1	Summary

This report analyses some of the privacy and non-discrimination issues raised by genetic technology.  This is a key step in bringing a full and ongoing debate about these issues to the Federal Parliament. 

The key conclusion of this report is:

I introduced this Bill to stimulate debate, highlight pressing concerns and provide policy initiatives for the Government.  Without a comprehensive privacy scheme, similar to the scheme proposed by the Attorney General in 1996, Bills such as this, and dealing with other areas of particular concern (such as surveillance, smart cards, electronic commerce, etc.), will be necessary.  I would welcome this broader approach to privacy regulation in Australia and I hope the belated recognition of the need for this debate stimulates the necessary activity.  I would also note a range of other issues addressed by this Bill (such as the regulation of Australian research, consent, property rights over genetic materials, etc.) need to be considered in this debate.

I am of the view that genetic privacy (and genetic discrimination) is best dealt with in a comprehensive privacy scheme.  This Bill cannot stand without the broader privacy issues being addressed and should be seen as a contribution to the ongoing debate about privacy and the related issues.  

The key findings of this report are:

•	Genetic technology is worth debating in all sections of the community with important moral and ethical questions to be resolved, and the Federal Parliament has an essential place in this debate; and

•	Adopting science and technology in our community involves questions of values and these are political issues which should be resolved through an informed community debate; and

•	Privacy “rights” in Australia are evolving and genetic privacy (and non-discrimination) are a part of this evolution; and

•	Privacy in Australia should be dealt with through clearly stated and uniform national laws which have an effective complaints, investigation and enforcement mechanism set out in legislation and applying to all sectors of the Australian community; and 

•	Existing regulation of genetic privacy and non-discrimination in Australia is not adequate and should be reviewed and appropriate legislation introduced; and

•	This Bill raises and suggests solutions for a number of complex and unresolved issues in Australia with respect to genetic technology, including:

-	all samples collected for genetic testing should require informed consent; and

-	counselling should be a key component for all genetic testing; and

-	genetic privacy should be regulated on the basis of the autonomous individual, (although this raises issues for family and community genetic information which will require further debate); and

-	genetic discrimination should be outlawed, except in certain circumstances where employees will benefit directly from scientific advances, and insurance companies should only be allowed to collect relevant data necessary for commercial operations and they should not be allowed to use that information to discriminate against an individual or their family.  The onus should be on insurance companies to establish a need to use genetic information to discriminate before any form of discrimination is contemplated; and

-	genetic information in research should be regulated; and

-	mechanisms need to be established for complaints, investigation and enforcement of privacy breaches and discrimination, and this is best done by the Human Rights and Equal Opportunity Commission under the Privacy Act 1988 (Cth) and the Disability Discrimination Act 1992 (Cth); and

-	penalties should be imposed for breaches of privacy and for discrimination; and

•	A number of other issues are discussed, including donated gametes, indigenous issues, constitutional issues, reproductive choices, etc. which require further community debate; and

•	The report concludes further discussion and debate of the issues raised by genetic technology is needed in the Federal Parliament, and at a minimum some legislation is necessary to deal with privacy and non-discrimination issues; and

•	The Australian Democrats welcome a debate on genetic technology in the Federal Parliament, and the participation of all sectors of the Australian community, as a necessary stage in the integration of every new technology into the community.

This Bill places the issues of genetic privacy and non-discrimination on the agenda of the Federal Parliament and provides a basis for further discussion.  I welcome the participation and contribution of researchers and clinicians in the debate about this Bill and other policy issues dealing with this technology.  I also recognise the need for the involvement of different groups including philosophers, lawyers, lay people and community organisations reflecting the broader interests and concerns of the society.  I appreciate the contribution of all individuals and groups taking the opportunity to review the consequences of this technology and legislative initiative, and place their views and thoughts before the Senate.  

2	Structure of report

This report presents a brief analysis of some of the issues as they relate to genetic privacy and non-discrimination, together with a summary of the major arguments presented to the Committee.  The analyses and arguments presented are not comprehensive, but rather the significant arguments presented to the Committee and the first step towards a comprehensive debate about these and other genetic technology issues in the Federal Parliament.  The Table of Contents provides a summary of the major issues considered in this report and the range of issues addressed in submissions to the Committee.

3	Science and the legislature	

3.1	Genetic technology – a challenge worth debating

Justice Michael Kirby has stated:

“Perhaps, from the perspective of history, the most important scientific breakthrough of this century may be seen, in time, to be neither nuclear fission, nor interplanetary flight, nor even informatics, but the fundamental and basal molecular biology which permits the human species to look into itself and find, at last, the basic building blocks of human and other life.  Who knows where this discovery will lead the imaginative human mind?  Lawyers, and indeed citizens everywhere, should begin thinking about the issue.  In its resolution may lie the very future of our species”.

And the University of Tasmania submission states:

“As with other technological and scientific developments, genetics and the Human Genome Project must be explained carefully to the public so that they appreciate the benefits without exaggerating the risks.  We should not shy away from healthy disagreement and the debates about benefits and risks.  It is a hallmark of a generally democratic society that we have differences about fundamental approaches to new challenges and through this process, may make wiser decisions about policy and legislation”.

The debate about this Bill should be just one of many discussions about genetic technology (and science and technology generally) we have in the Federal Parliament.  This is now essential as Governments and the other parties and individuals represented in the Federal Parliament recognise the link between technology and the advancement in health, economic benefits and improved lifestyles for the general population.  However, we must not overlook the potential harm imposed by hasty adoption of new technologies and the failure to consider the broader goals of sustainable employment, environment, health, reconciliation, education, etc.  These are the framework of values which we apply to our everyday lives and we should apply the same principles to technologies we incorporate into our lives.

3.2	Science and technology are political

The dominant paradigm of science likes to present itself as an apolitical, asocial and ontologically objective form of inquiry.  However, like most other intellectual disciplines and issues of the desirability of a science or a technology, there are social values attached to the endeavour and these are political issues which should be determined in consultation with the broader community.  The Privacy Commissioner of Canada contrasts genetic technology with atomic technology (noting the latter is now among the most tightly regulated activity undertaken in our community):

“One is struck by the parallel between unlocking the gene in the '90s and unlocking the atom in the '40s.  In both cases the excitement of discovery dulled critical assessment of the implications.  In both cases we allowed scientists to unleash forces which can alter life as we know it, paid for their efforts with public funds and, at least initially, set few ethical or legal controls on the enterprises”.

Social values set the bounds of what information we should attain and how that information should be used.  This has been established through charters such as the Nuremberg Code, the Helsinki Code, the Belmont Report, the rules established by our Parliaments and by our experience.  The Human Genome project and other technological advances, which provide us with the opportunity of great new knowledge to uncover the considerable human suffering from disease, etc., also brings the responsibility to deal with that new information appropriately: “[w]e accept that knowledge can generally overpower fear; but we have also learned that the application of new knowledge often has a dark side that can lead to brutality and disaster”.  We are responsible for setting legislation reflecting those social values to avoid the “brutality and disaster”.

I am generally of the view that the introduction of technology into our society should be based on consultation and informed debate, so as to avoid an anti-intellectual backlash against technology and the path of ignorance rather than the responsibility of new knowledge.  Genetic technologies are particularly susceptible to mis-informed analysis and debate because of the significant social, and therefore political, effects these technologies will have – few other technologies have the potential to change our very identities. 

Early attempts to address decision making about genetic technology were dominated by a belief in self-regulation.  For example, the 1975 Asilomar Conference was a meeting of scientists participating in what was then called “Recombinant DNA research”, to discuss the possible limits that should be imposed on this new field of research and a moratorium on certain research procedures.  This self-regulation was criticised for the uniformity of participants resulting in a uniformity of outlook and “[t]his was probably the first time in history that the incendiaries formed their own fire brigade” so that “[t]he edit published in due course, which lists the various forbidden items, reads like a combined curriculum vitae of the convenors of the conference”.  That is, the major flaw was the view scientists could self-regulate without public involvement.  This early regulation may have been adequate, but it is the perception of legitimacy which undermines this approach to regulation: “Scientists may be best qualified to calculate risks and to predict benefits…but they have no such special qualifications when it comes to deciding whether the risks should be assumed”.  This sentiment was succinctly stated by Senator Edward Kennedy about the Asilomar Conference:

“It was commendable that scientists attempted to think through the social consequences of their work.  It was commendable, but it was inadequate.  It was inadequate because scientists alone decided to impose the moratorium and scientists alone decided to lift it.  Yet the factors under consideration extend far beyond their technical competence.  In fact, they were making public policy.  And they were making it in private”.

I am conscious of the variety of views which may exist within a vibrant science community.  I am also aware of the flaw in relying on “experts” and the exclusion of the broader community.  This is starkly illustrated by a survey of scientists on social questions about health risks and other information, which found scientists working in corporations were much more likely to share the opinions of their executives, compared to university and government employed scientists.  This debate must not be confined to just the “experts”.  It must involve a range of experts together with the broader community and the “political” resolution of this process should be clearly stated guidelines in legislation.

However, government regulation may often be flawed in its ability to make good laws which deal with unpredictable outcomes.  There is no easy solution to these approaches, but the prospects of genetic technology are exciting and “[s]cientists have the potential to make these discoveries, but some guidance as to how this new knowledge might be used and for what purposes, is required.  It must come from informed discussion within the community”.  Put another way, Schwartz suggests “newly developed genetic information offer us the potential for fabulous medical and social advances – a chance to overcome problems that have cursed our species from time immemorial.  They also offer us an opportunity to perpetuate the worst that our species has developed over centuries, and to develop a true genetic caste system.  We ought to design the legal and social institutions that will control the use of genetic information with the presumption that the intellectual excitement associated with genome research, and the money that will flow from it, will provide powerful incentives for both paths”.

I am also concerned that one of the significant barriers to the proper political debate of scientific issues, such as genetic technologies, is the language.  This contributes to the esoteric perceptions about genetics, but we must not let this stop proper debate of the political issues.  Other esoteric endeavours steeped in technical jargon, such as economics, have been included in the political processes.  The challenge in this instance will be to deal with the language of statistics, rather than the “certainties” of other sciences, and induce public and parliamentary debate away from its focus on economics to the exclusion of other important social issues.

With this discussion we will be better able to identify the great benefits of genetic technology and avoid the potential detriment, dealing with the ethical and moral concerns as well as finding a balance between the need to limit and promote the advancement of this technology through appropriate legislation.  These are public policy decisions and essentially political decisions which should not be made in private.

3.3	New technologies have social consequences

The social consequences of the evolution and development of genetic technologies was noted very early: “Although these accomplishments are still outside the realm of the possible, problems attendant upon them can easily be foreseen.  For example, creating nitrogen fixing plants could severely damage the chemical/fertiliser industry while giving a boost to pharmaceutical firms.  What will it do to food prices and to farmers’ incomes? How will our diet change? Will nitrogen fixing corn and ‘normal’ corn taste different? Will a stigma come to be attached to products that have been genetically treated? Who will know about it? What institutions will have records of it? The point is clear – these ‘benefits’ do not come unadulterated or without social implications”.

New technologies have costs – “technology’s double edged sword” – and consequences.  Technopolitical decisions, such as the widespread making available and use of reproductive technologies, qualitatively affect the essence of humanity with unforeseeable consequences.  Work on practical and operational aspects of these new technologies (technoscience) are not ethically neutral.  Further, the new developments impose new responsibility and new ethical norms, or meta-responsibility – “to be responsible not just for certain actions but for the moral orientation on which all our actions are based”.  For example, “the possibility of prenatal diagnosis compels us not only to make a decision about our behaviour in the very special case of a confirmed congenital disease; it also forces us to decide when human life is or is not worth living (so that, if not, an abortion can be legitimised)”.  These are significant judgements of value and they may not be “beneficial” simply because they progress knowledge.

The lessons of history are significant in this debate, and they show the very significant effects of genetics on society – such as the justification for abhorrent social and political movements.  The long history of the genetic study of Huntington's disease, including compulsory sterilisation laws, the eugenic views practiced in Nazi Germany, the lack of ethics in the context of social inquiry collecting human data, etc., illustrates the social consequences of genetics.  The need to reflect on moral and philosophical issues in genetics is reinforced by this history.  Modern geneticists (and scientists) are not responsible for activities in the past, but they have a central role, together with the broader community to make sure this never happens again.  

The Human Genome Project has rapidly advanced the social consequences of genetics and provides a good illustration of the social issues this technology poses.  Annas has suggested the Human Genome Initiative “provides an opportunity to examine the relationship between science and society”, so scientists and social science policy makers can work together to maximise the benefits of this project while minimising its dangers.  He sets out the legal and ethical issues raised by the Human Genome Initiative as including:

(i)	Individual/family issues – the autonomy and confidentiality of the individual to ensure there is adequate consent to the information being collected and once collected the information is not disclosed without the individual’s consent.  The legal and ethical issues arise through genetic screening and counselling where the individual’s genetic information reveals an individual’s or family’s real or possible genetic problem, or, where an individual’s genetic information may be of interest to an employer or insurer to the potential benefit and/or detriment of the individual or their family;

(ii)	Society issues – the possible benefits to the community of population based screening to identify or eliminate a particular genetic trait where there is mandatory data collection and the results are made public without consent.  Other issues include resource allocation and commercialisation (what resources should be allocated to genetic data collection, who should benefit from the data and how to balance the resources between identifying and treating genetic traits?) and eugenics (how to deal with the past experience of eugenics, how to make and avoid these policies and practices in the future and whether to use genetics to improve our (and other) species)?; and

(iii)	Species issues – with insight into our genetics we will have changed the way we view ourselves and our perspective of ourselves (will we reduce ourselves to the billions of bases making up our genome and will we make genes paramount to our environment?).

Annas concludes:

“The challenge is to get beyond the literary archetypes, the stereotypes, and the cliches, and to work together to develop a coherent set of goals against which to judge scientific priorities and actions.  Once these goals are agreed upon in an open and public forum, it will be reasonably easy to devise methods to accomplish them”.

As a response to these recognised social consequences scientists and policy makers have undertaken a range of approaches.  The United Nations Educational, Scientific and Cultural Organisation (UNESCO) Universal Declaration on the Human Genome and Human Rights is a recent example of this.  The Declaration was the result of a world-wide debate on the ethical, legal and social implications of the development of the life sciences.  The result is a non-binding, non-treaty declaration that is imperative in its nature because it has the flexibility needed in a document that addresses all the cultures of the world and seeks to obtain the widest possible international consensus, and sets out principles of universal value that can adapt to scientific progress: “The Declaration sets universal ethical standards on human genetic research and practices which balance the freedom of scientists to pursue their work in the field with the need to safeguard human rights and protect humanity from potential abuses”.  The Declaration is founded on three basic propositions:

•	That the human genome is part of the heritage of humanity;

•	That human beings should be respected and treated in a dignified fashion regardless of their genetic characteristics; and

•	That genetic determinism should be rejected and there should be recognition that the genome is subject to mutation through evolution and contains potentialities that are expressed differently according to each individual’s natural and social environment.

The General Conference of the United Nations Educational Scientific and Cultural Organisations (UNESCO) adopted, unanimously and by acclamation, the Universal Declaration on the Human Genome and Human Rights.  The General Conference of UNESCO matched the Universal Declaration with a resolution on its implementation, which provides, in part:

“Urges Member States:

(a) in the light of the provisions of the Universal Declaration on the Human Genome and Human Rights, to take appropriate steps, including where necessary the introduction of legislation or regulations, to promote the principles set forth in the Declaration, and to promote their implementation;”

Significantly, Article 7 of this Universal Declaration provides:

“Genetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose must be held confidential in the conditions set by law.”

The agreement to this Declaration is recognition of the social consequences of genetic technology, and an approach to dealing with a new technology.  The Bill reflects these propositions and provides framework legislation reflecting these values and social consequences.

4	Privacy and non-discrimination in Australia

4.1	Privacy in Australia

There is no agreed definition of privacy in Australia, however, there are generally recognised categories, including privacy of the person (privacy in relation to a person’s own body), privacy of space and territory (ability to conduct personal affairs in private), privacy of communications and privacy of information.

In Australia there is no recognised common law “right” to privacy.  However, there are a number of common laws which provide incidental privacy protection, and recent legislation (such as the Privacy Act 1988 (Cth)) has created a framework of enforceable privacy principles.  Privacy in Australia may be traced back to a recognition of the “right” to privacy under international conventions which Australia recognises:

(i)	Article 12 of the Universal Declaration of Human Rights (1948):

“No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation.  Everyone has the right to the protection of the law against such interference or attacks”.

(ii)	Article 17 of the International Convenant on Civil and Political Rights (1966):

“1.	No one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation.

2.	Everyone has the right to the protection of the law against such interference or attacks.”

These covenants have a “powerful” influence on the development of the common law, but compete with the “right” to freedom of speech.

Since these early statements, privacy has evolved as an issue with the advent of new technologies which make the collection, storage and use of information easier.  In 1988 the Privacy Act 1988 (Cth) was enacted following the Australia Card debate.  This Act provides for binding rules dealing with the collection, storage, access, correction, use and disclosure of “personal information”.  The term “personal information” is defined in section 6 of the Privacy Act 1988 (Cth) to mean:

“information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion;”

Since then, the Privacy Act 1988 (Cth) has been amended to extend the scope of privacy regulation in Australia.  This regulation now extends to certain data matching, spent criminal convictions, certain health programs, certain credit rating services, Public Interest Determinations, Tax File Numbers, certain case management services for the long term unemployed, and some telecommunications.  In some of these areas this regulation covers the private sector, although it generally does not apply to the States and Territories (except the ACT).  

Leading into the 1996 Federal Election all main political parties promised to introduce legislation extending the Commonwealth’s comprehensive privacy laws to the private sector.  The Coalition stated that the “Coalition regards personal privacy as a cherished right in a free society” and that the Government would “work with industry and the States to provide a co-regulatory approach to privacy within the private sector in Australia, comparable with best international practice”.  This commitment seemed to be in place when the Attorney General launched a Discussion Paper on 12 September 1996 saying “Privacy protection will be enhanced for all Australians with the extension of the Privacy Act 1988 to the private sector...I intend to be in a position to develop legislation for introduction next year”.

The Discussion Paper released by the Attorney General set out a scheme based on the existing Information Privacy Principles in the Privacy Act 1988 (Cth).  It added Codes of Practice and a range of additional provisions which addressed the particular concerns of the private sector.  In essence this was a proposal for industry codes of practice supervised by the Privacy Commissioner and subject to statutory backing - a co-regulatory approach.  This scheme would have been consistent with the schemes adopted by New Zealand, Hong Kong, Taiwan and the European Union.

Then, on 21 March 1997 the Prime Minister stated: “I took the opportunity of today's Premiers Conference to raise the Commonwealth’s concern's regarding proposals to implement a privacy regime for the private sector...The Commonwealth will not be implementing privacy legislation for the private sector”.  The reasons for this decision was said to be meeting the concerns of business: “The Commonwealth opposes such proposals which will further increase compliance costs for all Australian businesses, large and small...At a time when all heads of government acknowledge the need to reduce the regulatory burden, proposals for new compulsory regimes would be counterproductive”.  

In August 1997, the Privacy Commissioner issued a consultation paper addressed to the introduction of a national scheme for fair information practices in the private sector.  In February 1998, the Privacy Commissioner and the Attorney General launched the first stage of a national scheme for privacy protections.  The Privacy Commissioner is presently consulting with business and government bodies about the implementation and compliance mechanisms.

On 16 December 1998 the Government announced its intention to introduce privacy laws to all sectors of the Australian community.  The details of this proposal are still unclear.

The Australian Democrats have sought on a number of occasions to have the Parliament embark on an informed and inclusive debate about privacy and its various effects on our community, including genetic privacy.  These initiatives have been thwarted by the old parties.  Then on 14 May 1998, the Senate referred a broad ranging privacy inquiry to the Senate Legal and Constitutional References Committee.  The terms of Reference to this Committee are:

“That the following matters be referred to the Legal and Constitutional References Committee for inquiry and report by 12 August 1998:

(1)	The need for Commonwealth privacy legislation to be extended to the private sector, with particular reference to:

(a)	relevant international standards and obligations;

(b)	international comparisons;

(c)	current legislative and other frameworks for privacy regulation in the Commonwealth, States and Territories;

(d)	the role, responsibilities and practices of Commonwealth, State and Territory governments;

(e)	the needs and responsibilities of the private sector; and

(f)	the rights of consumers.

