ARCHIVED - Government Response to the Report of the Standing Committee on Health, Organ and Tissue Donation and Transplantation: A Canadian Approach

Contact: Policy and Promotion Division

INFORMATION September 1999

Canada's organ and tissue donation rate is one of the lowest among western industrialized countries. Donation rates have levelled off at 14.5 donors per million at a time when the need for transplants has increased by 50 per cent. To address this issue the federal Minister of Health, the Honourable Allan Rock, requested that the Standing Committee on Health broadly consult and provide advice on 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.

The Standing Committee worked quickly while simultaneously hearing from a broad section of interested organizations, stakeholders and members of the public and from officials from Health Canada. Within two months the committee members and staff developed eighteen (18) recommendations in eight key areas, some of which pertain directly to the federal role and mandate in this area, while others will require consideration of provincial and territorial governments and key non-governmental organizations.

The government congratulates the Standing Committee members and staff for its outstanding work in identifying what is required to improve the state of organ and tissue donation and transplantation in Canada and thanks the Committee for its excellent recommendations. These recommendations describe a comprehensive and accountable solution that can only work with support from all levels of government. Therefore, the government accepts these recommendations as the framework for discussions with the provinces and territories towards the establishment of a sustainable solution for transplantation in Canada.

The recommendations made by the Standing Committee are in the following areas:

• a comprehensive transplantation network;
• donor intent and consent;
• public education and awareness;
• professional education;
• xenotransplantation;
• demand reduction;
• increased information tracking and reporting, and research.

Comprehensive Transplantation Network

Recommendations: A number of the recommendations (recommendations 1 to 6) call for a national coordinating and integrating body to provide oversight in organ and tissue donation and transplantation.

The Committee further recommends that the national network be organized into four program areas. These were described as: donor intent; potential and actual donor identification and management; sharing, matching and allocation of donated organs and tissues; and transplantation outcomes.

Government response: The federal government recognizes the importance of increasing organ and tissue donation rates in Canada. Efforts across the country throughout the 1990s have been fragmented, and rates in Canada are still the lowest among developed countries. While the Standing Committee made a set of recommendations which described the elements of a national network, it did not have the opportunity to fully explore the financial implications for such a proposal. Health Canada is committed to continue working in close collaboration with the provinces, territories and the many other stakeholders to explore in detail options for addressing the organ and transplant issue.

The federal/provincial/territorial Advisory Committee on Health Services (ACHS) of the Conference of Deputy Ministers has developed a National and Provincial Strategy on Organ and Tissue Donation to further the objective of developing an affordable, efficient and safe national system that ensures equitable access and distribution to transplantation. This 13-point strategy was approved by federal, provincial and territorial Ministers of Health in September 1997 and covers many of the elements included in the recommendations made by the Standing Committee.
The ACHS appointed a National Coordinating Committee on Organ and Tissue Donation and Transplantation - which consists of representation from the provinces, territories, the federal government and non-governmental associations - to examine the requirements for implementing this strategy.

Health Canada will continue to work collaboratively with the National Coordinating Committee in furthering the 13-point strategy. One of the key elements of that strategy relates to safety standards and Health Canada's work in this area is already well advanced. Safety standards are expected to be published for public consultation within the upcoming year.

Donor Intent and Consent

Recommendations: The Standing Committee recommends that community-based initiatives to highlight the involvement of families in the donation process be supported by the federal government and that donors and their families receive recognition for their contribution to saving the lives of others.

Government response: The federal government encourages initiatives at the community level and supports recognition of donors and their families. Sharing good news stories is an excellent vehicle for raising public awareness. Health Canada will continue to work with the provinces and territories, as well as with other non-governmental organizations across the country to raise not only awareness about the issue, but also understanding of the process that takes place should a loved one die. This is particularly important since, although Canadians indicate through public opinion polling their support for organ donation and individuals may have previously indicated to their families their wish to donate, more than 60% of families will not consent to the donation at the time of their loved one's death.

The use of awareness vehicles such as an annual insert in MP's householders, as recommended by the Standing Committee, is an excellent recommendation and will be pursued with the Speaker of the House of Commons. Similarly, the initiative for Governor General commemorative medals or plaques, as suggested by the Standing Committee will be further explored.

