Chapter 5
OPTIONS FOR REGULATION
Introduction
5.1 The adequacy of the existing regulatory structure and the need for
further legislative intervention have been considered in the previous
chapter, in the course of the committee's examination of the various privacy
and discrimination issues. This chapter examines the role of the Commonwealth
in legislating on genetic privacy and non-discrimination issues; the extent
to which the issues are sufficiently clear as to require legislation at
this time; and the regulatory structure the Commonwealth should adopt.
Should the Commonwealth legislate on the issue?
Constitutional powers
5.2 An immediate issue that must be addressed is the constitutional head
of power that is to be relied upon for the enactment of the bill. Although
some submissions have raised this issue [1],
the committee has received little evidence on point. The committee notes
that neither the bill nor Senator Stott Despoja's second reading speech
make any direct reference to a head of power (although the discussion
of the UNESCO Universal Declaration on the Human Genome and Human Rights
may indicate a reliance on the external affairs power [2]).
5.3 Although there are several other potential heads of power [3]
that can be used in whole or in part, the committee considers that any
legislation covering this area should explicitly identify the source of
the Commonwealth's legislative power. Paragraph 51(xxxvii) could also
be used if the areas of genetic privacy and discrimination were referred
by states.
The need for a national approach
5.4 The committee considers that there are sound reasons to pursue a
national approach in dealing with many of the issues raised by the areas
of genetic privacy and discrimination.
5.5 The Queensland Government, for example, argues that the emerging
bio-technology industry will be of enormous economic significance, and
that it is important to safeguard the interests of that industry by providing
a clear and consistent regulatory approach:
Australia has the potential to develop a major biotechnology industry
given its rich and unique biodiversity …
One of the key factors influencing the development of bio-industry
is the existence of a clear regulatory path that address key issues
of safety and, where appropriate, ethical issues. It is important that
products derived from gene technology are subject to rigorous scientific
assessment for their impact on the environment and human health. However
it is also important that regulatory systems be kept streamlined, impose
restrictions only where they are demonstrably necessary, ensure that
the costs of regulation are kept to a minimum, and foster rather than
stifle innovation. [4]
5.6 One of the only ways to achieve such consistency is to pursue a national
approach to the issues raised.
5.7 The committee also recognises the importance of the ethical, legal
and social issues arising from the emerging genetic technology, and appreciates
the need to participate as a nation state in the international arena for
the development of appropriate regulations and standards. As Professor
Chalmers and Dr Nicol point out:
There is a growing acceptance that regulation ought to develop in an
international context as it is highly undesirable that “genetic
paradises” develop where genetic research can be conducted without
accepted international standards or accountability. [5]
5.8 Finally, the committee believes that a strong national approach ensures
that the interests and concerns of the Australian community are adequately
addressed. The creation of clear guidelines, standards and laws governing
the use of genetic technology and associated information would provide
a benchmark, encapsulating the intentions of government and minimising
the need for court or tribunal interpretation. [6]
Is it an appropriate time to legislate?
5.9 The committee has received a number of submissions that suggest that
it is premature to attempt to enact comprehensive legislation in these
areas, because the issues are not yet clear enough to make appropriate
judgments and the associated ethics debate is not yet sufficiently resolved.
Are the issues clear enough?
5.10 The committee considers that it is premature to regulate on genetic
privacy and non-discrimination. While the general nature of the issues
raised is apparent, genetic technology is still in development. As the
submission of the Research Group for the Study of the Legal and Ethical
Implications of Human Genetic Research in Australia stated:
For all its impressive technology, there is greater promise in the
new genetics than actual applications to medical practice at this stage.
…
Genetics is a rapidly developing scientific area and it is not possible
to take a snap-shot of current practices and project a regulatory system
into the future with confidence. [7]
5.11 The evidence the committee has received suggests that genetic information
is not yet in wide use in the community, and that there is little, if
any, evidence of abuses of genetic information or resulting discrimination.
For these reasons, the committee considers that there is no immediate
need for regulation or protection, and that the development of appropriate
legislation would be best served by monitoring the privacy and discrimination
issues outlined in Chapter 4. This would provide legislators with a clearer
understanding of the direction the technology is taking; how it will be
applied; and the privacy and discrimination issues that arise as a result.
