The law and problematic marketing by private umbilical cord blood banks

Abstract

Background: Private umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada. Main body: Because the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada's regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are "false or misleading in a material respect." A representation is materially false or misleading when it could "influence a consumer's behavior or purchasing decisions," and consumers are likely to be considered to be "credulous and inexperienced" for the purposes of assessing an advertisement's general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary obligations that further prohibit misleading marketing. Conclusions: Private cord blood bank marketing that advertises hypothetical future treatments can be misleading and may influence consumer behaviour. This marketing may breach existing advertising law. Regulatory bodies should enforce the law in order to help prevent public health and personal financial harm.

Peddling promise? An analysis of private umbilical cord blood banking company websites in Canada

“…Because the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada’s regulatory scope, which is generally limited to health products and devices. Yet, as we have argued in a separate legal analysis, claims about speculative future treatments that are misleading in a way that can influence a consumer’s behaviour or purchasing decisions are illegal in Canada under the Competition Act (Murdoch et al 2020 ). Moreover, the legal standard by which the general impression of an advertisement is judged likely assumes that consumers are “credulous and inexperienced” (Richard v. Time Inc., access 2020 ).…”

“…This includes analyzing the online marketing of the private cord blood banks as these companies’ practices may elude regulatory oversight, particularly with regards to misleading the public around the probability of usefulness and the practical benefits of private cord blood banking. Indeed, these companies require accreditation to operate in Canada, and it is their responsibility to adhere to government mandated truth-in-advertising standards (Murdoch et al 2020 ).…”

Fresh Umbilical Cord Blood—A Source of Multipotent Stem Cells, Collection, Banking, Cryopreservation, and Ethical Concerns

“…Private banks are profit organizations that provide services to store UCBs for individual use. These organizations incur storage fees but do not guarantee that the UCB from a person is useful to treat a specific disease condition of the same person (autologous UCB transfusion) or a family member [ 98 ]. The fundamental goal of private banks is to retain the high-quality UCB units used to transplant hematopoietic stem cells as regenerative medicine.…”

“…Personal engaged storage is not permitted in public UCB banks. The UCB in public banks is available for all patients to transplant, which is known as allogenic UCB transfusion, and it is not limited to a family or an individual [ 98 ].…”

Stem cell preservation for regenerative therapies: ethical and governance considerations for the health care sector

“…Several of the ethical, legal, and social (ELS) issues about the cord blood banking apply to the stem cell preservation market which uses MSCs and iPSCs. Among them, topics such as ownership and disposition authority, disclosure of information during informed consent, and withdrawal and non-payment are particularly relevant to stem cell preservation 14,26,[29][30][31][32][33][34][35] . In addition, new ELS issues also deserve consideration about private stem cell preservation, including medical validation and trust.…”