HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, February 18, 1999

• 0914

[English]

The Chair (Mr. Joseph Volpe (Eglinton—Lawrence, Lib.)): Ladies and gentlemen and colleagues, pursuant to Standing Order 108(2), a study on the state of organ and tissue donation in Canada continues with our sixth hearing on the subject.

• 0915

Today, colleagues, we have with us several representatives of organizations, including the Eye Bank of Canada, with Dr. David Rootman, who is its director; the Canadian Bone Marrow Registry, with Dr. Hans Messner, director; and from the University of Alberta, John Akabutu, medical director of the Alberta Cord Blood Bank.

I'm going to make a little bit of an adjustment. We had in our second panel Dr. Michael Gross, medical director of the Queen Elizabeth II Tissue Bank Health Sciences Centre. I'd like to begin with Dr. Gross first, because he has some flight commitments. I'm going to ask, as well, that when we go into the question and answer session, if you have any questions of Dr. Gross direct those to him first, so I can give him an opportunity to leave.

Gentlemen, thank you very much for coming. I gave you a brief description of what happens in this committee. We can begin almost immediately.

Dr. Gross, you're up first.

Dr. Michael Gross (Medical Director, Queen Elizabeth II Tissue Bank Health Sciences Centre): Thank you.

Thank you very much for the opportunity of coming to address this committee. I want to tell you I'm wearing three hats today. I wear the hat of the director of the tissue bank of the QE II Health Sciences Centre, which is a tissue bank where we've incorporated all the different disciplines of transplantation of bone, skin, eyes, bone marrow, cardiac heart valves, etc. We run that as a concert unit. I'm also chair of the National Standards Committee on the Transplantation of Organs and Tissue, and I chair the subcommittee on tissue transplantation. We've been responsible for setting the Canadian standards for transplantation of tissues. I also chair the subcommittee on xeno-transplantation, about which you will have read a lot recently. I co-chaired the national forum with Margaret Somerville where we explored the issue of xeno-transplantation and recommendations thereof, which have been recently posted to the web under the Bureau of Biologics. What I'm going to say to you covers those three areas.

I think it's generally accepted that we need more and more organs and probably tissues for transplantation. It's becoming apparent that we have to set in place a system where there's an ethical and rigorous and transparent system so that patients waiting for organs and tissues stand an equally fair chance of getting those organs and tissues.

I'm sure there are going to be some commonalties of what you hear from the presentations today. They have a common theme. The theme is standards, accountability, and accessibility. As far as I'm concerned, a lot of this relates to a national agenda. The national issues are how do we institute and pay for the necessary sharing of organs and tissues, and how do we deal with the increasing globalization of this, which is other countries getting access to our organs and tissues, and the implications of cross-border trade and the implications of people being free to travel to and from other jurisdictions for transplantations and all the things that implies?

From the point of view of a regional tissue bank, I'm going to wear that hat for just a minute to explain what happens on the ground. The difficulty we've had is maintaining standards in the face of declining funding from the hospitals that have traditionally supported programs that go beyond the hospital.

I have to tell you that over a year ago I closed our tissue bank. Closing the tissue bank was the only way I could draw to the attention of the hospital administration that we had a funding crisis, that our capital equipment requirements were not being met. This is something that I believe has to be addressed federally and provincially, in that transplantation has to be seen as bigger than just the hospitals that support that activity.

The second issue we see as a problem is the organization and support of donations. Donations require public education. The public education of the need for tissue transplantation is not quite as high as the public education for the need of organ transplantation, but it needs an initiative that spreads across the country so that everybody becomes aware, outside of the hospitals as well as inside of the hospitals.

• 0920

The third issue relates to the fact that there's no clear provincial or national mandate to coordinate and support all aspects of organ and tissue donation. I'll give you an example that's occurring in our part of the country. We are seeing American companies come to Canada and offer to provide tissues for transplantation for Canadians, but the quid pro quo is that they take tissues from Canadians to the States for sale in the States. They're banking on the fact that we don't use as much tissue in Canada at the moment and we have a higher rate of donation in certain areas and they can make money selling tissues in the States. This is very attractive to local hospitals, because the local hospitals have a system whereby they now get tissues for free, but it's very unattractive on a national level and is something that is creeping in because we're underfunded on the ground level.

I'm going to leave that now and I'm going to talk about the subcommittee on standards of tissue transplantation. There's not a lot to say. We've met, and we've come out with a set of standards. We have involved the Canadian Standards Association as a way of referencing these standards, but we need for this process to move faster than it is. There is a recognized need across all of the country that we have to have national standards for tissue transplantation, and that those standards have to be dynamic, have to move as new information comes to bear, and we need a committee of experts to keep on monitoring those standards. Unfortunately, events haven't moved as quickly as all of us would like in terms of getting the system in place whereby the institutions that maintain tissue banking of any type have to reference to those standards. There is no onus on them at the present time to reference to standards. We need that, obviously enabled through your good offices.

The last and most exciting issue is xeno-transplantation. Xeno-transplantation has the biggest potential for problems and the biggest potential opportunity to cater for patients who are dying at the present time through lack of human organs for transplantation. I'm an orthopedic surgeon; I have no particular expertise. But I'm a chairman, and as a chairman I get to see everything, from the ethicists, to the experts in the area, to the beds. And we've been through a very interesting process.

What I need to say to you is that the Canadian public has to be approached. The Canadian public has to be educated. We have to have a system that allows both education and research to move forward at the same time. This field is expanding. We cannot sit by and let other countries move forward, because it will impact on our citizens. Our citizens will travel and will get xeno-transplants if this becomes available elsewhere. We must have a system whereby we quantify the risk; we identify the risk factors to patients who may be recipients; we educate the Canadian public as to what the problems, the solutions, and the benefits are; and we engage in a constructive dialogue with all concerned, from the animal rights activists to the potential recipients, to make sure all issues are addressed.

It is an opportunity for Canada to take a lead. The reason is that in other countries there hasn't been the consultative process we've started with our national forum. If we continue that process of working with the public, we have a better chance of getting this as an accepted treatment for patients who need the organs. If we antagonize or ostracize or fail to consult with all players, then we're going to have some of the situations you've seen in Europe, where a moratorium has been put on xeno-transplantation.

My plea is that this kind of process is different. It needs support. It needs funding. And it needs for a national group of experts to continue to meet to monitor what's going on and to feed back that information to hospitals where individual researchers may be struggling to try to bring xeno-transplantation closer to reality. It is not enough for the hospital ethics or peer review committee to make those decisions alone. The decisions on forward movement have to be made at a national level. Again, I think this is an area in which there has to be federal and provincial agreement and support for this very exciting but potentially dangerous initiative.

• 0925

With that, I'd like to conclude my remarks.

The Chair: Thank you, Dr. Gross.

I'd like to go to Dr. John Akabutu, who is the medical director from the Alberta Cord Blood Bank.

Dr. John Akabutu (Medical Director, Alberta Cord Blood Bank, University of Alberta): Thank you for the invitation to appear here today, Mr. Chairman.

In many respects, we are the new boy on the block when it comes to this area of organs and tissues and transplantation. Until 1989 none of us knew that after the birth of an infant the leftover blood in the placenta and umbilical cord would become an important source of stem cells for the treatment of disease. Today there are banks around the world that specialize in the processing and storage of waste umbilical cord blood.

The initial use of these stem cells is in bone marrow transplantation for the treatment of diseases such as leukemia in children. Currently, bone marrow transplantation uses bone marrow stem cells obtained from family members or from the population at large. Unfortunately, however, several adults and children cannot find appropriate stem cells for treatment, and may die from their diseases. This is particularly true of first nations patients and other minorities in the country.

The discovery of another source of stem cells from waste umbilical cord blood—normally we would throw it away—is a very welcome addition to the options that we have for transplantation of blood-forming stem cells. Umbilical cord stem cells cannot replace bone marrow transplantation with bone marrow stem cells today. However, they do provide us with an additional dimension to the science of stem cell transplantation in humans.

There are some compelling reasons why we need to continue to take a close look at umbilical cord blood stem cells, including the fact that the supply is inexhaustible. Unless Canadians stop having babies, we will continue to have this source of stem cells. There is also the absence of infectious diseases, because the material is coming from a pristine source. Babies don't usually have infectious diseases when they're born.

There is a curious, very interesting phenomenon of an immunological tolerance between the donor and the recipient, both before the transplant and after the transplant. Also, once we've banked the sample, it is immediately available for use, unlike the difficulty encountered with unrelated bone marrow donor transplantation. With the latter, it takes time to locate the stem cell source.

