64.3 The Hon Tony Abbott MP, former Minister for Health and Ageing, noted in 2004 that:
Australia is a world leader in health and medical research. On a per capita basis, our research output is twice the OECD average, even though we spend much less, per capita, than the UK or the USA.
Investment in health and medical research makes good economic and health sense. It generates significant returns both in terms of health benefits—longevity and increased quality of life for Australian people generally; and economic benefits, through increased knowledge based jobs and economic activity.
64.4 There is strong community support for health and medical research in Australia. In a survey conducted for Research Australia in 2007, 89% of participants thought that health and medical research was an industry important to Australia’s future. Of survey participants, 85% considered that increased funding for health and medical research should be a priority for the Australian Government.
64.5 In a joint submission to this Inquiry, the Cancer Council Australia and the Clinical Oncological Society of Australia noted that cancer accounts for more deaths in Australia than any other individual cause. One in two Australian men and one in three Australian women are expected to be diagnosed with cancer by the age of 85. The submission also noted that cancer survival in Australia has improved by 30% over the past two decades, in large part facilitated by breakthroughs in epidemiological, laboratory and clinical research.
64.6 The NHMRC plays an important role in fostering health and medical research in Australia. The NHMRC is a statutory authority, within the portfolio of the Minister for Health and Ageing, established by the National Health and Medical Research Council Act 1992 (Cth) (the NHMRC Act). The Act provides that the role of the NHMRC is to:
raise the standard of individual and public health throughout Australia;
foster the development of consistent health standards between the various states and territories;
foster medical research and training and public health research and training throughout Australia; and
foster consideration of ethical issues relating to health.
64.7 The NHMRC is also the peak funding and advisory body for health and medical research in Australia and makes recommendations to the Minister for Health and Ageing on the funding of health and medical research and training. Australian Government funding of such research is provided primarily through grants from the Medical Research Endowment Account (MREA), established under the NHMRC Act. The Australian Government has more than doubled investment in health and medical research since 1999. Funding provided for the MREA was $430.4 million in 2005–06, $627.2 million in 2006–07 and $530.3 million in 2007–08. Some research funding also is provided through the Australian Research Council and other schemes.
64.8 In a 2004 report, the Investment Review of Health and Medical Research Committee estimated that, of the $1.7 billion invested in Australian health and medical research in 2000–01, 47% was provided by the Australian Government, 44% by the private sector and 9% by state and local government.
64.9 The report noted that the bulk of Australian Government investment in this period was directed to the higher education sector, although some of this research was then performed by, or in conjunction with, other institutions. Smaller amounts were spent by the Australian Government directly through agencies such as the Department of Health and Ageing (DOHA) and the Commonwealth Scientific and Industrial Research Organization (CSIRO), or channelled to businesses or non-profit groups. State governments spent the bulk of their investment in their own institutions, including state departments of health, medical research institutes and public hospitals. The business sector largely funded its own research. The non-profit sector funded half of its research from its own fundraising, and the other half through investment from the Australian Government, state governments and business.
64.10 The NHMRC noted in its submission to the Office of the Privacy Commissioner’s (OPC) review of the private sector provisions of the Privacy Act (the OPC Review) that:
Consistent with patterns of the provision of clinical care, the conduct of health and medical research in the Australian health care system frequently spans the public and private sectors.
Much health and medical research is multi-site or multi-jurisdictional, involving participants who move between the public and private health sectors.
64.11 Under the NHMRC Act, the Australian Health Ethics Committee (AHEC)—a principal committee of the NHMRC—has responsibility for developing guidelines for the ethical conduct of medical research. The primary set of guidelines for human research, developed jointly by the NHMRC, the Australian Research Council and the Australian Vice Chancellors’ Committee (AVCC), is the 2007 National Statement on Ethical Conduct in Human Research. This National Statement replaces the 1999 National Statement on Ethical Conduct in Research Involving Humans and was developed following extensive public consultation and debate.
