Health Committee on March 4th, 2008

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Mr. Chair, and thanks to all of you for your presentations today.

Let me start with Ms. Gillham-Eisen.

You just said there's nothing in all of this to prevent people from donating their organs, yet it seems to me that the way this whole exercise was done has precisely that effect. It discourages people from offering their organs for donation and leaves a bad taste in many people's mouths on top of that, in the sense that they feel they're being discriminated against.

Was it done this way to in effect achieve a ban but avoid a charter challenge?

[Liz Anne Gillham-Eisen]

No. The criteria are science-based, and we are looking at what is identified as a risk factor. Exceptional distribution is a clause used for MSM--it's used for others. Organs from men who have had sex with other men are used in this country, but again we recognize that this is a higher risk factor.

We in this country allow patients to make their own decisions based on health and what they are willing to do, follow up on, etc. So it is not meant by any means to be that. We're using language within standards and regulations that has been used and has been practised since the mid-1990s. This was never identified as an issue before.

I think media attention stating that we have banned gay donors has been a factor in this. When we read the regulations, they do not ban homosexual men from donating organs.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I hear what you're saying. That may be true in the way it's written, but the way it's communicated and the way it affects our whole donation policy is another matter.

Regarding what we're all concerned about, surely there was another way to do this. It seems to me one option would have been to leave your section 13.1.3 as the basis upon which decisions would be made. Why did you feel you had to go beyond that and have a list of exclusionary criteria that specifically identified gay men and put them at the very top of the list? Surely there was another way to do it. What was wrong with leaving it as it was in section 13.1.3?

[Liz Anne Gillham-Eisen]

These regulations, and particularly the standards, were developed by the community, by transplant experts. To leave something in without giving it more context.... Again, these are based on science. We have to go back to the science and the risk factors.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Let me ask about the science. Maybe I should ask the transplant specialist.

Can you give us specific scientific studies on the 10 criteria listed as exclusionary? Can you table those with us? I don't expect you to give us a detailed answer now. Can you table with us studies that link each one of those conditions to contaminated organs?

[Dr. Marc Germain]

On the specific issue of men having sex with men, it has been stated before that there are epidemiological studies showing that the risk of HIV infection in this group is higher compared to the general population.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Could you get some of those studies to our committee?

[Dr. Marc Germain]

Sure. They're actually included in the references that were--

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I'm just wondering if the science has kept up with the changes in which sexual activity takes place. Knowing about the transmission of HIV and AIDS today and the many risk factors involved--multiple partners and unprotected sex--has the science kept pace? Are you referring to recent scientific studies that reflect this? Why not simply include multiple partners and unprotected sex as exclusionary criteria in a list? If that's the best way to describe the risk involved, why not just do that?

[Dr. Marc Germain]

I'm sorry, why not just do what?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Why not put in your exclusionary criteria people who have had multiple partners and unprotected sex in the last five years?

[Dr. Marc Germain]

To the best of my knowledge, this is not a situation where we know for a fact there is an increased risk. The simple fact of having multiple partners will not necessarily put you at higher risk. It depends on who the partners are.

The other thing is that it has always been very difficult to define exactly what constitutes multiple sex partners. There is no operational definition for that. What's the number? Is it 2, 5, 10, 15? We don't know, and there are no data to support a cutoff that could be used in daily operations of screening cell tissue and organ donors or blood donors that would reliably identify those who are at higher risk. These groups that are listed in annex E correspond to groups of people who have been shown to be at higher risk compared to the general public.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

You could have left it at 13.1.3, which specified persons with HIV, HPV, or HCV or persons at high risk of HIV, HPV, or HCV. Why not leave it at that? Why get into a language that is—

[Dr. Marc Germain]

That cannot be operationalized. People at higher risk of HIV, what does that mean? How do you define who is at higher risk for HIV? You have to look at specific situations where you can say yes, the person belongs to a higher risk group, or no, he or she doesn't belong. That's why annex E is there. It is to specify very clearly what we mean by higher risk. It doesn't say that someone who is in that group will be infected; it just means that this group has been identified as being at higher risk.

