pdf (154.26 KB)

Table of contents

Introduction

A Standing Advisory Body on Human Genetics

Genetic Testing

Information and Health Privacy Law

Human Genetic Research

Human Genetic Databases

Health Services

Insurance

Employment

Other Contexts

Law Enforcement

Introduction

Background

In October 2001, as part of a joint inquiry into the protection of human genetic information, the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) published Issues Paper 26: Protection of Human Genetic Information (the ‘Issues Paper’). In response to the Joint Inquiry’s wide-ranging consultation process, this Office presented its Submission from the Federal Privacy Commissioner in March 2002 (OFPC Submission G143). In June 2002, a supplementary submission Genetic Samples and Privacy (OFPC Submission G164) was presented by this Office to the Joint Inquiry[1].

To further the consultation process, the Joint Inquiry has published its Discussion Paper 66: Protection of Human Genetic Information (the ‘Discussion Paper’) and has invited further responses from the community and relevant stakeholders. Reflecting the diversity of the submissions on the Issues Paper and the depth of the Joint Inquiry’s further researches, the Discussion Paper canvasses the issues relating to the protection of human genetic information in further and considerable detail.

I welcome both the scope of the Discussion Paper and the further opportunity to respond to these significant issues, since the proper privacy protection of all forms of health information in a range of medical, scientific and commercial situations is critical for the well-being of our society.

The approach of the submission

This submission will build upon:

1. The two previous OFPC Submissions and the basic positions adopted in those papers;
2. Views expressed in other submissions to the Issues Paper;
3. Arguments advanced in the Discussion Paper.

In doing so, the submission will affirm the three conclusions reached in the first submission:

1. There is a need for much more research and thinking to be done about the, as yet, largely inadequately–understood implications of the advances in genetic science and medicine;
2. With some adjustments, the foundations for the institutional protection of genetic information are in place, so long as they are applied consistently and comprehensively;
3. Informed debate and discussion across the community should be focused on the adequacy of existing laws for the protection of privacy and whether, even with appropriate education and/or enforcement measures, there are compelling reasons for the law to be changed.[2]

The Discussion Paper makes a number of proposals and asks questions about a variety of topics. Without reproducing in full the arguments of the first OFPC document, this submission will respond, where appropriate, to those proposals and questions in the sequence they are asked. In particular, the responses will be from a privacy perspective only, focusing on those issues which have significant privacy implications.

Framework of submission

As with the previous OFPC submissions to this Inquiry, the proposals and questions will be analysed within a framework which takes account of:

• The need for humility in our language when confronted with the as-yet untapped potential of the human genome and its implications;
• A rejection of ‘genetic exceptionalism’ while acknowledging the special characteristics of genetic information;
• The capacity of genetic information to be regarded as a form of health information within the meaning of Sec. 6 of the Privacy Act 1988 (the Act);
• The basic adequacy of the existing framework of protections for the privacy of human genetic information;
• The necessity of finding the most effective means of remedying any inadequacies in that framework; and
• The desirability of implementing the simplest and most effective means of achieving a desired outcome without undue complexity and reliance on new legislation[3];
• The fundamental importance of engaging with the public and of building and sustaining public confidence in the way an individual’s interests in the protection of their genetic privacy are acknowledged and respected;
• The need to establish and resource transparent and accountable processes of review which are applied consistently across all jurisdictions;
• The ultimate challenge of finding a reasonable balance between the public good and the private good.

‘Genetic information’, activities and harms

Chapter 6 of the Discussion Paper canvasses what is ‘genetic information’ Indeed, the Joint Inquiry is reluctant to specify “a precise and exhaustive definition of ‘genetic information’”.

“Instead, the Inquiry’s strong preference is to consider the context, to determine whether the use or application of genetic-related information requires any special handling or protections.”[4]

The meaning of the term can often be determined by the context. The term itself, in its general sense, can be used also to locate a particular discussion. It is critical, however, for it to be as clear as possible as to when the term is used in any specific proposal. In other words, it should be made abundantly clear what is intended to be covered as regards personal information and/or human material. In some circumstances, it may be fundamental to an understanding of a proposal to clarify, by means of a “precise and exhaustive definition” exactly what is meant by ‘genetic information’. This precision can:

• Avoid the dangers in ‘unfairly privileging genetic information as against all other forms of relevant health and medical information’[5], i.e., the dangers of ‘genetic exceptionalism’;
• Recognise the unintended consequences and possible harms associated with including inadvertently many other forms of health and personal information by a reference to ‘genetic information’;
• support the necessity of considering the extension of the proposal to cover other forms of health information.

The Joint Inquiry’s reference (quoted above) to the process of determining ‘whether the use or application of genetic-related information requires any special handling or protections’ (emphasis added) is consistent with the approach generally taken by this and the previous OFPC submissions to the Joint Inquiry. It is one which focuses on the activities involving the handling of human genetic information and samples and the need to constrain those activities because of the potential or demonstrable harms associated with those activities. In this paper, the concept of harm is not limited to compensable wrongdoing, but extends to the unwarranted defeating or thwarting of a person’s interests, especially their privacy interests[6].

An institutional learning system

The first OFPC submission stressed the critical importance of adopting an institutional learning framework, which is “designed to meet the singular challenges of protecting genetic privacy” and which has certain roles and characteristics[7]. It was argued that they should be the hallmark of all Australian social institutions engaged in, or affected by, genetics-related activity and that they should inform the fabric of the system as a whole[8].

It is essential to ensure the free flow of knowledge and experience throughout the community at the appropriate levels. Our social institutions of government, health, law, our universities and schools, commerce, the media, and our civil society, responding to the concerns and perceptions of the public, can provide the impetus by which wide-spread knowledge and understanding of genetics and its implications can dispel ignorance and fear. Our law-makers and policy-makers will be armed to articulate and achieve the protections that genetic information requires, while facilitating the enjoyment of the benefits of advances in genetics. Only by such responsive and systemic processes will Australian society be equipped to meet our ‘genetic future’.

As set out in the first submission, the role and characteristics of such a learning system are as follows:

• To keep abreast of advances in genetic knowledge and to learn from the experience of its constituent elements and the experience of the scientific and medical applications of advances in genetic knowledge;
• In particular, to ensure that health care professionals and medical researchers learn from the community support groups representing those with genetic disorders in developing policies and strategies;
• To incorporate that knowledge and experience in their decision-making processes;
• To make certain that their decisions are transparent and accountable;
• To provide the community with the best possible means of understanding developments in genetic knowledge, its implications and of participating fully in the decisions which may dramatically affect their lives;
• To be receptive and responsive to community perceptions, concerns and to the promotion of their legitimate interests; and
• To regard as paramount an ethical approach to all their activities and outcomes[9].

It is within this context that the proposals of the Joint Inquiry will be assessed in this submission.

A Standing Advisory Body on Human Genetics

The establishment of a HGCA

Proposal 3–1. A Human Genetics Commission of Australia (HGCA) should be established under federal legislation as an independent, stand-alone, statutory authority with sufficient resources to fulfil its mission.

I continue to support the establishment of a Human Genetics Commission of Australia in the terms proposed[10]. The HGCA would have a critical role in the protection of genetic privacy in the manner described by the Joint Inquiry in para 3.87[11].

The HGCA would serve as the paradigm and focus of the responsive institutional learning framework referred to in the Introduction to this submission.

The function and responsibilities of a HGCA

Proposals 3–2 and 3–3. The function, role and responsibilities of the Human Genetics Commission of Australia.

In general, I support the proposed role, functions and responsibilities of the HGCA, while making the following observations:

• To enhance the privacy protection of genetic information, it could consult with, and co-ordinate the policy-making functions of, the federal and state privacy commissioners, together with those who hold similar positions in the health privacy field in the other states and territories;
• The Discussion Paper’s views on the HGCA ‘providing a mechanism to assist with developing a more consistent national approach to … harmonised legislation and practices where appropriate’[12] could be included as a separate item within Proposal 3–2;
• Proposal 3–3 identifies specific functions and responsibilities of the HGCA. If this body is to take on regulatory, approval or other decision-making functions, the following questions may require careful consideration, in order to ensure that its work contributes to, rather than inhibits, the responsive learning framework:
  1. Will the model work in the Australian federal system?[13]
  2. What will be the impact on the existing regulatory framework of a new high-level decision-maker and the capacity of consumers to appreciate the role of a new regulator?[14]
  3. Whether the legislation establishing the HGCA should specify those regulatory bodies involved in, or affected by, genetics, which are required to consult with the HGCA in the discharge of their functions (in other words, the new body would work to assist the existing decision-makers)?

A HGCA can have a valuable role in enhancing the work of existing bodies by the provision of technical, policy, legal and ethical advice, which could be achieved by targeted cross-membership between the HGCA and the regulator or by other formal means of consultation. These processes could be clearly defined in the legislation establishing the HGCA.

For example, in the context of discrimination and insurance, the Joint Inquiry has proposed that no predictive test should be used in underwriting mutually rated insurance, unless the test has been approved for that purpose by the HGCA (Proposal 24–3)[15]. Consideration should be given instead to whether the HGCA (or a Genetics and Insurance sub-committee of the HGCA) could provide the expert advice to an existing regulator, such as the Australian Prudential Regulatory Authority, in setting standards for the industry. This would simplify decision-making and minimise the impacts on the existing regulatory framework and retain the advisory focus of the HGCA, especially in relation to the broader ethical and social implications.

