Health Committee on March 4th, 2008

[Kimberly Young, Chief Executive Officer, Canadian Council for Donation and Transplantation]

Thank you for the invitation.

I'll begin by introducing our agency and providing disclosure.

My name is Kimberly Young, and I'm the chief executive officer of the Canadian Council for Donation and Transplantation, or CCDT, a federally incorporated not-for-profit advisory organization established by the Conference of Federal-Provincial-Territorial Deputy Ministers of Health to support their efforts to coordinate and improve activities relating to organ and tissue donation and transplantation, or OTDT, in Canada.

According to the CCDT vision, every Canadian who needs a transplant should have equitable and timely access to safe tissues and organs; every Canadian who wishes to donate should be optimally considered and, when possible, supported; and all donation should be compassionate, safe, and efficient.

As of April 1, 2008, the Canadian Blood Services, or CBS, will assume responsibility for some national services for organ and tissue donation and transplantation, which includes a transfer of functions currently performed by the CCDT. For this reason, I would like to introduce Dr. Graham Sher, chief executive officer of the Canadian Blood Services.

[Dr. Graham Sher, Chief Executive Officer, Canadian Blood Services, Canadian Council for Donation and Transplantation]

Thank you, Kim, Mr. Chairman, and honourable committee members.

Throughout today's testimony, you will be made aware of several challenges facing organ and tissue donation and transplantation in Canada, not just those associated with donor deferral criteria. I would like to impart to the committee that there has recently been some positive momentum on this front. The federal, provincial, and territorial governments indicated that Canadian Blood Services will be given a mandate to begin work on key national services for organ and tissue donation and transplantation in Canada. Based on our existing national infrastructure and service delivery model, our experience in donor recruitment and deferral, our experience in biological product manufacturing and processing, our information systems and registry management, our independent governance structure, and our credibility with Canadian stakeholders and the public in general, the FPT governments have recognized that Canadian Blood Services is uniquely positioned and qualified to deliver those services within Canada's national organ and tissue supply chains.

Our understanding is that the focus of this hearing will be on the exclusionary criteria set out in the new safety of human cells, tissues and organs for transplantation regulations. While Canadian Blood Services was not involved in the development of these regulations, we will soon be operating under them and are therefore a key stakeholder.

We have extensive experience in operating in a highly regulated environment, since blood is subject to similar regulations under the Food and Drugs Act, where difficult decisions about donor eligibility must frequently be made in the name of patient safety. We have an earned reputation for openness and transparency and go to great lengths to include Canadians in our decision-making processes. We are also currently embarked on extensive discussions around the blood-related deferral, similar to the one under discussion today. We trust that this hearing will continue to ensure that the CTO regulations are developed in similar fashion.

I want to leave the committee with the sense that as we work with the donation and transplantation communities across Canada to improve performance in these critical aspects of the health care system, we will continue to engage all stakeholders in the many complex decisions that lie ahead. I am strongly encouraged by the opportunities before us and the sense that Canada can begin to improve upon its current poor performance in organ and tissue donation and transplantation.

Thank you.

Back to you, Kim.

[Kimberly Young]

Prior to discussing the regulations, I would like to disclose the CCDT's involvement in the development of the regulations.

First, prior to the formation of the CCDT, individuals who are currently council members or staff formally recommended that Canadian standards be established in this area.

Second, several CCDT council members and staff, including me, have been and continue to be involved in the Canadian Standards Association committees.

Finally, as part of their ex officio capacity, a representative of Health Canada attended CCDT meetings to brief members on the development and implementation of cells, tissues, and organs regulations, and the opportunities for consultation.

With that disclosure provided, I'll now respond to the new organ donor regulations from the CCDT perspective. Both the invitation questions and the controversy highlighted in media reports suggest we are here today to answer two main questions.

First, do the new regulations make sense, and were they developed in a consultative way?

