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.