HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, March 24, 1999

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[English]

The Chair (Mr. Joseph Volpe (Eglinton—Lawrence, Lib.)): Colleagues, ladies and gentlemen, thank you for coming to our...[Technical Difficulty—Editor]...pursuant to Standing Order 108(2), a study on the state of organ and tissue donation in Canada.

The committee is coming close to the end of its considerations and deliberations, and today we have with us another group of witnesses, a very interesting group, I think, who will share some of their expertise and insight with us.

From the Canadian Blood Services, we have Lynda Cranston, chief executive officer, and Dr. Graham Sher, vice-president, medical, scientific and clinical management. To you both, thank you very much.

From the Canadian Coordinating Office for Health Technology and Assessment, we have with us John Dicaire, chairman of the board of directors, and Hussein Noorani, research associate. Welcome to both of you.

From the Medical Research Council of Canada, we have Dr. Mark Bisby, programs director, and from Health Canada, we have Dr. Jay Wortman, director general, non-insured health benefits.

Thank you all for being here. Gentlemen and lady, in our usual process we have about five minutes for each of the interveners. Then we go into questions and answers with a panel of our colleagues around the table.

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Mr. John Dicaire, I think we'll start with you.

Mr. John Dicaire (Chairman, Board of Directors, Canadian Coordinating Office for Health Technology Assessment): Thank you, Mr. Chairman.

I've really come here today to address one aspect of the letter that Ms. Vachon sent to us, that is, to talk very briefly about health technology assessment in general and to give you a brief overview of what CCOHTA is, because I know the committee is interested in governance models of organizations that deal with national health issues.

Very briefly, health technology is defined as any medical intervention utilized in health treatment and maintenance. Therefore, it could include everything from drugs, devices and medical procedures to health care systems. The definition is that it is a very broad, all-encompassing field.

What is health technology assessment? It's really a multidisciplinary field that looks at specific technologies and answers. As an example, it answers these questions: does this treatment work?; for whom?; at what cost?; how does it compare with other available treatments? It assesses the medical, economic, ethical and social implications of a technology and its utilization and diffusion in Canadian society.

How do we carry out health technology assessment? Health technology assessment, as an emerging field in Canada, is not basic research. It is the definition of a question that is of concern to health policy-makers and decision-makers, and CCOHTA's role is basically to review the research that is available, that is, to apply a rigorous scientific review of that information, to ensure the validity of the information and to put that together in an understandable format for decision-makers who are faced even more every day with more complex decisions in a time when we are seeing a substantial reduction in the resources available to us.

Very briefly, CCOHTA is a creation of the federal-provincial-territorial Conference of Deputy Ministers of Health. Under its articles of incorporation, the deputy ministers are the actual board of CCOHTA, a responsibility they have delegated to senior officials in health departments for which they are responsible. It's the only national health technology assessment organization in Canada and plays a major role, particularly in co-ordinating the activities of health technology across the country, because we have a number of such organizations such as B.C. COHTA, the Alberta Research Foundation, etc., all of which are involved, in one way or another, in health technology assessment.

We have a board of directors. We have management and research staff at CCOHTA and are supported in our activities by two specific groups. One is a scientific advisory panel, which is made up of key leaders in health research and scientific endeavour in Canada, and one is a pharmaceutical advisory committee, which is made up of the program directors for provincially funded prescription drug programs in Canada.

The scientific advisory committee, as the name would imply, deals with the science. The pharmaceutical advisory committee basically deals with the ranking of the pharmaceutical products they wish CCOHTA to look at. An example is the group of drugs related to multiple sclerosis, like Betaseron or that whole class of drugs. There are research questions that are raised in that context.

What do we produce? We produce research reports, briefs and newsletters. We provide an information service to researchers in Canada. We put on seminars, symposia and workshops across the country. In many instances, we partner with other researchers or health technology assessment organizations in Canada to achieve the objectives that the Conference of Deputy Ministers has put before us.

That's a very quick overview of health technology assessment and CCOHTA. I'd now like to turn this over to Hussein, who will speak to the direct issue of CCOHTA's role in organ transplantation.

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Mr. Hussein Z. Noorani (Research Associate, Canadian Coordinating Office for Health Technology Assessment): Thank you.

As stated by the chair, I am a research associate with the Canadian Coordinating Office for Health Technology Assessment. I am also project director for a study in organ transplantation that we at CCOHTA are currently undertaking. The purpose of this five-minute presentation is to provide an overview of the study for the members of this committee.

Turning to study specifics, over the past year CCOHTA has undertaken a study to identify the current criteria for adult recipient selection selection for heart, cadaveric kidney and liver transplantation in Canada, focusing on the ethical and social implications.

CCOHTA is submitting to the committee a preliminary report based on survey data regarding criteria for patient listing, which were collected from Canadian transplant centres. The executive summary of the draft report has been distributed in both official languages to the members of this committee.

For the purposes of this report, the study methodology consisted of a mail questionnaire tailored for transplantation by organ type. The survey consisted of five sections: demography and employment; comorbid disease; substance abuse; social and community support; and types of transplants performed.

Our study sample consisted of 34 centres throughout Canada that are performing adult transplants, including 10 heart centres, 16 kidney centres and 8 liver centres. Twenty-nine transplant centres responded to the survey. This corresponds to a participation rate of 85%, representing 9 of 10 heart centres, 14 of 16 kidney centres, and 6 liver centres.

Based on the synthesis of the survey responses, which are summarized in the submitted report, our data demonstrates that although heart, kidney and liver centres generally practice similar methods of listing patients nationwide, there is variability among centres in the degree of importance given to certain criteria for patient listing. As stated in the submitted executive summary of the draft report, variability or differences in criteria for patient listing is demonstrated both within a particular organ group and between organ types.

Given these findings—differences in certain criteria for patient listing—it would be of benefit to standardize, at the national level, organ-specific criteria for the selection of patients on the waiting list. Standardized criteria are of paramount importance, given the ethical and social implications associated with the factors under consideration for patient listing. The ethical and social implications are currently under examination in a comprehensive review of the relevant literature.

These implications will put into context the findings of the nationwide survey of transplant centres. CCOHTA will be pleased to provide the committee with a subsequent final report once it is completed. The final report will include the results of the nationwide survey of the criteria for selection of adult recipients for heart, cadaveric kidney and liver transplantation and the associated ethical and social implications.

In conclusion, I would like to take this opportunity to thank the members of this committee for their invitation and interest in this study.

Thank you for your patience for this presentation.

The Chair: Thank you very much for the presentation. The clerk has explained to me what the process will be for you to get that final report to us, although we're in possession of a non-translated draft. We thank you for that as well. We can't distribute it because it is not translated, but it will serve our purposes nonetheless.

Let me go to Dr. Mark Bisby from the Medical Research Council.

Dr. Mark Bisby (Director, Programs, Medical Research Council of Canada): Thank you.

I'm going to do three things. I'm going to introduce the council briefly to you, then tell you about what we're doing at the moment in the area of organ and tissue transplantation research and what we're supporting and finally go on to discuss the future of this area of research in the Canadian context, which is a very exciting one.

MRC is the largest federal agency that supports health research, with a current budget of about $273 million that is used to support approximately 2,400 research projects in hospitals, universities and research institutes across the country. We also provide training stipends to about 1,500 young scientists and salary support for about 450 of the country's top health researchers.

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MRC has a history of being concerned primarily with biomedical and clinical research, but over the last six years it has widened its mandate to include the whole spectrum of health research, including population health, health services research and psychosocial and behavioural issues that affect the health of Canadians.

Every single dollar of MRC's support to health research is allocated on the basis of competitive peer review. Our success rates in these peer-reviewed competitions have recently fallen rather low—to about 25% of the applications being funded—but we anticipate that in the future, with increased funding, we'll be able to fund many more worthy but currently unsupported applications.

I'd like to turn now to the kind of research that we support in the area of tissue and organ transplantation. We currently invest about $1.6 million per year in support of 24 research projects that are directly relevant to this issue of organ and tissue transplantation. That's about 1% of our grants budget and about 1% of our total grants.

