Public Meets Private: Challenges for Informed Consent and Umbilical Cord Blood Banking in Canada 1

Transcription

1 Public Meets Private: Challenges for Informed Consent and Umbilical Cord Blood Banking in Canada 1 Lorraine Sheremeta This paper is a substantially modified version of a poster presented at the DNA Sampling Conference in Montreal, Quebec, June 4-7, 2006: Lorraine Sheremeta & Suzanne DeBow, Public Meets Private: Challenges for Informed Consent and Umbilical Cord Blood Banking in Canada DNA Sampling Conference, Montreal PQ, June 4-7, 2006 (poster presentation). Background As reported previously, the potential utility of umbilical cord blood [UCB] as a source of stem cells for use in the treatment of disease has led to the emergence of several public and private cord blood banks across Canada. 2 In a preliminary discussion paper, the process of informed consent for the donation, collection, processing, storage and future use of UCB was identified as a key area of concern. 3 In the context of private, for-profit UCB banking, the issues are particularly vexing. 4 Informed consent was the focus at a first multi-stakeholder workshop on umbilical cord blood hosted by the Centre de recherché en droit public at the University of Montreal in August 2005 and discussed in greater detail at a second multi-stakeholder workshop hosted by the Health Law Institute at the University of Alberta in Edmonton in June The purpose of this short paper is to identify the key similarities and differences between private and public UCB banks and to further elaborate on the informed consent and contractual challenges that arise in light of these similarities and differences. In Canada and in other countries, there is a discernable trend towards the collection and storage of UCB for use as a medical treatment of a variety of malignant and non-malignant diseases including leukemia, serious blood disorders, and immune and genetic disorders. 5 Parents may opt to store UCB in a private bank for potential future use by family members or they may opt to store UCB in a public bank where the UCB is made available to anyone who may need it for medical treatment. At present, more than a dozen cord blood banks exist in Canada (see Table 1), most in the Toronto area. The rapid emergence of private banks in Canada parallels their emergence in the United States and elsewhere. 6 Several general concerns have been raised about UCB banks including: the lack of adequate regulatory oversight of UCB banks (both public and private) in Canada; 8 the overly optimistic nature of information provided to parents about the benefits of UCB banking, Health Law Review 15:2 (2006) 23

2 Table 1: Inventory of Cord Blood Banks in Canada 7 Private UCB Banks in Canada Baby Chord WEBSITE: LOCATION: Mississauga, ON Canadian Cord Blood Registry WEBSITE: LOCATION: Edmonton, AB AFFILIATION: Alberta Cord Blood Bank Public UCB Banks in Canada Alberta Cord Blood Bank WEBSITE: LOCATION: Edmonton, AB AFFILIATION: Canadian Cord Blood Registry Hema Quebec WEBSITE: LOCATION: Montreal, PQ Cells for Life WEBSITE: LOCATION: Markham, ON. AFFILIATION: Victoria Angel Registry of Hope is the philanthropic arm of Cells for Life Cord Blood Bank of Canada WEBSITE: LOCATION: Markham, ON CReATe Cord Blood WEBSITE: LOCATION: Toronto, ON Healthchord Cryogenics WEBSITE: LOCATION: Vancouver, BC Hema Stem Therapeutics WEBSITE: LOCATION: Hamilton, ON Insception Biosciences WEBSITE: LOCATION: Mississauga, ON Lifebank WEBSITE: LOCATION: Burnaby, BC. Progenics WEBSITE: LOCATION: Toronto, ON Stem Sciences Inc. WEBSITE: LOCATION: Toronto, ON 24 Health Law Review 15:2 (2006)

3 transplantation, and cellular therapy for the treatment of a vast array of diseases in the absence of sufficient scientific evidence to support the practice; 9 and the rapid proliferation of private banks and the increasing potential that private cord blood banks could go bankrupt. 