Regulatory and intellectual property conundrums surrounding xenotransplantation

Clinical xenotransplantation seems close: Ethical issues persist

“…For example, at least 29 xenotransplant treatments were available in 12 different countries by 2010; 9 of the 12 countries had no regulations addressing xenotransplantation 34 . Xenotransplantation oversight lacks clarity, as many jurisdictions have not determined the legal framework to regulate human‐animal chimeras or animals with multiple genetic changes 35 . In the U.S., regulation falls under the Food and Drug Administration, 36 but different branches regulate different aspects; for example, one branch manages genetic modifications of the animal and another regulates the use of the resulting organs as medical treatments.…”

Unaddressed regulatory issues in xenotransplantation: a hypothetical example

“…It is clear that numerous regulatory concerns need to be addressed before such an approach can be translated into routine practice. In our previous work, we described three key issues pertaining to the creation of human-pig chimeras/multitransgenic pigs, namely: (1) the potential uncertainty as to which framework captures humananimal chimeras or multitransgenic pigs; (2) what the end product is and by which regulation it is captured; and (3) who the owner of the xenoproduct is (13,14). While we previously discussed these in terms of hindrances to prospective supranational or international regulatory frameworks, we will now play out the scenario in a concrete jurisdiction by describing the necessary steps to be undertaken in order for a patient to receive a chimeric organ for two reasons.…”