Of these 24 grants, 7 are related to bone marrow transplant for leukemia; 7 to the development of alternatives to organ transplants, such as the development of artificial organs and tissues; 4 are involved with islet cell transplantation for diabetes; and 4 are related to liver transplantation. A number of these projects also have the issue of rejection of transplanted organs as a major focus of their investigation, and 2 are specifically concerned with xenotransplantation between animals and humans.

I'd like to give you just three examples of the kinds of research projects that we support. At Laval University in Quebec City, Dr. François Auger and his team of tissue engineers are developing artificial skin to be used as grafts for burn victims. His current project is to find ways to stimulate blood vessels to grow into the artificial skin to speed up its viability and gradual replacement by the body's own tissues when it's applied clinically.

Two laboratories in Toronto, led by Dr. John Coles and Dr. Ren-Ke Li, are investigating whether heart transplants can be avoided by transplanting healthy heart muscle cells into heart muscle tissue injured in heart attacks. Dr. Li's goal is to obtain healthy cells from the patient, grow them in culture and then return them to the patient's heart.

Dr. Ray Rajotte and colleagues at the University of Alberta are pioneers in the area of islet cell transplantation for the treatment of type I diabetes. They want to develop methods that will eliminate the need for continuous immunosuppressive drug treatment following transplantation and will allow pigs to be used as the sources for islet tissue in order to overcome the shortage of human donors.

These three examples and the other related projects currently funded by MRC deal with improvements and alternatives to currently available transplantation techniques and depend for their success on a better understanding of cell biology, gene manipulation and the functioning of the immune system. In these related areas, MRC invests over $20 million per year.

MRC also supports more applied research, such as clinical trials, new transplantation procedures or studies into the health services aspects of transplantation. We don't fund any of those kinds of grants at the moment. We have done so in the past and we will do so in the future, subject, of course, to favourable peer review.

I want to end by focusing on the future of research into transplantation in Canada. As you know, the February 16 federal budget was notable for the announcement of the creation of the Canadian Institutes for Health Research. By fiscal year 2001-2002, the budget for the institutes is expected to exceed $500 million—roughly an 86% increase from the current MRC budget. With this funding, 10 to 20 individual institutes will be created, each focusing the attention and the energies of the Canadian health researchers on the major health problems of Canadians. Within each one of these health research institutes the whole range of health research will be represented, including biomedical, clinical health services and population health approaches.

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While the identity and the mandate of the individual institutes have yet to be determined by the interim governing council of the Canadian Institutes for Health Research, an analysis of MRC's existing research activity shows that all currently supported health research could be accommodated within a list of 15 institutes. One of these institutes has the provisional title of “Institute for Immunology and Transplantation Research”.

As a first step in their existence, we anticipate that the institutes will develop research priorities based on scientific opportunity and public health needs and will launch funding programs designed to address these priorities. While the CIHR will benefit all areas of health research, the creation of an institute with a specific mission to address problems of transplantation will clearly boost research activity and encourage more health scientists from all disciplines to apply their talents to solving the many important and difficult problems in this area.

Thank you.

The Chair: Thank you, Dr. Bisby. I'm going to turn now to our representatives from the Canadian Blood Services, who are here to share some perceptions on governance with us.

Ms. Lynda Cranston (Chief Executive Officer, Canadian Blood Services): Thank you.

Mr. Chairman and members of the committee, thank you for having Canadian Blood Services here today. First, before I launch into my presentation, I would like to extend my apologies for the misunderstanding earlier this month about our appearance at the committee.

The Chair: We've already forgotten all about it. You're here and we're happy. Thank you.

Ms. Lynda Cranston: All right.

You will recall that a common thread that ran through the Krever inquiry and the 1997 final report from Mr. Krever was the need to establish a national blood operator with strong independent authority in order to attempt to prevent events such as those that occurred in the past.

The federal, provincial and territorial ministers of health recognized this and agreed to create the Canadian Blood Services as an organization to operate the blood program at arm's length from government. The provincial and territorial ministers of health are the members—the shareholders, if you will—of the corporation. They have charged CBS with the responsibility for a national blood supply system that assures access to a safe, secure and affordable supply of blood, blood products and their alternatives and supports their appropriate use.

Through the Bureau of Biologics and Radiopharmaceuticals, we are regulated by the federal Minister of Health. The CBS board of directors was appointed in March 1998 and had its first meeting in April. I was hired in June 1998 and hired my new management team from August through to early October of last year. We took over the operation of the blood program from the Red Cross in September, 178 days ago. Next Monday will mark our six-month anniversary.

The CBS mission statement, which we have developed and is under discussion with our board and employees, is as follows:

Canadian Blood Services operates Canada's blood supply system in a manner that gains the trust, commitment and confidence of all Canadians by providing a safe, secure, effective and accessible supply of blood, blood products and their alternatives.

During the transition planning, three distinct periods were identified for the early days of CBS. The first was the transition itself and the days immediately surrounding the takeover. The second was the period immediately following the takeover, the stabilization period, during which we would assess the operation and begin to develop a new operational model. This is the period we are now concluding. Finally, the two-year period following stabilization was identified for implementation of a new organizational model.

We are happy to report that the transition was a smooth one and that blood donations were maintained, thanks to the hard work and dedication of thousands of donors, employees and volunteers and the support of the public generally.

Our brief provides a cursory overview of our operations. We operate 14 blood centres, 2 plasma centres, 3 regional offices, a head office and many fixed collection sites. We serve about 800 hospitals. We have 3,400 employees and thousands of volunteers. We hold over 10,000 collection clinics every year and have almost 1,000,000 donor visits to those clinics. About 300,000 recipients receive our products annually. We have standardized operations in all of our facilities; we follow standard operating procedures that are written by us and reviewed by Health Canada, our regulator.

You will have seen in our brief that we chose to focus on two aspects of our program: our governance and the unrelated bone marrow donor registry.

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Let me say a few words about our governance. The provincial and territorial ministers, as I've mentioned, are the members, and they appoint the board. The board has a total composition of 13 members and they're made up of four regional representatives: one represents B.C. and the Yukon; one represents Alberta, Manitoba, the Northwest Territories and Saskatchewan; one represents Ontario; and one represents Nova Scotia, New Brunswick, P.E.I. and Newfoundland. We have six scientific and business representatives, two consumer representatives and a chair.

To ensure the autonomy of the board, ministers agreed that public servants may not serve on the board of directors. The board is responsible for the development of our strategic and business plan and for the overall direction of our affairs. Our funding comes from the provinces and territories and is based on a business plan submitted to and approved by the members. We operate at arm's length from government and we are regulated by Health Canada's Health Protection Branch.

I will now ask Dr. Graham Sher, CBS's vice-president of medical, scientific and clinical management, to say a few words about some of the challenges that we face in our operation of the blood program generally and more specifically in operation of the unrelated bone marrow donor registry.

Dr. Graham Sher (Vice-president, Medical, Scientific and Clinical Management, Canadian Blood Services): Thank you, Lynda.

Thank you, Mr. Chairman and committee members, for the invitation.

Blood is the most common tissue transplant in Canada. As you've heard, we collect about 750,000 units of red blood cells annually, in addition to plasma and platelets and other blood components, to transfuse to a total of around 300,000 to 350,000 recipients. Without blood components and blood products for transfusion, solid organ transplants, bone marrow transplantations and other tissue transplants could not occur. By way of example, an orthotopic liver transplant may consume anywhere between 500 and 300 units of blood, typically in the order of 15 to 20 per procedure. A bone marrow transplant patient may utilize dozens of units of red cells, plasma and platelets during the course of a hospital stay.

The advantage of blood collection is that it is a renewable transplant, in contrast with solid organs which only can be collected on a single occasion. Blood is easily collected, portable and easily transfusable, in direct contrast with solid organs and other tissues. The only requirement for blood transfusion is that it is matched by A, B or O blood group.

Most donations collected are collected without a predetermined recipient. However, there are two distinct collections where identified recipients are made. For autologous blood donations—that is, a blood donation you make for yourself, usually three to four weeks prior to elective surgery—this blood can not be used for any other recipient. Directed donations are units of blood collected for a single, targeted, specific recipient. These are generally discouraged from a medical perspective and are certainly no safer than volunteer blood donations. Currently in Canada they are permissible from parent to minor child. In rare circumstances, we collect such directed donations for individuals with very rare blood groups.