Those who received clotting factors in the days when the blood products were not as safe versus HIV are deemed to be at higher risk. They're not all infected; it's just that as a group they are at higher risk. Therefore, we need to take that into consideration when evaluating the risk.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Dr. Germain.

Now we will move on to Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair.

As I listen to this discussion, I reflect back to when I had my car accident and I could have been a multiple organ donor myself, but as it turned out, I was the recipient of a blood transfusion instead. Thankfully, that transfusion proved to be a healthy thing to do. However, a lot of people at that time did not receive clean blood, and they contracted hepatitis C. There is a long saga of compensation for those people who shouldn't have got hepatitis C in the first place but did. It wasn't until the time of this current government that $1 billion compensation was awarded to those victims pre-1986, post-1990.

Having reflected on the past of the Canadian blood system, I wonder if any of our witnesses could comment on what would happen—and by the way, a lot of the hepatitis C blood came from high-risk groups, I understand—if we deviated, as has been suggested, from the science that you are basing your decisions on.

[Dr. Graham Sher]

Mr. Fletcher, I'm prepared to answer that as the current head of the blood system in all of Canada, except for the province of Quebec.

I think your question is an important one, and I do think, as my colleagues said earlier this morning, this does need to be science-based and evidence-based to the extent that it can. But by their very nature, these exclusionary criteria are broad-based and blanket-approached, and I do think, as Dr. Germain has repeatedly said, it does not address every individual at the time of the criterion, but takes the broad approach to groups of individuals who may pose risk.

I think your points are well said. We are where we are in Canada because of some history of poor screening in a major component of the public health system, namely the blood program. We do have very similar deferral criteria today in the blood program. However, at the same time in that program, you have a slight distinction in that you have a much larger supply of raw materials than you do in the organ situation. Hence the deferral criteria currently in place in the blood system are even more rigid than those contemplated in the cells, tissues, and organs regulations, where first of all you have the current five-year policy, and second, you have the exceptional release component, precisely to balance the risk-benefit equation that a clinician and a transplanter will make at the time they are discussing with the recipient the receipt of an organ.

Those sorts of exceptional release criteria do not exist in the blood program, because we have a much larger supply to draw on and can provide alternate product to a patient in need. However, I think the premise of your question is that if we didn't have these sorts of rigorous, science-based, epidemiologically based and evidence-based approaches to deferral criteria, we could potentially be facing the situation of infected organ recipients as much as we faced transfusion recipients in the past.

My last comment, in closing, is that while I support all the questions and comments raised by committee members, if you're going to bring additional witnesses to bear to this committee, I would suggest you bring transfusion and transplantation recipients as well as bringing some other donors, and particularly groups of excluded individuals or potentially excluded individuals.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

That's a very good point.

I have one more question, Mr. Chair, and I'll pass the remaining time to Ms. Davidson, if there is time.

A few months ago, in November 2007, in Chicago, there were four organ recipients who contracted HIV and HCV from high-risk donors. What was Health Canada's reaction? Are these regulations in reaction to that, or are they there based on past Canadian experience?

[Liz Anne Gillham-Eisen]

Again, that was a situation that I think emphasizes the need for donor screening.

In this particular case, there was one organ donor who basically was identified with a high-risk behaviour, a risk of transmitting disease. The decision was reached by the transplanting physician to go ahead and use the organs for transplant.

The media has reported that not all the recipients were made aware that their organ was at slightly higher risk. In media reports, one particular recipient went forward to say they were not given the opportunity to discuss the fact that their donor was at slightly higher risk.

As we've pointed out, within these regulations, which are under the Food and Drugs Act, there would be a requirement to discuss that the donor is at a slightly higher risk. But again it underlines and emphasizes that a negative test result does not always mean that the donor does not have an infection, and that those at higher risk must be identified and a discussion ensue between the transplanting physician and the potential recipient.