(2)	The effectiveness of any privacy scheme that does not have legislatively- backed complaints, investigation and enforcement mechanisms.

(3)	The appropriateness of using the National Principles for the Fair Handling of Personal Information, as produced by the privacy Commissioner, as a basis for a co-regulatory regime for the private sector and the best means of implementing such a scheme.

(4)	The appropriateness of the provisions of the Privacy Amendment Bill 1998 (Cth).”

This inquiry should address the broader issues and complement other Parliamentary inquires directed at particular issues which have touched on privacy.

Notably, the Government recently introduced the Privacy Amendment Bill 1998 (Cth) to amend the Privacy Act 1988 (Cth) to apply to personal information held by contractors in relation to services provided to the Commonwealth.  This measure became necessary to satisfy public concerns that outsourced personal information would be safe.

Other recent and relevant inquiries include:

•	The Senate Standing Committee on Legal and Constitutional Affairs which is presently investigating the rights and obligations of the media and in particular “the right to privacy and the right to know”.  This Committee is still accepting submissions and has already presented its first report: “Off the record: shield laws for journalists’ confidential sources” (October 1994);

•	The House of Representatives Standing Committee on Legal and Constitutional Affairs which examined the protection of confidential and commercial information held by the Commonwealth (June 1995);

•	The Senate Economics References Committee which considered the impact of telecommunications on industry, employment and the community and involved an examination of the Privacy Act 1988 (Cth) (November 1995);

•	The Senate Finance and Public Administration References Committee which considered service delivery by the Commonwealth Public Service and the role of the Privacy Act 1988 (Cth) (December 1995);

•	The Senate Community Affairs References Committee report, “Access to medical records” (June 1997);

•	House of Representatives Standing Committee on Legal and Constitutional Affairs, Inquiry into the retention of Census data (May 1998).

•	The Senate Finance and Public Administration References Committee inquiry into contracting out of government service including all aspects of outsourcing the information technology requirements of Commonwealth departments and agencies (May 1998); and

•	The House of Representatives Standing Committee on Financial Institutions and Public Administration which is presently investigating alternative means of providing banking and like services in regional Australia.

Australia has considered privacy in a number of other forums, including:

•	The Morrison Report in 1973 recommended a statutory privacy scheme for Australia;

•	Consideration and rejection of legislation by the South Australian (Privacy Bill 1974) and Tasmanian (Privacy Bill 1974) legislatures;

•	The Invasion of Privacy Act 1971 in Queensland;

•	The Privacy Committee Act 1975 in New South Wales;

•	Australian Law Reform Commission report on privacy in 1983;

•	The Privacy Committee Act 1984 in Queensland;

•	The Privacy Act 1988 and (subsequent amendments) by the Commonwealth;

•	The Report to the House of Representatives Standing Committee on Industry Science and Technology, “Genetic Manipulation: The Threat or the Glory?” (February 1992);

•	Attorney General’s Department, Privacy Protection in the Private Sector - Discussion Paper (September 1996);

•	The Health Records (Privacy and Access) Act 1997 in the Australian Capital Territory; and

•	Legislative Assembly of Queensland Legal Constitutional and Administrative Review Committee, Privacy in Queensland (April 1998).

The Senate has recently considered a number of Bills dealing with specific privacy issues.  This has included:

•	Health Insurance Commission (Reform And Separation Of Functions) Bill 1997 (Cth), permits any complaints or investigations under the Ombudsman Act 1976 (Cth) or the Privacy Act 1988 (Cth) and requests under the Freedom of Information Act 1982 (Cth), which may have been or have been made prior to the Medibank Private fund-transfer day, and which relate to Medibank Private, to be completed;

•	Telecommunications Bill 1997 (Cth) was debated in both the Senate and the House of Representatives on the basis that the Government would be introducing a comprehensive privacy scheme applying to the private sector.  Such a scheme would have applied to the telecommunications industry and would have provided an incentive for the industry to develop codes of practice and comply with good privacy practices.  This would have addressed many of the Australian Democrats' concerns;

•	Trans-Tasman Mutual Recognition Bill 1997 (Cth) enacted domestic laws which conform to Australia's treaty obligations with New Zealand under the Trans-Tasman Mutual Recognition Agreement.  The Agreement is directed to removing barriers to goods and occupations between Australia and New Zealand.  This legislation included specific provisions about privacy which ensure that personal information provided to authorities registering an occupation protect the privacy of that information.  This is the recognition in domestic law of an Agreement between Australia and New Zealand and the failure of Australia’s privacy laws to meet international standards;

•	Health Legislation Amendment Bill 1998 (Cth), in part, amends the Health Insurance Act 1973 (Cth) to assist the direction and management by the Commonwealth, States and Territories of the immunisation programs by releasing de-identified data for research purposes from the Australian Childhood Immunisation Register; and

•	Privacy Amendment Bill 1998 (Cth) which would extend the operation of the Privacy Act 1988 (Cth) to Commonwealth contractors as an element in the Government’s policy to outsource government services.  This Bill is presently before the Senate Legal and Constitutional References Committee.

The Australian Democrats have advocated a strong and enforceable national privacy scheme which assures citizens their personal information is adequately protected.  The Australian Democrats would like to see a scheme where every sector is either covered by legislated privacy principles or develop their own codes of practice with the co-operation of the Privacy Commissioner which are tabled before the Parliament as disallowable instruments.  The codes of practice should maintain comprehensive and enforceable privacy protection with powers conferred on the Privacy Commissioner which are similar to those presently set out in the Privacy Act 1988 (Cth).  This is essential to keep pace with the developments in other countries and the advances in information collection and exchange technology. 

I believe genetic privacy (and genetic discrimination) is best dealt with in a comprehensive privacy scheme.  This Bill cannot stand without the broader privacy issues being addressed and should be seen as a contribution to the ongoing debate.  I introduced this Bill to stimulate debate, highlight pressing concerns and provide policy initiatives for the Government.  Without a comprehensive privacy scheme, similar to the scheme proposed by the Attorney General, Bills such as this, and dealing with other areas of particular concern (such as surveillance, smart cards, electronic commerce, etc.), will be necessary.  I would also note a range of other issues addressed by this Bill (such as the regulation of Australian research, consent, property rights over genetic materials, etc.) need to be considered in this debate.  I welcome this broader approach to privacy regulation in Australia and I hope the belated recognition of the need for this debate stimulates the necessary activity.

4.2	What is genetic privacy?

In Australia the major focus of Commonwealth privacy legislation has been to protect so-called information privacy (discussed above).  For example, section 14 of the Privacy Act 1988 (Cth) proposes a number of Information Privacy Principles (IPPs) directed at the protection of information privacy, and particularly “personal information” held by the Commonwealth.  However, these measures are arguably not effective across a range of other privacy categories and types of personal information.  Genetic privacy is a category of privacy that is, arguably, different from other forms of information privacy and should therefore be dealt with as a discrete subject.  This distinction is set out in the second reading speech and has been recognised by a number of other commentators.  

The Privacy Commissioner sets out the reason for being cautious about the use of personal genetic information:

“Our genetic make-up certainly influences our physical characteristics and a wide range of inherited physical conditions; it probably influences important psychological characteristics like intelligence; and quite possibly influences behavioural characteristics like alcoholism and criminality.  Every day particular genes are identified as playing a role in a particular disease or life outcome or behavioural predisposition.  But our genes interact with each other and with our environment in ways which are often extremely complicated and are so far well understood only in simple cases.  So information about out genetic make-up is often ambiguous information about our likely experiences in the most important aspects of our lives.  No more sensitive personal information exist”.

Genetic privacy may be said to be the confidentiality that should apply to any “[g]enetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose.”  That is, a person’s genetic information should be private.  This is addressed in the Bill by clause 7 which defines “genetic information” to mean:

“(a)	information from a DNA sample about genotype; or

(b)	information from mutational analysis; or

(c)	information about nucleotide and polypeptide sequence(s); or

(d)	information about gene(s) or gene products”.

The limits on the “genetic information” is set out in clause 6 of the Bill, which provides:

The objects of this Act are:

(a) 	to define the circumstances under which:

(i) 	genetic information may be collected, stored, analysed, and disclosed; and

(ii) 	DNA samples may be collected, stored, and analysed;

(b) 	to define the rights of individuals and persons with respect to genetic information;

(c) 	to define the responsibilities of persons with respect to genetic information;

(d) 	to protect individuals and families from genetic discrimination;

(e) 	to establish uniform rules that protect individual genetic privacy; and

(f) 	to establish effective mechanisms to enforce the rights and responsibilities established under this Act”.

In a submission to the Committee, the Privacy Commissioner stated personal genetic information had a number of characteristics which made it different from general personal health information and other personal information:

(i)	personal genetic information can predict that a person may develop a particular condition in the future and predictive information may be particularly sensitive because of its “shock value” and potential long time between the prediction and the event makes this information “exceedingly sensitive”;

(ii)	personal genetic information is shared information and allows inferences to be drawn about other relatives;

(iii)	some personal genetic information and especially information that predicts the onset of health problems in the future can result in discrimination on the basis of their genetics;

(iv)	most personal genetic information tells us about probabilities and not certainties;

(v)	a person’s genetic make-up is an intimate part of his or her personal identity, such as brown eyes to psychological characters such as behaviour;

(vi)	the genetic material of a person remains with them all their life;

(vii)	except for sex cells, every other cell in a person’s body contains all their genetic information; and

(viii)	genetic testing is a developing technology making certain results uncertain and open to misinterpretation.

There is some overlap in the application of developed privacy principles across the recognised privacy categories, including the specific category of medical health information and personal genetic information.  In some jurisdictions this has been considered broadly.  However, it has been suggested, “it is appropriate that debate about issues relating to genetic privacy should be kept separate from the general privacy debate, lest the important social issues underlying this Bill become obscured by current contentions on privacy and the private sector”.  I would favour genetic privacy forming part of the broader privacy scheme of regulation, and probably in the form of a co-regulatory approach with a specific code dealing with genetic privacy which is supervised and administered by the Privacy Commissioner (as discussed above).

4.3	What is genetic discrimination?

Genetic discrimination describes the different treatment of individuals and their family based on genetic differences (presumed or actual) and may be distinguished from discrimination based on having symptoms of a genetic disease.  The General Conference of UNESCO adopted, unanimously and by acclamation, the Universal Declaration on the Human Genome and Human Rights, which provides at Article 6:

“No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity.”

This Bill “does not attempt to create new human rights.  The rights it seeks to protect have been long recognised by international covenants and the common law.  The Bill is designed to fence off a ‘loop hole’ of potential abuse of these rights by entities such as employers and insurers”.

Existing Commonwealth discrimination legislation would be relevant in these circumstances, except it is unclear whether this legislation would apply to genetic discrimination in all circumstances.  Particularly concerning is the likelihood the definition of “disability” in section 4 of the Disability Discrimination Act 1992 (Cth) is not wide enough to prevent genetic discrimination where an asymptomatic individual has an increased susceptibility to a condition or has a late onset condition.  I favour a clear recognition of genetic discrimination as an identifiable head of discrimination in legislation and which is supervised and administered by the Human Rights and Equal Opportunity Commission.  The Bill proposes a mechanism (Part 4) to make genetic discrimination unlawful, except in certain limited employment circumstances, administered by the Human Rights and Equal Opportunity Commission and which relies on the range and breadth of international agreements and general statement of discrimination.

4.4	When to regulate?

Technology and innovation based on a new technology are not entirely predictable.  However, where regulation is essential and inevitable, as I believe it is for genetic privacy and non-discrimination, early regulation has significant benefits over delayed and late regulation.  These benefits are partly commercial, in that practices would be implemented and factored into every activity involving genetic information, partly social as the community grapples with an issue seeking acceptable guidelines for the future application of that technology, and partly a measure of community concerns for particular issues.  This sentiment is partly reflected in some of the submissions.  For example, the Privacy Commissioner suggests:

“It is appropriate at this time that we assess whether our current arrangements for dealing with…[genetic]…information are adequate.  I believe there are areas in which they could be improved…I will mention here four issues of particular importance:

•	Every Australian should have a guarantee of access – with the most limited exceptions – to information about their own health, including genetic information.  The law as it currently stands does not provide that guarantee.

•	There should be realistic but binding limitations on the ways in which the many different people who have access to our personal health information are able to use it.

•	No-one should be able to administer a genetic test without providing the person tested with adequate information about the test and its possible consequences.

•	Unless public safety is clearly at stake, no-one should be required to take a genetic test against their will.

As my submission makes clear, I have reservations about the way the Bill tackles some of these issues.  But it is essential that they are addressed by Australian legislatures in the near future.  It may be appropriate for the law to follow some way behind technology but recent explosive advances in the fields of genetics and information technology mean that we need to take some basic steps soon if we are to derive the benefits of these advances without paying too high a price in our personal lives”.

A number of submissions suggested there was no evidence of privacy breaches or discrimination to require legislative action.  However, these claims overlook the anecdotal evidence of particular groups affected by genetic disorders, existing inadequate practices in Australia, past experience in analogous areas and existing reports of dubious practices.  For example:

(i)	the use of HIV/AIDS status to the disadvantage of the person in employment, insurance and the provision of services.  Although this may not be a genetic disease, the reported discrimination against individuals with the condition is significant and analogous to the discrimination expected from disclosed genetic information;

(ii)	prenatal screening without specific consent;

(iii)	the community experience with screening programs for sickle cell anaemia in the United States and insurance discrimination in the United States;

(iv)	the practice of heel prick screening blood samples from newborn babies (Guthrie spots) in Australia is undertaken without formal consent although parents are informed of the general nature of the tests;

(v)	survey of access to stored heel prick screening blood samples in the United States to third parties showed a willingness to release the cards to insurance companies, employers, law enforcement agencies, etc.;

(vi)	the experience of disability discrimination in Australia and in particular the experience of discrimination in employment;

(vii)	the recognition by the House of Representatives Standing Committee on Legal and Constitutional Affairs that census data should be stored confidentially for 99 years and that the records might be used for compiling genetic information;

(ix)	documented examples of discrimination on the basis of predictive genetic information in Australia;

(x)	the particular impact on women of genetic testing: “Researchers conducting a multi-year Pennsylvania study designed to understand how to keep women with breast cancer gene mutations healthy reported that nearly one-third of the high risk women invited to participate in the study refused because they feared discrimination or loss of privacy”; 

(xi)	the likelihood of increasing use of computers in clinical settings where genetic information is easily copied, transferred and analysed (especially sequence data) “raise[s] acute concerns about the confidentiality of genetic records”; and

(xii)	“According to the professor, the technology is improving so rapidly genetic testing will be affordable in the next decade.  ‘Almost every individual will receive some sort of testing as part of standard health care’”.

These examples show there are some serious issues of privacy and discrimination which need to be dealt with.  Existing regulation in Australia may not be adequate to meet these changes.  A review of existing regulation and the consideration of renewed/reviewed regulation is now necessary because of the changing ways research and technology development is taking place in Australia and internationally:

“Although it is often stated that the Human Genome Project, in itself, creates no new ethical issues, it is important to consider how this research is to be conducted.  Interestingly, such research is changing the academic scientific ethos.  Much of the research is being conducted outside the University and those which are involved in the Human Genome Project are being forced to face up to commercialism”.  

Further, Rachelle Lewitan suggested this Bill:

“is an important and appropriate response to a new need which has arisen because of technological advancements in the area of genetic research.  The law must be able to regulate science, and should change to meet new developments which potentially erode human rights which are currently protected by the common law, statute or regulation.  The Bill does not attempt to create new human rights.  The rights it seeks to protect have been long recognised by international covenants and the common law.  The Bill is designed to fence off a ‘loop hole’ of potential abuse of these rights by entities such as employers and insurers”.

4.5	Existing regulation in Australia

Existing regulation in Australia dealing with genetic privacy and non-discrimination relies on a number of Commonwealth legislative instruments, State and Territory legislative instruments, self-regulatory guidelines and the common law.  At the Federal level, the Commonwealth oversees the Commonwealth’s human right package, the Commonwealth’s privacy laws package, self-regulation through the National Health and Medical Research Council (NHMRC), the Therapeutic Goods Administration (TGA) and the Genetic Manipulation Advisory Committee (GMAC), some incidental legislation and some self-regulatory measures confined to particular sectors.  At the State and Territory level, there is some similar legislation, and specific legislation dealing with the donation of human tissues for specific purposes including transplantation, therapeutics and medical or scientific purposes.  

The ACT recently enacted the Health Records (Privacy and Access) Act 1997 which covers personal health information (including genetic information) held in both the public and private sectors with protections comparable to the Privacy Act 1988 (Cth), including requirements for fair, lawful and relevant collection, individuals to be notified about the purpose and handling of personal health information, adequate security, individual access and correction of records and limited disclosures, with complaints handling carried out by the Community and Health Services Complaints Commissioner.  No other State or Territory (except the ACT) has introduced such legislation at this time.  Although there is also some legislation dealing with some issues which might be relevant to genetic information.  For example:

(i)	Freedom of Information legislation in all jurisdictions in Australia, except the Northern Territory, which enables access and correction of some health records, although none of these laws apply to the private sector; 

(ii)	some legislation and some self-regulating for in vitro fertilisation; and

(iii)	residents of nursing homes and hostels are covered by certain State laws (and Commonwealth laws) which provide them with some rights of access and correction of records.

The common law makes no specific provision for genetic privacy, although there may be some incidental protections (such as trespass, nuisance, passing off, injurious falsehood and breach of confidence).  However, the medical profession has a long history of maintaining confidential information from the practitioner-client relationship which forms part of the common law and ethics of medical practitioners, as well as voluntary guidelines, and the common law applying to medical records in the private sector places an obligation of confidence on the record holder.  It is to be noted that an individual cannot access, correct or consent to use or disclosure of the information in that record.  In the public sector generally there is a limited obligation of confidence.

The self-regulation is assisted with guidelines issues according to a Commonwealth legislative scheme.  Section 35 of the National Health and Medical Research Council Act 1992 (Cth) provides the Minister must establish committees, and in particular the Australian Health Ethics Committee (AHEC) which has a very wide brief to develop guidelines for the conduct of medical research involving humans, and in particular section 8 requires the NHMRC to issue these guidelines.  Further, NHMRC funding depend on approval of Research Ethics Committees, which make annual reports to the AHEC.  A draft Statement on Ethical Conduct in Research Involving Humans was issued in July 1998 for public comment as the second stage, after receiving written submissions from October 1996.  The AHEC stated about this second consultation stage: “The first stage of public consultation was advertised and gazetted in October 1996.  One hundred and twenty nine submissions were received.  The AHEC has not comprehensively altered the document, choosing instead to undertake a redrafting process to improve and update the guidelines”.  With respect to privacy this document provides, in part:

“A researcher must ensure that, where personal information about research participants or a collectivity is collected, stored, used or destroyed, this is done in ways that respect the privacy and confidentiality of the participants or the collectivity, as well as any specific agreements made with the participants or the collectivity”.

The Department of Health and Family Services indicated the AHEC were undertaking a work program over the 1997-1999 triennium “developing guidelines for the way genetic information might be gathered, stored, accessed and used and the ethical considerations underpinning those processes”.  This submission also indicated the Government was in strong agreement with the UNESCO Declaration on the Human Genome and Human Rights.

However, there is presently no legislation dealing specifically with genetic privacy and non-discrimination and there are a range of sectors in Australia which are not regulated and have no requirements to conform to any privacy or non-discrimination practices.  It is notable the existing regulations apply to approximately 30% of medical research funded in Australia leaving the remaining regulation to the practitioners and their institutions: “[s]uch protections are without doubt better than nothing but there is no mistaking the heavy emphasis on professional responsibility and the limited recognition of any rights of the people whose personal information is being used”.  The Privacy Commissioner notes that “[w]hile the system appears to be working reasonably well, non-NHMRC funded work may not go through the same processes and the sanctions available for improper use of personal information in the research context may not be sufficient to ensure an adequate level of information privacy protection”.