10 Specific questions have been raised about informed consent and the collection, storage and use of UCB; these include, among others: What is the appropriate timing of informed consent in relation to labour and delivery? Who can or must provide informed consent to store UCB for future use? What information must be conveyed to the parents at the time of UCB storage? How should hypothetical potential future uses of UCB be communicated to potential donors? How can research access to non-therapeutic UCB units be facilitated? How should the informed consent process reflect this potential? Who can or must provide informed consent for the use of UCB? What information must be conveyed to the recipient at the time of transplant? Is re-consent to store the sample needed from the child once the child becomes a mature minor or reaches the age of majority? Public & Private UCB Banking Distinguished The distinction between public and private UCB banking is an important one given that there are significant differences in the nature of the legal relationship between the parties (see Table 2). Private banks enter into contractual arrangements with customers for specific testing and long-term storage of UCB in exchange for monetary consideration. On this model, the bank functions as a bailee of the UCB, performing specific services and holding the sample under specified conditions until such time as the infant or other genetically related and appropriately matched family member requires it. 11 Conversely, public UCB banking depends on the altruistic donation of UCB samples to a public resource. The collection repository may be envisaged as a public good, much like existing blood banks. No contract is entered between Table 2: Similarities and Differences Between Private and Public Cord Blood Banks Commonalities: Whether UCB is to be stored in a public bank or a private bank, the following features are common: Collection of UCB Testing & Typing Storage Use Standards 13 UCB samples are collected from the umbilical cord at the time of birth (either pre or post placental delivery). Samples are HLA-typed and screened for infectious agents including cytomegalovirus, Epstein-Barr virus, HIV and hepatitis. Samples are cryopreserved and stored for a period of time (months to several (15+) years). Informed consent to store UCB should be obtained prior to delivery. Use is determined by medical need/appropriate matching of patient and UCB sample. The vast majority of stored UCB samples will never be used for medical treatment. In Canada, the public health system covers cost of medically necessary UCB treatment for all transplant recipients regardless of whether samples stored in private or public banks. Informed consent to UCB treatment is required prior to treatment. Z Cells Tissues and Organs for Transplantation and Assisted Reproduction: General Requirements (January 2003) Z Lymphohematopoietic Cells for Transplantation (February 2003). Health Law Review 15:2 (2006) 25

4 Distinguishing Features Collection Legal Basis for Relationship Character of Legal Obligation Payment* Ownership Private Bank Samples are often collected because of specific concerns about hereditary disorders that may require UCB or bone marrow transplant in the future. Samples, otherwise discarded, may be a valuable medical treatment for a family member. Contract/Bailment Bailment refers to the transfer of possession of UBC by the bailor to another person (the bailee ) for some temporary purpose (e.g. testing and storage) after which the property is either returned to the bailor or disposed of in accordance with the contract. 14 Contractual: Subject to potential obligation of good faith depending on contractual terms and circumstances. Money paid for provision of testing and storage services relating to the UCB sample. Fee for initial collection and testing, plus annual storage fees. Uncertain: Presumed to be determined by contractual terms; parents and offspring have ongoing interest in UCB by virtue of their genetic relation to it. There is legal uncertainty as to whether (or in what circumstances) this ongoing interest can (or should) be avoidable by contract. It is possible that a court may determine contractual terms, attempting to limit donor interests to be void as against public policy. 16 UCB is not a typical chattel. Public Bank As with standard blood donation, UCB samples are often donated to UCB banks for altruistic reasons. Samples, that are otherwise discarded, may be a valuable medical treatment for someone (including unrelated persons). Trust/Fiduciary A fiduciary relationship has three features: (1) the fiduciary has scope for the exercise of some discretion or power; (2) the fiduciary can exercise power or discretion that can influence legal or practical interests of the beneficiary; and (3) the beneficiary is in a position of relative vulnerability. 