I think it just emphasizes exactly why we've put into regulations what we have, and the exceptional distribution and the importance of donor screening.

Thank you.

[Meena Ballantyne]

Mr. Chair, if I may respond to the question, no, these regulations were not in response to the Chicago incident.

These regulations, as we've stated, started in the mid-nineties in terms of consultations. They basically formalized and made mandatory current practices in the transplantation community. We went through the CGI, or Canada Gazette, part I, process, which is a 75-day comment period. We went through the CGII and asked for a six-month coming into force. The CGII went in June 2007, and the regulations did not come into effect until December, to give the community time to adjust and to register with us. By the way, all 10 donor and transplantation organizations across the country have registered and are aware of our regulations.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

I'm sorry, Mrs. Davidson, you'll get an opportunity with the second panel.

Thank you very much to all the panellists, the witnesses, for your testimony.

If we could have the second round as soon as possible, that would be great. While everyone is getting prepared, I'd just like to make a few comments.

To those who gave us some written material, presentations, beforehand, if it's possible to cut your testimony a little shorter since we have it in writing, that would be great, because then we can get more questions. You'll find that we will get most of the information that you have through the question and answer period, as opposed to through the testimony. That would be appreciated.

We will be starting with Dr. Levy, director, multi-organ transplant program, University Health Network.

[Dr. Gary Levy, Director, Multi Organ Transplant Program, University Health Network, University of Toronto]

Thank you, Mr. Chairman. I would like to thank the Standing Committee on Health for giving me the opportunity of presenting today.

My name is Gary Levy. I am the medical director of the transplant program at the University of Toronto and its affiliated hospitals. For those of you who don't know our program, we perform over 600 solid organ transplants a year and take care of between 5,000 and 7,000 patients.

Solid organ transplantation is truly one of Canada's greatest success stories, and it sustains the lives of Canadians who would not be alive without this modality. Results today at one year and five years are greater than 90% and 80%, showing that this is really a remarkable treatment.

Most beneficiaries are in their most active years of life, in the 30- to 50-year range, and they have families that depend upon them.

Today over 3,500 patients are awaiting hearts, livers, kidneys, and pancreases across this country. The transplantation community, many of whom are here beside me, have worked very hard with government and the public to try to increase organ donation rates and to help people who could not be alive without this treatment.

I am here to discuss this recent Health Canada regulation, which I've outlined, and because of the time I will not go into it. It's outlined and published in the Canada Gazette, part II. It came into effect in December 2007.

It lists the exclusionary criteria. I think everybody understands what the word “exclusion” means. It means you're excluded if you have the following diseases or disease states: HIV, HBV, and HCV; transmuscular or subcutaneous injection of drugs in the preceding five years; the presence of tattoos; and you are a man who has had sex with another man in the preceding five years.

I want to point out--and it has been said by the previous witnesses--that these criteria are identified in other jurisdictions, and that's true. I brought them with me. I would be happy to leave them with the committee. However, in no other jurisdiction are they rules or laws. They are guidelines.

They provide for an effective process where, on a case-by-case basis, information about potential risk is communicated by an organ procurement specialist to a transplant specialist, and at that time a decision is made whether to use those organs, whether it is safe, and the communication is then made to the potential recipient. That guideline has existed in Canada since the nineties, and we do get recipients to sign a consent for all organs, because there is no such thing as a safe organ.

With the passage of this regulation, Canada has taken the unprecedented step of making these guidelines a law. The result is now that the ability to use organs that fall into these criteria can only occur through exceptional release clauses as outlined in annex E, and I won't read them, for brevity today.

Thus, this new regulation goes far beyond that of other jurisdictions in which donor history is a guideline to transplant physicians and surgeons who ultimately, in concert with other specialists, health care professionals, nurses, and ethicists, make a decision for the benefit of a potential recipient.