To be a blood donor in Canada you must be between the ages of 17 years and 70 years and in good health and you must be advised of the risk factors for recipients. You must pass all screening processes prior to your blood being collected. The minimum interval between blood donations is 56 days. Donors are deferred for a number of reasons potentially harmful either to the recipient or to the donor. Our total deferral rate annually is around 13.5% of our donor base.

CBS operates a registry of all our blood donors from coast to coast and the intention is to have a single national donor database once our new information system is up and running. We do not operate a registry of recipients. That data is managed at the hospital level and there is no national recipient registry.

There are some challenges in the blood world. We face periodic shortages of blood components, particularly red cells and platelets, and frequently blood groups are in particular shortages, most notably group O and group A. Shortages may be seasonal, such as at holiday periods when donor interest is low and demand may be high from motor vehicle accidents and other trauma cases.

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There are challenges in donor recruitment. We need a regular repeat donor database; repeat donors are much safer than first-time donors. We need young donors who will commit years to the system; our donor base is constantly aging. The donation paradox we face is that the more questions and tests we demand of our donors, the better and the safer our products; however, the more questions and tests we demand, the longer and more intrusive is the donation process and the more turnoffs we have from our donors. As I've said, our donor deferral rate is high and requires constant replenishment of the donor base. We face a constant need to educate, communicate and advertise to overcome perceived fears of donating and the legacy of the tainted blood history.

I'll now turn to the bone marrow registry. Canadian Blood Services owns and operates Canada's unrelated bone marrow donor registry. Bone marrow donors are recruited through regular information sessions conducted across the country, sometimes in blood centres and frequently in community halls, church halls and schools.

The intent is to recruit volunteer donors who have no specific reason for potential donation other than altruism. Recruitment processes are obtained at obtaining commitment from the donor and a willingness to donate to any Canadian patient and possibly to any international patient at any point in the future. In some circumstances, donors are recruited as part of a campaign linked to a specific patient such as a friend, colleague or family member. While such campaigns may be fruitful in the number of donors recruited, they are potentially weakly committed donors and may not be motivated to go through the bone marrow donation process for an unknown recipient, particularly if this recipient is called on some months or years after the targeted campaign. The attrition rate of these donors is exceedingly high.

Once bone marrow donors have been informed about the process and they have given their consent for donation, they are given a period to reflect on the process—usually around two weeks. They are then given appointments to return for the first set of blood draws to ensure that the laboratory capacity can handle all the samples, which need to be tested within eight hours of donation. These initial results of the HLA typing, which types the first four of six antigens to be matched at the time of transplant, are entered into our national registry based in Vancouver, where our search co-ordinating unit is housed. These results are available to be searched for any patient in Canada or internationally.

Currently we have over 180,000 donors on the marrow registry in Canada. We mail annual reminders to all our donors to retain commitment and to ensure that our records are up to date. When a specific patient's HLA type is entered into the registry, potential matches may be found for that patient or that recipient. These results are then sent to the transplant hospital and the treating physician, who will choose the best fit for his or her patient. Potential donors are then called back for second-level testing. These last two results are entered once again into the national registry. If the match is deemed perfect, the confirmatory testing is undertaken and the donor may be found suitable to donate to a recipient.

CBS does not have a role in the collection or harvesting of the marrow or in the transportation of either the donor or his or her marrow to the recipient. We essentially are restricted to recruiting donors, testing their blood and maintaining the registry of the results.

Finally, let me mention some of the issues facing us in the bone marrow program. There are quality principles by which any bone marrow registry must abide to ensure its integrity. There is an ethical framework ensuring absolute confidentiality and separation of both donor and recipient. We need to operate a fast and responsive registry that offers equal and uniform accessibility to each and every patient. We need to ensure safety of both the donor and the product, and we need to ensure that the laboratory HLA typing is of the highest quality.

We have a challenge facing the ability of the program to deal with these specific, targeted, family recruitment campaigns, in which recruiting donors may have very high emotions that may cloud their long-term commitment to the registry. Sometimes our screening facilities may become overwhelmed during these family campaigns, particularly because of the time limitation between blood collection and HLA testing in the laboratory.

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As an aside, I should mention that internationally to date no match has ever been found for a patient through a targeted family campaign.

Finally, a very large challenge in operating the bone marrow registry is the need to ensure the correct ethnic mix or diversity within the registry. Simply recruiting more donors may not increase the chance of a match being found for a Caucasian patient for whom almost all HLA combinations are well represented within the registry. Recruitment is best targeted, therefore, to specific ethnic groups, notably aboriginal, oriental and African populations.

Finally, what has CBS done about the UBMDR since we have taken over operation of the program? There is a commitment to substantially increase funding compared to the previous operator, new regional donor recruitment co-ordinators have been hired and there is a commitment to formalize and ensure implementation of the principles previously referred to. We are presently undertaking a full ethical and operational review of the program and upgrading the information system platform, not only for Y2K compliance but to meet and sustain the needs of the rapidly growing registry.

Finally, later this year we will be undertaking a national forum, partly funded by Health Canada, to address many of the emerging scientific, social and ethic issues facing a registry.

Thank you.

The Chair: Thank you, Dr. Sher.

You may have done yourself a big favour in terms of rejuvenating your potential donor base, because in our audience we have a very large representation from a group of young people who are part of the Forum for Young Canadians. They're here this week, and they're following the hearings and this particular hearing. It's most timely for you—and for us, in fact.

Also, sitting just behind a member of the national press, we have four young representatives from the Carleton School of Journalism, so the word will be carried beyond these four walls.

Dr. Graham Sher: Thank you, Mr. Chairman.

The Chair: Next is Dr. Jay Wortman from Health Canada.

I don't believe we have a brief from you, but I think you've come with an eloquent preparation nonetheless. Am I right?

Dr. Jay Wortman (Director General, Non-Insured Health Benefits Directorate, Department of Health): That's correct. Our understanding was that you had an interest in having a witness who could answer questions related to aboriginal health programs at the federal level. I'm here to represent the medical services branch and to answer any questions you may have.

I'm sure you understand that we don't have any programs specifically related to organ transplant, as most of that activity is in the provincial domain and in the insurance services domain. Those aren't the kinds of programs that we offer, but I can certainly offer some background information should questions arise.

The Chair: But you might have a few words to say about the non-insured health benefits program.

Dr. Jay Wortman: Correct. We do provide that program. I am the director general of that program. Organ transplant issues and issues of renal dialysis and so on impact on that program even though we don't necessarily have a specific part of the program that deals with organ transplants or renal dialysis. We pay for medical transportation costs, for instance, for renal dialysis patients, and therefore we obviously do have an interest in the outcomes of organ transplant programs in the provincial domain.

The Chair: I was going to ask you to give a brief summary, but I think I'll hold that. I know that there are a couple of members around the table who will be interested in asking you specific questions in regard to that particular function. If you don't mind, I'll leave it to members.

I want to thank all of you for your presentations. I'll go to members, but allow me to do something for a moment for the group of young students in the Forum for Young Canadians. The members around the table to my right are members of the government party, the government side, and the members on the left of the table are members of the opposition side. We conduct our committee hearings more or less as we do the House of Commons, but we always give precedence for first questions to opposition members.

[Translation]

Mrs. Picard, you have the honour of asking the first question.

Mrs. Pauline Picard (Drummond, BQ): I would like to welcome you all. Thank you for taking the time to come and share your expert knowledge with us as part of this study. I'd like to direct my question to Mr. Noorani.

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You told us about a study, but unfortunately, we were not able to go through it before meeting with you. The interpretation also presented a problem. In any event, I would really appreciate it if you would tell us about this study. It must be a fairly lengthy document.

In the Executive Summary, which I have here, we read that the study analyzed the ethical and social viewpoints. In this study, you also reviewed current patient listing practices for various types of transplantation, and you also identified current criteria for adult recipient selection through a nationwide survey.

