HEAL Committee Report
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CHAPTER 5
FEDERAL RESPONSIBILITIES AND OPPORTUNITIES
A primary goal for the Committee was to understand the appropriate role for the federal government in the development of national safety, outcome and process standards for organ and tissue donations, as well as in promoting public and professional awareness and knowledge regarding organ and tissue donation, procurement and transplantation.
While witnesses were emphatic about the need for a federal presence in any national approach, they also supported some specific roles for the federal department of health. Witnesses readily acknowledged Health Canada's authority under the Food and Drugs Act to generate and enforce regulatory standards on the safety and quality of organs and tissues and supported the federal regulation and inspection process to ensure compliance. Witnesses also stressed Health Canada's ability to initiate nationwide awareness campaigns aimed at the public and healthcare professionals. In addition, witnesses pointed to ways that Health Canada can be involved through its ongoing efforts in health promotion and prevention, with specific population groups, and in general health system support. A few witnesses noted the role of the Medical Research Council (MRC) in supporting biomedical and related research.
For many donation and transplantation issues, the federal government is seen as playing a major role through the suggested national body. However, for others, the Committee also saw room for a complementary but independent role by the federal government, primarily through Health Canada. In particular, the Committee feels that the Minister of Health can take immediate steps to address the following identified needs and to advance the area of donation and transplantation. Once established, the Canadian Transplant Network can then assume further sustaining steps.
The importance of the Health Protection Branch in conducting ongoing regulatory work (through the Therapeutic Products Programme (TPP) on blood, tissues, and organs was unchallenged by witnesses. The Committee observed the current presence of regulations for blood and semen and sees a clear role for the federal government in developing similar regulatory standards for safety and quality in other organ and tissue areas.
Outcome and process standards are addressed more thoroughly under the considerations for a national framework. Some witnesses have argued that much of this would relate to professional and facility standards and would therefore fall under provincial jurisdiction. The Committee agrees in large part with this analysis but has already emphasized the need to ensure that, not only safety, but also availability, equitable distribution, and ultimate results are achieved. Part of the focus on outcomes relates to the need to monitor transplants for adverse outcomes. Much of the attention is on infectious diseases, but other negative outcomes leading to reduced quality of life or retransplantation could possibly be part of Health Canada's efforts at surveillance, either through the TPP or through the Laboratory Centre for Disease Control.
As already noted, the process of formalizing the Canadian General Standard for Safety of Organs and Tissues for Transplantation has taken several years. Given the frequent calls for strong national safety standards, the Committee seeks confirmation that the CGS and its subsets will shortly be given the authority of regulation through reference in the Food and Drugs Act. The Committee is pleased that the TPP supports regular review and revision of these national standards and that TPP expects to receive conformity assessment reports from transplant programs within one year after regulatory enactment.
12. The Committee therefore recommends that:
12.1 The Minister of Health ensure that the Canadian General Standard for Safety of Organs and Tissues for Transplantation and its subsets be approved and made mandatory through incorporation by reference into regulations made under the Food and Drugs Act as soon as possible, preferably within six months;
12.2 Health Canada provide annual public reports of the review process and any revisions of the standards.
The question of standards for xenotransplantation is a more complex matter. The Committee received a draft of a proposed Canadian Standard for Xenotransplantation and was told that no xenotransplantation has yet been approved by Health Canada. However, it is also aware that the transfer of live animal cells, tissues or organs into humans is increasingly viewed as one possibility for overcoming human organ shortages. Health Canada stated that, in the absence of an explicit regulation, xenografts are considered to be a therapeutic product and governed as such by the Food and Drugs Act. This means that under the Regulations, submissions for clinical investigations or clinical trials involving xenografts could be approved by TPP in the future. The Committee is concerned about this process.