Composition and liaison

Proposal 3–4. The HGCA structure should involve at least two principal committees: (a) a Technical Committee, and (b) an Ethical, Legal and Social Implications Committee.

The establishment of at least two principal committees of the types proposed will be essential. In keeping with the Office’s advocacy of a responsive learning framework, it may be advisable to consider:

• How the community’s concerns and perceptions around the handling of their genetic information could best be brought to the attention of the committees (and any of their working groups and sub-committees) so as to better inform their deliberations;
• The establishment of a consultative body comprised of people with genetic disorders modelled on the UK HGC’s Community Consultative Panel[16].

I support the remaining Proposals 3–5 to 3–7 in the terms proposed, except that I invite the Joint Inquiry to consider explicitly including the OFPC in the terms of Proposal 3–7, as an agency with particular expertise in the protection of privacy across Australia.

Genetic Testing

Privacy Issues

The privacy issues arising from unrestricted genetic testing can be summarised as follows:

• The purpose of any testing is to collect, store, use, or disclose an individual’s genetic information;
• It is inherent in an individual’s right to privacy that the individual has an appropriate degree of control over their genetic information;
• Given the special characteristics of genetic information, an individual’s (or a genetic relative’s) interest in their genetic privacy may be a paramount concern as regards their health and well-being;
• The proliferation of unrestricted opportunities for genetic testing raises justifiable concerns around the quantity and quality of the genetic information which has been collected unknown to individuals and, necessarily, beyond their control.

Regulating access to genetic testing

Proposal 5–1. The National Pathology Accreditation Advisory Council (NPAAC), in consultation with NATA and the Royal College of Pathologists of Australasia (RCPA), should consider whether accreditation standards should ensure that laboratories conduct genetic testing only on bodily samples collected with the appropriate consent of the individual to whom the sample relates or as approved by a Human Research Ethics Committee (HREC).

This proposal represents an appropriate means of achieving its implicit goal of privacy protection by limiting the quantity of genetic information that is collected without the knowledge of the individual. The proposal, however, has wider implications with respect to other proposals in the Discussion Paper. Its clear intention is the protection of the interests of individual, to whom a bodily sample relates, by means of defined restrictions on pathologists, which can be incorporated in accreditation standards. This proposal will need to be examined against the Joint Inquiry’s proposal in Chapter 7 that the definitions of ‘personal information’ and ‘record’ in the Act be amended in order to protect the privacy interests associated with bodily samples.

As regards the quality of the genetic information, the OFPC has long had an interest in the maintenance of data quality. Both the National Privacy Principles (NPPs) and the Information Privacy Principles (IPPs) in the Act[17] (as well as state health privacy legislation/regulation) impose obligations on laboratories to maintain data quality.

Home use testing

Proposal 5–2. The Therapeutic Goods Act 1989 (Cth) and Therapeutic Goods Regulations 1990 (Cth) should be amended to enable the Therapeutic Goods Administration (TGA) to regulate home use genetic in vitro diagnostic devices (IVDs) and home use DNA identification test kits, including for parentage testing.

Proposal 5–3 The proposed HGCA should be responsible for developing codes of practice and other advice on home use genetic testing, including advice to the TGA on the regulation of genetic home use IVDs under the Therapeutic Goods Act 1989 (Cth).

As to the issue of home use testing, I share the concerns of the Joint Inquiry in its Discussion Paper[18] and welcome these proposals. From a privacy perspective, the following issues may require close attention:

• The validity of the consent (if any) for the taking of a sample for testing;
• The provision of adequate consumer information as regards the privacy implications involved in the service and the quality of the information supplied;
• With increasing use of the Internet, the potential harms arising from the retention and exploitation of a consumer’s genetic information by the service provider.

It will be necessary for there to be increased monitoring of the up-take of these services and of the efficacy of existing privacy restraints against abuses of home use testing[19].

‘DNA theft’

Proposal 5–4. The Standing Committee of Attorneys-General should initiate the development of a model criminal offence relating to non-consensual genetic testing, for enactment into Commonwealth, state and territory law.

Proposal 5–5. Criminal liability should attach to any individual or corporation that, without lawful authority, submits a sample for genetic testing, or conducts genetic testing on a sample, knowing (or recklessly indifferent to the fact) that the individual from whom the sample has been taken did not consent to such testing.

In dealing with a social phenomenon such as that described by the term ‘DNA theft’, a multi-layered approach, which may include the use of law, should be explored[20]. The need to find the most effective and simplest means of protecting privacy is a recurring theme of the Office’s submissions to the Joint Inquiry. A gap in existing legislative protections would need to be clearly demonstrated, such as to warrant the introduction of ‘new law’.

Essentially, Proposal 5–5 seeks to criminalise the act of submitting (and the act of testing) an individual’s bodily sample taken without the consent of the individual. It may be necessary to consider the following:

• The purpose of submitting a sample for testing will be to collect personal (genetic) information about the individual;
• The subsequent harm to the individual arises from the uses and disclosure of that personal (genetic) information, such as paternity testing or celebrity ‘trophy hunting’);
• The extent to which existing federal, state and territory regulatory measures constrain those unjustifiable uses and disclosures or whether alternative, more effective means of preventing those harms can be identified and implemented (for example, by restricting the legal admissibility of improperly obtained genetic information);
• Whether the strong and influential support by the U.K. Human Genetics Commission for the introduction of the criminal offence of ‘DNA theft’ in that jurisdiction was motivated by gaps in the Data Protection Act 1998 (U.K), which may not exist in the Australian regulatory framework;
• Whether, if an individual’s bodily sample was collected without consent for the purpose of submitting it for genetic testing, any criminal liability would attach to that conduct, in the event of a failure, for whatever reason, to submit the sample or to conduct the test? In other words, it may be necessary to identify the actual harm which is sought to be prevented and whether the proposed offence of ‘DNA theft’ is an adequate means of preventing that harm. There is the potential for criminal liability to attach to innocent actions (or even to ‘attempted DNA theft’) which may fall within the ambit of the proposed offence.

 

Information and Health Privacy Law

Harmonisation of health privacy law

Proposal 7–1. As a matter of high priority, Commonwealth, state and territory governments should pursue the harmonisation of information and health privacy legislation as it relates to human genetic information. This would be achieved most effectively by developing nationally consistent rules for handling all health information.

The development of nationally consistent rules for handling all forms of health information is a matter of high priority. In December 2002, the Australian Health Ministers’ Advisory Council National Health Privacy Working Group published a draft National Health Privacy Code and Consultation Paper for public consultation. This commonwealth, state and territory initiative to achieve a uniform code is welcome, though much will depend on the manner in which it is implemented.

The Privacy Act and genetic samples

Proposal 7–2. The Privacy Act 1988 (Cth) should be amended expressly to: (a) define personal information to include bodily samples from an individual whose identity is apparent or can reasonably be ascertained from the sample; and (b) define a ‘record’ to include a bodily sample.

This Proposal raises some basic questions around privacy and genetics and the approach that should be taken to the regulation of information handling activities and health information generally.

As outlined on p.4 of this submission, there are certain criteria against which the Joint Inquiry’s proposals should be assessed. Special emphasis should be placed on the following:

• The basic adequacy of the existing framework of protections for the privacy of human genetic information;
• The necessity of finding the most effective means of remedying any inadequacies in that framework; and
• The desirability of implementing the simplest and most effective means of achieving a desired outcome without undue complexity and reliance on new legislation.

In the second OFPC submission, the protection of the individual’s person and their body parts was described as ‘one of the most fundamental parts of the fabric of civil society imaginable’[21]. The criteria which determine what constitutes appropriate protection for body parts were enumerated in that paper[22]. It was emphasised there that when advancing proposals to protect the privacy of bodily samples, it is critical to scrutinise the adequacy of existing protections for human samples, with a view to identifying gaps in those protections. Proposal 7–2 necessarily assumes the inadequacy of all forms of existing protections, as well as assuming that the proposal would not adversely affect the efficacy of existing protections. Before the Act is amended in accordance with the Proposal, both assumption need to be thoroughly tested.

It is useful to examine what it is that the Act does not presently cover. The very moment at which ‘personal information’, as defined by the Act, is derived from a bodily sample, then that personal information is collected and covered by the Act. If that information is sensitive information, a higher level of protection applies. However, the collection of the bodily sample itself, prior to the moment when the personal information is extracted, will not be covered by the Act. It is also arguable that the secure storage of bodily samples is not covered by the Act.

The question then arises whether the Act provides the most effective means of regulating the collection and storage of bodily samples. To take but one among many examples, will it then be necessary to establish privacy standards, enforceable by the Privacy Commissioner, relating to the refrigeration of the bodily samples which are kept by many medical practitioners for purposes unrelated to the genetic properties of those samples? To take another: how would the amendments to the Act relate to the provisions of the common law regarding ‘trespass to the person’, to statutory criminal law dealing with assault and other interferences to an individual’s physical integrity and to the provisions of the Human Tissues legislation?

Similarly, it does not appear to be clear how this proposal will relate to Proposal 5–1 (the regulation of pathology laboratories) and to the proposed new criminal offence of ‘DNA theft’ (Proposals 5–4 & 5–5), in so far as they involve the collection of bodily samples. Vital issues and relationships involving existing and proposed legal forms of protection and standards of practice will need to identified and resolved before the proposal under consideration could be said to be “the simplest and most effective means of achieving a desired outcome without undue complexity and reliance on new legislation.”[23]

In the second OFPC submission, the conceptual distinction between ‘information privacy’ and ‘bodily privacy’ was also canvassed[24]. There are related questions which arise:

• Whether the inclusion of ‘bodily samples’ within the definition of ‘personal information’ and ‘record’ in the Act is justifiable by the genetic properties of the sample, as compared with their other properties?
• Whether the inclusion of bodily samples within the Act for the purposes of protecting material identified as ‘genetic samples’ and as ‘genetic information’ is an example of unwarranted genetic exceptionalism?

