HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, March 4, 1999

• 0912

[English]

The Chair (Mr. Joseph Volpe (Eglinton—Lawrence, Lib.)): I now call the meeting to order. Pursuant to Standing Order 108(2), a study on the state of organ and tissue donation in Canada, the committee will resume its hearings.

Today we have witnesses who will share their expertise with us primarily on the issue of standards. We may go beyond that, but that is the initial intent.

We have had a couple of last-minute cancellations, I should warn colleagues around the table. People have had difficulties getting out of Toronto and Montreal, so we may find that Dr. Gary Levy from the Toronto General Hospital will not be here. He called us from the airport. Dr. Margaret Somerville from McGill University may experience the same sort of difficulties. As of about an hour ago, there was some question about whether she'd be able to make it here. At any rate, we have her down for our second panel. If things change in the next hour and a half, we may find her here.

We are, however, pleased that others could be with us, especially someone who has come from as far away as distant Calgary. We have with us Dr. John Jarrell from the Calgary Regional Health Authority, where he is the chief medical officer. Welcome, sir. From the Canadian Council on Health Services Accreditation we have the associate general director, Dr. Jules Martin. Bienvenue, monsieur.

We have a couple of other colleagues from Health Canada who have appeared before this committee in the past. We have Mr. André LaPrairie, blood, tissue, organ, and xenotransplantation project manager, Health Protection Branch. André, bienvenue. As well, we have Dennis Brodie, assistant manager, policy division, Bureau of Policy and Coordination of the Health Protection Branch. He only handles the difficult questions, and we're happy to have him here.

• 0915

Because we also have a little delay in some of our own staff's ability to get to the table, I'm going to begin with André and Dennis. Dr. Martin, you'll be the last one up. I think in baseball they call you the clean-up hitter. So we're going to set everything up for you. How's that? The slugger is Dr. John Jarrell. André, is it going to be you or Dennis first?

Mr. André LaPrairie (Blood, Tissue, Organ and Xenotransplantation (BTOX) Project Manager, Health Protection Branch, Department of Health): We flipped a coin. It's going to be Dennis first.

The Chair: Okay. Go ahead, Dennis Brodie.

Mr. Dennis Brodie (Assistant Manager, Policy Division, Bureau of Policy and Coordination, Health Protection Branch, Department of Health): Thank you. Mr. Chairman and members of the committee, we're pleased to be here again. There was a rumour that I didn't speak, so André suggested that maybe I should lead off this morning. There's also talk that we're now referred to as Butch and Sundance. I'm not sure what that means, but we'll try to live up to that reputation.

Actually, we don't have a lot to say this morning. André will provide you with a brief update, just to give you a progress report on what we've been up to during the last few weeks. But we'd be pleased to answer any questions you have about the standards process, the proposed risk management framework, anything to do with the regulation of organs and tissues in Canada.

So I'll just turn it over to my sidekick, and he can give you just a brief update on what we've been up to.

The Chair: André.

Mr. André LaPrairie: We have a Canadian general standard for the safety of organs and tissues for transplantation and specific subsets for solid organ transplantation, tissue banking, ocular tissues, reproductive tissues, and stem cells, which include bone marrow. Those subsets are now in first-draft form with the Canadian Standards Association. Someone from the CSA will be speaking to you this morning. We anticipate that the drafts will be approved by our expert committees and will be available for distribution and comment in April of this year. At the same time we will begin our consultations for the regulatory framework and methods that hospitals and tissue banks will have to demonstrate compliance to, as the regulator of the therapeutic products program.

On February 6 we also issued a notice of intent that we are developing a regulatory framework for xenographs. As well, we have a group of experts working on standards for xenographs that could potentially be used in transplantation. That notice of intent also indicates that we'll be distributing further information and that Canadians will be involved in further public consultations as we develop appropriate policies for xenotransplantation.

I think that's it for us for now.

The Chair: Thank you very much.

Dr. Jarrell.

Dr. John Jarrell (Chief Medical Officer, Calgary Regional Health Authority): Thank you very much.

I come from the balmy shores of Calgary where I've only worn a coat once this year during the winter.

The Chair: Is there a conspiracy between you and Mr. Elley here, who's going to pick daffodils later on this afternoon?

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): I lived in Calgary for nine years, and I can attest to the truth of Dr. Jarrell's statement.

Dr. John Jarrell: It's wonderful back home.

The Chair: You kind of stick together, I guess.

Mr. Reed Elley: Like glue.

Dr. John Jarrell: Although coming as the chief executive medical officer from Calgary, my role is as an individual who has been responsible for the accreditation of reproductive services in Canada for a number of years. This is through the Canadian Fertility and Andrology Society. I would like to express appreciation on behalf of the society for allowing us to participate here today.

My remarks are specifically directed toward the question, what value can the Canadian Fertility and Andrology Society bring to the state of human organ and tissue transplantation? The society has several hundred physicians, scientists, nurses, technologists, and private citizens. It began in 1954, and it has four specific missions: it promotes the study, education, and research of fertility, sterility, and andrology; it responds to social needs with regard to the complexity of human reproduction; it provides expertise in the credentialing and accreditation of clinical and laboratory therapeutics in the new reproductive technologies; and it establishes valid processes for the measurement of outcomes of therapy.

• 0920

We're aware of the Royal Commission on New Reproductive Technologies. This is one area we've been actively involved in over the past years. Many of our members participated in this activity from 1986 to 1993. Our members were both researchers and consultants on the commission. The society was aware of the concerns expressed by many regarding the need to have an improved approach to the oversight of human reproduction and its treatment. The society has participated with Health Canada in identifying approaches to such an oversight. The Royal Commission on New Reproductive Technologies recommended the creation of a national regulatory agency. Bill C-47 was proposed. It did not pass, but there are still activities taking place in that regard, and we are supportive of that direction.

In this challenging environment during the period from 1993 to the present, the society recognized the need to ensure that improved care occurred for patients undergoing reproductive treatment. We've taken a series of initiatives both alone and in combination with others to make this happen. The first activity was to create therapeutic donor insemination guidelines, which were begun in 1986. With the transmission of the HIV virus to humans by sperm transplantation, the regulations were used to create the new FDA. They were the substrate for that legislation, which was passed in 1996.

We've also had some key partnership and cooperative ventures. Although the society has identified its wish to provide expertise in the medical, scientific, and laboratory aspects of accreditation, we recognized that we had no capability of doing the actual accreditation process. So we created a strategic partnership with my colleague to my left, the Canadian Council on Health Services Accreditation. This partnership was established and past by their council, and it has been recognized recently by contracted services from Health Canada. We have also had cooperative ventures with the Canadian Medical Association, the Canadian College of Medical Genetics, and the Society of Obstetricians and Gynaecologists of Canada.

We completed standards of clinical practice for donors, recipients of reproductive tissues—and by reproductive tissues I'm referring to eggs, sperm, and embryos—and laboratory practice data requirements. The standards were written by members of the society. They were created by a process of consensus, and they have been subsequently modified to comply with the methods of the Canadian Council on Health Services Accreditation.

Together with the council we undertook a pilot testing of the standards in five university teaching hospitals that have been involved in in vitro fertilization. Approval for voluntary accreditation was received from the chief executive officers of five hospitals located in London, Calgary, Halifax, Ottawa, and Hamilton. The pilot testing met the objectives, and it was recommended that further undertakings be done through private facilities.

An additional initiative was to pilot test one private facility in 1996. This was done at the Toronto Centre for Advanced Reproductive Technologies, which is involved in all aspects of human reproductive tissue transplantation. Officials from the Canadian Council on Health Services Accreditation were in attendance. There was an invited representative from Health Canada as well. In addition to accrediting this facility, we also undertook an inspection with regard to the licensure through the Food and Drugs Act, Bill C-47, of the processing and distribution of semen for assisted conception regulations.

Again, the review of this process indicated there was sufficient success that we should proceed. We also felt that we had been able to identify a process where accreditation and regulation could come forward in a uniform method. We were able to identify that both processes of continuous improvement, as well as inspection on serious issues, could be handled through a joint effort.

• 0925

The seventh initiative was a successful application to Health Canada for funds related to standards review, establishment of performance indicators, and assistance with pilot testing of new approaches. This year, 1999, the society has received funding in the form of a contract from Health Canada to assist current work on standards and performance indicators. The society will continue to partner with CCHSA to assist with the coordination of these standards, linking them to CCHSA tools for accreditation.

In addition, our eighth initiative is to partner with the Canadian general standards project, which our colleagues have just referred to. We are part of the Canadian general standard on reproductive tissues, and we will continue that process.

The ninth initiative occurred in June 1998, and we had a consensus conference in Toronto of all IVF directors in Canada. We achieved 100% unanimity from all the directors in the IVF group that this accreditation process should be continued. They've also agreed to share all their data on outcomes.

To answer the question about the value that the Canadian Fertility and Andrology Society can bring to the state of human organ and tissue transplantation, on reflection, the activities over the past decade indicate that the society has acted and taken initiative in bringing an established approach for safety for reproductive failure. The society has worked in partnership with a number of important organizations. We feel the society brings value to organ and tissue transplantation in terms of the knowledge of its membership and its willingness to participate in a merging system that will provide better service for Canadians.

Our recommendations are twofold to the standing committee. The first is that the Canadian Fertility and Andrology Society wishes to participate with government in the planning, development, implementation and management of the appropriate oversight mechanisms that relate to tissue and organ transplantation, particularly in relation to reproduction. Secondly, the Canadian Fertility and Andrology Society wishes to offer its expertise in the field of medical, scientific and laboratory aspects of reproductive medicine.

Thank you.

The Chair: Thank you, Dr. Jarrell.

[Translation]

Dr. Martin, you have the floor.

Dr. Jules Martin (Associate General Director, Canadian Council on Health Services Accreditation): Mr. Chairman, I'd like to begin by thanking the Standing Committee on Health for giving the Canadian Council on Health Services Accreditation the opportunity to take part in this debate on organ donation in Canada.

Before I go any further, I'd like to give you a brief history of our organization. You will find this on pages 1, 2 and 3 of the fact sheet circulated to members this morning, or on pages 4, 5 and 6 of the French version.

Briefly, the CCHSA is a non-profit organization established in 1958 by health sector representatives. Its mission is to set standards for health services organizations so that the latter can assess their compliance against these standards. Assessing performance is made possible through a self-assessment process which health services organizations undergo by measuring performance against a set of standards. This self-assessment process is then validated during a visit by experts or peers who review performance indicators and measure the level of satisfaction of the clients who use the organization's services.

The value of accreditation is derived from the following points listed on page 2 of the fact sheet.

The first point is national standards that focus on processes and outcomes. I'd like to focus for a moment on the meaning we give to the word "standards". As far as we are concerned, the term refers not only to essential standards, but also to standards of excellence. Essential standards are those that demand immediate compliance at all times, whereas standards of excellence or guidelines can only be applied fully after a certain number of years.

• 0930

We talk about national standards of excellence to the extent that they are defined not by the head offices of the CCHSA, but by a committee of experts invited every three years to validate and modify these standards. That's why we call them national standards.

We advocate the use of self-assessment as a tool because in the health services sector, procedures and processes can be complex. No one is in a better position to evaluate these processes than health services providers.

Of course, one can argue that this is a highly subjective process. That is why we recommend three ways of validating the self-assessment process: first, a visit by peers, by people who are actively involved in the health services network and by experts in this field; second, a review of performance indicators; and third, an assessment of the level of client satisfaction.

In light of the CCHSA's experience in assessing health services, the working group set up by the FPT Advisory Committee on Health Services asked the CCHSA to be involved in the development and implementation of a federal-provincial organ donation and transplantation program. a brief description of the proposed national steering/coordination committee along with its mission established by the working group is found on page 7 of the handout.

Critical components of the proposed program, which is described on page 8 under Element 2, are donor identification and organ procurement. The following step is noted in point 2.1: "Develop national outcome and process standards for donor identification and procurement within hospitals". This includes identifying hospitals for which standards should apply; a process for assessing donor potential; desired consent rates; the role of key hospital staff; assessment of time needed and timely notification of the procurement agency; and lastly, and very importantly, communications with the family. Point 2.3 outlines how these standards should be incorporated into an accreditation process, while point 2.4 describes how targeted hospitals can be encouraged or required to adopt this organ procurement program.