It is my hope that as our knowledge improves and we can manipulate these cells in laboratory, cord blood stem cells may become very important and be preferentially used for the transplantation of blood and blood-forming organs.

We do have a disadvantage with cord blood stem cells in that we have small volumes because the material comes from babies, and also because we only have a single sample. But right around the world today, there are laboratories working very hard to overcome this limitation. I wouldn't be surprised if, within the next five years, we have advanced enough so that we can use the one sample for multiple transplantations in both children and adults.

• 0930

Worldwide, over 1,000 transplants have been performed, mostly in children with cancer and diseases of other blood-forming organs. Sadly, in Canada we have lagged very far behind, both in the use of cord blood stem cells and in the development of the banks that house these cells. Our bank in Edmonton is the only Canadian public bank in which we store cord blood stem cells for use by any Canadian who might need this material for therapy. We have been very encouraged by the enthusiasm of Canadians from coast to coast who have voluntarily donated these samples to our bank. In addition to that, the physicians, nurses and midwives from across the nation have again voluntarily helped us to collect this material.

Over the past two years, since we started this bank, we have had very meagre resources. Most of our funding has come from private donations. At the present time, we have a proposal before our provincial government—and before the federal government through them—for consideration for funding. We hope to be the national bank for Canada, and we will therefore need funding to be able to fulfil this mandate. Our difficulty in the beginning was the fact that there was no national funding agency to which we could apply since we set ourselves the goal of a national mandate.

The data that we accumulate from these cord blood stem cells is in a database that is the Canadian cord blood registry. At the present time we only have 50 samples in that registry, although we have collected 850 samples. In other words, 800 of these samples have not been typed and are not available for use by transplanters in Canada. By the end of 1999 we hope to collect more samples, and we also hope to have typed the 800 samples that we have sitting in our bank at this particular time.

A good public bank must adhere to the highest quality standards mandated by good manufacturing practice. This process is both expensive and very laborious. Although it is a tall order, we hope we will be able to satisfy the quality assurance requirements within the next two years. That's how long it is going to take us to get our house in order and to therefore be assessed and declared to have good quality cord blood stem cells. With our quality assured, we hope we will be among the best banks in the world.

In conclusion, our ability to expand the use of umbilical cord blood stem cells is only limited by our imagination. The properties of these cells make them very suitable for use in other areas such as gene therapy. It is very gratifying that the exhilarating fact of the birth of one's child can also provide the opportunity for a mother and family to save the life of another individual.

I thank you very much for your attention this morning.

The Chair: Thank you, Dr. Akabutu.

We go now to Dr. Hans Messner, who comes from the Canadian Bone Marrow Registry.

Dr. Hans Messner (Director, Canadian Bone Marrow Registry): Thank you, Mr. Chairman.

I wear two hats today. I'm the chairman of the Canadian Bone Marrow Transplant Group. From that angle, I'm representing the transplanters. From the other angle, I'm carrying on as vice-chair of the advisory committee for the Canadian Bone Marrow Registry, an unrelated donor registry. My other hat, then, is looking at an organizational component to find donors.

Let me take you a little bit further back in order to add to what Dr. Akabutu told you. Bone marrow as a whole is different from the solid organs. It's a renewable resource. We carry it, we can lose part of it, and we can rebuild it in very short order. We don't have to die to be a contributing member to somebody else. The bone marrow produces billions of cells every day. You can appreciate that if production of this is disregulated, fatal disorders occur: aplastic anemia means no blood production; severe combined immune deficiency means immune disorders; leukemia. These are all in the purview of bone marrow.

• 0935

The marrow can be replaced by a healthy marrow, or if you want, by these stem cells that Dr. Akabutu mentioned to you. These stem cells can be found, as you anticipate, in the bone marrow. They are also present in the peripheral circulation, and they are seen in the cord blood—tissues that we all can use for this same purpose, and that means the correction of fatal defects in the bone marrow.

When we look at the requirements for a transplant, we have to say that a certain degree of compatibility has to be established, and that the information that we need is dependent upon the genetic information present in all of us. Half of this information comes from the father, half from the mother. Within a family, we have a chance of one in four to find a donor. In the Canadian family size at the moment, we would be able to serve 30% to 35% of patients in need out of this pool. That means the majority will not have access to a related donor, which is how the concept of looking at unrelated donors was born. Over the past ten years, we have indeed developed not only a national program, but have also had to forge international links.

Over the last ten years we have been able to really increase this resource, from 5,000 to 180,000 Canadian volunteers. There's still a problem with this. In spite of 180,000 volunteers in regard to their tissue type, we still don't meet the needs of the nation. The reasons for that shortfall are the uniqueness of all of us, and the specific problems that we have with our culture, with the ethnic composition of this country, which looks at different, multi-racial origins. It was therefore very important not to rely on our own resources. Out of Canadian sources at this very moment, we only cover about 45% of the transplants that are done in Canada from unrelated donors. We had to expand into the international realm and form a network that allows us a trade of marrow, if you will, with other national registries.

On a worldwide basis, there are now five million volunteers available. Out of this resource, at least for Caucasians at the moment, we can find donors for 65% to 70% of patients. We do have a worldwide underrepresentation of other races, including the Oriental population and the African population. Therefore, we still are required to look at additional developments—cord blood being a very important component, for instance—to add to this resource. To have a well-functioning registry, however, we do need to require certain standards. These standards have to be embedded not in a national framework, but in an international organization, so that this trade of organs—that means trade of marrow—can occur and does occur across borders.

The other component of a well-functioning registry is dependent on the speed with which this donor can be identified. Clearly, you do have patients who require a decisive intervention within a very short of period of time of need. Patients with acute leukemia do not live many years. Patients with acute leukemia or various other hematopoietic malignancies require decisive intervention as quickly as possible. The complete typing, that with the highest technology, has to be made available so that these donors can be readily accessed. The computer systems have to be upgraded and the recruitment process has to improve. For us, as Canadians, I think we really have to look at our very specific needs in terms of the ethnic inequity and aboriginal inequity that we are still seeing at the moment.

• 0940

We are surrounded by a number of supportive lay groups that have taken the lead in helping us in this situation. We have actually been successful with Minister Rock in achieving the next level that we feel is necessary, and that is a national forum to discuss these issues, how to improve the possibility of providing the appropriate marrow, and the various alternative technologies. I understand this will probably be happening this fall. We have already been able to recruit a number of internationally renowned speakers in the field to help us shape this whole aspect of health care delivery in the field of hematopoietic malignancies.

Yes, there are complementary technologies that we are clearly having to monitor, cord blood being a very exciting component. The possibility of in-culture expansion of the stem cells to larger quantities, and the possibility of correction of some of the defects that we're dealing with by insertion of genes, are two important components that we need to follow up on.

The last part that will help us to expand this area is related to other possibilities. That means now considering biologically a greater degree of mismatch between a donor and the recipient by using cutting-edge, up-front technology. If this can be included, we would then be able to offer bone marrow transplantation for the majority of patients in need.

Thank you very much.

The Chair: Thank you, Dr. Messner.

I'd like to go to Dr. David Rootman, from the Eye Bank of Canada.

Dr. David Rootman (Medical Director, Eye Bank of Canada): Thank you, Mr. Chairman. I'd like to thank you and the members of the committee for allowing me the opportunity to address you today regarding this important issue of eye banking in Canada. I believe we're definitely standing at a critical juncture in the area of eye banking.

First of all, to introduce myself, I come here representing the Eye Bank of Canada, the largest and oldest eye bank in Canada, established in 1955. I'm a corneal surgeon, which means I do many corneal transplants each year to help restore vision to children and infants at the Hospital for Sick Children, and to adults at the Toronto Hospital. I'm also an associate professor of ophthalmology at the University of Toronto, and I spend part of every week helping to administer the Eye Bank of Canada as its medical director.

As mentioned, the Eye Bank of Canada's Ontario division was started over forty years ago. This was the brainchild of Colonel E.A. Baker, of the Canadian National Institute for the Blind, who envisioned a network of eye banks across the country. Hence, ours is called the Ontario Division, Eye Bank of Canada. However, while there have been many more eye banks developed across this country, the dream of provincially and federally linked eye banks has not altogether been realized.

Just to inform you about what a corneal transplant is, the cornea is the front window of the eye. In fact, it is the eye's major focusing lens. If it becomes damaged by congenital defects, infections, trauma or aging processes, it becomes clouded and causes blindness that can only be cured by replacing the damaged tissue. The whole eye is not transplanted, just the cornea.

The number of transplants in Ontario alone has risen from two in the year of inception in 1955, to over 1,200 provided by tissue from our eye bank based in Toronto in 1998. This is due to many factors. Surgical techniques and scientific understanding have advanced enormously, making outcomes better and safer. As we all know, the population is growing and aging at a significant rate. Before, many people may not have lived long enough to experience corneal problems requiring surgery, but a small proportion of people requiring corneas has become much larger over the years.

