The NHMRC’s Australian Health Ethics Committee (AHEC) has developed a Background and Issues Paper called Ethics and the exchange and commercialisation of products derived from human tissue. The 2007 NHMRC guidelines on organ and tissue donation noted that there was a need for continuing community debate and regulatory oversight over commercialism in tissue banking. The matter was subsequently referred to AHEC to consider the ethical issues. The paper notes that products derived from human tissue are already being processed, exchanged and sometimes traded in Australia. While these products have the potential to deliver significant benefits to human health, this paper highlights ethical aspects that may be applied to their commercialisation.
Plain Language Statement – Commercialisation of Human Tissue Products
If a donor or family consents to donation of tissues after death, this donated tissue may be used in the manufacture of commercial products. Products derived from human tissue are used for medical procedures, laboratory testing, research, or in reconstructive surgery. Examples include bone used in orthopaedic surgery and research using stem cells.
The National Health and Medical Research Council (NHMRC) acknowledges that the use of products derived from human tissue may provide benefit to the community. However there is a need for ethical guidance in this area and in response the NHMRC have developed Ethics and the exchange and commercialisation of products derived from human tissue background and issues. This paper discusses the commercialisation of products derived from human tissue for use within the community and the ethical issues which need to be considered.
The donation of human tissue from deceased persons is governed by the various Human Tissue Acts in each state and territory. The use of human tissue is governed federally by the Therapeutic Goods Act, and regulated by Therapeutics Goods Administration. The Ethics and the exchange and commercialisation of products derived from human tissue background and issues has considered this Australian legislation.
In the paper, five criteria have been proposed to assist in determining whether a commercialisation activity is ethically permissible:
- Whether the human body is being treated as an object;
- Privacy considerations;
- The benefit to the community and equity of access;
- Whether it might change the way that the people involved behave or are treated by others, and whether it might cause them harm; and
- Whether the people involved may feel they are being exploited.
Page 3 of the Issues Paper indicates that the paper reflects the situation in Australia at June 2009. There have been changes to the regulatory environment since this time. The statement on page 20 of the above document (“in Australia, human tissue products used for therapeutic purposes are regarded as ‘medical devices’ by the Therapeutic Goods Administration and are subject to the Therapeutic Goods Act 1989”) is no longer accurate.
On 31 May 2011, legislation for a new regulatory framework for biologicals commenced through amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.
As of May 31st 2011, therapeutic goods that comprise, contain or are derived from human cells or human tissues (Biologicals) are regulated under the Therapeutic Goods Administration’s (TGA) Regulatory Framework for Biologicals. Exceptions include human cells and tissues which are either:
a) declared to not be therapeutic goods in the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 or;
b) specified in the Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011.
All Biologicals for supply in Australia must be registered on the Australian Register of Therapeutic Goods, with transition arrangements in place for those that are in current supply. Note that the existing TGA mechanisms that allow access to unapproved therapeutic goods in certain circumstances also apply to Biologicals.
More information on the Biologicals Framework is available at http://www.tga.gov.au/regulatory-framework-biologicals#framework
Phone: TGA enquiry line (1800 678 799) or email: firstname.lastname@example.org.
Questions and Answers
Q1 Does this document support a trade in human tissue in Australia?
Answer: No. It is illegal to trade in human tissue in Australia. The Ethics and the exchange and commercialisation of products derived from human tissue background and issues considers the ethical issues concerned with the use of donated tissue in commercial products that can be used in medical procedures, medical tests, medical research and reconstructive surgery.
Q2 Is tissue donation for commercialisation of products derived from human tissue different to organ donation for transplantation purposes?
Answer: Yes, these tissues will undergo a manufacturing process and may be converted into a commercial product.
Q3 Does this include the donation of tissues which are donated for transplantation, but which are not whole organs?
Answer: No, donations made for transplantation purposes are not made into commercial products.
Q4 Can the donation of tissues after death be limited to ensure the donation of specific tissues only?
Answer: Yes, the type of tissue to be donated can be specified.
Q5 Why doesn’t the donor family receive a payment if the tissue of a deceased relative is used to make a profit?
Answer: Payment for donated human tissue is illegal. However, these products derived from human tissue undergo a manufacturing process. Once the tissue has been processed it is considered to be a derivative, and it can be traded.
Q6 How can I be sure that my body will not been used to source commercial products?
Answer: Your tissue cannot be used to make commercial products unless you or your family specifically provide consent. The consent form that allows the donated tissue to be used for the manufacture of a product derived from human tissue will be a different document to the organ donation form.
Q7 Could the donation of tissue for commercial products assist in the developments of tests or cures for people with disease?
Answer: This depends on what the tissue will be used for. The consent form should provide information which will help you to answer this question. The person who is being asked for consent should be able to ask questions about this at the time of consenting.
When an organisation or individual delivers a benefit to the community other than any kind of payment or direct advantage to the donor of the human tissue. The concept of benefit sharing is relevant to equity and access in relation to the use of human tissue or human tissue products.
Commercial use or commercialisation
Trade where a fee is charged for the purpose of making a profit.
This is distinct from:
- gift – where custody is transferred without a fee being charged;
- not-for-profit exchange or trade – includes payment for transfer of custody or for access (to tissue or a product derived from human tissue) but no more than for the purposes of cost recovery.
A collection of individuals, which may extend from the whole population to a smaller grouping associated by cultural, geographical, social or political factors or some other commonality.
In the context of commercialisation of human tissue products, denotes benefit to the individual donor, family or ethnic grouping, benefit to others in the community, and issues of justice and equity of access to human tissue products. The notion of community benefit applied to availability of human tissue products for health purposes should ensure that those who would benefit have access to them.
Exchange or trade (cf commercialisation)
Where something is transferred in return for some payment or advantage. Not-for-profit exchange or trade includes payment for transfer of custody or for access (to tissue or a product derived from human tissue), but only for the purposes of cost recovery.
Gift or Donation (cf commercialisation)
Where custody is transferred without a fee or other benefit being charged.
In the context of this document, a person’s decision to donate that is voluntary and based on sufficient information and adequate understanding of the activity and the implications of participation. There are two duties involved: a duty to inform and a duty to obtain consent. The aim of communicating suitably presented information to potential participants and seeking consent should not be merely a matter of satisfying a formal requirement. It requires an adequate understanding of the purpose, methods, demands, risks and potential benefits of the activity. The aim should be mutual understanding between the donors and those involved in obtaining, storing and using the tissue. A person who donates tissue for research purposes is considered a participant in research for the purposes of the National Statement and the donor is the subject of obligations in relation to the use and storage of the tissue.
Differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy.
Implies a right to unrestricted use and the right to sell or otherwise dispose of property.
A cell that remains relatively undifferentiated and is capable of self-renewal and generating more differentiated cells.
All constituent parts of the human body formed by cells.
Any product derived from human tissue, including those used for medical research, diagnostics, medical devices, therapeutic activities or consumer products such as cosmetics.
For the purposes of this paper, a “product” involves some level of manipulation to transform human tissue into something functionally different from the source tissue. Cell cultures including stem cell cultures are considered to be human tissue products.
Trade (cf commercialisation)
An exchange that may or may not involve profit.
Contact details for more information
Health & Research Ethics Section
Research Translation Group
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
F: (02) 6217 9175