What recommendations could you now make to the committee from each of these viewpoints?

[English]

The Chair: Mr. Noorani.

Mr. Hussein Noorani: Thank you.

It's a conditional recommendation; it is until we undertake the ethical and social implications review of the criteria. We've found differences in certain criteria. These have been listed in the executive summary. These include age—for example, with respect to recipient age for kidney transplantation. We had a five-point scale, from zero, no importance, to five, absolute importance. We asked the programs or centres if they could please grade on the scale to what extent this factor or criterion was important to them.

For kidney transplantation, we had 16 centres, with 14 of 16 responding to our survey. We found, for example, differences ranging from no importance for age in certain programs to certain programs identifying, on a scale of zero to five, a four, which means very important. We found differences in that. We also found differences, for example, in factors such as employment status. However, we had a small sample size and there are study limitations, which are stated in the complete report. Again with respect to relative importance, of the 9 centres reviewed, 3 of 9 stated that employment status would be of relative importance. However, 6 of 9 remaining centres stated that it was of no importance to them in the decision-making process.

We also found differences between the organ groups. For example, tobacco use was much more important for heart centres compared to kidney and liver centres. Alcohol abuse and illicit drug use were important to all centres throughout the three organ groups, but tobacco use was of more importance for heart transplantation.

We also had a question about whether their program requires social and community support mechanisms or programs in place prior to listing a patient on a specific transplant. Again we found differences among heart, kidney and liver, with heart being much more rigid. Given that this was a really specific question, saying “requirement” and “formal social and community mechanisms”, we found heart being rigid, liver intermediate and kidney on the lower end of the scale, stating about 20%. About 20% of the kidney programs surveyed said, yes, they do require social and community support mechanisms. However, for heart it was 78% of the programs and for liver it was 50%.

Given these differences and acknowledging the limitations of the study, we think it would be of benefit to standardize organ-specific criteria and to standardize criteria for patient listing within the organ group. That is a recommendation. It's a conditional recommendation, and of course the next step we are undertaking, because of the significant ethical and social implications, such as human rights issues and access to health care, is that if substance abuse is important for all three organ groups, then we have issues around responsibility for illness and individual control.

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These are the implications we are currently elaborating on, given the important criteria that we've identified. Now we're looking at the ethical and social implications for these criteria at the national level.

I hope that does answer your question.

The Chair: Thank you, Mr. Noorani.

[Translation]

Mrs. Picard, you'll be able to get into the round of questions in a few minutes.

[English]

Madam Wasylycia-Leis.

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

I'd like to thank all the presenters for coming here this afternoon.

One of the themes we're trying to pursue today is the whole question of what kind of mechanism needs to be put in place to actually serve as a body to co-ordinate, on a national scale, the question of organ donations and transplantation. In fact, I think some of you are here today to help us determine whether or not the model from which you operate is an appropriate one when it comes to organs.

In each case there are some questions, though, that need to be clarified. Let me start with the Canadian Blood Services since in fact there are some perceptions out there in the public about whether or not the move from the Red Cross to the Canadian Blood Services has actually led to more accountability, more transparency, more independence and less bureaucratic and hierarchical approaches. Whether that's real or perceived, the issue is that it's out there and does pose a serious question for all of us as we look for a way to deal with organ transplantation and donation. I'll start with that first question and then go on to a couple more if time permits.

The Chair: Ms. Cranston, do you want to handle that?

Ms. Lynda Cranston: Certainly it has been CBS's intention to convince the public and gain the confidence of the public in our organization through being a transparent and open organization and being out there in terms of discussing issues around CBS and the activities that we're undertaking.

We have a board of directors that has consumer representatives and has representation from across Canada. That's one way we do it. We also have a number of advisory committees, scientific advisory panels outside of the organization, who give us advice independently on things like emerging risks and research and development and consumer issues. The other way in which we're an open and transparent organization is that all agendas of the board of directors are on our web site prior to the meetings of the board and all records of decisions of the board of directors' meetings are also published on the web site.

Those are some of the ways in which we have tried to be a more open and transparent organization since undertaking the responsibility as of September.

Ms. Judy Wasylycia-Leis: Just as a follow-up, one of the issues that brought these concerns more to the public was with respect to the U.S. donor who had CJD and the question of quarantine and the way in which Health Canada responded. I guess it was also mentioned at your annual meeting, your open public meeting.

Is there a problem here in terms of co-ordination between CBS and the department when it came to regulation around safety of blood product on the market? Based on your experience, is that a problem that needs to be sorted out before we pursue any further model? One of my concerns, in fact, is that in the Health Protection Branch there may be a less than rigorous application of Krever's recommendations around ensuring that anything on the market is safe. That's an important issue for us with respect to organ donation. Is there an experience you can offer on those two points I've made?

Ms. Lynda Cranston: In relation specifically to the issue of the Utah donor, we worked very closely with Health Canada and with the regulator in particular, the Bureau of Biologics and Radiopharmaceuticals, when they in fact put the product on hold. We spent time going back and forth and keeping in touch with the BBR until they had drawn together their scientific panel, consulted with the Centre for Disease Control in the U.S.A. and talked to the FDA as well. They then released the product, and from our opinion we had no reason to question their scientific evaluation of the evidence that it was classic CJD.

The difficulty that arose and that was alluded to at the open forum that CBS held was in fact the ability of CBS to then get to all hospitals, all centres, but right down to every hemophilia patient who was relying on Kogenate, which is the product that was put on hold. There are a variety of ways that the patient actually receives the drug. Some receive it through hemophilia clinics scattered across the country and others directly through our blood centres, which, again, are scattered across the country.

• 1625

As a result, we've taken the feedback that we received as a result of that incident and, in fact, we are working with the Canadian Hemophilia Society, the BBR and hemophilia clinic centre directors and nurse co-ordinators in setting up a template for what will be the way in which, should another incident of that nature occur, we will be able to communicate without any difficulty whatsoever so that everybody has very timely information in the right amount of time.

The complicating factor in the CJD incident was that it happened on December 24—

Ms. Judy Wasylycia-Leis: —at 4 o'clock in the afternoon.

Ms. Lynda Cranston: That's correct. I can tell you that anything in the blood business happens on Friday afternoon at 4 o'clock.

The Chair: Thank you, Ms. Wasylycia-Leis. We'll come back to that.

Madam Caplan.

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

I wanted to follow along on not only the theme of models of governance but also on the goal of evaluation on the basis of effectiveness, fairness, openness and transparency, which is one of the things that this committee is very concerned about in whatever models we recommend.

My first question has to do with your survey. We know how important it is to get all of the different—some would say players, others would say partners, and certainly I would use the words providers of service—providers of service to cooperate. I'm curious as to whether your report is going to have a list of all of the transplant centres and a list of all of those who participated, and I'm curious as to whether or not any follow-up was done to find out why centres didn't respond. You said you had 29 out of 34 centres responding. I'm curious about whether there was any follow-up as to why the other centres didn't respond. These are issues of accountability.

As a follow-up to that, in whatever model is set up, finding out why they didn't reply is very important if you're going to foster a positive environment of cooperation. Also, when you're co-ordinating, how do you make sure you have compliance in quality assurance programs that require responding to requests?

So if anyone would like to respond, while this is specific to your survey, there is the issue of what sort of national—and by that I mean federal-provincial-territorial—legislation or regulation or policy, whatever it is, should be required policy to require compliance with the accountability framework in order to ensure Canadians that whatever the governance model is, it has the cooperation of all of those providers of this important service.

The Chair: I'm going to have to ask you to really tighten up the answers.

Mr. Hussein Noorani: Responding to question about the programs that did not respond, we had five. Two were unwilling to participate. We got the response through our fax correspondence. We also had stated “if you are not willing to participate, please give us the reasons”. The reasons were not given. We haven't followed up on that to date. For the remaining three programs that did not participate, we did not get a response, either way, by our survey deadline.

Ms. Elinor Caplan: I think the committee would be interested in the list of the five that didn't respond. Could you provide us with that?

