EmailHospital Circular 01/2010
Date Issued: 26 January 2010
Distribution: Public Hospitals, Public Health Services, Private Hospitals
Subject: The Australian Paired Kidney Exchange Program
Purpose: To provide hospitals and health services with information regarding the Australian Paired Kidney Exchange Program (AKX) and the application of the Victorian Human Tissue Act 1982.
The Australian Paired Kidney Exchange Program (AKX)
The Australian paired Kidney eXchange Program (AKX) is a nationwide live kidney donor exchange program which will become operational in January 2010 and operate under the auspices of the Australian Organ and Tissue Authority (the Authority). Due to the lack of cadaveric (deceased) kidney donors, living directed kidney donation is a means of increasing the number of renal transplants in Australia. Approximately 30% of willing living kidney donors are however incompatible with their intended recipient such as a partner, family member, or close friend, due to blood group or tissue type mismatch, and thus cannot proceed to live donor transplantation.
The goal of the Australian Paired Kidney Exchange Program is to increase live kidney donor transplants by helping incompatible donor-recipient pairs. The AKX seeks to identify donor recipient pairs in the same situation and to organise an exchange of the donors’ kidneys to achieve two compatible transplantations.
The National Paired Kidney Exchange Advisory Committee developed the Australian Paired Kidney Exchange Program Guidelines (the Guidelines), which were issued in December 2008.
AKX will follow international and Australian best practice in living kidney donation. The program will be guided by principles of good governance involving transparency, accountability and equity so that the management and operation of AKX complies with ethical, financial and legislative requirements, as well as relevant policy and frameworks.
The Australian Paired Kidney Exchange Program and the Human Tissue Act 1982
The Human Tissue Act 1982 (Vic) (the Human Tissue Act) governs (amongst other things) the donation of tissue and blood by living and deceased persons for various purposes. Kidneys are considered tissues under the Human Tissue Act. Part 8 of the Human Tissue Act prohibits trading in tissue by prohibiting a person from:
- Selling, or agreeing to sell, tissue (including his/her own tissue) or the right to take tissue from his/her body (section 38); or
- Buying, agreeing to buy, offering to buy, holding him or herself out as being willing to buy, or inquiring whether a person is willing to sell to the person or another person tissue or the right to take tissue from the body of another person (section 39).
The Human Tissue Act does not define what constitutes "selling" or "buying" for the purposes of the Act. However, as long as no additional benefit flows to donors or recipients besides the receipt of a donated kidney, it is the opinion of the Department of Health that a paired kidney exchange conducted in accordance with the AKX Guidelines does not constitute “selling” or “buying” for the purposes of the Human Tissue Act. This is because the Department believes that Paired Kidney Exchange (PKE) conducted in accordance with the Guidelines is a donation, rather than a transaction that could be described as "trading" or "in the course of commerce."
Consent
Donations of kidneys as part of the AKX are subject to the consent provisions in Part 2 of the Human Tissue Act. Donor’s consent must be obtained before the kidney can be removed and the donor may revoke his or her consent at any time, either verbally or in writing.
The AKX has clear and detailed protocols and processes in place regarding informed consent and registration on the AKX register. During the informed consent process, clinicians and transplant co-ordinators must provide potential participants with information provided by the AKX and/or the Authority, on the nature, implications, foreseeable risks and benefits of program participation. This information must be presented in a non-coercive way that supports individual decision-making and does not create an improper inducement to participate in AKX.
It is expected that clinicians/transplant co-ordinators will obtain written informed consent from each participating donor and recipient pair in accordance with agreed protocols. This information will be provided to the AKX. It would be prudent for hospitals to obtain a certificate of consent from the medical practitioner who explains the informed consent process to AKX participants. Further, hospitals should satisfy themselves that AKX participants understand that the participation consent form is not an enforceable contract but a reciprocal agreement with no monetary reward and no legal remedy for participants’ withdrawal from the arrangement.
It should be noted that the Department cannot provide hospitals or health services with individual legal advice nor with clinical advice in relation to paired kidney exchange, the AKX, or specific patients.
If a hospital or health service has any concerns, independent legal advice should be sought.
Further Information
See general information on the Australian Paired Kidney Exchange Program website.
For the AKX Program Guidelines, Information Brochures, Consent Forms, and Tissue Typing Guidelines:
Contact the Australian Organ and Tissue Authority on (02) 6198 9800
or the National AKX Coordination Centre on (08) 9431 3600.
Professor C W Brook
Executive Director
Wellbeing, Integrated Care and Ageing