15 Equitable: A fiduciary s obligation is one of utmost good faith. Trustee, as fiduciary, has duty to act in best interest of beneficiaries. Sample is donated to bank; there is no charge for testing, storage or transfer of sample to treatment facility. Divided: Legal/beneficial. Samples are held by trustee (who has legal ownership) for the benefit of the public at large. Though the legal ownership of samples may transfer, beneficial ownership does not. Trustee has a strict duty to act in the best interest of all potential beneficiaries. Control Determined by contractual terms. Trustee manages and acts as custodian of the sample repository. Use Winding-up/ Insolvency Only specified blood relatives may access the sample. Access to sample is determined by bailee in combination with treating physician. Problematic if not specifically contemplated in contract. Samples may be transferred to another legal entity or person with no obligation to hold samples. UCB samples could be viewed simply as assets of the firm and transferred or sold to a third party. Physician of any patient who is a match may request access to sample for clinical use. Trustee provides access to UCB in response to physician request demonstrating clinical need and appropriate biological match. It is envisioned that samples would transfer to an alternate trustee that would be legally obliged to hold them for the beneficiaries. * Note that both private and public UCB banks will often facilitate the collection and storage of UCB samples for directed donation without charge or at a substantially reduced rate for families if there is evidence of a strong medical need. 26 Health Law Review 15:2 (2006)

5 the donor and the public bank; no money changes hands. Parents may opt to store their infant s UCB in a public bank and samples may be accessed by physicians to treat any appropriately matched person who needs it. Donors must sign an informed consent form, provide a medical history and agree to have the sample tested for infectious disease and various markers for matching purposes. The value of the bank to society depends on the number of samples stored and the odds that an individual requiring haematologic stem cells for transplantation will be appropriately matched with a stored sample. 12 Under this model, UCB is stored by the bank, as trustee, for the benefit of all potential beneficiaries. Contracts & Informed Consent As part of this project, we reviewed information and forms provided by UCB banks to potential donors either mailed to us as hard copy documents or obtained independently through the respective websites. In general information provided to donors or paying customers by public and private UCB banks in Canada is thorough and presented in a professional and responsible manner. 17 Particular problem areas have, however, been identified. Private UCB banks post contracts, informed consent documents and a variety of other forms on their websites. For example, CReATe Cord Blood Bank posts two key documents on its website which include the Personal information, shipping and billing information, medical health history, partnership agreement and consent form and medical questionnaire and a Confidential medical history and risk assessment questionnaire. 18 In its contract for services CReATe includes the following provision in the fees section: [I]f we have not provided the payment in full of The Bank s invoice for the child s Stem Cells within 90 days of the anniversary date of their cryopreservation, The Bank shall be entitled to donate the child s Stem Cells for use in research projects or public banking or to dispose of them, as The Bank shall decide in its sole discretion and in accordance with any governing legislation at the material time. 19 To parents, particularly those storing a UCB sample because of concerns about a genetic predisposition, should be concerned about the implications of this provision and other similar contractual provisions. While it is recognized that private banks are in the business of service provision and should not be expected to provide ongoing services without payment, the reality is that people make mistakes and family situations change. One could envision a situation where a family unit is broken because of divorce. The parents each mistakenly think that the other is responsible for payment of the UCB banking fee, neither pays, and the agreement lapses. A significant question remains as to whether the bank, as bailee, can (or ought to be able to) transfer, dispose or destroy UCB samples in accordance with contractual terms. It is the position of this author that inclusion of a provision that permits disposal or destruction raises the spectre of unconscionability. 