Products Derived from Human Tissues

The harvesting of bodily tissues without consent is considered battery; however, using tissue previously removed during medical procedures to facilitate research experiments is not prohibited.  Without tissue donations, the production of certain biomedical products would be impossible to produce. Recent law, however, has sided with pharmaceutical companies by stating that tissues removed through a medical procedure can, in fact, be used for “medical research” or commercial purposes without the consent of their donor (Moore v. the Regents of the University of California). Is it immoral for biomedical corporations to profit from products derived from tissues of patients who are not compensated for their use?

There are very few regulations governing the distribution and development of products created using “donated” human tissue. According to the Food and Drug Administration (FDA), tissue banks are largely unregulated. Although they are required to submit to regular inspections, most of these inspections do not take place due to budget constraints.

Even though tissue and organ banks are required to screen organs for diseases, “[i]n 2001, federal investigators reported some human tissue banks repeatedly retest tissue until it complies with safety regulations, a process that is scientifically unsound and unsafe.” This questionable practice may promote the transmission of harmful diseases. Federal Statutes impose penalties of up to $50,000 and up to five years in prison for anyone violating the standard of care by facilitating the implantation of contaminated body parts. Furthermore, due to donor confidentiality issues, there is no way of tracking where particular organs originated. It is therefore nearly impossible to trace that contaminated organs until after their transplantation .

The potential negative implications of the lack of regulation in an industry basing its livelihood on improving human life are frightening. We are faced with an interesting and novel dilemma. The existing situation creates a necessity for change, but the implementation of these improvements will undoubtedly prove difficult. Hopefully, this problem can be resolved through successful litigation and legislation designed to protect the public-both from the transmission of disease and the exploitation of their bodily tissues.