit in this committee today, I've learned an awful lot about this subject, but Canadians coast to coast to coast probably don't know the regulations, the rules regarding consent, and section 8, in this very important and controversial subject—technical subject, I guess.
My question is, has there been any discussion about how we're going to educate the Canadian public regarding this? Perhaps there could be pamphlets made by Health Canada for general practitioners to have in their offices concerning questions regarding assisted human reproduction. This is something that obviously would be very difficult for someone to contemplate and plan for, but I can tell you that when it happens—God forbid that it happens and there's a tragic loss—I know people personally who wish they might have had an avenue to have a baby.
I wonder if you can answer that question about education on the subject for Canadians. Thanks.
:
Yes. I was just wondering how it would take place, and you described it. That's fine.
Are there any other questions from the committee? I don't have any others here.
I want to thank you very much for coming in and giving us an overview of the piece of regulations, section 8. It was very interesting. Thank you very much for your presentation and for the questions. Next time we'll have some third-party, shall we say, individuals coming in to address some of the problems of Madame Demers. Thank you very much for your attention.
For the committee's information, we were to look at the steering committee's report. I'm wondering if we should leave that to the next meeting, since three of the steering committee are not here. I'm the only one here, and there's some controversy. Why don't we leave that until next meeting? Is that fair?
Some hon. members: Agreed.
The Chair: The meeting is adjourned.