Witnesses were divided in their views as to whether Canada should pursue research into xenotransplantation. Most witnesses who supported a ban in this area based their view on ethical grounds but others testified that the potential safety risk to the public, although as yet unproven, was sufficient to justify a complete ban on research. Other witnesses said that any unanswered questions about xenotransplantation could be resolved only through research and that the potential benefits of xenotransplantation justify pursuing the research. The potential safety risks to the general public were acknowledged by most witnesses; however, supporters of this research held the view that properly designed experimentation to explore this risk could supply the answers without risking the health of any individuals. When asked about the guidelines followed for xenotransplantation research, the MRC reported that the Tri-Council Policy Statement on Ethical Conduct currently binds its researchers when research involves humans; researchers would presumably be required to adhere to any regulatory standards as well.
13. The Committee feels that the issue of research into xenotransplantation needs more informed public debate under a clearly identifiable institution. The Committee recommends that:
13.1 All research or other activities in the area of xenotransplantation be open and transparent to the public;
13.2 Health Canada be proactive in providing information to and consulting with the public;
13.3 Health Canada ensure that clinical trials for xenografts not be approved until the proposed xenotransplantation standards are enforceable; and
13.4 The Medical Research Council, and any other federal granting body, ensure that its researchers adhere to any established standards.
The dissemination of health information, one of Health Canada's most visible roles, is performed through conferences, publications and, more recently, information technology initiatives such as the Canadian Health Network. Developments within Health Canada's Office of Health and the Information Highway support an infostructure to provide reliable and equitable access to health information. The department's use of social marketing strategies targets individuals seen as key influencers in program and policy development and specific segments of the general public who need an information base for health decisions. All these endeavours suggest to the Committee that the broader public, as well as healthcare professionals, may soon benefit from enhanced health knowledge.
At present, Health Canada provides information through general initiatives and those targeted at specific groups such as children, seniors, and women. Ongoing efforts could easily be adapted or supplemented to provide multi-faceted ways of ensuring that the facts of donation and transplantation are readily available to the public and to the healthcare professionals. In addition, the Aboriginal Health Institute for information dissemination, human resources development, and healing practices is seen as a possible vehicle for enhancing the focus on tissue and organ needs.
14. The Committee has already identified multiple areas where information is needed to educate the public and professionals and recommends that:
14.1 Health Canada use its existing initiatives to develop and disseminate specific information in collaboration with the numerous organizations already active in this area.
A few witnesses pointed out that prevention is one avenue to reducing the need for organ and tissue transplantation. Several of the organizations that promote awareness of the need for donation also promote the need for increased public and professional education to prevent, or to detect at an early stage, those factors contributing to outcomes such as organ failure. For example, the Canadian Liver Foundation supports research and education into the causes and prevention of liver disease while the Canadian National Institute for the Blind conducts prevention efforts through the E.A. Baker Foundation for the Prevention of Blindness.
These groups emphasized the need for Health Canada's support to ensure national coordination of research and information dissemination related to prevention. Health Canada already assumes significant responsibility for developing partnerships and for ongoing surveillance in areas such as diabetes which is associated with damage to the kidneys, heart and eyes. The Committee heard that Health Canada plays a key role in diabetes education through the Medical Services Branch and its work with First Nations and Inuit communities. The high rate of diabetes within the Aboriginal population has in turn led to the probability of increased renal transplantation. While not providing specific details of spending, the departmental representative indicated that significantly less money was spent by the federal government on prevention efforts compared to transplantation through the Non-Insured Health Benefits Program.
15. The Committee believes that more focus on the prevention of disease conditions contributing to organ failure and tissue needs is essential and recommends that:
15.1 Health Canada take a lead role in identifying key areas where prevention and early detection would reduce the demand for organs or tissues; and,
15.2 Health Canada establish a specific program to promote work in this area.
The Committee heard testimony on the state of biomedical research in Canada dealing with organ and tissue donation and transplantation. Xenotransplantation was a frequent topic but the Committee also heard about research in the fields of immunosuppression, prevention and in breakthrough technologies such as tissue engineering and artificial organs and tissues.