64.12 The National Statement sets out ethical principles relevant to research involving humans and guidance on the formation, membership and functions of Human Research Ethics Committees (HRECs). It is important to note that, while the guidelines in the National Statement that are applicable to the conduct of health and medical research involving humans are issued by the NHMRC in fulfilment of its statutory obligations, the National Statement applies to all research involving humans, not only health and medical research.
64.13 The National Statement provides that any research proposals involving more than a low level of risk to participants must be reviewed and approved by an HREC. It also sets out requirements to be followed by:
institutions or organisations in establishing HRECs;
researchers in submitting research proposals to HRECs; and
HRECs in considering and reaching decisions regarding research proposals and in monitoring the conduct of approved research.
64.14 The Privacy Act regime incorporates the HREC approval process established by the National Statement to ensure that where research is conducted using personal information without consent, that research is conducted with due regard for the balance of public interests and the protection of personal information.
64.15 Although the National Statement is not legally binding, the Statement stipulates that it must be used to inform the design, ethical review and conduct of human research that is funded by, or takes place under the auspices of, the NHMRC, the Australian Research Council or the AVCC. Compliance with the National Statement is a condition of NHMRC grants of research funding. In addition, in order for an institution to apply to be an NHMRC Administering Institution for the purposes of applying for, and subsequently administering, NHMRC research funds, all research conducted within the institution—whether or not funded by the NHMRC—must comply with the National Statement.
64.16 The power to withdraw funding is the most important and direct mechanism by which the NHMRC may induce compliance with the National Statement. As noted above, however, not all health and medical research is funded by the Australian Government on the advice of the NHMRC. The issue of enforcing compliance with the National Statement was considered in detail in Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96). In that report, the ALRC and AHEC recommended that the NHMRC review the mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within and funded by the private sector.
64.17 The recommendations set out in the following chapters will ensure that any research—whether conducted in the public or the private sector and however it is funded—that is undertaken on the basis of the research exceptions in the Privacy Act, will have to be considered and approved by an HREC constituted in accordance with, and acting in compliance with, the National Statement.
 Investment Review of Health and Medical Research Committee, Sustaining the Virtuous Cycle For a Healthy Competitive Australia (2004), Minister’s Forward.
 Research Australia, Health and Medical Research Public Opinion Poll 2007 (2007).
 Cancer Council Australia and Clinical Oncological Society of Australia, Submission PR 544, 23 December 2007.
National Health and Medical Research Council Act 1992 (Cth) s 3.
 Ibid pt 7.
 National Health and Medical Research Council, Role of the NHMRC <www.nhmrc.gov.au/about
/role/index.htm> at 25 March 2008.
 Australian Government Department of Health and Ageing, 2005–06 Portfolio Budget Statements: Outcome 11 Health and Medical Research (2005).
 Australian Government Department of Health and Ageing, 2006–07 Portfolio Budget Statements: Outcome 14 Health and Medical Research (2006).
 Australian Government Department of Health and Ageing, 2007–08 Portfolio Budget Statements: National Health and Medical Research Council (2007).
 Investment Review of Health and Medical Research Committee, Sustaining the Virtuous Cycle For a Healthy Competitive Australia (2004), 17.
 Ibid, 17.
 National Health and Medical Research Council, Submission to the Office of the Privacy Commissioner Review of the Private Sector Provisions of the Privacy Act 1988, 10 December 2004.
National Health and Medical Research Council Act 1992 (Cth) s 35(3).
 National Health and Medical Research Council, Australian Research Council and Australian Vice Chancellors’ Committee, National Statement on Ethical Conduct in Human Research (2007).
 Australian Law Reform Commission and Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, ALRC 96 (2003), [14.1]–[14.8].
 National Health and Medical Research Council, Administering Institutions Policy, 6.
 Australian Law Reform Commission and Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, ALRC 96 (2003), Ch 14.
 Ibid, Rec 14–1.
 See, in particular, Recs 65–9 and 65–10.