Before I begin, I want to thank the committee for providing me and our officials the opportunity to answer your questions about Heath Canada's Safety of Human Cells, Tissues and Organs for Transplantation Regulations.
I'm responsible for the Health Products and Food Branch, which is the arm of Health Canada that under the Food and Drugs Act regulates the safety, efficacy, and quality of therapeutic products, including cells, tissues, and organs.
I have with me today Liz Anne Gillham-Eisen, who can provide more specific information on the regulations themselves and the organ donation process. Ms. Gillham-Eisen is a registered nurse who started working in the field of organ and tissue donation 19 years ago, as a transplant coordinator at the Ottawa Civic Hospital. In 1992 she established the organ and tissue donation program at the Ottawa Hospital, and managed this program for 10 years. As president of the Canadian Association of Transplantation, she participated as an expert in the development of the national standards. In 2002 we were lucky that she joined Health Canada and led the development of the federal regulations around these standards.
I would like to bring three points to the attention of this committee. First, I would like to say unequivocally that contrary to what has been reported in certain media, the regulations do not ban homosexual men and others with identified risk factors from donating organs. No Canadian will be prevented from becoming an organ donor based on gender, race, age, or sexual orientation. Organs save lives, and too many people who depend on their availability are on transplant waiting lists. Some will die waiting.
Second, I also wish to emphasize that the primary focus of these regulations is safety--with the recipient in mind. We have moved a long way since the lessons of the tragic tainted blood scandal. Those lessons must never be forgotten.
We have moved a long way since learning those lessons and we must continue to learn.
The prevention of transmission of disease to transplant recipients is the primary focus of these regulations.
The third point I'd like to make is that at the centre of our regulatory framework is sound, science-based risk management, and this is consistent with international practices.
Let me now clarify the fundamental principles that have guided the development and implementation of the cells, tissues, and organ regulations.
Science is always evolving. That is why Health Canada has been, is, and will continue to be engaged with independent scientists, health professionals, standards organizations, and other regulators around the world to ensure that our work is informed by the latest established science.
It was the transplant community that first asked Health Canada for regulations--more specifically, regulations based on national standards. It was also the Standing Committee on Health, in its 1999 report entitled “Organ and Tissue Donation and Transplantation: A Canadian Approach”, that recommended that cells, tissues, and organ safety standards be made mandatory through incorporation by reference into regulations under the Food and Drugs Act.
In response, Health Canada committed to developing a standards-based regulatory framework for the safety of cells, tissues, and organs for transplantations.
Experts in the field of donation, transplantation, ethics and transplant recipients were assembled to draft the content of what they felt should be in these national standards.
These experts included representatives from the University Health Network, the Canadian Association of Transplantation, and the Canadian Society of Transplantation.
The Canadian Standards Association was contracted as an independent body to take the outline of these draft standards and transform them into national standards. They formed the basis of the Health Canada regulations.
People in need of cells, tissues, and organs are extremely vulnerable. Their health is compromised. One donor who donates both organs and tissues can be the source of more than 100 transplants. Clearly, the potential impact of a single donor with an infectious disease on the health of Canadians is great.
Donors must be assessed for medical conditions and risks that could result in the transmission of a disease to a recipient. This assessment is made through a combination of a physical examination of the donor, questioning of the donor's next of kin, and testing of samples of the donor's blood. We must keep in mind that in the case of deceased organ donation, all this happens after a donor has been declared clinically dead.
Donors are considered to be at a higher risk of transmitting diseases such as human immunodeficiency virus or hepatitis if they have engaged in certain behaviours, including men having sex with men, intravenous drug use, sex trade work, and certain body piercing and tattooing practices. The men having sex with men risk factor is applied to all male donors, regardless of their sexual orientation.
