Regulation of private sector human genetic research

[G]enetic research depends on the medical-industrial complex. The gene has become a kind of commodity as vital to the economies of developed countries as oil or uranium. … Developed countries are fiercely competing with each other to take the lead; universities are running the risk of becoming the handmaidens of private industry; and corporations are locked in battle to be the first to perfect the molecule that will enable them to forge ahead of the competition and line the pockets of their shareholders.[27]

14.27 Consultations and submissions highlighted the continuing convergence of public and private research. Many private sector organisations receive public funding and there is increasing collaboration through public and private partnerships—collaboration recommended and encouraged by the Wills Report.[28]

14.28 Investment in research by private commercial interests is likely to have at least two relevant consequences. First, institutions conducting privately funded research may not be dependent on remaining eligible for public research funding. Second, the commercial interests of researchers and research organisations may lead to conflicts of interest that can compromise the validity and safety of research.

14.29 In 2001, the House of Representatives Standing Committee on Legal and Constitutional Affairs reported on its inquiry into the scientific, ethical and regulatory aspects of human cloning and stem cell research. The Standing Committee observed that:

The growth and spread of cloning research and the substantial involvement of the private sector in it renders it very difficult for a body such as the NHMRC or AHEC to monitor this area of risk. The leverage of the NHMRC is very much tied to its capacity to grant or withhold funding and hence its real capacity to influence the private sector must be problematic as AHEC itself acknowledged. In such an environment sanctions such as the loss of research funding may have minimal influence.[29]

14.30 The Committee concluded that the current regulatory environment for medical research was ‘deeply unsatisfactory’ and was the product of an era when the majority of research funding was provided by government and most research occurred within tertiary institutions that were publicly funded.[30] The Committee stated that consistent regulation should be applied to both publicly and privately funded research.

If the current framework continues … it is likely to lead to the evolution of a system increasingly similar to that in the United States … There the public sector is regulated and the private sector, where much of the research is undertaken, is subject to limited regulation.[31]

14.31 Human genetic research involves significant private sector funding, public/private partnerships and commercial pressures on public sector research, such as that conducted in universities. The Standing Committee’s observations may be as relevant to the regulation of human genetic research as to human cloning and stem cell research.

[27] H Doucet, ‘The Role of Ethics in the Development of Genetics’ (2001) 2(3) Isuma: Canadian Journal of Policy Research 40, 43.

[28] Health and Medical Research Strategic Review, The Virtuous Cycle, Working Together for Health and Medical Research (1999), Commonwealth of Australia, Canberra, Ch 8, App 1 (Government Response to the Recommendations and Actions in the Report of the National Health and Medical Research Strategic Review—NHMRC to Action).

[29] House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001), Parliament of the Commonwealth of Australia, Canberra, 162–164.

[30] Ibid, 167.

[31] Ibid.