What can we do to improve on the current situation and prepare for future developments and issues? I've summarized it in five points. Of course this is an incomplete list, but I'll do my best to emphasize the important points.

First, we need to try to improve interprovincial and intraprovincial sharing by solidifying the existing loose networking between existing eye banks across Canada. This will require better communications systems and, as echoed by the other members who have come to give witness today, uniform standards to qualify between the eye banks.

• 0945

For instance, in Ontario we will often have a surplus of tissue at various times when surgeons may be away, and because we adhere to a different set of standards, or we haven't been certified by the same eye banking organization that is in British Columbia, British Columbia will not take corneas from us, even though they have a tremendous waiting list of almost two years in most instances.

In other words, to facilitate we must all have the same standards. I recognize the work of the health protection branch and the committees Dr. Gross alluded to in trying to establish Canadian standards for eye banking. Currently, we have not been successful in establishing those standards nation-wide. However, the Eye Banking Association of America is probably the best-known and longest-standing organization. It has produced an exquisite set of standards and has a certification process to which many of the eye banks in our country adhere. We are currently trying to bring our standards up to par, and have run into problems because we go back 40 years and have all the historical baggage that goes along with being an older institution.

Essentially, the Canadian standards mirror the American standards. It may not be necessary to reinvent the wheel, but rather work together with the eye banking organizations in the United States.

Second, funding must be made available to ensure that all eye banks are able to afford this certification. Our funding is largely from three sources. We get a provincial grant to administer and run our eye bank. We receive a healthy amount of money from the Canadian National Institute for the Blind, without which we could not function, as they pay for most of our transportation costs. The University of Toronto gives us the housing, space and infrastructure to do the job we do.

However, there is no funding available from any source on a regular basis for equipment needs and equipment updating. For example, we currently run the fourth-largest eye bank in the world—the largest in Canada, of course—and we do this on the backs of five full-time equivalent staff—much fewer than necessary to keep up with all the necessary paper work and tasks for certification. So it's critical that some mechanism be found to ensure that our funding is tied to our production and we are properly funded. We currently have trouble keeping staff on a long-term basis because of the stresses of working under difficult circumstances.

Third, we need to ensure that all eyes for donation are procured, and not just the ones that will definitely go for transplantation. In Ontario this happens. A fee is provided to physicians who will go out in difficult circumstances and retrieve eyes for the eye bank. However, in other provinces, specifically British Columbia, the eye bank receives no funding unless those corneas are actually used for human transplantation. This greatly decreases the donor pool and has left British Columbia with this long waiting list of patients. Whereas we will procure any tissues that are donated, in fact to be effective I believe you need at least double the eyes procured in order to get enough corneas of proper quality to ensure a safe transplant.

The side spin-off of that is the eyes that cannot be used for transplant can be used for the training of ophthalmic surgeons, if there is proper consent. In fact, if you look at it very carefully, you'd probably realize that more eyes have been saved by those training eyes than by the ones that have gone for transplantation.

Fourth is the promotion of eye banking. We tend to be very low-key, as we do not have the same glamour and life-saving punch as heart or kidney transplants. Also, over 40 years of service does not make us front page news very often. But believe me, we change lives in material ways and need to have the means to make this well known and encourage eye donation. We need the funds to solidify and maintain the networks that currently exist involving MDs, nurses, local CNIB, service clubs, local and provincial police forces, and local volunteers.

• 0950

Finally, we need laws that can be enforced to promote the required asking. Families need to know how easy it is to donate and what a difference the donation makes. For instance, with the solid donor there are so many very stringent criteria for what tissues can be used for the heart, kidneys or lungs, whereas with the eye, in most instances, your age, eyeglass prescription and the disease that takes you from this world don't matter, as most patients can become eligible eye donors. It is very important to have some way of encouraging that and enforcing the laws that are already in effect in many parts of the country.

Can this job be accomplished? Yes, I think it can. We're probably 80% or even 90% of the way there. To get to the 100% level, we need the proper support from both federal and provincial sources. We have an existing network that already functions fairly well, but we need to be able to hone that and secure enough corneas to provide sight-giving surgery to all in need in Canada, and elsewhere in the world.

Thank you for the opportunity to speak.

The Chair: Thank you, Dr. Rootman.

I'd like to go to the questions and answers now. We'll begin with Mr. Elley from the Reform Party.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you very much, Mr. Chair.

Thank you very much for appearing before us this morning, gentlemen. It's very important that we hear from you.

I'd like to ask Dr. Gross a couple of questions. Perhaps some of the rest of the panel would like to jump in at some point.

You talked about regional tissue banks, Dr. Gross, and declining funding from participating hospitals for them. At one point you actually closed down the bank to highlight the problem. Do you think more stable alternate sources of funding should be forthcoming, particularly from provincial governments, in terms of health budgets?

Dr. Michael Gross: The short answer is yes. The long answer is it varies from province to province. It would be appropriate in Atlantic Canada for us to have an Atlantic approach, an Atlantic agency that would coordinate the procurement and distribution of all tissues and organs, with stable funding and outcomes that are measurable with respect to the population health, the number of transplants done, and the adverse responses.

It's not that hard to see an organization that would meet all the requirements of the different players sitting at this table. It's also something that has to be addressed federally so the provinces are willing and able to talk to each other, so when a cornea is available in Toronto, we can have it transplanted in Halifax or Vancouver. That also requires some federal coordination.

I would agree with you this is the kind of health care service that is best done outside of a hospital and best coordinated on a provincial or interprovincial basis.

Mr. Reed Elley: Thank you. I have another question for you, and I'd like to have Dr. Messner's response to this also. It concerns the perhaps ethical and political questions that arise from the cross-border procurement of organs and tissue and those sorts of things.

We all know that many Canadians are just reeling from the results of cross-border blood transfusions in the 1980s. Is there any way we can be sure this kind of thing will never happen again in terms of cross-border transplants of diseased organs, or that sort of thing?

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You hear some anecdotal material from time to time of people down in the States selling their surplus organs for cash, and where these things end up, one doesn't know. You talked about the American companies that are coming up into Canada and buying tissue, and I don't think you were too happy about that. Dr. Messner talked about the cross-border trade in bone marrow, which seems to be okay. Talk a little bit about this whole area and perhaps try to calm us about any problems in that area.

Dr. Michael Gross: The problems arise when there's a vacuum due to lack of standards or lack of agreements, and lack of accessibility.

As I said in my preamble—if I can cover the different areas—regarding tissues, there was a problem with cross-border trade in tissues in Europe. Tissues were being taken from donors in eastern Europe and processed in western Europe and exported to the States. They were of a poor standard, and the FDA stopped it for that reason.

So without Canadian standards, we can't make any provision for stopping cross-border flow, or encouraging cross-border flow, or even looking at cross-border flow. We have to have the standards. They have to be enshrined in some form of legislation and referenced to.

The second thing is, with respect to organs, if an individual goes to India and receives a kidney transplant and they are a Canadian citizen and they come back to have their post-op care in Canada, what do we do? We haven't addressed that, but we have to. There are no easy answers.

The third thing is, if an opportunity exists in another country to get technology that doesn't exist in Canada, we also have to address that. For instance, porcine neurotransplants are being performed in countries other than Canada. That technology is moving on, and this is why I'm suggesting that we have to have a forum in which we discuss these, in which appropriate standards are developed by experts around the table. But in terms of xeno-transplantation, the public has to be involved.

Mr. Reed Elley: Mr. Messner.

Dr. Hans Messner: In the field of bone marrow transplantation, of course we have a slightly different situation because we do have a living donor, and that donor can be tested, and tested repeatedly. It would be, at the moment, clearly in the related situation as well as in the unrelated situation, following an established list of parameters that we would have to go through before we would say this patient is now going to be transplanted from an eligible donor. The standards basically can be set by the recipient centre. So if I have a patient here in Toronto and the donor is in Germany, I can prescribe what I would like to see, and I can then take or reject that particular donor.

There are, however, situations that you may appreciate. For instance, if you have acute leukemia and the only donor worldwide has hepatitis C, would you take this donor or not? There's a situation where clearly a blood services situation would say no, whereas in a direct intervention between the patient, with full risk analysis, and the transplant physician, you may come to the conclusion that the patient says yes, I appreciate that I might have hepatitis C, but I might add five, ten, or fifteen years, or whatever, to my life.

Those are the most difficult situations we have to deal with. But I think the critical issue here is that we try to develop really international standards.