While the CCDT recognizes that the process for developing and implementing the regulation, particularly the exclusionary criteria, is a complicated one with potential legal, ethical, and social aspects, the CCDT will only focus its response from a health system perspective. Our response is based on a number of principles that underpin the need for regulations related to cells, tissues, and organs including that exclusionary criteria. I will highlight a few of these principles.

The safety of transplant recipients is of paramount importance. While regulations must consider the interests of donors and potential donors, their primary purpose is to minimize the potential health risks to Canadian recipients.

Every person should have the opportunity to be considered for donation and provided with an explanation for why he or she is not eligible to donate.

The decision about which organs and tissues are used for transplantation is a clinical and medical decision made in consultation with the patient or their family.

The transparency of the health system and medical decisions is important and can be facilitated through regulations and common practices.

Standards and regulations are an important mechanism of risk management. Government standards and regulations are important to the strong functioning of the Canadian health system and the OTDT system in particular.

Government standards and regulations must be well understood by the public in order to maintain the public’s trust in government’s ability to execute its fiduciary responsibilities to its citizens.

With the foundation of principles presented, I'll proceed to answer the questions.

First, do the regulations, including the exclusionary criteria, make sense?

Based on the principles outlined, the CCDT fully supports the importance of and need for the federal regulation of cells, tissues, and organs in Canada. In addition to the assurance of safety provided by such regulations, they also contribute to the transparency and standardization of the health system related to OTDT. We believe the regulations are sound and make sense because they are patient-centred, evidence-based, and allow for the discretion of the health care team, in consultation with the recipient, to weigh the risks and benefits of exceptions, that being exceptional release and distribution.

For each of those areas, I'll further describe the basis for the CCDT determination in relation to patient-centred.

Health care decisions are made daily on which treatments will be in the best interests of an individual patient. Medical decisions are the legal responsibility of the physician, in consultation with the patient and the health care team, and are made on a case-by-case basis.

The exclusion criteria in the regulations provide a necessary resource when dealing with donation and have been established to eliminate possible risks to the recipient that may offset the benefit.

The CCDT supports the authority of physicians and the health care team to use professional judgment in making decisions about organs and tissues suitable for transplant, within the confines of legal and regulatory requirements and hospital policies. In fact, the new regulations make room for this decision-making in the form of exceptional release.

In relation to evidence-based as part of the CCDT's mandate, we fully explore issues through background research, environmental scans, and international reviews, and we develop evidence-based consensus recommendations in consultation with experts and the OTDT community. We have successfully developed and published a number of these reports. The CCDT understands that a similar process has been undertaken in the development of the CTO regulations.

Finally, further to the application of the regulations and the exclusionary criteria, in practice, as part of the pre-donation assessment, a coordinator completes a medical and social history questionnaire with the donor or the donor’s next of kin. Responses will determine what tissues or organs are eligible for donation. If an exclusionary criterion is identified, it is normal practice for tissues to be deferred.

Current practice for organ programs is to weigh the benefit of the transplant for the recipient against the possible risk of disease transfer from the donor. Due to a greater demand for organs, more attention has been given to that area of acceptable risk. If it is deemed that the benefit outweighs the risk, the transplant surgeon as well as the recipient must consent for the transplant to proceed.

Now to the second question and the purpose for being here. Were the CTO regulations developed in a consultative way?

Their development began in response to requests from the Canadian OTDT community more than a decade ago. Health Canada struck a working group of experts to develop safety standards for CTOs. In 2000, Health Canada contracted the Canadian Standards Association, as we've just heard. They struck a technical committee, with broad representation, that was responsible for the simultaneous development of the general and subset standards.

Prior to the formal development or consultations, Health Canada utilized a directive guidance document to prepare the community.

An international consultation was undertaken to ensure comparability with other jurisdictions. Coast-to-coast in-person consultations were conducted, which we attended. In March 2003 a national review of establishments handling or processing CTOs also occurred to assess adherence to the basic safety requirements.