As the Law Council of Australia states:
In the Law Council's view, more detailed consideration needs to be
given to the question of potential misuses of information in these circumstances.
[8]
5.12 These considerations assume particular importance with respect to
research. Developments in genetics offer great promise in alleviating
human suffering caused by hundreds of genetic conditions, as well as economic
prospects for the emerging bio-technology industry. In order to ensure
that this eventuates, it is important to avoid policies that could stifle
innovation in research. Premature or overly restrictive regulation of
genetic technology could have the effect of depriving society of the benefits
of the technology. [9] However, at the same
time, there is an expectation that those involved in research will act
ethically and appropriately as the regulatory policies and procedures
develop.
Is the ethical debate advanced enough?
5.13 As outlined in Chapter 4, the regulation envisaged by the bill is
underpinned by a number of ethical questions and value judgments. The
committee agrees with submissions that argue that the ethics debate in
Australia is insufficiently advanced to have come to any conclusions about
the emerging genetic technology. [10] As Dr
Thomas Faunce argues in his submission:
In the US, legislation in this area has been long suspended in anticipation
of more substantial data gathering and public debate. … I am not
sure [that this] has taken place in Australia and thus am concerned
that the legislation may suffer from being premature. I have read both
the Australia House of Reps Committee report Genetic Manipulation:
the Threat or the Glory and the Privacy Commissioner's The Privacy
Implications of Genetic Testing and consider that they serve, at
best, as starting points. [11]
What other options could be considered?
5.14 Although it is probably too early to attempt to legislate in this
area, the committee considers that, in the future, the issues raised in
Chapter 4 will inevitably generate legislation. For this reason, the committee
considers that to do nothing at this time is inappropriate. Simply awaiting
overseas developments will be disadvantageous to all parties as it runs
the risk of causing significant injustice to individuals, as well as failing
to provide a desirable level of certainty and clarity to researchers and
industry.
5.15 Rather, the committee considers that further examination of the
issues is necessary. This examination will have three important objectives.
The first is to monitor developments in genetic technology, particularly
the ethics and legal implications. The second is to contribute to and
sponsor an informed public debate that will lead to community feedback
on the acceptable uses for, and controls on, genetic technology. As one
submission states:
Since the demise of the National Bioethics Consultative Committee …
in 1991, there has been no high profile, independent, cross disciplinary
public policy body on bioethics and social impact of biotechnology.
… There is currently a great deal of media attention being given
to the ethics and social impact of genetic engineering. In these discussions,
scientists especially talk of “the community” needing to decide
on what it does and doesn't want to happen. The trouble is we have no
way to directly involve “the community” in public policy.
[12]
5.16 This will provide the basis for the third objective, which is to
recommend a framework for the appropriate regulatory framework. This would
include consideration of other legislative models that have been developed
overseas, to determine whether there are elements of these approaches
that may be worth adopting.
5.17 In particular, the committee considers that it is important to clarify
the appropriate balance between protecting privacy rights of individuals,
and the extent to which law enforcement agencies, insurers, employers
or researchers may collect and use individuals' personal genetic information.
It is also important that a proper consultation process occurs between
the Commonwealth and the States and Territories, to determine an optimum
regulatory structure that avoids uncertainty and conflict between existing
laws. The committee notes that no such dialogue has yet occurred. [13]
This is particularly necessary in light of the subject matter that runs
across a number of areas of regulation, and a mass of existing legislation
in all jurisdictions.
Recommendations
5.18 The committee recommends consideration of the following options:
- Creation of a national working party. The appropriate Commonwealth
departments would be tasked with the administration of the consultation
process, and the establishment of a working group including State and
Territory representatives, experts and representatives of stakeholder
groups. [14]
- That the Commonwealth Government give consideration to a reference
to the Senate Legal and Constitutional References Committee to undertake
a thorough examination of the issues relating to genetic privacy and
discrimination, including consideration of insurance, employment, provision
of goods and services, clinical diagnosis and treatment, conduct of
medical and other research and genetic information concerning children.
