Amendments to the Human Tissue and Transplant Act 1982

Overview

The Western Australian Government is committed to ensuring a strong legislative framework to regulate the sale and supply of human tissue products for transplantation, or other therapeutic purposes, or medical or scientific purposes in Western Australia (WA). The WA Department of Health (the Department) is seeking feedback on the proposed amendments to the Human Tissue and Transplant Act 1982 (the Act). Your submission will inform our recommendations for the WA Minister for Health.

Why your views matter

A case for amendment

Since 1982 there has been a significant growth in the range of medical therapies and technologies which utilise human tissue and products derived from human tissue.  New human tissue products are regularly being approved for supply in Australia by the Therapeutic Goods Administration (TGA), and WA clinicians are seeking to access these products to treat patients. The current restrictions on the sale and supply of human tissue products required by the Act may prevent WA clinicians from accessing new human tissue products approved by the TGA for supply in Australia.

Three rounds of consultation have already been undertaken with stakeholders from the Department and other government agencies, industry, consumer advocates and professional organisations. The consultations have shown support for the proposed amendments. The proposed amendments to the Act  include provisions similar to those found in the legislation in other Australian jurisdictions.

The Human Tissue and Transplant Act 1982 can be accessed here.

Amendments

The principal objectives of the proposed amendments to the Act are:

• to provide regulation that supports the availability of human tissue products for transplantation, or other therapeutic purposes, or medical or scientific purposes for the health and wellbeing of patients, and to support related education, training and quality assurance.
• to ensure donated tissue is removed in accordance with the regulations, without the risk of loss of potential donor tissue.
• to ensure that the principle and practice of tissue being altruistically donated (gifted) is promoted and protected and that human tissue is not treated as a commodity to be commercialised or traded for profit. 

The proposed amendments to the Act are:

• Amending section 24 (1) (b) to include provision for an authorised person other than a medical practitioner to remove skin or musculoskeletal tissue* from a deceased person for the purpose of transplantation, other therapeutic purposes, or medical or scientific purposes.

(Amendment of section 24 of the Act is required to support more timely and efficient removal of tissue. The amendment would bring the removal of musculoskeletal and skin tissue into line with that of corneal tissue).

• Amending section 29 to include an exception to the prohibition for the sale and supply of tissue if the tissue has been subject to processing or treatment.

(Amendment to section 29 of the Act would support tissue banks* or other authorised suppliers to cover the inherent costs for the retrieval, processing, storage and supply of  human tissue products. Consent for the donation and use of tissue must be based on an understanding that organisations involved may recover costs associated with this activity).

• Amending section 29 to allow the Minister for Health to provide written approval, under special circumstances, for a contract or arrangement that would otherwise not be allowed under section 29.

(The approval must be under special circumstances and where the contract or arrangement has been recommended by an advisory body responsible for regulations in that area. Human reproductive tissue (eggs, spermatozoa, embryos and fetal tissue) would be excluded from the proposed amendment).

• Amending section 29 of the Act may offer an opportunity to review whether the penalties for offences committed under section 29 of the Act are commensurate with their purpose as both penalty and deterrent.
• Expanding upon existing requirements for consent to remove tissue for transplantation, other therapeutic purposes, or medical or scientific purposes already set out in other sections of the Act, to allow consent to be given for the use of tissue for education, training and quality assurance in relation to transplantation, other therapeutic purposes,or medical or scientific purposes.  The amendment is not intended to apply to embryos

* Definitions:

Musculoskeletal tissue means bone, tendons or ligaments which can be processed in various ways.

A tissue bank is an organisation which collects, processes, stores, and distributes donated tissue. Tissue banks may be government entities, not-for-profit organisations or private providers. The two WA tissue banks are not-for-profit organisations.

What happens next

Submissions to the consultation will be taken into account in the formulation of recommendations for amendments to the Act, which will then be submitted to the Minister for Health for consideration.