Given the current critical shortage of organs and some tissues, the Committee believes strongly that any research into improving the viable lifetime of the transplanted organs, enhancing patient quality of life, reducing the number of patients requiring retransplantation and finding alternate sources for tissues and organs should be encouraged. Instead the Committee was told that federal funding of this research is inadequate. The Medical Research Council (MRC) informed the Committee that it currently invests $1.6 million per year to 24 projects directly involved in organ and tissue transplantation. This figure is approximately doubled when provincial and non-profit agencies are included. The Committee was told that on a per capita basis the United States spends 30 times more on transplantation research than does Canada and that the large majority of funds are obtained from the pharmaceutical industry.
MRC described its areas of funding related to organ and tissue research. These included: seven grants on bone marrow transplants for leukemia, seven on development of alternatives to organ transplants (i.e. artificial organs and tissues), four on islet cell transplantation for diabetes, four on liver transplantation and two on preliminary aspects of xenotransplantation. MRC also indicated that a number of these projects are focused on the problem of tissue rejection. Future plans for research into this area centre around the creation of the Canadian Institutes for Health Research (CIHR), which, the Committee was informed, includes a proposal for an Institute for Immunology and Transplantation Research.
16. The Committee recommends that:
16.1 Additional federal funding be provided for transplantation research; and
16.2 Such research be broadened to cover a fuller range of health issues, including the biomedical concerns, social issues, prevention, and practice outcomes.
The Committee is aware that the provinces have full discretion for specific hospital and physician health services. In relation to transplantation concerns, the provincial governments address waiting lists, critical care and emergency services, and diagnostics. Several witnesses did, however, call for funds to support hospital initiatives in procurement and transplantation. The Committee does see possibilities for funding pilot projects related to primary care and integrated service delivery through the Health Transition Fund. For example, the Committee heard about several innovative pilot projects that are generating evidence about physician or nurse communication with donor families and about the role of coordinators in enhancing procurement of organs and tissues.
The Committee also saw the renewed commitment by many provinces to the principles of the Canada Health Act evident in the Social Union as supportive of efforts to monitor and measure outcomes in the area of transplantation. The national partnership on Coordinating Committee Reciprocal Billing chaired by HC provided one example of ways to ensure portability between provinces by establishing agreement on transplant costs. In addition, Health Canada could track inequities in access to medically necessary transplantation procedures and apply financial penalties for non-compliance with national principles or extra billing and user fees. For example, the Committee heard about limited access to procedures requiring reproductive tissues.
17. The Committee recommends that:
17.1 Health Canada examine the possibility of joint efforts with the provinces and territories to establish relevant projects through the Health Transition Fund; and,
17.2 Health Canada, working with the national body, monitor compliance with the Canada Health Act as it affects transplantation and if necessary, enable the establishment of a federal/provincial/territorial mechanism for resolving any concerns.
In the view of the Committee, action is needed immediately. It urges the federal, provincial and territorial governments to move quickly to address the urgent issues arising from inadequacies of donor numbers versus transplantation needs. The Committee recognizes that a fully operational national body cannot be established immediately. It heard from the National Coordinating Committee on Organ and Tissue Donation and Distribution (NCC) that, in its work for the F/P/T Advisory Committee on Health Services (ACHS), it is currently focussing on four key national concerns: accreditation standards, sharing algorithms, tracking system for allocation, and transplant access.
The Committee feels that, in the short period of transition to a permanent national oversight body, the NCC could act in an oversight advisory role to advance the needed work. With secretariat and other support from appropriate personnel at Health Canada, the NCC could ensure that the preparatory coordination work to assist the national body begins immediately. This new responsibility for the NCC is not intended to pre-empt, make redundant or negate their current work. Additionally, it is not the intention of the Committee to further burden members of the NCC who are volunteering their time and expertise.
18. Therefore, the Committee recommends that:
18.1 While pursuing sustained efforts to establish a national body, the federal Minister of Health immediately seek support from the National Coordinating Committee on Organ and Tissue Donation and Distribution and provide it with a small team of Health Canada personnel to initiate action.
18.2 The National Coordinating Committee on Organ and Tissue Donation and Distribution provide a progress report to the House of Commons Standing Committee on Health within six months.