Further, the patchwork of legislation and self-regulation guidelines is not a satisfactory approach where clear and nationally consistent laws can be implemented.  This is particularly important in Australia following the High Court decision in Breen v Williams which established there is no common law right of access to medical records and in response to which a Senate Committee recommended there should be “comprehensive national legislation enshrining the right of access to medical and other health records in the public and private sectors”.  I am of the view this is a necessary requirement of our laws and should be addressed nationally, through uniform and enforceable legislation.  A component of this reform process will address privacy and non-discrimination in the health sector, the research sector and every other sector where genetic information is collected, stored and used.

I am also concerned the responsibilities placed on Research Ethics Committees (REC) may be unnecessarily onerous and undermine the key role they play in Australia’s research effort.  It has been suggested “there is good reason to believe that RECs are not competent to engage in the complex scientific, legal and ethical decision making which is required of them”.  REC are created according to the NHMRC guidelines under sections 8 and 35 of the National Health and Medical Research Council Act 1992 (Cth), and their review functions and responsibilities are a combination of common law principles, legislative provisions and NHMRC and Therapeutic Goods Administration (TGA) guidelines.  The legal status of the NHMRC guidelines is uncertain, although it is claimed “[i]t is not accurate to describe compliance with NHMRC guidelines as voluntary”.  Significantly, there is considerable medical research conducted outside this review process.  I am of the view the role and functions of the RECs need to be reviewed to make sure they are adequately placed to deal with increasingly complex decision making in all areas of human based research.  This might include clarifying their ethical responsibilities, additional training to assess research proposals and a clear statement of their legal responsibilities.  The aim of any review should be to enhance their role.

The NHMRC under the National Health and Medical Research Council Act 1992 (Cth), is the primary regulator of human experimentation, and this effectively relies on the ability of the NHMRC to regulate through the “big stick” of funding.  It is not clear whether this continues to be the best approach to regulating various research activities in Australia.  The Privacy Commissioner argues that personal genetic information is subject to provisions which apply to personal health information which may be inadequate, and that the guidelines, where they exist, have limited application and no legal force, despite commanding some respect within the professional genetics community.  This is unsatisfactory and this Bill goes towards remedying this situation. 

4.6	Is legislation necessary?

The Privacy Commissioner has examined the privacy implications of genetic testing, although the report was limited in scope to the privacy of personal information, and did not consider the broader human rights issues.  The report concluded the limited number of tests presently undertaken in Australia and their concentration on serious clinical conditions meant that privacy concerns were being adequately dealt with, although “[i]t is impossible to be confident that it will continue to do so”:

“The existing piecemeal framework for handling such [genetic] information is unlikely to be robust enough to strike an appropriate balance between the individual’s right to privacy and the disparate interests of the people and organisations to whom genetic information is valuable”.

The report concluded general policy principles were necessary together with specific codes of practice to individual industries or sectors developed in consultation with the stakeholders and approved by a neutral authority.  The report made no detailed suggestions for general policy principles, but was rather an “initial contribution”.  This report also noted there was a lack of systematic information about how much genetic testing was being done in Australia, how the generated information was handled and future collection trends, all being data that would contribute to policy in this area.  The Privacy Commissioner also concluded the potential for discrimination based on personal genetic information was “clear”.

The Privacy Commissioner argues the existing limited regulation of personal health information is under pressure because:

(i)	increasing health costs may require increasing analysis of personal health information to assign health resources effectively and protect scarce government funds;

(ii)	the exponential growth of information technology which makes the consolidation of personal health information through increasing linkage of information sources a real possibility raising questions of how these links happen, who has access and what safeguards apply; and

(iii)	the increasing diversity of health care providers with a need for access to the personal health information.

The recent inquiry in Queensland recommended that “specific consideration needs to be given to issues associated with the privacy of health information”, particularly in the private sector.  This inquiry also examined a number of other topics (non-information privacy concerns), including “genetics”, and the Committee recommended, “that, given:

•	the complexity of the issues associated with genetic testing and the collection and use of personal genetic information; and

•	the national dimension of many of those issues;

the matter be the subject of further consultation and the inquiry by the proposed Queensland Privacy Commissioner.  However, this consultation and inquiry should be undertaken in light of developments at the federal level and in conjunction with the relevant federal bodies”.

The Queensland inquiry also noted genetic privacy might be dealt with either by:

(i)	“modification” of the existing Information Privacy Principles (IPPs) in the Privacy Act 1988 (Cth);

(ii)	“stand alone legislation addressing genetic information privacy and issues directly related to genetics (such as discrimination)”.

It is notable the Queensland Committee stated: 

“the Committee believes that due to the national dimension of many of the issues arising from the collection and use of genetic information, effective regulation of those issues may need to be addressed on a national basis.  In this regard, the Committee notes with interest the recent introduction of the Genetic Privacy and Non-discrimination Bill 1998 and Senator Stott Despoja’s accompanying comment that: ‘there is a need for the Commonwealth to lead this debate and provide the guidelines’”.

Further, legislation dealing with genetic privacy and non-discrimination is timely because of the distinctive place of genetic technology.  The Nuffield Council on Bioethics clearly identified this issue stating genetic technologies:

“differs from many areas of medical advance in three distinct ways: first, the astonishing speed of its development; second, its inescapable effect not only on individuals, but also on their families and society generally; and, third, the fear it arouses that it may be interfering with the basis of life itself.

Hence the urgency of examining the complex range of ethical issues and exposing them to wide professional and public debate, and of identifying the action to be taken and the further work to be done”.

The Attorney General proposed a co-regulatory approach to privacy protection in Australia which would have legislated privacy principles together with enforceable codes of practice supervised by the Privacy Commissioner for particular sectors.  This scheme, before it was stopped by the Government, would arguably have applied to genetic information and required the development of specific codes of practice to deal with the special place of genetic information.  These would have been enforceable, been supervised by the Privacy Commissioner and addressed many of the issues set out in the Bill.  In those circumstances, there would have been no need for this Bill to deal with privacy, and an effective legislated scheme would have been introduced.  The failure of this initiative has highlighted the need for legislation dealing with genetic privacy (and non-discrimination).  Further, the ACT recently introduced the Health Records (Privacy and Access) Act 1997 to deal with privacy and access to medical records (which in many circumstances would include genetic information) because of a gap in existing legislative protection highlighted by the High Court decision in Breen v Williams.  Both these measures suggest legislation is appropriate to deal with medical information privacy issues, and in particular genetic information.

4.7	International developments

Genetic technology and the potential information following the advances in the technology are conducted from a world perspective.  The issues addressed by this Bill are being faced in other nations and the responses of these other nations to these issues is instructive for Australia.  The following reports are significant and canvass may of the issues raised in submissions, and include:

•	Nuffield Council on Bioethics report by the Working Party on Genetic Screening;

•	United Kingdom Department of Health, “Population needs and genetic services: an outline guide”;

•	United Kingdom House of Commons Select Committee on Science and Technology report on human genetics and its consequences;

•	United Kingdom Human Genetics Advisory Committee report on the implications for genetic testing in insurance;

•	Council of International Organisations of Medical Sciences;

•	European Parliament draft report on the ethical aspects of new biomedical technologies;

•	Task Force on Genetic Testing report on promoting safe and effective genetic testing in the United States;

•	Privacy Commissioner of Canada report on genetic testing and privacy; and

•	United States House of Representatives report on designing genetic information policy.

As a measure of concern for genetic privacy and non-discrimination issues in the United States, 68 bills have been introduced in 28 State legislatures dealing with cloning and genetics, and 16 States have passed genetic privacy laws.

4.8	History of this Bill

Genetic privacy and non-discrimination may be traced to a need to place controls of the potential applications of genetic technology.  Modern science relies on reductionism, or reducing the component parts of nature to smaller and smaller parts.  This has been very successful in modern genetics.  However, the moral and philosophical effects of these developments on society are not a limit imposed on the science itself.  This Bill grew out of an observed need for an informed debate on the broader issues of genetic engineering, so that a moral and philosophical perspective are considered.  This Bill is however limited to the issue of privacy and non-discrimination which are particularly important:

“…increasing demands for, and use of, biological information in all spheres of life, the commercialisation of diagnosis through the development and marketing of diagnostic products, and the social construction of disease, create a market for, and ‘sensitise’, diagnostic information, with resulting risks of discrimination and breach of privacy”.

I have sought to have these issues debated in the Senate a number of times.  I have set out a number of these concerns and my reasons for wanting this debate in the Parliament:

“Recently, I moved a motion to establish a Select Committee to inquire into various social, economic and ethical aspects of genetic technology.  Unfortunately, the Coalition and Labor Party did not consider this is a worthy subject for a Committee, because they claim there are other more pressing issues.  I disagree, and I think many Australians would as well. 

The Commonwealth should lead this debate and provide the guiding principles.  A harmonising national approach is essential to make compliance with any laws as easy as possible and avoid the potential for different, and conflicting, State and Territory legislation.  This has flow on effects for investment in the technology, research and the provision of health care.  Further, a Commonwealth lead will reassure the Australian community that genetic science and (bio-)technology are being used for the benefit of society.”

This Bill was drafted after the Senate rejected my attempts to have a broad ranging inquiry into privacy.  This has now changed with a reference to the Senate Legal and Constitutional References Committee addressing the broader privacy issues, including genetic privacy.  This Bill was introduced before the Senate agreed to this reference, and addressed one of the key issues that need to be canvassed in this debate.  Therefore, many of the reasons for presenting this Bill have been overtaken by the agreement of the Senate to conduct a broad ranging privacy inquiry.  However, I believe the general issues of genetics does need to be further debated in our Federal Parliament:

“The genetic technology is very new, very technical and very complex.  This requires patience, education and tireless explanation of the benefits and dangers to the community in a way they can understand.  This is necessary so the community can make informed decisions and choices”.

Significantly, this Bill has canvassed issues which may not have been addressed in a Senate Committee inquiry principally directed towards private sector privacy of “personal information”.

4.9	Why this Bill?

After considering a range of possible measures to address the potential uses of genetic information, the most appropriate approach, in my view, is clearly stated rules in legislation.  I have set out this view previously with respect to the privacy of “personal information”:

“The Australian Democrats believe personal information should be protected through a comprehensive national legislative scheme.  This should be a strong, enforceable privacy protection which covers both the public and private sectors with powers vested in an independent body to investigate and enforce its decisions based on clear principles of what constitutes a breach”.

Privacy regulation by self-regulation does not provide the certainty and guarantee of protection necessary to safeguard personal information, including personal genetic information.  The reasons for this have been clearly stated by the Australian Law Reform Commission:

“The Commission considers that voluntary privacy codes can never be an entirely effective form of regulation as they suffer from a ‘free-rider’ problem.  This is as the effectiveness of a voluntary scheme depends on whether or not a firm has agreed to participate in the code.  Disreputable organisations, which do not participate in the voluntary code, can ride on the back of the industry’s reputation as responsible and safe, due to the existence of and participation in an industry based voluntary code by reputable organisations.  The voluntary nature of the code can therefore suggest to individual members of the public that the industry has in place adequate levels of privacy protection and safeguards for breaches thereof, and disguise the fact that there is no remedy against disreputable firms which do not voluntarily subject their operations and activities to the privacy code”.

I believe the most effective way to protect genetic information is to legislate for the protection of identifiable DNA samples (or the human sample from which the genetic information is characterised).  The model legislation proposed by Annas et al. accords with this approach:

“…the overarching premise of the Act is that no stranger should have or control identifiable samples or genetic information about an individual unless that individual specifically authorises the collection of DNA samples for the purpose of genetic analysis, authorises the creation of that private information, and has access to and control over the dissemination of that information”.

On 11 March 1997, the Genetic Confidentiality and Non-discrimination Bill 1997 was introduced into the United States Senate by Senators Pete Domenici, Christopher Dodd and James Jeffords. This Act was based on the Annas et al. model, and at its introduction Senator Domenici said, in part:

“Now is the time to have a serious debate in the US Congress about how that [genetic] information should be protected.  The Bill which I introduce will begin that dialogue in the appropriate committee”.

The Bill introduced into the Australian Senate on 11 March 1998 was based on the Annas et al. and the United States Senators Domenici et al. models, with changes to reflect the Australian institutions which deal with privacy and non-discrimination.  However, some of the detailed requirements set out to meet the particular United States institutions have been excluded and some additions have been made to meet the particular institutions we have in Australia.

The number and breadth of submissions confirm the need to canvass diverse groups with their different views and interests on the issues raised in the Bill.  I am also keen to ensure Australia’s leading role as a research centre of excellence in genetics and make sure this includes the social issues.  Australians have a significant role and contribution in the international dimensions to this debate, and Australians must participate with our unique institutions and cultural values.  This Bill will provide a basis for comparison and analyses of Australia’s institutions and practices compared to others around the world and ensure our place in the international debate.

5	Policy issues raised by this Bill

The intention of the Bill is to set out clear guides for the privacy of genetic information and to ensure the genetic information is not used to unfairly discriminate against individuals.  However, in setting out these guides a number of issues are raised which the Bill addresses in achieving its intentions.  The following discussion examines some of these policy issues.

5.1	Constitutional powers

It is always necessary to determine whether the Federal Parliament is able to legislate in this area.  There is no clearly stated Constitutional power to legislate for privacy and non-discrimination and a number of relevant international instruments do not satisfy the criteria necessary for the Federal Parliament to found a power to legislate (such as the UNESCO Declaration on the Human Genome and Human Rights).  However, the Federal Parliament has passed legislation in both the privacy (such as the Privacy Act 1988 (Cth)) and the non-discrimination areas (such as the Disability Discrimination Act 1992 (Cth)) and proposed extending the Privacy Act 1988 (Cth) to the private sector.  Additional sources of power in the Constitution may be derived from a combination of other heads of power (such as subsections 51(i) trade and commerce, 51(xiv) insurance, 51(xx) corporations, 51(xxix) external affairs, 51(xxxiii) acquisition of property, etc.) and preferably with reference of any other necessary powers from the States under subsection 51(xxxvii).  Further support may be available through implied rights, a range of existing powers and their scope and international obligations.

Within the Bill the term “Convention” has been defined to mean “any international agreement to which Australia is a party or has signified agreement” (clause 7).  This in part reflects the broad ranging nature of the subject matter of this Bill and the diverse range of international agreements which have a bearing on the subject matter.  These international agreements include (although it is acknowledged they may not found a complete and valid Constitutional head of power):

•	United Nations Universal Declaration of Human Rights (1948);

•	United Nations International Convention on the Elimination of All Forms of Racism (1965);

•	United Nations International Covenants on Economic Social and Cultural Rights and on Civil and Political Rights (1966);

•	United Nations Declaration on the Rights of the Mentally Retarded (1971);

•	United Nations Declaration on the Rights of Disabled Persons (1975);

•	United Nations Convention on the Elimination of All Forms of Discrimination Against Women (1979); and

•	United nations Convention on the Rights of the Child (1989).

In addition to finding a Constitutional power (or referred power) there is a requirement for consultation with the States and Territories.  This is a process which should be undertaken by government and would be welcomed by the Australian Democrats, although the Federal Parliament must remain able to review and change any legislation which comes before the Federal Parliament.

Bill attempts to maintain the operation of State and Territory laws which are not directly inconsistent with this Bill: “It is the intention of the parliament that this Act is not to affect the operation of a law of a State or of a Territory that is capable of operating concurrently with this Act” (clause 3).  This is necessary to deal with a range of existing State and Territory legislation (predominantly criminal statutes) which this Bill is not intended to displace.  However, it might be necessary to clearly set out which statutes are exempt.  

5.2	DNA samples

This Bill is drafted to protect genetic information based on the protection of identifiable DNA samples (or the human sample from which the genetic information is characterised), although other models have been considered, such as the regulation of data banks.  This approach is favoured because “to effectively protect genetic privacy unauthorised collection and analysis of individually identifiable DNA must be prohibited”.

The Bill as presently drafted provides an inclusive definition of “DNA sample” which recognises the molecular characteristics of genetic material (the DNA, RNA, polypeptides and tissue from which DNA may be extracted) and what is a DNA test (the ordinary meaning), but excludes blood in a blood bank, biopsy specimens, autopsy specimens, clinical specimens and diagnostic specimens (clause 7).  The scope of this definition is broadened by the term “genetic information”, which includes genotype information, mutation information, sequence information and gene or gene product information (clause 7).  The intention of these provisions is to broadly cover the sources of genetic information which should subsequently be private and should not be misused to discriminate against the individual.

A number of submissions suggested the term “DNA sample” was unclear.  This suggested some confusion as to whether potentially all samples in a hospital were included and dried blood spots in newborn screening programs.  Without a legislative measure which captures all genetic information the aims of protecting privacy and preventing unfair discrimination would be undermined.  Clearly, any legislation attempting to regulate privacy and non-discrimination should deal with all genetic information, which no matter what its source may be disclosed or used to discriminate.  For example, if genetic information is collected for one purpose which is outside the scope of this Bill and then subsequently used for another purpose (which would have been excluded if collected within the scope of the Bill), this will undermine the confidence we will have that our genetic information is safe and not being misused.  This approach also avoids the failings identified in proposed legislation in the United States which only regulates the conduct of the end-user, which is not adequate to protect privacy.

The Bill does not define the term “DNA test” in the definition of “DNA sample”.  This was considered appropriate as limitations are imposed on the reach of this Bill by such terminology, and it is the intention of this Bill to apply broadly to circumstances where genetic information is obtained.  This is an issue worthy of further analysis given the potential for poor drafting to have unwanted consequences. 

5.3	Confidentiality and consent

The Privacy Act 1988 (Cth) sets out clear statements of consent (or at least notification where there is compulsory acquisition of personal information) in the section 14 Information Privacy Principles (IPPs), and the limited exceptions to the use and disclosure of that personal information.  

The Privacy Act 1988 (Cth) also sets out duties of confidentiality on Commonwealth agencies in sections 90, 92 and 93.  In particular, section 92 provides:

“Where a person has acquired personal information about another person and the first-mentioned person knows or ought reasonably to know that the person from whom he or she acquired the information was subject to an obligation of confidence with respect to the information, the first-mentioned person, whether he or she is in the Australian Capital Territory or not, is subject to a like obligation.”

Personal genetic information, whether it forms part of a medical record or not, is information which the individual would consider confidential and is arguably subject to a duty of confidentiality by our laws.  The duty of confidentiality may be described as “that the recipient of confidential information is subject to a duty not to use that information for a purpose other than that for which the information was given”.  This is subject to some exceptions:

(i)	where consent has been given;

(ii)	compulsion by law:

(a)	statutory duty to disclose; or

(b)	judicial or other proceedings require disclosure; and

(iii)	the public interest.

The use of identifying genetic information requires the consent of the individual, both in law and ethics: “[i]n law, these objections arise from duties of confidentiality and concepts of privacy while in ethics, objections are based upon principles of respect for autonomy (and its expression in the need for consent), justice and beneficence” or “[t]he legal requirement to obtain consent is based…on ethical principles of bodily integrity, autonomy or self determination and privacy, which impute a notion not only of consent but also of information giving”.  The issue of what consent is necessary remains unclear in our laws, although there has been some guidance from the courts and some guidelines.  However, what consent is necessary is contentious.  So for example, Magnusson has argued:

(a)	“the law requires specific patient consent to HIV testing and genetic screening in order for such testing to be lawful.  Although it is unlikely the failure to obtain specific consent or to provide pre-test counselling would amount to a battery or a breach of duty of care, it may nevertheless involve a breach of fiduciary duty by the doctor”; and

(b)	“where tissue is to be used for non-therapeutic research purposes, the doctor withdrawing the tissue owes the patient a fiduciary duty requiring patient consent to withdrawal for that specific purpose”.

Further, it has been argued that in a society where there is an increasing need to fully inform individuals and treat them autonomously, issues of consent are increasingly important and current practices are failing to achieve what is necessary.  The consent itself in any dispute will depend on evidence of that consent, and the documentary evidence of consent forms.  Hand written notes are useful in any dispute, except they require considerable time and effort which may be impractical.  The alternative is a consent form.  Although here again there are some problems, some of which Nagree has identified as including blanket phrases which authorise a particular procedures and treatments (which are of little value except for procedures to prevent death or very serious health consequences), the individual must be able to understand the contents of the form and what they are consenting too, expiry of the consent and time of consent.  The benefits of an extended consent form (and information sheet) will be to encourage further communications between the health care worker and their patient and where there is any dispute there will be useful evidence.