These questions also require closer attention in the context of the Joint Inquiry’s present approach to ‘genetic information’, ‘genetic samples’ and ‘information privacy’. This submission has already referred to the Joint Inquiry’s approach to the definitional issues surrounding the term ‘genetic information’, noting the Joint Inquiry’s decision to consider the context in which the term is used and ‘to determine whether the use or application of genetic-related information requires any special handling or protections.’[25] (emphasis added) As this submission has also noted, this is an approach which the Office consistently supports[26], as it properly emphasises the desirability of regulating the activity involving an individual’s information, rather than the source or the nature or type of that information.

In Chapter 7, however, the Joint Inquiry shifts its focus from uses or applications of ‘genetic-related information’ to the nature of ‘genetic samples’. While the Joint Inquiry disassociates itself from any intention:

‘…to reform existing laws dealing with the protection of the individual’s person and their body parts. … [t]he focus remains on information privacy and on protecting genetic samples as an immediate source of personal information.’[27](emphasis added)

The goal appears to be the protection (within the scope of ‘information privacy’) of the ‘personal information’ which is contained in ‘genetic samples’ (and, necessarily, in the whole body). Since almost any body sample with cellular properties contains all of an individual’s genes, a body sample, however large or small, can be a ‘genetic sample’. If that bodily or ‘genetic sample’ is collected and perhaps stored in a refrigerator, the Act does not apply. At the moment any information, whether genetic or otherwise, contained in that bodily sample is derived from the sample, all ‘uses’ and ‘applications’ involving that information are covered by the Act. These include any subsequent uses or disclosures of that information. The reasoning which supports bringing all bodily samples within the coverage of the Act to protect the collection, and possibly the storage, of bodily samples may need to be re-visited.

The Proposal gives rise to further questions, only some of which include:

• The issue of retrospectivity of amendments to the Act to cover all bodily samples requires considerable attention. On the introduction of the private sector amendments to the Act in December 2001, Section 16C covered the transitional questions as to the application of the NPPs to a range of information handling activities. Similar detailed consideration would need to be given to the retrospectivity of the amendments to the Act, particularly in relation to the impact on private sector health service providers, who may have held their patients’ bodily samples for clinical purposes for many years. The samples would still be regarded “as an immediate source of personal information.”[28]
• The constraints upon research generally, and their impact on the enjoyment by the community of advances in scientific and medical knowledge, of treating all human physical material as ‘personal information’ subject to the Act;
• The costs to researchers and their host institutions of the very significantly increased application of Section 95 and 95A Guidelines under the Act, the correspondingly significant increase in compliance costs and, finally, the ability of HRECs to supervise research – all of which would flow from the broader definitions of ‘personal information’ and ‘record’.

Impact on OFPC Compliance functions

Question 7–2. What are the implications of Proposal 7–2 for the operation of the existing audit, investigation, complaints handling and enforcement provisions of the Privacy Act?

Without providing a detailed analysis of the impact of the Proposal on the functions of the OFPC, the implications for the Office generally and for the compliance unit in particular are substantial. They are not limited to major resourcing issues.

The Office would necessarily need to develop an expertise which is capable of meeting the challenges posed by breaches of the Act involving bodily samples. To return to the example used above, the audit functions of the Office would need to encompass the standards of refrigeration of all bodily samples wherever kept and for whatever reason. That expertise will need to encompass an understanding of genetics (in particular, in relation to the adherence to appropriate standards by hospitals), even if the intention of the Proposal is limited to the coverage of ‘genetic-related information’ derived from the ‘genetic sample’.

Depending on the scope of the proposed amendment, the Proposal may raise major issues around how the regulation of all activities relating to bodily samples would interact with other regulatory standards and functions conducted by this Office.

The complaints handling functions of the Office use alternative dispute resolution techniques. Mediation and conciliation of complaints between organisations/agencies and individuals presupposes certain minimum levels of knowledge and understanding as to privacy obligations and the corresponding privacy rights. Professional and public awareness is promoted by appropriate education strategies. The introduction of the concept of ‘bodily privacy’ into the Act increases the degree of complexity attaching to those obligations and rights. Proper regard needs to be paid to the capacity of the health service providers and individuals across Australia to absorb the implications of the proposed changes for their daily work and lives. Whether appropriate and effective education measures can be undertaken which will be adequate to develop the necessary understanding and knowledge within the community will require careful examination, given the conceptual complexities involved.

As regards the resourcing issues, the resource requirements for the Office to enforce the Privacy Principles for body samples in any meaningful way across the health sector alone would run into millions of dollars for an Office whose total budget is currently less than $5 million.

Transborder issues

Question 7–4. Should genetic samples obtained in Australia be exported only to jurisdictions whose laws provide protections equivalent to that of the Privacy Act and the NHMRC’s National Statement on Ethical Conduct in Research Involving Humans?

Question 7–5. Is NPP 9 of the Privacy Act an appropriate model for regulating the export of genetic samples?

Setting aside the question of protecting body samples (and the practical issues involved), as a matter of principle, the export of personal information, in whatever form, to overseas jurisdictions should be conducted in accordance with NPP9. A policy approach that underlies the Act and its Privacy Principles is that they are not intended to stop the flow of personal information, but instead to ensure that personal information is handled in a way that respects the privacy of the individual.

Deceased Individuals and the Act

Question 7–6. Does the Privacy Act adequately deal with issues that may arise in relation to the genetic samples and information of deceased individuals?

In general, I agree with the Joint Inquiry’s observation that the high level principles for the handling of personal information contained within the Act provide a ‘flexible basis for dealing with this issue’[29]. Since a special characteristic of genetic information is its familial nature, the matters raised by the Joint Inquiry in this context would be suitable for consideration by the proposed HGCA.

Amendments to the Act

Proposal 7–3. The Privacy Act should be amended to clarify that ‘health information’ includes genetic information, whether or not the information is collected in relation to the health of, or the provision of a health service to, an individual.

For the reasons advanced in the first OFPC Submission[30], I support this proposal.

Proposal 7–4. The Privacy Act should be amended to ensure that all small business operators that hold genetic information are subject to the provisions of the Act.

As to the exemptions introduced by the private sector amendments to the Act, the first OFPC submission recommended:

‘In so far as they apply to all forms of health information, the exemptions from coverage under the Act, which are presently afforded to employee records and to small business operators, be removed.’[31]

The supporting material for this recommendation made reference to previous OFPC submissions to the House of Representatives and Senate Committees’ Inquiries into the Privacy Amendment (Private Sector) Bill 2000[32].

The Joint Inquiry’s Proposal is for the Act to be amended to cover ‘genetic information’ held by small business operators. As noted above[33], clarity of intention is critical when referring to ‘genetic information’ in specific proposals, since there is the potential for the unintended coverage of an individual’s information, which is unrelated to the intention of the proposal.

Proposal 7–4 also introduces unnecessary complexity into the regulatory framework applying to small businesses. The federal Government’s aim in including the small business exemption was to exempt many small businesses from the Act altogether. Anything that brings them back under the Act defeats the object of the exemption and does so in an unnecessarily complex way. Since Proposal 7–4 may have the effect of bringing virtually all small businesses back within the coverage of the Act, a far simpler proposition, with virtually the same effect as the one advocated by the Joint Inquiry, would be to repeal the small business exemption.

Human Genetic Research

Compliance with the National Statement

Proposal 11–1. The National Health and Medical Research Council Act 1992 (Cth) should be amended to prohibit the conduct of any human genetic research, other than in compliance with the NHMRC’s National Statement on Ethical Conduct in Research Involving Humans (the National Statement).

Compliance with the National Statement by all research bodies that undertake research involving humans was recommended in the first OFPC submission[34].

Human genetic research and consent

Proposal 12–1. HRECs should be required to report annually to AHEC with respect to human genetic research proposals for which waiver of consent has been granted under the National Statement.

Question 12–1. What sort of information should be contained in HREC reports to AHEC on waiver of consent?

I support this Proposal. Effective and beneficial medical research often depends on the altruism of research participants. OFPC research into community attitudes has demonstrated that a significant number of people (13%) are reluctant to hand over their genetic information[35]. Without adequate protective mechanisms, public confidence in research involving genetic information will be eroded, as will the public’s altruism.

As acknowledged in the first submission, the existing protective mechanisms are ‘fundamentally sound’[36] The ‘fulcrum point’ of those mechanisms is the Human Research Ethics Committee (HREC), acting in accordance with the National Statement and under the supervision of the Australian Health Ethics Committee. Since, within that existing framework, the requirement of consent is fundamental, any waivers of consent requirements by HRECs will need close attention.

The flexibility of HRECs and their ability to understand the circumstances of a particular research proposal in the context of the local conditions rank among the advantages of this system. If, however, there emerges significant disparities between HRECs in their interpretation and application of the waiver of consent provisions, public confidence may be adversely affected. Transparent and accountable processes of reporting and review can be instrumental in securing a desirable degree of consistency.

In response to Question 12–1, HREC reporting on waivers of consent might include a summary of the reasons justifying the decisions made. These summaries would refer to the factors[37] which have been taken into account and an indication of the factors which were most persuasive. These requirements should be supported by the allocation of sufficient resources to the HRECs to enable the highest standards of reporting.