Throughout the development, the OTDT community was invited to provide ongoing feedback through a website and through publications in the Canada Gazette. And a process was established, through the CSA technical committee, to vet that community input.

Therefore, based on the above, we believe these regulations were developed in a consultative way. However, based on recent media reports, it appears that some individuals and groups did not feel informed or consulted. While we understand that Health Canada undertook a broad public consultation, we were not privy to whether direct consultation occurred with populations affected by the exclusionary criteria.

In closing, on behalf of the Canadian Council for Donation and Transplantation, I respectfully submit the following suggestions to the House of Commons Standing Committee on Health.

First, the CCDT suggests that you support the regulations, including the intent of the exclusionary criteria, which is to protect transplant recipients through the safeguarding of cells, tissues, and organs available for transplantation in Canada. We believe that the regulations and exclusionary criteria were based on sound science and broad consultation. They serve to ensure the safety and transparency of the system to the greatest degree possible. Furthermore, the exceptional release procedure ensures that no Canadian is automatically excluded as a donor.

Second, ensure that the regular review mechanism, as outlined in the regulations, is utilized to review current evidence and leading practices so that exclusionary criteria, as worded, are still relevant and viable.

Third, ensure ongoing dialogue with those opinion leaders and organizations expressing concern about the exclusionary criteria.

Fourth, support a comprehensive communications strategy to inform the public and affected groups about the continued need for organ and tissue donation.

In closing, I would like to thank the standing committee for this time and the opportunity to discuss these regulations.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Ms. Young and all the presenters.

Now we're moving to questions from Mr. Thibault.

[Robert Thibault, Liberal, West Nova, NS]

Merci, monsieur le président.

Thank you to all the presenters for being here today.

There are a couple of points that concern me about this. I think we all agree that we need a safe standard of care, safety in the supply, safety in the chain, and safety in handling. What concerns me a little bit is that when I am on my death bed and I need a transplant, I want to be able to take an informed risk. I'm not going to worry that it's going to make me sick if it's going to keep me alive.

Second, to take that informed risk, there has to be a supply. It appears that with the measures that have been taken, we're reducing the availability of the supply. We're eliminating a whole group of individuals in society who may pose no more risk because of the safety of their organs than I do. But they can't now, based on the criteria given, sign their donor cards. Should they die in an accident, or should they die quickly, their organs are not available for the patient to take an informed risk and consider.

So I think our job is to see if there is a better way to achieve the same thing. It is to see if we can modify what you've come up with in a way that achieves both those things.

The first quick question I would have for Ms. Ballantyne is whether, when these regulations were gazetted, the general standards were included with the regulations. Did the people who were checking the regulations have access to both?

[Meena Ballantyne]

No, the general standards weren't included, but there was reference to the standards at the CSA, because that's the current government practice in terms of incorporation by reference. So you don't include the standard in the regulations, but you point to the CSA standard in the regulations.

[Robert Thibault, Liberal, West Nova, NS]

At that time, Madame Kiraly, could the standards be visited on your website?

[Suzanne Kiraly]

The standards were able to be seen before they were published, as well as after they were published.

[Robert Thibault, Liberal, West Nova, NS]

During the gazetting process, when they were visited, you said, by 1,000 people, or through that whole period, not just during the gazetting period, was annex E included?

[Suzanne Kiraly]

Yes.

[Robert Thibault, Liberal, West Nova, NS]

I have had a hard time doing that follow-up on the Internet, to get through all those areas such that you would see them all. It didn't appear to me to be too user-friendly, that if I checked the regulations, I would automatically be brought to or focused on annex E. If I look at the regulations by the Department of Justice in accordance with the Canada Health Act and then I look at the general standard, in the regulation it points me to section 13.1.3. Then I look at section 13.1.3 and I see nothing offensive there. Then if I go further and look at the annex, I can see where people are concerned, because it raises some questions for me that might not necessarily....