In discussing what consent may be necessary to undertake genetic tests, Skene suggests the content of the consent “might be expected to include”:

“-	the purpose of the test and its expected accuracy (including probability of error);

-	the method of testing…;

-	risks;

-	the possibility of repeat tests, with or without recontacting the patient;

-	the possibility of incidental findings;

-	how long the DNA will be stored and whether the donor may request that it be removed from storage; and

-	who will have access and under what conditions to the test results”.

Legislation in all Australian jurisdictions provides for consent to the donation of human tissue for specific purposes including transplantation, therapeutics and medical or scientific purposes.  This legislation makes it an offence to remove tissue except with the prescribed consent or for certain other purposes which would include most medical, clinical and research purposes, leaving the issue of consent to the common law.

In a medical context of consensual diagnosis and treatment it is usually assumed there is consent to collect a DNA sample and disclose the information, and where consent has not been expressly obtained it may be implied.  Generally, a competent adult should decide which treatment, action or procedure they will undergo based on adequate information to make an informed choice, and in Australian law this isssue is fairly well settled.  However, where there is an issue of non-consensual diagnosis and treatment, the generally endorsed view is specific consent is necessary, although this is not settled in Australian law.

The Bill deals with consent by making specific provision for what must be satisfied at the time a DNA sample is collected.  Clause 12 provides:

Except as otherwise provided by law, a person may collect a DNA sample from an individual for genetic analysis, only if the person:

(a)	obtains the written authorisation of the individual described in section 16; and

(b)	provides the information to the individual described in section 15; and

(c)	provides the notice of rights and assurances described in section 14; and

(d)	collects the sample in accordance with the authorisation and notice.

And clause 13 provides:

Except as otherwise required by law, a person may store or conduct a genetic analysis of a DNA sample from an individual, only if the person:

(a)	has the written authorisation of the individual and notice has been provided; and

(b)	stores or conducts the analysis of the DNA sample in accordance with the authorisation and notice of rights and assurances.

Clauses 14, 15 and 16 then provide details of the confidentiality and consent requirements, which include all the elements necessary for there to be informed consent where a DNA sample is collected in Australia.  Therefore, the Bill recognises the fundamental importance of adequate information and an informed decision by the person from whom the DNA sample is being taken.  The issue of consent to research is discussed further below.

The Bill is drafted to specifically allow the operation of other laws which have been enacted and which deal with the collection, storage and conduct of “DNA samples” (clause 7).  For example, the Crimes Amendment (Forensic Procedures) Bill 1997, sets out certain forensic measures, would not be inconsistent with the provisions of this Bill.  These provisions will also deal with mandatory genetic testing as part of a health or other program (such as defence, blood donation, etc.) so long as that program is authorised by law.

5.4	Counselling

Counselling should be a key component of any genetic testing for the individual and anyone associated with that individual and the genetic information who needs counselling.  Counselling is necessary to deal with the subtle interplay of social norms and individual choices brought about by genetic information and the need for an individual to make informed choices.

The Bill makes specific provision for counselling where a DNA sample is collected (subclauses 14(h) and 15(k)) to deal with my concern that in any dispute evidence should be admissible as to what counselling was available.  This is a necessary requirement following the decision of McGarvie J in PQ v Australian Red Cross Society to exclude evidence of limited or inadequate resources on the basis the defendant’s negligence was to be determined according to a reasonable person adequately resources for the enterprise.

I believe the effect of the counselling provisions in this Bill make counselling a key part of every sample collection and ensure that counselling will be available.  If counselling is not available, this will be highlighted in every circumstance.

5.5	Collection, storage and analyses of DNA samples

DNA samples may be collected in a number of circumstances, including prenatal (including pre-implant), neonatal, carrier screening of healthy individuals (pre-symptomatic) and as a diagnostic in symptomatic individuals (post-symptomatic).  Samples may also be relevant as biopsy, autopsy and clinical specimens for a range of other purposes, such as identification in criminal matters.

A number of submissions suggested a distinction needed to be drawn between genetic tests for pre-symptomatic conditions, where the individual is presently healthy but with genetic testing may be found to be susceptible to a genetic condition, and post-symptomatic conditions where the individual already exhibits the genetic condition.  Others suggested there were valuable distinctions between genetic tests for monogenic traits and multigenic traits recognising the accuracy and predictability of monogenic trait testing (such as Huntington’s disease) and the uncertainty of the latter (such as a predisposition to heart disease), which new developments were making more reliable and accurate.  Others suggested the Bill failed to recognise the subtleties of different types of genetic testing and their clinical applications.

However, the Bill is drafted recognising that regulation of the collection of the DNA sample is central to adequate privacy protection, and therefore the same rules should apply to all collections.  Thus, genetic information obtained from a routine clinical test may have broader application and it would be inappropriate to distinguish between the same genetic information on the basis of how the genetic test was undertaken.  To avoid this potential it is vital that all collections achieve a basic minimum standard.  Further, the suggested basic requirements are consistent with existing best practices.

The Bill also addressed the issue of ownership of a DNA sample (paragraph 16(1)(f)).  The background to this issue is set out in the Second Reading speech:

“The case of Moore v Regents of the University of California concerned the ownership of biological materials and illustrates the problem.  John Moore was diagnosed to have hairy cell leukaemia and sought help from Dr David Golde at the UCLA Medical Centre.  John's cancerous spleen was removed and Dr Golde and his laboratory cultured cells from the tumour.  They discovered unusual proteins in a cell line and filed a patent.  The matter resulted in a dispute when Dr Golde attempted to get John to sign away his rights, which ended up in court.  The court eventually decided that Dr Golde should have revealed his research to John, but granted the property rights of the cell line for a limited period to Dr Golde.

The effect of this decision was to say that John did not own his own bodily material.  This does not seem to be a satisfactory result and by extension means that bodily material, such as blood and DNA, used to obtain genetic information becomes the property of the tester.  This is unfair.  A patient with their unique biology should not be removed to the status of an interesting source of wealth, and their body and its materials should not be owned by another.”

The Bill provides, at paragraph 16(1)(f), that authorisation:

“must include provision that permit the individual to consent to…(ii) commercial use of the DNA sample, with a waiver of, or a provision for, economic benefit to the individual;”

Although the Bill does not specifically state a property right exists in genetic information, a similar right is effectively achieved by requiring specific consent from the individual to store or release the genetic information (see clauses 12 and 13).  This is a compromise position recognising the need for the issues of ownership and financial benefits to be resolved early on and to avoid bitter dispute, as occurred in the Moore case.  However, this provision is also consistent with proper consent.  An individual, in every case, should know what their DNA sample will be used for, otherwise the consent would not be informed, and they should have some control over its destiny and any benefits that might arise from the information (or tissue).  In the Moore case, the court eventually found a fiduciary relationship between the doctor and his patient.  “It is worth adding that while Australian human tissue legislation prevents donors from selling their tissues in the absence of ministerial permission, reputable suppliers in some jurisdictions are permitted to sell processed tissue for medical or scientific purposes, where it has been freely donated.  Economic incentives to use patient tissue for a researcher’s own interests may therefore exist in Australia.”

5.6	Discrimination prohibited

Genetic discrimination is based on a variation from the “normal” human genotype.  These are subjective assessments and open to abuse because genetic information “is widely viewed, correctly or incorrectly, as saying something about who the person is, not simply what he or she has done, encountered, or eaten”.  Genetic discrimination deals with how genetic information is used and the purposes for which it is use.

Genetic discrimination already exists in the health and life insurance industries, and in a range of other circumstances in Australia and has been reported for the disclosure of genetic tests that revealed false paternity to an unsuspecting husband, disclosure of a person's genetic make-up to a spouse, disclosure against a patient's wishes to relatives at risk, ambiguous test results and disclosure of genetic information to institutions.  This raises the spectre of a new “social underclass” based on genetic discrimination.  There is the potential for genetic discrimination in employment, insurance, education, criminal law, family law matters (such as child custody abuse and the determination of who is a “good parent”), immigration, access to services, etc.  This may be avoided through legal protection (and a health care system) which prevents genetic discrimination.

Legal protection against discrimination is also justified by the following issues.

5.6.1	Rapid pace of technology

The rapid pace of genetic technology promises a mass of genetic information as well as the means to apply this information.  For example, the computer and communications technologies makes the use and transfer of personal genetic information easier and enhances the prospect of using this information contrary to the best interests of the individual.  This concern is expressed by Suzuki and Knudtson:

“Powerful computer systems permit scientists to rapidly sift through a huge quantity of data on human genetic differences – much of it highly tentative – in search of possible statistical associations with health and disease.  As a result, these tentative scientific findings often become available to employers long before the scientific community has had sufficient opportunity to thoughtfully assess them”.

This concern was also raised by the Privacy Commissioner:

“It may be appropriate for the law to follow some way behind technology but recent explosive advances in the field of genetics and information technology mean that we need to take some basic steps soon if we are to derive the benefits of these advances without paying too high a price in our personal lives”.

5.6.2	Genetic determinism

Genetic determinism is a concept that persons are what they are solely because of their genes and include the concepts of naturalism, genetic discrimination (including workplace, insurance, and reproductive testing), genetic justice, and ethical considerations and principles.  These are significant issues in the genetic privacy debate because it has been argued a new genetic determinism serves a conservative social policy that blames ill health on the individual rather than on environment or social conditions, and that genetic prediction can therefore threaten the privacy and civil liberties in our community.  This is a significant issue where genetic information may be used to make predictions.  For example, “[b]ecause genetic information (particularly DNA analysis) is technically reliable, it could play an important part in the diagnostic process.  Unfortunately, its role in prognosis is less certain – a presumed gene for alcoholism will not predict with certainty whether the individual will be a bar room brawler, a sullen quiet drunk, or a teetotaller.  Clinicians will have to guard against the tendency to believe that basic genetic information actually provides useful data for the clinical setting (which it may not), the assumption that an individual is destined to get an illness if a hereditary susceptibility is present, and the notion that the chronicity and morbidity of hereditary conditions are substantially different from those of disorders with non-genetic etiologies”.  

Further, assignment of a genetic “cause” may affect the health of the individual as a result of their perception of their own genetics to the exclusion of other factors (such as prevailing belief systems, vested interests and ideologies).  For example, a study of three groups (the first was screened and found to be carriers of the Tay-Sachs gene, the second was screened and did not have the Tay-Sachs gene and the third was a control group which was not screened) all viewed their present and past health in the same manner, but the carrier group was less optimistic about the future.  

The Australian Democrats are concerned the present narrow focus of our governments on short term economic agendas, with increasing restrictions on welfare spending and a reliance on individuals to meet their own circumstances, will mean there is a real possibility that genetic information might be used to restrict access to government services, other community services, resources, opportunities, etc.  We are concerned genetic determinism should not become an easy answer to justify public policy decisions which reduce some members of our community to a genetic under-class.  There should be an ethics of responsibility to care for the person.

5.6.3	Reliability

A significant concern for the use of genetic information is the reliability of that information and the potential to use unreliable information to make decisions which may severely impact on an individual’s exercise and enjoyment of accepted rights in our communities.  The early experience with DNA profiling in the United States courts provides an insight – DNA profiling promised accurate identification of criminals and was readily applied in the courts.  Despite the promised benefits of these techniques and their ready incorporation of what was a new technology, there has since been considerable evidence of the unreliability of these technique to provide conclusive evidence of identity, etc.  There has been a “tide of unquestioning zeal for technological advances” which has tended to overlook the deleterious consequences of a new technology.  In Australia, the unreliability of DNA profiling has also been questioned, and some reform measures have been considered in the recently debated Crimes Amendment (Forensic Procedures) Bill 1997 (Cth).  This example highlights the acceptance of a new technology for making specific assumptions about genetic information and individuals, which may have significant impacts on the individuals if they are incorrect.

Published anecdotal information on cases of insurance discrimination showed the major problems include the accuracy of test and interpretation of results.  Other example include the statistics for cystic fibrosis genetic testing which show the test failed to detect up to 15% of carriers.  These concerns are stated:

“The danger is that genetic information is often credited with greater probative value than it deserves, in many cases treated as if it was medical fact rather than a prediction.  Genetic information is extremely complex even for medical practitioners.  There are definite limits to the extent of clinical knowledge and it is not uncommon to find disagreement amongst experts regarding the interpretation of genetic test information.  A fortiori, there is greater uncertainty about its relevance in the calculation of risk for the purpose of insurance underwriting.  Many genetic tests change probabilities and are not about certainties.  Establishing relationships between genetic indicators and the economic costs of the risks identified is a painstaking process which must develop separately for each genetic condition – a factor often forgotten because genetic information tends to be thought of in a monolothic fashion.  Indeed, a number of respondents from within the field of clinical genetics predicted that it will be many years, quite possibly decades, before an accurate picture emerges.  In these circumstances, it is not unreasonable to suggest that at this stage, there is insufficient reliable evidence regarding the extent to which genetic test results can be used to predict life expectancy or onset of ill health and it is therefore impossible for insurers to be in a position to use this information accurately”.

5.6.4	What is “healthy”?

I am concerned that shaping definitions of illness and health, normality and abnormality, may reinforce inequities in the distribution of health care and affect our social policy as a result of unfair stigmatisation and ostracism of those who are found to have “undesirable” traits as well as individual revision to “unhealthy”.  It is also likely the cause of disease will shift to the individual (genetic determinism, discussed above) so that we are personally responsible for “our” disease and for dealing with that disease: “[b]y focusing tightly on genetics we frame the relationship between health and responsibility narrowly, excluding other questions that might also be relevant”.  The Bill does not define the term “healthy” in order not to limit the scope of this term.  The Bill relies on the plain meaning of this term as it would be applied to a particular individual.

I am also concerned genetic information may be used to create distinctions and health conditions which go to the diversity we presently have in our communities and which do not address health conditions in a traditional sense.  This is well illustrated by Williams, who states: 

“When I was in America earlier this year it was announced that one in five infants can be found to have brainwaves that denote shyness in later life.  This can be diagnosed as early as four months of age and so is likely to have a genetic component.  What if some clown turns up having supposedly isolate the shyness gene and offering a remedy?”.

The submission from the National Caucus of Disability Consumer Organisations provides the example which shows the important place of this issue in Australia today: 

“…the ethics of technological interventions associated with the deaf community, which is defined in a socio-linguistic sense as a minority, and do not see themselves as either unhealthy, disabled or defective in any way.  They reject the notion of the pathology being deaf, but a hearing perspective sees them to have pathology and to require health intervention.  Whose interpretation is to be used?  This is a good case study given the genetic basis of much deafness”.

The broader community needs to have assurances backed by enforceable legislation to make sure they take advantage of the health and welfare potential of genetic information.  Decisions to take genetic tests should be based on considerations of health and welfare and not a fear of that information being used to deny other benefits or welfare in other circumstances, such as to deny insurance.  Similar concerns exist for genetic testing of children (and others who have a legal disability) and researchers.

5.7	Employment discrimination 

The potential to use genetic information to make employment safer and healthier is exciting.  The contribution of science to human well-being and happiness is one of its highest values.  But, the use of genetic information in employment raises a number of issues which reflect competing interests: equal opportunity against health protection, equal opportunity against free enterprise, fairness to the handicapped against the greatest happiness of the greatest number, individual freedom against social control, common knowledge against privacy and paternalism against autonomy.  Some insight into these issues were very clearly raised in the United States supreme Court decision in United Automobile Workers v Johnson Controls, where the court unanimously ruled it was unlawful to discriminate against fertile women for a specific job because of the possibility of foetal damage.  In this case, the employer manufactured lead batteries and excluded women from employment unless they has proof of surgical sterilisation on the basis that exposing fertile women to lead might damage a foetus.  This case showed the potential for unfair discrimination because lead is harmful to all adults, rather than just fertile women.  The focus was on excluding a particular high risk group rather than removing or controlling the hazard in the workplace.  The employment choices of one group should not have been excluded where the hazard was shared by all workers.  Genetic testing of employees is susceptible to this same oversight. 

There are a number of examples of employment discrimination based on genetic information that have already been reported.  For example:

(i)	earlier this century those with a fair or freckled complexion were often turned away from employment in tar and creosote factories because they were believed to develop skin cancers as a result of exposure to the petroleum products; and

(ii)	in the 1970s the United States Air Force screened African American trainees for the sickle cell anaemia blood trait which occurs in their community on the basis that it might interfere with the oxygen carrying capacity at high altitudes, even though there was no evidence of an effect.

Workplace genetic screening may be considered as:

(i)	genetic screening tests – a test applied to every employee who is taking up employment at a particular workplace and directed to determining a predisposition or susceptibility to a workplace hazard.  That is, screening for susceptibility in a workplace.  For example, a glucose-6-phosphate dehydrogenase deficiency may be associated with oxygen depletion and damage to the employee with prolonged exposure to naphthalene, and so screening a possible employee for this deficiency, if it in fact exits, may prevent damage to the employee or unfairly discriminate against the employee;  and

(ii)	genetic monitoring tests – a test to assess the possible genetic effects of a workplace on an employee.  For example, workers exposed to1,2-dibromo-3-chloropropane have a high propensity to sterility from non-disjunction of the Y chromosome during meiosis and can act as an early warning sign for unsafe practices in a workplace.

Most of the debate and evidence of workplace genetic testing is found in the United States.  The relevant issues in Australia are significantly different from the United States, because Australia provides a universal health system and social security system as a safety net to (almost) anyone excluded from employment.  In the United States health care is available in an emergency and in other circumstances a person receives health care according to what he or she can pay for.  However, the issue of cost shifting from employer to another individual or group is a live issue in Australia, because any individual excluded from employment will usually be supported by the taxpayers (at least in part).  

The present laws in Australia would operate to prevent some forms of discrimination based on genetic information, including the Sex Discrimination Act 1986 (Cth) on the basis of sex, the Racial Discrimination Act 1975 (Cth) on the basis of race, the Disability Discrimination Act 1992 (Cth) on the basis of disability and some of the State and Territory non-discrimination legislation.  The effect of existing laws would allow, subject to some exceptions, employers to require genetic information as a pre-condition to employment.  The issue is more complex where an employee is presently “healthy” and may have a susceptibility to a genetic condition.  In these circumstances there is no clear law in Australia, although it might be argued:

(i)	an employer owes their employees a duty for occupational health and safety which is met by obtaining genetic information about workplace hazards; or

(ii)	an employer owes their employees a duty for occupational health and safety which is satisfied by identifying potential workplace hazards and offering to obtain genetic information.

Once this information is available to an employer, the Disability Discrimination Act 1992 (Cth) would make any use of that information against the employee unlawful, because genetic information of susceptibility is most likely a “disability” for the purposes of the Disability Discrimination Act 1992 (Cth) because it is about a disability that may exist in the future or is imputed to the person.  Any use of that information could not be justified to discriminate against the “healthy” employee because the employee would be able to carry out the existing work tasks, etc.  However, it might be argued that every individual carries some deleterious gene(s) making everyone disabled and therefore the legislation meaningless.  These uncertainties are best addressed through clearly stated provisions in legislation.

I am of the general view that employers in Australia should not exclude employees who might impose some costs on the employer as a result of available genetic information, because this will be detrimental to the individual employee and the broader community.  This is likely to arise through pre-employment and post-employment genetic testing to screen out potential employees for on-the-job health costs, although it is likely many of these decisions will not be directly related to the persons employment skills.  However, I accept the great potential from genetics (and science generally) to make employment safer and healthier and we should not exclude this potential with a blanket exclusion on genetic discrimination in employment.  For example, there may be a very real value in genetic testing in employment to uncover genetic damage from pollutants, or more generally, where a genetic condition were so rapidly serious and irreversible that monitoring could not prevent harm, if data demonstrate that abnormality results in many susceptible persons.  There are very few examples of such circumstances, although screening for sickle cell anaemia provides one such example.  The Nuffield Council reports:

“In the one genetic screening program currently in use by a UK employer, those who apply to join occupational categories of HM Airforce which involve exposure to atypical atmospheric conditions undergo sickle cell screening.  An example is aviation.  Candidates who are carriers of the sickle cell gene are considered to be unfit for duty in such occupational categories.  They may, however, be accepted for other duties.  This is primarily because of the risk of sickling on exposure to reduced atmospheric pressure or hypoxia.  (Sickling is a change in the shape of the red blood cells which can lead to blockage of blood vessels).  Candidates with sickle cell disease are considered to be unfit for any form of service.  This screening process is not part of a NATO-wide program although other NATO Forces undertake sickle cell screening and may have different policies on acceptability”.