- An ongoing responsibility for the appropriate Commonwealth departments
to monitor developments [15], with a view
to drafting legislation as required.
5.19 The relevant working party, parliamentary committee or departments
may draft suggested national guidelines, and make recommendations for
the formulation of a regulatory system, that would reflect community views
and a whole of government approach on the issues involved.
How should the Commonwealth regulate genetic privacy and discrimination?
5.20 Although the committee is of the view that it is premature to legislate
on genetic privacy and non-discrimination, and that further examination
is needed of the appropriate regulatory structures, the committee has
received evidence on this aspect of the issue and makes the following
comments.
Self regulation or legislation?
5.21 An important consideration is whether the self regulatory systems
currently in place (which principally apply to insurance and research)
should be continued.
5.22 The committee notes the view that a self regulatory approach, with
its inherent flexibility, is a useful interim position, while the ethics
and legal issues become clearer. Australia can monitor the evolving situation
and the experiences of other countries prior to finalising a legislative
solution. [16]
5.23 However, the committee was concerned at the lack of enforceable
privacy rights covering the private sector and considers that there is
a need to extend the legislative regulatory structure to the private sector.
[17]
Specific legislation or amendments to existing legislation?
5.24 The committee has considered whether it is more appropriate to have
legislation specifically covering genetic privacy and discrimination or
to reinforce existing legislative and regulatory structures to provide
the required protections.
5.25 It has been argued that genetic information has certain special
characteristics that make it different in character from other information,
and that in the emerging area of genetic technology it is important to
clarify the intention of parliament by creating specific legislation.
Specific legislation also prevents a fragmented approach to the issues.
[18]
5.26 Other submissions have argued against such legislation:
The Bill has attempted to cover the whole field of genetic privacy
and possible discrimination. Its attempt to cover the whole field is
probably its downfall. [19]
5.27 The bill addresses matters falling within quite different areas
of government responsibility and private activity, and in so doing attempts
to prevent discrimination and abuses of personal privacy. The committee
is also concerned that the bill, which draws on the US experience, is
not always relevant to the Australian context.
5.28 The committee considers that it would be more appropriate to amend,
where necessary, existing privacy and discrimination legislation to ensure
that issues raised by genetic technology are adequately covered under
that legislation, for example, the various federal anti-discrimination
acts, the Human Rights and Equal Opportunities Act 1986, and the
Privacy Act 1988.
5.29 The committee believes that such an approach provides a clearer
legislative base. It avoids the administrative and legal confusion created
by having different sets of rules applying to genetic information than
to other personal information. In this context, the committee notes submissions
which argue that genetic information does not differ to any great extent
from other categories of private information. [20]
The committee therefore considers that the creation of a coherent and
integrated national privacy protection system covering all private information
is the most suitable approach. [21]
5.30 Creating specific legislation such as the bill would also cut across
a number of regulatory systems already in place, or in the process of
being established, that are themselves the product of extensive consultation
and negotiation between stakeholders and state, territory and federal
governments. The development of the forensic procedures model provisions
for adoption by Australian jurisdictions [22],
the policy consultation processes under the National Health and Medical
Research Council Act 1992 [23],
and the development of the National Principles for the Handling of
Personal Information [24], are examples
of existing regulatory mechanisms. The committee believes it would be
inappropriate and counterproductive to override these existing arrangements
with regulations that have not been subject to the same level of consultation
or scrutiny.
5.31 At the same time, the committee considers that these processes offer
useful models that could be employed to develop appropriate legislation
for genetic privacy and discrimination.
Recommendation
5.32 The committee therefore recommends that the bill not proceed,
pending the further examination of the issues recommended above at paragraph
5.18 and the development of appropriate amendments to existing legislation,
in relation to genetic privacy and discrimination.
Conclusion
5.33 Recognising the complex benefits and dangers inherent in emerging
genetic technology, the committee considers that the development of a
national approach to issues of genetic privacy and discrimination, led
by the Commonwealth, is needed. However, the committee also considers
that a legislative response is not appropriate at a time when the exact
nature of the technology and the ensuing ethics and legal issues are still
unclear. For these reasons, the committee recommends further examination
of the issues involved, as set out at paragraphs 5.18 and 5.19 above.
