Terms of Reference

Protection of human genetic information

1. We, DARYL WILLIAMS, Attorney-General of Australia, and MICHAEL WOOLDRIDGE, Minister for Health and Aged Care, having regard to—

the rapid advances in human genetic technology; and

• the scientific and medical applications of human genetic information which are, or could be, of benefit to the Australian community; and
• ethical concerns in relation to the collection, storage and use of human genetic samples and information; and
• the potential for inappropriate use or application of human genetic samples and information; and
• evidence of, and the potential for, use of human genetic information by a number of sectors including employment; health, including medical research, pharmaceuticals and health administration; insurance and superannuation; intellectual property; and law enforcement; and
• emerging issues about the control of, ownership of, and intellectual property rights in relation to human genetic samples and information;

refer to the Australian Law Reform Commission and the Australian Health Ethics Committee of the National Health and Medical Research Council for inquiry and report pursuant to subsection 20 (1) of the Australian Law Reform Commission Act 1996 and paragraph 35 (3) (c) of the National Health and Medical Research Act 1992 respectively, matters relating to —

    (a) whether, and to what extent, a regulatory framework is required—

         (i) to protect the privacy of human genetic samples and information; and

         (ii) to provide protection from inappropriate discriminatory use of human genetic samples and information; and

         (iii) to reflect the balance of ethical considerations relevant to the collection and uses of human genetic samples and information in Australia; and

     (b) any related matter.

 2. In performing their functions in relation to this reference, the Commission and the Australian Health Ethics Committee shall—

     (a) conduct this inquiry jointly; and

     (b) identify and consult with relevant stakeholders, including the Privacy Commissioner and the Human Rights and Equal Opportunity Commission, and ensure widespread public consultation; and

     (c) have regard to the following matters —

         (i) the rapid advances in human genetic technology including progress of research towards the mapping of the human genome; and

         (ii) the scientific and medical applications of human genetic information which are, or could be, of benefit to the Australian community; and

         (iii) evidence of, and the potential for, the inappropriate use or application of human genetic information; and

         (iv) the range of Australian ethical opinion as to which, if any, uses and applications of human genetic information are ethically acceptable; and

         (v) the global dimensions of issues relating to research, regulation and the protection of interests; and

         (vi) any relevant existing or proposed international law and obligations; and

         (vii) any relevant constitutional issues; and

         (viii) any relevant existing or proposed Commonwealth legislation; and

         (ix) the implications of the recent decision by Australian health ministers to develop a national health information network; and

         (x) developments in other jurisdictions, including legislative and other regulatory action; and

         (xi) relevant research and discussion of human genetic information privacy and discrimination issues.

 3. The Commission and the Australian Health Ethics Committee are to report to the Attorney-General and the Minister for Health and Aged Care by 30 June 2002.*

Dated 5 February 2001

Daryl Williams, ATTORNEY-GENERAL

Michael Wooldridge, MINISTER FOR HEALTH AND AGED CARE

* In his letter of 25 January 2002, the Attorney-General stated that he and the Minister for Health and Ageing, the Hon Kay Patterson agreed to extend the deadline for the final report under this reference to 31 March 2003.