The Public Health Agency of Canada surveillance data, which we monitor on an ongoing basis, clearly shows that the highest proportion of positive HIV tests among adults in Canada each year continues to be within the men having sex with men group. It's 40% in 2006-07. The next highest incidence is among IV drug users, at 19%, and then sexual contact with a person at risk, at 12% in 2006-07. These three risk factors alone accounted for 70% of the new cases of HIV in 2006-07 and cumulatively have accounted for 85% of positive HIV test results since 1985. All of these risk factors are assessed during the donor screening process.
While testing used for organ donors is sensitive, it is not 100% reliable, and there still remains a slight possibility of a false negative result. This includes a window period during which the donor may be capable of transmitting a disease but will test negative for it. For this reason, screening a potential donor for risk factors remains a critical component of the donor assessment process.
Could we ask a different type of question, such as what type of sexual practice has the donor engaged in? There are differing views on this, but I must stress that the deceased donation often occurs under conditions of intense emotional distress and must be treated as the most generous gift one human being can give to another. It is not the donors themselves who must answer these delicate questions, but their family members at a time of intense grief.
Under these circumstances, some families may be even more uncomfortable and may not wish to proceed with donation. Potential donors themselves may not wish to consider organ donation if they know that their families will be subject to this type of interrogation.
As I indicated at the very beginning, Health Canada does not prevent anyone from being considered as an organ donor. Despite the identification of risk factors based on science, an exceptional distribution provision in the regulations allows the transplant of an organ from a donor considered to be at a higher risk, provided that the transplant physician judges it to be in the patient's best interest and the recipient gives his or her informed consent. The recipient and the people caring for him or her after surgery can then make their own decisions on precautions to be taken and follow-up testing.
It is important to note that donor screening for behavioural risk factors has been practised in Canada and the United States since 1994, long before either country had laws mandating it. Therefore, the coming into force of the regulations presented a status quo situation with respect to donor screening in Canada.
Throughout the development of these standards and regulations, there were numerous consultations conducted in which members of the transplant community and general public were provided opportunity to comment on these risk factors. No comments or concerns were raised during any of these consultations about the inclusion of the men having sex with men risk factor or any of the other risk factors.
Any changes to the requirements in the standards will be based on valid scientific data, with, as always, the protection of the organ recipient in mind.
With this, members, I thank you for listening. We'd be happy to answer other questions.
Good morning. My name is Suzanne Kiraly, and I am the president of the Canadian Standards Association, or CSA.
I am here today to describe CSA's role in the development and maintenance of Canada's national standards for cells, tissues, and organs for transplantation.
CSA is an independent, not-for-profit, member-based association that serves business, industry, government, and consumers in Canada and around the world. Established in 1919, CSA is one of four organizations accredited by the Government of Canada to develop national standards. Our organization maintains more than 3,000 standards, codes, and information products for safety, design, and performance in a wide range of areas, including health care, the environment, and public safety. We have been developing health care standards for more than 40 years.
As a standards development organization, CSA functions as a neutral third party, providing a forum for committees of experts to work within a rigorous and accredited process. Our technical committees are created using a balanced approach that capitalizes on the combined strength and ensures that no single group dominates. The technical committee that developed the transplantation standards included health care professionals; regulators; general interest members, including a transplant recipient; and an expert on ethics.
When a draft standard has been completed, it is submitted for public review so that any interested person or organization can comment. The draft is amended if necessary and then submitted to committee for formal approval.
Once a standard is published, CSA continues to maintain it and will make amendments as needed to keep it current. Each standard is reviewed at least every five years.
CSA is not a government body and does not have the power to make a standard mandatory. A standard becomes law only if a federal, provincial, or municipal government references it in legislation. For the transplantation standards, Health Canada has referenced specific sections in its new regulations, making those sections mandatory.
Specifically, CSA began its work on these standards for cells, tissues, and organs in transplantation in 2000, at the request of Health Canada. In early 2002, the draft standards were posted on the Internet for public review, and over 1,000 comments were received. The standards were completed in early 2003, and they were approved as national standards by the government.
