LIST OF RECOMMENDATIONS

1. In light of the repeated calls for a national coordinating and integrating body to provide oversight in this emergent healthcare area, the Committee recommends that:

1.1 The federal/provincial/territorial ministers of health establish the Canadian Transplant Network to oversee organ and tissue donation and transplantation;

1.2 The federal Minister of Health ensure that the establishment of such an organization and accompanying strategy be discussed formally with provincial and territorial counterparts within the next six months;

1.3 This organization have a permanent secretariat and an appropriate budget;

1.4 This organization provide annual public reports through the F/P/T Conference of Ministers of Health; and,

1.5 This organization provide annual reports through the federal Minister of Health to Parliament on results accrued from federal contributions and such reports be considered in connection with National Organ Donor Week.

ORGANIZATION OF CANADIAN TRANSPLANT NETWORK

2. The Committee therefore recommends that:

2.1 The Canadian Transplant Network be composed of four permanent program areas using expert advisory groups to address respective areas: individual donor intent; potential and actual donor identification and management; sharing, matching and allocation of donated organs and tissues; and transplantation outcomes;

2.2 The expert advisory groups be composed of members drawn from existing organizations involved in organ and tissue activities and rotated on a regular basis;

2.3 The expert advisory groups be responsible for providing direction to the Canadian Transplant Network on the establishment of goals and the measuring of outcomes; and,

2.4 These goals and outcomes be included in the annual report produced by the Canadian Transplant Network on each specific program area.

EXPERT ADVISORY GROUP FOR DONOR INTENT AND CONSENT

3. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of individual intention to donate undertake the following general activities:

3.1 Monitor the progress and effectiveness of existing provincial intended donor registries with a view to determining any future national role;

3.2 Assist in the design and implementation of ongoing national public awareness and education campaigns with required evaluation; and,

3.3 Assist in the design and implementation of ongoing national professional education and training campaigns with required evaluation.

EXPERT ADVISORY GROUP ON DONOR IDENTIFICATION, MANAGEMENT AND PROCUREMENT

4. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of potential donor identification, management and eventual procurement from actual donors undertake the following activities:

4.1 Facilitate the establishment of national databases on potential and actual donors utilizing the expertise of the Canadian Organ Replacement Register within the Canadian Institute for Health Information and relevant provincial organizations;

4.2 Assist in public and professional education initiatives, including recognition and support of donor families and professional training on approaches to families of potential donors;

4.3 Encourage the development of systems to monitor hospital processes and to initiate measures including appropriate incentives such as reimbursement for positive action;

4.4 Work with the F/P/T Conference of Ministers of Justice to evaluate mandatory request and reporting provisions under provincial Human Tissue Gift Acts;

4.5 Monitor the standards development, implementation and revision process and ensure the effectiveness of regulatory standards for organ and tissue procurement, storage, and testing; and,

4.6 Monitor standards and quality control mechanisms for laboratories.

EXPERT ADVISORY GROUP ON WAITING, SHARING AND ALLOCATION

5. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of waiting, sharing, matching and allocation undertake the following activities:

5.1 Facilitate the establishment of a national real-time waiting list for all solid organs such as heart, etc.;

5.2 Assist in public awareness and professional education and training initiatives;

5.3 Monitor the development of sharing algorithms for allocation and any mechanism for enforcement of sharing; and,

5.4 Provide a tracking system for information and encourage policy development on the import and export of organs and tissues.

EXPERT ADVISORY GROUP ON TRANSPLANTATION OUTCOMES

6. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of transplantation outcomes undertake the following activities:

6.1 Facilitate the establishment of a national database to track transplantation outcomes utilizing the expertise of the Canadian Organ Replacement Register within the Canadian Institute for Health Information;

6.2 Coordinate the development of public education and awareness programs employing recipients;

6.3 Monitor professional performance and practice outcomes and assist in the development of related professional education and training; and,

6.4 Establish a monitoring mechanism to assess whether the Canada Health Act principles apply and are enforced in the area of transplantation of tissues and organs.

CHILDREN

7. The Committee understands the unique requirements of the pediatric transplant recipients and recommends that the new national body oversee that:

7.1 The real-time waiting lists for solid organs include a distinction of all pediatric cases;

7.2 All sharing rules established for heart and lungs take into account the pediatric requirements; and,

7.3 The Canadian Organ Replacement Register include in its data collection a distinction of all pediatric figures.

FAMILIES OF DONORS

8. To assist in the process of educating and involving families, the Committee recommends that:

8.1 The Speaker of the House of Commons consider working with Members to develop an awareness insert for annual inclusion in the "householder" developed by each Member of Parliament at a time close to National Organ Donor Week.

9. The Committee agrees that the involvement of families in the donation process is essential and recommends that the new national body oversee that:

9.1 Any national public awareness campaign on donation provide reassurance that consent of next-of-kin will be acquired regardless of the patient's intent status.

10. The Committee agrees that the donors deserve recognition through their families and recommends that:

10.1 The Governor General of Canada consider offering commemorative medals or plaques in a ceremony to all donor families.

BRAIN DEATH

11. The Committee wants to ensure that the brain death criteria are applied consistently and recommends that the new national body, through its provincial and territorial members, encourage:

11.1 Hospitals where donation takes place to develop clear protocols for determination of brain death, ensure professional and institutional accountability for each instance of a diagnosis, and provide thorough and periodic training for all healthcare professionals on the concept of and criteria for brain death.

STANDARDS

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.

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.

INFORMATION DISSEMINATION

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.

PREVENTION

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.

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.

HEALTH SYSTEM SUPPORT

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.

TRANSITION

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.