The HTA regulates organisations that remove, store and use human tissue for research, patient treatment, post-mortem examination, anatomical examination, surgical training and display in public. These activities require appropriate consent to be in place in order for them to lawfully take place, and a number of them are also licensable. Our code of practice on consent gives guidance on how to comply with the consent requirements of the Human Tissue Act 2004.
Under section 32 of the HT Act, it is an offence to engage in commercial dealings in 'controlled material'. Controlled material means material which consists of or includes human cells (excluding gametes and embryos), which is – or is intended to be – removed from a human body for the purpose of transplantation.
A person guilty of an offence under section 32 is liable to imprisonment and/or a fine. The HT Act is, however, silent on the sale of bodies, body parts or tissue for other purposes and such sales are therefore outside the remit of the HTA.
The exception to paragraph 4 is the sale of items derived from or including human tissue that are visible to the public whilst on sale. The public display of human tissue is an activity which is subject to licensing by the HTA and strict legal requirements relating to consent. Anyone displaying human tissue in public without an HTA licence for public display, or without the appropriate consent, may be liable to imprisonment and/or a fine.
Anyone directly involved or facilitating the sale or purchase of human bodies, body parts or tissue should ensure that they are aware of the consent and licensing provisions of the HT Act and should make potential purchasers aware of these provisions.
Those involved in the sale or purchase of human bodies, body parts or tissue, and those who may host adverts for such sales (such as internet sites), may be subject to their own professional standards or other external requirements. Individuals and organisations intending to advertise, sell or purchase human bodies, body parts or tissue should consider the appropriateness of doing so within these established frameworks.
Establishments, such as medical schools or research tissue banks, may charge for providing human tissue to other establishments or researchers, including those working for private companies, so that their running costs are recovered. Where cost recovery, or any other charging mechanism, is in place it is important that establishments are able to satisfy themselves the information provided to potential donors is sufficient to ensure they understand that their tissue samples may be shared, subject to a fee being charged. We also recommend that establishments ensure transparency by providing easily accessible information about how and why they charge, and to whom they will supply human tissue. This is important to ensure that the consent sought from donors is fully informed.
A key principle on which the HT Act is based is that all bodies, body parts or tissue should be treated with respect and dignity. The HTA considers that the need to maintain dignity and respect is paramount in the handling of all human bodies and tissue.