In North America there is a foundation for accreditation for hematopoietic cell therapy, which was spawned out of two professional groups: one is the laboratory-driven standard, how to prepare the samples; and the other group is from the American Society of Marrow Transplanters, the professional standards of what is necessary to be a transplant centre. Those two have come together and developed a North American standard.

Dr. Gross and I were sitting on the same expert working advisory group to Health Canada, and you probably appreciate that the Canadian standard is supplemented, as the umbrella document, by organ- or tissue-specific standards. We were allowed to accept the North American fact standard as the bone marrow transplant standard. I do know that there are efforts on the way to harmonize this with the European Community and to see that we actually adopt this across the Atlantic, at least.

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Mr. Reed Elley: Thank you.

The Chair: I'd like to go to Dr. Patry from the government party.

[Translation]

Mr. Bernard Patry (Pierrefonds—Dollard, Lib.): Thank you very much, Mr. Chairman.

[English]

I'll address my question to Dr. Gross. In your presentation you commented on the fact that the education of the public was one of the many problems contributing to a shortage of tissue and organ donors, and you said that one of the reasons is because the public seems to see it as still being experimental. But I was surprised and close to being shocked when I heard—and I didn't know about this—that some hospitals get some tissue free and sell it to the States. I see this as quite an ethical problem. Is it this way in general in the whole country, or does it include just a few hospitals or a few provinces? Which tissue are we talking about? In your view, what would be the reaction of the public, our future donors and family donors, if they knew that the hospitals were selling tissue in the States?

Dr. Michael Gross: That's an excellent question, because the whole problem with donation is that it's an emotionally charged issue. The issue of donation occurs at a very bad time, and anything that upsets that process or puts a black mark against one part of donation affects the donation of everything. That is why I used that as an illustration of the vacuum that exists. Because we don't have adequate funding, for instance, for a bone bank, it's very attractive for a hospital in isolation to enter into a third-party agreement with a United States tissue-procurement organization. To me that is inappropriate. That's why I bring it up and why I use that illustration as a way to push for the establishment and maintenance of Canadian standards, and then it won't occur.

Again, the whole issue of public education is crucial to this whole process, whether it's the donation of tissue and organs or xeno-transplantation. The public has to be on side and comfortable with the process we go through as well as with the standards. They have to believe we are dealing with well-informed scientists with no particular axe to grind. It's very easy for the press to get hold of the wrong angle and say here are some researchers who hold shares in this company who are doing work in this area, and that would destroy public confidence.

That is why I think in this area we need strong leadership, and the national committees we've been working on are an appropriate way of providing the leadership. But we have to be supported in being open to the public. The public must feel that they have access to the information and that we're making a realistic judgment as to the risks associated with the different transplantations. If we tell the public what the risks are and quantify them and also try to quantify the potential benefit, then I think that is the right way to go.

Mr. Bernard Patry: I have another question, Mr. Chair, which I'll again direct to Dr. Gross.

You talked about xeno-transplantation. We had a witness appear before us a couple of weeks ago, and we heard about the pros and cons about that. But now you say that there is a moratorium in Europe regarding xeno-transplantation. Can you tell us why there's a moratorium? Is it a question of funding, ethics, or public education? Do you know something about this?

Dr. Michael Gross: It's a combination of factors related to education, ethics, and the fear that is prevalent of the possibility of a virus or viral-like particle that is presently in animals changing and becoming a problem in the human population. That is a potential risk. There's no doubt about that.

The way to address that is to quantify that risk and to have a system that monitors carefully what happens. In other words, you cannot say we're going to stop it, because if it doesn't happen in Europe, it's going to happen elsewhere. But what we have to do is say yes, this is a real fear and your concerns are appropriate, but we think the system we've set up to monitor this is an appropriate one, and we'd like to have you involved. We had, for instance, the animal rights people involved in our forum. We wanted to make sure that then people could say yes, we have a system that allows us to move forward in this area. This is where I think Canada has a great opportunity, because if Canada institutes this system, we can be leaders.

Mr. Bernard Patry: Thank you.

The Chair: Thank you, Dr. Patry.

I'd like to go to Ms. Wasylycia-Leis from the New Democratic Party.

• 1005

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

I'll direct my questions to Dr. Gross, but the other panellists may also wish to answer. I'd like to carry on the discussion on xeno-transplantation. As Dr. Gross has suggested, there's an opportunity here but there are also many challenges. I think what you've suggested is that there's a huge vacuum in terms of regulations and standards. It would seem to me that there is also a vacuum or a gap in terms of information about exactly what is going on in this country. Many of us have received correspondence from the Animal Alliance of Canada, who you're in contact with.

Do we have any understanding of what is happening today in Canada with regard to the use of non-human, animal-derived products? I'm not an expert on any of this, so I don't know if it's an area that's restricted to organs from pigs. What are the non-human products that are being used? Has so much happened in this field in Canada that it might be hard to put a lid on it, to shut the barn door after so many animals have already left the barn? Should there be a moratorium in this whole area until we get a handle on it? To what extent is this happening in this country? It's a lucrative market, and big corporations are getting involved and hoping to benefit from this vacuum.

The Chair: Do you want to add another question on there, Ms. Wasylycia-Leis?

Ms. Judy Wasylycia-Leis: I might. Maybe I'll stop with those questions.

The Chair: Okay. Good.

Dr. Michael Gross: Let's just start with the first. What's driving this process is that people are dying because they don't have organs. So the doctors who are taking care of those people are saying, is there any way I can improve the chances of saving more people? That's what's driving it. It's a very ethically driven process.

Obviously, corporations are interested in getting involved, just like corporations that make drugs are interested. We have a system that allows us to introduce drugs to the general population, to assess the risk associated with them, and to follow up on them.

All I'm saying is that we should have the same system for allowing us to explore this new area of xeno-transplantation. We don't need a moratorium.

We need to continue with the expert groups that have come to the table. We already had the Bureau of Biologics appear before the committee with regard to the safety of organs and tissues. That subcommittee has provided some draft standards, which are now being circulated to all players. Their comments will come back, and we will then propose that these are the standards for now. But we also need a standard monitoring committee so that as information changes, the standards reflect current knowledge, not yesterday's knowledge.

The use of pigs is in the experimental stage. The barriers to successful transplantation of pig livers, for instance, are still huge. Those barriers will be addressed with appropriate ethical experimentation similar to what happens every day in many different Canadian institutions. What we need from the federal level is support for the process so that the process that has already started can continue.

The Chair: Dr. Messner.

Dr. Hans Messner: I think there's one other important piece of information, and that is a communication system that allows us to interact with the various stakeholders. Whenever we bring this issue up anywhere, they say, you have health records. Health records do not really capture the intricacy of a cutting edge field. I think one of the most important components we can ask you to support is the capability to develop the appropriate registries so that we will know not only how many transplants we're doing, which is fine, but also what the outcomes are. We could establish a cross-linkage to see that with this information flow one minimizes the problems we might run into and that if problems do occur, they're recognized early and appropriately addressed by the experts.

The Chair: Ms. Wasylycia-Leis.

• 1010

Ms. Judy Wasylycia-Leis: I have two quick questions.

As follow-up to Dr. Messner, is the mechanism proposed in the budget for dealing with health information appropriate? Do you see that as the vehicle by which we might move forward?

Dr. Hans Messner: I think that is precisely what we need. We do need this recognition that very specific medical information has to be gathered for the purpose of looking at a unique uniform type of information system that captures really the country as a whole, not just the Toronto hospital or the hospital in Halifax, etc. It really requires this national presence.

The Chair: The parliamentary secretary, on behalf of the Minister of Health, thanks you for that response.

Ms. Elinor Caplan (Thornhill, Lib.): I think it's important just to clarify that the experimentation on pigs is not human experimentation. Would you just clarify that, please?

Dr. Hans Messner: It's not human experimentation.

Dr. Michael Gross: That's correct.

The Chair: Ms. Minna.

Ms. Maria Minna (Beaches—East York, Lib.): I wanted to go back to some of the things that were discussed this morning but also in the previous submissions we've had. Yesterday we had some of our presenters who were talking about a national organization that would be legislated by the federal government and that would be with national standards. But also they were looking at very strong legislation—some of them, anyway—that would obligate referrals and there would be penalties if they weren't referrals in certain instances, whether it be hospitals or what have you.

My question has a number of aspects. First, would you agree with such an organization would have those kinds of strong penalties and with obligatory referrals and so on? Second, would one national organization in this area suffice, or are we looking at wanting to have a national one specifically for bone marrow and to break it into more than one organization?