Mr. Hussein Noorani: Confidentiality reasons may.... We had a consent statement saying that no programs would be identified and no centres would be identified individually, so confidentiality may not let me do that.

Ms. Elinor Caplan: So how does that fit within an accountability framework to ensure that our governance model has the information it needs to ensure compliance with standards?

Ms. Lynda Cranston: If you're going to establish a national organ donor referral registry or have a national program, I think for sure that you will need to have national standards and some kind of regulatory authority or accrediting body to make sure that those national standards are in place and are adhered to.

• 1630

We meet national standards across our organization, CBS, are regulated by BBR and follow good general manufacturing practices. The regulator monitors that very closely and we meet those standards on an ongoing basis. I think that's particularly important. Personally, from my experience in health administration, I think a critical issue around this is that it is on the ground, in the hospitals, where you get the organ donations.

The Chair: Madam Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: This is an important area. The issue is that no matter what sort of national co-ordinating body we choose to help facilitate a national organ donor program, it doesn't mean anything unless you have in place proper regulations and a very clear set of standards that are monitored on a proactive basis. One of my concerns is that we know this clearly from the whole blood scandal, but despite all of that, we have a proposal for a risk management framework for organ donors that recommends rejecting a highly regulated model, which presumably means a less proactive approach around adherence to the standards and surveillance and so on.

My question is this: haven't we learned from the Krever commission that as a bottom line you must have an active, highly regulated model when it comes to blood and organs and tissues? I'll ask the CBS and Lynda to respond.

Ms. Lynda Cranston: As it relates to blood, of course, we actually manufacture products and therefore must be highly regulated in order to make sure that those products are actually produced according to certain standards and regulations.

Whether you use the word “regulate” or the word “accredit”, you need to do one or the other. Accrediting national standards for an organ program might meet your needs without being very highly regulated.

Dr. Graham Sher: I think that's an important distinction. You can certainly use the analogy of the hospital setting; hospitals are accredited to ensure that they're delivering health care in a manner that meets standards. With this sort of registry, I think accreditation is probably the way to go rather than very tight regulation, which is really applied much more to the manufacturing arm of the industry than it is to the standard-setting arm.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: But does that really address the problem of organs or tissues coming into the country or going out of the country and causing the real possibility of transmission of disease and unknown factors? Don't we need something more than simply standards on paper that facilities or organizations must adhere to? Don't we need an active role by government in terms of oversight, surveillance and monitoring?

Ms. Lynda Cranston: As Graham mentioned, through the accreditation process there is an oversight role. It's done through a separate distinct organization that does the accrediting, but I think you raise a good point about tissues coming in and out of the country. That raises an interesting point. The key issue, though, is that there are national standards that are monitored on an ongoing basis and people should have to adhere to them.

The patients in St. John's, Newfoundland, want to make sure that they're getting the same level of care and meeting the same standards as the patients in Victoria, British Columbia. Canadians don't want to feel that the level of health care that they get is different depending on where they live in this country—and so they shouldn't.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: The other thing that seems to be required, notwithstanding the model we choose, is the will of government to act to implement standards. One of the issues with respect to the Canadian Coordinating Office for Health Technology Assessment is an issue that came up in Parliament recently around the reuse of disposable medical devices. In fact, there's an example of where your council did a lot of work, brought people together and clearly called for standards. Yet for five years this document sat while nothing was done. Suddenly it became an issue because of being exposed in Manitoba, and now it might be put on the agenda of the health ministers sometime in May. Isn't there also a question here of the need for us to find a way to get government to act and move when there is an identified concern and when work around standards is done by organizations like your own?

The Chair: Do you want to try that, Mr. Dicaire, in the next 15 seconds left for you?

• 1635

Mr. John Dicaire: In terms of CCOHTA's role, it certainly was made very clear by the conference of deputies that CCOHTA does not recommend. CCOHTA provides advice and evidence to support that advice. It falls to the provincial jurisdictions as to whether or not they accept that, i.e., New Brunswick says they aren't listing Betaseron on their formulary and every other province in Canada does. That option is left to the policy-makers at that level.

What we do ensure is that the evidence is factual, is valid, but a decision is not based strictly on evidence, as we all know. There are other factors that are brought to bear on it. With respect to reuse of disposable devices, CCOHTA did a lot of work on that. It was the topic at a national forum, highly involving to a number of hospital corporations at the time—now they're regional health authorities, I suppose—that had a very extreme interest in it, basically because they saw it as a way to save money, for example, “if we can reuse single-source devices, we should”. A number of them did.

So the information was certainly disseminated across Canada, but it was disseminated to the provider level because it really was not a policy decision of government as to whether you used that or not. It was a policy decision of the board, of the corporation, of the medical advisory committee of a corporation, and the management of that facility as to whether or not they wished to accept that.

The Chair: Thank you, Mr. Dicaire.

Dr. Bisby, in the context of these discussions about the establishment of standards and providing the appropriate evidence and data required for making decisions, the MRC, it would appear, is uniquely positioned to gather good scientific information, on the basis of which certain standards will be developed or maintained. In the MRC, are you engaging in research in xenotransplantation? If so, are you heading towards establishing standards for all other scientific researchers who may wish to pursue that field of study?

Dr. Mark Bisby: Yes, we are supporting some research into xenotransplantation, but I think I would characterize it as being at a stage that is earlier than one where the results of this research can be directly applied to clinical practice. For example, for some of the research I mentioned, the topic of research is the following: can we insert genes into the xenotransplanted tissue so that it will be recognized by the body as its own tissue? That is at least one step removed from direct application of that kind of technique to clinical practice.

We also do get involved further along the line between discovery and application. Certainly, for example, one could imagine a clinical trial that we might support which would give rise to information that could be used to set national standards in this field. But at present, most of what we support is, as I say, earlier in the discovery pipeline, if you like.

The Chair: There are those who suggest that perhaps we should not be involved in xenotransplantation, either in fact or in research.

Dr. Mark Bisby: Yes.

The Chair: What controls...if that's too harsh a word, I'll withdraw it and suggest something a little bit more diplomatic. What guidelines impact on the decisions of the MRC committees that would support research in that area?

Dr. Mark Bisby: I would say they are bound, if you like, by the guidelines of the tri-council ethics document, which certainly don't in any way prohibit or sanction research into xenotransplantation. Their other primary goal, and really the overriding issue that they are interested in when they adjudicate a research grant application, is this: is this going to advance our knowledge?

• 1640

Xenotransplantation is a difficult issue because of the as yet unknown risks of the spread of viruses from animals into humans in this setting. Clearly we need to know a lot more about that, but I think their primary guide is whether this is going to advance our knowledge in that area, not whether xenotransplantation is an avenue that we should go down—or not. As you know, internationally the jury is still very much out on that particular issue.

The Chair: Well, you skated around that pretty well. I thank you for it.

Mr. Jackson.

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

These two questions are probably directed to the Canadian Coordinating Office for Health Technology Assessment. I am particularly interested in the fact that technology drives a lot of things. It's a very important factor, for instance, for cutting costs and for drugs and the tracking of them and various other things, but there is one thing that I think is a bit of a question and I don't know how we'll handle it. Each regime across the country will have a different program, a different approach, and one of the biggest problems is that these computers don't talk to one another. Also, of course, technology is changing rapidly. In fact, you might well have some brand new program that does a better job.

As politicians, we get questions from various regions simply because somebody didn't get a contract, so I would like to know how you would get a regime in place to make sure that these things will talk to each other, that they don't in fact become obsolete and that you're not wasting the resources used to purchase them.

I have a second question with regard to technology. We've heard a lot about cards. It would appear that many hospitals use a whole bunch of different cards that have different bar codes and things like that. Would it not be best if at least whatever card they're using had a bar code that we could use to get the pertinent information in an expeditious way?

The third question is probably for CCOHTA—and maybe for the MRC. We have been talking a lot about transplantation, but one of the problems is that we don't talk a lot about prevention, about the environmental problems that actually kill people and maybe damage their organs, or about safety, where a lot of people die. Maybe it's great, sort of, when a lot of young people end up in motorcycle accidents because you can harvest a lot of spare parts. I don't know. There's lifestyle too. How do you co-ordinate all these things in order to make our country better, to make our citizens better? Obviously some people are better at it than others. How are we working to make sure that every Canadian has that information, to make sure that the members of society live longer and have a better lifestyle?

