Terms of reference
On 11 November 2008, the Senate referred matters relating to
the patenting of human genes and genetic materials to the Senate Community
Affairs Committee (the Committee) for inquiry and report by the last sitting day
On the basis of the official schedule of sittings, the Committee was therefore required
to report by 26 November 2009.
On 24 November 2009, the Senate agreed to an extension of time
for the Committee to present its report. The Committee sought this extension
because it required more time to consider the extensive evidence received and
the complex nature of many issues associated with this inquiry. Further
extensions were granted on 23 February 2010 (until 17 June 2010)
and 16 June 2010 (until 2 September 2010).
On 19 July 2010, the Governor-General prorogued the 42nd Parliament. The
Committee tabled a brief report on 26 August 2010, which stated that, after due
consideration, the Committee had determined it was unable to provide a
comprehensive report and would reconsider these issues in the event that the
inquiry was re-referred to the Committee in the new parliament. On
30 September 2010, the Senate agreed to a request by the Committee for
the inquiry to be re-referred with the original terms of reference and a
reporting date of 25 November 2010.
The terms of reference for the inquiry directed the Committee to inquire
The impact of the granting of
patents in Australia over human and microbial genes and non-coding sequences,
proteins, and their derivatives, including those materials in an isolated form,
with particular reference to:
the impact which the granting of patent monopolies over such materials
has had, is having, and may have had on:
the provision and costs of healthcare;
the provision of training and accreditation for healthcare
the progress in medical research; and
the health and wellbeing of the Australian people;
identifying measures that would ameliorate any adverse impacts arising
from the granting of patents over such materials, including whether the Patents
Act 1990 should be amended, in light of the any matters identified by the
whether the Patents Act 1990 should be amended so as to expressly
prohibit the grant of patent monopolies over such materials.
Conduct of the inquiry
Information about the inquiry was advertised in The Australian and
on the Committee's website, which included an invitation to make submissions on
the terms of reference by 19 March 2009 (due to extensions to the reporting
date, submissions were in fact accepted throughout the course of the inquiry). The
Committee also wrote to relevant organisations and individuals to notify them of
the inquiry and inviting submissions. The Committee received 78 public
submissions. A list of the submissions authorised for publication by the
Committee is provided in Appendix 1.
The Committee held eight public hearings for the inquiry. These took
place in Canberra (19 March 2009, 20 August 2009, 14 September 2009,
18 May 2010 and 15 June 2010); Melbourne (3 & 4 August 2009);
and Sydney (5 August 2009). Witnesses who appeared at the hearings
are listed in Appendix 2.
Chapter 2 of the report provides the background to the inquiry, and
briefly outlines those aspects of the patent system, both in Australia and
internationally, that are most relevant to the inquiry terms of reference.
Chapter 3 considers the extent and impacts of the granting of patents over
human genes and genetic material (term of reference (a)(i) to (iv)); Chapter 4
considers whether the Patents Act 1990 should be amended so as to
expressly prohibit the grant of patent monopolies over such materials (term of
reference (c)); and Chapter 5 identifies measures to ameliorate any adverse
impacts arising from the granting of patents over such materials, including
whether the Patents Act 1990 should be amended (term of reference (b)).
Terminology used in this report
The inquiry terms of reference directed the Committee to consider the
impacts of granting patent monopolies over 'human and microbial genes and
non-coding sequences, proteins, and their derivatives, including those
materials in an isolated form'. As noted by IP Australia, there is no
internationally recognised definition or common understanding of what is a 'gene patent' other than that they
are a subset of biotechnology patents.
The report uses the term 'gene patent' to refer to patents that specifically relate
to gene sequences. More general references such as to 'human genes and genetic materials'
may be understood as referring to all substances listed in the inquiry terms of
The Committee notes that patent law, genetic science and health research
are all areas which rely on specific and technical vocabularies, and the report
seeks to avoid unnecessary use of technical terms wherever possible. The
Committee wishes to acknowledge the patience and assistance of the many
witnesses who assisted the Committee in developing an understanding of the complexities
of patent law and genetic science.
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