Public Education/Public Awareness

Recommendations: The federal government should coordinate the development of public education and awareness programs, including using the existing information dissemination mechanisms available through Health Canada. Canadians must also be assured that next-of-kin consent will be required regardless of the status of the potential donor's intent.

Government response: The government recognizes that public education, awareness and understanding is key to increasing the number of people who consider organ and tissue donation. Surveys conducted in Canada, the U.S. and Spain show that failure to approach the family of a potential donor in one of the main reasons for low procurement rates. The government also recognizes that more individuals need to consider declaring their intent to become an organ donor. Health Canada will work in partnership with the provinces, territories, communities, the voluntary sector and professionals to incorporate public education and awareness activities within existing initiatives. The goal of these activities will be to promote a better understanding of organ and tissue donation and transplantation, to encourage more individuals to sign donor intent cards and to discuss their intentions with their families.

Ongoing health promotion activities will be adapted or supplemented to provide multi-faceted methods of ensuring that the facts on donation and transplantation are readily available to the public and to healthcare professionals. In addition, the Aboriginal Health Institute for Information Dissemination, Human Resources Development and Healing Practices is another important vehicle for enhancing the focus on tissue and organ need among Aboriginal peoples.

The federal government supports initiatives aimed at recognizing donors and their families. In this regard, it also encourages Members of Parliament and Senators to seek opportunities to inform their constituents on the merits of organ and tissue donation and to encourage dialogue with families and friends. Special recognition of donors and their families could be instrumental in raising awareness in the community and through the media.

Professional Education

Recommendation: The Standing Committee recommends that professional performance and practice outcomes be monitored to assist in developing relevant professional education and training.

Government response: In addition to the work completed by the Standing Committee and its recommendations, surveys in the U.S. and Spain (both of whom have high donor rates) confirm that the low donor rates in Canada could in large part be due to the fact that health care professionals are not adequately trained to approach family members during periods of grief.

Health Canada recognizes the important role that health professionals play in the procurement and transplantation of organs and tissues. Working with professional health organizations and the F/P/T Advisory Committee on Health Human Resources, Health Canada will encourage the development of professional training, curriculum and standards for doctors, nurses and other health professionals in this area.

Xenotransplantation

Recommendations: All research or other activities in the area of xenotransplantation must be open and transparent to the public. As well, the Medical Research Council, and any other federal granting body, must ensure that its researchers adhere to established standards.

Government response: In order to ensure openness and transparency, the names of the investigators, the titles of the research and the amounts awarded for research grants are available from the Medical Research Council (MRC).

The MRC, along with the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC), published the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans in September 1998 It is the leading Canadian statement of policy in this area. The MRC and NSERC also founded the Canadian Council on Animal Care (CCAC) in 1968, and are its principal sources of funding. The CCAC sets the standards for all research involving animals. Funding from the MRC and the NSERC requires compliance with these policies.

Health Canada is committed to continuing working in a transparent manner and will consult stakeholders and the Canadian public on this sensitive issue.

Reducing the Need for Organ and Tissue Transplantation

Recommendations: The Standing Committee believes that more focus on the prevention of disease conditions contributing to organ failure and tissue needs is essential and recommends that: Health Canada take a lead role in identifying key areas where prevention and early detection would reduce the demand for organs or tissues; and that Health Canada establish a specific program to promote work in this area.

Government response: In response to the February 1999 federal budget, Health Canada is presently developing a Canadian Diabetes Strategy which will have three main components: the broadly-based Canadian Diabetes Initiative (CDI); the Aboriginal Diabetes Initiative (ADI); and the National Diabetes Surveillance System (NDSS), which will support both the CDI and ADI. The high rate of diabetes within the Aboriginal population has, in turn, led to the probability of increased renal transplantation.

In addition to care and treatment, surveillance, national coordination and lifestyle supports, the Canadian Diabetes Strategy will include a major element of prevention and education. Activities will be aimed at educating the public about diabetes and its complications, preventing and/or delaying the onset of Type 2 diabetes, preventing complications resulting from diabetes and improving the quality of life for those with diabetes.