These standards were created to enhance safety and effectiveness for donors and recipients and health care personnel. They represent the best efforts of the leading experts in Canada, drawing on the combined knowledge and best practices of the top national and international organizations in this area.
The series consists of a general standard that applies to all cells, tissues, and organs, and five additional standards that provide requirements for specific types of transplant materials. These standards set minimum requirements for organizations or individuals involved in all aspects of transplantation. These standards are designed to provide a common management framework. Organizations can use them to develop their policies and procedures, hire and train staff, and manage their operations. The goal is for everyone involved in transplantation to safely manage their responsibilities in a consistent and organized way.
CSA standards are revised to address changing requirements and respond to emerging technologies. The technical committee is currently reviewing the documents, and new editions are slated for 2009. We are committed to maintaining and improving the standards to keep them relevant. We welcome comments and suggestions on the standards from all interested organizations and individuals.
Yes, I'm going to speak on behalf of the CSA.
Good morning. My name is Marc Germain. I am here today as the incoming chair of the technical committee on cells, tissues and organs for transplantation and assisted reproduction. In my regular job, I am also vice-president and medical director of the human tissue division at Héma-Québec. I would like to thank the committee for the opportunity to speak today.
The CSA standards on cells, tissues and organs were developed over the course of several years through a careful and well-defined process, as just described by Ms. Kiraly. I would like to make a couple of specific points related to the standards, in particular with regard to the criteria that are applied to qualify cells, organ or tissue donors.
First, as has already been said, it is important to recall that the goal of these qualification criteria, often called exclusion criteria, is to decrease the risk of disease transmission by transplantation and to make the donated cells, tissues or organs as safe as possible for the recipient.
Second, I must also repeat that, with communicable diseases, the qualification criteria based on the assessment of high-risk behaviours are only one of several ways in which the risk of disease transmission by transplantation is reduced. Other steps that are taken to reduce this risk include, for example, the testing of donors' blood for specific transmissible infections. However, for the reasons previously mentioned, it is important to recall that the assessment of high-risk behaviours remains an essential component of the overall safety of transplanted cells, tissues and organs.
Third, I must emphasize that, when developing standards for the safety of cells, tissues and organs, the technical committee took into consideration existing consensus and best practices in the field of transplantation. In particular, the committee attempted to harmonize with other existing standards and regulations, both nationally and internationally, whenever this was felt to be justified. It should be noted that the exclusion criteria related to high-risk behaviours that were included in the CSA standards are very much in agreement with other national and international standards.
The fourth point has also already been mentioned, but it bears repeating. The CSA technical committee and all other stakeholders recognized from the outset that organ donation represents a unique situation. Organs are and probably always will be in short supply. They can very often be life-saving to the potential recipient. Because of this, the standards allow the retrieval and transplantation of organs obtained from donors who might not meet all the qualification criteria, through a process called exceptional release. This process requires only that the transplantation physician and the potential recipient be made aware of the specific situation in order to be able to make an informed decision about the relative risks and benefits of accepting a transplant from a donor who might not fully qualify according to the criteria set forth in the standards.
In conclusion, I want to emphasize that the selection of the best possible qualification criteria, especially the exclusion criteria based on high-risk behaviours, has been discussed extensively over the last several years. Some of you are already well aware of these discussions. For example, in 2006, there was a meeting sponsored by the FDA in the United States to look specifically at those issues, both from the blood donation point of view, and from the cell, tissue and organ donation perspective. Several international stakeholders attended that meeting, including representatives from Canada such as myself. It is an area of intense scrutiny and I can assure you that the CSA technical committee will continue to monitor the situation closely.
I would like to thank you again for your time. I will be happy to take your questions.
I'll be happy to take your questions in English too.
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.
Back to you, Kim.
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.
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.
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.
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.
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.
Good afternoon, everyone. Thank you for inviting us to speak. My colleague Jan Emerton, president-elect of the Canadian Association of Transplantation, is here with me.