I know, and it has been presented, that you can use disclaimer forms to get around it. So anybody can be a donor with a proper disclaimer, and I understand that it's common practice in the transplant community to get disclaimers signed by, I think, almost every patient. They are asked to sign a disclaimer. But it doesn't take away the problem of the availability, because if I look, the first thing I see is that men who have had sex with another man in the preceding five years cannot be on the donor list. They would not be encouraged to sign a donor card. Certainly we know that community now has reduced. So that one would be altered.

Why don't we include “if that brings risk”? I could maybe understand if somebody has had many partners and was active in the community; there may be an added risk. But for somebody in a monogamous relationship, how would their risk be higher than a heterosexual couple married for 20 years and engaged in anal sex?

[Dr. Marc Germain]

I guess that question is for me.

There are two points to your question. The first point has to do with the last part of your question, and it's the case not only for organ, cell, and tissue donation, but also for blood donation.

When we assess the risk in a given donor, we work from the principle that we don't assess the risk that is specific to this individual. We assess the risk that exists in a group of individuals to which this person belongs. Of course, a given person is either infected or he or she is not infected. Ideally, you would want to have that information, the exact information, on hand when you determine whether a donor is eligible or not for whatever type of donation.

We don't have that. We have to work with basic information. One is, does this person engage in certain types of behaviour that puts them at risk? One of the types of behaviour we are looking for—and this is a very wide consensus in the community—is men having sex with men. So that is the basic issue.

[Robert Thibault, Liberal, West Nova, NS]

I think people may disagree with you, Mr. Germain. People may disagree that two men, living together in a monogamous relationship for 40 years and not engaging in intravenous drug use, and not doing body piercing with common equipment that others have done body piercing with, would have no more risk of HIV than the general public.

[Dr. Marc Germain]

I totally agree with you. In the situation you are describing, it's more than likely to be the case. The problem is that in a real-life situation where you need to assess the risk status of a given donor, you may not have the details of all of what you just explained at hand. First of all, especially for organ, cell, and tissue donation, the donor is often deceased at the time of the donation.

[Robert Thibault, Liberal, West Nova, NS]

I agree, Mr. Germain, you may not have all those things, but I'm informed by the transplant community that prior to doing the transplant, there is an interview with the donor's family. There are those questions to discover that type of information to establish risk as much as possible.

[Dr. Marc Germain]

This is why the procedure for exceptional release is in place. Once you have the basic information that this person might be at increased risk of transmitting an infectious disease based on the assessment that's put forth in the standards, if you have that possibility by reviewing the donor's chart, by interviewing the family members, you might fine-tune your evaluation of the risk status and then decide to go forward with the organ donation through the procedure of exceptional release. And that is what's being done on a daily basis, I would say.

[Robert Thibault, Liberal, West Nova, NS]

I understand that, but I submit that you are removing people from the list of potential donors with which you could have that consideration.

[The Vice-Chair, Liberal, Lui Temelkovski]

Madame Gagnon can probably continue on that line of questioning.

[Christiane Gagnon, Bloc, Québec, QC]

In all the testimony I have heard this morning, nothing convinces me of the need to exclude some people who have engaged in high-risk behaviours and not other types of people who have also engaged in high-risk behaviours such as heterosexuals who have had various partners.

I understand that we must be certain about the quality of an organ that we are giving to a recipient, who is very vulnerable as well. Why not group all high-risk behaviours together, including those engaged in by heterosexuals? Just because people at risk are mainly in the gay community, why target only that community for exclusion?

[Dr. Marc Germain]

I am going to refer back to Ms. Ballantyne's explanation. She explained that identifying some groups as being at especially high risk of these diseases is the result of very rigorous scientific studies that are widely accepted in our community. For example, those studies show that men who have had sexual relations with other men are, generally speaking, at the greatest risk of contracting HIV.