For First Nations and Inuit people, it is critical that prevention and education programs be culturally appropriate and holistic in nature. Health Canada has a unique responsibility with respect to the delivery of care and treatment services for First Nations on-reserve and in Inuit communities. The Medical Services Branch at Health Canada is working in partnership with Aboriginal representative organizations, health care providers, regional staff and communities to ensure that prevention and education programs and activities will be culturally appropriate, and that they will meet the diverse needs of the communities.

By carrying out these education and prevention activities, and by improving the care and treatment for First Nations on-reserve and in Inuit communities, the Diabetes Strategy is expecting to be able to reduce the prevalence of Type 2 diabetes, and delay the onset of diabetes-related complications. These complications include end-stage renal disease. Once end-stage renal disease occurs, the kidneys are no longer functioning, and the only solutions are dialysis or kidney transplant. An effective Canadian Diabetes Strategy should reduce the incidence of end- stage renal disease among people with diabetes, and so reduce the need for kidney transplants.

In addition to the Canadian Diabetes Strategy, Health Canada has initiated other disease prevention and health promotion activities which may result in less demand for organ transplantation.

With respect to Hepatitis C, the second most common reason for liver transplantation, Health Minister Allan Rock announced a comprehensive proposal in September 1998 to provide better prevention and treatment for those afflicted with this disease. This initiative includes community based support programs and research. In addition, the Health Protection Branch has sponsored two national conferences and has issued guidelines on the prevention and control of Hepatitis C.

Health Canada supports the Heart Health Initiative, a multi-level strategy for the prevention of cardiovascular disease. This initiative has been instrumental in creating extensive networks and coalitions involving the provincial departments of health, the Heart and Stroke Foundation of Canada, as well as over 1,000 other public, private and voluntary organizations.

Smoking is a cause of chronic obstructive pulmonary disease, which can result in the need for lung transplantation. The Office of Tobacco Reduction Programs, Health Promotion and Programs Branch, is the focal point in Health Canada for activity including public education initiatives aimed at reducing tobacco use and smoking prevalence. In support of this work, the Minister of Health announced in May 1999 the creation of an Expert Committee on Nicotine and Tobacco Science, which will provide guidance and advice to Health Canada in developing strategies to reduce tobacco consumption and its accompanying adverse health effects.

Information Tracking and Reporting

Recommendation: the Standing Committee recommends that a tracking system be established, including a national database to track transplantation outcomes, utilizing the expertise existing in the Canadian Institute for Health Information (CIHI). In addition the Standing Committee recommends that a national database be established using the expertise of the Canadian Organ Replacement Register within the CIHI.

Government response: Health Canada will continue to work with its many partners, including the provinces and territories, to improve information collection, distribution and reporting. The potential for establishing a national database will form a component of multi-partner discussions around the effective utilization of scarce resources at all levels of government. It is anticipated that the assignment of priorities such as a database will be an integral part of on-going discussions as Canada works towards a coordinated approach to organ and tissue donation and transplantation.

Research

Recommendation: Additional federal funding should be provided for transplantation research. Such research should be broadened to cover a fuller range of health issues, including the biomedical concerns, social issues, prevention and practice outcomes.

Government response: Health research generates new knowledge of disease processes and helps clarify the factors that affect the health of people and communities. It also leads to the discovery of new cures, medical technologies and procedures and helps us tailor the health care system to the needs of all Canadians.

The evolution of the existing Medical Research Council to the Canadian Institutes of Health Research (CIHR), announced in the February 1999 federal Budget will open new opportunities for research that meets the standards of peer review in all areas of health, including transplantation research. Increased funding of $550 million was announced in the 1999 Budget to transform and integrate health research in Canada

The CIHR's mandate is in all areas of health research, including the biomedical, social, prevention and practice outcomes. Linking health research and the power of information technology to the health of Canadians is also central to the vision of the CIHR.

Within the overall plans for integrating health research in Canada, the Canadian Institute for Health Information will lead a pan-Canadian, integrated effort to improve data-gathering and information exchange.