Thank you for asking us to speak in request to the exclusionary criteria of the Canadian general standards that are appended to the Health Canada regulations on the safety of cells, tissues, and organs. The Canadian Association of Transplantation, or CAT, as we're known, has represented health care professions in the donation and transplant field for 21 years. Over the years CAT members have participated on steering committees and subsequent advisory committees for the development of these standards.
The purpose of these regulations is to minimize the potential health risk to recipients of cells, tissues, and organs. The most important component of the organ donation process is that of the donor assessment. This provides the information required for decisions regarding acceptance or exclusion of organs for the purpose of transplant.
The following presentation will outline two of the main aspects of the assessment, which include organ function and risk assessment, both of which are required in order for a transplant physician to arrive at an acceptance or exclusion decision.
The organ function component involves a review of past and current laboratory investigations to determine organ-specific function as well as additional direct and indirect testing, which may include x-ray studies, electrocardiograms, echocardiograms, bronchoscopies, cardiac catheterizations, and diagnostic imaging procedures.
The potential donor's past medical history is also reviewed to identify if specific diseases exist that may directly or indirectly impair the organ function. Examples of this would include hypertension, high cholesterol, diabetes, chronic pulmonary lung diseases, or cancer.
The risk assessment utilizes two primary tools to identify any potential for disease transmission. First, serological or blood testing is conducted to determine the presence of infectious disease such as hepatitis B, hepatitis C, human T cell lymphotropic virus types I or II, Epstein Barr virus, cytomegalovirus, or human immunodeficiency virus--HIV--the virus that causes AIDS.
In addition to serological testing, a medical-social history interview is also conducted to identify risk factors. A number of questions are asked, ranging from past hospital visits to recent travel and social behaviours. For example, recent travel to warm climates may indicate a higher risk for West Nile virus. Some social activities have been identified to statistically increase the risk potential for hepatitis B and C and HIV, initially identified by the Centres for Disease Control in a 1994 document.
These activities have become standard screening tools for the American Association of Tissue Banks, the Eye Bank Association of America, and most recently, the Canadian Standards Association in 2003. However, we have been using a screening process since 1996.
The medical-social history is conducted only by trained coordinators in a private setting. The history is reviewed with the potential donor's next of kin, significant life partner, or other appropriate individuals, utilizing a standardized history questionnaire. A medical and social history interview is conducted with sensitivity, discretion, and respect. The purpose of the interview is explained with a brief description of the types of questions that will be asked of these folks. This process allows the presumed historian the opportunity to decide if he or she is the best historian for these types of questions or if another person should be included.
The interview may take place in person or over the phone. The interviewer should indicate that due to the personal nature of the questions, only those individuals who are providing information should be present. The family is welcome to request that others remain in the room. However, it is helpful for the interviewer to request extra individuals leave the room to save the historian potential discomfort.
The interviewer is familiar with the medical-social history questionnaire and always asks questions in a sensitive manner. When given an affirmative answer, the interviewer strives to obtain as much information as possible about the answer. This may include direct quotations from the historian. The interviewer is always aware of non-verbal cues such as looking away, coughing, and fidgeting, which may indicate that a historian is being less than forthcoming, or that another person present has additional information that he is uncomfortable sharing with the group at this time.
In some cases, it may be helpful to ask the historian to recommend another individual who might be able to provide more information to the coordinator. A typical example would be a young adult donor; parents would be providing the medical history, and friends or siblings would be providing the social component to the history.
In addition, the final question for any medical and social history asks the interviewee to consider the donor's behavioural risk factors, and if there is any reason why organ and tissue donation should not proceed. No explanation is necessary from the interviewee. The intent of this question is to allow the next of kin, the significant life partner, or others the opportunity to stop the donation process when they are hesitant to disclose sensitive information regarding the donor.
If the answer is yes and the interviewee does not wish to give more specific information, the donor will be deferred. But again, organs may be used and deemed acceptable by the transplanting physician, when the risk of not receiving an organ is greater than that of disease transmission, through the use of exceptional distribution that includes the informed and verified consent of the recipient.
