Ethics in a regulatory framework

6.60 Identifying the function of ethics in a regulatory framework can raise some profound issues about the relationship between ethics, governance, politics and law. Saunders and Komesaroff, noted that ‘a major issue that requires examination at the philosophical level is that of the relationship between law and ethics’ and suggested that:

the law should focus on the settings in which individuals engage in ethical decision making and seek to ensure that it is open and free from coercion and that adequate information is provided to allow individuals to make their own decisions after full and careful reflection.[43]

6.61 Such a facilitative role is reflected in recommendations in this Report concerning the HGCA. Given this facilitation, the functions of ethics in a regulatory framework relate to individual decision making, justification of policy and regulatory choices and ongoing assessment of effectiveness and acceptability.

6.62 The necessity for individual decision making in a regulatory framework draws attention to an essential feature of ethical obligation. In its submission, the Department of Health of Western Australia noted, in relation to measures to govern the management of genetic databases, that:

…. the level of protection provided by such technical matters may still be compromised by failure in the integrity of the researchers and this is an important matter to be addressed by HRECs, institutions and the researchers themselves.[44]

6.63 The integrity of researchers, and indeed of any decision makers in a regulatory environment, should be assessed by reference to the ethical values and principles on which that framework is based. The adherence to those values and principles is a matter of personal conviction not enforcement. This central feature of ethical obligation was described in IP 26:

It is intrinsic to the nature of ethical obligation that it be felt and followed because of an individual’s commitment to it, whatever the source of that commitment: whether to a principle, because of a virtue or a felt obligation to a community. One motivation for behaviour that is not usually regarded as significant is the threat of enforcement or regulation. To ascribe the efficacy of an ethical code to the efficiency of its enforcement mechanism or to its regulatory force might be said to confuse the nature of ethical obligation with that of legal obligation. Evidence of the efficacy of ethics, or health care ethics, is perhaps better found in the conforming behaviour of the people taken to be subject to the obligations.[45]

6.64 Ethics as the personal commitment to, and implementation of, values and principles operates to maintain the coherence and consistency of an ethically founded regulatory framework. Such a commitment is based on awareness and understanding of ethical principles derived from education and experience. It is important that ethics continues to promote, guide and justify good conduct and decisions by citizens, professionals and regulators in the handling of genetic information.

6.65 At a broader level than that of individual obligation, an essential role of ethics in a regulatory framework is that of justification.

In public policy debates, governments will make choices—even the decision to postpone and put off making a definitive choice is itself a choice. Making choices raises a central ethical issue: whether and how choices can be justified? That is, when people or institutions are faced with choices they want to make reasonable choices—choices supported by good reasons. But there are many different kinds of reasons for making particular choices … The decision could be made on the basis of current policy, interest group lobbying, public opinion polls, administrative precedent, the personal feelings of senior bureaucrats or politicians, etc. But it is to be hoped that the decision will be made on the basis of good moral reasons which as indicated above are motivating reasons that are impartial, promote human well-being, non-arbitrary and overriding considerations of self-interest. But to justify the choice of one of these requires moral argumentation. That is, it is fair to ask whether a particular choice can be justified from the moral point of view. The moral point of view should be one that all the affected parties can reasonably endorse. It should not just reflect the interests of some of the parties, but all of them. That is, the choice should be justifiable interpersonally.[46]

6.66 In providing reasons for such public policy choices, ethics can express the ethos of a society. In time, that ethos is frequently, though not invariably, expressed in the laws that a society chooses to make, or the regulatory frameworks that it chooses to devise and implement. However, as McDonald recognises, ethics tends to be expressed in widely shared principles so perfect justification may not always be demonstrated.

The ethical perspective urged here is to treat the use of ethics in public policy as a way of judiciously balancing or weighing relevant considerations—considerations usually identified by principles in common use. The objective, of course, is to make good ‘all things considered’ moral judgements that can be used to ground and formulate public policy. …

In the sometimes messy and often times complex world of public policy-making the aim is not ideal or perfect justification but something more moderate and achievable—as it were ‘good enough’ policy-making, that is decisions reasonably supported by common moral principles (including principles of good governance).

While appeal in ethical reasoning is made to principles in common use, there must be openness to the idea that at least some commonly accepted principles are improperly used, restrictively applied, or otherwise inadequate. Otherwise, there would be no possibility of moral change or moral progress.[47]

6.67 The function of ethics in policy making can be illustrated by the Report’s recommendation in Chapter 32 that genetic information from employees be collected and used to protect third party safety only where the danger cannot otherwise be avoided and the employee’s condition poses a risk of serious danger to the health and safety of third parties. The formulation of this recommendation reflects an attempt to strike a balance between, on the one hand, ethical protection of individual freedom and privacy and, on the other, ethical recognition of the need to protect innocent third parties from harm.

6.68 This recommendation may also be used to illustrate the role of ethics as a touchstone against which the continuing acceptability of regulatory frameworks may be assessed. As decision makers and regulators gain experience in the practical application of the recommended balancing test between individual freedom and third party safety, the effectiveness and acceptability of this formulation can be reassessed against the ethical foundations on which it was established.

6.69 In these ways, ethics can inform and justify the establishment of a regulatory framework, promote, guide and justify individual decisions in that framework and inform the continuing assessment of the framework’s effectiveness and acceptability.


[43] N Saunders and P Komesaroff, Submission G084, 9 January 2002.

[44] Department of Health Western Australia, Submission G271, 23 December 2002.

[45] Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, IP 26 (2001), ALRC, Sydney, 121.

[46] M McDonald, Biotechnology, Ethics and Government: A Synthesis, Canadian Biotechnology Advisory Committee, <>, 7 February 2003, 10.

[47] Ibid, 10.