What I'm trying to get at is if we were to have a national registry or national organization on transplantation, with standards and with all kinds of accountability objectives, whatever, coordination, would one organization suffice to deal with tissue, with corneas, with bone marrow and with organs, or would you see that this is too much for one organization? I get the impression that there's phylos here today, and then the other side of course is how strong this legislation would be. Would you go as far as penalties and referrals being mandatory?

Dr. Hans Messner: I think from our experience with the expert working group with Health Canada, we clearly appreciate that you can set a general standard. I do, however, also believe that the general standard has to then be supplemented by tissue-organ-specific standards, and that we will need this second tier of a governing body or committee, or whatever it is, to really look at the very specific problems, specific to the tissue that is being transplanted. This is because the cutting edge in one area is completely different from the cutting edge in another area.

With xeno-transplantation, for instance, this is for the solid organ transplants. For us it's the ability in the bone marrow transplant field to isolate stem cells to manipulate them genetically and to really rebuild this whole bone marrow system from a single cell on if you want to. You can appreciate that we don't have to go to xeno-transplantation to do this; we can do this within the human species. So for us, there's the question of gene transfer, the question of what factors can you put from the outside into the cell environment to try to optimize it. So I think simply these are quite different and require the specific input of the experts in that particular area.

Dr. Michael Gross: If I can pick up on that, I think we have a system that works. We set Canadian standards, then we have subcommittees related to the different specialities. Each subcommittee has different pressures and different areas where there are concerns. Obviously the xeno-transplantation subcommittee has very different concerns. But each one of those subcommittees has to be supported. As we work on that and it's developed and brought into effect, it will work very well, I think. The question is whether it's supported so that we do gather the data where it's needed.

• 1015

I don't think we need to gather a lot of data in tissue transplantation, but we need to know everything that happens in xeno-transplantation because of its potential risk. So the risk assessment allows us to concentrate our resources on specific areas, and this I think is the model that would work.

I wasn't here for the submissions yesterday, but I have some concerns about penalties for non-reporting. I think we've always worked best with coercion of a gentle nature, and also I've been impressed that Canada is a small enough country in terms of people that we communicate well. Obviously, if there's negligence, that is covered under existing legislation; I don't think we need to get into it. But in terms of making transplantation safe, most of the people who are players have been at the table and they've been consulted, and would have an inherent belief in pushing forward and adhering to these standards.

The Chair: Mr. Rootman.

Dr. David Rootman: I think we're hearing from all of the witnesses today about the need for standards so that we can try to share more effectively. But you can't dictate standards without paying the cost for it as well, and I don't think it's been really clarified as to who's going to pick up the bill for all of this. That's left us, who are responsible for providing safe tissues and organs, in a very precarious position.

So my strongest plea would be that someone has to get together and say go ahead and do it. And I think we can do it under one umbrella for sure, because I think there is adequate respect for the uniqueness of each of the individual areas, and I know that's been pointed out time and again. So I think it is possible.

With regard to penalties, I would agree as well that penalties rarely work, and coercing people, because as soon as you introduce a penalty you have to introduce someone to police the situation. I know from the Ontario situation, some of our smallest hospitals are the biggest contributors, way out of proportion to the size of their hospitals, for eyes. It's simply individual commitment. Even though there are laws in place that require tissue procurement committees and all sorts of other committees to facilitate eye, tissue, and organ donation, it just doesn't always happen unless there's someone there who is uniquely involved and uniquely interested. So I think the mechanisms have to be there to strongly encourage it, but I don't know what kinds of penalties you're going to introduce that are going to be effective.

The Chair: Mr. Akabutu—or Dr. Akabutu.

Dr. John Akabutu: I was going to remark, Mr. Chairman, that I'm the only one over here without a Dr. in front of my name. I am indeed a doctor.

The Chair: I apologize for not giving you the appropriate deference at the very beginning.

Dr. John Akabutu: We are very fortunate in the area of cord blood banking that we are just starting, and we are looking at all the experiences the other people have had in the area of tissue and tissue banking. Upfront it is going to be very important for us to adhere to regulations that make sure the product that comes out is of the highest quality that can be used in human beings. As Dr. Messner pointed out, there are organizations now to whom you can apply for certification.

The process is very laborious and it is extremely expensive. I have to agree with Dr. Rootman that in addition to doing what we must do, we have to be funded in order to be able to maintain our quality. That's very important.

On the second area, I can't but further echo what my colleagues have said about the regulatory environment in which there are punitive measures if one doesn't follow such standards. I think those kinds of things do not augur well for innovation and improvements in the field, so I would tend to discourage that. The idea should be that indeed we should have regulations, but individual sectors should be allowed the latitude to be able to deal with their specific issues.

If you look at cord blood and bone marrow stem cells, for example, with other solid organs, for intance the heart, you know exactly where to put it. The kidney, you know exactly where to put it. But when we transplant stem cells all we do is put them into the blood and they have to find their way somehow into the bone marrow and begin to do their work there. Our thought processes in this transplantation area are very different from the transplantation for individuals with those solid organs.

• 1020

The Chair: I wonder if you could clear something up for me, Dr. Akabutu. It's the question of accreditation. Initially in your presentation you indicated there are some problems in that area. Who does the accreditation for cord blood donations?

Dr. John Akabutu: At the present time there is no organization in Canada, so to speak, that will accredit a bank such as ours. We're depending upon the organization Dr. Messner mentioned, and the American Blood Banking Association, both of which have suggestions for the maintenance of good manufacturing practice. We are being allowed to continue without development of our bank because we are associated with a university hospital and a university, and we have to maintain good laboratory practice in that arena.

It is true that at a future date, in about two years' time, we must meet certain stringent criteria, which are still being developed. I think that's part of Dr. Messner's group, which will be forthcoming. The difficulty we have in Canada right now is we do have some private cord blood banks where people are donating cord blood samples for use by the children at a future date. The difficulty is that at the present time they are not regulated. I think those kinds of issues will need to be addressed at a future date.

The Chair: Before we leave this particular topic, is it the case that today there is no agency establishing standards, and you're just following the good laboratory standards set by the university hospital?

Dr. John Akabutu: At the University of Alberta, yes. Also, we are following the accreditation standards of the American Blood Banking Association and the foundation for....

Dr. Hans Messner: The Foundation for Hematopoietic Cell Therapy.

Dr. John Akabutu: I think that's what everybody is doing in the world whilst we develop the whole process. As a matter of fact, I was the only Canadian at a conference called by the FDA two years ago to look into this whole area of accreditation for cord blood banking. What is happening now is that the FDA has come up with suggestions for accrediting cord blood banks. It remains a work in progress, and those of us in the area are following those guidelines very closely. As you can imagine, the guidelines are changing with time as we know a little bit more. We are in touch with Health Canada and they know what we are doing. We actually had a visit from them. But as a regulatory agency, no, there is not one just yet.

The Chair: But the organization that's establishing or thinking about standards, that's your group, Dr. Messner, and that hopefully would apply to—

Dr. Hans Messner: That's right. Their principle basically was that we have the Canadian standards document as the umbrella document. For anything that is a bone marrow transplant, which would include peripheral blood, cord blood, etc., we have this document that was developed by the Foundation for Accreditation for Hematopoietic Cell Therapy.

This had been accepted by the expert working group as the appropriate document that should basically be the prime document for a future accreditation process. The difficulty at the moment is to find the accrediting agency that would be able to do this. Can FAHCT, for instance, develop deemed status in Canada to become the official component? You have to appreciate that there are Canadians, such as the president of FAHCT, who have contributed—accreditors who can go to the U.S. or here in Canada to perform this accreditation role.

• 1025

The process, as we speak at the moment, is somewhere between Health Canada and the Canadian Standards Association. We have a meeting next Friday to be updated on that current level. I trust within the next period of time, an appropriate decision will be made as to who can apply for deemed status as the accreditor.

The Chair: Thank you, Dr. Messner.

I have a couple of other questions I'll reserve for a little later, but just before I turn to Mr. Grewal from the Reform Party, let me welcome in our audience the First Nations Elementary School from downtown Toronto.

Some hon. members: Hear, hear.

The Chair: They're from Mr. Mills' riding.

Mr. Dennis J. Mills (Broadview—Greenwood, Lib.): Thank you very much, Mr. Chairman.

As you know, these young children from the first nations are from all over the city of Toronto. They go to the only school in downtown Toronto for first nations, which is called the First Nations Elementary School. They are here to witness the committee in action, and I thank you for recognizing them.

The Chair: Mr. Mills, I hope you will elaborate on the function of the committee and the parliamentary process for them. They're welcome.

Mr. Grewal.

Mr. Gurmant Grewal (Surrey Central, Ref.): Thank you very much, Mr. Chairman.