First, I want to applaud Health Canada for its unstinting work in continuing to improve the health of Canadians. I believe the intent of the regulation was to improve donor safety. Although there was consultation and representation by transplantation practitioners on the committee--incidentally, I was on that committee until 2001--the directors of the transplant program, many of whom are here today, were not directly consulted. We did not know about this regulation or law. I was not informed about it until a member of the media approached me.

This regulation, as written, will not improve organ safety over current practice, for the reasons that I will now outline for you. I will confine my comments to the most troublesome exclusionary criterion, the singling out of men who have had sex with men, which I personally believe is totally discriminatory.

First, our knowledge of HIV has expanded exponentially since its emergence in the early 1980s. I was actually a medical student and saw one of the first cases of HIV. Although the prevalence of HIV is highest amongst men practising homosexual sex, recent data from this committee, from Health Canada, published in 2006, show that the epidemiology has changed. Worldwide, 50% of new cases are heterosexual in origin.

In Canada, women aged 15 to 24 account for 40% of new cases. Most of these are young women who are immigrants from high endemic areas.

Second, today the new testing modalities for HIV, including third-generation serology, which measures antibody responses, RNA and DNA PCR, provide transplant practitioners with enhanced tools to screen potential donors and organs. Properly used, they make the transmission of HIV exceedingly unlikely. Consistent with this is the safety of our present transplantation system in Canada. This is largely because we've adopted most of these modalities. If Health Canada wishes to reduce the window in which individuals with negative serology, meaning antibody, might be infectious, I advise this body to make DNA and RNA PCR testing mandatory. Don't wait until we have another case. My understanding from talking to HIV experts in Toronto, Montreal, and Vancouver is that if this were undertaken, the risk of transmission, even without a donor history, would be one in a million.

Third, the new regulation will be difficult to enforce with confidence, as it will be nearly impossible to get the information that you are asking us for. In my experience, family members and contacts don't know the information you want from them. It's offensive to them. Why would anybody even volunteer such information? Why would anyone presume to offer information about whether a male has had sex during the past five years? Who knows what anyone has done in the last five years?

Fourth, this regulation has the potential to reduce organ donation. In fact, I believe that since this controversy became public, organ donation has decreased coast to coast. Because of this, last week in our centre three young people died because they did not get access to organs.

Fifth, the legislation as currently worded is exclusionary. I know what the word “exclusionary” means. It excludes gay men from being organ donors. They can become donors only if a transplant doctor executes an exceptional release clause. This regulation targets a specific group in society on the basis of its sexual orientation.

Instead of targeting individuals or groups, we should target high-risk behaviours. There are several reasons for this. Targeting groups brings moral and political dimensions into a law that should be based strictly on medical science and the best possible health care results for Canadian society. Instead of singling out a group, possibly erroneously, the regulation should focus on behaviour as the only thing we use to make a medical judgment. The risk in this case is sex with an HIV-positive partner. It doesn't matter whether it's a homosexual or a heterosexual experience.

As a specialist who has committed himself to the field of transplantation for over 30 years, I believe this controversy has had a negative effect on organ donation. Because of the coverage the issue has received and the misunderstandings that have developed, it is more than likely decreasing people's willingness to donate organs. I know the donation rate in Ontario has declined since December 2007, and I spoke about this to our procurement agency experts yesterday.

I strongly encourage the committee to reconsider this regulation and amend it for its stated purpose, namely, to improve organ safety in line with our current scientific understanding of HIV, HPV, and HCV. What do I want you to do?

One, amend the regulation consistent with the scientific facts.

Two, establish a strong national organ transplantation agency. I have been in contact with Dr. Graham Sher and I know that this is his intent.

Three, consult broadly with experts before instituting changes to legislation.

Thank you for the opportunity to present here today.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you, Dr. Levy.

We'll continue with the Canadian Society of Transplantation, Dr. James Shapiro, president.

[Dr. James Shapiro, President, Canadian Society of Transplantation]

Thank you, Mr. Vice-Chairman, ladies and gentlemen.