In general, the committee does not consider that a specific law covering
genetic privacy and discrimination should be enacted, and recommends
that the Genetic Privacy and Non-discrimination Bill 1998 not proceed,
as set out at paragraph 5.32 above.
Senator Marise Payne
Chair
Footnotes
[1] Submission No. 24, Australian Medical Association
Limited, p.1 and Submission No. 38, Mr Michael Fleming, pp. 14-15.
[2] Paragraph 51(xxix) of the Constitution.
[3] Paragraph 51(i) – trade and commerce
power; paragraph 51(xiv) – insurance power; paragraph 51(xviii) –
copyrights, patents and trademarks power; paragraph (xx) – corporations
power; and section 122 – territories power.
[4] Submission No. 18, Queensland Government,
p. 7.
[5] Submission No. 19, Research Group for the
Study of the Legal and Ethical Implications of Human Genetic Research
in Australia, Appendix 2 (Current Regulation of Human Genetic Research
and Therapy in Australia, Professor D. Chalmers and Dr D. Nicol), p. 33.
[6] Submission No. 2, Health Issues Centre,
Department of Epidemiology and Preventive Medicine, Monash University,
p. 2.
[7] Submission No. 19, Research Group for the
Study of the Legal and Ethical Implications of Human Genetic Research
in Australia, pp. 7-8. See also Submission No. 30, Muscular Dystrophy
Association of NSW, p. 1.
[8] Submission No. 36, Law Council of Australia,
p. 1.
[9] Submission No. 18, Queensland Government,
pp. 6-7; Submission No. 31, SmithKline Beecham International, p. 3; Submission
No. 36, Law Council of Australia, p.2; Submission No. 38, Mr Michael Fleming,
p. 22.
[10] Submission No. 19, Research Group for
the Study of the Legal and Ethical Implications of Human Genetic Research
in Australia, p. 9.
[11] Submission No. 7, Dr Thomas Faunce, p.
1.
[12] Submission No. 11, Ms Heather Dietrich,
p. 2. See also Submission No. 6, Human Genetics Society of Australasia,
p. 1.
[13] Submission No. 47, South Australian Government,
p. 1.
[14] The committee notes the strategy used
to develop the new Australian Oceans Policy: creation of a Ministerial
advisory group, and a consultation process that included workshops, discussion
and issues papers that preceded the release of a final draft policy (Canberra
Times, 30 June 1997, p. 7). Submission No. 19, Research Group for
the Study of the Legal and Ethical Implications of Human Genetic Research
in Australia, at p. 5, suggests that the United Kingdom Human Genetics
Advisory Commission offers a good model for such a body.
[15] A similar course of action was recommended
by the UK Nuffield Council on Bioethics.
[16] Submission No. 19, Research Group for
the Study of the Legal and Ethical Implications of Human Genetic Research
in Australia, Appendix 4 (Implications of the Human Genome Project for
Australian Insurance Law and Practice, Dr Margaret Otlowski), p. 54.
[17] The committee notes that the Commonwealth
Government announced its intention to legislate to extend privacy protection
to the private sector on 16 December 1998.
[18] Submission No. 2, Health Issues Centre,
Department of Epidemiology and Preventive Medicine, Monash University,
p. 1; Submission No. 47, South Australian Government, p. 1.
[19] Submission No. 24, Australian Medical
Association Limited, p. 5.
[20] Submission No. 30, Muscular Dystrophy
Association of NSW, p. 2.
[21] See also Submission No. 40, Privacy Commissioner,
Human Rights and Equal Opportunity Commission, p. 2 and Submission No.
43, ACT Government, p. 1.
[22] Submission No. 15, National Institute
of Forensic Science Australia, p. 2.
[23] Submission No. 8, Australian Health Ethics
Committee, National Health and Medical Research Council, pp. 1-2.
[24] Submission No. 40, Privacy Commissioner,
Human Rights and Equal Opportunity Commission, p. 9.