Question 12–2. Are any changes needed to: (a) the National Statement; or (b) the s 95 or s 95A Guidelines under the Privacy Act, in relation to waiver of consent by HRECs to the collection, use or disclosure of genetic samples or information for research purposes?

Under para. 16.13 of the National Statement, a HREC may take into account a number of factors in deciding whether to waive consent. In the interests of maintaining confidence in the HREC system, consideration could be given to making it obligatory for a HREC to consider those factors. In this context, I share the concerns of the New South Wales Privacy Commissioner as to this aspect of the National Statement[38].

It is also appropriate to note that the National Statement does not include references to the National Privacy Principles, in particular, nor to the Act’s coverage of the private sector generally. One of the Statement’s strengths in regulating the ethical conduct of research, especially as regards privacy issues, is the incorporation of the legislative standards of the Act by means of references to the IPPs[39]. The National Statement could benefit by attention to these matters.

Proposal 12–2. The proposed new chapter of the National Statement dealing with human genetic research databases (see Proposal 15–1) should provide guidelines dealing specifically with obtaining consent to unspecified future research.

In supporting this proposal, attention is drawn to the following matters relevant to the protection of the research participants’ privacy and to issues of consent to unspecified future research:

• The individual’s consent for the storage of their human tissue for future research purposes should be obtained if the genetic information derived from their tissue may be required;
• Good privacy practice encourages openness and communication between agencies/organisations and individuals. Guidelines could promote good privacy practices by encouraging researchers to devise practical measures to inform, and in appropriate cases to keep informed, the altruistic donors of their samples and their information;
• If genetic information is derived from human tissue, it is ‘collected’ in terms of the IPPs and NPPs; similarly, future uses or disclosures of that genetic information by researchers will also be covered by the Privacy Principles applying to research;
• A critical consent issue may be what is considered to be ‘impracticable’ (in terms of seeking consent) in all of the circumstances (for example, as in NPP2.1(d)(i)); at present, the OFPC Guidelines on Privacy in the Private Health Sector says:

‘Whether it is impracticable to seek consent will depend on the particular circumstances of the case. Simply incurring some expense, or having to exercise some effort to seek the consent of individuals whose information is to be used or disclosed, would not ordinarily make it ‘impracticable’ to seek consent. Circumstances where it may be impracticable to seek consent could include where there are no current contact details for the individuals in question and where there is insufficient information to get up-to-date contact details. This might occur in longitudinal studies of old records.’

• The value of HREC supervision of research in accordance with the Guidelines under Section 95 and 95A of the Act should be acknowledged in this context.

Strengthening review by HRECs

Question 14–4. How else might the role of HRECs in ethical review be strengthened? For example, should HRECs be accredited or should there be changes to their structure, composition or resourcing?

The recognition of the research potential of genetic information is accelerating and the role of HRECs is critical in a number of ways. These include achieving a balance between the benefits of research and the protection of participants. With its mixture of professional and lay members and its localized and flexible nature, institutional review committees can also be regarded as a ‘fulcrum point’, or a point of focus, within the learning system that has been advocated as a prerequisite for a national institutional framework[40]. By appropriate reporting on research proposals and by analysis of the bases of their decisions, HRECs have the capacity to add greatly to the flow through the community of vital knowledge about genetics, research and the ethical and social issues they give rise to.

This function can only be brought to fruition if the appropriate support for the HRECs system is guaranteed. As was argued in the first OFPC submission[41], the functioning of HRECs currently depends on the good will of many generous members of the community. Their scientific, medical and legal expertise and experience, together with the disinterested participation of the lay members, constitute a forum for ethical judgments that reflect the understandings and wisdom of the wider community. As such, their role in community life is invaluable. The rapidly increasing call on these people to make ever greater contributions should be acknowledged through realistic levels of funding and other means of support.

From a privacy perspective, compliance with HRECs requirements by researchers should be at a premium. If the growing research challenges are to be met in the interests of the community and participants, HRECs will need every assistance by way of resourcing and administrative support and in the provision of guidance on such matters as applying the Guidelines under Act. Effective reporting mechanisms and monitoring of HRECs approvals are achievable, if all aspects of the HREC system are provided with adequate resources.

Specific funding allocations should therefore be made in research grants to enable researchers to properly inform HRECs of all pertinent issues and to comply with the relevant protective guidelines, such as the Section 95 and 95A Guidelines under the Act. Those research grants should also include specific funding allocations for the involvement of HRECs in the research project. Recognising the need to provide adequately for this element of research infrastructure will be closely aligned with the growing recognition in recent years of the need to fund research institutions for the full costs of research initiatives, instead of merely supporting more narrowly defined marginal costs.

 

Human Genetic Databases

Human genetic research databases

Proposal 15–1. The National Statement should be amended to include a new chapter providing ethical guidance on the operation of human genetic research databases.

The National Statement should include ethical guidance on the establishment and operation of human genetic research databases. The first OFPC submission extensively canvassed the issues in relation to human genetic databases, with particular reference to the adequacy of existing regulatory mechanisms to protect the privacy of genetic information[42]. It is noted that the focus of this chapter of the Discussion Paper is primarily on research activities. As the agency having the primary role in health and medical research in this country, it is appropriate for the National Health and Medical Council, perhaps in consultation with the proposed HGCA, to have the responsibility for devising forms of guidance as regards the establishment and operation of genetic databases for those research-related activities.

The proposals for enforcing compliance with the National Statement, which were advanced in Chapter 11 of this Discussion Paper, would have a significant influence upon the protection of research participants and the privacy of their genetic and other personal information. There are two further factors which are influential in this respect:

1. The requirement for consent underpins much of the National Statement. The importance of informed consent in the legitimate collection of bodily samples and the uses of the information derived from those samples for research purposes is fundamental for the protection of research participants. Genuine consent arrangements which are clearly explained to the public and which can be exercised freely are essential. The lessons surrounding these crucial consent issues to be drawn from the experience of the Iceland genetic research database have been noted in the first OFPC submission[43];
2. From a privacy perspective, the involvement of HRECs as the means of balancing the potential harms to privacy with the benefits of research will be a critical imperative for this research. The experience of conducting medical research, which involves the linkage of genetic information with health information within isolated communities and which is under the close supervision of HRECs has been described in the context of the current Tongan research project[44].

Question 15–1. Should human genetic research databases be subject to a licensing or registration scheme?

It is vital to acknowledge the importance of maintaining public confidence in the operation of human genetic databases and the altruistic donation of samples and information to those databases. A well-designed licensing scheme, as described by the Joint Inquiry, can ensure the maintenance of standards of privacy protection, with particular emphasis upon the security of the material to be stored for long periods of time. The following factors may need to be considered :

• Care will be needed in distinguishing between what is a ‘research database’, containing health information and what is a ‘genetics research database’. Health information can be collected from a number of people for research which is unrelated to genetics, but that information may nonetheless remain capable of being described as ‘human genetic information’, just as a collection of that information, if for research purposes, could be said to be a ‘human genetics research database’. There is also the related question of the necessary justification for differences in the treatment and control of ‘genetic research databases’, compared with other forms of ‘research databases’;
• Whether the licensing system is sufficiently robust and flexible to accommodate the developments in genetic and bioinformatic technologies;
• How any new scheme of regulation by way of licensing will ‘fit’ with existing forms of regulation;
• The lessons to be learned from local and international experience of regulating large databases of health and other personal information;
• The need to ensure the flow of knowledge through the national learning framework, which can inform the work of a licensing authority, with particular reference to community concerns around the storage and future uses of human tissue and sensitive information derived from that tissue.

Question 15–2. Should the proposed HGCA have any role in the regulation of human genetic research databases?

The functions of the proposed HGCA have been commented upon earlier in this submission[45].

Question 15–3. Should the use of a gene trustee or other independent intermediary be a condition of the licensing or registration of human genetic research databases?

I maintain my support for the adoption of practical mechanisms for the protection of an individual’s privacy, such as a gene trustee[46]. Whether the use of a trustee of an individual’s genetic information should be confined to the regulation of human genetic research databases or whether the concept of an ‘information trustee’ could be employed more widely to protect privacy in the research and commercial applications of health information could warrant consideration. Again, definitional issues may determine the nature and function of such mechanisms, since it may be difficult to determine what is and what is not a ‘genetic database’. Such questions will also fall to be determined on a wide range of factors, not the least of which are cost and practicability. It offers, nonetheless, an effective, transparent and accountable form of protecting an individual’s health information against the risks inherent in the establishment and operation of large databases.

In the specific context of research databases involving genetic information, attention could be given, for example, to legislating for the office of an independent information trustee within the National Health and Medical Research Council, whose functions would include liaison with both this Office and the proposed HGCA, on the most effective means, inter alia, of protecting the privacy of that information.

Question 15–4. Do we need legislation governing the disclosure, for law enforcement purposes, of genetic samples and information held in human genetic research databases?

Nationally consistent legislation provides one avenue to balance the benefits of disclosures of aggregated health information for such purposes as law enforcement with the harms from unjustifiable interferences with privacy. As a matter of general principle, regard should be had to the public interest in securing the benefits to public health of the uptake of health services by individuals, who are undeterred by any fear that organisations and agencies will have unrestrained access to their health information for such purposes as research, employment, insurance and law enforcement.

