Abstract

BackgroundPrivate 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 bodyBecause 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.ConclusionsPrivate 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.

Highlights

  • Health Canada Health Canada’s role in the regulation of private cord blood banking depends on the functions banks choose to perform

  • Private banks that store for allogeneic use are subject to routine inspections and the Safety of Human Cells, Tissues and Organs for Transplantation Regulations [16, 40]

  • Direct-to-consumer marketing usually pertains to private cord blood banking for future autologous or familial allogeneic use, and these banks are regulated under the Food and Drugs Act [16, 41]

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Summary

Conclusions

When making decisions about biobanking, consumers must be presented with accurate information about the likelihood of private banking resulting in benefit. Though we have used Canada as an example, and there may be legal differences in other jurisdictions that manifest as slightly different limits on the extent of permissible prognostication, the general proposition holds that such marketing is materially misleading in a way that is likely to impact consumer decision making – and especially the decision making of a "credulous" and inexperienced consumer [59] Regulatory bodies such as the Competition Bureau, industry associations such as Ad Standards and nonprofit advertising watchdogs such as Truth in Advertising should all act to encourage enforcement of existing law, to help prevent new parents from being persuaded to privately store tissue that is likely of no personal utility and may result in significant financial and public health cost

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