As I understand it, there are many factors that limit transplant activity. Some of them are a shortage of blood supply and a shortage of hospital beds. What would the witnesses recommend or expect from the government to ensure that the health care system has a greater capacity to deal with transplants? Anyone can answer that.

The Chair: Do you want to try that first, Dr. Messner?

Dr. Hans Messner: Okay.

I think transplantation as a whole has moved out of the realm of a single institution. It has become more and more the tool with which the health care delivery system has to work. It could be considered a provincial entity, if you want.

For instance, in Ontario we have developed, with the Minister of Health, a mechanism for bone marrow transplantation to start the dialogue and start interacting. In 1993 we were able to set up a steering committee, with the Minister of Health and the transplanters represented, as well as the organizations.

We were charged with developing an indications document plus a mechanism on how to handle waiting lists and a financial document to look at a costing exercise and put it in a package to show what it would cost on an individual basis, whether the resource is available, and if the resource in a specific region is not available, whether transfers of patients could occur. We've practised basically everything.

Each one of the transplant centres provides up-to-date information to the ministry on a quarterly basis to try to project the needs for additional health care dollars. We have been able to achieve an increase on two consecutive shortfalls. Last year we were a bit short and it was difficult, but at least we had a direct input to the officials at the ministry and they are made aware of shortfalls as soon as possible. Sometimes we can deal with the issue so we don't increase the waiting list, but that increased funding can be made available and appropriate mechanisms can be put into place to deal with this.

It clearly requires that the whole group that looks after specific projects or programs speaks to the ministry as one voice, rather than fragmented groups. I would imagine this would also apply to eye banking and solid organ transplants.

We have to be more and more aware that budgeting is becoming more and more difficult. We're not only looking at the cost within the institution; we are looking at the cost associated with home care and the delivery of fairly high intensive care, not in the tertiary referral centres but in the local hospitals, etc., and that coverage will eventually have to be provided.

Mr. Gurmant Grewal: Dr. Rootman, do you have a brief comment? I have a question on blood supply for Dr. Akabutu after that.

• 1030

Dr. David Rootman: Corneal transplantation is a surgical procedure that by and large is performed only in hospitals in this country. For that purpose, we have to ensure that the resources are available at the end stage and the cornea can actually be used.

Mr. Gurmant Grewal: What kinds of resources do you mean?

Dr. David Rootman: I mean mainly operating room resources, because most of our patients now are handled as outpatients. In our hospital alone we suffered a 20% OR cut two or three years ago, and in the last six months suffered another 15% cut of our resources. This restricts our ability to provide the services. Even if we get all the tissue we need, if we don't have a place where we can install it we won't be able to fix the window.

Mr. Gurmant Grewal: After the Red Cross fiasco, Mr. Akabutu, what are the innovative initiatives to enhance the blood supply in the market or overcome the blood supply shortage? I'll just give you an example or an idea, and you can comment on it.

If I'm allowed to donate blood and they reserve that blood for me for a certain time, are we motivated to donate blood more frequently because that blood will be reserved for me for a certain time, and after that it can be used by anyone who needs it? This is an innovative idea. Do you think there is a place for it in the blood market? Will it enhance blood supply availability in the market?

Dr. John Akabutu: Mr. Grewal, I'm actually not a blood banker, I'm a cord blood banker—that's just a little different. But it just so happens I recently sat on the committee for the provincial government looking at alternate methods for blood transfusions, so maybe I'll be able to use that experience to answer your question partially.

As I understood from my colleagues on the committee, the difficulty with self-donated blood that is subsequently put into the mainstream for use is that the testing done on it is very limited, compared to anonymous donations. So the transfer from self-donation to anonymous donation cannot occur because the same standards don't apply. Self-donation, therefore, will have the tendency to decrease the total donor base that's available for the anonymous pool.

Mr. Gurmant Grewal: But if the standards are compatible or something is done to make the standards compatible, do you think it would enhance the blood supply in the market?

Dr. John Akabutu: I don't know if it would enhance the blood supply, but it might make it neutral. Those people's blood might be used in the anonymous system, but I don't think it would add very much to it.

Mr. Gurmant Grewal: Transplant surgery is negatively affected by certain factors like alcoholism, drug addiction, HIV-positive, primary cancer and things like that. What criteria are important for making decisions about potential recipients? Are there any standardized criteria available? Are they being developed or broadened?

Dr. John Akabutu: Do you mean for cord blood?

Mr. Gurmant Grewal: Yes, I mean for blood and for organs.

Dr. John Akabutu: I'll speak on cord blood, and then my colleagues can address that.

The criteria for acceptance of a cord blood unit into our bank are very strict. They are the same criteria we use for the acceptance of anonymous donors into the blood system. All the viral serality must be negative, in the mother especially, and all infectious disease material must be negative in the cord blood.

We also obtain family histories to make sure we can eliminate genetic diseases from the cord blood samples we have. In addition to that—we haven't done it yet because we haven't had any funding to do so—we plan to check on the health of the infant at six months to make sure the baby is still healthy. At that point, that cord blood sample becomes available for use. Those are the criteria we have.

• 1035

Of course we can only do what current knowledge in medicine allows us to do. There may be genetic diseases out there that we can't diagnose at this point in time. As Dr. Messner pointed out, I think there are risks, and you have to weigh your risks. If you're going to worry about genetic disease that may be diagnosable 2,000 years from now and you're going to die in the next three weeks if you don't receive this sample, you have to pay your money and take your choice.

The system is not perfect. It will never be perfect. There will always be those risks available. But we minimize them.

The Chair: Dr. Akabutu, when we talked about cord blood as a donation, for me that implies a certain consent. Is in fact consent sought and/or required before you collect it?

Dr. John Akabutu: Absolutely. The mother and lately the families are required to register with our cord blood bank, and on the form it is stated that this donation is going into a public bank. So it wouldn't be available for use by that family. In addition to that, they also sign their own hospital consent forms, consenting to the donation of cord blood sample. Even though this is biomedical waste, we feel it is prudent that we obtain consent from the donors.

Just as an aside, the only transplant we have done from our bank actually happened this way. We had a family living in Edmonton who donated to our sample anonymously for use by anybody. They went to Toronto—it must be the air in Toronto. They had a two-year-old son who then developed leukemia. The mother remembered that she had actually donated a cord blood sample to our bank, and told the physician that. The physician called me and said “Can you find this sample?” I said “I can't find it with a name, but I can find it maybe with the genetics of the HLA typing.” We went into our bank and found it. We sent it back to Toronto and it was transplanted, and that child is now eleven months from the transplantation and doing extremely well.

This is the kind of story that warms your heart. This material that would have been tossed away in the garbage now has saved the two-year-old brother's life. I think that's the extent of this thing.

Mr. Gurmant Grewal: I think Dr. Rootman wants to comment on the criteria for transplant of organs.

The Chair: Can you read his mind, Mr. Grewal?

You're quite welcome to comment.

Dr. David Rootman: On the criteria for acceptance of a donor for transplantation, is that right?

I'd feel more comfortable talking about corneas and eye tissues, rather than the solid organs, but we do share certain commonalities. All of the donors are screened according to a stringent medical history form. The donors are inspected to make sure there are no high-risk factors for transmission of diseases like HIV or hepatitis B or C. We will not use a cornea unless we get proper blood sampling and the blood is tested for both hepatitis B and hepatitis C and HIV. Of course the corneas would not be used unless all three of those tests are negative.

Once the cornea is procured, the eye is inspected and it is ensured that it's as healthy as possible, free of any scars or any problems that could result in failure of the transplant. Then it's stored in special storage media that keep the cornea for up to 10 to 14 days, and then it's distributed to the various hospitals.

These are all standards that are outlined by the Canadian Standards Association and essentially mirror the standards that have been in place by the Eye Banking Association of America.

The Chair: Dr. Rootman, in your previous answer you gave us an indication—and I hope I heard you wrong—that the standards are not especially elevated.

Dr. David Rootman: I'm sorry if I gave you that impression.

• 1040

The Chair: I made a note about it: that your standards are low compared to those in B.C.

Dr. David Rootman: I wouldn't say that they're low. We are in the process of attaining certification with the Eye Banking Association of America. Whereas the eye bank in Vancouver is a relatively newer one, they have had those standards. They have had the accreditation in place. We are in the process of going through that accreditation process at the current time.

The Chair: Just for the sake of assuring those who are uninitiated, like myself, when you're talking about low standards, you're really talking about a relative standard.

Dr. David Rootman: We're talking about official recognition. We have been following the standards to the best of our ability for a number of years, but we have not gone through the formal accreditation process that some of the smaller eye banks have been able to go through. Their eye banks may be only 10 or 15 years old, whereas ours, as I've said, started as a Mom and Pop operation and in the last 10 years has exploded into a very large facility. So we are maintaining standards, but I think it's important to have the seal of approval from an accreditation agency. We've had a pre-inspection already, and we're going through the process to get full accreditation.