I have proposed a measure which makes discrimination on the basis of genetic discrimination unlawful except in the stated exceptions (see clause 17).  Employment is one of these exceptions (clause 18) and is subject to the following limitations - the genetic information may only be collected and used:

(i)	to enable a susceptible employee to avoid a dangerous workplace containing substances that are mutagenic or teratogenic; or

(ii)	where a genotype that is necessary for a work and this is consistent with business practices; and

(iii)	in all circumstances this is further confined by the need that this distinction must not restrict the rights and benefits of the employee or prospective employee.

I am of the view this, or a similar provision is suitable, because:

(i)	this leaves open the potential to use positive and beneficial discoveries from genetics (and science generally) to improve the health and safety of a work place;

(ii)	this is consistent with other discrimination legislation in Australia which recognises there are some limited forms of acceptable discrimination in employment;

(iii)	this places a responsibility on employers to make sure their workplaces are healthy and safe by removing their claim they could not take advantage of genetic information because it would be discriminatory;

(iv)	this does not allow employers to create unhealthy and unsafe workplaces and then select employees who will be less susceptible to exposure at work because this will not be “directly related to the work” or “consistent with business necessity”;

(v)	the term “business necessity” is used because it is a broad ranging term which requires a comparison of the particular practice in question together with similar practices in other businesses which would very likely highlight any discriminatory practices; and

(v)	this does not remove the requirement that any genetic information be dealt with according to the provisions of this Bill.

The presently formulated clause leaves open the possibility an employer could make employment or prospective employment subject to the provision of genetic information.  This analyses would be subject to the stringent provisions of the Bill which require informed consent, information and a range of other protections including a duty to inform the individual their genetic information might exclude the person from employment.  I am always concerned about requiring information when this relates to fundamental questions of individual rights (and in this case dealing with some of our most personal information) and the delicate balance between individual freedom and social control and paternalism and autonomy.  In this circumstance it is significant that employers have greater resources than an employee or prospective employee (information to know what genetic advances are relevant to the workplace and money and infrastructure to undertake the appropriate testing) and an employer would be bound by the strict rules set out in the Bill for the collection, storage, use and disclosure of any genetic information.  Any other uses of the genetic information in employment, other than those set out in clause 20, would be subject to the existing non-discrimination legislation (discussed above).  It may also be appropriate to provide specific assistance in finding work for anyone excluded from a workplace because of their genetic information.

This formulation is consistent with similar measures recommended against the unregulated use of genetic information by employers and in proposed legislation in other countries.  However, an alternative formulation of this provision which maintains the potential to benefit from the advances of science to make workplaces safer and healthier might be a blanket exclusion on discriminating use of genetic information, subject to specific exemption by regulation.  An example of this approach is suggested by paragraph 30(2)(h) of the Sex Discrimination Act 1984 (Cth), which provides “the position is declared, by regulations…to be a position in relation to which it is a genuine occupational qualification to be a person of a particular sex”.

5.8	Insurance discrimination

In the United States, President Clinton recently said:

“We know that in the 1970s, some African Americans were denied health care coverage by insurers and jobs by employers because they were identified as sickle cell anaemia carriers.  We also know that one of the main reasons women refuse genetic testing for susceptibility to breast cancer is their fear that the insurance companies may either deny them coverage or raise their rates to unaffordable levels.  No insurer should be able to use genetic data to underwrite or discriminate against any American seeking health insurance.  This should not simply be a matter of principle but a matter of law”.

Australia has a different health scheme from that in the United States, so the issues in Australia are similar, while having a different context.  In Australia, health insurance is provided universally under the Medicare scheme which has no place for genetic information in its determination for eligibility, and private health insurance, which supplements this scheme is regulated under a statutory scheme which prevents genetic information from being used to discriminate.  The major focus of this debate in Australia therefore focuses on other forms of insurance, such as life, disability, trauma, property, employment, etc. insurance.

There is no evidence of insurance discrimination on the basis of genetic information in Australia, although there are anecdotal reports and an acknowledgment that it is possible.  There is evidence of such practices in other countries.

Existing laws in Australia allow insurers to take existing genetic information (as well as family medical history which might include genetic information from other family members) into account when underwriting insurance.  The only limitation at present is the insurer may not discriminate within the framework of existing Australian non-discrimination laws.  For example, section 46 of the Disability Discrimination Act 1992 (Cth) provides, in part:

(1)	This Part does not render it unlawful for a person to discriminate against another person, on the ground of the other person's disability, by refusing to offer the other person:

(a)	an annuity; or

(b)	a life insurance policy; or

(c)	a policy of insurance against accident or any other policy of insurance; or

(d)	membership of a superannuation or provident fund; or

(e)	membership of a superannuation or provident scheme;

if

(f)	the discrimination:

(i)	is based upon actuarial or statistical data on which it is reasonable for the first-mentioned person to rely; and

(ii)	is reasonable having regard to the matter of the data and other relevant factors; or

(g)	in a case where no such actuarial or statistical data is available and cannot reasonably be obtained – the discrimination is reasonable having regard to any other relevant factors.

The effect of this provision would be to allow an insurer to discriminate against a person on the basis of their genetic information (assuming the genetic information was a disability for the purposes of section 4) if there is actuarial or statistical data, data and other relevant factors, or where there is no data then having regard to undefined but reasonable relevant factors.  This regulation of insurance contracts allows distinction between individuals, and arguably this includes discriminating on the basis of genetic information, although it prevents discrimination which is not based on relevant grounds, and where an applicant’s future may be properly estimated then discrimination will be lawful.  The key issue remains in this assessment – what is reasonable?  For example, would a low risk from a pre-symptomatic test as determined by actuarial and statistical data be sufficient ground to discriminate, and how low would the risk have to be for it to be un-reasonable?

The issue of whether insurance companies should be able to use genetic information in their assessments is conflicting, and often depends on the perspective of the advocate.  For example, insurance companies, those being or likely to be tested and medical geneticists view the issue differently.  The different views may be stated as:

(i)	against any use of genetic information in insurance – “There is no epidemic of genetic conditions.  They are already reflected in the actuarial tables used by insurers to establish rates.  It is misleading for insurers to suggest that their financial solvency will be jeopardised if they are obligated to insure people at risk for genetic conditions.  Previously, however, it was not possible to identify those people at risk for genetic conditions before they became ill with the disorder.  There is no reason for insurers to begin to use this new predictive information now, merely because it is available”;

(ii)	for the use of genetic information in insurance – “…insurers must have access to the results of genetic tests already undertaken and which are known to the prospective insured in order to protect themselves from the adverse selection by at-risk individuals.  It is argued that is insurance companies are denied information about results obtained, widespread adverse selection may threaten the solvency of life insurance companies, particularly if there is a converse trend for those whose genetic test results indicate very low risk of early death not to take out life insurance.  The argument runs that if there is a disproportionately high level of high risk individuals amongst the insured population, the level of claims will increase, thereby increasing the cost of life insurance for the majority of the population.  This is turn would reduce the number of low risk people prepared to pay for cover, with people on lower incomes most likely to be affected”.

I am of the view genetic information should not be used by insurance companies to exclude insurance coverage.  The reason for this clear view is the ability of the insurance industry to undertake their business up to now without genetic information, the unreliability of most genetic information in insurance decisions, the considerable undermining of confidence for an individual making a health and welfare decision where that the genetic information in another circumstance may disadvantage them and the very great impact the use of this information will have on the individual (discussed above).  The formulation of clause 19 effectively excludes the use of genetic information in any assessment of insurance for a “healthy” person (and their family), while allowing insurance companies to collect information which may be relevant to the making of actuarial and statistical tables.

Some of the submissions suggested the Bill failed to address the situation where individuals with a known genetic condition used that information to obtain an unfair advantage from insurance.  These are a valid concern and clause 19 specifically addresses this concern by allowing insurance companies to collect information (subject to the provisions of the Bill) which will enable a proper assessment of these concerns.  The insurance companies are better placed to collect, assess and lobby governments for changes to legislation if their information establishes those with known genetic conditions do obtain an unfair advantage from insurance.  Without this data, the development of fair and equitable rules allowing insurance discrimination are unlikely and the onus should be on the insurance companies to establish their case.  This approach is also supported by the uncertainty of the decision making process in purchasing insurances and whether genetic information would be a decisive factor, the likely impact of particular individuals on the insurance pool and the time frame of insurance.  This approach may also provide data on different sectors of the insurance industry which may then need to be dealt with differently.  For example, disability insurance from genetic conditions is likely to affect more people that life insurance which may requiring tailored legislation to reflect these sectoral differences.

Perhaps, insurance companies should have the right to ask about relevant genetic tests in large or unusual life insurance applications, but not for “normal” policies.  This approach has been adopted in other countries and has some support in Australia.  However, this is a compromise between the interests of insurers and the insured and leaves open the problems of adequate information necessary to make informed decisions about the incidence and validity of claimed insurance discrimination (and whether it is justified), what is a fair level for a “normal” policy and the effects of this approach on the commercial viability of the insurance industry.  It is notable many of the criticisms of this approach are similar to those of a complete ban on using genetic information, and without relevant actuarial and statistical data the same inconclusive result.  Particularly, this applies to arguments that excluding genetic information from insurers will result in increased premiums beyond the reach of low income, as a ceiling approach will arguably have the same effect.  Further, the Human Genetics Advisory Commission in the United Kingdom concluded:

“it is unlikely that actuarially important genetic predictions of common causes of adult death will be available and validated for some time to come…On balance…the life insurance industry could currently stand limited adverse selection…Concern about the perceived threat of discrimination by insurers…remains an important issue and…the Advisory Committee on Genetic Testing should keep the situation under review…We recommend that for the time being the insurance industry should respect a moratorium on requiring disclosure of genetic tests”.

No attempt has been made to define the term “healthy” (discussed above).  However, where a person ceases to be “healthy” and an insurance company uses their genetic information, the insurance company would be subject to the existing provisions of the Disability Discrimination Act 1992 (Cth) and limited to making use of that information according to actuarial or statistical data, data and other relevant factors, or where there is no data then having regard to undefined but reasonable relevant factors.

5.9	Research

Where samples are collected for the purposes of research, the questions of confidentiality and consent are relevant because of the sensitive information which may be made available (discussed above).  In any legislative scheme, it is necessary to balance the possible legal requirement for specific consent and confidentiality against the public interest in conducting research and the possible difficulties obtaining specific consent in every circumstance.  This is a difficult balance because of the equivocal nature of confidentiality in the public interest.  Further, the form of consent has been described as the “lightning rod” for dissatisfaction with a regulatory scheme for research into humans:

“…in open national meetings of serious scholars interested in safeguarding individual privacy, informed consent was denounced as meaningless, in a nihilistic diatribe.  On the other side, those who embrace the primacy of autonomy and informed consent are sorely vexed by the way the legalistic consent form has usurped the opportunity for communication, dialogue, understanding and shared decision-making…”

However, on balance I am of the view specific consent should be necessary because:

(i)	it would be unethical to diagnose an individual anonymously because they might not be warned to obtain treatment (subject to their not wanting to know) or be able to warn others (for example, of an infectious disease); and

(ii)	the better view is specific consent is required by law; and

(iii)	the non-consensual disclosure of confidential information for medical research does not fall into any of the exceptions because it does not maintain the doctor patient relationship, is not required by law (subject to some existing statutory exceptions) and “does not support the public interest in that medical research is not a public responsibility in the way that enforcement of the criminal law is”.

It must also be recognised the issue of consent is some circumstances will remain difficult and contentious, especially where the research subjects are cognitively impaired.

An additional reason for seeking specific consent may include “a professional or career interest in obtaining tissue samples for research purposes which potentially conflicts with their [the doctor’s] role as physicians”.  The example of the United States case Moore v Regents of the University of California highlights this potential conflict.  Further, the person’s specific knowledge is necessary to protect the patients interests, which has been stated:

“As doctors we implicitly promise that when we do things to our patients – especially when we cause them some pain and remove bits of their bodies – we do so to benefit them, and it is partly on the basis of that implied promise that patients and society allow us to do the extraordinary things that we are allowed to do…We trade on a deceit…if without either explicit or implicit permission we start using our patients for the benefit of others.  The deceit is compounded if in so using our patients we discover important information that they may wish to know and we have deliberately both failed to find out whether or not they would wish to know it and so organised matters that we cannot pass it on even if they wish to know”.

However, specific consent may be inappropriate where samples might be used in research not contemplated at the time the sample was collected and where DNA samples have been collected and stored for other purposes and have relevance to a new research project.  Seeking consent in these circumstances may be difficult.  However, the potential harm from this information where it is linked to an individual (or family) is no different to other genetic information and should attract the same measures of consent, etc. 

The proposed clauses in Part 5 of the Bill recognise the special place of research and propose some modified measures for dealing with genetic information for research purposes.  This accounts for the definition of “research” and “researcher” in clause 7.  If a person satisfies these terms they can rely on the special provisions which in most instances relax the strict regulation of DNA sample collection, storage and analyses set out in Part 3.  For example, the disclosure of information for statistical or epidemiological studies without the authorisation of the person from whom the sample was collected, but subject to provisions which maintain the privacy of the individual (clause 21).

The Privacy Commissioner notes Part 5 of the Bill “largely sets out good practice in the research context”, however, “[t]he main question is whether incorporation of these standards in a Bill of this kind is desirable at this point in time”.  I have set out the reasons for community participation in the research effort, and point in particular to the research sectors not presently covered by any form of regulation (discussed above).  The Bill as drafted reflects most of the requirements of the NHMRC draft Statement on Ethical Conduct in Research Involving Humans and enshrines the DNA sample must be “essential to the research project” and “the potential benefit of the research project to society outweighs the potential risks to the research subjects” as necessary for the collection of any information (paragraphs 20(1)(a) and (b)).  These phrases rely on existing ethical standards to determine the research norms in Australia, and would require all research conducted in Australia covered by this Bill to comply with these norms, which would undoubtedly be guidelines such as the NHMRC draft Statement on Ethical Conduct in Research Involving Humans, the Human Genetics Society of Australia Guidelines for DNA Predictive Testing, etc., as well as existing legislative schemes, such as the guidelines issues by the NHMRC and approved by the Privacy Commissioner under section 95 of the Privacy Act 1988 (Cth).

I am of the view clearly stated regulation is required to provide guidance to researchers.  The existing patchwork scheme is flawed because it has limited operation, relies heavily on self-regulation and sets out vague concepts of privacy which are unclear.  The following examples illustrate these flaws:

(i)	the NHMRC draft Statement on Ethical Conduct in Research Involving Humans sets out “Ethical Principles”, and provides, in part:

“A researcher must ensure that, where personal information about a research participants or a collectivity is collected, stored, used or destroyed, this is done in ways that respect the privacy and confidentiality of the participants or the collectivity, as well as any specific agreements made with the participants or the collectivity”.

(ii)	the section 95 of the Privacy Act 1988 (Cth) guidelines have a limited scope, with subclause 2 of the guidelines providing, in part:

“The guidelines apply to medical research undertaken by a researcher not employed by a Commonwealth agency where that research involves personal information obtained from a Commonwealth agency the disclosure of which may involve a breach of an Information Privacy Principle (IPP).  However, it is recommended that the guidelines be applied to all research involving the use of personal information”.

5.10	Other breaches and penalties

The Bill proposes a range of other penalties for breaches if the matter is outside the scope of investigation and determination by the Privacy and Human Rights and Equal Opportunity Commissioners.  The provisions may apply to a person who negligently or wilfully, or induces another to negligently and wilfully, collect, store or analyse a DNA sample, and gives the court considerable latitude to order compliance with the Bill, equitable relief, actual damages, fixed damages amounts and the costs of any action.

5.11	Genetic information and the criminal law

In Australia there are a range of State and Territory forensic procedure provisions which affect the collection, storage, analysis and disclosure of genetic information.  The Commonwealth Parliament is presently considering the Crimes Amendment (Forensic Procedures) Bill 1997 which introduces into the Crimes Act 1914 (Cth) model provisions developed by the Model Criminal Code Officers’ Committee of the Standing Committee of Attorneys-General and incorporating a number of recommendations of the Victorian Consultative Committee on Police Powers of Investigation.  This Bill:

“lays down a principled and balanced regime for carrying out forensic procedures during the investigation of Commonwealth offences, and for the storage, use and destruction of material derived from those procedures.  The Bill carefully balances the rights of the suspect against the public interest in gathering evidence of serious offences.  The rights and interests of suspects are protected by providing numerous safeguards, and by requiring scrutiny of magistrates before the carrying out of most procedures where a suspect does not or cannot provide consent.  Further safeguards have been built in to protect those under 18, persons who are ‘incapable’, and Aboriginal and Torres Strait Islanders, as those groups may be particularly vulnerable in the circumstances contemplated by the Bill”.

In other countries there has been considerable discussion and the introduction of some legislation dealing with the use of DNA samples and information banks.  For example, a United States Government report examined a Florida criminal conviction based on “DNA fingerprinting” which greatly raised interest in using these tests as well as raising concerns about infringement of civil liberties.  The linkage of information in public and private sources was seen as equivalent to creating a national database, raising issues of informational privacy, data security and the quality and reliability of the data.

The (Genetic Privacy and Non-discrimination) Bill in clause 3 and Part 3, clauses 12 and 13 makes special provision for the collection, storage and analysis of materials that would otherwise be covered by that Bill.  In clause 3 there is specific saving of State and Territory laws which may operate concurrently with this Bill and clauses 12 and 13 include the words “Except as otherwise provided/required by law” to enable the operation of other legislation.  This would allow the operation of legislation such as Crimes Amendment (Forensic Procedures) Bill 1997 (Cth) and State laws such as the Criminal Law (Forensic Procedures) Bill 1997 (SA) and the Crimes (Amendment) Bill 1997 (Vic).  The suitability of State and Territory laws or other Commonwealth legislation operating concurrently or in addition to this Bill are not considered here.

The Privacy Commissioner accepts there may be some justification for collecting and storing genetic information, although she cautions:

“…unconstrained collection and use of a DNA sample in this context, as in the health care context, would raise significant privacy issues.  There are three points that I regard as particularly important:

primary legislation should specify that the only information about those convicted of serious crimes of violence may be included an any identified DNA database; it is essential that the list of offences is determined by a disallowable instrument so that any proposal to extend the database must be considered by Parliament;

if a conviction is overturned on appeal, there must be procedures in place for the person’s DNA sample be returned to them or destroyed and for the profile derived from that sample to be removed from the national database; and

each jurisdiction should introduce legislation limiting the use and regulate the management of its sample collection; this is the most effective way of managing the risk that samples, or information generated from them, may be misused”.

6	Other issues

6.1	Donated eggs, sperm, embryos, etc.

The issue of privacy and discrimination for the group identified as conceived from donated eggs, sperm or embryo have not been considered in detail by this Bill.  As some submissions suggested, for example, from the Donor Conception Support Group, these are complex issues and they need to be addressed.  It is notable that this Bill is drafted to incorporate the various State legislation dealing with aspects of donor conception (see clause 3) and in part ascribes genetic information to the “biological mother” (see subclause 24(1)).  However, it is acknowledged there is some overlap between this Bill and various State and Territory legislation and some failure to comprehensively cover these issues and this does need to be addressed.  For example, discrimination against those donating gametes for donor conception.

6.2	Consultation with States and Territories

The Queensland Department of Premier and Cabinet suggested there was a need for this Bill to be addressed through the Commonwealth-State consultative process managed by the Commonwealth Department of Prime Minister and Cabinet, especially as this Bill puts into effect principles contained in the Universal Declaration on the Human Genome and Human Rights.  The Australian Democrats would welcome this process and urge the Government to deal with this issue in this forum. It is notable from the submissions a number of States and Territories believe genetic privacy and non-discrimination needs to be debated, although others question the need for such legislation.