I would like to draw your attention to the item "Considerations". In order to integrate these steps into an organ transplantation program, it will be critical to have the participation of services normally found in health care facilities, in particular hospitals - services such as emergency rooms, intensive care units and neurosciences staff.

Since the CCHSA has for a number of years been assessing the extent to which these services coordinate their activities, we feel that we are ideally positioned to add this dimension to our mandate and to encourage institutions to assess for themselves how successful they are at meeting these standards, whether essential standards or standards of excellence.

On December 7 last, we drew the attention of Health Canada officials to a document, a brief summary of which begins on page 10. This draft proposal is entitled Organ and Tissue Donation and Distribution. The project's stated objectives are listed on page 14. They include: to develop national outcome and process standards for donor identification and timely organ procurement within hospitals; and to encourage hospitals to participate in a program of this nature.

• 0935

I will now gladly answer any questions you may have.

[English]

The Chair: Thank you, Dr. Martin.

Let me go to Mr. Elley.

Mr. Reed Elley: Thank you very much, Mr. Chairman.

Again, I want to welcome all of you here and thank you for braving the weather. Dr. Jarrell and I are travelling back as fast as we can to the west after this meeting in order to get back to the warm weather.

Dr. Martin, I'm interested in the suggestions and the goals that you have outlined for us on page 14 of your document. One of the things we're grappling with on this committee is the whole question of informed consent. Most of us feel very strongly that this is something that has to be settled nationally. People who are going to be potential donors, and their families—we need to include families in this, from my perspective—should have all of the facts laid out before them before they sign on any card or whatever it is that they're going to do to become a potential donor.

You're working with hospitals to set up some kind of accreditation process so that there is a national standard across the country for organ procurement. At the end of the day, would these standards be quasi-voluntary through accreditation? If they were, and if there was a glaring incident in which informed consent did not take place, for instance—suppose something happened that caused a great deal of upset in terms of the procurement of an organ for donation—would there be any recourse to penalties against a hospital or a team within a hospital if the protocol was not followed?

[Translation]

Dr. Jules Martin: Mr. Chairman, I believe the answer to that question is yes, in that we feel we must make every possible effort to secure the informed consent of the patient or his family. In my view, a health care team or facility will have failed if it cannot show that it did everything it possibly could to obtain that informed consent.

When the going gets tough, that's when our standards, our clinical practice guidelines, come in handy, since they advise on how to achieve optimum conditions for securing this consent. It is difficult for a health services team to approach a family and to ask it to sign a donor consent form when that family feels that we, as health care providers, have a responsibility to do everything we possibly can and more to save the patient's life. Family members will immediately ask us if we have done everything humanely possible and if we are certain of our diagnosis that death is imminent.

There is no foolproof formula for obtaining consent. Rather, we want to promote the best possible approach health services teams can take to obtain donor consent. In our view, getting that consent is critically important.

[English]

Mr. Reed Elley: Thank you, Dr. Martin.

Perhaps this is a question to anyone on the panel who would like to answer it. When we look at the best way to do this across Canada, to set a national standard so that every jurisdiction is working concurrently with the others, do you have any personal preferences as to how we ought to do it? There has been some suggestion, of course, that we go to income tax forms, that perhaps the census is the proper way to go, or some other way. Could any of you share with us your own personal thoughts on that?

• 0940

[Translation]

Dr. Jules Martin: In some provinces, people are asked to sign the donor card attached to their driver's licence when they are still in good health. Nevertheless, in my view, prior consent must be obtained. And what if I am at death's door? Then my family is authorized to act on my behalf.

This same authorization is sought when a person's renews their health card. The same question is asked in each province. Perhaps there could be a place on the back of the card where a person could sign, consenting to the eventual donation of his or her organs.

[English]

Mr. Reed Elley: Thank you.

Dr. Jarrell, do you have any thoughts on that?

Dr. John Jarrell: I certainly support broadening the area and the element of awareness among Canadians in terms of the need for tissue donation. I'm also aware that it's very important to have a true understanding of what's involved with this, so I find that a signature on a card is one way to go. I'm similar to Dr. Martin in that I believe there's a lot more work involved in gaining true consent for the process.

I'm also aware of the complexities associated with another area of care, and that's in the critical care area and the complexities associated with potential donors within the critical care issue. This is an area that does require careful consideration. The appropriate recognition of what constitutes a potential donor must fall into the domain of a responsible physician involved in that debate, or else we could end up in some very difficult and inappropriate decision-making. As we proceed in that particular area, I think it's very important that we engage with critical care physicians and how to make those very difficult initial decisions that respect human life, but that also promote donation appropriately.

Mr. Reed Elley: Do any other panel members want to contribute to that?

Mr. André LaPrairie: I think you've probably heard from most of the experts who are actually in the hospital and are dealing with informed consent. They seem to be saying that regardless of the documents that may have been signed previously, they'll still be approaching families. The major purpose or use of the signed form as a tool is seen to be as something that makes it easier for families to realize that someone did want to donate. That has obviously helped a great deal in getting that consent.

So in come the logistics of what the best system is to use. If you're putting something on a census or a tax form, will that be available in a hospital? I guess that's the question, but I don't know who can answer it for you. It would seem less likely that you'll get copies of someone's tax records than you would their driver's license. The proof of the pudding is which system will give you that indicator, so that families can have an easier time making a decision.

Mr. Reed Elley: Thank you.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you, Mr. Chairperson.

I'm glad the two departmental officials have a sense of humour this morning. In fact, I'm hoping they can tell me it's a joke that the name of the department for which they work has actually been changed in all of the official public documents. We just received the estimates book, and there is not a mention of the Health Protection Branch. As I understand it, your office is now called Management of Risk to Health Services. My question, first of all, is whether or not you are in the middle of going through a name change. If so, will you soon be indicating to us that you are now working for Management of Risk to Health Services?

Mr. Dennis Brodie: That's certainly news to me. As far as I know, we're still the Health Protection Branch. I think what you're referring to in the estimates is what is referred to as a business line. There's this business line of management of risk to health of which the Health Protection Branch is a part. That's my understanding, but I'm certainly not an expert in that.

• 0945

Ms. Judy Wasylycia-Leis: I appreciate that comment. However, if one compares this year's estimates book with last year's, we have seen an actual documented change from the Health Protection Branch as the business line to management of risk to health line.

The Chair: Sorry for interrupting you, but we'll have an opportunity to go through the estimates in a very thorough fashion.

Ms. Judy Wasylycia-Leis: This is totally relevant to the discussion at hand, because in fact—

The Chair: Well, then please make the connection.

Ms. Judy Wasylycia-Leis: The connection should be obvious, Mr. Chair. We're dealing with the question of what regulatory framework is applied in terms of organs, tissues, and animal research, especially in light of the paper the department has presented around dealing with this issue, which is called “Risk Management Framework”. In that paper there's a clear debate portrayed for the public about whether to go for a firm regulatory approach that is absolutely mandatory and obligatory or a more voluntary standards-based approach. That's the debate we have to have as a committee.

I would like some information from the department officials on what basis they would recommend a standards-based approach for dealing with this whole area as opposed to a much more rigorous regulatory framework.

Mr. Dennis Brodie: The standards-based approach is certainly mandatory. What will happen, what we propose to happen, is that the standards as developed by consensus, by experts and consumers, would be referenced in the regulations, in fact then making them law and making them mandatory. That's our proposition. There is no voluntariness attached to this. There might be some confusion with respect to what the Canadian Council on Health Services Accreditation performs. Certainly their requirements for hospital accreditation are voluntary. We're not proposing that these standards be voluntary. They will be criminal law under the Food and Drugs Act.

The Chair: Dr. Martin.

[Translation]

Dr. Jules Martin: Even though the accreditation program has been voluntary for a number of years now, over the past decade, given the media's and the public's awareness of its existence, institutions are being asked increasingly why they either participate or don't participate in the accreditation program.

Health services organizations across the country are under considerable pressure to become involved in this type of program. Even we feel the pressure. Since we don't want institutions telling the media that the reason why they are not involved in the program is because they don't think it's sound, we must constantly strive to develop the highest standards of excellence and to comply with essential standards as well. I think the media and the public are to some extent transforming what was once a voluntary program into a mandatory one.

[English]

The Chair: Dr. Jarrell.

Dr. John Jarrell: Thank you. The standards approach is gaining increasing support in the reproductive areas. It is apparent, however, that in the practice of medicine things develop very quickly and change is constant. There's always progress.

I guess the benefit of the experience we had in evaluating the Toronto Centre for Advanced Reproductive Technologies was that we actually did both. We went in and reviewed a standard that was the semen regulations. We also spent a fair bit of time involving continuous improvement. It's very difficult to improve the quality of care through a policing activity only. The principles associated with continuous improvement—peer review and challenging each other—are also very valuable in moving the practice and the knowledge base ahead. The standards will never lead the practice of medicine, but they will ensure that they are in conformity with good-quality care.

• 0950

I guess I would just argue from our experience that the two can occur together simultaneously in an environment in which people really want to improve care.

As a second point, we also investigated the HFEA, which is the English regulatory authority. We went over to visit the HFEA project, which is a regulatory authority, and it's quite interesting. They operate with a very centralized authority, with a very small number of inspectors, and they operate through the clinic through what they call a person responsible. That person responsible is responsible for not only maintaining the standards of care, but also has a dual responsibility. He or she is responsible for the quality improvement and the changes in practice. So it's a dual kind of thing as well in the HFEA. I think the two have to go hand in hand.

The Chair: Rose-Marie Ur.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Thank you, Mr. Chair.

I thank you for your presentations this morning. We've had several meetings on this particular subject, and I don't want to throw a negative cast on presentations, but we've had several good programs presented...agencies.

I'm sitting back here listening to your good points here this morning and I'm wondering, are there too many groups out there? Every group that presented knew what the problems were: we have a low donation rate, organ procurement.... Everyone knows what the problem is, but we seem to see all these different groups springing up or that have been there for a while, and you just wonder if everyone is there spinning in their tracks. Everyone knows what the problem is. With all these dollars going out into these various satellite agencies, do we have a problem here? Is there a struggle for that particular agency or program to be the superstar, to come up with a great answer to what we can do here? I hope I'm wrong.

The Chair: Dr. Martin.

[Translation]

Dr. Jules Martin: Certainly we feel the self-assessment approach ensures that those involved realize the problems they have and move to set up an action plan, one that is much more likely to be implemented.

From our standpoint, validated self-assessment is the best approach to encouraging institutions and members of the general public to look favourably upon organ donation. I don't know whether any of the other associations that have appeared before this committee have mentioned the efforts made in terms of self- assessment. We feel that this is a critical element.

[English]

Mrs. Rose-Marie Ur: Did you wish to respond, Dr. Jarrell?

Dr. John Jarrell: I'm not sure the answer always has to be to create a unitary structure to be in charge of things. One of the really strong benefits of what we're seeing—and we've gone through this with the royal commission as well, where there was the approach to have a national regulatory agency to do all things. It is apparent that there are chunks that can be put together using existing facilities, even if there is sort of a small regulatory agency. One of the strongest benefits I found is actually what our colleagues have done, to get these Canadian general standards that everyone has to comply with if they're going to do organ and tissue transplantation, including all the subsets. That's a national standard and that seems to me the direction the Canadian government is moving. Whether or not that has to be housed in an organization that takes on a management capability and operational responsibilities, that's a very big question and I'm not sure that has to happen. To operationalize all organ and tissue transplantation becomes a very different model.

Mrs. Rose-Marie Ur: I agree with you. Really, our first priority should be national standards, and then a registry. Then probably the next issue that comes up quite often is the true consent. As you are well aware, you can sign your card, but the family is there to decide otherwise should they feel differently at that particular time.

• 0955

Would that be your order of significance on making progress?

Dr. John Jarrell: Absolutely. I would agree that the first priority in this area, the standards of care, is absolutely fundamental. The aspects of consent derive out of that. I believe what we're going through here is a political debate, because there are some very strong feelings held about this consent issue.

Mrs. Rose-Marie Ur: Are recipients used a lot in that? Recipients and their families I think would be a most welcome tool on that particular avenue to really extol the virtues of going through the process. We can judge from being outside, but they can judge from being within. Are they used often?

Dr. John Jarrell: Probably not as much as they should be.