Once again, I hate to drill home the same point, but it's something that requires the financial support of the people who are saying we need standards. We agree with that, but you can't do it without the money to do it.

The Chair: Thank you, Dr. Rootman.

Madam Redman, from the government party.

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

Dr. Rootman, you're giving me a perfect segue, because earlier you talked about who would write the cheque. My question to you would be, how big should that cheque be? Has anyone done costing? If we're going to move this initiative forward, how much would have to be dedicated? Obviously legislation and regulation is one part of it, but there also seems to be a continual theme that it's also a money issue.

Dr. David Rootman: I can tell you approximately what it costs us to procure and process the eye and distribute it. It's somewhere in the range of $400 or $500 per eye for transplants. That's a very low cost compared to what you'll find in most eye banks in the States, which charge a tissue processing fee. The tissue processing fee can range anywhere from $1,200 to $1,800 U.S. So we're a very cost-effective organization. I think in order to do it effectively, we need to probably double our staff to do it properly. Right now, with all the additional paperwork we've taken on for ourselves, it's made it very difficult.

The Chair: I don't want to cut into Madam Redman's time, but when you mentioned the $400 fee, that's for harvesting, storing, and transplanting?

Dr. David Rootman: No, not for transplanting. This is just for the processing of the tissue. If you take together all of our costs and divide it by the number of corneas we're able to provide yearly, it works out to about $300 to $400 per eye. Of course there are all the other costs—hospitalization, OR supplies, surgeon fees, post-operative care—that are not factored into the situation. We could certainly save the sight of probably a hundred people with the cost of one solid-organ transplant.

Mrs. Karen Redman: Would either of the doctors like to respond to that question?

Dr. John Akabutu: I'd like to respond to that as well.

For us to collect cord blood, have it transported from wherever in Canada, and process it and then freeze it in our bank costs somewhere between $700 and $1,000 Canadian. In the United States it is even more expensive; it costs about $1,500 U.S.

As we do more, our costs should come down, if we have economies of scale. If you compare the procurement of a cord blood sample to the procurement of other sources of stem cells, the cord blood sample becomes quite a lot cheaper. The issue is that setting up the bank is extremely expensive, and that is not taken into account when we calculate the cost of $1,000. We just take it as an infrastructure development, but it costs $1,000 to process the sample.

• 1045

Dr. Hans Messner: The bone marrow transplant registry is a situation we have to deal with reciprocally with the other countries. There are certain fees set. If one looks at a Canadian donating to a Canadian, you are only looking at the process in the operating room and the transfer. We are talking about $5,000. If I have to get a marrow from Germany it costs me $20,000. If I get it from the U.S. it costs me $30,000. If a Canadian marrow goes to the U.S., the U.S. pays back $30,000 into the Canadian registry, and vice versa. So it's on a cost-sharing basis that the countries have agreed to say that if I charge that much, you get that much back from us.

Based on this trade, we were actually able to increase the number of marrows we have been able to send out of the country. For instance, last year it was 45, in comparison to ten years ago, when we sent none, or two, or five. So we have become a contributor to the international scene in this particular situation, and in part this is related to the fact that we have developed a fairly good international reputation. However, that has nothing to with the transplant; this is just to get the marrow.

The infrastructure support that you need to maintain a national registry of course is somehow aided by the transfer, or it is being negatively influenced if we have to import too many marrows from outside. So a certain independence within the country would be a significant bonus and would be cost-effective.

Mrs. Karen Redman: Previous witnesses talked about the fact that the Spanish model is perhaps one that would work very well in Canada because of its multilevel approach and the fact that there's a shared jurisdiction with the provinces as well as the need to have good teams that educate potential donors at the hospital level in a very sensitive way. I was wondering if any of you have looked at that model.

Dr. Hans Messner: Well, for the unrelated bone marrow transplant donors, what has happened is that as it was under the purview of the Canadian Red Cross and is now under the purview of CBS, we basically follow the recruitment strategy to have regional recruiters available. At the moment there still is not sufficient personnel out to handle, basically, the requests.

In particular, we run into the difficulties, and this will actually be part of that.... One of the workshops that will be held at the national forum is if no donor can be found, what do we do next? Here is where a family in distress tries to find somebody urgently. Then you see the development of donor drives, etc. This can be done either very professionally or this can be done to the detriment. Unfortunately, many of those drives end up not finding a donor, costing a lot of money, and the individuals that are typed afterwards have only consented to this one particular person for whom the drive was conducted and are lost for the common good.

I think what the organization has to develop is a strategy for harnessing these particular need-driven initiatives. I think the consultations here with the stakeholders, the public, are so important because this is such an emotionally charged issue.

On the other hand, there is support outside that drives will usually be associated with donations of funds to try to do the testing in a timely fashion. I think what we need to do is just put the professional fabric into this so that these can be channelled appropriately.

The Chair: Dr. Akabutu, did you want to comment?

Dr. John Akabutu: Yes, I would like to comment.

One of the mandates we set ourselves is to collect cord blood samples that reflect the genetic diversity of Canadians. That means that we have to collect samples from just about everywhere we can.

The groups that are not represented well in the unrelated donor registry are for the first nations and minorities. They are very difficult to recruit into that system. We are finding the same thing in the recruitment of the donors for the cord blood bank.

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What we have begun to do, really, is to approach the groups with sensitivity and to provide a lot of education in order to let them know the advantages of us harvesting this material. We have approached, for example, the Aboriginal Wisdom Committee, which is located in Alberta and which covers Alberta and the Northwest Territories. We presented to them the idea of them helping us to obtain more cord blood samples so that we can represent the first nations in our bank. It was quite an eye-opening experience, for me anyway, in that there are several ceremonies associated with the cord and the placenta, and these have to be respected before a collection can be done. We have left the matter in the hands of the elders to advise us what the best way is.

I have to tell you that we haven't gone out to educate the public at large for one simple reason, that is, we don't have enough money. If we were flooded, we wouldn't be able to handle it. Hopefully, when we get funded, we will go out and educate everybody. What is gratifying is that Canadians are still altruistic. Most of them want to donate their cord blood samples to our public bank rather than bank it for themselves. I often get phone calls from physicians who don't know about the program, and I keep telling them, “I can't tell you about it because I don't have any money. As soon as I get some money, you'll know about it.” So funding becomes a major issue there.

The Chair: Thank you, Dr. Akabutu.

I think you wanted to pass on this one, Dr. Rootman.

Sorry, are you finished?

Mrs. Karen Redman: Yes.

The Chair: Dr. Patry, you wanted to ask another question.

Mr. Bernard Patry: Yes. It's still directed to Dr. Akabutu. Regarding your work as a pediatrician, it seems to be very interesting.

When reading your brief, I noticed that there are two private banks, one in Toronto, one in Vancouver. Who is behind these banks? The public system could do the job. You notice that in that one case of the kid who is now 10 months old using the HLA to find out his genetics and things like that was successful. But what's behind these banks, and how are are the hospitals involved with this? Do the private donors also pay the hospital for collecting the blood from the cord? To me it seems to be incompatible with our Canadian medicare system, the public system.

Dr. John Akabutu: I don't know how the private banks actually operate. It's not that I'm ignoring them, but I have enough on my own plate. There are a lot of private banks in the United States.

We often get requests from prospective parents as to whether or not they can store the material for themselves. I think the reason given for self-donation is that this material would be available for use at a future date by that person, and if you use your own samples, obviously, you're not going to have any trouble with rejection and so on and so forth.

That doesn't make very much scientific sense. In the first instance, our technology today only allows us to store cord blood samples for five years. That's how long we will store them for. Secondly, if you're going to need your cord blood when you are about 40 years of age, the volume is going to be too small for you anyway, so it is of no value at that point in time. Thirdly, we think for any child who might need their cord blood sample within six months or so, probably the particular problem that developed at six months was present at birth. So for all of these reasons we don't think it makes any sense for people to be banking their blood. But it's a free country, so people are free to do what they want to do.

Mr. Bernard Patry: I think they're just playing on people's emotions. It's about that.

Dr. Hans Messner: There are two components to the private banks. One is that you already have a directed donation. It means that if, for instance, a child has acute leukemia, the parents have a second pregnancy, and this is then immediately harnessed to use for a directed bone marrow transplant. Under those conditions, sometimes a planned pregnancy.... And yet you do still need the cord blood to be appropriately stored and appropriately quality-assured, and then that transplant is done. So he already has a directed donation based on an existing need.