6.3	Indigenous issues

The foundation of this Bill is the autonomous individual and the definitions of “individual”, and “person” (clause 7) recognise this foundation.  However, I am concerned the place of genetic information in a range of groups does not meet this individual approach, but rather a family or community or group approach.  I accept this is an issue which requires further attention, together with a broader discussion of intellectual property rights, etc. of indigenous peoples. 

6.4	Reproductive choices

Genetic information is information which may be used to make reproductive choices to avoid conception or terminate pregnancy, change the “character and mood” of pregnancy, select a partner, etc.  The benefits of prenatal testing have been significant, with tests for phenylketonuria (PKU), cystic fibrosis (CF), Tay-Sachs, sickle cell anaemia, etc. considerably reducing the anguish of disease, impairment and suffering.  However, difficult moral and ethical issues arise about how these reproductive choices are to be made and the consequences of these choices on individuals and the broader community.  The issues for regulation in this area are considerable because procreative freedom demands individuals make these decisions.  However, regulation might have a significant beneficial place in requiring competent health care advice before, during and after procreation, making the facilities available so that a minimum standard of reproductive choices are available to everyone in the community and providing the resources to ensure adequate education and information about reproductive choices.

I share the concern of the Australian Catholic Bishops Conference that in formalising distinctions among “individuals”, “persons” and a process of genetic testing, there may be severe consequences where “so-called cost pressures would result in life pressures; that it, it is cheaper (or more ‘cost efficient’), and more convenient, to terminate life than to palliate or to provide long term treatment and care to the sick and disabled – whatever the cause”.  These are very difficult issues on which I welcome further debate and an active involvement in the legislative process.

7	Conclusions

This Bill was introduced to further debate in our Federal Parliament about this important new technology.  I hope this will contribute to the development of a fair, efficient and equitable application of this technology for all Australians.  However, to ensure this outcome we need to better understand the potential of the technology, both good and bad, and make choices which will achieve the best results.  This requires extensive consultation and reflection, and our Federal Parliament should lead the way.

Regardless of the outcome of this Committee, we should heed the recommendations of the Privacy Commissioner - the Federal Parliament should consider as a very minimum:

“if the Committee is not disposed to support the present Bill, it should consider other legislative options for delivering these protections:

-	provide a basic set of protections for all personal health information in an Act which also contains some specific provisions for personal genetic information; or

-	deal with privacy of personal genetic information is a specific Act; or

-	in either case, deal with anti-discrimination issues by amendment, where necessary, of existing anti-discrimination law and deal with databases of DNA profiles for forensic purposes in separate legislation”.

Natasha Stott Despoja
Deputy Leader of the Australian Democrats
Senator for South Australia
March 1999

APPENDIX	Summary of issues raised in submissions

The following discussion presents a summary of the major arguments presented to the Committee.  This makes no assessment of the validity of the arguments, but rather presents the arguments grouped under headings.  This presentation is important to reflect the diversity of views and opinion on how the Bill might be improved, what needs to be considered further and a number of criticisms of approach.  

1	General comments about the Bill

A significant number of submissions supported the general principles of the Bill, while others rejected the Bill without reservation.  Generally, these comments about the Bill might be divided into:

1.1	Legislation in this area is necessary

The Privacy Commissioner suggested that many of the Bill’s purposes might be achieved within a framework of protections for general personal health information.  The Privacy Commissioner concludes “[m]y view is that it would be better to deal with personal genetic information as a specialised part of a more general scheme for protecting privacy of personal health information.  However, if a more general scheme for the health sector proves to be unachievable I would strongly support the introduction of the sort of protections that the Bill proposes, even if they apply only to personal genetic information”.  The Privacy Commissioner also notes the proposals in the Bill are “largely” consistent with the proposed National Principles for the fair handling of personal information, although the terminology is different in some cases.

The Privacy Commissioner concluded:

“…a number of the Bill’s provisions would provide important protections which are not currently provided by any law, these include:

•	a right of access to personal health information, including personal genetic information, subject only to very limited exceptions;

•	realistic but legally binding limitations on the ways in which the different people who have access to our personal health information are able to use and disclose it;

•	requirements that people be given adequate notification when personal health information is being collected about them; and

•	conditions on the collection and use of personal genetic information in the insurance and employment contexts”.

Rachelle Lewitan stated “the Equality before the Law Committee of the Victorian Bar “recognised the need to protect the privacy of the individual and the necessity of protecting the individual from discrimination resulting from the misuse of genetic information” and “is of the view that the law should directly protect the individual from the misuse of genetic information resulting in breaches of privacy and discrimination in any area of public or private life”.  

1.2	Legislation in this area is totally unnecessary

The Australian Health Ethics Committee suggested legislation has not generally been used to deal with genetic privacy and discrimination and that its treatment in the Bill as an exclusive area was outside the attempts of the Australian Health Ethics Committee “to incorporate developments in genetics into the general framework and principles of the existing research and health systems”.

The Murdoch Institute for Research into Birth Defects stated: “[w]hilst the principles underlying the Bill are well-intentioned, we consider that the details of the remainder of the Bill in its current form are inappropriate in an Australian clinical setting and we believe that they are too broad to form the basis of a legislative Bill before Parliament” and that “obtaining and disclosing clinical genetic information should continue to be regulated by the medical and allied health professionals and not by Parliament”.  This submission then added : “[t]he issues relating to disclosure of genetic information…should be addressed within the appropriate Codes of Practice imposed by exiting legislation and by self-regulation.  We believe that relevant bodies such as the Australian Medical Association, the Human Genetics Society of Australia and the NHMRC’s Australian Health Ethics Committee can be involved in re-defining appropriate practices in the context of obtaining and disclosing of genetic information.  While the public debate that this Bill will engender is welcome, the privacy provisions are unrealistic and unnecessary”, and concluded: “[w]e recommend that it would be more appropriate for Parliament to legislate only on the use and misuse of genetic information in a discriminatory fashion by employers, insurers and government, but this should form the basis of a separate Bill with input from relevant experts and with an informed public debate”.

The Australian Huntington’s Disease Association questions the need for specific legislation and whether guidelines together with existing legislation would be more appropriate.

The University of Tasmania concluded that it was premature to legislate in this area because it “is a fast developing branch of science” and that legislation was likely to impede scientific developments or become outdated.  

The Muscular Dystrophy Association of New South Wales suggested education was a better response to genetic privacy and genetic discrimination rather than legislation which “is likely or certain to result in an outcome which is excessively proscriptive, burdensome and administratively complex, to the point where it is likely to be impracticable”.  This submission concluded education needed was “very broad and encompasses everything from starting to teach genetics in primary school to general public discussion and awareness of the privacy and discrimination implications of genetic testing”.

The John Curtin School of Medical Research suggested most of the issues addressed by the Bill were already covered by regulation under the auspices of Institutional Ethics Committees and that their major concern was “using legislation too excessively in this area is that developments in technique may occur rapidly (as was the case with PCR – polymerase chain reaction) and completely alter the method and nature of genetic research” and that ethics committees “are closer to the coal face of research and better able to respond to such rapid progressions”.  They therefore suggest as an example the Bill “may make the degree of subject informed consent contemplated by this Bill very difficult to achieve”.

The National Health and Medical Research Council suggested the Bill attempted to address “some perceived inadequacies” and that a balance between the present and future benefits and problems should be carefully considered.  This submission argues the Bill “fails to recognise the complexity and, at times, subtle nuances involved in DNA testing, which can range from complicated and extensive familial investigations to a straightforward routine laboratory test”.  The submission contrasted the comprehensive testing for BRCA1 and Huntington’s disease against the routine testing for thalassaemia.  It was argued the Australian Health Technology Advisory Committee had recommended a review of DNA technology that a comprehensive review of genetic disorders was necessary and that review might identify the need for legislation.

1.3	The proposed model is not appropriate for Australia

The Health Issues Centre suggested the Bill was weakened by its American derivation which made the Bill rigid and prescriptive, which reflected the dictates of the US system of health insurance.

Thomas Faunce stated “I am…concerned that the legislation may suffer from being premature” and that “[m]ore contact needs to be made with employers and insurers to see whether a real threat of discrimination exists and what form it will take”.  This submission also expressed concern that there was insufficient data collection and public debate in Australia about these issues, and that debate in the United States was also awaiting further data.

The University of Tasmania questioned the suitability to Australian conditions of an American styled legislative document.

The National Caucus of Disability Consumer Organisations suggests there is a good intent in the Bill, but that it fails to reflect “some of the statutory and research realities of the Australian situation, having been modelled on US legislation”.

1.4	Other relevant general comments

Heather Dietrich commended the Bill and addressed areas of omission suggesting that “it is not the what but the how of genetic engineering that matters.  By this I mean we need to address the way we decide on what should happen rather that try to devise rules and regulatory structures that can make definitive prescriptions of what sorts of genetic engineering is allowed under what conditions…What is needed is a process of ongoing discussion and policy formulation that involves community participation and is intimately linked to the scientific innovation as it happens not added on after the event.  Such a process would be based in conflict resolution processes rather than stand-point debate in order to achieve decisions on outcomes at any particular time”.

The Tiwi Health Board Trust expressed particular concern that they, the Tiwi Island people, made up 0.5% of the Australian Aboriginal population and attracted some 8% of Aboriginal medical research, which gave them a “vested interest” in this Bill.

The National Caucus of Disability Consumer Organisations suggests the Bill does not” fully take on board the realities of living with disability or imputed disability in Australian society”.

The New South Wales Department of Health argues the Bill does not acknowledge the different types of testing and “the requirements of the Bill are more appropriate to complex genetic testing…rather than more routine diagnostic testing”.

The New South Wales Department of Health suggest the Bill will have significant implications for genetic testing which is not health related and these matters should be considered further (such as parental testing and criminal uses).

The South Australia Department of Premier and Cabinet suggest the authorisation and writing requirements are onerous and may require additional staff to administer, inconvenience patients and the relationship between the different persons involved with the genetic information will need to be more clearly defined.

The West Australian Department of Health suggests not all genetic tests are molecular genetic tests and the scope of the Bill should be broadened to other ways of obtaining genetic information.

1.5	Other comments

The Australian Society for Biochemistry and Molecular Biology expressed a general concern “that the Bill provides so much protection, that known or suspected criminals may be protected from having valuable DNA evidence collected or used in their prosecution or defence”.

The Australian Medical Association concludes the Bill:

(i)	fails to clearly define the rights of donors of genetic materials;

(ii)	does not adequately cover the field it attempts to cover; and

(iii)	has possible unintended consequences.

The Australian Medical Association suggests the Bill could apply to all life forms and should be restricted to human genetic information only.  

1.6	General privacy concerns

The Law Council of Australia:

(a)	urges the “Federal Government not to undertake piecemeal regulation of privacy and to consider extensive privacy legislation for the private sector on a national basis”.  However, this submission suggests this Bill is narrowly focussed and that some of the requirements might be “excessively rigorous” and that other approaches might be more appropriate; and

(b)	queries whether the issues addressed by this Bill have been sufficiently considered and that its rigorous scheme might not be counter-productive “notwithstanding its sound philosophical base”.

2	Constitutional issues

The Australian Medical Association queried the basis of Constitutional power upon which this legislation might rest, especially the provision which sought to deal with patient access to medical records.

The University of Tasmania questioned the Constitutional head of power founding the Bill and suggested there might need to be the referral of some State powers for such legislation.

The Department of Health and Family Services suggested the reliance on the UNESCO Declaration on the Human Genome and Human Rights in connection with the external affairs power would require advice from the Attorney General’s Department.

The National Caucus of Disability Consumer Organisations are concerned that the Bill does not make adequate reference to the Universal Declaration of Human Rights.

Margaret Boyes notes that genetic testing may be done by mail order in the United Kingdom by University Diagnostics Ltd and it is not clear whether Australian laws would be effective against testing done outside the jurisdiction.

3	State/Territory issues

The Queensland Department of Premier and Cabinet set out a number of concerns about the impact of this Bill on existing Queensland legislation.  The Bill:

(i)	establishes a different duty of confidentiality and authority to disclose genetic information as compared to other health information;

(ii)	would require separate genetic records from medical records for all Queensland patients and these might need to be managed differently from existing medical records;

(iii)	there may be some inconsistency between Part 3 of the Bill and sections 10 and 13 of the Transplantation and Anatomy Act 1979 (Qld);

(iv)	might set a precedent for the access to genetic information held by the private sector and this might raise objection from private sector hospitals and doctors; 

(vi)	might override State laws dealing with the collection of DNA samples in criminal proceedings;

(vii)	may have consequences for the promotion and development of a vibrant and productive biotechnology industry in Australia; and

(viii)	there should be a cost benefit analysis according to established protocols.

The Victorian Bar suggested the Bill exhibited an intention to preserve the operation of State laws, such as the ability to take a DNA sample and use the information before the court (Subdivision 30A of Division 1 of Part III of the Crimes Act 1958 (Vic)), but that the preferable approach would be to make specific exemptions for State legislation.

The West Australian Department of Health notes the Bill “has the capacity to render void (by inconsistency) provisions of State and Territory legislation” concerning freedom of information, human reproductive technology, Quality Assurance, discrimination and police DNA testing.

4	Legislating ethics

The Faculty of Medicine at the University of Sydney suggested the Bill was well intentioned, but it was unlikely the legislation could deal with developments in gene technology because the issues were ethical, rather than legal.  Therefore, by proposing to replace ethics with legislation the Bill has certain problems for the issues of ownership, privacy and discrimination and research.

The University of Tasmania submission suggested many of the ethical concerns about genetic knowledge (such as the right not to know) are still being debated in the community and that legislation should follow these debates, rather than proceed them.

The Queensland Clinical Genetics Service concluded that “it is important that families with genetic disorders perceive that their elected representatives are more interested in the rights of individuals compared with big business”.

5	Definitions

The Human Genetics Society of Australia suggested the following definitions were inadequate:

(i)	“family” – legal relations arising from genetic analysis are more like third party interests rather than direct health interests;

(ii)	“genetic analysis” – a more precise definition is necessary to distinguish the type of testing (such as, diagnostic, carrier or predictive) and the type of mutation (such as somatic or germ line) which have different privacy implications for the extended family; and

(iii)	“genetic services” – a gene test may not be covered by laboratory and genetic counselling services (such as making, confirming or advising) about a genetic diagnosis.

The Bill fails to define what it is to be “healthy”.

Thomas Faunce made the following suggestions:

(i)	the term “disclose” appears to cover only direct disclosure rather that indirect actions and therefore the term “facilitate” might be a useful inclusion; and

(ii)	in the definition of the term “family” the term “material interest” is unclear.

The Australian Catholic Bishops Conference queries the distinction drawn by “individual”: [t]his Bill is perhaps the only legislation, enacted or proposed, which formalises the academic distinction, based upon a legal fiction, between those members of the human family who are accorded legal recognition and status (“person”) and those who are not (“individuals”).

The Australian Huntington’s Disease Association suggested genetic counselling is “an important component of genetic testing and should be included in the interpretations”, and that this should include pre-test information as well as the opportunity for post-test counselling and follow up.

The Muscular Dystrophy Association of New South Wales suggests the term “genetic counselling” should be defined.

Rachelle Lewitan suggests the term “collect” does not need to be defined as the term is self-evident and that it is “very broadly and nebulously defined”.

The University of Tasmania suggests the term “DNA samples” could include all tissue samples held by a hospital.

The Christian Lawyers Society suggested the definition of “DNA sample” might include blood samples being used for research into antibodies.  There was some concern that the definition did not make clear whether blood collected for this purpose was within the definition and therefore attracting the penalty provisions of the Bill.

The Australian Society for Biochemistry and Molecular Biology expressed concern that human tissue samples were often collected in their research which were used for the “measurement of the function of specific proteins or enzymes without prior extraction of DNA, RNA or polypeptides, and that these measurements gave information about the genotype, without falling within the definition of a “DNA sample”.

The Australian Medical Association suggests the term “DNA sample” is not clear and it is uncertain what distinguishes a DNA test from another medical test.  

Margaret Boyes argues the definition of “DNA sample” would not include stored dried blood spots collected in State newborn screening programs (Guthrie cards), which are in effect DNA sample banks.  These samples have been collected since the 1960s and have “inadvertently become DNA banks”.  There has been some use made of these stored samples for purposes other than screening programs, and there is some concern this may have broader application as genetic testing becomes more prevalent.  These cards are stored until seven years after the person has turned 18 years old and up to eight years after this if there is some litigation.  The cards may be used for medical purposes and for research purposes when they have been de-identified.  The cards are protected and released only with completion of a detailed consent form and later testing depends on new specimens rather than the card which provides identification of identity unless new material is not available.  “The threat to privacy exists because the original consent for the test was given to detect metabolic disorders in infancy” and not other purposes.  These DNA banks are a significant issue because they are collected without the informed consent of the person, they were never intended to form DNA banks and the ownership of this material is unclear.

The Privacy Commissioner indicates the definition of “DNA sample” does not cover the situation where a DNA sample is collected for one purpose and later used to conduct a DNA test, such as a Guthrie spot.

The Muscular Dystrophy Association of New South Wales argues the term “DNA sample” “excludes a specimen taken for doing a test that is not a DNA test” and “[i]t should, however, include such a specimen, from the time that there is an intention, however long after the actual collection of the specimen, to extract DNA from it for testing”.

The Muscular Dystrophy Association of New South Wales suggest the term “genetic information” should include any information from which a genotype may be inferred and that a distinction between information from a laboratory and from clinical practices “is not a useful one”.

The John Curtin School of Medical Research suggests the term “genetic information” is too broad and could include almost any biological substance which would make the Bill’s application problematic.

Thomas Faunce noted the breadth of the definition of “genetic information” in clause 8 could limit the ability of doctors to discuss patients genetic information with colleagues in a professional context.

Rachelle Lewitan suggested the definition of “genetic information” overlaps with the definition of “DNA” and “DNA sample” producing some confusion in clause 8.

The National Health and Medical Research Council suggests “[t]here is an error to suggest that DNA can be derived from a polypeptide.  Presumably the making of synthetic DNA based on a polypeptide sequence does not fall into this category”.

The University of Tasmania suggests the term “genetic information” potentially includes information about relatives and is too broad to be useful.

Rachelle Lewitan suggested the phrase “whether recorded in material form or not” was unclear in the definition of “genetic record” and queried whether this included an electronic form.

The Queensland Clinical Genetics Service suggested the use of the term “biological mother” in clause 23 needed to be defined because of the possible ovum donation and where “the woman carrying the foetus is not the biological mother”.

The Australian Medical Association also suggested the term “biological mother” should be defined as the woman carrying the foetus is not always the biological mother, and this might cause some doubt as the Bill presently suggests the genetic tissue donor retains all rights to genetic information of the foetus, even though that person may not be carrying the foetus.

The New South Wales Department of Health suggest the term “genetic services” is unclear and could mean laboratory services as well as counselling, etc.

The Queensland Department of Premier and Cabinet suggests there may be some inconsistency in interpretation of clause 24 dealing with the information derived from the unborn, and that this might be overcome with the inclusion of a reference to “pregnant women” in the definition of “individual”, assuming this was the intention as set out in the Explanatory Memorandum.

Rachelle Lewitan supports the definition of the terms “individual” and “person” as defining the operation of the Bill, but expresses the concern the Bill does not address the interests of the indigenous community whose interests need to be catered for separately.  Further, there is uncertainty about the words “where appropriate” as they relate to minors and incompetent persons.

Rachelle Lewitan also suggests the term “subject” was confusing and could be omitted and the definition of “individual” amended to state: “The term includes an individual who is the subject of genetic research…”.

6	Individual autonomy

The Health Issues Centre noted the Annas et al. origins of the Bill and its recognition of individual autonomy, and cite favourably requirements for the provision of information prior to providing a (HIV) test in Victoria and that such laws are “warranted because of the potential for economic, social or psychological harm associated with the mere having of the test”.

The University of Tasmania suggested the inspection and copying of records (clause 10) might have unintended effects as the genetic information of one person will include information about other family members and so information about one person is information about another person.  Attachments to this submission indicated the primary guiding principle “must be the right of the individual to autonomy – the right to determine whether information is kept and the purposes for which it may be used and under what circumstances the information may be divulged to other parties".

The Law Council of Australia accepts that genetic information about an individual should be controlled by the individual.  However, they noted that disclosure within the family group might give rise to “significant ethical dilemmas arising from certain disclosures”.