On the issue of privacy intrusive activities for law enforcement purposes, I have previously noted that, where there is likely to be a significant impact on privacy the following points should apply:

• “the power should be conferred, or the measure introduced, expressly, not by implication;
• privacy intrusive powers or measures should be conferred by an Act, not by subordinate legislation;
• the grounds on which power of intrusion may be exercised should be stated expressly and in objective terms; and
• the authority to exercise intrusive powers, for example, search or seizure, should generally be dependent on special judicial authorisation (a warrant); and
• other intrusive activities, for example seeking documents using statutory notices or other legislative mechanism, would at least require an appropriately senior officer to authorise the activity.”[47]

Furthermore, close attention will also have to be given to implementation of mechanisms to ensure transparency and accountability:

“A general principle in relation to accountability and transparency would be that the reporting requirements and independent oversight powers should be commensurate with the extent of the intrusion resulting from the activity.

………….

These two ideas are complementary. They go to the notion that there needs to be some report back to the community on the operation of intrusive prevention strategies or on the exercise of additional powers and the transparent and independent handling of the inevitable complaints. The objective is in part to reassure the community that measures are being properly implemented and that safeguards are being adhered to. The various forms of accountability also allow assessments to be made about whether there needs to be modification or removal of measures or powers or indeed if accountability measures themselves need to be strengthened.”[48]

Finally, the regular review of the operation of the privacy intrusive measures will:

“… help make sure they are or are continuing to do the job they are intended to do. Reviews also provide the opportunity for measures to be amended or removed if they are no longer necessary. Reviews are also a way to identify and rectify unintended or undesirable consequences – for example the targeting of the Financial Transaction Reports Act ….”[49]

In this context, much will depend upon the outcomes of informed public debate around the value to be ascribed to the competing interests of law enforcement and the privacy of the individual’s genetic information.

Human tissue collections

Chapter 16 of the Discussion Paper:

“is concerned with the collection, use, storage and disclosure of genetic samples and genetic information held in tissue [which includes blood and other bodily samples] collections maintained by hospitals or pathology laboratories. These collections, which have not been collected primarily for use in research are referred to in this Chapter as human tissue collections to distinguish them from human genetic research databases (see Chapter 15).”[50]

There are significant commercial, health and privacy implications in the ways in which the handling of human tissue and of bodily samples (and all forms of health information derived from tissue and samples) is regulated. Chapter 7 of the Discussion Paper proposes amendments to the Act which would place the regulation of bodily samples within the scope of the Act. It is critical that clarity, simplicity and effectiveness are the goals of the Joint Inquiry. The impact of those amendments on the proposals to be advanced on the issue of human tissue collection needs to be fully analysed. For example, would the legislative approach adopted in response to Question 16–2 below necessarily mean that legislation regulating secondary uses and disclosures of Guthrie cards would form part of the Act, if the Chapter 7 proposals are to be implemented?

Question 16–2. Do we need legislation governing the disclosure, for law enforcement purposes, of the genetic samples or information held on Guthrie cards?

The Victorian Privacy Commissioner has canvassed the issues and proposed an appropriate approach to this question, which includes the need for legislation:

“Further consideration is required to determine whether it is appropriate for police to be able to access existing genetic registers (or tissue banks, where individuals provide samples solely for the purpose of possible use in research), having regard to the public policy interests that led to the establishment of such registers in the first place. When parents of newborns consent to the blood test, the furthest thing from their mind is any measured judgement of the potential use by the state, through the police or otherwise, of their child’s DNA. Individuals may be less inclined to seek a genetic test or to provide a tissue sample if the genetic register or tissue bank becomes a pool of data into which police may routinely dip. Such reluctance to have newborns tested would not be in the public interest….[The issue] should not be decided by default through occasional or routine administrative arrangements between police, other authorities and custodians of the cards. Transparency and accountability are vital.

It should be a matter for thorough public debate and considered parliamentary decision before collections of infant DNA or research volunteers’ tissue are tapped for law enforcement purposes. If approved expressly under statute, any such use should:

1. be subject to clear purpose limitations;
2. be a technique of last resort in only the most serious cases;
3. not result in the addition of the DNA or derived data to any other database;
4. require informed consent in all but the most unusual cases; and
5. in all cases require a court order made after public proceedings about which reasonable notice should be given to relevant parties to put appropriate submissions to the court.”[51]

I endorse both the analysis and the recommendations of the Victorian Privacy Commissioner. It is consistent with approach to privacy intrusive law enforcement measures as outlined previously in this submission[52].

The approach taken, however, by the New South Department of Health and the New South Wales Police is at variance with the position advocated above and raises concerns about the protection of the personal information contained in the Guthrie spots collected in that state. On 17^th August 2002, these agencies entered into a Memorandum of Understanding (MOU) whose terms relate to the provision of access by the police to the “Newborn Screening Blood Samples” held by the Health Department.[53]. Essentially, the MOU contains a protocol describing the process by which the police can gain access to the samples to identify human remains and/or to assist in locating a “suspected victim” whose “forensic samples” have been taken from a “suspected crime scene” and where there are “no other reasonable means” of matching the samples (Clause 2). The Police must make “reasonable efforts” to secure the express consent of relatives or guardians, but impracticability or the potential for compromising an investigation are grounds for dispensing with the consent requirements (Clauses 3 and 4).

The following observations are relevant:

• As New South Wales government agencies, the parties to the MOU are subject to the provisions of the Privacy and Personal Information Protection Act (NSW) 1998, as expressly acknowledged by the MOU (Clause D);
• The newborn samples, presumably, are accessible by the police upon the service of a duly executed search warrant upon the Health Department.

It is critical, however, that the following points are made:

1. The Guthrie spots were collected from the infants for purposes totally unrelated to law enforcement, a use which, it may be assumed, would not have been contemplated by the parent(s) of the newborn infants;
2. The decision to enter into this MOU was made, to the best of my knowledge, without any recourse to “thorough public debate and considered parliamentary decision”[54];
3. There is an absence of express effective measures to ensure the accountability of both agencies;
4. The failure to include processes of review of the operation of the protocol and a limit on the duration of the MOU has the potential to encourage ‘function creep’.

In light of the above, uniform, nationally consistent legislation governing the disclosure, for law enforcement purposes, of the samples and information held on Guthrie cards should be introduced as a matter of priority. As the use and disclosure of the DNA information contained in the Guthrie spots are for the purposes of law enforcement, consideration could be given to the inclusion of appropriate legislation in Part ID of the Crimes Act (Cwth.) 1914.

Proposal 16–1. The Australian Health Ministers’ Advisory Council, in collaboration with key professional bodies, should develop nationally consistent policies and practices in relation to the collection, storage, use of and access to pathology samples, banked tissue, Guthrie cards and other samples collected and stored as part of a population genetic screening program.

In view of the present complexity in regulation and guidance around these issues, as described by the Joint Inquiry[55], I support the terms of the Proposal. Consideration could also be given to providing access by AHMAC to the expertise developed by the proposed HGCA.

Ownership of samples and the Human Tissues Acts

In Chapter 17 of the Discussion Paper, the Joint Inquiry “presents other possible approaches to regulating the handling of genetic samples…”[56] Those approaches include amendments to the various Human Tissues Acts which apply in the Australian jurisdictions. It is appropriate, however, to refer again to the need for careful analysis by the Joint Inquiry of the impact upon that existing legislation of the proposals in Chapter 7 of the Discussion Paper, as well as analysing the merits of amending the Human Tissue legislation.

Proposal 17–1. The common law right to possession of preserved samples, which is currently enjoyed by hospitals and others, should continue to be upheld, but full property rights in genetic samples should not be granted.

In response to this proposal, I adopt the view taken by the New South Wales Privacy Commissioner in NSW Privacy’s submission to the Joint Inquiry’s Issues Paper[57]. There is a great need for conceptual clarity if the Common Law relating to property rights is to be discussed in terms of protecting privacy. Traditional privacy concepts derived from respect for persons, such as informed consent, do not sit easily with the concepts of property rights, as described in the Discussion Paper.

Proposal 17–2. The Human Tissue Acts should not be used as the vehicle for regulating collection, storage, access to, or use of genetic samples, whether for the purposes of human genetic research or otherwise.

The Joint Inquiry’s ‘preferred starting point for any comprehensive reform of the law’ relating to the handling of genetic samples is the proposed amendments to privacy legislation[58]. The Discussion Paper includes the arguments advanced by the Centre for Law and Genetics in support of the amendment of the Human Tissue legislation[59]. The Centre’s proposals have the advantages of conceptual consistency and a focus on the authorisation/restriction of activities involving human tissue for legitimate purposes.

I note the Joint Inquiry’s arguments against the amendment of Human Tissue legislation. In effect, most of the consequences of that approach could apply also to its preferred amendment of the Act, with particular reference to the arguments based on the creation of complexity. Before any preference for one proposal over another can be expressed, a more thorough-going analysis of the competing proposals should be undertaken, than is reflected, for example, in the reference to the difficulties of the ‘drafting exercise’[60] that would be involved in the amendment of the Human Tissue legislation.

On balance, and in the absence of a more thorough-going analysis, preference should be given to regulating the handling of human tissue in such legislation as the Human Tissues Acts.

 

Health Services

Health professionals and family genetic information

Proposal 18–1. NPP 2.1(e)(i) of the Privacy Act should be amended so that disclosure of genetic information by a health professional to the genetic relatives of a patient is permitted where failure to disclose would place the health or life of a genetic relative at serious risk.

Proposal 18–2. State and territory governments should consider amending their privacy legislation in accordance with Proposal 18–1.

