Process of reform

1.9 The ALRC adopts similar methods across its law reform projects, although these may be tailored to the circumstances of a particular inquiry. The process is essentially one of intensive research on the part of members and staff of the Commission, which is informed by the guidance of an Advisory Committee, targeted consultations with stakeholders, and written submissions received in response to the publication of community consultation papers. Each of these elements is described further below.

Advisory Committee

1.10 It is standard operating procedure for the ALRC to establish a broad-based, expert Advisory Committee to assist with the development of its inquiries. In this Inquiry, the Advisory Committee included a number of judges, as well as leaders in the areas of genetic and molecular biological research, clinical genetics, community health, indigenous health, health economics, health education, intellectual property law and practice, commercialisation of biotechnology, and pharmaceuticals.^[6] As always, attention was paid to achieving a balance of interests and perspectives, while also giving consideration to matters of gender and geography.

1.11 The Advisory Committee met on 23 May 2003, 27 November 2003 and 14 May 2004 to provide general advice and assistance to the ALRC. The Committee has particular value in helping the Inquiry to maintain a clear focus and arrange its priorities, as well as in providing quality assurance in the research and consultation effort, and commenting upon reform proposals. However, ultimate responsibility for the Report remains with the ALRC’s Commissioners. An Advisory Committee does not determine the ALRC’s views on any issue addressed by an Inquiry.

Community consultation

1.12 Under the terms of its constituting Act, the ALRC ‘may inform itself in any way it thinks fit’ for the purposes of reviewing or considering anything that is the subject of an Inquiry.^[7] One of the most important features of ALRC inquiries is the commitment to widespread community consultation.^[8]

1.13 The nature and extent of this engagement is normally determined by the subject matter of the reference. Areas that are seen to be narrow and technical tend to be of interest mainly to experts. Other ALRC referenceshave involved a much greater level of interest and involvement from the general public and the media. The Inquiry into gene patenting falls into the latter category. In releasing the Terms of Reference for the Inquiry, the Australian Government specifically asked the ALRC to ‘undertake widespread public consultation and consult with key stakeholders’.^[9] Thus, while it was essential that the ALRC familiarise itself with the latest developments in Australia and overseas, it was equally important to consult widely and provide the community with an opportunity to have its say.

1.14 For this purpose, the Inquiry arranged a large number of targeted meetings with key stakeholders, to gain expertise, perspectives and to hear their experiences. These meetings were valuable in informing the Inquiry and in helping to develop sound policies that would both meet existing concerns and work effectively in practice. At the completion of the Inquiry, 73 such meetings had taken place around Australia, involving several hundred individuals. These included meetings with:

• federal, state and territory departments responsible for health, industry and technology;

• advisory bodies to government in the areas of intellectual property, health, biotechnology and innovation;

• the regulatory agency in the field of competition policy;

• bodies involved in the provision of public funding for genetic research;

• organisations concerned with health consumer education and advocacy;

• leading genetic researchers, genetic research laboratories, and public research institutions with an interest in commercialising biotechnology;

• companies involved in the commercialisation of genetic research or in the delivery of medical genetic services;

• peak industry bodies in the areas of biotechnology and pharmaceuticals;

• professional and academic associations dealing with intellectual property; and

• academics in intellectual property, competition law and health economics.

Written submissions

1.15 The Inquiry strongly encouraged interested persons and organisations to make written submissions to help advance the policy making process. The first round of submissions was received in response to the Issues Paper (IP 27),^[10] and a second round was received in response to the Discussion Paper (DP 68).^[11]

1.16 IP 27 was released in July 2003 and sought to identify the main issues relevant to the Inquiry, provide background information, and encourage informed public participation through 62 targeted questions. DP 68 was released in February 2004. It differed from the Issues Paper in that it contained a more detailed treatment of the subject matter, as well as identifying 49 proposals for reform. It also included a small number of additional questions on matters that either were not raised in IP 27 or received insufficient response to enable the ALRC to form a view.

1.17 The Inquiry received a total of 119 written submissions. These varied substantially in size and style, ranging from short notes written by individuals providing personal views, to large, well-researched documents prepared by government departments and agencies, research centres, industry bodies, professional associations and individual researchers. From the outset, the Inquiry was aware that some of the information in submissions might have commercial sensitivity, and the ALRC left open the possibility of receiving submissions in confidence. Of the submissions received, only three have been designated as confidential.