EXPLANATORY STATEMENT

 

Select Legislative Instrument 2009 No. 269

 

Australian Organ and Tissue Donation and Transplantation Authority Act 2008

 

Australian Organ and Tissue Donation and Transplantation Authority Regulations 2009

Section 60 of the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (the Act) provides that the Governor-General may make Regulations prescribing matters required or permitted to be prescribed by the Act; or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The Act established the Australian Organ and Tissue Donation and Transplantation Authority (the Authority) on 1 January 2009, to drive a new national approach to provide access to transplants and transplant outcomes for Australians. The Act provides the legislative framework to implement the measures included in the Australian Government’s national reform package for organ and tissue donation and transplantation announced in July 2008.

 

The purpose of the Regulations is to specify exclusions to the definition of tissue, prescribe an alternative name for the Authority and specify additional individuals authorised to give consent to the publication or dissemination of patient information. The Regulations are the Principal Regulations for the Authority.

 

Details of the Regulations are set out in the Attachment.

 

The Department of Health and Ageing consulted the Australian Organ and Tissue Donation and Transplantation Authority prior to and throughout the drafting process. In addition, the Department of Health and Ageing consulted the Department of the Prime Minister and Cabinet, Privacy and FOI Policy Branch, on the proposed Regulations in relation to section 58 of the Act, addressing all aspects of the advice received. Consultation was undertaken in accordance with the best practice regulation requirements.

 

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on the day after registration on the Federal Register of Legislative Instruments.

 

ATTACHMENT

 

Details of the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2009

 

Regulation 1 – Name of Regulations

This regulation provides for the Regulations to be referred to as the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2009.

 

Regulation 2 – Commencement

This regulation provides that the Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

Regulation 3 – Definitions

This regulation provides that ‘Act’ means the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 in these Regulations.

 

Regulation 4 – Tissue – exclusions

This regulation provides that the definition of tissue in section 4 of the Act does not include the following substances:

(a)    blood or blood products, including progenitor cells such as in cord blood and bone marrow;

(b)   reproductive, including sperm and eggs, or foetal tissue; and

(c)    stem cell tissue.

 

The definition of tissue in the Act excludes a substance or thing specified in the regulations. The term includes a wide range of substances and things, and medical science is continually evolving in respect of the use of tissue for transplantation, so excluding substances or things by specifying them in the regulations will allow flexibility and avoid misapplication of the definition. Regulations can be amended quickly and will thereby ensure the currency of the definition. This approach will also assist in ensuring that the legislation has a clear definition of tissue and that it has the ability to accommodate any future advances in medical science and technology.

 

Regulation 5 – Alternative name for the Authority

This regulation provides that the Authority may also be known as the ‘Organ and Tissue Authority’ in accordance with subsection 8(2) of the Act.

 

As the current name of the Authority is relatively long (noting that the legal title covers both the organ and tissue donation and transplantation sectors), section 8(2) of the Act provides that the Authority may also be commonly known by another shorter name. The name provided becomes the operational name of the Authority.

 

Regulation 6 – Patient confidentiality – authorised persons

This regulation provides that if a donor is less than 18 years old, the parent or legal guardian of the donor is authorised to give consent to the publication or dissemination of information, in accordance with paragraph 58(2)(c) of the Act.

 

Currently the Act refers to individuals authorised to give consent if a donor is over 18 years old or deceased however does not identify individuals authorised to give consent if a donor is less than 18 years old.