Proposal 18–3. The NHMRC should develop guidelines for health professionals pursuant to s 7 of the NHMRC Act dealing with disclosure of genetic information to the genetic relatives of their patients. These guidelines should address the circumstances in which disclosure to genetic relatives is ethically justified or required, and the need for patients to be counselled about the disclosure of information in these circumstances.

The Joint Inquiry has offered four reform options by which genetic information could be disclosed by health professionals to lessen or prevent harm to genetic relatives[61]. Whichever option is adopted, national consistency would be desirable.

Each of the options can be analysed in the following terms:

1. The NPPs are designed to give individuals a degree of control over all forms of their personal information which is relative to the sensitivity of that information;
2. In the context of health information, NPP2 builds upon the existing laws and practices relating to professional confidentiality;
3. NPP2.1(e) provides exceptions to the obligation of non-disclosure which are ‘aimed at two types of emergency situations’[62]. In other words, the exceptions are distinctively limited to two comparable situations: first, threats to an individual’s life health and safety and, secondly, threats to public health and safety;
4. Specifically, it is the familial character of genetic information that has prompted consideration of an exception to the rules of confidentiality and the legislated obligations of non-disclosure. Hence, any further exception to NPP2 can be, to adopt Magnusson’s phrase, ‘genetic-specific’[63], which would confine the scope of the exception in a manner similar to that referred to in sub-paragraph (c);
5. The need to take into account other legislative provisions relating to privacy (such as the IPPs) and desirability of national consistency in privacy regulation.

As regards the Joint Inquiry’s four options outlined on p.496:

• The ‘more permissive formulation’ of NPP2.1(e)(i) in the first option would apply to all personal information within the private sector. The Joint Inquiry has expressed a preferred policy position by which ‘exceptions to the duty of confidentiality should be recognised where disclosure of genetic information to genetic relatives is legally and ethically justified’[64]. There may need to be broader policy arguments to justify the weakening of existing privacy protection to the extent implicit in this proposal. Consideration would also need to be given to the impact of a corresponding amendment to IPP11.1(c).
• It is not clear from the formulation of the second option whether the proposed exception applies to all personal information, health information or genetic information. Any corresponding amendment to IPP11.1(c) would again need examination. Reference is also made to NPP10.2(b)(ii) which has a similar form of words. In this context, it may be instructive to enquire as to the experience of health professionals in availing themselves of this exception to NPP10.
• The third formulation captures the arguments advanced in the first OFPC submission. The involvement of national bodies, in particular the NHMRC, would enhance the prospects of securing a nationally consistent approach to disclosure in the limited circumstances described. The NHMRC and this Office have demonstrated the capacity to develop and approve guidelines under Sections 95 and 95A of the Act in the context of research, which enable flexible and localised decision-making. There may also be merit in having a statutory link between the NHMRC guidelines (that are, in fact, proposed in Proposal 18–3) and the relevant NPP and IPP.
• As to the fourth option, it may be preferable to effect a legislative alteration to the obligations of professional confidentiality within the primary instruments of the Act (the NPPs and the IPPs) rather than by way of subordinate legislation. The making of a Public Interest Determination would depend also upon whether the specific criteria under Section 72(1) and (2) of the Act can be met. Proposals for legislative amendments are able to take account of a wider range of factors. The relative times required by each process would need to be taken into account.

On balance, the third option is to be preferred.

Proposal 18–4. The guidelines referred to in Proposal 18–3 also should assist health professionals in dealing with requests for access to genetic information by the genetic relatives of their patients.

I support this Proposal. The Guidelines should be prepared by the NHMRC in consultation with the HGCA, with a view to their incorporation in the ethical standards of the relevant professions and their adoption within appropriate educational and research literature.

Genetic registers and family genetic information

Proposal 19–1. An organisation operating a genetic register for public health purposes should seek a Public Interest Determination (PID) under the Privacy Act to ensure that it can continue to collect family medical history information without breaching the NPPs.

Proposal 19–2. State and territory governments should consider amending their privacy regulation in accordance with Proposal 19–1.

Question 19–1. Should the proposed PID referred to in Proposal 19–1 also apply to the collection of health information from other health professionals for the purpose of verifying information provided by the registrant?

If an application is made under Section 73 of the Act for a PID, the issue will be determined in accordance with Section 72(1) or (2) and the criteria set out in its provisions. In this case, an organisation/register would need to satisfy the criteria that the collection of the health information by an organisation/register breaches or may breach a NPP and that the public interest in the collection of that information substantially outweighs the public interest in adhering to the NPP.

It is appropriate to observe in this context, and generally, that the Privacy Principles are not designed to prevent organisations or agencies from pursuing their activities involving an individual’s personal information. The intention behind the Privacy Principles and their implementation is to ensure that the individual’s personal information is handled in a fashion that respects the privacy of the individual.

The PID provisions of the Act are, however, an ancillary mechanism by which the unintended harms which may be occasioned by compliance with one or more of the Privacy Principles can be avoided. For example, in relation to PIDs 9 and 9A[65], compliance by health professionals with NPP10 in collecting family medical and social histories would have had the unintended consequence of diminishing the quality of health care and treatment for many individuals in the community. In that sense, the public interest in allowing health professionals to continue to collect that information in breach of NPP10 substantially outweighed the public interest in securing the consent of those family members in accordance with NPP10.

PIDs 9 and 9A came into effect on 11 December 2002. It should be noted that their combined effect is much wider than that of the Temporary Public Determinations. In summary:

“Under PIDs 9 and 9A, a health service provider may collect health information from a health consumer about a third party without the consent of the third party when both of the following circumstances are met:

• the collection of the third party’s information into a consumer’s social, family or medical history is necessary for [the health service provider] to provide a health service directly to the consumer; and
• the third party’s information is relevant to the family, social or medical history of that consumer.”[66]

If those conditions are met, then the health service provider will not be in breach of NPP10 when it collects a third party’s information without their consent.

As to the specific terms of Proposal 19–1, careful consideration is required as regards two issues:

• Whether the genetic register is an ‘organisation’ within the terms of Section 6C of the Act. The Joint Inquiry has noted “that, with few exceptions, all genetic registers are public hospital based’[67]. If the public hospital, within which the register is situated, is a ‘State or Territory authority’, as defined by Section 6C(3) of the Act, then generally speaking the register will not be an ‘organisation’;
• The definition of ‘health service’ in Section 6(1)(a)(i) of the Act refers to “an activity performed in relation to an individual that is intended (expressly or otherwise) …by the person performing it…to record …the individual’s health”. In other words, the activity of recording the information is, in itself, the provision of a health service directly to the individual/consumer. Whether a genetic register falls within the terms of PIDs 9 and 9A will be determined by whether the register provides a ‘health service’, as defined, to an individual/consumer (apart from the attendant public health benefits).

As to Question 19–1, the collection by the register of the third party’s health information (for the purposes of verification of diagnoses) is not from the individual/consumer, but from other health service providers. This fact would be sufficient to take the collection outside the terms of PIDs 9 and 9A. The consent of third parties would then be necessary, if NPP10.1 is not to be breached.

The terms of Proposal 19–1 refer to the operation of genetic registers for “public health purposes” and the Joint Inquiry quotes the submission from the Hereditary Bowel Cancer Register as emphasising the importance of the Register for, inter alia, “research”[68]. In the appropriate case, the provisions of NPP10.3 may be applicable to those registers which operate in the private sector. In this context, it is noted that the provisions of NPP10.3 contain references to what is ‘reasonable’ or ‘impracticable’. The effect of these terms will depend on the particular circumstances of each case, allowing for responsible decision-making that respects privacy and facilitates the operation of the registers in the interests of public health. These concepts and their application are elaborated in further detail in OFPC Guidelines and Information Sheets[69].

Population Genetic Screening

Question 21–1. Should tests used in population genetic screening programs be required to meet an agreed standard for reliability, sensitivity and utility? If so, should the proposed HGCA play a role in such regulation?

Proposal 21–1. The Australian Health Ministers’ Advisory Council, in collaboration with the proposed HGCA and key professional bodies, should develop nationally consistent policies and practices in relation to the implementation and conduct of population genetic screening programs, covering such matters as informed consent, counselling and testing standards.

I support the development of nationally consistent policies and practices through the appropriate bodies. As previously observed, it is preferable that the proposed HGCA be used as a source of expertise and advice to existing regulators, instead of as a further decision-maker.

Since population screening will give rise to large aggregations of genetic and other personal information, particular attention should be given to proposals for the use of that information for research or other secondary purposes to ensure that the privacy interests of participants are respected.

The Joint Inquiry properly stresses the importance of the protection of an individual’s right not to know, especially in the case of incurable conditions or where there may be significant implications around insurance issues.

In terms of respecting the interests of participants and community needs in genetic screening programs and the use of a ‘gene trustee’, there are valuable lessons to be learned from the screening programs conducted in Sydney Jewish secondary schools for Tay-Sachs disease from 1995-1998.

The proposal could benefit also from a further refinement which would take account of the variable potential for discrimination or other potential harms which attend different conditions or diseases. Attention could be given to the need to identify those conditions with which there are associated degrees of stigmatisation or social injustice and whether the policies and practices, as well as being nationally consistent, should reflect the corresponding potential for harms. As the scientific and medical correlations between genetic characteristics and medical conditions become more sophisticated, together with society’s understanding of their social impacts upon individuals, so will the need for flexibility in genetic screening policies increase to take account of the prospective harms to individuals identified by the screening processes.

