Commercialism in tissue banking

1


Currently in developed countries such as Austao lia, there are a lot of tissue banks are run as not-for-profit
operations, relationships are formed with for-profit companies, so the Australian Human Tissue Acts prohibit
trading in human tissue, but allow recovery of legitimate costs associated with processing and treatment.62

This area requires continuing community debate and legislative oversight. The experience overseas indicates
that commercialism in tissue banking can lead to undue focus on revenue rather than on the benefits to
recipients and the community. In the US, which has a similar legal framework to Australia, tissue banking is a
major industry and there have been examples of unethical behaviour by individual tissue banks in their
relationships with commercial groups.

While there are many benefits to the community from the production and use of therapeutic devices where these
are superior to synthetic products, it is essential that commercial imperatives do not overtake the ethical
principles on which donation and tissue banking are based. Tissue commercialisation raises potential conflicts
with these ethical principles, as indicated by the following points.

a) Consent issues as consent for release of donated tissues for manufacture of therapeutic devices is not
covered by the AODR, there would need to be mechanisms for obtaining separate and explicit consent for use of
tissues for the manufacture of therapeutic devices.
b) Need to protect the spirit of altruism it is vital that the altruistic spirit that underpins donation in Australia
is maintained; some degree of scrutiny of commercial processes would be needed to ensure that altruism is not
eroded (eg by on-selling of donated tissues).
c) Effect on the public perception of organ and tissue donation great care would need to be taken in
implementing commercial arrangements, as any public perception that there is trade in human body parts could
undermine the established system of organ and tissue donation, including blood and bone marrow donation.
d) Conflicts of interest Great care would need to be taken to ensure that commercial arrangements avoid any
financial conflicts of interest. There should be clear separation of roles, especially for any practitioners involved
in collection, processing and clinical use of therapeutic products and devices.
e) Need to protect recipients from harm given the risks to people who receive products sourced from donated
body parts, there would be a need for standards and mechanisms for screening of donors and production of
therapeutic devices using donated tissues.

1. Australian Goverment: National Health and Medical Reserach Council. Organ and tissue donation after
death, for transplantation: guidelines for ethical practice For health professionals. Australia: National
Health and Medical Research Council of Australia; 2007.