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ORGAN AND TISSUE DONATION AND TRANSPLANTATION MINORITY REPORT TO THE HOUSE OF COMMONS STANDING COMMITTEE ON HEALTH NEW DEMOCRATIC PARTY

Judy Wasylycia-Leis, M.P. - Winnipeg North Centre

It is well established that the organ donation situation in Canada is serious with our organ donor rate among the lowest in the western world. Currently there are more than 3 000 Canadians waiting for solid organ transplants, yet less than half of these will get the organ they need before year's end. Lives are being lost and the costs related to waiting are high. The absence of a national program and the lack of federal regulations are at the heart of the problem. The failure of the Health Committee to advance a clear national donor strategy and to come down clearly on the side of safety is the reason for this minority report.

Scientific activity in the field of transplantation has outstripped our ability to account for its safety. Restoring that balance to enable further progress within a safe health environment is a key purpose of our present endeavour. The committee was charged to consider 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 to increase awareness regarding organ and tissue donation, procurement and transplantation.

In this task, the Committee benefited from a broad-based selection of witnesses who shared insights and expertise gleaned from the early stages of tissue and organ experimentation through to the present day. I would like to acknowledge that contribution whether made by the scientists at the cutting edge of current research, by those working in the health delivery system, or by those who came before us with personal experiences.

It is clear from Committee testimony that Canadians have been active within all aspects of tissue and organ transplantation. It is also clear that there is an urgent need to bring these diverse activities together by way of a coordinated national organ donor system within the regulatory framework of Health Canada where they belong. Canadians clearly want action, bold steps and decisive leadership, not another report added to the pile of studies already done on this critical health care matter. The NDP, therefore, calls on the federal government to immediately coordinate a national organ donor strategy in partnership with the provinces, and makes the following recommendations:

1. National Registry of Organ Donors

The need to increase the organ donation rate in Canada is an urgent priority. It won't happen by focussing only on increased public education and improved hospital systems. It requires innovative and pro-active approaches starting with a national registry of organ donors to increase the pool of potential donors and a clear, simple mechanism for expressing wishes. It is important to give Canadians the opportunity to say: (i) yes, I want to donate, (ii) no, or (iii) undecided at this time. This combined with a donor registry available 24 hours a day and providing real-time information is a reasonable way to try to increase the supply of organs.

2. Federal Leadership and Funding

One of the most promising ways of increasing donations is through dedicated asking staff and fully functional donor teams at the hospital level. They have to be trained to know the criteria for organ donation, to speak with families of potential donors, to answer questions knowledgeably, and to be the contact for the national donor registry. The need for this approach as well as for national public awareness and education campaigns is well documented. Provincial governments have shown interest in advancing such an agenda. The missing ingredient is a demonstrated will to act and a serious financial commitment on the part of the federal government. Clearly, the onus is on the federal government to establish incentives for a coordinated donor system, to further restore health care transfer payments so that no candidate for transplantation is denied an organ because of bed closures or nurse shortages, and to increase the emphasis on health promotion and primary prevention thereby reducing illness and demand for organs.

3. Health protection, not risk management

The single most glaring omission in the Committee's report is an emphasis on safety. The best it can do is call for a standards-based approach and a passive regulatory model. It takes no exception to the risk-management framework for organs and tissues being advanced by Health Canada and completely ignores the lessons learned from Canada's blood tragedy. Organs and tissues are no different than blood. To reject a highly regulated model is contrary to the precautionary principle and puts a price tag on human safety. Similarly, the pursuit of xenotransplantation in the absence of any regulatory framework raises serious safety and ethical questions. A national donor system must ensure that safety is paramount and include the following:

• Active, not passive, regulation of organs and tissues, including frequent inspections, strict enforcement of all regulatory requirements, and a built-in capacity for active health hazard intervention.
• Rejection of any notion that there is a need for indemnification from liability as has been proposed by Health Canada.
• Enforcement of Canadian regulations pursuant to any importation of organs as well as controls on the export of tissues for processing.
• Establishment of a comprehensive inventory of xenotransplantation research and conducting of an inquiry into the importation and propagation of transgenic pigs into Canada for use as tissue and organ sources for xenotransplantation.
• Immediate convening of a national dialogue on xenotransplantation research, as well as the breeding of any transgenic animals for this purpose.
• Development, in consultation with the public, of stringent guidelines for preclinical and clinical xenotransplantation research.
• Conducting of a full, independent public investigation into the Health Protection Branch in order to ensure the critical role of health protection is restored and the safety of organs and tissues is paramount.

4. Equality of access and public accountability

The issues of accessibility and accountability have to be made central to any organ donor strategy. Borrowing from Justice Krevor and his report on Canada's blood system, it is recommended that a national stategy be governed by several basic principles: organs and tissues are a public resource; there is no role for the market, no room for profit in an organ donor system; Canadians should have free and universal access to organs and tissues; and decision making should be open and transparent. Flowing from these principles are the following recommendations:

• All aspects of organ and tissue donation and transplantation be kept within the public, non-profit domain.
• National standards for outcomes of transplant programs, allocation of available organs, and sharing of organs between provinces and programs be established.
• Complete rejection of a two-tier system as has been allowed to develop in other aspects of the health care system, most notably in the areas of cataract surgery and hip and knee replacement.
• Public participation in all advancements pertaining to transplantation and biotechnology in order to balance ethical, medical and safety issues.

The opportunity exists to make Canada a world leader in organ donation and transplantation. Immediate action on a national strategy grounded in the principle of safety will make that happen.