I run the medical staff for Calgary Regional Health Authority. There are 1,700 physicians there, four hospitals, four intensive care units. We are very supportive of organ tissue donation, but we're concerned as well that we don't look at everything through a single pipe. There are other aspects of care.

I mentioned the intensive care physicians. Our concern is that the physicians who are responsible for identifying potential donors are held accountable for their activity professionally. That has to happen. But in addition to that, people should be making the right decision.

There's a lot of concern being expressed by our critical care physicians that inappropriate pressures that are not truly informed consent could lead to inappropriate use of ventilators in ICUs. They are concerned that it's very important that the first decision be made on a totally knowledgeable basis and that the physicians involved be responsible and accountable for their decisions.

They have a very compelling argument. I think it speaks to the nature of looking broadly at a serious problem and not just focusing through the lens of transplantation but looking at it broadly through the practice of medicine.

[Translation]

The Chair: I have a question for you, Dr. Martin. On page 13 of your submission, the following is stated in the fourth paragraph: "It is also perceived that Ontario and Quebec have the least...

[English]

for sharing organs, since they can meet most of their needs internally. Maybe it's the weather, but that sounds to me like there isn't really a problem in Ontario and Quebec. If they can meet their needs internally, where's the organ shortage?

[Translation]

Dr. Jules Martin: This perception is no doubt due to the high population figures in these two provinces. This is the opinion of the Advisory Committee on Health Services, not ours. It is our view that these two provinces experience the same kinds of problems as other provinces do. Because of the larger population, there is a greater likelihood of organs becoming available, but the need for organs for transplantation may be even greater. There are more people who are sick because the population is larger. We do not share this view. It is someone's else opinion, not ours.

[English]

The Chair: I just didn't see that the perception was wrong.

Dr. Martin.

[Translation]

Mr. Keith Martin (Esquimalt—Juan de Fuca, Ref.): Thank you very much, Mr. Chairman.

[English]

I'm getting confused here with the two Martins at the table.

The Chair: So we shouldn't call you Dr. Martin.

Mr. Keith Martin: Thank you very much to all of you for coming today.

Dr. Jarrell, it would be safe to say that transplantation is a safe procedure in Canada today. I think it would be safe to say also that transplantation is done as a critical intervention for somebody who, if they do not receive that, will probably die or at best be on a life-supporting mechanism such as dialysis. I would submit to you, sir, that because it's safe and because of the nature of the procedure, we should not wait for national standards to be established in this country before we implement something like a national registry, which could be essential in increasing the available number of donors, of which we have a critical shortage at this point in time.

• 1000

If we prioritize what we need in this country today, we desperately need an increased number of organs that are available, and the establishment of national standards can in fact wait. I was reading the provincial-federal agreement and all the complexity of the national standards—which one of course has to go through—and I felt a bit saddened that if we waited for the i's to be dotted and the t's to be crossed, many more Canadians would die needlessly.

I would submit to you that question: Do you think that would be more reasonable, that we institute things such as the national organ donor registry and other interventions before we wait for the standards?

I would also ask Mr. LaPrairie if he feels that punitive measures would be necessary against hospitals that are not fulfilling their expectations. I'm not in favour of punitive action against hospitals; I think convincing them that it is in their best interest and the community's best interest to participate in organ donor retrieval procedures is a better way of doing it.

Lastly, with respect to the standards, the United States has standards. Do we need to reinvent the wheel, or can we adopt and look at much of what they've done and just put them in the Canadian context?

I'll open that to whoever wants to answer those questions. Thank you.

The Chair: Dr. Jarrell.

Dr. John Jarrell: Well, I'm not familiar with the process on approval of the standards. I guess having participated in the establishment of the Canadian general standard, my sense is that these are being undertaken now by those individuals who participated with the standards. They are moving out. The ones related to our society have been endorsed by our board.

It's an evolutionary kind of thing. So I'm not troubled by the timelines on organ donor registry and standards development, because I think the standards that have been put together by the groups are moving into place anyway through the voluntary actions of societies. And the solid organ group are using those activities. People really want to do the right thing. We live in a community where people practise a very high level of medical care, so I think those who are really interested....

I think what you're asking is whether you can have a system of compliance and inspection in that regard before you do the donor registry. No, I don't have that problem.

Mr. Keith Martin: No, the crux of my question is do we have to wait for these national standards to be implemented before we actually implement things such as a national registry or a mandated choice strategy, which would in my view greatly increase the number of available donors in a very short period of time and give critical relief to the people who need it now, rather than waiting a year and having another 150 Canadians die unnecessarily?

Dr. John Jarrell: No. Personally, my sense is that these standards are not going to be like a light switch, and all of a sudden you're going from nothing to something. There is an evolutionary practice happening here. If there can be a process for donor registry, I certainly wouldn't object to that.

Mr. André LaPrairie: To speak on the implementation of a standard, they've already gone out in draft form to transplant programs. We've already seen many programs now standardizing their practices for screening donors, doing blood testing, keeping records. So even before the standard is finalized, we already see a change in activity, and it's encouraging. So you get that grassroots support for that standards practice.

I'm not a lawyer, so I'll let Dennis answer maybe in more detail about punitive measures. I guess you have to have them, but I think they're the last resort. It's best to have peer pressure and a desire to meet the standard, rather than the threat of being thrown in jail. I don't think we can count anybody who's been thrown in jail with respect to blood regulations in the past. So is that really a perfect solution to it?

• 1005

On the comparison to standards and the national registry, I guess the question is how quickly could a national registry be established and actually show benefit? It's still a new concept. The challenge of a proposed national or provincial registry is to see an increase in the number of donors. A standard can actually include, over and above the safety elements that are already there, talk about standards for identifying donors in hospitals and standards for the education of medical staff auditing the practices. Those standards are not safety standards. They may not be referenced in the food and drug regulations, but they are part of an accreditation process. Again, you have one focus through the standard that can achieve many things over and above simply the safety of transplants.

Do you want to say anything about punitive actions?

Mr. Dennis Brodie: I just want to agree with André and Dr. Jarrell. I think the best approach is this whole concept of best practices and peer review. When people buy into the standard and recognize it as the best practice, they tend to follow it. At the end of the day if there is a problem, certainly when a standard is referenced under the Food and Drugs Act, all the enforcement tools will be available to the federal government to take whatever action is necessary in the circumstances. Whether that means removing a licence, or filing an injunction or criminal prosecution, the whole range is there. What is appropriate in the circumstances is the question we can't answer.

The Chair: Let Dr. Martin respond to that and then you can come back.

Mr. Keith Martin: Just a clarification from Dr. Martin.

The Chair: Go ahead, Dr. Martin.

[Translation]

Dr. Jules Martin: If I understand your question concerning a national registry, I agree that moving quickly to set up such a registry won't increase the number of available donors. That will only happen when steps are taken to develop standards to encourage people to become organ donors.

If a national registry were in place today, it might be easier to find an available kidney in Newfoundland for a patient in Alberta, but it wouldn't make any immediate difference in the number of donors.

[English]

Mr. Keith Martin: I'm glad, Dr. Martin, you mentioned that. This goes for both you and M. LaPrairie.

As a point of clarification, I have been pushing for a national registry, but hand in glove with that has to go an increased opportunity to be an organ donor. When I mentioned the tax forms, it really would not be an opportunity for people to access people's income tax returns. Rather, on an income tax form there would be a separate sheet asking whether you wanted to be an organ donor or not. Every year you would have an opportunity to complete that. You could send it in to the national registry, for example, where you would have an opportunity to access that, perhaps through people's social insurance numbers or health numbers—particularly the latter.

It would not be linked, from a computer aspect, but would just increase the number of opportunities to be an organ donor, rather than once every five years by noting it on your driver's licence, which is completely and wholly inadequate. Marrying those two would increase the potential number of organ donors.

The Chair: I'm glad it was a brief question for clarification. I'm not sure that really required a response. If you feel you want to....

Mr. Keith Martin: Maybe a brief response.

The Chair: M. LaPrairie.

Mr. André LaPrairie: I think it would help to actually see described what you mean by a national registry—what the resources would be, what it would cost and how it would work. We've at least done that for our risk framework. It would be a lot easier to answer those questions if we knew what you meant by using the tax form, how a registry would be set up, how a hospital would have access to it, and how much it would cost.

Potentially it would have some benefit. It would provide some focus to donation rates. Right now there are many unanswered questions. It would be a lot easier to see a document that described what you hope to achieve.

• 1010

The Chair: Dr. Martin.

[Translation]

Dr. Jules Martin: Personally, I would object to having any record of my prior consent included in a national registry. Between the time prior consent is given and the moment some event occurs, such as my being admitted to an intensive care unit and the doctors evaluating my condition and my family endorsing my decision, there are too many possible variables. Therefore, I wouldn't want my name included immediately in a national donor registry.

The Chair: Thank you.

[English]

Mr. LaPrairie, you just made reference to the framework and in the framework you mention the general standards. You referred to them again in your presentation and response to Mr. Martin. Did you make those available to the committee, or are they for publication down the road?

Mr. André LaPrairie: We're waiting for the standards to be translated, so we hope they'll be ready for the community before much longer. That's been the only delay in getting them to you. We can provide some of the previous copies that were translated so you'll have an idea of what we're talking about, if that would be helpful.

The Chair: I think it would be helpful if the committee got a sense of them, because my understanding of your timetable is that they might actually be made public after the committee has concluded its study.

Mr. André LaPrairie: We'll make sure you get to see previous drafts, and we'll rush the translation so you can see the final drafts.

The Chair: Thank you very much.

Madam Caplan.

Ms. Elinor Caplan (Thornhill, Lib.): Thank you very much.

On the question of a national registry, the concern I have, based on the evidence we have heard, is that even when you have donors identified you still require families to be sensitively approached. It's fine to have the registry, but if people are not being asked in a way that will encourage a positive response, whether you have a person on a registry or not, you may not see the donor rates increase.

With the one they have in British Columbia, they're able to show the family the signature of the person. I found that quite an interesting model because part of the approach to families, in helping them understand the wishes of their loved ones, would help to improve donation rates.

I personally feel wishes should be respected, but I'm very aware of the traumatic time for family members and the need to deal sensitively with them. I would hate to see a regime put in place that did not involve the family in that important decision.

I'm concerned about focusing just on the development of a national registry and assuming that's going to fix the problem. My sense, from the evidence we've heard, is that alone will not give us the results we want.

I wonder if you want to comment on the different pieces that are necessary—the federal role and the provincial role—in making a real difference in both organ donation rates and ensuring that we do something effective as opposed to just window-dressing.

Dr. John Jarrell: I'm sensitive to your comments.

One of the challenges of the low rate of accrual of donors is, in part, the professional accountability of the attending physicians. There's a legitimate question as to whether or not we have been aggressive enough in holding the profession accountable for ensuring that is a standard of care overall.

Whether you have standards or an organ donation database, there needs to be an appropriate approach, probably by our provincial colleges of physicians and surgeons, to elevate the professional integrity of those who are involved in care. It certainly has come to our attention that extreme frustration exists when a patient is extubated in the emergency room, there could be a donation, but there just isn't the time or effort made to approach the family. So my sense as a clinician is that there's a better bang for the buck in trying to improve the practice standards of physicians involved in this—and there are initiatives ongoing—rather than creating a policing kind of function, which never works in the practice of medicine.

• 1015

Ms. Elinor Caplan: But you do use the term “accountability”.

Dr. John Jarrell: Yes.

Ms. Elinor Caplan: What sort of accountability mechanisms do you envision would work?

Dr. John Jarrell: They fall into the complex matrix of professional accountability that exists in hospital-based systems, regional health authorities, licensure, but the accountability for most physicians to change their practice is still that they don't want to be seen as an asterisk. No physician wants to be seen as being six standard deviations outside the mean.

Ms. Elinor Caplan: So public reporting of—

Dr. John Jarrell: Accountability or even reporting of individual physician practice within their divisions to give that information to the intensivists on availability of donors, or the true sense that this is an important enough issue that your department head or division chief is really beginning the process of education. So it should be something that is owned not only by the transplantation teams but also the critical care teams and the emergency physicians, particularly neurosurgeons, for example.

So where is the continuing education and professional development in that? My sense is that there's much more value with a concerted approach there than in creating a policing state.

Mr. André LaPrairie: It's a little bit unfair to criticize too strongly the issue of a national registry or provincial registry, and maybe the best people to tell you whether it's working or not are in British Columbia. They certainly are the furthest ahead. They'll probably have a nice description of how it works and what it costs and they may be the best ones to say how this can unfold.

