Contributions to Law Reform

CLG Involvement in Law and Policy Reform

One of the central activities of the Centre for Law and Genetics is our involvement with law and policy reform processes within Australia and also internationally, particularly our work with the Australian Law Reform Commission (ALRC).

Some examples of our law and policy reform activities are presented below.

Protection of Genetic Information

In 2002 the Australian Law Reform Commission (ALRC) and Australian Health Ethics Committee (AHEC) began a major inquiry into the protection of human genetic information. The first step was an issues paper, which made calls for public submissions. Subsequently, various public forums were held around Australia. A discussion paper followed, with further calls for public submissions and public forums. Finally, a two volume final report, Essentially Yours, was tabled in federal parliament in 2003.

CLG members played an active role at all stages of the process, both in the form of detailed written submissions (co-authored by Don Chalmers, Dianne Nicol, Margaret Otlowski and Loane Skene) and as consultants and members of the advisory panel to the inquiry (Don Chalmers and Margaret Otlowski). Margaret Otlowski also led a submission to this inquiry by her genetic discrimination research team.

Following the publication of Essentially Yours, the Human Genetics Advisory Committee (HGAC) was established. Don Chalmers was a member of the HGAC for six years, followed by Margaret Otlowski for a further six years. They have both also served on AHEC, Don Chalmers as a member from 1993, chair from 1994 to 2000 and Margaret Otlowski as member in common with the HGAC from 2009 to 2015.

In addition to the involvement of the CLG in the comprehensive inquiry undertaken by the ALRC and AHEC, members of the CLG have also been involved in a number of other law and policy reform developments relating to the protection of human genetic information, particularly in relation to genetic privacy:

• Don Chalmers, Margaret Otlowski, Loane Skene and Dianne Nicol wrote a submission to the Senate Legal and Constitutional Legislation Committee on Provisions of the Genetic Privacy and Non-discrimination Bill 1998 (as introduced in the 38th Parliament)
  Genetic Privacy and Non-discrimination Bill 1998
  Senate Report
• Margaret Otlowski and Dianne Nicol wrote a submission to the Australian Health Ministers' Advisory Council on National Health Privacy Code (draft) Consultation Paper, April 2003
• Margaret Otlowski was a member of the Federal Privacy Commissioner's Health Leaders Forum (2004-2010).
• Don Chalmers, Margaret Otlowski, Loane Skene, Dianne Nicol and Mark Stranger wrote a submission to the Second Consultation on the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, April 2006
• Margaret Otlowski, Don Chalmers and Dianne Nicol contributed written submissions and oral evidence to the ALRC inquiry reviewing general privacy laws in Australia. The final report, For Your Information was released in 2008

Gene Patents and Related Patent Issues

Dianne Nicol, Jane Nielsen and John Liddicoat have made contributions to a diverse array of law and policy reform activities in the area of gene patenting. Law and policy reform discussions relating to gene patenting began in earnest in 2003 when the ALRC was given a further reference from the federal government, following the release of Essentially Yours, to inquire into the relationship between gene patenting and human health. Dianne Nicol was appointed as a consultant and member of the advisory panel to the inquiry, and she and Jane Nielsen made detailed submissions to the ALRC's issues paper and discussion paper. The final report, Genes and Ingenuity, was released in 2004.

A series of further law and policy reform inquiries have followed. While some related specifically to gene patenting, others considered more generic patent-related issues.

Some of the team's most significant contributions are listed below.

• Dianne Nicol and Jane Nielsen wrote a submission to the Advisory Council on Intellectual Property (ACIP) inquiry into patents and experimental use in 2004 and a subsequent submission to the IP Australia consultation paper, Exemptions to Patent Infringement in 2009.
• Dianne Nicol and Jane Nielsen wrote submissions to the Advisory Council on Intellectual Property (ACIP) inquiry into Patentable Subject Matter in response to the issues and options papers released by ACIP in 2008 and 2009 and Dianne Nicol attended a roundtable discussion organised by ACIP in 2008.
• Dianne Nicol and Jane Nielsen wrote a submission and were invited to give oral evidence to the Senate Community Affairs Committee Inquiry into Gene Patenting in 2009.
• Dianne Nicol and John Liddicoat (with Ben Mee) wrote a submission to Senate Standing Committee on Legal and Constitutional Affairs, Inquiry into Patent Amendment (Human Genes and Biological Materials) Bill 2010 and were invited to give oral evidence.
• Dianne Nicol, Jane Nielsen and John Liddicoat wrote various submissions to the IP Australia inquiry, Getting the Balance Right: Towards a Stronger and More Efficient IP Rights, in 2009-2010, which led to significant amendments to the Patents Act 1990 (Cth) through the Intellectual Property Amendment (Raising the Bar) Act 2012 (Cth).
• Jane Nielsen, Dianne Nicol and John Liddicoat, wrote a submission to the Productivity Commission, Issues Paper: Compulsory Licensing of Patents, September 2012.
• Dianne Nicol was also appointed to a three-member panel to review pharmaceutical patents in 2012-2013: Anthony Harris, Nicolas Gruen and Dianne Nicol, Pharmaceutical Patents Review Final Report (2013).

Biobanking

Margaret Otlowski, Dianne Nicol and Mark Stranger were consultants to the National Health and Medical Research Council's initiative considering the management and governance of biobanks in Australia,and they took carriage of drafting the NHMRC Biobanks Information Paper (2010).

Internationally, Don Chalmers, Dianne Nicol, Margaret Otlowski and Mark Stranger, wrote a submission to the OECD on Draft Guidelines for Human Biobanks and Genetic Research Databases, May 2008.