I am a transplant surgeon from the University of Alberta. I am the immediate past-president of the Canadian Society of Transplantation. I am joined today by Drs. Lori West, Tom Blydt-Hansen, Lee-Ann Tibbles, and Marcelo Cantarovitch, all of whom are executive members of council of the Canadian Society of Transplantation.

What is our society? It represents our membership of 560 key leaders, physicians, surgeons, nurses, and managers in all provinces and all programs across our country. We are the voice of transplantation in Canada.

The gay donor exclusion is a very important issue. It marginalizes Canadians and it's not acceptable. Monogamous relationships are not associated with increased risk. In practice, organs are utilized, and the laws do permit their transplantation under this exceptional release waiver, which must be signed by the recipient before transplantation. The newly introduced CSA standards have become so stringent, at least in Alberta, that the majority of organ transplants must now proceed under the exceptional release in our site. On occasion this may lead to compromise or potential compromise in donor anonymity.

This issue speaks to a much more fundamental issue, the fact that we lack a national infrastructure for transplantation in Canada. The provincial health care delivery has failed to provide adequate national coordination and accountability for the delivery of transplantation. Organ donation has fallen through the provincial cracks, and as a result, Canada is underperforming. We need a national structure that must be accountable to our Canadian public and to government.

Canada is one of the only remaining western countries not to have a national strategy for organ donation and transplantation. The International Transplantation Society and the World Health Organization have called us to task and have emphasized that in order to diminish trends in transplant tourism, every country must ensure an adequate supply of donor organs for its citizens.

There are 4,167 Canadians currently awaiting an organ transplant, a figure that has remained nearly constant since 2000--and this is an underestimate. However, there were only 492 deceased donors in Canada in 2007. That's a donor rate per capita of 14.7 per million population. Canada's deceased donor rate is half that of countries such as Spain, which has a rate of around 32 per million.

The deceased donor rates in certain provinces are not acceptable. For example, in British Columbia it was 5.9 per million, and in Manitoba 5.1 per million, compared to the average of 14.7 per million. That was in 2005. This falls far short of our national average.

Canada does 40% fewer deceased kidney transplants than the U.S. per capita. We were the same 20 years ago. Canada's current rate of deceased donor kidney transplantation is the same as that of Croatia. This costs lives: 146 Canadians died in 2007 while waiting for an organ. The true cost of loss of life cannot easily be measured.

Transplants save lives. Transplants save costs for health care. The cost of dialysis and other organ-supportive care is enormous. Each kidney transplant results in $100,000 in net savings. We should have done over 500 more kidney transplants last year, which would have saved our health care systems $50 million per year.

The Canadian Blood Services--and you heard from Graham Sher this morning--will take on the initial task of developing a national framework. The Canadian Society of Transplantation has engaged with this process with the Canadian Blood Services and strongly embraces this initiative. The CBS has secured federal and provincial support for the next five years. The Canadian Society of Transplantation enthusiastically applauds Canada's federal government's vision in participating in this process. This is an important start, but it may not be sufficient.

So on behalf of the Canadian public, the transplant community, the Canadian Blood Services, and the Canadian Society of Transplantation, we believe this Standing Committee on Health must commission a task force to work with the CBS. This task force should formulate a report defining Canada's deficiencies in donation and transplantation and offer potential solutions.

The task force should turn to the U.K., for example, where the Department of Health has recently completed its report by the Organ Donation Taskforce. It should turn to the U.S., with its United Network for Organ Sharing, UNOS, and the National Organ Transplant Act, NOTA, and to other countries, such as Spain, that are head of the pack.

We owe it to our Canadian public and to our governments to restore our performance rates in transplantations. The solutions lie in ABCDE: we must “advocate” for our patients, “benchmark” with other countries and between provinces, “collect” reliable data, “distribute” organs as necessary, and “engage” with other international agencies.

Thank you for allowing us to be here today.