In summary, I would like to say that the Canadian Association of Transplantation has supported the development of the Health Canada regulations over the past decade. Our primary concern is that of maximizing safety and minimizing risk to the transplant recipients. We feel that the regulations do not discriminate against any individual wishing to donate organs, but instead ensure full assessment of potential donors that better enable transplant physicians to make risk-benefit decisions.
Thank you for allowing CAT to participate in this meeting today.
Yes, and I have to say, Mr. Chair, that it's a bit frustrating. We've had so many witnesses and so many questions that this can't possibly be done this morning.
I'm very grateful, Dr. Levy and Dr. Shapiro, for your suggesting very clear recommendations on what you would like to see from this committee's report from this morning in terms of either a task force or certainly the call to have the regulations consistent with science and the practical, on-the-ground reality.
As much as I have sympathy for Ms. Gillham-Eisen's story of her son, I also think that most of the time, to be a clinician and to have to turn down an organ for what you know is a monogamous gay man, it seems ridiculous that we would actually have to go through.... You know, two of my best friends have been together as long as my husband and I have, for 29 years. They know perfectly well the sexual habits of one another. I just don't understand how we could end up, literally, with tough cases making bad law.
I have no idea where the science has come for most of the annex. What happens if the kids had been vaccinated against hepatitis? What if, in terms of people...know the behaviour of somebody in a prison? It just seems to be so wide, and then you are stuck having to go through all of this exception stuff to be able to turn down an organ. So I am a bit lost here.
I have been a minister where, when the department said they had consulted, I would spend my next two weeks finding out that the people who should have been consulted hadn't been consulted.
So I am not happy with this. I think it's almost impossible to do this today.
I would love recommendations, from any of you, on where you think we go from here in terms of putting the evidence back in instead of ideology, and in terms of real risk. The fact is that we are grown-ups. If my son needed an organ, I hope it would be done through consultations by Dr. Levy and Dr. Shapiro, not some list of things designed in some committee somewhere. So I expect that you would let us decide together whether or not we see this as an acceptable risk for the organ that's forthcoming.
Please let me know what you think we should do next.
First of all, before this regulation came into rule, we had a guideline that we used, and the community accepted the guideline. Incidentally, what has been brought into law or regulation, some people have argued, is not that different from what we have.
So what is the difference between a guideline and a regulation? A guideline is a notice to us. That's what the United States has. We are notified about a high-risk behaviour—very much like what we heard about this morning. We get the results of the serological tests, as we pointed out, for HBV, HCV, hepatitis B, hepatitis C, and so forth.
And you should be aware that we're not working in opposition here; we're also here to provide a safe system—and it is a safe system. So what we've done is use words like “exclusion” in a law, a word that was not used before. We've used very harsh language. I would argue, first of all, that we need to talk about high-risk behaviour. After all, when you've talked about MSM, that's a behaviour, perhaps. I would not get into defining a group, or whatever the case may be. I think we can leave people to decide. I don't think people necessarily want to be defined as groups.
The other thing you should know, in regard to the reference made to the case in Chicago—which is in the courts, and which I've been consulted about but am not allowed to give the details of—is that there was a lack of transmission of the data. That's what happened. There was a failure of the system. Nothing that we would have done would have protected.... This law will not prevent that; it was a breakdown in the system.
You asked what we wanted, Ms. Bennett. One, I think we need to amend this to reflect what we're trying to accomplish, and I would encourage you to mandate that we use the best test possible.
In regard to HCV, incidentally, which Mr. Fletcher alluded to, Canada did not embark on the high road. You didn't use the surrogate test. And I'm not talking about this government, so I apologize if you're assuming I'm a political animal; I am not. I'm an apolitical animal. I'm an advocate for patients. But the reality is that the Canadian government at the time did not take the best advice from the doctors. You should have used the surrogate tests. The United States did, and they didn't suffer the same costs.