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The second thing is more what I think you're thinking about. This is, of course, the insurance type of mentality, and it could happen. I've got a thousand extra dollars, so I'm just going to do this.

I think that is really the problem we're facing here. I think what we have always tried to do is look at it from the point of view of the public domain and basically enshrine these kinds of resources into the public domain.

I suppose the difficulty arose in part out of the situation that there was no public funding available because there's no policy in place, and yet we have educated individuals around that said they would like to have it. So it's adjusting to a need that's out in the public.

Again, I think the issue here is who owns the material, what's the transparency, who pays for it, etc. Do we develop a two-tiered medical system if we have this happening? I think those are the most important things we need to look at, need to be aware of. And I would believe if there is a more public-funded system in place, we would most likely not have the need for the private.

Mr. Bernard Patry: Thank you.

Dr. John Akabutu: We also do the directed donation where we do store material for families who have defined diseases such as cancer, aplastic anemia, or bone marrow disorders. So we do the same thing as well.

Mr. Bernard Patry: Thank you.

The Chair: I think that response elicits another question our researchers have ably put forward, and that relates to the Canadian Institute for Health Information.

Since a lot of things have been done essentially on a volunteer basis, now that there's some money in the budget—and it's probably unfair for me to refer this to you, because I'm sure you haven't had a chance to review every element of the budget—should the CIHI be required to assemble, first, information regarding donation and transplantation of tissues in order for—

Dr. Hans Messner: I think that's precisely what we asked for before, an appropriate network of information to be established so that you can be actually at the pulse of what's going on, on an ongoing basis. If you think about it at the moment, you're not going to go to the library or drag an article out. You go to your computer and you look in the Internet-based MEDLINE searches or whatever, and within seconds you can find 25 articles from the last five years, and you scroll through them and you've got updated information available. Yet when we look at this system here that we have at the moment, which we're basing policy decisions on, etc., we don't really have the finger on the pulse. I think that's the most critical piece of information that we need to get—the development.

While we were in the Krever commission saying safety is paramount, and that's absolutely true, what can we deliver in terms of a safety package? We can deliver risk analysis, risk assessment, and safety as it is available today, but we don't know what our information ten years from now will be like.

So the development at the moment in the whole field of medical informatics is such that we can talk to each other, but it is an expensive proposition to have this available.

I think if we look at expensive health care delivery, which all of the transplants are, we must look not only at how to have a minimum system, but also how to evaluate it. We must have outcome measures.

The Chair: Dr. Akabutu.

Dr. John Akabutu: First of all, I think we all in the scientific world welcome the new initiative with the new funding that's coming onstream. It would have been extremely useful for such an organization to have existed when we embarked upon our program, which we wanted to be national, because we didn't have anywhere to go to apply for a national project.

Just to give you an example of what's happening in the United States with the issue of cord blood and cord blood transplantation, they are now into the second year of a five-year study of $30 million, which has been devoted strictly to the study of cord blood and its users. This is being done at the national level. About five cord blood banks and eight transplant centres in the United States are participating in the study to make sure that there's a head-to-head comparison between unrelated bone marrow transplantation and unrelated cord blood transplantation. Hopefully, we will have some answers in the next few years.

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The advantage they had was that they had a national organization to which they could apply for funding, something we don't have in this country.

The Chair: Dr. Rootman.

Dr. David Rootman: I think a unified system of medical records would definitely be helpful in our area, as well, in that we could then track where the areas of need are and make sure that tissues are distributed and none go to waste, because there are, for instance, times of the year when all the hospitals are shut down, at least in our province, between Christmas and New Year's, or we often will have a surplus of tissue. Right now we have a very loose network, where we make long-distance calls to Halifax, Calgary, or Saskatchewan to see if anybody does need tissue, but if we were online, it would certainly facilitate that process for us.

The Chair: I thank you all. I don't see any other questions from the committee members.

Is there a final comment you want to make, Ms. Caplan?

Ms. Elinor Caplan: You said you didn't have any other questions. I don't like to monopolize the time, but I would like to ask this panel the question I've been asking other panels.

I've heard you talk about the need for having outcomes and standards. I think that's all part of the accountability agenda. The one thing I didn't hear was the notion of reporting, making public that information about not only the standards but the outcome information.

Would you support that kind of public accountability, making that information available as a way, perhaps, of encouraging greater donation, raising public awareness, and also perhaps pointing out problems in areas where we have to improve?

Dr. Hans Messner: I think this is a very important part, but it also requires now an educational piece that usually does not yet exist. That is, the individual in need might not necessarily know where to go and look, so they surf the Internet and they get all this information that may be very good or may be not very good. Then they need this possibility of bouncing certain things off an expert. They're not necessarily saying they don't trust their physician, but they want to have that second opinion.

What we're trying to do right now, for instance, is get a 1-800 number for the bone marrow transplant registry so that a query could be directed immediately and then funnelled to the appropriate expert for this particular question. I think we need to make use of the professionals around this table, and broader, to provide also an information network that feeds it back into the public. This way the transparency would enhance significantly the trust into the system as a whole.

The Chair: Dr. Rootman.

Dr. David Rootman: I would agree with all of those remarks as well.

Part of our standards is a follow-up of the patients to find out how those transplants did. We have a reporting structure for any adverse reactions, plus, at various intervals, the surgeons are asked to follow up on the patients they've operated on and seen in the last six months.

The Chair: Dr. Akabutu.

Dr. John Akabutu: In Canada, based on our population, I think what makes sense is for us to network and cooperate. Although competition is a very good thing because it leads to innovation, I think in this particular area it behoves us to really cooperate with each other so we can develop these systems to their highest standard possible.

Ms. Elinor Caplan: Do you believe one of the incentives for that cooperation is making public the outcome information?

Dr. John Akabutu: Absolutely. Without the public understanding what they had done, I think they wouldn't be willing to donate. The only reward, so to speak, that the donors to cord blood banks are going to get in the future is to know that some child's life was saved by what they did. I think that's extremely important.

The Chair: Dr. Messner.

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Dr. Hans Messner: One of the problems we're facing is certainly also funding of the medical procedure. Many of these things are cutting edge. The question is are they experimental, or are they a part of our mandate? This is a very fine line: what is experimental today may be mainstream medicine tomorrow.

I think one has to also recognize that we need a mechanism in place to evaluate these things upfront. So if a technology comes on board there should be a recognition that, yes, this is novel technology, it needs to be appropriately evaluated under standard conditions, and then it should be listed not as something experimental but something that's actually now really mainstream medicine.

I think again if one does this on a national theme, not every one of us can do the same research. So if a group in Vancouver has a technology they want to try out, then it should be accepted in the Maritimes as a very similar strategy and should be appropriately then integrated into the provincial network and into the provincial envelope.

The Chair: Ms. Caplan.

Ms. Elinor Caplan: If I could comment, I heard two things and I wanted to just share some information.

I think the opportunity that is there.... Hopefully the new emerging Canadian Institute for Health Information is exactly the kind of national network that would lead to the kind of research you're talking about. I know they'd be very interested in the discussion today. It is new and it is emerging, so I think there is a real opportunity.

The second thing is on the public information. Sometimes budget initiatives do get overlooked. I wanted to mention the Canadian Health Information Network, which is going to be available and up and running fairly soon. The purpose of that is to have valid and good information for, as you mentioned, people surfing the net. Are you aware of that initiative as well, and do you have any comments about it?

Dr. Hans Messner: I think that is probably a very good cornerstone to get started with. For instance, what we have implemented in our own institution is we put a computer terminal into the waiting room with access to the Internet so that people can actually do this and come with their printout before we see them.

But I think simply the awareness that patients are much more educated now than they were ten years ago has to raise that transparency.

Ms. Elinor Caplan: The goal of empowering people with knowledge that is accurate is the goal of the Canadian Health Information Network. For those of us who have surfed the net, sometimes the volume of information and the conflicting information can be very confusing. Does anyone want to comment on that?

Dr. John Akabutu: The net is both good and bad. There is a lot of dangerous information on the net. As a treating physician, I'm often confronted with requests by patients to undertake certain procedures based on what they've seen on the Internet, and sometimes it can be extremely difficult to persuade people that the information may not be accurate.

So I have to agree with Hans that all efforts should be made to provide the most accurate information to people, because people want the information.

The Chair: Okay, thank you very much, Dr. Akabutu, Dr. Rootman, and Dr. Messner. It's been a most interesting encounter. On behalf of all the committee members, I thank you very much for your frankness and the fulsomeness of your answers. Thank you very much.

I'm going to suspend for five minutes and then we'll be back to do our work session in camera.

[Proceedings continue in camera]