 

Insurance

Introduction

The Joint Inquiry makes the following comments in relation to insurance and privacy:

‘It would appear that there is a developed awareness of privacy principles and appropriate personal information handling practices across the insurance industry in Australia. Both the Insurance Council of Australia and IFSA have been active in promoting these principles to their members and in contributing to the development of sound practices in the insurance industry.’[70]

I agree with this observation, together with the further comments as to the low level of complaints about improper handling of personal information by life insurance companies[71].

Insurance and Genetic Privacy

Proposal 25–1. Insurers should review their consent forms, including medical authority forms, to ensure that they contain sufficient information about the collection and use of genetic information to allow applicants to make an informed decision about whether to provide the information

I support this proposal for the reasons advanced by the Joint Inquiry[72].

Question 25–1. Does the practice of ‘bundling consents’ by insurers undermine the ability of an applicant to make an informed decision about whether to provide genetic information to an insurer? If so, what measures should be taken to address this problem?

The OFPC’s concerns around “bundled consents” are directed against the practice of financial institutions making it a condition of an individual’s access to their services that the individuals agree to a wide range of further uses and disclosures of their information. In other words, the individual’s consent to those further uses and disclosures in some circumstances may lack the requisite voluntariness and range of options. In other circumstances, the consents sought from the individual are unduly broad or loosely worded, allowing an organisation to interpret the consents in a manner which is ultimately intrusive or harmful to the individual. While the practice of bundled consents may not be in breach of the Act, it must be regarded as contrary to the spirit of the legislation.

Since the OFPC’s first submission on this topic, the Office has continued to monitor the situation and to encourage best practice through a range of avenues, including consultation with financial institutions. The Office has already received and resolved complaints about bundled consents in insurance claim forms and the resolution of these complaints has resulted in the re-wording (or the “unpacking”) of the consent forms. An example of the resolution of a complaint involving bundled consents can be found on the Office’s website[73].

In the event that the issue of bundled consents remains one of concern, it is likely that it will be included within the two-year review of the private sector provisions of the Act.

Proposal 25–2. Insurers should seek a Public Interest Determination under the Privacy Act in relation to the practice of collecting family medical history from applicants for use in underwriting insurance policies in relation to those applicants.

The general issues relating to applications for a Public Interest Determination (PID) under Sections 73 and 72(1) or (2) of the Act have been canvassed above. It was also noted that the terms of PIDs 9 and 9A have a broader scope than the Temporary Public Interest Determinations made in December 2001 [74].

As regards Proposal 25–2, the collection of family medical histories from applicants for insurance, generally speaking, may fall within the terms of PIDs 9 and 9A. Much will depend upon whether the activity falls within the concept of a ‘health service’, as broadly defined in Section 6(1)(a)(i) of the Act[75]

It is, however, important to observe also that the consequences of a granting of a PID are the lowering of privacy protections for individuals (in this case, the members of the insurance applicant’s family who would otherwise enjoy the protection of NPPs 1 & 10 or their equivalents in a privacy code). It would be necessary to enquire into the relative benefits and harms arising from the practice, such as minimising the risk of adverse selection. In terms of Section72(2)(b), I would have to be satisfied that the public interest in underwriters collecting family histories substantially outweighs the public interest in adherence to provisions of a code or the NPPs.

Apart from an assessment of the competing social interests, there are practical matters involved, such as the form of the question(s) asked of applicants for insurance products. In effect, it may be a productive exercise to examine the suitability of the specific questions asked of applicants in the context of the purposes of underwriting particular insurance products and whether the particular form of question is necessary to facilitate better risk analysis.

In summary, the combination of finding practical solutions within the industry and the use of the new PIDs can resolve the proper concerns that the industry may have around compliance with the NPPs.

Employment

Employment and Genetic Privacy

Proposal 30–1. The definition of ‘employee record’ in the Privacy Act should be amended to exclude genetic information held by an employer in relation to a current or former employee.

Proposal 30–2. The pending inter-departmental review of the employee records exemption to the Privacy Act should consider whether health information generally should be excluded from the ambit of the exemption.

Recommendation 5 in the first OFPC submission and the arguments advanced in that document[76] supported the repeal of the exemption as it applied to ‘health information’. A far simpler way of achieving the same end as the proposal advanced by the Joint Inquiry, however, would be to repeal the employee record exemption, given that Proposal 30–1 would require almost all employers to protect some of the information of their employees, which would, thereby, defeat the main aim of the exemption[77].

I note that the pending inter-departmental review of the employee records exemption to the Act is still under way.

Other Contexts

DNA Parentage testing

Proposal 31–1 to Proposal 31–12

I support these proposals where the proposals have implications for protecting the privacy interests of individuals against unwarranted harms. Reference is made to the matters canvassed in this submission under the heading of ‘Genetic Testing’[78].

Particular attention should be given to measures which ensure the adequacy of the consent from the individual whose sample is being tested (Proposal 31–6). The protection of vulnerable children and their privacy interests should be a priority, together with the means to ensure the appropriate recognition of the wishes of mature children. As regards the privacy interests of children generally, the Joint Inquiry may wish to consider the views expressed in the forthcoming discussion paper from the federal Attorney-General’s Department on children and information privacy under the Act.

Law Enforcement

Introduction

As regards the privacy implications of forensic DNA testing, the first OFPC submission described the critical framework issues[79]. Other matters requiring careful attention include:

• Since community trust and confidence in law enforcement and in the protective mechanisms designed to safeguard their liberties are both prerequisites for the establishment of effective forensic DNA procedures, then the public should be fully engaged in a well-informed and continuing debate on all relevant issues;
• It is appropriate to note that the Forensic Procedures Review Committee (the Review) has been conducting an independent review of the operation of Part 1D of the Crimes Act (Cth) 1914, pursuant to Section 23 YV of Part 1D. Included among its Terms of Reference are “any issues relating to privacy or civil liberties arising from forensic procedures permitted by this Part”(Section 23YV(1)). The Review must give the Minister a written report of the review which is to be tabled in Parliament (Sections 23YV(2) and (3)). It will be important to take into account the Review’s recommendations on the issues raised by the Joint Inquiry’s Proposals in Chapters 35 and 36.
• The national DNA database system is in its infancy. Many of the provisions of Part 1D remain untested in both a practical and a legal sense, as are the laws of the participating jurisdictions. In many cases, the effectiveness of existing privacy safeguards can be determined and assessed only through experience. Hence there is a pressing need for future well-resourced reviews of the operation of the national DNA database and the efficacy of existing privacy protections.

DNA testing technology is becoming increasingly powerful[80]. With these advances there remains the fundamental need for proportionate controls over testing procedures and for robust and flexible systems of accountability and oversight. The OFPC responses to the Joint Inquiry’s proposals in Chapters 35 and 36 seek to reflect that need.

Harmonisation of forensic procedures legislation

Proposal 35–1. The Commonwealth, States and Territories should work together to achieve harmonisation in Australian forensic procedures legislation, in particular in relation to the collection, use, storage, destruction and index matching of forensic material and the DNA profiles created from such material. Inter-jurisdictional sharing of forensic material and DNA profiles, whether on a bilateral basis or via the national DNA database system, should be permitted only after such harmonisation has been achieved.

I support this proposal. Lack of legislative uniformity may have the unintended consequence of diminishing the utility of the national DNA database system, as well as compromising an individual’s privacy rights. The need for legislative uniformity, however, should not provide an excuse for an extension of the power to collect, use, retain and match DNA profiles, in ways which would have the effect of diminishing the standards of privacy protection. While it should be noted that the Commonwealth, States and Territories have committed at the highest level “to legislate in the priority areas of model forensic procedures before the end of 2002”[81], achieving a high degree of uniformity may be many years away. In the meantime, the means should be found to make the best use of existing transparency and accountability mechanisms. This would probably include such existing accountability bodies as the Ombudsman and the Privacy Commissioners.

Proposal 35–2. In order to achieve greater transparency, ministerial agreements for the sharing of information and inter-jurisdictional matching protocols should be prescribed in regulations.

There are competing arguments in regard to such ministerial agreements being prescribed in regulations. The NSW Privacy Commissioner noted that there is the chance that reliance upon ministerial agreements on an ad hoc basis to achieve these goals could weaken the safeguards of the Model Bill[82]. On the other hand, the Commonwealth Attorney-General’s Department observed that these arrangements will be public documents and “will not impact upon the safeguards that are in [Part 1D]”[83].

Without any experience of the functioning of national DNA database system and of the operation of Part 1D, it may be advisable for this proposal to be evaluated at a later date, with the benefit of experience. In the event of the statutory provisions[84] requiring a further Review of Part 1D being invoked by the current Review, the opportunity will arise for further consideration of this issue.

Criminal investigations

Proposal 36–1. Except in relation to volunteers, the consent provisions should be removed from forensic procedures legislation so that an order by the appropriate Australian Federal Police officer or judicial officer is required before a forensic procedure can be carried out on a suspect or serious offender.

While the “inherently coercive nature of criminal investigations”[85] is acknowledged, the removal of the consent provisions from the legislation may not be the most effective means of remedying any procedural inadequacies. There are a number of factors that need consideration, including:

• The existing requirements for the subject’s consent to the procedure to be adequately and genuinely informed and voluntarily given do, in effect, provide a measure of restraint or control over the taking of samples and can, in practice, provide benchmarks for complaints, audits and other oversight measures;
• An emphasis on the voluntary nature of the consent can alleviate the sense of coercion, inherent in most investigations;
• The individual who provides a sample can be assured of receiving a degree of relevant information, such as the purpose and the consequences of the procedure; and
• The probable impact on the ‘workability’ of forensic procedures as an investigative tool, if the order of a senior officer or of a judicial officer is to be sought in the conduct of the majority of forensic procedures.