Clearly, the experience of most people when they are being approached for a donation is that if a donor card is signed families tend to respect those wishes, so the question is how can you get that information to them consistently so that you'll have the good batting average that people want to see?

The Chair: Mr. Jackson.

Mr. Ovid L. Jackson (Bruce—Grey, Lib.): Thank you very much, Mr. Chairman.

Right across the board, not only in this particular committee, we hear that other countries perform certain things and do them; they've already had the trials. But yet when we get into studies like this we tend to stall, because sometimes we are told we have to go through the trials and have the appropriate practices before the Health Protection Branch gives permission to go ahead with a new drug, or a new technique or what have you.

I would like to know why it is that we can't adopt the U.S. standard or the European standard, for instance, and how we come to our conclusions. How do our methods differ from the rest of the world?

Mr. André LaPrairie: I think we always look to international standards as an option, and if there were ones readily available and they met the criteria that they've been achieved through consensus, that they're in both official languages, etc., it makes it easy to reference them. In fact, for pharmaceutical drugs many times that takes place. You reference an international pharmacopoeia or whatever.

The U.S. isn't necessarily further ahead in the development of standards than we are. They're probably further ahead in describing which tissues fall within their jurisdictions and which ones are medical devices or whatever, but I don't think they're further ahead in standards, at least not for transplanted organs or tissues. In fact, we're hearing comments that they like our model, especially because we're standardizing all of the areas.

In the U.S. they regulate organ transplantation separately from stem cell transplantation, separate from tissue transplants, and they're just now trying to figure out where reproductive tissues fit in. So maybe if they had to start again they would have chosen a comprehensive standard, as we're doing.

Mr. Ovid Jackson: Is their system driven more by the industry than the national public good? How does our system compare with them in that regard?

• 1020

Mr. André LaPrairie: For solid organ transplantation, it was the public good. They recognized, again, maybe they have a different health system and there was some inequitable allocation of organs, so they actually put together an act and established organ procurement organizations throughout the country that are run by contract through their federal government. In that case, certainly, public good was established.

For tissue banking, since they're able to recover costs, it was the industry that actually set up standards in tissue banking, because they had to make sure they didn't have competition that was cutting corners. They set up accreditation almost independently of the government initially, and now the FDA is getting involved in that practice. So depending on what kind of transplant you're talking about, there are different aspects to it.

Mr. Ovid Jackson: I don't want to get into the ethical part of who gets the organs; that's always a problem. I know my colleague Judy usually asks that question. But once you get into this two-tier system, the problem does become that those with the most resources and the people who know the most will be those ones getting the organs.

Are we talking about enough safeguards to make sure this does not happen?

Mr. André LaPrairie: Our system is different from the Americans', and so because we already have hospitals that are run by the provinces, there's no competition. Certainly each province runs its own list of patients waiting for organs and allocates them on an algorithm basis. You probably heard that from some of the other experts. I don't think there's a claim that there's a two-tier system for allocating organs.

There is some concern that different provinces may have different criteria for listing their patients and for allocating the organs; that makes it hard to share. If one centre decides that patients over the age of 55 will not be listed for a heart transplant and another centre has a different rule that says 65 or 70 years of age, that makes it hard to share between centres. Why would you share a heart if you wouldn't have transplanted that patient in your own hospital? That's maybe where they're looking for some standardization.

Mr. Ovid Jackson: Thank you.

The Chair: John, do you want to close this part off?

Dr. John Jarrell: Just for information, in the reproductive area there's not uniformity on insurance payments, and most provinces actually do not pay, so it exists as a two-tier system of access in Canada. In Alberta, none of the reproductive technologies are paid for; in Ontario, some are, some aren't.

Just to answer your question, there is a two-tier system in reproductive care.

The Chair: Mr. Vellacott, very briefly.

Mr. Maurice Vellacott (Wanuskewin, Ref.): We have come back at this a time or two before, and that's the whole issue of how you get this into a national census form, or an income tax filing thing, this type of scenario. I still think our researchers are going to get back to us in terms of there being criminal prosecution, for example, people not filling in a full census form, this type of thing.

I missed the first part here. Was there comment in respect to that in terms of the advisability, or maybe not the advisability, of putting it on such a thing as a census form or an income tax form in terms of a donor check-off kind of thing? I don't know what the form of the question would be. It would have to be specific, such as there might be some measure, or perceived measure, of informed consent. Does each of you have any comments on that?

Mr. André LaPrairie: I said earlier that I think we would need to see more details on how that census would work, how it would be accessible by hospitals, in order to provide any real comments. Right now it sounds interesting, but to give you really concrete opinions would be difficult.

Mr. Maurice Vellacott: Dr. Jarrell.

Dr. John Jarrell: Again, I have a similar position to that of Mr. LaPrairie. How this would work, and its operationalization, is very complex, and I think it would enhance our awareness and improve the donor accrual, potentially. But it still falls into that complex morass of what happens in the practice of medicine. I think that's where the devil is in the detail on this one, because it does fall into practice, the day-to-day practice.

Having signed the name, does that automatically mean there will be a donation in the event of an untoward occurrence? I'm not sure that will always occur and that this would still be an appropriate thing to do. That's where the system, whatever one it is you're recommending, would have to take into account the complexity of services that occur in care.

• 1025

Mr. Maurice Vellacott: Do I hear you saying, then, that it would almost be like an indicator of interest, and that you'd still have to go through the refinement if an accident happened or there was a person...that you'd have to check it out thoroughly again and be sure this is what they meant and so on?

Dr. John Jarrell: My sense is that the success of improving rates of organ donations for transplantation is a multi-targeted approach in which there's professional development among the clinicians, perhaps a donor awareness campaign or a sign-on for interest, but it needs to be a broad and comprehensive approach. There's no single silver bullet that's going to fix it.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Earlier, Dr. Jarrell, you made the interesting comment or astute observation that this country is moving towards a more standards-based approach, and you referenced that in terms of reproductive technologies. In your estimation, then, is it likely that we will never see replacement legislation for Bill C-47 on this whole area?

The Chair: Ms. Wasylycia-Leis, do you want to make the connection with what we're talking about here, with organ donations?

Ms. Judy Wasylycia-Leis: Mr. Chairperson, I'm referencing a point made by one of our speakers, a clearly stated indication.

The Chair: We're not talking about Bill C-47. We want to stay on topic.

Ms. Judy Wasylycia-Leis: We're talking about tissues and organs, and my question pertains precisely to this whole issue. It's a matter that my colleague Pauline Picard has raised on numerous occasions. I think it deserves an answer, and I think you should allow this to proceed uninterrupted, Mr. Chairperson.

The Chair: I'm going to ask Dr. Jarrell if he wants to respond, but there's no reason to get into the issue of whether Bill C-47 would come again. Go ahead.

Dr. John Jarrell: I will give you a personal observation. My sense is that Health Canada is moving in a regulatory sense, although I don't know the details. We're supportive of that concept, but I guess I don't know how it works between that and what this group is doing. I think we really need to get our ducks in a row on this, though. I'm hopeful that we will have something that's a whole lot better, because I personally am very upset that even to this date, about six years after the royal commission, we don't have any. We've done what we can in terms of accreditation, but I'm concerned Canadian women still don't know what the success rate of the clinic is that they're going to when those women are still paying out huge sums of money. I'm very troubled that we still have that defect in our system, so I'm very encouraging of any kind of regulatory process, whether it's son of C-47 or what my colleagues are doing. It doesn't matter, but we have to do something.

Ms. Elinor Caplan: Don't you think people should have the success rates for the possible procedures?

Ms. Judy Wasylycia-Leis: I have a few more questions. Could I finish my question?

The Chair: Madam Caplan and Madam Wasylycia-Leis, I will entertain a continued question on this topic. I will rule another question in that general vein out of order. Go ahead.

Ms. Judy Wasylycia-Leis: Thank you, Mr. Chairperson.

I would like to pursue Dr. Jarrell's other comment around an objective that he said should be before this committee, that of a balanced approach with respect to organ donations and tissues. I think everyone would agree with that. My concern is that the proposal, the risk management framework for this area, doesn't provide that balanced approach. It talks about a standards-based model and rejects the regulatory approach. In fact, it suggests that licensing and inspection of programs is too costly and that we therefore must pursue other approaches.

I think Canadians would be frightened by that notion, and I'm wondering if we can't find a way to combine a standards-based approach—which no one would disagree with—with a proactive role on the part of government to at least do occasional inspections of programs, to do investigative work, to do scientific surveillance, so that Canadians can be assured of the organs that are being brought in or used for transplantation.

The Chair: Mr. LaPrairie, you have about thirty seconds to answer that.

Mr. André LaPrairie: I think you may be reading into that proposal that we would not be doing any of those activities you just described, and that's not true. What we're trying to do is allow third-party accreditation to be part of the demonstration of compliance, but we would still have inspectors and they would still do audits. They may even, as we work towards solutions, do combined inspections. But the idea is to take advantage of the experts, take advantage of an accrediting system that goes beyond the safety of organs and tissues and into the practice of transplantation, and to harmonize those two elements. So it is not to spend all our resources on regular annual inspections, but to do audits, to do follow-ups, to do the surveillance work, which you may hear in the second round of presentations.

• 1030

The Chair: Thank you very much.

Mrs. Redman.

Mrs. Karen Redman (Kitchener Centre, Lib.): Thank you, Mr. Chairperson.

I have two quick questions. The first one is for clarification from Dr. Martin. When I read your brief, is it accurate to say you're costing out your model at $150,000 over three years?

[Translation]

Dr. Jules Martin: I can't give you any information on that. I think it's in line with the amounts Health Canada claims to have given us to start up the program. But I can't give you any more details at this time.

I can tell you, however, that this usually includes the research, setting up a panel of experts, gathering documents that have been put out by the regulatory body, training experts for site visits, training institutions on the self-assessment process and lastly, conducting the site visits per se.

I can't give you a breakdown of the funding, at least not today.

[English]

Mrs. Karen Redman: Thank you.

Dr. Jarrell, you really struck a chord with me when you were talking about how comprehensive the approach needs to be. I would agree with you. That's certainly what I've taken away from the witnesses.

In your view, aside from the regulatory things the government can do and the fact that we can train and put teams in place in national hospitals, as far as the comprehensive education of the Canadian population goes, have you turned your mind to that at all? What would be the best thing the government could do, and who would be the lead organization?

Dr. John Jarrell: I don't know, except that I'm aware that the government has provided leadership on teenage health, smoking cessation—a variety of things. I think a similar initiative could be undertaken with significant benefit.

I don't know that I would know which organization would take the lead on it. It's a provincial mandate in terms of health. But my sense is that there would be an opportunity perhaps to speak to the.... I really do think one area needs to be provoked, and that is the provincial colleges, sort of elevating the professional standards in our own profession. There are mechanisms for doing that.

So I think professional communication to all Canadians about the importance of transplantation is important. I do think the activities that are taking place regarding licensing...if people know that licensing is there, they're going to behave well. But you can't police the practice of medicine. So there has to be more than that, and I think that's what my colleagues are saying.

Mrs. Karen Redman: Thank you.

The Chair: Thank you very much on behalf of all colleagues around the table.

Ms. Elinor Caplan: Can I have just one small question?

The Chair: No.

Thank you very much, Dr. Martin, Dr. Jarrell, Mr. LaPrairie, Mr. Brodie. As always, and especially for the last two, you've been most informative and helpful. Thank you, and Godspeed on your way home.

We're going to take about 90 seconds before the next group. Thank you.

Ms. Judy Wasylycia-Leis: I have a point of order, Mr. Chairperson. I wonder if you could clarify the rotation system you're using for this committee so that we'll know when on the opposition benches we get a chance to ask questions. It had been the practice that we rotate back and forth. That has not been followed this morning. There are five people on the opposition side. I think there should be an ample opportunity to ask questions. Could you clarify?

The Chair: Sure. You're on pretty shaky ground here, Madam Wasylycia-Leis, because of the nine people around the table today you had two of the nine sets of rotations. One of your sets of rotations went for eight minutes, three minutes beyond the usual five.

The process for rotation is that the opposition gets two. Then we go to the government side. Once I've satisfied both sides, I go according to the order.