Again, this does not mean that a person in that group will necessarily be infected. That is not the issue. This is about identifying a group at risk. Men who have had sexual relations with other men are at risk. So are intravenous drug users. So are heterosexuals who have had sexual relations with people known to be at risk for HIV, whether they be men who have had sexual relations with other men or intravenous drug users.

These groups are deemed to be at higher risk. The other groups you refer to are at no higher risk than the general population. The basis on which the criteria have been established is a scientific, epidemiological one. The criteria apply to organ, cell and tissue donation just as they apply to blood donation.

[Liz Anne Gillham-Eisen]

Thank you very much.

On the point as to who should sign to be a donor, I think every Canadian should. You're not automatically excluded as an organ donor based on this high-risk criterion. I think that needs to be clear.

On the high-risk behaviours, I think they're very difficult to interpret. As the ADM said, the newest statistics show that 40% of the new cases of HIV are within the men having sex with men group. I think many people have interpreted that to mean that they're below the half; 60% are in the other group.

That statistic is 40% of the new cases, which represents a population group of approximately 5%. If we estimate that the gay and lesbian community is approximately one in ten--10% of us are gay and lesbian--approximately half of them are gay men, so that would be 40% of the cases, over 5%, versus 60% of the cases, over 95%, the rest of the population. That's what makes it a risk factor.

Again, it's not to say that every gay man is involved in risky sexual activity, unprotected sex, etc. The question is at that level because that's what's reported on. We depend on the science. The science reports on the category of men having sex with men, so that's what we have used.

Also, as the ADM pointed out, when are we actually asking these questions, and who are we asking in the case of organ donation? We're asking the next of kin. We're asking a family member, who has just recently lost perhaps the most important person in their life. The question of whether a loved one, a man, has had sex with a man is something they may not be able to answer, but I think it's the highest level when you're talking to a parent or a sibling.

As the mother of a 21-year-old gay man, I could not tell you in an interview that my son has protected sex. I don't know the last time he had sex. I don't know how many sexual partners he has. I don't know if he has anal intercourse. That is not information I have. But I can very clearly, and without hesitation, tell you my son is a man who has sex with other men.

In the context of where this organ donation occurs in the case of deceased donors, this is the question. It is not meant to be discriminatory; it is based on science. We are still at a point where 40% of the new cases exist in approximately 5% of the population. That is a very important fact.

Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

You have one minute.

[Christiane Gagnon, Bloc, Québec, QC]

Ms. Young, you said that Health Canada had held wide public consultations but you did not have sufficient information to be able to confirm whether the views of populations affected by the exclusionary criteria had been directly sought. That concerns me a little. It is a little disturbing, and it is why I really wish that we could have heard this morning from the community that is targeted by one of the exclusionary criteria.

You say that, as Health Canada, you are not aware. How did you do your consultations?

[Liz Anne Gillham-Eisen]

There were two types of consultation for the development of these standards. The first was the consultative process that was undertaken by the CSA That consultation process included publication on websites. There was identification of over 1,000 programs and establishments and patient advocacy groups, which received the standards by e-mail or Canada Post, etc.

As the CSA pointed out, over 1,000 comments came back. The CSA addressed all 1,000 comments, and they had to review them as part of the process for developing the regulations.

On the regulations, as we pointed out at the beginning, these regulations were called upon by the community itself. The actual draft of the standards existed as far back as 1995. There have been consultations on both a formal and informal basis, because many of the people involved in donation and transplantation participated on these committees.

The consultation on the regulations has been unprecedented. Because the community is not accustomed to regulations, we did face-to-face meetings, and we sent out copies of the regulations. We did information kits explaining the regulations and the incorporation of standards. There was an awful lot done. We did cross-country tours, the website, and we did the whole issue around gazetting in the Canada Gazette and the 75-day comment period and responding to--

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

Madam Wasylycia-Leis.