I support the introduction of effective legislation as regards all forensic procedures subjects:

1. to simply the information provided to subjects;
2. to ensure an appropriate level of comprehension by the subject of that information; and
3. to achieve a degree of uniformity across jurisdictions with informed consent procedures.

As important as those goals are, the achievement and maintenance of the integrity of the forensic procedures are of equal significance. A community perception of impropriety, particularly where the essence of the procedure is its consensual nature, may be fatal for maintaining public confidence. Standards of integrity will not always be achieved and maintained by the passage of legislation. For those reasons, practical measures will need to be devised to ‘field test’ or monitor the conduct of as many procedures as possible, whether those procedures involve one individual or a whole community.

In the event of a subsequent review of the operation of Part ID, in accordance with Section 23YV(5), it will critical for any such review to have data from the participating jurisdictions as to their experiences in administering the informed consent procedures – in short, the results of their ‘field tests’. Until that sort of analysis is made, the introduction of the measures suggested in Proposal 36–1 may be premature.

Proposal 36–2. Notwithstanding Proposal 36–1, forensic procedures legislation should continue to provide that suspects and serious offenders must be given prescribed information about the nature and consequences of the forensic procedure prior to it being carried out.

I support this proposal and refer to the discussion relating to the preceding proposal. In all cases, the prescribed information should also include prominent information on appeal rights and avenues for complaints, including time limits, if any, for pursuing rights of appeal and complaints.

Proposal 36–3. Forensic procedures legislation should provide that children and incapable persons who are volunteers should be given the prescribed information about the nature, purpose and consequences of a forensic procedure prior to it being carried out.

I refer to the preceding proposals.

Proposal 36–4. Forensic procedures legislation should provide that a forensic procedure may be carried out on a child volunteer of 12 years or above only with the consent of a parent or guardian and the child.

In principle, I support this proposal. The over-riding concern should be the protection of children of any age, the promotion of their well-being and respect for their interests. Much will often depend on the maturity of the individual child and the circumstances of any particular situation that involve a child and forensic procedures.

There should be wide-spread community consultation on this issue. It will be important to take into account the relevant recommendations of the Review and the forthcoming Commonwealth Attorney-General’s Department’s issues paper on Protecting children’s privacy.

Proposal 36–6. Regulations or police guidelines should be developed in every jurisdiction on the conduct of mass screening programs, both in relation to the approval process for initiation as well as the manner in which such programs are conducted.

I support this proposal in principle. It may prove difficult, however, to formulate ‘universal’ regulations or guidelines with any degree of precision. A screening program and its implementation may be devised to achieve a certain forensic goal. The local circumstances and the nature of the investigation may influence the conduct of the screening processes.

As discussed in relation to Proposal 36–1 above, much will often depend upon the maintenance of the integrity of the procedure by the investigating officers and of their respect for the participating subjects. Objective data, obtained by appropriate means of ‘field-testing’ or monitoring the conduct of the program will be critical. Ultimately, the effectiveness of such programs may depend upon dispelling perceptions that they are privacy-intrusive for the participating individuals.

Proposal 36–7. Forensic procedures legislation should be amended to delete reference to the DNA profiles of blood relatives of missing persons from the definition of the ‘missing persons index’.

I support this proposal for the reasons advanced by the Joint Inquiry[86].

The events in Bali in October 2002 have demonstrated the public interest in having access to DNA profiles to identify victims of catastrophic events. In the absence of uniform legislation across all jurisdictions, the Commonwealth Government found it necessary to enact urgent legislation providing for access to the national DNA database by law enforcement officers for identification purposes. Federal and state police officers collected DNA samples from the relatives of persons missing in Bali and, together with the victims’ samples, they were stored in a separate database to enable profile-matching[87]. These measures demonstrated the importance placed on ensuring that, both legally and technologically, it would be extremely difficult to link this database with any other database. The community has a demonstrable interest in law enforcement agencies maintaining the integrity of these processes.

Careful thought and attention should continue to be given to those legal and technical measures, which will ensure that the DNA profiles of all volunteers collected for this, or any future, catastrophe are not included in an inappropriate index or used for any unrelated forensic purposes.

Proposal 36–8. Forensic procedures legislation should provide that samples (including crime scene samples) collected or otherwise obtained for use in the law enforcement context may be subject to genetic testing and analysis only with respect to the non-coding sections of the DNA, and only for the purposes of creating a DNA profile, quality assurance or equipment validation.

In principle, I strongly support this proposal. The relative ease of access by law enforcement agencies to DNA database information is predicated on the understanding that no genotypical information about the subject, other than their sex, will be revealed. This understanding is explicit in the Second Reading Speech of the Crimes (Forensic Procedures) Bill 2001[88].

If, however, DNA-related research is conducted on the subject’s sample by the research arms of law enforcement agencies (with a view to developing more sophisticated DNA profiling methods) which involve genotypical information, then urgent consideration should be given to enacting legislation to regulate such activity. This legislation should be directed at limiting DNA collection and analysis for prescribed law-enforcement purposes and/or against the potentially harmful collection of sensitive genetic information for purposes other than that for which the sample was collected[89]. Criminal sanctions may be appropriate in this context.

Proposal 36–9. Forensic procedures legislation should provide that forensic analysis of genetic samples must be conducted only by laboratories accredited by NATA in the field of forensic science.

I strongly agree with this proposal.

Proposal 36–10. Forensic procedures legislation should require the permanent retention of forensic material found at crime scenes to ensure the preservation of crime scene material for post-conviction analysis.

I support this proposal, provided that there are adequate safeguards to protect the privacy rights of the individual who may be identified through that forensic material.

Proposal 36–11. Forensic procedures legislation should provide that forensic material taken from a suspect, and any information obtained from its analysis, must be destroyed as soon as practicable after the person has been eliminated from suspicion, or police investigators have decided not to proceed with a prosecution in relation to that investigation.

In principle, I support this proposal. It is essential to recognise the distinction between a personal or bodily sample and the DNA profile derived from that sample. Once a suspect is eliminated from suspicion with respect to an investigation or an investigation involving that suspect is terminated, there is no justification for retention of that person’s bodily sample. The retention of the sample would increase the potential for unrelated secondary uses of the material (i.e. “function creep”). The sample should be destroyed.

It may not always be possible, however, to find and destroy all records relating to that sample and the profile, which are capable of identifying the suspect. Hence it is recommended that, in the case of ‘eliminated suspects’, the investigative officers and laboratory staff undertake to use their best endeavours to destroy all DNA-related information capable of identifying that suspect[90]. In the event that the personal information of an eliminated suspect is improperly obtained or used or disclosed, that information should remain subject to the laws of evidence relating to improperly obtained evidence. The person mishandling that information should also be the subject of criminal sanctions.

Proposal 36–12. Forensic procedures legislation should be amended to prohibit the establishment or maintenance of any DNA database that does not fit within the legislative definition of a DNA database system.

Generally, I support legislation limiting the linking of DNA samples and profiles with any samples and profiles in a database, which is not the subject of law enforcement legislation.

Proposal 36–13. Forensic procedures legislation should be amended to provide for independent, co-ordinated and nationally consistent monitoring of the operation of the entire national DNA database, and in particular the interaction of the forensic procedures regimes operating in each jurisdiction that participates in the national DNA database system.

I support this proposal in principle. Legislated arrangements for the nationally coordinated, independent and objective monitoring and oversight of the entire DNA forensic procedures system will be fundamental to an assurance of the community that there are effective privacy and accountability safeguards.

No less important will be a seamless, transparent national framework for complaints-handling, audits and investigations. It will be critical that an individual complainant does not ‘slip between the cracks’, simply because their DNA profile has passed from one jurisdiction to another, with the attendant risks of breaches of privacy in the profile’s passage between jurisdictions. The audit and investigation functions should command a high level of independent analytical resources, capable of responding to the development in the forensic applications of DNA technology.

An accountability framework has been proposed by the Victorian Privacy Commissioner[91], which has much merit. However, as discussed above, the goal of complete uniformity of forensic procedures legislation may be some years away. Hence it may be advisable, at this stage, to use the existing mechanisms in a more strategic fashion. For example, the Ombudsman, Privacy Commissioners and auditors in each jurisdiction could work together to develop and agree upon reporting, auditing and complaint-handling mechanisms. The mechanisms can be designed to meet the imperatives of effective oversight and accountability. In the event of any further review of Part 1D, the success or otherwise of these measures could be evaluated. This would ensure that any inadequacies within the system can be identified and remedied by effective measures.

Proposal 36–14. Forensic procedures legislation should be amended to:

• specify the person responsible for notifying the forensic laboratory, and CrimTrac, of the destruction date of forensic material and any information obtained from it;
• establish a process for persons to obtain confirmation that their forensic material, and any information obtained from it, has been destroyed; and
• provide (in regulations) a standard consent form for use at the time the forensic procedure is carried out to enable a volunteer (or parent or guardian) to specify the retention period for both the forensic material and any information obtained from it.

Question 36–1. Should the definition of ‘destruction’ in Part 1D be changed to provide for physical destruction of forensic material and information obtained from its analysis? Do the practical difficulties in tracing and physically destroying all remnants of a sample, and all records of the profile, justify confining privacy protection to de-identification rather than physical destruction?

In general, I support this proposal, subject to the qualifications expressed in response to Proposal 36–11. Question 36–1 will be answered within that response