• 1035

You were satisfied initially, as was the Reform Party. The Bloc eschewed the opportunity to go. Government members went according to order, and then I went according to the order of those who requested. I accommodated Mr. Vellacott because I want to give all members an opportunity to ask questions.

Madam Caplan.

Ms. Elinor Caplan: I would like to put my question on the record. If the witness would be prepared to answer in writing, I would be pleased.

Dr. Jarrell raised the fact that people don't know success rates of procedures. I'm wondering if he's aware of anywhere in this country where individuals—

The Chair: Madam Caplan.

Ms. Elinor Caplan: —can get that kind of information on any procedure—

The Chair: Madam Caplan.

Ms. Elinor Caplan: Why can't I ask a question?

The Chair: Because I've already adjourned this section. We can write to the witnesses.

We'll invite you to respond to any other questions in writing. Thank you.

We'll suspend for two minutes as the other witnesses come forward.

• 1036

• 1040

[Editor's Note: Technical difficulty]

The Chair: ...by Dr. Antonio Giulivi, associate director, bureau of infectious diseases, blood-borne pathogens division, at the Laboratory Centre for Disease Control, Health Protection Branch. Welcome, Dr. Antonio Giulivi.

As well, from Health Canada, we have Mr. Brian Crowell, who is the director of the Canadian Blood Secretariat. I see that Dr. Margaret Somerville from McGill University's Centre for Medicine, Ethics and Law, has made it, notwithstanding our first concerns that she might not have been able to make it. Welcome. I'm glad you made the trip.

From the Canadian Standards Association, we have André Wisaksana, who is the project manager for standards development. Thank you very much.

The process is that we go for about five minutes apiece and then we'll go into question and answer. I think some of you were in the audience, so you'll see that members are anxious to ask questions.

Let's start with André Wisaksana.

Mr. André Wisaksana (Project Manager, Standards Development, Canadian Standards Association): Thank you, Mr. Chairman, and thank you for the opportunity today to speak before the committee.

I'd like to start by introducing CSA a bit. I'll lead off into CSA's involvement in the area of standards for safety of transplantation of organs and tissues.

CSA is an independent not-for-profit organization. We're a member-based organization with roughly 8,000 members. We're a leader in standards development and in the application of standards through certification testing and management systems registration. All of our standards are developed through consensus by technical committees of members. Our members represent groups most likely to be affected by a particular standard.

The process for standards development really starts when a request is made by either manufacturers, industry associations, consumer groups, educational institutions or government to help with a particular issue around safety, performance or quality. The process of standards development involves an open and transparent, consensus-based decision-making process. That's outlined within a publicly available document entitled The CSA Policy Governing Standardization. It's a code of good practice for standardization.

Our process ensures that the views of all parties involved in standards development are adequately considered, with every effort made to arrive at solutions that ensure an effective standard and yet reflect legitimate concerns of all parties involved in the process. Using this process, we have established standards for a wide range of areas, health care being one of them. Our involvement in the area of national standards for transplantation came about out of a Health Canada request.

The use of national standards to address safety in transplantation is a unique approach, given the broad range of participation of stakeholders who would be part of this. Our role at CSA is to provide the forum whereby consensus may be achieved and to manage, facilitate and ensure the integrity of the standards development process.

At this point in time we're expecting six standards on transplantation. The first one of them will be an umbrella document with five particular subsets. The standards are currently in the early stages of the development process. To date, I can say that the administrative framework for a technical committee has been established. An inaugural meeting of this committee is planned for some time in June 1999.

We have also identified a chair-designate for this committee. He is Dr. Paul Dubord, who is also the chair of the Canadian Eye Bank Committee and the chair of the international medical standards and accreditation committee of the Eye Banking Association of America. This committee is using the draft documents that have been developed by Health Canada's expert working group on the safety of tissues and organs for transplantation. We anticipate completion of the standards by December 1999.

That marks the end of my presentation.

• 1045

The Chair: Thank you very much.

We'll go to Dr. Margaret Somerville.

Dr. Margaret Somerville (Gale Professor of Law, McGill University Centre for Medicine, Ethics and Law): Thank you, Mr. Chairperson.

I must admit that as an ethicist sitting here listening to the previous discussion, it was very hard to remain in my seat, because there were so many issues you brought up that have ethical implications and effects.

One of the things I thought about, in listening to that, is that it may be beneficial to try to structure some underlying ethical framework through which you could view these issues. I certainly can't do that in five minutes today, but there is a document that was done for the Canadian Biotechnology Strategy, which tried to set out how you go about setting up an ethical framework, and that is part of the Biotechnology Strategy's web site. That's something that could be useful to this committee as a background document.

For instance, when I listened to the questions this morning, it was obvious, I would suggest with respect, that you need to separate issues that we would call micro-level ethical issues. For instance, informed consent is basically a micro-level ethical issue because it involves what you have to do in a relationship between an individual physician and an individual patient. There are also of course other levels of implication of that, because what we do with it forms our values. But when you look at something about setting up a regulatory system, you're talking about meso- or institutional-level ethics and often macro- or societal-level ethics. The kinds of principles that you use ethically at those levels are not necessarily the same as the ones you use at an individual level. So that's really by the way.

I did prepare a short text, and so I'll mention the points I make in that, and then if the committee has questions perhaps I can address the issues more fully there.

First of all, we always need to keep in mind, in dealing with medicine, and if we're particularly engaged on one treatment or process, that this forms part of a very much larger whole and that we can't deal with that issue in isolation. There are concerns that sometimes, particularly in recent years, we get focused on some very high-tech intervention, we try to work out rules for that, and we don't realize that those rules also have to be compatible with our whole general medical, ethical and legal structure. So that would be the first point.

The other point is that people relate very powerfully to medicine, so what we do right in medicine becomes something we do right in society in general. But the correlative is true as well: what we do wrong has very much broader implications than just that treatment or just medicine itself.

Interestingly, organ transplantation has always been at the forefront of facing new ethical issues in medicine. In fact, most of us in bioethics regard the first heart transplant as the birth of bioethics. Also interestingly, after we went through great trauma about how to deal with that, we thought we had solved all of the issues when we got heart transplants initially organized. We were of course very wrong, and organ transplantation has continued to face us with new and difficult issues.

We do need to keep in mind, as well, how extraordinary some of the issues that the first heart transplant faced us with were and how very much we've become used to those issues. In a way, this committee is a revisitation of those. For instance, I saw a newspaper report of the evidence you had presented to you on what constitutes death. We went through enormous traumas, including preparing a report of the Law Reform Commission of Canada, as it then was, on what we called the “criteria for the definition of death”; and this idea that we would define “criteria” to identify when death occurred rather than defining “death”—which is a very sophisticated and subtle difference—hadn't been articulated at that time.

The most recent controversy in that area is whether we should require full brain death, which is what we require in Canada, or whether upper brain death would suffice. I think it should be full brain death, and that's currently what I believe the law is in Canada. In that area, there's been a very recent controversy with the complete reversal of opinion by one powerful medical group in the United States.

As I also know you've heard in evidence presented before you, there's a severe shortage of organs from infants for transplantation. One suggestion was that what are called anencephalic infants, that is, babies born without an upper brain, could be treated as a special class of organ donors and that they would be called brain-absent instead of brain-dead. At one point, that was recommended by one group in the United States. The outcry that followed caused that recommendation to be reversed. You can imagine the ethical issues doing that raises.

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Other controversial issues are whether we should use contracting in, which I believe you've heard of by now, or contracting out. Within that there is a very important ethical sub-issue, which I heard raised this morning, that is, when the person has signed an organ donor card, transplant surgeons in practice always require the consent of the family if the family is there, but should we be doing this ethically and legally?

Within that context again I think there's a special group of people, parents whose children have met sudden death and those children are the donors. Some of these parents—for instance, the founders of The Silent Hearts group in Australia—as a result of their own experiences of trauma and suffering, have set up donor family organizations to try to anticipate the harms and reduce these. Now, what's important about that is that it's not just a “feel good, let's be kind” approach. Reducing the suffering of families and increasing the likelihood of organ donations through non-coercive means actually makes organ transplantation and the collection of organs for that more ethically acceptable than it would otherwise be. So some of the things we have to think about are the ethics of non-coercive means.

In short, every time we thought we had things fixed in organ transplantation, we didn't. What I'd like to put on the table for you this morning is the latest area where we definitely know we haven't got it fixed—and I'm not sure what presentations you've had on this—that is, the issue of xenotransplantation, taking organs out of animals to put them into humans. This is ethically challenging us in very profound ways.

Xenotransplantation raises all of the ethical issues faced in medical research involving human subjects in general, which are pretty extensive, but it also raises some special ethical issues. Perhaps I could just name a few of those for you.

First of all, it involves transgenesis, putting human genes into animals. So that raises an ethical issue.

Secondly, it involves the use of animals as the source of donor organs and, in particular, the ethics of the way in which we treat these animals to make them suitable for organ donor use in humans. That is a very big issue that has to be addressed.

Thirdly, there are risks not only to the direct research subjects but also to their sexual partners and families. There's more concern with xenotransplantation about risks to secondary subjects than in the vast majority of other medical research. Scientific and ethical requirements include lifetime monitoring of transplant recipients, their partners, and families. So of course you don't just have the informed consent issue with regard to the transplant, you have the issue of future projection of informed consent, that someone will agree to be lifetime monitored, which we don't usually have.

One of the features of the informed consent is that you can withdraw it at any time. It raises possible confinement should the transfer of the next infectious agent have occurred, and it raises issues such as compulsory autopsy after death. That might sound simple, but, for instance, some religious groups have a religious prohibition on autopsy. Would that exclude them from xenotransplant were we to introduce it? So you can think of all sorts of ethical ramifications.

There's also, most contentiously, the possibility of the transfer to the public of an infectious agent from a person who had received an animal organ, which could spread through the human population.

Outside the context of xenotransplantation itself, and something that's raised as well within organ transplantation in general, is the allocation of health care resources. We are governing our medicine at the moment largely through political pressure brought to bear by advocacy groups. But we do have obligations for the larger common good, and a lot of that common good is not represented by advocacy groups. So there are very large ethical issues in how those resources are allocated.

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Finally, I'd like to turn to the ethics of public involvement in the decision-making concerning xenotransplantation. Although there are good arguments for public involvement in general in ethical decision-making that concerns society, there is a stronger than usual argument in relation to xenotransplantation. If the public is potentially at risk from this, then under the usual ethical requirements governing medical research the informed consent of those people put at risk by the research must be obtained. Clearly, it's not feasible to obtain the consent of each Canadian citizen, but before proceeding with any clinical trials of xenotransplantation, there must first be a very informed, widespread public debate. Ultimately, I suggest to you, it must be Canadian society that decides whether to proceed with xenotransplantation and, if so, under what general conditions.

There are problems there to how we can establish an adequate public debate, but what I would suggest is that when we work out how we can do that, we should proceed on the basis of what's called a precautionary ethic. That would mean that the burden of proof of showing reasonable safety and ethical acceptability of xenotransplantation would be on the people who want to undertake it. In assessing that, we also have to assess what other developments might be available that would make taking the risks of xenotransplantation unnecessary.

Thank you.

The Chair: Thank you, Dr. Somerville.

Dr. Antonio Giulivi.

Dr. Antonio Giulivi (Associate Director, Bureau of Infectious Diseases, Blood-Borne Pathogens Division, Laboratory Centre for Disease Control, Health Protection Branch, Department of Health): Thank you, Chairperson.

I could bring to the table two or three perspectives now that I'm dealing with surveillance and blood and new-variance CJD for Health Canada, and also being involved in the transplant field for almost seven years and dealing with regulations and development and collaboration at the federal government level and also at the American level.

As you know, I work for Health Canada, but I also have another hat. I'm the V-P of regulatory affairs for the Canadian Bone Marrow Transplant Group.

What we have gone through in the past four years shows that we can collaborate with different groups throughout the new transplant field.

You heard the comment before that it's an issue that involves not only informed consent and the recruitment of donors but also it's a medical practice issue. That is important to realize. If the physician in charge of the transplant and so on doesn't have the background on how to approach a patient or the family after there was some kind of sense that the patient or the donor is willing to give the organ.... How to approach that without affecting the person's own health is the number one issue.