The Queensland Clinical Genetics Service suggests some acknowledgment of shared family records is necessary where information about family is and can be compiled.

The Human Genetics Society of Australia stated that genetic records might contain information about several family members and that clause 10 needed to ensure that an individual only had access to his/her own genetic information and that an individual may request access whist protecting the privacy of other family members.

The Caroline Chisholm Centre for Health Ethics suggested privacy “should not be absolutised in relation to the common good, especially health.  The releasing of non-identifying genetic information may well be justified without requiring the consent of each individual concerned”.

Arnold Ward expressed concern that there should be an informed consent in the process which authorised the collection, storage and analysis of a DNA sample.

The Faculty of Medicine at the University of Sydney said that nowhere are the duties of individuals with genetic anomalies mentioned.

7	Privacy

The University of Tasmania suggested the Commonwealth Parliament should have a role in monitoring and overseeing genetic privacy either through the existing mechanisms of annual reports or through a new committee modelled on the Human Genetics Advisory Commission in the United Kingdom.  However, it was also suggested that the Bill’s treatment of privacy was unsatisfactory because:

(i)	there were problems finding a head of Commonwealth power to justify imposing privacy laws;

(ii)	there is no exemption for doctors who currently have ethical duties to breach confidentiality where the protection of minors or immediate danger to adults is involved;

(iii)	there is no express extension of the Privacy Commissioner’s role to the private sector and over State government bodies;

(iv)	the provisions may adversely affect research undertaken in Australia; and

(v)	the Privacy Act 1988 (Cth) could be amended to achieve the aims of this Bill.

The Victorian Bar suggested the disclosure authorised in clause 8(2) required further consideration and reformulation because it “contained a vague and imprecise test”.

The Australian Medical Association suggests the definition of “person” in clause 8 (Disclosure of genetic information) is very broad and might allow for example a corporation to disclose genetic information without the ethical protection of the doctor/patient relationship.  This submission also suggests there might need to be some provision for the amendment of genetic information after it has been disclosed.

Rachelle Lewitan suggested:

(i)	clause 8 was unclear because of overlapping definitions making the words “characterised from the DNA sample of an individual” un-necessary because the term “genetic information” is defined to include “information from a DNA sample about a genotype”;

(ii)	use of the term “person” was very broad and might allow an employer or an insurer to make an assessment of what is a “serious and imminent threat”, and a health care professional was probably suitable for such an assessment; and

(iii)	the test of “reasonable extent necessary” in subclause 8(2) requires reformulation because it is vague and imprecise and does not reflect the Explanatory Memorandum.

The Australian Medical Association argues that “a person’s genetic information is of a unique nature that requires separate processes for access and disclosure”.

The Department of Health and Family Services indicated:

(i)	Genetic information about “oneself”:

(a)	the Government does not believe it is appropriate to introduce national legislation giving access to patient records or extend privacy legislation to the private health sector;

(b)	the Government supports the development of voluntary codes of practice developed with the assistance of stakeholders who have shown an interest in this process; and

(c)	the Government will monitor this process before embarking on legislation;

(ii)	Genetic information about a “relative”:

(a)	this is an issue which requires wider consultation taking into account matters such as age, mental competency, nature of relationships, etc.; and

(b)	whether a voluntary code would be appropriate in these circumstances;

(iii)	Genetic information about an “unrelated person”:

(a)	the Bill requires permission of the individual concerned, but might follow other models, such as access to electorate enrolment information;

(b)	the issues of legislative mechanisms dealing with employment and insurance discrimination require further consultation.

The Muscular Dystrophy Association of New South Wales raise some concern about the distinctions draw in sub-clause 8 and the different criteria for disclosure and re-disclosure as well as the use of general terms such as “serious” and “imminent”.

The Muscular Dystrophy Association of New South Wales suggests there is an inconsistency between clause 8 and Schedule 1.

The National Caucus of Disability Consumer Organisations expressed concern that clause 8 does not set out the reach of this provision and that a number of the terms used in the clause (such as, “serious threat to life”, extent reasonable”, “direct benefit of a patient”) are not adequately specific to have a clear meaning.

The National Caucus of Disability Consumer Organisations are also concerned that clause 9 is “well intentioned”, but nevertheless is discriminatory because the “requirement for writing and signing is ablest” rather than merely requiring a permanent record and the ability of an individual to “utilise an agent either because they have a disability or because they are not able to consent”.

The National Health and Medical Research Council suggest clause 8 is “vague” and pose the example of an airline pilot who has a genetic abnormality (such as epilepsy) which would place the testing physician under a legal obligation to inform a third party as a result of potential accidents (supposedly causing hurt), and that the physician has no notion where to place the risk barrier and for how long to keep assessing this risk.

The Privacy Commissioner indicated:

(i)	that clause 8 might have the unintended consequence of limiting the disclosure of information necessary to make informed reproductive decisions and that some consideration should be given to expanding the disclosure provisions to include the effects on “potential” children;

(ii)	some relaxation of disclosure might be required between health care deliverers in the “immediate team”;

(iii)	it would be desirable if disclosures “required or authorised by or under law” also required the individual to be notified subject to some exceptions where there is a law authorising, such as certain law enforcement contexts; and

(iv)	there might need to be some mention of exemptions for research (similar to that set out at sub-clause 21(2)) in clause 8.

The Faculty of Medicine at the University of Sydney suggested the effects of State and Territory privacy laws are not addressed by the Bill and might override their rights to privacy in the Bill.

The Human Genetics Society of Australia raised a concern that there was some ambiguity as to who genetic information could be disclosed to and that the provisions were proscriptive and impractical so that they could not be implemented.

The New South Wales Department of Health argues clause 8 is more restrictive than the existing requirements of confidentiality imposed on health workers by section 22 of the Health Administration Act 1982 (NSW) and “there may be compelling reasons for disclosure to occur which fall within the scope of ‘lawful excuse’ but outside the ambit of clause 8(1)”.  It is argued subclause 8(2) is more limited than subclause 8(1) and that difficulties might arise in deciding whether a disclosure was covered by subclause 8(1) or 8(2) and that genetic information would need to be treated differently to other health information.

The South Australia Department of Premier and Cabinet suggests “it is generally accepted that they [privacy laws] have the capacity to provide protection over genetic personal information”, and that this Bill contradicts the Federal Government’s position not to extend privacy laws to the private sector.  This submission also suggests subclause 8(2) “may be difficult to police”.

8	Inspection, copying of records and correction

The Australian Huntington’s Disease Association suggests genetic records may contain information about other family members and access to the records should maintain the privacy of other family members.

The University of Tasmania suggested the inspection and copying of records (clause 10) might have unintended effects as the genetic information of one person will include information about other family members and therefore the words “genetic information of an individual” might (“arguably”) allow access to that information.

The Australian Medical Association suggests:

(i)	“some acknowledgment needs to be made that genetic records are generally held on families and information in them may be compiled following a number of interviews with different family members”; 

(ii)	that in practice the person providing a non-technical explanation would be a medical practitioner and that the Bill should set some standard for this person – the Australian Medical Association suggests “the responsible medical practitioner”;

(iii)	the Australian Medical Association raises the problem of who is going to pay for the inspection and copying of genetic records; and

(iv)	some concerns about what is necessary to constitute “reasonable effort” in clause 11 and what should be done if the other person cannot be contacted.

The Muscular Dystrophy Association of New South Wales suggest genetic information is usually maintained in files with information about other family members and that the Bill should address this as access to the record would disclose information about other family members.

The National Health and Medical Research Council suggest clause 10 “is difficult because it makes no distinction between a family study and a single individual DNA test result or record”.  The effect of this could be to “discourage health professionals from the keeping of good medical records because of the concerns that other individual’s privacy could be infringed”.

Rachelle Lewitan notes the “clash between the inspection and amendment of records provisions (clauses 10 and 11) and the common law right of access to medical records as set out in the decision in Breen v Williams.  She suggests there may be some difficulty in distinguishing between genetic information and other medical information as the definition of “genetic information” in the Bill is so broad: “serious though needs to be given to the issue of whether it is necessary for patients to have the rights set out in clauses 10 and 11 as well as the general right of authorisation”.  She concludes: “The Committee supports the inclusion of clauses 9 and 16 in the Bill, but queries whether the substantive effect of clauses 10 and 11 is to create a proprietary right in the genetic information and in so doing offends the ratio decidendi in Breen v Williams.  The Committee is also of the view that there may be special cases where it is not in the best interests of the patient to have unfettered access to genetic records, and that a doctor’s discretion to decide what is in the best interests of the patient needs to be acknowledged”.

The South Australia Department of Premier and Cabinet questions the ability of an individual to “have the knowledge or expertise to be able to dispute a genetic record”.

The South Australia Department of Premier and Cabinet queries whether the Bill should make provision for the destruction of a record containing genetic information, in the same way as it provides for the destruction of a sample.

9	Collection, storage and analysis

The Murdoch Institute for Research into Birth Defects suggest many of the proposals in these clauses are already followed and these exiting processes are “more appropriate in an Australian setting”, and that legislating these practices “may simply serve to restrict the provision of genetic services in an impractical way which may ultimately downgrade their high standard in most Australian states”.

David de Kretser suggests the Bill deals adequately with safeguards to the uses of genetic information, although he suggests the procedures for obtaining the information are “clumsy and unworkable”.  In particular, the term “genetic record” is unclear and the processes for the collection of samples “assumes the use of DNA sampling for genetic analysis is going to be a limited and occasionally utilised technique.  If this technology, as it is highly expected to do, forms a basic part of medical practice, it is totally impractical to obtain written authorisation as outlined in the subsequent section and also to provide notices of right and assurances in accordance with” clause 14.  He provides the example of a karyotype from a blood sample where under current practice the blood drawing implies consent and the blood is discarded after the test and the information is recorded in the medical record which “cannot be divulged to third parties without the patient’s written consent”.

David de Kretser suggests there is a failure to distinguish between routine clinical genetic testing and the use of samples for research, the latter requiring the listed authorisations, etc., while the latter are argued to be adequately protected under existing procedures.

The University of Tasmania suggests the clauses dealing with disclosure (clause 8), authorisation (clause 9) and information to be provided are problematic because they are complex, and so unlikely to be workable in practice because:

(i)	clause 8 it is not clear who may disclose the information and that this measure may impose costs and burdens; and

(ii)	there is no general duty to warn in Australia and this is an ethical question unsuitable for legislation at this time.

The Australian Medical Association believes genetic counselling in “not optional” and suggests there may be some confusion between the person ordering the test and the collection of the test.

The Australian Consumers Association suggests “it would be in the public interest to develop and maintain a database to track the growth of genetic testing.  This suggestion may not need to form part of the Bill itself, but a database would be worthwhile for genetic testing services to institute on a national basis.  This would provide an ongoing monitor on such things as nature, locality and cost of tests being done around the country”.

The Tiwi Health Board Trust wanted to see strengthened provisions for the collection, storage and analysis of DNA:

(i)	samples stored for later use – the Tiwi Island people “are aware of samples currently stored which researchers appear to regard as subject to their unfettered right to hold for unlimited periods for use in whatever subsequent line of enquiry”;

(ii)	destruction and disposal – the Tiwi Island people “are concerned that current samples are taken, and there is no further notification of use or disposal”;

(iii)	samples held after death – the Tiwi Island people (and Aboriginal people generally) are concerned “at the preservation of body material following death and they need some assurances that such material is not retained; and

(iv)	storage – the Tiwi Island people “are concerned at the possibility that samples may fall into the wrong hands during projects and subsequently used malevolently.

The Department of Health and Family Services suggested the written notification of rights, which accompanies each sample collection, should include “advice that information may be disclosed if a person believes, on reasonable grounds, that disclosure is necessary to prevent or lessen a serious or imminent threat to life or health”.

The Muscular Dystrophy Association of New South Wales raises concerns that an individual has authority to determine whether or not a DNA sample may be retained after testing because retention of the DNA sample “is partly for the maintenance of quality control and that this serves the public interest”, such as re-testing.

The Muscular Dystrophy Association of New South Wales suggest details about disclosure and re-disclosure should be included in any information provided to the individual (clause 15).

The John Curtin School of Medical Research expressed concern that rapid changes in research techniques would make the authorisation “useless” and would “have to be revised which will be expensive and time consuming and will significantly delay research”.

The John Curtin School of Medical Research suggest the words in clause 14 “any other person upon request” are too broad.

The National Health and Medical Research Council raises concerns about the destruction of a DNA sample after a test because this would prevent re-testing in the case of discrepancies, which might not be immediately obvious.  Further, to overcome this concern, the tester would need to choose an arbitrary destruction date and because their resources are limited they would be open to breaches of legal obligations for destroying the samples before the destruction date.

The Privacy Commissioner “welcomes” clauses 13 and 14 and notes they are consistent with Information Privacy Principles in the Privacy Act 1988 (Cth).  The Privacy Commissioner also notes the existence of certain mail order genetic testing services which would be difficult to cover by Australian law, other than to make their use unlawful.  There is said to be insufficient evidence to justify this action at this time.

The New South Wales Nurses’ Association expresses concern the Bill makes no specific provision for minors and people unable to provide their own consent and that this needs to be specifically addressed by the Bill.

Rachelle Lewitan suggests that if the intention of the Bill is to exclude various State laws (such as subdivision 30A of Division 1 of Part III of the Crimes Act 1958 (Vic)), then “it may be preferable to make a more specific exemption from State legislation of this kind”.

The Christian Science Federal Representative for Australia suggest the Bill should provide an exemption, except in the case of criminal investigations, for persons who have “sincerely held religious beliefs or practices”.

The South Australia Department of Premier and Cabinet suggest it may be appropriate to require the authorisation in clause 16 to be retained until the information derived from the sample is no longer required or identifiable.

10	Counselling

The National Caucus of Disability Consumer Organisations argue genetic counselling is an important notion with a variety of different interpretations and therefore the Bill should define this term and take account of existing guidelines such as those articulated by the NHMRC.

The New South Wales Department of Health say the genetic counselling process should be defined and the information given to an individual should include information about disclosure, re-disclosure and privacy.

The National Caucus of Disability Consumer Organisations suggest it is important that genetic counselling “be available free of charge or…there is an assurance of no barrier to such counselling being available”.

The John Curtin School of Medical Research states “[w]e consider genetic counselling to be absolutely essential where genetic records are returned to an individual…we don’t deal with research subjects and give them their records ever.  A doctor always does this in our research…whilst we can provide the percentages etc. required by genetic counsellors we do not have this skill or the qualifications ourselves.  If required to counsel ourselves studies would be cancelled.  The Bill should mandate genetic counselling through licensed professionals and not introduce requirements which necessitate it without ensuring it is adequately funded and in place”.

The National Health and Medical Research Council suggest the legal requirements of the Bill “overshadow the clinical information to be provided to at-risk parties who then need to make informed choices.  To satisfy the legal requirements of the Bill, it is likely that emphasis in the counselling process, as well as the obtaining of complex informed consent, may shift more to the legal obligations than the medical or humanitarian considerations”.

The National Health and Medical Research Council states sub-clause 14(h) is “inappropriate” because “[a]ll individuals irrespective of whether DNA is involved, should have access to genetic counselling”.

The National Health and Medical Research Council stated sub-clause 15(f) could result in litigation because in the case of a family study the removal of critical information from an individual might make the information about the other family members invalid.

The West Australian Department of Health says the individual should also be offered post-testing counselling.

11	Consent

The Health Issues Centre state: “a legislative requirement of this type is valid and sends an important message to the health fraternity about genetic testing and about considering the patient’s social circumstances in the medical context.  An important precedent is also established concerning access to and amendment of the medical record”.

Human Genetics Society of Australia accepts consent to the collection of a DNA sample should be voluntary and informed, but they suggests the requirements set out in the Bill (clauses 14 and 15) would not be practical.  They suggest a general approach, similar to that set out for discrimination (clause 17), is preferable, and they note it may be impossible, unethical and that there is not a duty of care involved in communicating a test result to a family member of the individual.  They also note the information from a test cannot be predicted before the test is done, which makes the implications of the information unpredictable.

Thomas Faunce argues clauses 14(h) and 15(k) which require advice “about the availability, or the lack of availability, of optional genetic counselling” highlight the problem of how the patient will deal with their genetic information, and states these clauses are “the most embarrassing subsections in the whole Bill!!!  They highlight the naivety and lack of political muscle and will with which this issue is currently being approached by legislators in Australia”.

The Australian Health Ethics Committee argue that diagnostic genetic information and predictive genetic information are dealt with in the same way by the Bill even though their sensitivity to privacy and discrimination are “very different” and that getting consent is also “different”.

The Royal College of Nursing suggests the issue of legal disability requires further clarification because there is no process set out to resolve conflicts between family members, and in particular the cases dealing with incompetent adults.

The Australian Huntington’s Disease Association notes that individuals should be advise of the consequences of destroying DNA samples.

The Muscular Dystrophy Association of New South Wales argue the Bill provided for unreasonable requirements for some genetic tests.  They contrasted genetic counselling for Duchenne Muscular Dystrophy which requires repeated counselling so that the couples are likely to know more about the condition than their family doctor, with routine tests, such as haemochromatosis may be one of a number of similar DNA tests, where the interpretation of the test is simple.

12	Testing

The Human Genetics Society of Australia argue the Bill did not recognise the subtleties of genetic testing and their clinical applications and that the requirements for genetic counselling “are incomprehensible and impossible to implement in clinical practice”, put at risk newborn screening programs, and fails to recognise the need to store material “consistent with…good laboratory practice or in the subject’s best interests”.

The Australian Health Ethics Committee suggests the Bill fails to distinguish between germ line DNA and somatic DNA and with the broad definition of “DNA sample” the Bill “would create enormous problems and perhaps inadvertently result in the paralysis of all diagnostic tests involving patient sample”.

13	Ownership of biological materials

The Faculty of Medicine at the University of Sydney considered because the Bill deals with the commercial potential at the time of sample collection, it would leave open a possible commercial development without maintaining their interests in the biological materials.

The Human Genetics Society of Australia suggests the clauses dealing with “ownership” requires further investigation, and note ownership by individuals is contrary to the NHMRC and some legal positions.

The University of Tasmania argue this Bill was too closely based on its American counterpart and failed to take into account the “greater willingness” of Australians to participate gratuitously in research for the community benefit and that the United States experience (such as the case of Moore v Regents of the University of California) “will not necessarily be followed in Australia, due to the unique Australian jurisprudence in trust and fiduciary law”.

The Australian Society for Biochemistry and Molecular Biology suggest the Bill should address the issue of ownership of genetic information following the death of the individual, and that this might be resolved by the individual’s next of kin taking ownership following death.

Margaret Boyes argues the DNA banks resulting from screening programs (Guthrie cards) are a significant ownership concern because a large number of young adults in New South Wales have their blood stored and the ownership of these samples has not been determined.  This submission notes similar samples in New Zealand have been returned to Maoris on request because they are regarded as body parts with traditional significance.

The Law Council of Australia consider the disclosure and use of genetic information for profit would need to be considered carefully.

The National Health and Medical Research Council argue subclause 16(f)(ii) “would be counter productive in most clinical scenarios” as opposed to research scenarios, because it “seems unreasonable to spend time attempting to counsel an individual/couple or family about the implications of a genetic disorder, followed by the uses and problems of DNA testing in this disorder, and to complete the counselling session will need to come a further discussion about the (unlikely) event that the doctor will make a profit from the study of an individual’s DNA, and the break-up of this profit between the doctor and patient”.  This submission suggests the circumstances set out in the case Moore v Regents of the University of California “must represent a very unusual and rare event”.

14	Use of sample for other purposes

The Health Issues Centre indicate the alerting of a patient to the possible use of a DNA sample for medical research was a valuable initiative, while the John Curtin School of Medical Research suggested this was an “impossible requirement” and would “grossly inhibit research” because of the need to keep going back to the individual who provided the DNA sample.

15	Discrimination

The Health Issues Centre indicate the specific description of genetic discrimination clarified the intent of government and provides clear guidance to the courts and tribunals.

Thomas Faunce suggests the inclusion of discrimination provisions in the same Bill as privacy is to burden the Bill with too much complexity and that clause 17 which makes genetic discrimination unlawful “probably suffers from being based on the farcically drafted UNESCO Declaration on the Human Genome and Human Rights”.

