Health Committee on Dec. 7th, 2006

[The Chair, Conservative, Rob Merrifield]

I call the meeting to order. This is our first meeting on the reproductive technology regulations. It's on section 8, which is consent.

We have a panel of witnesses before us today from the Department of Health. I'll let them introduce themselves and explain what their role is exactly. Representatives from the Canadian Institutes of Health Research are here as well.

We will start with the Department of Health. We look forward to your presentation.

Quite a few, actually. She's like an old welcome face.

[Francine Manseau, Senior Strategic Policy Advisor, Assisted Human Reproduction Implementation Office, Department of Health]

Merci. It feels like home almost.

[Hélène Quesnel, Director General, Policy Development Directorate, Department of Health]

A second home.

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.

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.

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.

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.

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.

[Kata Kitaljevich, Acting Director, Assisted Human Reproduction Implementation Office, Department of Health]

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.

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.

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.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

That's all, Francine?

[Francine Manseau]

Yes.

[The Chair, Conservative, Rob Merrifield]

Okay.

We have CIHR. We'll entertain your remarks at this time.

[Dr. Burleigh Trevor-Deutsch, Director, Ethics Office, Canadian Institutes of Health Research]

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.

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.

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.

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.

These are my introductory comments.

My colleague, Dr. Chartrand, and I will of course be pleased to answer your questions.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for your presentation and for being here. I'm sure we'll have lots of questions in regard to this.

We'll start with Ms. Bennett. You have ten minutes.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thanks very much.

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?

[Hélène Quesnel]

I will start by commenting that I of course totally agree. Informed consent associated with counseling will be key to how we proceed. I would only like to confirm that section 8 consent is very specific to a certain type of consent under the act, and of course section 14 of the act provides fuller coverage.

In regard to what we heard during consultations, I think I would like to ask Francine to comment more specifically on that.

[Carolyn Bennett, Liberal, St. Paul's, ON]

In that answer, could you let me know what you think counselling is? Is it a nurse handing over a clipboard and asking a person to sign something?

[Francine Manseau]

As Hélène was saying, if you look at section 14 of the legislation, it provides a broader framework for consent. It basically says that before you can accept gametes from a patient or before you even do a procedure, you have to make sure counseling is provided as per the regulations. You have to provide the patient with information that the agency will be collecting and making available about outcomes. You also have to provide information on what the regulation says about what's going to happen to the gametes and the information it will need to provide.

As Hélène said, section 8 is certainly very narrow in terms of the consent and the information required. It's really to use your gametes to create an embryo, and it's with respect to reproductive autonomy. It's a small part of the broader consent and information that's going to be provided.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Yes, go ahead, Rob.

[The Chair, Conservative, Rob Merrifield]

I have a clarification.

This is specific consent for the gametes, and that's fair enough. I think Ms. Bennett was referring to consent for the procedure, which you refer to as being under section 14.

[Francine Manseau]

Yes.

[The Chair, Conservative, Rob Merrifield]

I would question whether we should be putting some reference to section 14 in here, because we don't have 14 yet. I suppose the discomfort that we don't have 14 is being reflected in the question, so we have a difficult time judging this without 14, especially when there's no reference to 14.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Unfortunately, in our country, a lot of this is still carried out in private clinics that have a monetary advantage from people going forward with the procedure.

Are you going to put in place within the agency a 1-800 number for neutral advice, such that people can hear all sides of it, not from somebody who gets paid the more people who show up and have it done?

[Francine Manseau]

Yes. The agency has a mandate to provide educational material and information to patients.

[Carolyn Bennett, Liberal, St. Paul's, ON]

But one on one, human interaction, with a knowledgeable person on the other end of a 1-800 line? If I'm trying to decide whether to have the procedure, can I call somebody who is completely neutral and disinterested on whether I go forward or not?

[Francine Manseau]

I cannot talk for the agency, but certainly they have a responsibility within the mandate to provide educational material and information to patients. As I said, they will also be publishing outcome information that's going to be made available to the patient, that's going to be unbiased and verifiable information.

[Carolyn Bennett, Liberal, St. Paul's, ON]

My problem is, in adult education, we know that handing people pamphlets and pieces of paper doesn't work. Adults only learn in an interactive way by being able to ask questions. So I'm worried that unless we define what educational material, unless people in their own language can be asking the questions—

[The Chair, Conservative, Rob Merrifield]

Go ahead.

[Hélène Quesnel]

When regulations are developed under section 14, what constitutes informed consent, what constitutes counselling, will be the subject of the types of issues you raise today. They're valid questions, of course. We will have the opportunity of talking to parents, to children from these procedures, as well as to clinicians and practitioners to find out the current practices, as you referred to some of them, and what will constitute adequate education.

In terms of what the obligations will be on the clinics, we're not there yet. This particular section of the regulations is very specific to section 8. Section 14 will deal much more with the types of issues you raise today.

[The Chair, Conservative, Rob Merrifield]

When we last looked at the piece of legislation as a committee, one thing we insisted upon was a third party, unbiased consult. That's pretty specific, and I think this is what the discomfort is with regard to this area of the section. If it's all in 14 and we're dealing with consent in 8, and 8 is here, perhaps some reference to section 14 should be put in this area of the regs. That would help me feel better about it. I don't know how the rest feel, but thank you very much.

Madame Gagnon.