The second issue is what I just went through now. We went through a voluntary accreditation of the lab I control here in Ottawa, and also our clinical colleague went through it, and that was an organization of an international society of stem cells. We went through it, and we got good reviews. We went this way because it shows how not only the area of laboratory but also the area of medical practice come together, and it also shows that you don't really need the policing that certain people are suggesting. It could work through a collaborative process that Health Canada has been developing, as you heard previously, and it does work because it does give the input of changing medical practice.

As in infectious disease, what I do worry about is that we also have to somehow put in context the field of surveillance and getting back to the recipients to see if there has been any type of damage from the transplant. That's a really particular issue. That could happen not only with infectious disease but also with other stuff, such as the expression of oncogenes, the transmission of cancer, and so on.

So what I'm trying to say is that just having a registry won't help. You have to attack the problem in four or five different ways.

The Chair: Dr. Giulivi, thank you.

Mr. Brian Crowell.

Mr. Brian Crowell (Director, Canadian Blood Secretariat, Department of Health): Thank you, Mr. Chair.

I'm basically here to help fill in the blanks, if required, on Dr. Giulivi's side. Dr. Giulivi and I have been working together since basically 1992. I was at the Canadian Red Cross formerly as the manager of R and D programs there, and I then left the Red Cross in 1994 to join Health Canada as the director of the Canadian Blood Secretariat. I have an interest, actually, in blood tissues, organs and xenotransplants, and I also sit as a member of the Health Protection Branch's BTOX committee—the blood, tissue, organ and xenotransplantation committee. I'm also a member of the interdepartmental committee on xenotransplants.

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The secretariat is basically a lightning rod for blood issues within the department, and it is basically a coordinator for those issues. It has a number of crosscutting areas, including organs, tissues, blood and policy. We also have a support function in that we're providing support to our litigators in ongoing claims against the crown for hepatitis C, HIV and CJD claims. So I'm here basically to help Dr. Giulivi in that sense, if I can.

Thank you.

The Chair: Thank you, Mr. Crowell.

Mr. Vellacott.

Mr. Maurice Vellacott: I first want to address my question to Dr. Somerville, and it is of the nature of a macro issue.

You alluded to some of the previous day's testimony in this committee, and that was around the subject of brain death. One of our witnesses, Dr. John Dosseter, indicated in his testimony something going back to the whole defining of brain death as synonymous with death a few decades ago. He said:

I oppose expansion of the “brain death” concept to include Permanent Loss of All Neocortical Function (in the presence of viable areas of lower brain and brain stem function). This would include the persistent incognitive vegetative state (PIVS) as being within the definition of “brain dead”. There may be a time in the future when these rare cases may be viewed differently but we, as a society, are not there yet, in my view.

That's a rather interesting statement. The idea that someone might come to is somewhat troubling to me—and there are those who question that brain death is synonymous with death. But now we're talking about possible expansion of that to include other broader definitions. You alluded to that, so that's my first question.

Dr. Margaret Somerville: I agree with Dr. Dosseter. I don't know that we ever will come to that.

I was privileged to work on this particular paper with the Law Reform Commission of Canada, and I know the commission came to the conclusion that it should be total brain death. That means brain stem and upper brain function, whereas what is being suggested there is that once the upper brain function is gone, it doesn't matter if the brain stem is still functioning. What that would mean in practice—and this is why we thought it was unacceptable—is that somebody with spontaneous respiration could be considered dead. If you think about that in pretty gruesome terms, that means you could wheel a breathing corpse into a crematorium. I don't think anybody in Canada would think that's acceptable.

I think this is a good example of why we always—but particularly here—have to listen to more than just our scientific reason. Even though we can say scientifically that we might as well treat this person as dead, from a lot of other cultural, religious, traditional, emotional, or all sorts of other perspectives, that would be wrong. It's certainly wrong in terms of values.

Mr. Maurice Vellacott: What's a little chilling to me is the last part of the statement, when he said, “There may be a time in the future when these rare cases may be viewed different, but we as a society are not there yet, in my view.” The inference is that there may well be a drift in that direction, that it may be viewed differently. Do you have a comment on that?

Dr. Margaret Somerville: Yes.

We follow what we call ethical reaction to issues. We know it often starts off with total horror, but gradually people become less rejecting of it, they move to neutrality, and sometimes to acceptance. We're starting to think and write about the idea that we should monitor our reactions in that way, because sometimes we may not be justified ethically in simply getting used to the situation. For instance, we can take heart transplants as a very good example. People went around throwing up their hands and saying that the sky was falling when they did the first heart transplant. Today it's a routine medical practice, and we've sorted out a lot of the ethical issues.

One of the great difficulties is that when we respond to an individual person in serious individual need, it's hard not to feel that you want to do everything possible for them when his or her life is on the line. In doing that, we can sometimes transgress a whole lot of other values that we need at the community level. This is an example here.

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Mr. Maurice Vellacott: Getting to the micro level, then, the issue of informed consent—I was talking to Mr. Brodie, one of our previous witnesses here—if you have a donor card on a licence or on a census or on a tax form, one of the presenters here before inferred that maybe this would be more an indication of interest, and you'd still need to get specifically an informed consent at a later point, closer to the time of the person's decease.

In your view as an ethicist with a legal background, what does informed consent require from a legal point of view? Would it require a video, an explanation, and kind of walk you through or talk you through what would occur?

Dr. Margaret Somerville: I think that's far too extensive.

I'm a great proponent of informed consent, and informed consent means that the person has to give consent, having been given all the information that would be material to a reasonable person in the same circumstances, and understanding the nature of what they're doing and the consequences of giving that consent.

There are arguments when you give consent in advance—surrogate motherhood is a good one—where people have said, well, you can't really know what you'll feel about giving up the baby until you are actually faced with it, therefore you can't give consent in advance. In fact, we use that in relation to adoption. But you also have to view what are the long-term harms of relying on perhaps a less extensive consent, and I think the long-term harms of relying on it in relation to organ transplantation are virtually minimal.

The only harms you have in taking organs, except if you're contravening cultural or religious norms—and I'm leaving that aside—is that you will somehow disrespect the person whose organs are taken, and secondly, you give a message to people of that disrespect and also fear for them of what will be done to them. But if you have the person's consent, then you don't have any of those fears. All of those fears are dealt with. As for whether it is as informed as you would want it to be if it was a procedure that was going to have risks you would have to live with, I think it probably isn't, but, quite frankly, I don't think that matters.

However, I do think we have to take into account the feelings and emotions and suffering of the family. We don't die as individuals, we die as members of a family and a community, so we do have to look at the harm to them of what this does.

Mr. Maurice Vellacott: That was the point.

The Chair: Thank you, Dr. Somerville.

Ms. Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Thank you, Mr. Chairman. Welcome to this committee, Ms. Somerville. Your reputation precedes you and we were most interested in what you had to say. The same goes for the other witnesses and their considerable expertise.

The committee has struggled a little this week trying to grasp the concept of brain death. I'm still not sure where I stand on this issue. Some experts claim that a person who is brain dead is still alive, while others would disagree. Perhaps you or someone else could enlighten us by defining brain death.

My question, Dr. Somerville, relates to something you said at the beginning of your testimony. You stated that you had heard some experts speak on the subject and that you would have liked to have an opportunity to put some questions to them, or to make some comments. What questions would you have wanted to ask them?

[English]

Dr. Margaret Somerville: Thank you. I'll try to be as brief as I can.

Going back to the brain-dead, look, I'm not an expert in this, but I've sat in many discussions involving it, and I have two comments.

First of all, our body dies in stages, and some of the cells go on living long after everybody would agree we're dead. So there's a difference between the death of our person and the death of every cell in our body. It's really a continuum from total livingness to total deadness, and somewhere along that we draw a line and say, before this you're alive, and after that you're dead. So it's a question of working out the criteria for drawing that line. I think our current criteria in Canada, which are brain death criteria, are very good. That's my opinion.

The other thing is that I did see this evidence that was presented to you, reported in the newspaper, about people being declared brain-dead and getting up and walking out of the hospital. That is impossible. If you're really brain-dead, that can't happen.

There is a study—I could find the reference for you—in the New England Journal of Medicine. It was done by Dr. Ronald Cranford, who is a neurologist. They used very stringent criteria for brain death. They followed about 100 people, I think it was, and made sure they all fulfilled these criteria, and none of them recovered. They all were dead.

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It is a matter of being careful with the criteria. You see this wrongly referred to in the newspapers. They'll say things like “The person is brain-dead, but then they decided to turn off the respirator.” Well, probably they're not brain-dead until after they've turned off the respirator. That depends. Anyway, that's the first thing.

As to the other questions, on the standards approach, one of the queries I would have is that we have to be very careful, first of all, to ask whether something is inherently ethically acceptable, and it's only if it is that we can then work out the standards that should govern it. If we shouldn't be doing it at all, we shouldn't be drafting standards and saying this will become ethically acceptable if we adhere to those standards. Not everybody would agree with me about that.

The other thing is that standards can go to both safety and ethics, and I think it's very important that they do. Most people think standards are simply physical, risk-controlling standards, but you can have standards that will help with ethics.

I also think we need multi-factorial approaches, and that was really brought up. Just because we use standards...they are necessary but they are not sufficient, particularly for ensuring good ethics.

Another thing that came up in that discussion was that people talked about the accountability of attending physicians to make sure they reported who might be donors for organ transplantation. But you have to be extraordinarily careful at the micro-ethical level, where the physician's obligation is what's called a “primary obligation of personal care” to each patient, that you don't evolve rules that would put that physician in a conflict of interest, where the physician is thinking more about whether he can get those organs for transplantation then what is best for this patient. We must maintain that, because the patient's trust in the physician is primary to all good medical care, including good transplantation systems.

Anyway, those were just some of the things that came up.

The Chair: Thank you, Dr. Somerville.

Madam Ur.

Mrs. Rose-Marie Ur: Thank you to all the presenters. Dr. Somerville, I'm most impressed with your presentation this morning. You're very articulate, and as Pauline said, we were looking with great anticipation to your arrival. I'm glad the weather didn't hold you back.

In your statement you mentioned public involvement so the perception is transparency, openness. I totally agree. Being a nurse in my previous life as well, I can appreciate public involvement on ethics, and you speak so well on the subject.

How would we ever come to any kind of consensus bringing in the public, which I agree should be involved? There's the medical ethics as well as the emotional ethics. There is a legal way of looking at things and the emotional way of looking at things, and it's a tough one to compromise on.

Dr. Margaret Somerville: I think we can do it. I don't know that we'd ever reach consensus, but that's a different thing from requiring public involvement in the decision-making.

The other thing I've just started to think about is what I am starting to call science timelines and ethics timelines. What I think has happened is that our science timeline is very short. I mean, with our molecular biology and the new genetics, we see on the front pages of our newspapers every day some extraordinary new things that we couldn't do last week, and it raises massive societal-level ethical issues. Yet our ethics timeline is quite long, to try to deal appropriately with that.

I think xenotransplantation falls into this field. People who want to do xeno want to do it now, and that's normal for the scientists and the physicians and people who want to save lives and get on with it. But the ethics timeline is there, particularly when you have to bring in the public to that initial decision-making. What you have to do is embed your ethics in your decision-making, not do your decision-making and then do your ethics afterwards. That takes time, and I don't believe that beyond a certain point we can compress the time we need to do ethics.

This committee's a very good example of a public doing of ethics in Canada, sitting here talking about this, the fact that it's going to be televised. But again, we need multiple approaches. I don't know that we'll reach consensus, but I think we will reach more ethical decisions than we would reach if we didn't do this.

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Mrs. Rose-Marie Ur: Do you think the ethical approach was really brought more into the forefront with transplantation mentioned?

Dr. Margaret Somerville: Absolutely, because anything that's new and anything that surprises our equilibrium of what we're used to, which xenotransplantation does, shocks us into rethinking. What is interesting is that we start to think of the ethics of the new thing, and very often that sends us back to relook at the ethics of the old things. For instance, human cloning is sending us back to relook at some of the ethics of new reproductive technologies we thought we had sorted out. It always turns us around.

Mrs. Rose-Marie Ur: You may not have the answer to this question, but do you feel there is sufficient time spent at medical school with our doctors on this particular subject?

Dr. Margaret Somerville: I have to declare a conflict of interest before I answer that question.

Mrs. Rose-Marie Ur: Is anyone gutsy enough to answer it?