20 If litigation were to arise between the bank and a customer following the destruction or transfer of a UCB sample, this provision would almost certainly attract the interest and attention of the court. Given that the subject matter of the agreement is unique, non-renewable and may be the only or best treatment for a hereditary illness that may be fatal or life-threatening to a child or an adult, there is a good argument for declaring such a provision unconscionable and severable from the agreement. Given that there are less drastic measures that could be considered by the bank for example, the transfer of the sample to a public bank either as a directed or undirected donation 21 - private banks should consider striking all contractual provisions of this nature from existing contracts and/or informed consent documents. Importantly, the consideration of unconscionability in this context should be separated from the discussion over stored embryos given the direct clinical utility of UCB. Conclusions Informed consent is a concept that does not rest easy with contractual relations characteristic of private UCB banking practices. In the context of private UCB banking, the service contract itself is a critical document reflective of the agreement between the parties. It comprises part of the information that parents must consider when deciding whether or not to bank their child s cord blood. Accordingly, any consideration of informed consent in the context of private banking practices must contemplate this agreement. Contracts are legally enforceable if the parties are competent, the subject matter is identifiable, legal consideration is exchanged, and there is mutuality of agreement and obligation. A contractual/bailment relationship is appropriate Health Law Review 15:2 (2006) 27

6 vis-à-vis parents and cord blood banks where the bank s function is simply to store the blood in exchange for a fee. The nature of the bailed material, however, makes the inclusion of certain contractual terms (including the right to transfer or discard cord blood if the storage fee is not received) potentially unconscionable. This potential deserves further legal scrutiny. Relationships between trustees/beneficiaries and doctors/ patients are equitable in nature and are founded on principles of utmost trust and good faith. The trust construct that underlies the public/fiduciary model of UCB banking should be considered by private UCB banks as an ethically defensible business model that would support the interests of those individuals who opt to store their UCB in a private facility. 22 The main benefit of using the legal trust would be to protect the repository of UCB samples from falling into the general asset pool in the event that the bank goes bankrupt. For purposes of informed consent, a clear distinction must be made between collection, testing and storage of a UCB sample as contrasted to its use as a therapeutic treatment. UCB banks, whether private or public, have an obligation to provide general information about the types of diseases that UCB may be used to treat, but informed consent to medical treatment using UCB is the obligation of the treating physician. It is also relevant to the discussion of informed consent to recognize that UCB treatment remains innovative and that some uses remain experimental. 23 Clarity on this issue is needed as certain obligations of the treating physician, including obligations concerning informed consent, may well rest on this distinction. Lorraine Sheremeta, Research Associate, Health Law Institute, University of Alberta, Edmonton, Alberta. 1. This research is funded by the Stem Cell Network Catalyst project entitled The Future of Cord Blood Banking in Canada, the aim of which is to examine ethical legal and social issues [ELSI] surrounding UCB banking and to develop an ethical framework to guide policy makers in mapping out an ideal future for cord blood banking in Canada. I would like to thank Suzanne DeBow for her excellent research assistance on this project and Bartha Maria Knoppers and Timothy Caulfield for their insightful comments on various versions of this work. 2. Lorraine Sheremeta, Margo Plant & Bartha Maria Knoppers, The Future of Cord Blood Banking in Canada (2006) 14:3 Health L. Rev Madelaine Saginur, Linda Kharaboyan & Bartha Maria Knoppers, Umbilical Cord Blood Stem Cells: Issues with Private and Public Banks (2004) 12 Health L. J Catherine Waldby, Umbilical Cord Blood: From Social Gift to Venture Capital (2006) 1 Biosocieties 55; Joanne Kurtzberg, Anne Drapkin Lyerly & Jeremy Sugarman, Untying the Gordian Knot: Policies, Practices, and Ethical Issues Related to Banking of Umbilical Cord Blood (2005) 115 Journal of Clinical Investigation 2592 [Kurtzberg]; Nicholas M. Fisk et al., Can Routine Commercial Cord Blood Banking be Scientifically and Ethically Justified? (2005) 2:2 PLoS Medicine e Karen Ballen, New Trends in Umbilical Cord Blood Transplantation (2005) 105 Blood 3786 [Ballen]; B. Anthony Armson, Umbilical Cord Blood Banking: Implications for Perinatal Care Providers (2005) 27:3 Journal of Obstetrics and Gynaecology Canada 263 [Armson]. 