Evidence of meeting #15 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was donor.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Clerk of the Committee  Mrs. Carmen DePape
Meena Ballantyne  Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Suzanne Kiraly  President, Canadian Standards Association
Marc Germain  Chair Designate, Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction, Canadian Standards Association
Kimberly Young  Chief Executive Officer, Canadian Council for Donation and Transplantation
Graham Sher  Chief Executive Officer, Canadian Blood Services, Canadian Council for Donation and Transplantation
Gary Levy  Director, Multi Organ Transplant Program, University Health Network, University of Toronto
James Shapiro  President, Canadian Society of Transplantation
Raylene Matlock  President, Canadian Association of Transplantation
Lori West  Past President, Canadian Society of Transplantation

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Order, please.

I would first like to thank the witnesses for coming in.

We have two panels of witnesses today, so we have to move rather quickly.

Mr. Fletcher will make a few opening remarks, I believe.

11:10 a.m.

Bloc

Réal Ménard Bloc Hochelaga, QC

There's a point of order here.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

There's a point of order?

11:10 a.m.

Bloc

Christiane Gagnon Bloc Québec, QC

Yes.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Oh, pardon.

11:10 a.m.

Bloc

Christiane Gagnon Bloc Québec, QC

Thank you for allowing me to speak, Mr. Chair.

I thank the witnesses for being here today. My remarks do not mean that I am not pleased to see them here today.

I am looking at the witness list, and we are missing groups who should have been here this morning. I would like to know how it can be that no one representing the gay and lesbian community is here. I know that attempts to contact them have been made since January, but I have heard that the letter did not arrive. It is important that Gai Écoute be here this morning. These are the people who were approached when these regulations were being developed. They were the ones behind them.

I hope that there will be another meeting because I am not happy with the fact that we will not be hearing some testimony about the impact on the gay and lesbian community this morning. What first caught our attention, in fact, was the discriminatory nature of a section of the regulations.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

That's a good point of order. I think Carmen, our clerk, will be able to explain what has transpired.

11:10 a.m.

The Clerk of the Committee Mrs. Carmen DePape

Ms. Gagnon, I sent a letter of invitation to Mr. McCutcheon a few weeks ago. I do not recall the exact date; but it was in February, at least two weeks ago. I received nothing back from him. I tried to call him, but there was no voice mail. I could not reach anyone by telephone. I sent a reminder asking for someone to get back to me, but there was no reply to that either.

11:10 a.m.

Bloc

Christiane Gagnon Bloc Québec, QC

We spoke to Mr. McCutcheon.

11:10 a.m.

Bloc

Réal Ménard Bloc Hochelaga, QC

On the same point of order. Mr. McCutcheon runs an organization called Gai Écoute. I am in touch with that organization three times a week, so I do not understand how you were not able to reach them. If they are not there, you leave a message on a machine. I am confused as to how you were not able to reach a national association like that.

Like my colleague Ms. Gagnon, I too express my disappointment at having a group of institutional experts before me. We do not question the relevance of what they have to say, but it would have been interesting to have a variety of points of view this morning. Those varied points of view are not available to us. We are very disappointed about that.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Monsieur Ménard, I'd like you to give the phone numbers of these groups of witnesses to the clerk. We will make every attempt to make sure they are included. We will have another meeting sometime to make sure we hear from these witnesses.

11:10 a.m.

Bloc

Christiane Gagnon Bloc Québec, QC

I also asked that Mr. Tremblay, from the Canadian Organ Donors' Association, be here. You told us that there would be too many witnesses and that others could not be invited. That was another kind of testimony that we would like to have heard this morning. That is the answer I received when I said that I would like to have had that witness at the table this morning. I am a little disappointed.

I am pleased that you are here. You will be able to answer some of our questions, but you do not represent a community that is specifically targeted by an element of discrimination that can be read in the standards that were developed during the consultations on the regulations.

Thank you.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

I was speaking with our clerk, and the suggestion is that at the end or the beginning of the Thursday meeting we take some time to do committee business and make sure we agree on a time for them to appear as witnesses at the committee, if that's the choosing of the committee.

11:10 a.m.

An hon. member

Or the steering committee.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

The steering committee is not operational, because we've done our work already.

11:10 a.m.

Bloc

Christiane Gagnon Bloc Québec, QC

There is something I do not understand. Last week, I asked why Mr. McCutcheon had not yet been contacted. I was told that a letter had been sent to him and that he had not replied. As I understand it, he received an e-mail on Friday. That really was too little time. He could have been reached by means other than a letter. If he could read an e-mail on Friday, he could have... I think that the witnesses were chosen a little sloppily.

11:10 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Thank you.

Mr. Fletcher.

11:10 a.m.

Conservative

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

Thank you, Mr. Chair.

First, I'd like to welcome Monsieur Ménard to committee today. It's like old times, when he was health critic for the Bloc.

Colleagues, I want to inform you--the chair is unable to be with us today, unfortunately, so it's up to me to do this--that there is a statutory obligation for Parliament to undertake a review of the 2004 first ministers accord on health, entitled A 10-Year Plan to Strengthen Health Care. The Minister of Health has asked that the committee fulfill this mandate.

I'll give you the key paragraph here:

Given that the Standing Committee on Health is authorized to study and report on all matters relating to the mandate, management and operation of Health Canada, in my view it would be appropriate for the Standing Committee on Health to undertake the review as referenced in the aforementioned legislation.

The letter goes on--I'm sure the clerk will table it or pass it on--but the gist of it is that we need to review this legislation before the end of March.

So when we talk about our agenda, maybe on Thursday, we can talk about how we're going to fit this in. It's probably going to have to be next week. I know that Health Canada officials will be ready to come in and deal with that.

11:15 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Thank you very much, Mr. Fletcher.

We will review that on Thursday and try to fit that into the working schedule as soon as possible to make sure we get a smile out of you.

Now, pursuant to Standing Order 108(2), we'll have a briefing on the new organ donor regulations. Our first witnesses are from the Department of Health: Ms. Ballantyne, Assistant Deputy Minister, and Liz Anne Gillham-Eisen, a unit manager.

We'll start now with your presentation, and then we'll continue with the other panellists. We're short of time, as you can see.

Thank you.

11:15 a.m.

Meena Ballantyne Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Thank you, Mr. Chair.

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.

11:25 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Thank you very much, Ms. Ballantyne.

Now we'll move on to the Canadian Standards Association, with Suzanne Kiraly, president, and Marc Germain, chair designate.

11:25 a.m.

Suzanne Kiraly President, Canadian Standards Association

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.

Thank you.

11:25 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Thank you very much.

Now we will go to the Canadian Council for Donation and Transplantation, with Ms. Kimberly Young. We also have Dr. Graham Sher.

Oh, are you following as well?

11:25 a.m.

Dr. Marc Germain Chair Designate, Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction, Canadian Standards Association

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.

11:30 a.m.

Liberal

The Vice-Chair Liberal Lui Temelkovski

Thank you very much, Dr. Germain. I'm sorry about skipping over you.

Now we'll continue with Ms. Young.