Dr. Antonio Giulivi: You're right, there's not enough time devoted. The way the medical schools are run now, quite a bit is crammed into the first three years. There is a lot of exposure to patients, but the ethics part—what I had to go through in the last four years—no. You learn it on the ropes.

Mrs. Rose-Marie Ur: That may be one of our little problems.

Dr. Antonio Giulivi: You heard the comment before that it has to be brought up by the college of each province, including the federal college. They need to have seminars on this because it's missing.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you, Mr. Chairman. I'd like to begin by asking about xenotransplantation, starting with the two departmental officials from the newly named Management of Risk to Health Services Branch.

It has been suggested, given the information that a number of transgenic pigs have made their way into this country from Great Britain, that there should be an inquiry as to where they've gone and what they're being used for. Have you been asked to carry out such an inquiry? What is the state of that particular situation in the government?

Dr. Antonio Giulivi: My job with the federal government is dealing with blood transfusion and blood profile. It must have been asked by other people not from our department.

Mr. Brian Crowell: I'm not aware of that request being made. I sit on the interdepartmental committee on xenotransplantation and that has not been brought to the floor yet. It hasn't been brought to the floor of the BTOX steering committee either.

Ms. Judy Wasylycia-Leis: On a related question, it has also been suggested that Health Canada should have a set of detailed guidelines with respect to research into xenotransplantation. Does a set of guidelines now exist? If so, can you provide the committee with such information?

Mr. Brian Crowell: To my knowledge, there is not a set of guidelines yet on research.

Ms. Judy Wasylycia-Leis: Let me ask Dr. Margaret Somerville something, since she opened up this very important topic and it is causing a great deal of concern on the part of not just animal activists, but Canadians, as they learn more about what is happening.

It has been suggested that in order to pursue your suggestion to have a wide-open public debate, we need to put a moratorium on all research into xenotransplantation. What would be your response to that request?

Dr. Margaret Somerville: I wouldn't say it should be on all research, but we're worried about the human clinical trials, where you would actually take the tissues or organs and put them into human subjects. I don't know what has happened in the last few days in Europe, but my understanding is—and there was a report in Nature Medicine about two weeks ago—the European Community was given a recommendation from its bioethics committee that they should put a moratorium on the clinical trials of xenotransplantation until further research is done.

I was in Germany last week and had the opportunity to speak to somebody from England, which is where those pigs came from. They bred the pigs at Cambridge University in England, and he told me they may have done some trials in England. He thought it would be a considerable time before any approval would be given for that—if, of course, it will be given in the end. That's as much as I know about it.

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Ms. Judy Wasylycia-Leis: How much pre-clinical and clinical xenotransplantation research is going on in this country?

Dr. Margaret Somerville: I can't answer that question. I co-chaired a two-day forum for Health Canada in October 1997, and we probably had the information that was available at that time on what was going on. But I haven't been updated since then, except for the report of the forum, which really wasn't an update; it just reported what had happened at the forum.

Dr. Antonio Giulivi: I only know about the two-day forum Dr. Somerville talked about. I'm not directly involved with xenotransplantation.

The Chair: Madam Caplan.

Ms. Elinor Caplan: I would like to echo the others who said what an interesting panel this has been, with the important issues that have been raised.

One of the things we've been talking about here is the need for greater accountability. I wonder if, as part of your advice to us, you could suggest some mechanisms that you think might be appropriate in giving Canadians more information that would help them understand their role. The previous presenter suggested, for example, we should be publishing success rates and that kind of thing. He was referring to new reproductive technology, but to the best of my knowledge there's no information available on transplants of that kind; we just have an overall percentage. I just wonder if you've given any thought to what kind of accountability measures you think would help in the discussion of the ethics and give Canadians information they rightly should have.

Dr. Margaret Somerville: I have some thoughts on this, because it's extremely important. I think we learned a lot of lessons from the Krever commission in this respect.

We also have to realize that medicine is big business, and especially biotechnology. Of course, we know that in Canada we have to focus on biotechnology as part of our very important economic future, and I think that raises new issues, particularly for how the government handles this.

It wasn't the government, in the case of the HIV in the blood system, but it was a big institution; it was the Red Cross. We also had things like the Federal Centre for AIDS, where there was also some conflict of interest between not causing a big public fuss because it wouldn't have been politically good and saying things that would scare people and make life difficult for all of us.

We have to think carefully about separating the people who promote and develop these technologies, the governance and management of those technologies, and the regulation of those technologies. They have to be separated so you don't have people with conflicts of interest. Once you have any one body doing more than one of those things, I think you have an inherent conflict of interest that's not ethically acceptable.

If you look at the current Canadian Biotechnology Strategy and Industry Canada, which is doing a wonderful job of promoting that to the benefit of a lot of us, you can't have Health Canada promoting that too. You need to have somebody in government who steps back and says “Hey, wait a minute, there have to be checks and balances in this.” We have to be sure those institutions are at sufficient distance from each other that they can operate ethically in implementing those checks and balances.

Then afterwards, if something goes wrong, we the public have to grow up and not denigrate politicians who say they made a mistake. That's the worst thing. When you can't learn from your mistakes you have a disastrous situation ethically, especially when, by the very nature of the sort of decision-making we're talking about here, it has to be decision-making in conditions of great uncertainty. But the ethics of that is to disclose the uncertainty and, when the mistake is made, to disclose the mistake. That's accountability.

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Ms. Elinor Caplan: What about the role of accreditation organizations and arm's-length bodies that can—

Dr. Margaret Somerville: They're all helpful processes to achieve, but what you have to be careful of is not to confuse the mechanism with the end. The end is to have ethical, accountable regulation and use of these technologies. Some of the mechanisms are accreditation, peer review, whatever else you need.

Ms. Elinor Caplan: What kind of reporting from, say, transplant centres would you expect to see as part of that multifaceted approach?

Dr. Margaret Somerville: I fear I'm giving an ethics lecture here, but I think the first thing you have to do is...and I also agree that you can't take a direct policing approach to medicine. It simply doesn't work. It's countercultural in medicine, and it doesn't get the best ethical response.

I think the most important basis is trust, and what we have to look into is how we can augment trust. All of these sometimes petty little pieces of bureaucratic paper that we feel are safeguards are very often counterproductive. We have to have adequate reporting, but we don't want to turn this into bureaucratic pinpricking. You have to have trust, and you have to have very serious ramifications for breach of trust, and that goes for whether it's a bureaucrat, a politician, a physician, or whoever it is.

Ms. Elinor Caplan: So would you recommend more of a compliance approach rather than an inspection approach?

The Chair: Thank you, Madam Caplan.

Mr. Martin.

Mr. Keith Martin: Thank you very much, Mr. Chairman, and thanks, all of you, for coming to see us on such a day with inclement weather.

For the record, I want to state a couple of things that really relate not so much to this panel but to your previous one, that enkephalin and brain death are not the same thing, and also that when one is engaging for a patient who is a potential donor, one does not engage in a superficial neurological examination with deep pain threshold, corneal reflexes and cold calorics to determine whether that person is dead or not. That's a point that was alluded to in a previous panel and, I think, erroneously and misleadingly so.

To get to the bottom line, people are dying right now because they don't have access to organs, and the sharp end of the stick is that many of these people do not have an option.

I want to address an issue, Dr. Somerville, that's really heart-wrenching for any of us who have engaged in it, and that's dealing with pediatric trauma and the lack of organs for children who desperately need them to save their lives. Do you think it is ethically correct for parents—because we're asking adults to do this for themselves—to decide beforehand whether or not their children should potentially become potential donors if they meet with death?

The second question I want to raise is that I think there is potentially a way out so we don't have to get into a lot of the thorny ethical issues, and we've heard some very effective testimony to the effect that if an individual decides to be a donor and they communicate that to their loved one at the time they decide to be donors, the number of times when their wishes are respected jumps from about 55% to about 91%. So encouraging people to say to their loved ones that they've decided to be a donor or not to be a donor goes a long way and obviates a lot of these very difficult ethical issues that you so eloquently brought to us.

The last point is the issue of xenotransplants. Notwithstanding the scare of the bovine encephalopathies that occurred in England, and also the slow viruses, the Creutzfeldt-Jakob disease that Dr. Giulivi mentioned and so on and so forth, in spite of that, the scientific experience is that we do not have any evidence to show that any of these diseases are transmitted to humans through the xenotransplants that have taken place to date.

I draw your attention to the American experience of over a quarter century. I'd like you to please comment on that, if it's correct and whether or not we can be vigilant but not err on the side of bringing forth bureaucratic questions that are really preventing those patients who need those organs in order to live from obtaining them. They simply do not have an option. Thank you.

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The Chair: Dr. Somerville, I must caution you that Mr. Martin has used up most of the time allotted for your response. I'm afraid you're going to have to be very brief.

Dr. Margaret Somerville: All right, I'll try to be very brief, Mr. Chairman.

First of all, on advanced consent for children, the answer is that ethically, because there are things we can do for ourselves as confident, consenting adults, it does not necessarily mean we can do them for people for whom we consent. I think people would see planning to give away your child's organs before anything happens as macabre, so I would advise against it simply on an emotional level.

On the advanced directives communicated to one's family, that's a very good idea. What you focus on after the death of the person is respecting the person and respecting the person's prior wishes. That's the whole basis of advanced directives in general, like living wills, durable powers of attorney, etc. So that's an excellent idea.

As for the xeno, there's no evidence of transmission of infective agents, mainly because we haven't had long enough to know if that's correct or not. We haven't done much of it. Also, the question you raise really goes to burden of proof: Should you be allowed to do this unless there's evidence that it's harmful, or should you not be allowed to do it until you show that it's reasonably safe and ethically acceptable to do it? I belong to the second group, because that is actually consistent with what we do with drugs. You can't put a drug on the market until you're sure it's reasonably safe and effective. That's a reverse burden of proof, and all I'm suggesting is that xeno should be in the same group.

The Chair: Thank you, Dr. Somerville.

I wonder if I can go to Mr. Crowell for a moment. Earlier on, Dr. Somerville talked about the separation of the three elements: promotion, governance and regulation. Do you separate those three elements in your secretariat?

Mr. Brian Crowell: Yes, we do. For example, we were involved in the governance structure of the new blood system. That particular initiative was run out of the secretariat and was led by the federal government. The policy side was also basically covered in the secretariat too, but in a different cell, if you like. However, they were connected to each other for obvious reasons of transfer of information, etc. On the regulation side, the regulator has always maintained that it must be separate from other processes that are ongoing, but it must be able to tap into the information as and when required in order to make informed decisions.

I just wanted to pick up on what Dr. Somerville was saying about the need for society to decide on whether or not xenotransplants will be able to take place in the end. With the BTOX steering committee that I'm a member of, we're actually wrestling with that and a number of other issues right now. We've just actually approved a six-phase plan for engaging the Canadian public at large. We've wrestled with that for almost a month and a half in terms of how we're going to do that. There are many different opinions. How do we get such a broad variety of interests encapsulated into one cogent group that can come up with recommendations on how we should proceed in this area?

I can assure you, Mr. Chairman and the rest of the members of the committee, that we are taking this extremely seriously. I can also assure Dr. Somerville that she will be involved intimately in this process.

I hope that's been helpful.

The Chair: Thank you very much.

Mr. Jackson.

Mr. Ovid Jackson: To get back to the ethical part here, Dr. Somerville, I asked earlier on about something you just alluded to. When a medical treatment is available, some Canadians, particularly those who are quite sick, feel they should have it right away. Are you saying we still have to go through our own trials because that's the made-in-Canada way, and that the only way we could really approve the thing is to make sure all our ethical practices are known? Or could we fast-track something that has already been approved by, say, the Germans, other Europeans or the Americans?

Dr. Margaret Somerville: We do fast-track things. As has already been given to you in evidence, we do use the evidence that other people find around the world, because science is not jurisdictionally based, science and medical science are universal.

We also have what are called compassionate release provisions in our laws. Those provisions will allow access for somebody who is terminally ill and for whom there is no other treatment. We developed that through the AIDS crisis, when so many people wanted access to some of the new treatments that were coming on-line. And I think ethically we're required to have those kinds of provisions.

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Xenotransplantation raises an issue beyond that, however. If it's only the patient who is at risk, I have much less problem with allowing dying or very ill patients to have what they want. Not everybody is as liberal as I am on that, but I think they have the right to try it.