The Chair: I think the first two questions were for John Dicaire and Hussein Noorani, and the third one will probably be a toss-up between Mark Bisby and Jay Wortman.

John Dicaire.

Mr. John Dicaire: Through you, Mr. Chairman, in terms of the question that was posed by the honourable member, CCOHTA itself is not into system development, whether that's computer systems, software, etc. That certainly is an issue, for example, if it's a MEDITECH system versus another system. Normally those are local decisions as to who or what company you deal with in purchasing that type of material.

Just for a moment, though, I think I can relate part of the issue to what CCOHTA is doing nationally and internationally. Health technology assessment, as an evolving field, requires a great deal of co-ordination to ensure that resources invested in this particular field in Canada and around the world are being fully utilized for the best purposes. One of CCOHTA's major roles is the co-ordination of that, and we are heavily involved internationally.

The second thing is to develop standards, an example being the guidelines for the economic evaluation of pharmaceuticals. In Canada, it was developed by CCOHTA. If all researchers apply those guidelines, each provincial territorial jurisdiction will accept the results of the work that was done in other jurisdictions, so we are not repeating that. That is also happening internationally. So in terms of co-ordination through the development of standards documents and the application of those in co-ordination efforts, we hopefully eliminate duplication. We do talk to each other, and the resources put in by the public internationally are getting the best return possible.

• 1645

It's interesting that you mention health care cards. I was responsible in New Brunswick for probably one of the national flops dealing with a private sector company in trying to develop a computerized medicare system. It used card technology with a bar code. I actually have the card here. It has three bars on it: one is your medicare number, one is the “chargex” or banking number in case we could ever charge for certain items in the health care field, and I forget what the third one is. The bar code technology is pretty standard as it exists in Canada. The main difference came in bar-coding versus a smart card. The smart card was the card that had a computer chip in it in which specific health information was contained.

The bar-coded card deals with a stand-alone database, so it's interactive with that database. Your medical history is in a computer, and when that card is swiped it can draw on that information—versus having to update a card at specific points in time. To answer your question, the technology is standardized. It's just a matter of deciding what code you want to use. We put all three just for the reason that you're stating: no one had yet decided—in Canada or internationally—what bar they would use. We think we've covered all options at this point.

The Chair: Yet it was a flop?

Mr. John Dicaire: The problem was that we never got to the point of applying it because the private sector developer failed to deliver on that particular system. It's not dead yet. We're going back.

The Chair: Mr. Jackson has a quick question.

Mr. Ovid Jackson: I was just going to add that it happens often, and you have to be very mindful that the people who make the computer are the same people who do the program. If you get a programmer and you don't have the computer manufacturer.... You have to be very careful when you purchase. You will get a flop if you aren't. I'm just...[Technical Difficulty—Editor]...the other questions, I guess.

The Chair: If you don't mind, Mr. Jackson, I'm going to come back to you. Then you can direct it where you want it to go, to Dr. Bisby or to Dr. Wortman.

Mr. Grewal, did you want to wait?

Okay, Madam Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you. Just to follow up on Mr. Bisby's comments about guidelines or the whole area of xenotransplantation and what purpose is being served right now, I appreciate what you said. Red flags go up—for me, at least—when we look at any kind of research going on in an area with an organization that has obviously had to develop, maintain and pursue private partnerships. That's a concern for us as we look at appropriate models for overseeing any kind of organ donor system.

One of the concerns is an issue specific to MRC. We received copies of a letter last fall from someone who had been asked to invest in Canadian Medical Discoveries Fund Inc., which is a partner of MRC. The concern was that mixed in with the biotech companies receiving financial support was HRG, which is the organization pushing the private hospital in Alberta. That immediately put up red flags for this person, who said they didn't want to invest money if they had any sense that there was any effort there to further the agenda of a two-tiered health-care system. I think you need to clarify for us how you're handling that situation and how we can pursue meaningful initiatives that ensure independence from and freedom from conflict of interest in this area of organ transplantation.

Dr. Mark Bisby: Thank you.

I'm obviously not aware of the specific details of that letter or of that particular arrangement. MRC's relationship with the Canadian Medical Discoveries Fund is one where we will put ideas for investment through our peer review system so that the agency has the assurance that this is quality work that's being supported.

MRC also has a number of partnership programs with the private sector, both with the industrial sector and with the voluntary health agencies. All of the MRC funding that supports these partnered programs is subject to peer review, just like any other part of MRC's work. That's peer review totally free of any commercial input or commercial influence.

Ms. Judy Wasylycia-Leis: I'm sure I don't have much time left on this round, so if I may, I'll ask Jay a question on aboriginal issues. One of the things we've discussed has been how to put in place a fair system of allocation when organs are available for transplantation. It would seem that right now we're probably not able to address the needs of people in remote northern communities, particularly first nations communities. What's your sense of the ability of first nations to access organ transplantation on an equitable basis?

• 1650

Dr. Jay Wortman: From our appearances here, I think you're familiar with our program. We pay for medical transportation costs, drug benefits and other additional benefits for first nations people. To the extent that first nations people live in remote areas, they do have access to our program, which funds their travel and accommodation costs for medical services provided through the provincial system. Because of the program we provide, if a first nations person is eligible for an organ transplant, there should be no barrier in terms of them having the capability to get from where they live to the site where they would receive the transplant and the care around the transplant.

Ms. Judy Wasylycia-Leis: Okay. Obviously, though, there is an agenda of moving forward with a complete transfer of responsibility for provision of health care services—and the non-insured benefits program as well—to first nations communities. Right now there are complaints about the ability of reserves to meet needs with the transfer funds they have. If that isn't addressed in a meaningful way, how are these communities ever going to be able to pay for organ transplantation?

Dr. Jay Wortman: The medical transportation portion of our program is about 50% of the expenditures in that part of the program and at the present time is managed by the communities themselves. I think the communities have had a pretty good record of managing within their budgets and providing a level of service equal to or possibly even better than what we've provided when we ourselves provided it directly. It is a challenge to make sure that communities who do take transfer of this program have a good business plan and the management capacity to be able to do it. In the event that there was a failure by the community to do that, in a circumstance like that I'm sure we would cover the costs of the transportation.

The Chair: Thank you, Dr. Wortman. Ms. Minna.

Ms. Maria Minna (Beaches—East York, Lib.): Thank you, Mr. Chairman. I wanted to go back to Mr. Noorani for a moment on a couple of things.

As a result of your study, you talked about standards that need to be developed in organ-specific areas. Obviously we've heard for some time, from a great many presenters, that we need national standards and that kind of thing. Some organizations that appeared before us—I can't think of the names offhand—have already been working at developing standards. Have you been involved with or have you shared the results of your study with these other organizations that are in the field now looking at this kind of thing—or not yet?

Mr. Hussein Noorani: We have developed informal partnerships with the Canadian Society of Transplantation. They will be getting a copy of the preliminary report that we have tabled today. Each of the working groups there are working on algorithms for organ-specific areas and they'll be getting our report. We will also submit a report to the director general of Quebec Transplant. So we do have partnerships, however informal, with the societies who are involved in the field.

Ms. Maria Minna: So at some point in terms of negotiating or arriving at some sort of national agreed-upon standards, this preliminary work is already being done. It's a matter of having some sort of co-ordinating body or some help to get together with both the regional and the national levels. Am I right to assume that?

Mr. Hussein Noorani: Yes, that's right.

Ms. Maria Minna: Okay.

I'd like to ask you, Dr. Sher, something with respect to the registry. If I'm not mistaken, I think you said there was a high attrition rate in your donation registry for bone marrow. You also said that after people had indicated they wished to donate, they were given a period in which they could reconsider before doing so. Was the high attrition rate prior to their period of reconsideration or after?

