Promising discoveries about the lifesaving attributes of umbilical cord blood (UCB) stem cells have led to the emergence of public and private cord blood banks throughout Canada. UCB cells are currently used in the treatment of a variety of malignant and non-malignant diseases and for research purposes. (1) There is also much talk of their potential use for the treatment of a broad range of degenerative, hereditary, post-traumatic and central nervous system related conditions. (2)
The primary purpose of public UCB banks is to create an inventory of UCB units for unrelated allogeneic hematopoietic stem cell transplants. The UCB is donated to the bank and the units are made available to suitably matched recipients regionally, nationally or internationally. In contrast, private banks allow parents to store their newborn's cord blood for autologous (use by donor) or familial use. Thus, for a fee, the UCB is stored as a form of 'insurance' in case the child or a matched family member should have a need for it in the future. In Canada, two public banks and at least nine private banks have been established to date. (3)
At present, the role that Canada should play in UCB banking remains unclear. Because Canada has a universally accessible healthcare system, public policy makers will soon be confronted with the difficult task of deliberating the merits and economics of establishing a national network of public cord blood banks, as well as deciding on the place of private banking of UCB for autologous use. A policy framework is necessary to guide this decision making.
On a regulatory level, the Canadian Standards Association has published standards which are applicable to UCB banking for transplantation: Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements, and Lymphohematopoietic Cells for Transplantation. (4) These national standards will be incorporated into Health Canada's new regulations regarding the safety of cells, tissues, and organs for transplantation which are currently being elaborated. (5) In the meantime, Health Canada has released a Directive and a Guidance Document to encourage adherence to basic safety standards. (6) The standards set by accreditation bodies also help to promote the safety of UCB banking practices, although the accreditation process remains voluntary and therefore cannot be relied upon to protect the public]
UCB banking in Canada is still in its early stages, and there are many regulatory and policy issues that have yet to be addressed. It is during this period of development that it is crucial to prospectively address the socio-ethical and legal issues surrounding cord blood banking. In this manner, an ethical framework can be elaborated to provide guidance to policy makers seeking to effectively regulate cord blood banking in Canada. This paper aims to provide a selective overview of some of the key socio-ethical and legal issues involved. Four main topics will be broached: 1) public awareness and perceptions relating to UCB banking, 2) the process of informed consent for the collection, donation, processing, storage, and future use of UCB, 3) issues related to ethnic diversity, and 4) the possibility of a national UCB program in Canada.
The discussion would be incomplete however, without a brief review of the ethics of private cord blood banking for autologous use. Policymakers cannot chart the future of UCB banking in Canada without taking into account the existence of private banks and their potential role in meeting future clinical needs, as well as their actual and potential contribution to research in this domain.
A number of organizations have taken the position that UCB banking for autologous use should be discouraged. (8) The Society of Obstetricians and Gynaecologists of Canada Clinical Practice Guidelines, for example, state that "[c]ollection and long-term storage of umbilical cord blood for autologous donation is not recommended because of the limited indications and lack of scientific evidence to support the practice. …