By the way, I'm really pleased about the marijuana decision this morning. I think that's excellent. But what we're talking about here is that in getting what you want, you might put the public at risk. And the question of when we're justified in doing that is a different question. It's a terribly hard thing to say no to a dying person. It's extraordinarily hard.

Mr. Ovid Jackson: Okay. I have one other question, Mr. Chair.

Let's say I have a relative, and I'm completely compatible with them and want to give them my extra kidney. What are the ethics of that? Would you object to that?

Dr. Margaret Somerville: No problem. What we're talking about here is putting animal organs into humans. And we're not worried about the person who gets the organ as much as we're worried about letting some infective agent be transmitted into the human population. That's our major worry here.

Mr. Ovid Jackson: You were saying there should be an autopsy just to make sure, as a check and balance, that we don't have this?

Dr. Margaret Somerville: If we were going to do the research, that would mean we'd have people who had had xenotransplants. Part of the requirement of good ethics is that you can't do good ethics without doing good science. And good science would require that you did everything possible to learn as much as possible from as few cases as possible. So things like monitoring, testing, and autopsies are part of your good science that gives rise to good ethics.

Dr. Antonio Giulivi: After we issue the report on infectious diseases and xenos.... It's true there have not been any reported cases of diseases from xenos, but we do have natural ways of seeing that this could happen. The chicken virus and the human virus in influenza that happened last year in Hong Kong was a merging of those two viruses. And that could happen in xenotransplantations. So what I'm saying is that xeno is good, but we have to have some kind of surveillance—surveys or autopsies—to see what's going on. And as Dr. Somerville said, certain people should have it, but then let's really follow them to a “T” to see what's going on and make sure it doesn't spread to the whole community.

The Chair: Before I go to Madame Picard, Dr. Somerville, a moment ago you said that science is not and should not be jurisdictionally based. For the purposes of our discussion here, should I interpret the words “science” and “medicine” as being coterminous and synonymous?

Dr. Margaret Somerville: No.

The Chair: Thank you.

[Translation]

Ms. Picard.

Ms. Pauline Picard: My comments are directed to Dr. Giulivi and to Mr. Crowell.

Legislation is not keeping pace with science today. Six years ago, the Royal Commission on Reproductive Technologies issued a report. Recently, we had the Krever Commission which looked into Canada's blood supply. No regulatory framework was put in place. And now you're asking us to set up another commission to examine xenotransplantation.

I'm wondering if possibly we could link xenotransplantation technologies to the studies conducted by these two commissions in recent years. Do we really need another commission, given that we are already lagging behind in the fields of genetic engineering and reproductive technologies? Organ and tissue transplantation are other issues to consider. I believe that according to Justice Krever, blood is also a tissue.

Why do we always seem to be struggling to catch up, and why does this seem to be increasingly difficult? We don't need yet another scandal like the recent tainted blood fiasco.

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I'm bothered by the fact that there could be yet another study calling for regulations and standards to govern these procedures. When will we really be able to reassure members of the public and provide quality heath care to them?

[English]

The Chair: Dr. Giulivi.

Dr. Antonio Giulivi: Science changes all the time. I'm involved in the stem cells, cell expansion, cell death, and so on, and I do research in that area. What we usually do is we do the research, we advance, and from those questions the ethics questions come out. There will be a multitude of questions, but that will be the way of life. Science will evolve. In the last 10 years that I have been in this field, it has evolved completely.

You're saying the issue is whether you want to stop all this and have a regulatory framework. I believe not. What we have done in Ottawa is we have committed our people—the physicians, the transplanters, myself—to self-regulate, to bring these issues up, and to apply to an external review. That's what we did with this general review with the Americans. We passed, and now we're an accredited lab. So that's the way we're doing it, and it's with our peers.

You heard the comment before that in medicine it's a peer review system. If you put regulation in this, you will block quite a lot of the technology that should be advanced. Then you say this might lead us to other risks. Yes, it could lead us to other risks, such as the transmitting of viruses and so on. But we have learned a lot from the past. HIV was a virus that opened our minds ten years ago to have exposure and then have a disease. That was never thought of before. CJD exposed it. So now our minds are very open on these issues, and these are the questions that scientists ask every day.

The Chair: Dr. Somerville, do you want to comment?

Dr. Margaret Somerville: Madame Picard, I understand your frustration, but there are two things, I think.

First of all, if we just took the Royal Commission on New Reproductive Technologies, it's not a waste, even though we didn't necessarily get legislation out of it. We have to be prepared to engage in that process, and that process has a value in itself. You don't have to have a product at the end of it.

The second thing is that in ethics at the moment, because, as Dr. Giulivi says, science is moving so quickly, we have to make sure we try to—that's why this committee is so important—ask as many of the right questions as possible and structure a framework out of those questions so we can see what we're asking, in which areas, and why. We can't expect to have the answers.

What we're really trying to do is use questions to govern uncertainty, because the uncertainty is absolutely unavoidable. There's no way we can have scientific advance without uncertainty. But it's a matter of trying to keep the risks of that uncertainty to the ethical minimum.

The Chair: Thank you, Dr. Somerville.

Madam Ur, do you want to pass your turn?

Mrs. Rose-Marie Ur: Yes, that's fine.

The Chair: Thank you.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you, Mr. Chairperson.

Let me pursue this discussion, because it's a real dilemma for us. You've all identified the problems with xenotransplantation—the transgenesis issues, the transfer of diseases. Mr. Giulivi, you've identified the problems of the chicken issue in Hong Kong.

Knowing all of that, it really begs the question of why, as a society, we don't at least put a moratorium on the clinical and pre-clinical xenotransplantation research until we get a bit of a basis for proceeding and the public debate that everybody keeps calling for. Why don't we at least do that?

Dr. Antonio Giulivi: If you do that, then we won't be able to ask the questions. We could do scientific experiments using different...you don't have to use people, you could use viruses themselves, or different cell media, cells that are grown in media. The whole thing in this area is that there is very little expertise in doing this; there are few people. Then you have the public demanding xenotransplantation, and you also have the commercial ventures that are happening in the United States.

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In Canada, I think we were the only ones who had a forum of that sort for xenotransplantation to show the other societies what we're doing. We're also moving ahead in developing research in this area, but at the level of the laboratory.

Dr. Margaret Somerville: Yes. I wouldn't be as vague as you were there. For instance, Europe probably will have a moratorium. The U.S. did have a forum. The NIH had one, but it wasn't nearly as diverse in its representation as the one we had in Canada.

The other thing is that this is just a research ethics rule in general, that you can't start doing research on human subjects until you've done all possible prior animal experimentation. One of the things I hear out of Europe is that there hasn't been sufficient prior animal experimentation. So we might not need a moratorium, because our normal research ethics rules would say you can't do this anyway. Certainly my understanding is that nobody intends to do this in Canada without some form of official approval.

Ms. Judy Wasylycia-Leis: Just to follow that up, we don't have a moratorium in this country per se. We really haven't had the public debate. And we learned today that there are no prescribed, rigorous guidelines with respect to the research that's going on. Shouldn't we at least, as a minimum, have some specific guidelines from Health Canada around clinical and pre-clinical xenotransplantation research?

Dr. Antonio Giulivi: As Dr. Somerville said, the only way you're going to do that is if you do it in secret, because the way the system works in Canada, the transplanters are provincially regulated and everybody's going to know about what they do. So they're not going to do a transplant from a pig to a man. It's not going to happen. There are already steps involved at the provincial level, so that won't happen.

Mr. Brian Crowell: In fact, if I may add to that, Mr. Chairman, a letter to hospitals for physicians and surgeons has gone out, I believe this week, notifying those at the hospital level that if they wish to engage in some heroic measure to save an individual using either a pig's liver or the islets of the pancreas from a pig for severe, life-threatening diabetes, then that particular clinical trial is subject to the therapeutic products program's approval. They will have to get approval from the Health Protection Branch to carry out that particular trial. That letter has gone out this week.

So we're moving forward quickly on that front and, at the same time, trying to put together a public involvement process that will be very widespread and engage a lot of Canadians in this debate.

The Chair: Mr. Crowell, I wonder if you'd make that letter available to the committee as well. Just send it to the clerk, and we'll see that everybody else gets it.

Mr. Brian Crowell: Very well.

The Chair: Thank you.

Mr. Jackson.

Mr. Ovid Jackson: I don't have any questions. I'll give the opposition—they were complaining—some more questions.

The Chair: We'll give it to Mr. Vellacott, then.

Mr. Maurice Vellacott: We've obviously established the fact that xenotransplants are fraught with a lot of ethical issues. I think we'd also see that there are some that crop up around present organ transplantation as it is.

I have an excellent article here from the Canadian Medical Association, and it says: “Ottawa researchers enter home stretch in race to produce artificial heart”. That's right here in Ottawa, and it's come up in the news of late again. I'm just wondering, Dr. Somerville, if in your view there are ethical issues of any kind, as many, or maybe none at all, surrounding the whole issue of a mechanical heart, when that comes to be and it's approved. Would there be ethical issues involved around this issue of a mechanical heart?

Dr. Margaret Somerville: There are always ethical issues involved in human medical research, but the ethical issues surrounding the heart are no different in their nature from the ethical issues that surround any other sort of new and advanced medical technology. That can be distinguished from xenotransplantation.

One of the issues that is really interesting, and again it comes down to a timeline—I mention it in the last paragraph of this short paper I gave you—is that if there's an alternative to xenotransplantation, but that alternative is in the somewhat distant future, what are the ethics of avoiding altogether the risk of xenotransplantation by waiting for these other new developments? It's not just the mechanical heart, but there's also discussion—and Dr. Giulivi raised the issue—of stem cells and possibly being able to use those to generate organs for transplant. These would be human organs that would raise this issue. But again, that raises other serious ethical issues about the use of human embryos for research and that sort of thing.

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Mr. Maurice Vellacott: I just wondered, with something like that, sometimes we tend to think in a box in terms of existing...and we need paradigm shifts almost. So that's the nature of my question there.

My other question might not be a bad question to be asking all the panel members. Trying to keep it, in a way, as impersonal as possible, assuming that you believe in practising what you preach or walking the walk, as we say, would there be someplace in our country a signed donor card with the name of André Wisaksana, Dr. Margaret Somerville, Dr. Antonio Giulivi, Brian Crowell—a signed donor card, and you've talked with your family and you've consented to give organs?

Dr. Margaret Somerville: Do you mean have we done it?

Mr. Maurice Vellacott: Have you done it?

Mr. André Wisaksana: Yes, I have.

Dr. Margaret Somerville: No, I haven't, but there's a medical reason why not.

Dr. Antonio Giulivi: Yes, I have.

Mr. Brian Crowell: I have not.

Mr. Maurice Vellacott: You have not. I'm going to be asking that question in future to panel members, I think, if the chair allows me that.

The Chair: I appreciate your interest in that, but I'm not sure I can rule that kind of question in order, and it's unfair to witnesses.

Mr. Maurice Vellacott: Right.

The Chair: I would ask you to refrain from it.

Mr. Maurice Vellacott: Okay.

The Chair: Thank you.

Mr. Maurice Vellacott: I can ask it on a personal basis, probably between our breaks—

The Chair: Later on.

Mr. Maurice Vellacott: Whatever. I'll do that.

The Chair: Thank you. I'm sorry I let that go initially; I should have stopped it before.

Dr. Somerville, there's no need to clarify on that unless—

Dr. Margaret Somerville: I would like to add a comment about a research study that is very interesting. They surveyed a group of people about whether they believed in donating organs for transplantation, and 85% said yes, they did; and they went back and asked them exactly the question you just asked: have you signed your donor card? And only 15% had done so. They then looked at the others and said, “why did you say you believe in it but not sign your donor card?” And they said, “We thought you meant would we agreed to donating someone else's organs.”

Mr. Maurice Vellacott: I'm not asking that question.

The Chair: Mr. Vellacott, we're at the end of the session.

Thank you very much, Dr. Somerville. I think we'll end on a nice happy note. Mr. Crowell, Dr. Giulivi, Dr. Somerville—and Mr. Wisaksana, I'm sorry that people didn't ask you a lot of questions.

Mr. André Wisaksana: I'm more than happy.

The Chair: I guess the issues on standards were dealt with before. But I thank you nonetheless for coming and sharing some of your expertise with us.

The meeting is adjourned to the call of the chair.