Dr. Graham Sher: What I was referring to in terms of the attrition rate was individuals who are recruited into a program where the program centres around a specific patient such as a family member, a friend or a colleague. There's a lot of data from our registry and from other international registries to show that those individuals' long-term commitment to the bone marrow registry is very weak. If called upon months or years later to donate for somebody they don't know, they frequently decline, so you have offered hope to a potential patient and suddenly you withdraw that hope because these individuals say they thought they were recruited to donate only for that specific patient.

• 1655

Ms. Maria Minna: I see.

Dr. Graham Sher: That attrition rate is exceedingly high and, in my opinion, is quite dangerous for the potential patient.

Donors who are recruited into the marrow registry on a purely altruistic basis, without identification of a specific patient, are usually very committed to it. We do our best to mail them anniversary cards every year to make sure the address and information is up to date. There's in excess of a 95% success rate in keeping those people in the registry. When inviting them to donate marrow at some time down the road—and it could be years down the road—there's a very high success rate at retaining those sorts of donors.

I was reflecting attrition rates at those two levels.

Ms. Maria Minna: I see.

Would you be able to tell us at this point what the cost is of maintaining the national registry of potential donors? The reason I'm asking is that we've had a great deal of discussion about a national registry and the pros and cons of whether it's worth doing or not. Different presenters from different parts of the world—from the U.S. and from Spain—have said that it's not worth doing because it's really at the hospital level that it matters. But some others have asked for a national registry, for both potential donors as well as intended donors. I'm wondering what your cost is and whether it's worth doing.

Dr. Graham Sher: The cost of operating the unrelated marrow registry is driven in large part by the HLA testing that takes place in the laboratory. That is by far and away the most expensive component of the registry, something that doesn't apply in maintaining a national registry for solid organs. Of the budget that we have to operate the bone marrow registry, 80% or more goes to the laboratory testing. Only a small component goes to maintaining the computerized registry—not an insignificant component, but a small component—so I'm not sure that the figures really jell.

At present, we are in the region of about $5 million to operate the national registry, which includes recruiting the donors—actually holding the information sessions to recruit them—doing the various levels of laboratory testing and then maintaining the data in the registry. It's around $3 million to $5 million a year, depending on what level of testing we do initially. But again, the vast majority of that is the laboratory costs for the HLA typing, which is about $1,000 per patient; it's very expensive.

I don't think I can really give you figures in terms of what it costs us just to maintain the database. We have one office in Vancouver staffed by three people and we have a fairly complex computer system. That's really the database. The rest of it is the recruitment and the testing.

Ms. Maria Minna: How many do you have in that database?

Dr. Graham Sher: We have just over 180,000 Canadians in our registry and we're linked to 32 other national registries across the globe. In total, there are about 5.2 million potential bone marrow donors who are linked. In other words, a Canadian patient will first search our own registry, and if a match is not found, we can tap into any of the other international registries and search. Locally we have just under 200,000 donors in that registry.

The Chair: So you're still using the old Red Cross database.

Dr. Graham Sher: It was assumed at the time of acquisition. It was one of the things acquired by Canadian Blood Services.

The Chair: Thank you. Mr. Grewal.

Mr. Gurmant Grewal (Surrey Central, Ref.): Thank you, Mr. Chairman. I regret that I had to miss part of the discussion around the table and miss the presentations of the witnesses, but I join my colleagues in welcoming the witnesses to the committee.

I learned that there was some discussion about xenotransplantation around the table here. What bothers me is that although I agree on one side that xenotransplantation is helping the supply part of the equation, on the other side, how about the ethical concerns? Is there any suggestion of or any public consultation on the ethical concerns that come into the picture?

The Chair: Dr. Bisby.

Dr. Mark Bisby: I'll start this off, but I certainly can't pretend to give a complete answer to that question. It would help me if you would indicate which specific ethical concerns you mean. Is it the specific use of animals for this purpose? Is that your concern?

Mr. Gurmant Grewal: First of all, there is the use of animals only for this purpose. If we go deeper into it, probably we can see genetically altered tissue growth. For example, recently I was reading about an experiment in which they grew a human ear on a mouse. If we go still further into the details, we can be concerned about diseases that are transferable from animals to humans and areas like that.

• 1700

Dr. Mark Bisby: I could try to answer that in a couple of ways. One is that with respect to the whole issue of biotechnology, which is really what your question is addressing more broadly—

Mr. Gurmant Grewal: Yes.

Dr. Mark Bisby: —as you know, the government just announced, yesterday or the day before, I think, the chair of the Canadian biotechnology advisory committee, which is intended to provide that sort of public forum for discussion of issues of public concern surrounding biotechnology. This is part of the Canadian biotechnology strategy. The other members of that committee will selected over the next couple of months.

I've seen a paper which is a list of issues to be referred to that committee for consideration, and certainly, on it are many of the ones that you've touched on, like genetic engineering, xenotransplantation and so on. They're all aspects of biotechnology, and this is one way in which there can be public discussion of these issues.

Mr. Gurmant Grewal: Okay. Maybe Madam Cranston can give us some ideas on the artificial or synthesized blood that is being researched. I learned that synthetic blood has been developed in California, in the U.S. It has been practised on some animals and it has been working for a certain period of time. Is there any research in the direction of developing artificial blood or serum, whatever you call it, for human consumption in the long run? Are there any long-term plans in that direction in the Medical Research Council or in the Canadian Blood Services somewhere?

Dr. Graham Sher: I'd be happy to answer that, if you like.

The Chair: Dr. Sher.

Dr. Graham Sher: The terminology “artificial blood” or “synthetic blood” has been used for many years now to reflect a variety of ongoing research projects that are trying to find alternatives to standard blood transfusions. It's a very unfortunate misnomer that has gotten into the literature, because there are only six programs going on worldwide at the moment to develop alternatives to red blood cells, which is by far and away the most important aspect, and five of those six use human-derived donor blood in the first place. They take outdated blood from an organization such as our own and then modify it chemically and play around with it in the laboratory to produce a substitute for a bag of blood, but it is still derived from human donors in the first place.

There is only one corporation, based in the United States, that is developing purely synthetic hemoglobin to substitute for red cells. That is grown in a test tube, basically; it's not animal-derived in any way. There was a study going on using cow hemoglobin, cow red blood cells, to take just the hemoglobin molecule out of the blood cells and to look at that as an alternative to transfusion. That has not gone anywhere over the last number of years.

So when one talks about artificial or synthetic blood, in fairness, strictly speaking, it's not artificial, because in the majority of the cases it is derived from human donors in the very first place, except, as I say, for this one particular agent that is nearing clinical trials but is not yet in clinical trial; that's at least five years away.

Mr. Gurmant Grewal: I see.

Dr. Bisby, did you want to respond?

Dr. Mark Bisby: I'm not aware that the Medical Research Council is at this time supporting any research into the development of artificial blood.

Mr. Gurmant Grewal: Finally, very quickly, if I may—

The Chair: This is your last question.

Mr. Gurmant Grewal: —I'd like to find out what the yardstick is for the measurement of the performance of the Medical Research Council. How do you measure your performance, your activities and efficiency, etc.?

Dr. Mark Bisby: The usual performance measures are really the numbers of applications that are funded, the types of work that we support. We have begun to evaluate the output, what results from that process. We've engaged in a survey of the publications that result from the work that we and other funders in Canada do. We are very much encouraged by those results. It turns out that the percentage of world publications in the area of health research that is generated by Canadians is actually increasing steadily, in spite of the historical funding limitations we've had in this country.

Perhaps more to the point is the impact those publications have. The use that is made of those publications in furthering knowledge has also increased steadily over the past 10 years.

• 1705

Finally, Canada is one of the top three nations in the world—I can't remember if actually it's number one, number two or number three, but it's certainly one of the top three in the world—in terms of getting research results for research money invested. The top three are the United States, Britain and Canada, and they are way ahead of every other country.

Mr. Gurmant Grewal: Thank you.

The Chair: Thank you very much.

We're getting towards the end of this session. I have three very brief questions from colleagues on this side, so they'll be sharing some of the time left.

Madam Redman.

Ms. Karen Redman (Kitchener Centre, Lib.): Thank you, Mr. Chairman.

I've really looked forward to your presentations.