The Australian Huntington’s Disease Association suggests discrimination in employment and insurance is a major issue for families affected with Huntington’s disease.

The Victorian Bar suggest the formulation of the test of discrimination was “not a familiar formulation in Australian legislation for discrimination” and should be aligned to other existing anti-discrimination legislation. 

The National Caucus of Disability Consumer Organisations suggest there “is indeed an incidence of genetic discrimination in Australia but that genetic discrimination is largely indirect, which is more difficult to prove and usually found to be referred to in the academic literature to do with disability studies as ‘oppression’”.

The National Caucus of Disability Consumer Organisations argue the Bill does not adequately deal with the situation of genetic information available before the Bill takes effect as law and that a range of genetic information exists which might then be used to lawfully discriminate.

The John Curtin School of Medical Research express concern that the Bill “indirectly enshrine the capacity of insurers and employers to get access to genetic information”.  This was particularly concerning to this submission because “[t]his may make it difficult for us to obtain experimental subjects who will be fearful of discrimination”.

The Privacy Commissioner suggests people with disabilities are “routinely discriminated” in a way comparable to genetic discrimination by “the disability is misunderstood; its impact on a person’s capacities is misinterpreted; the measures that can be used to ‘work around’ the disability are not known or ignored or written off as too difficult”.  This submission concludes “[t]he relatively poor track record of most sectors of Australian society in understanding and responding to people with disabilities gives us no reason to be confident that discrimination in various forms will not accompany the current expansion of genetic testing to a wide range of other conditions”.  Further, “[i]n its potential to give rise to discrimination, personal genetic information is similar to information about a person’s existing disabilities or ethnic background or sexual preferences or religious beliefs.  It should be noted that these are just the categories of personal information that are accorded special protection in many information privacy laws as well as specific anti-discrimination laws”.  The Privacy Commissioner then states existing discrimination legislation may be adequate by maintaining “consistency of protection between symptomatic and asymptomatic individuals and keep the anti-discrimination legislative framework simpler and more accessible”.

Rachelle Lewitan suggests the formulation of discrimination in clause 17 “is not a familiar formulation in Australian legislation for discrimination” and proposes replacement clauses which are consistent with existing practices and case law.

Rachelle Lewitan also states: “[t]here is limited policy justification for either of the exceptions in clauses 18 and 19.  The mere fact of access to the information, for whatever purpose, and whether or not the information has been previously collected, is inconsistent with the spirit of the legislation.  It is unwise to make such a concession in the legislation, given that genetic discrimination is more likely to be perpetrated by insurers and employers than any other entity”.

The South Australia Department of Premier and Cabinet argue the Bill “does not extend the same protection to individuals regarding discrimination in employment and insurance as existing equal opportunity legislation (which presumably this Bill would override as the more specific enactment)”.  This submission suggests it may be preferable to mirror existing equal opportunity legislation.

16	Employment discrimination

The Faculty of Medicine at the University of Sydney suggest there was vagueness in the terms “consistent with business practice” for employment discrimination and that the insurance provision left open the possibility that it was left to the insurance company to determine what was “healthy”.

The Human Genetics Society of Australia suggests “employers should be obliged to notify employees and potential employees of possible conditions which may be deleterious for certain genotypes, and provide voluntary testing for employees”.

Thomas Faunce suggest this clause would be better focussed “on genetic abnormalities which impose a substantial or immediate risk to the employee or others as a result of workplace environmental exposure”.

The Australian Huntington’s Disease Association states “[w]e do not favour the use of genetic test information by employers and particularly pre-employment testing and the sharing of previously acquired testing information.  Adult onset disorders such as HD do not come on suddenly overnight”.

The Christian Lawyers Society accept there were often good reasons for employers being able to collect genetic information.  They however, suggested that once this information had been used it should be destroyed.  There was also some concern that the information should relate to identifiable risks of employment.

The Victorian Bar suggest it may have been an oversight leaving out the qualification (that the genetic information already available to an insurer can be used) in the employment context suggesting an employer might be able to compel an employee or prospective employee to provide a sample.  This submission questions the use of genetic information by an employer in any circumstances.

The Muscular Dystrophy Association of New South Wales suggests clause 18 may prevent an employer from restricting the type of employment which is destructive to an employee.  As an example, “the relationship between alpha-1-antitrypsin deficiency and susceptibility to lung disease in certain work environments…the employer is entitled to know whether the employee or prospective employee has alpha-1-antitrypsin, but he can’t direct the employee to a relatively safe, rather than a relatively dangerous work environment, if the employee doesn’t want to be so directed”.

The National Health and Medical Research Council suggest “[i]t is quite surprising that this section did not in fact prohibit the employer from requesting or requiring DNA testing, but at the same time ensuring that the employer provided this option and left the final choice to the employee”.

Rachelle Lewitan states there are “unexplained inconsistencies” between clauses 18 and 19, because clause 19 has a requirement for the test to already have been taken, whereas clause 18 leaves this requirement out.  “The Committee would not have thought this was intended and that clause 18 would only apply where an employee or prospective employee has voluntarily provided a sample”.

The South Australia Department of Premier and Cabinet suggest of clause 18: “[t]his provision appears quite broad and may benefit from further clarification.  More importantly, it appears mandatory on an employee to provide this information”.

17	Insurance discrimination

The Health Issues Centre note the Association of British Insurers have sanctioned the use of genetic tests for Huntington’s, Alzheimer’s and hereditary breast cancer and that this had been condemned by doctors, academics and consumer groups because of its discriminatory outcomes and the likelihood it would dissuade people from participating in research.

The Queensland Clinical Genetics Service suggest the Bill left families open to discrimination where a family member is known to be symptomatic for a disease and that there was evidence available of such discrimination.  This submission suggest the Bill was weak in comparison to other legislation in other countries because it “does not prevent ongoing discrimination on the basis of genetic predisposition to disease”, and that “a total ban on using genetic information in allowing access to insurance cover where the level of cover requested is incompatible with normal risks”.  

The Human Genetics Society of Australia note there is a worldwide debate about life insurance and that there is some argument for a limitation on the size of an insurance policy that can be taken out above which genetic information might reasonably be required.

Thomas Faunce said this clause would interfere with existing practices based on risk assessment and might drive up health care costs.

David de Kretser suggests an insurer could be given an opportunity to ask “a person identified with a genetic predisposition for a disease to undertake certain preventive measures” and “[i]f these preventive measures are not take, then should the insurer be entitled to seek the loading of the policy concerned?”.

The Australian Huntington’s Disease Association state “[w]e are adamant that there should be no compulsory genetic testing for the purpose of insurance and favour the ceiling approach which has been adopted in the Netherlands.  The Dutch Huntington’s Disease Association has been most active in the lobbying process for the introduction of this law”.  This submission also suggests “families with a history of HD always have problems in obtaining life insurance” and that anecdotal evidence suggested these families did not take out insurance because of the high premiums and therefore rely on the social security.  The Australian Huntington’s Disease Association agrees there should be tighter controls on the use of genetic information by insurance companies.

The Queensland Department of Premier and Cabinet suggest there should be consideration of a free choice to possibly reduce insurance costs on the basis of genetic information and that this possibility should be considered further.

The Christian Lawyers Society suggest the insurance industry should be “entitled” to the genetic information already available.

The Huntington’s Disease Association (Qld) express concern that an insurer might be able to obtain and use genetic information already in existence and that there was no control over the use of this information by the individual.  There was also some concern whether a “healthy” individual or family member includes a person who carries the defective Huntington’s gene.  This submission reported “ample evidence of families affected by Huntington’s disease being discriminated against for insurance purposes” and in particular an event that might never occur.

The Victorian Bar suggest it was unfair not to allow insurers to take genetic information into account once it had become available.

The Australian Medical Association believes insurers should not have access to genetic information and the Bill should make this clear.

The Australian Consumers Association set out the following matters as necessary in dealing with personal genetic information:

(i)	a binding industry wide code of practice for genetic testing and insurance, based on Investment Funds and Superannuation Association of Australia’s policy;

(ii)	clear information about the use of genetic tests and the rights of consumers to be spelt out to consumers on insurance application forms;

(iii)	strong standards for the handling of personal genetic information by insurance companies, health insurance companies and superannuation funds;

(iv)	a role for both the Australian Competition and Consumer Commission and the Privacy Commissioner to approve and audit insurance industry codes;

(v)	the inclusion of genetic testing within the scope of alternative dispute resolution schemes;

(vi)	consumer representation in the development and monitoring of industry codes and standards relating to genetic testing; and

(vii)	the development of a database to track the growth of genetic testing.

The Australian Consumers Association state they were “particularly concerned to ensure that the Bill’s provision for prohibiting genetic discrimination in insurance matters is not watered down”.

The Investment and Financial Services Association Ltd raise the following issues, and therefore considers the parts of the Bill dealing with insurance is not necessary:

“1.	the Bill would provide financial benefits to some policy holders that are not available to others.  In some cases these benefits could amount to very large windfalls, paid for by other policy holders;

2.	the Bill will inevitably increase the cost of cover, thereby shifting the burden from the genetically disadvantaged to all policyholders.  This will in turn raise the cost of cover out of reach of some and cause others to forgo cover due to the perceived lack of value.  This will lead to a progressive price spiral;

3.	the Bill has the effect of discriminating in favour of individuals with diseases diagnosed by genetic means and as a consequence discriminates against those with non-genetic diseases;

4.	the Bill’s reference to “healthy” in section 19 cannot be adequately defined.  This would give rise to disputation and make the Bill unworkable;

5.	the future will see rapid expansion in the availability and use of genetic tests.  Policy determined today needs to take into account the probability of changing use and attitudes towards these tests;

6.	solutions to the problem developed overseas will not have a noticeable impact today due to the current rarity of genetic tests in medical practice.  However, the Insurance industry must, by the very nature of its policy guarantees, take the long term view.  It would be folly to lock in solutions that may not be workable in the long term”.

The Department of Health and Family Services indicate private health insurance differs from general life insurance and that the National Health Act 1953 (Cth) deals with the issue of discrimination for private health insurance – private health insurers “are not able to discriminate on the basis of race, sex, sexuality, age, chronic disease, illness or other medical condition”.  This submission also suggests there may be a need to re-define the term “pre-existing aliment” to include manifestations of the aliment, illness or condition “rather than a genetic predisposition to the ailment, illness or condition”.

The Association of Superannuation Funds of Australia suggest that “[w]here a valid and robust statistical correlation exists between a test result and the incidence of death or disability, then an insurer should be permitted to take this into account”.  The submission concludes: “If insurers are not permitted to discriminate against individuals who have personal knowledge of a certain or probable development of premature death or disability, then there would be an incentive for individuals to ‘antiselect’ against insurance companies.  This would raise the cost of insurance and disadvantage the general population with insurance coverage.  ASFA expects that automatic acceptance of members will continue to occur under group insurance arrangements for basic cover, but that the viability of insurance cover for higher sums would be at question if individuals knew they had a high probability of a specific serious disease had the right to take out insurance at standard rates”.  This submission suggested the existing rights and obligations under the existing Disability Discrimination Act 1992 (Cth) were appropriate.

The National Health and Medical Research Council suggest that genetic information already available is accessible by insurance companies and that it is not clear why this should not continue to be the case.

The Privacy Commissioner:

(i)	believes the access allowed to insurance companies to use existing risk-relevant personal genetic information is consistent with other health information;

(ii)	“strongly supports” the principle that individuals should not be compelled to undergo genetic testing to gain insurance coverage;

(iii)	notes most life insurance companies have a draft code which states that genetic tests cannot be a condition for coverage, but that this “code has not been finalised, is not legally binding and is open to review” and therefore the Privacy Commissioner “believe[s] that this principle is so important that it should be embodied in legislation”; and

(iv)	suggests discrimination should only be allowed in exceptional circumstances, such as “there is compelling evidence in relation to the increase in risk attributable to possession of a genetic characteristic” and that the Bill should contain a provision similar to section 46 of the Disability Discrimination Act 1992 (Cth). 

Rachelle Lewitan suggests the terms in clause 19(b) “restrict” and “otherwise apply conditions to” “includes increasing insurance premiums on the basis of genetic information”, although this needs to be clarified.

The South Australia Department of Premier and Cabinet suggest of clause 19: “[I]t is unclear whether this provision would enable an insurer only to accept applicants if they have already undergone genetic analysis” and “[I]t would appear that this provision may still enable an insurer to substantially raise premiums for a person whose genetic analysis revealed certain characteristics”.

18	Research

The Health Issues Centre express concern that a sample analysed as part of a research project “when the potential benefit to society outweighs the risk to the research subject” which was said to be “odd” as a similar way of thinking “was derived out of the experience of so called medical experimentation in Nazi Germany”.

The Faculty of Medicine at the University of Sydney said there was no determination in the research provisions to what actions should follow evidence of an unsuspected genetic relationship and that this information raised as many legal and ethical problems as those of non-relationships.

Thomas Faunce suggests particularising research activities might inhibit the activities of existing regulatory strategies, such as ethics committees.

The Australian Health Ethics Committee argues clause 20 “in its current form does not accord with the principles for public consultation for the development of ethical guidelines in research contained within the National Health and Medical Research Council Act”.

The Murdoch Institute for Research into Birth Defects suggest “that ethical practices relating to research in this area are best regulated by appropriate bodies such as various Research Ethics Committees under the guidance and control of the Australian NHMRC Human Ethics Committee”.

David de Kretser state “the collection and storage of DNA to conduct genetic analysis as part of a research program requires, quite rightly, the individual to be informed of the reasons for the testing, to sign an agreement for the performance of the test, and for the storage of their DNA sample for further research”.  This submission suggests there needs to be a distinction between routine clinical testing and research uses.

The Christian Lawyers Society express concern that samples might be destroyed at the request of the person from whom the sample was collected.  The consequence of this provision was said to be the wasting of public resources in medical research and a reduction of funding to affected areas.

The Australian Society for Biochemistry and Molecular Biology express concern that the requirements of clause 14 (Notice of rights and assurances) would limit future access to tissue samples for research purposes, and that there was no reason for such material to be discarded.

The Australian Medical Association suggests the Bill does not clarify “how a researcher is to determine whether the research project’s potential benefit to society outweighs the potential risks to the research subjects”, and this should be specifically assigned to institutional ethics committees that comply with the NHMRC guidelines.

The National Caucus of Disability Consumer Organisations suggest Part 5 of the Bill should refer to the statutory right to publish guidelines associated with both the National Medical and Medical Research Council Act 1992 (Cth) and the Australian Health Ethics Committee.

The John Curtin School of Medical Research suggest there is no accurate data available for researchers to determine psychosocial risks and destruction of samples could inhibit research in areas such as linkage in family studies and cause unnecessary worry to research subjects.

The National Health and Medical Research Council argue that this Part introduces some inconsistencies with other provisions in the Bill and cite the way family testing is specifically dealt with here but not in other parts of the Bill.

The National Health and Medical Research Council state access to genetic information for statistical and epidemiological studies is inappropriate because “[t]he attempt at identifying which might be appropriate studies (if this could be done) diminishes the importance of ensuring that whoever has access to the information (for whatever reason) does so with the appropriate safeguards”.

The Privacy Commissioner points out that clause 20 applies equally to identified and de-identified samples and that there may be an argument that “genuinely and permanently” de-identified samples may not need to be covered by the Bill.  The Privacy Commissioner also notes Part 5 of the Bill “largely sets out good practice in the research context”, however, “[t]he main question is whether incorporation of these standards in a Bill of this kind is desirable at this point in time”.  The Privacy Commissioner does however note that “[w]hile the system appears to be working reasonably well, non-NHMRC funded work may not go through the same processes and the sanctions available for improper use of personal information in the research context may not be sufficient to ensure an adequate level of information privacy protection”.  The Privacy Commissioner believes these measures might be better dealt with in the broader context of health and medical research generally.

Rachelle Lewitan suggests the burden on researchers of determining the DNA sample “is essential to the research project” and “the potential benefit of the research project to society outweighs the potential risks” was considerable, and “could have a negative impact on science and the pursuit of knowledge. Because it will be impossible to determine the criteria”.  To overcome this issue she suggests there is a need for a entity to make such assessments, such as the Institutional Review Boards set out in the Annas et al model bill, and that this needs to be set out in this legislative regime.

The South Australia Department of Premier and Cabinet say it “would seem more appropriate for a person independent of the research project to make this determination” of whether the project’s benefit to society would outweigh the potential risks.

The South Australia Department of Premier and Cabinet suggests the requirement to seek authorisation for research purposes “would effectively make retrospective research impossible”.  Further, for samples collected before the commencement date “[w]ithout substantial publicity and promotion it is unclear how an individual will be aware that a sample even exists, let alone how and who to approach to have the sample destroyed”.

19	Miscellaneous

The Australian Medical Association suggests the clause 24 dealing with genetic information from the unborn does not deal with surrogacy and adoption.  This submission asks why the genetic information of a foetus should belong solely to the “biological mother” and that this issue needs to be carefully addressed.

The Muscular Dystrophy Association of New South Wales suggests “[I]t is very questionable whether the requirements of section 23 could be generally practicable.  Transfer of possession of samples may occur with little warning, eg. if the person in possession of the sample were to die or become acutely ill, or if the Government were to close down the hospital or laboratory in which samples were held”.

The National Caucus of Disability Consumer Organisations indicate that dealing with foetuses “has important implications, amongst other things, for the abortion debate in this country, and the status of human life at various stages of development, and whether one sees this as changing because of genetic characteristics or imputed disability”.

The John Curtin School of Medical Research note the transfer of genetic material was already regulated through the Australian Quarantine Inspection Service.

The National Health and Medical Research Council suggests there might be some concern for the transferred possession of a DNA sample where there is shared information with other family members being on a medical record.  The National Health and Medical Research Council also state clause 24 poses “an interesting point” as the clause “seems to imply that the genetic information of the foetus prior to birth, is considered to be that of the mother’s” and since “DNA analysis is quite precise, it is possible to identify what component of DNA or a gene or chromosome is paternal and what is maternal.  In this circumstance, is it correct to give ownership of the genome to a single party?”.

Rachelle Lewitan states clause 24 “satisfactorily resolves this complex issue” – “The Committee is of the view that this is the most suitable and appropriate resolution of what is a complex social and political issue”.  However, the dealings with extra-corporeal embryos (such as donated sperm and eggs for reproductive purposes), the “Bill should probably include a provision for relinquishment of all rights by the donor in relation to the disclosure, collection and analysis of a DNA sample and subsequently created using the donated gamete”.

The South Australia Department of Premier and Cabinet recommends all samples should be transferable providing the identifiers have been removed.

20	Privacy and discrimination complaints

The Australian Consumers Association suggest the Human Right and Equal Opportunity Commission (HREOC) may not be the best way to resolve a discrimination, particularly for insurance, and that such disputes might be resolved through alternative dispute resolution measures, such as the existing Life Insurance Complaints Service.

The Privacy Commissioner states: “While this would be a new role for me as Privacy Commissioner, there are a large degree of commonality between the kind of information privacy protections proposed by the Bill and the Information Privacy Principles in the Privacy Act, which my office currently administers.  I would have no objection to taking on the proposed role, although it should be noted that it would have some resource implications for my office”.

21	Damages

Victorian Bar suggest the damages provisions required further consideration because they were draconian and unclear.

The Australian Medical Association is concerned this provision “only addresses the collection, storage and analysis of a DNA sample” and does not address penalties for disclosure.

Rachelle Lewitan notes the damages provisions “will require some more consideration” because they are draconian and unclear.

22	Other issues which should be addressed

The National Caucus of Disability Consumer Organisations suggest the Bill does not deal adequately with the issue of “substituted decision making” which is a significant issue for disabled people and requires particular attention in the case of research.

Rachelle Lewitan suggest the Bill “should be clearer about the disclosure in respect of deceased persons, samples taken from autopsies and genetic analysis of long dead persons.

Rachelle Lewitan raises the issue of whether specific provision should be made where a “DNA sample” is collected and the “individual” is unknown at the time of collection, such as evidence at a crime scene.  She proposes a specific provision dealing with these circumstances, similar to that proposed in the Annas et al model bill (S 122).