6. Ballen, ibid. 7. See A Parent s Guide to Cord Blood Banks, online: ParentsGuideCordBlood < 8. For general information about UCB regulation in Canada, see Canada, Health Canada, Cells Tissues and Organs for Transplantation and Assisted Human Reproduction, online: Health Canada < cell/index_e.html>. See also Canada, Health Canada, Proposal to Publish Safety of Human Cells, Tissues and Organs for Transplantation Regulations, online: Health Canada < alt_formats/hpfb-dgpsa/pdf/brgtherap/ cto_rias-reir_reg_e.pdf> [Draft Regulations] (This document includes the Regulatory Impact Statement and Draft Regulations entitled Safety of Human Cells, Tissues and Organs for Transplantation Regulations. Importantly, these draft regulations are applicable only to allogeneic transplantation and not to autologous UCB transplants. As a result, public UCB banks will continue to be largely unregulated in Canada. A second phase of regulation is expected to close this regulatory loophole). 9. Armson, supra note 5. See also, Shane Smith, William Neaves & Steven Teitelbaum, Adult Stem Cell Treatments for Diseases? (2006) 313 Science 439; 28 Health Law Review 15:2 (2006)

7 David A. Prentice & Gene Tarne, Treating Diseases with Adult Stem Cells (2007) 315 Science The main concern here is that samples held by a bank that files for bankruptcy could potentially be sold off as assets of the firm without the donors knowledge. Public banks face different financial challenges mainly because revenues gained from the sale of UCB units for transplant are insufficient to support the basic operations of a bank especially those that are in the process of building sample inventories. See for example Kurtzberg, supra note 4 at See for example Courtney Witte, Cord Blood Storage: Property and Liability Issues (2005) 26 J. Legal Med Importantly, stem cells from UCB or from bone marrow may both provide an appropriate treatment for a particular individual; one or the other may be preferable in certain cases. 13. Draft Regulations, supra note See York v. Jones, 717 F. Suppl. 421 (E.D. Va.1989); Chauhan v. Dana Farber Cancer Institute Inc., Feb 28, 2001, No A, WL See Frame v. Smith, [1987] 2 S.C.R. 99, [1987] S.C.J. No See generally S.M. Waddams, Unconscionable Contracts: Competing Perspectives (1999) 62:1 Sask. L. Rev Comprehensive results of this review will be published at a later date by the full research team. 18. See CReATe Cord Blood Bank website, online: CRe- ATe < register_forms.asp.>. 19. CReaATe, Consent and Agreement for the Collection and Storage of Umbilical Cord Blood, online: CReATe < create_2forms.pdf> at Supra note Many banks, both public and private offer free, directed storage of UCB samples where there is a perceived medical justification for such storage. It is important to note that the transfer of samples and relevant medical history and testing results from one bank to another would be subject to provincial and federal legislation governing health information and/or personal information. See for example Personal Information Protection and Electronic Documents Act, S.C. 2000, c. 5; Health Information Act, R.S.A. 2000, c. H David E. Winickoff & Larissa B. Neumann, Towards a Social Contract for Genomics: Property and the Public in the Biotrust Model (2005) 1:3 Genomics, Society & Policy 8; David E. Winickoff & Richard N. Winickoff, The Charitable Trust as a Model for Genomic Biobanks (2003) 349 The New England Journal of Medicine But see Andrea Boggio, Charitable Trusts and Human Research Genetic Databases: The Way Forward? (2005) 1:2 Genomics, Society and Policy See for example J. Leor et al., Human Umbilical Cord Blood Cells: A New Alternative for Myocardial Repair? (2005) 7:3 Cytotherapy 251; J.D. Newcomb et al., Timing of Cord Blood Treatment After Experimental Stroke Determines Therapeutic Efficacy (2006) 15:3 Cell Transplantation 213; P.R. Sanberg et al., Umbilical Cord Blood-Derived Stem Cells and Brain Repair (2005) 1049 Annals of the New York Academies of Sciences 67. Health Law Review 15:2 (2006) 29