I would just like to ask one quick question, if I may, of the Canada Blood Services, because I think you have a lot to teach us as we grapple with this. One of the things that comes home to me is that there has to be a multi-pronged approach to this; there are some things we need to do now and some things we need to do later. Given your experience—I don't know if you one or both of you want to respond—in your view, what would be job one in moving forward with the issue of donor transplantation?

Dr. Sher has volunteered Ms. Cranston.

Some hon. members: Oh, oh.

Ms. Lynda Cranston: Yes, I noticed.

We agree that the establishment of national standards should be job one.

Ms. Karen Redman: Thank you.

The Chair: That's it? That's great.

Madam Caplan.

Ms. Elinor Caplan: Just for the record, I guess MRC is different, but none of the other organizations here are federal organizations. You're national organizations. I'd like you to describe your model of governance, how your membership is appointed, how you're funded and who you report to. That's question one.

Second, if you have time, could you describe the difference between a compliance model of regulation and an enforcement model of regulation and which you would recommend?

The Chair: I think the Canadian Blood Services already gave us their governance model and have told us who funds them and to whom they're accountable. I think Mark Bisby gave us part of that as well.

John and Hussein, you did not, so you might address that.

Then perhaps all of you can address the question on compliance.

Do you want to do that first one about where you get your money?

Mr. John Dicaire: In terms of governance, the board of CCOHTA is composed of the federal, provincial and territorial deputy ministers of health. We get all our funding from federal, provincial and territorial governments.

Ms. Elinor Caplan: How do they provide it?

Mr. John Dicaire: It's the standard population pro-rated formula. In the case of CCOHTA, the federal government actually pays 30%, not 20%, and we thank you for that.

The other provinces pay on a per capita basis. The only exception is the province of Quebec. Because Quebec has a very large infrastructure in pharmaceutical assessment, they were not willing to partner in that component of CCOHTA. However, they certainly do partner in the other technology assessment sides of it.

Ms. Elinor Caplan: You report to the deputy ministers?

The Chair: Compliance?

Mr. John Dicaire: We report to the Conference of Deputy Ministers of Health.

The Chair: Mark Bisby.

Dr. Mark Bisby: Do you want me to describe MRC model?

The Chair: No. We already know that. Just tell us who you answer to.

Dr. Mark Bisby: We answer to the Minister of Health.

Ms. Elinor Caplan: You're the only federal one.

Dr. Mark Bisby: Yes.

The Chair: Ms. Cranston.

Ms. Lynda Cranston: The shareholders of the corporation of CBS are the provincial and territorial ministers of health. They appoint the independent board of directors of CBS.

Ms. Elinor Caplan: The federal role is that of the regulator.

Ms. Lynda Cranston: Yes.

The Chair: There was a question of dollars initially, and I think you addressed the question of dollars, but in your earlier indication, you didn't tell us what the federal contribution was to your start-up. But all of your money comes from the federal, provincial...?

Ms. Lynda Cranston: As we move forward, the operating budget will come from the provincial and territorial organizations for the provinces and the territories. The federal government certainly assisted CBS in moving through transition and start-up, but now as we've moved into our operating budget, it's funded by the provinces and territories. The federal government is committed to advancing us money as we go forward, starting in the year 2000-01, for research and development.

The Chair: Okay. Mr. Jackson.

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Mr. Ovid Jackson: Mr. Chair, I humbly suggest another way to study organ transplantation. The deployment of resources, the amount of money available, the amount of emergency beds available and so on, could be enhanced, and it actually would move over to more transplantations happening, if we deal with some of the questions.... We can't do much about our genetic makeup, but we certainly can about the environmental, safety and lifestyle questions. I would like to know how we're collecting them and how we are going to use this mechanism to help us to get more resources to transfer for more organ donations.

The Chair: That was question number three, if you'll recall from an earlier round. You have had time to think about that.

Dr. Bisby.

Dr. Mark Bisby: Yes, I've had time to think about that.

From our perspective, perhaps the best way or one of the ways to have efficient health care is through research. Earlier you asked a question about prevention and whether we were interested in working on prevention rather than on the “down side” of disease, so to speak. We do fund considerable amount of work in the prevention area. I'll just give you two examples, if you'll allow me.

One is the biggest grant we've ever given, which we just awarded. It's $1.5 million a year in a clinical trial that looks at the use of vitamin supplementation to reduce risk factors for cardiovascular disease. If that trial turns out to give the results that it could—that we expect—it will have a very significant impact on health savings for the health care system, allowing resources to be diverted elsewhere.

One grant that we'll be announcing over the next few days, which we are able to fund because of the increased funding that we got this year, looks at diet and risk factors in osteoporosis. Similarly, if that study has a positive outcome it will have a huge impact.

Those are just a couple of examples of the kind of prevention work that we're interested in, which does have potential for big savings in the health care system.

Mr. Ovid Jackson: Do you have a way of getting this information to Canadians so they can use it right away?

Dr. Mark Bisby: I have to say that I think that is one of the problems. I think we—collectively we, not specifically the Medical Research Council only—are not doing as good a job of this as we might. This is one of the things that we promised to do in the Canadian Institutes for Health Research, by involving Canadians in the process and by having much more effective communication with Canadians.

The Chair: Dr. Wortman, maybe you would like to respond to that, because I think you're involved in a situation, at least in your area, where Mr. Jackson's question about prevention might be very apropos, given the clientele with which you deal.

Dr. Jay Wortman: Preventable illness clearly creates a big disease and mortality burden in the population we serve. Quite a significant amount of the programming in our branch is preventive programming, but probably the best example I could use that would be germane to the discussion here is the programming around diabetes.

As I'm sure you're aware, we have evidence of a significantly greater rate of type II diabetes in the first nations population than in the general Canadian population, diabetes being probably the major contributor to renal failure and creating a significant burden in our system to support patients who require renal dialysis. Therefore, we have an interest in the question of renal transplant.

In the last budget, a major program was announced to fund diabetes programming in our branch. A significant proportion of that will be preventive programming. Clearly you can make an impact on the disease burden of diabetes through good preventive programs. We really are in the business of prevention in our branch, with, I think, some potentially significant outcomes through those kinds of programs.

The Chair: Do you do a lot of education in terms of population health?

Dr. Jay Wortman: Yes, we do. We have health education programs as an integral part of the first nations and Inuit health program area. We have health educators in our regions and we generate quite a bit of health education material for dissemination to the communities we serve.

The Chair: This kind of question would seem a little bit unfair, and I apologize if it comes across that way, but I'm going to ask it nonetheless. Given what you just said and what others before you have said about the epidemic proportions of diabetes and perhaps kidney failure in the aboriginal community, what is the ratio of expenditure between prevention and actual care? The reason I acknowledge a certain unfairness is that I realize that a good portion of your costs are transportation, as you acknowledged.

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Dr. Jay Wortman: Obviously I don't have a precise figure for you, but—

The Chair: You can ballpark it for us.

Dr. Jay Wortman: I can't even ballpark a figure, but I can tell you that proportionately the amount on prevention would be significantly less than what we spend on care-related medical services and so on. It would be a significantly smaller proportion.

The Chair: I thank all of you very much.

Ms. Elinor Caplan: Can I ask, Mr. Chairman, with the consent of the committee, if anyone would like to answer the question on compliance models of regulation versus enforcement models?

The Chair: Well, I already asked them about compliance.

Enforcement, Lynda?

Ms. Lynda Cranston: The CBS operates under a licence granted to us by the Health Protection Branch. If we don't follow the standards or comply with the regulations, the licence can be removed or conditions can be applied to the licence. Within the Health Protection Branch there is actually a department called “compliance and enforcement”.

The Chair: Mark Bisby.

Dr. Mark Bisby: I don't particularly want to respond to this, thank you. I don't think we have any particular perspective on this issue.

The Chair: Right—peer review.

Mr. Noorani.

Mr. Hussein Noorani: Same here. No response.

The Chair: All right. I think I know your answer.

On behalf of all committee members, thank you. It's been a good way to finish off the day. We thank you for your rather frank responses.

I'm going to suspend this for exactly three minutes and then we're going to go into private session.

[Proceedings continue in camera]