Legal Issues in UCB Banking

This summary is based on the article Annas, G.J. (5/13/1999) NEJM, vol.340 no.19 , "Waste and Longing - The Legal Status of Placental-Blood Banking" by a member of the Health Law Dept at the Boston University School of Public Health.

• The legal treatment of bone marrow transplants has been based on the model of organ donation. Even though bone marrow is a renewable resource, its collection is invasive and poses risk to the donor. Although the privacy of donor and recipient are protected from each other, careful records are kept of the screening and testing process.
• By contrast, the legal treatment of cord blood has been based on the model of blood donation. The collection of cord blood poses no risk to the mother or newborn, and was previously considered medical "waste". Consequently, public registries feel justified in banking cord blood anonymously, stripped of all source identity. There are fewer records about the source of a public cord blood unit than there would be about the source of an ordinary blood transfusion.

This model becomes questionable now that cord blood is becoming very desirable as a source of stem cells for research, and is frequently sold for profit. If the cord blood is not waste, but has great value, then the collecting institution "has a fiduciary or trust obligation to inform the mother of the research itself, as well as the possible commercial applications of the research, and to obtain her consent to use the placental blood in this manner". I would add, also an obligation to make forecasts of the possible profits derived from these commercial applications, just like the "forward-looking statements" in a corporate prospectus.

Annas further states, "Permitting the storage company to sell the placental blood to others for therapeutic use, on the other hand, would create conflicts between the storage facility and both the donor (who benefits, if at all, only if the blood is retained in storage) and the recipient (who would want records kept of the donor even though the donors would not)."