Dated March 2002
This document is at http://www.privacy.org.au/Papers/SubmnALRC0110.html
The Charter Council welcomes the thorough and wide-ranging approach being taken by the Inquiry to this complex issue. The implications of genetic information are so profound that it is necessary to question all existing processes and conventions that are touched by availability of the information. We cannot emphasise too strongly that in our view no existing practices should be taken as axiomatically justified - even where on the face of it genetic information is simply being handled in the same way as other health information and no `problems' have arisen to date. It is necessary to examine each potential application of genetic information afresh to ascertain if the unique characteristics of that information (in particular its `multi-person' character') raise any new issues.
We make no apology for focusing on some privacy risks that we perceive. But in doing so, we acknowledge the major contribution that genetic information can make to many areas of life - in particular health care but also potentially to law enforcement. It will almost certainly be the case that in some cases, the loss of some degree of privacy will be justified, on balance, to obtain other public benefits. These benefits do however need to be clearly demonstrated and not just hypothetical. We reject the presumption that some existing uses of genetic information - in particular in law enforcement, are now so well established that they should not be challenged. While the Inquiry will rightly recommend safeguards for uses of genetic information, it should also, and firstly, critically examine all existing uses, and be prepared to recommend cessation of some uses if on balance the disadvantages and risks outweigh the benefits.
One consequence of a proliferation of secondary uses could be serious damage to the primary purposes, and to the undoubted health benefits. If individuals fear that there might be adverse consequences in the future, they will be less inclined to agree to testing which could both benefit them directly and contribute to health research and knowledge.
One of the main points we would like to make cuts across many of the `subject areas' and chapters of the Issues paper. This is the importance of minimizing the amount of incidental genetic information that is recorded in connection with any particular application. If records of tests or analyses carried out for a particular purpose contain information which can subsequently be used for other tests or checks, then pressure will inevitably grow for those other uses, and the temptation to authorize such uses without the express consent of the individual will be considerable. If, in contrast, it is necessary to obtain a new sample to undertake any new tests or checks, then the safeguard of express consent is much easier to uphold.
There will no doubt be arguments that it is more efficient to store extensive information to save the cost of re-sampling, and even that it is desirable to carry out multiple tests at the same time even if they are not immediately necessary. We also suspect that there will be arguments about `duty of care' to err on the side of extracting and keeping more rather than less information. We consider it very important for the Inquiry to recommend strongly against these arguments and in favour of strict purpose-specific sampling and testing (although there may be some cases where speculative multiple tests may be of direct benefit to the individual).
The same arguments apply to retention of samples. We understand that samples of human genetic material do not de-generate over time and that a sample can be subjected to the entire range of tests at any time in the future. Retention of samples therefore effectively undermines any policy of minimizing analytical results. It follows that in order to maximize the effective control over testing by the individual concerned, samples should generally not be retained - only the results of the specific test. Any departure from this general principle needs to be very clearly justified.
Another general principle is that wherever possible, genetic information should be held in a form in which the individual from whom it was derived is not identifiable. This should be possible in many areas of research. While there are obvious ethical issues about notifying individuals of potential detriment if they can be identified and contacted, these do not arise if there is no possibility of identification.
In other areas of research, it may be necessary to retain identification either to link subsequent records, or desirable because the potential detriment is so great. In these cases, the option of holding the identification particulars separately - perhaps under the control of a disinterested third party, should be considered. The third party could then authorize linkage, and where appropriate contact, where this was on balance necessary or desirable.
Given that genetics is still in its infancy, and the consequent potential for inaccurate test results and inferences, we believe there should be strict safeguards of the quality of genetic information. It may be appropriate to require the use of neutral accredited laboratories and analysts, rather than allowing `in-house' testing and analysis, where commercial or other pressures could be brought to bear inappropriately. An even for third party laboratories, there should be strict minimum standards, to avoid the problem identified in the Issues Paper of `quick and dirty' commercial testing for purposes such as paternity.
These issue are too important to only be the subject of a one-off inquiry, however thorough. We are attracted to the idea of a standing committee or commission, properly resources and genuinely independent, to monitor developments, and to play an adjudicative role in relation to exceptional uses, retention, data linkage etc.
3-1 - Some ethical standards can appropriately be left to professions but others need entrenching in law. The range of commercial, efficiency and other pressures bearing on professionals are so great that we cannot rely on voluntary codes of practice or the myth of a non-existent professional consensus.
4 - The legislative framework for privacy established by the Privacy Act 1988 and equivalent State laws in Victoria and NSW are a useful starting point but do not deal adequately with the privacy of genetic information. This is true even of the health specific privacy laws in Victoria and the ACT, and under consideration elsewhere.
In this section of our comments, we have tried to refer generically to privacy principles rather than specifically to the new private sector NPPs under the federal Act, or to any of the differing sets of public sector principles.
Firstly there are too many exemptions and exceptions which mean that a large number of organizations and individuals are not subject to those laws.
Secondly, it is not beyond doubt that all genetic information is health information and therefore subject to the additional rules for sensitive information (Q.4-2).
Thirdly, the collection principles, while generally acknowledging the need for a higher threshold of consent for collection of sensitive information, allow too many exceptions in relation to health care and research, and where required by law.
Fourthly, the principles concerning use and disclosure (including those in the Guidelines under ss 95 & 95A of the Privacy Act (Cwth)) allow for too many exceptions from the requirement to obtain consent - and even consent can be implied, and/or effectively mandatory as a condition of a transaction. For genetic information there needs to be a much greater emphasis on free, informed and express consent, with appropriate accommodation of the difficulty caused by genetic information relating necessarily to multiple individuals (refererred to in the paper as its familial nature).
Fifthly, the access principles in privacy laws do not deal adequately with the same familial nature issue.
In relation to collection and use and disclosure principles, the exception for required or authorized by law needs modifying, for genetic information, to be limited to where expressly required or authorized. This would ensure that the specific issue of genetic information would have had to have been expressly considered either by the law-makers or, in relation to the exercise of information gathering powers, by an appropriate judicial authority. Genetic information is too sensitive to be subject to generic information gathering powers (such as those possessed by revenue or benefit agencies) that do not require the issue of a warrant by a judge or magistrate).
There also needs to be a clear safeguard against the obtaining of consent as a condition of the provision of goods and services where the genetic information is not absolutely necessary. There will be some services and transactions which can only be performed if the individual gives consent to a genetic test, or the transfer of existing genetic information. But organizations should not be permitted to require testing or transfer simply because they would find the information useful for some secondary or future purpose.
The familial nature of genetic information raises obvious difficulties in relation to the `right to know' and the `right not to know'. It may be that a new principle is required prohibiting the `attachment' of genetic information to an individual's record, or the linkage of the records of family members, without the express consent of the individual concerned. But we can see that this might create practical difficulties for health professionals, and even in areas such as insurance and employment where it is necessary for other reasons to know about family relationships. Once genetic information which is predictive for relatives is on the record of individual A, it seems impracticable to prevent a range of people from legitimately knowing that the same prediction holds true for related persons B & C, even if there are controls on the recording of that knowledge. And once it is known by third parties, it is difficult to justify on ethical grounds keeping it from the individual themselves. Perhaps a new principle should require each individual to be notified that some genetic information exists that relates to them, giving them the choice of whether to seek access or not. But this may be impracticable on logistic grounds if there are too many individuals involved - how far would organizations be expected to trace the family tree? And there will also no doubt be situations where the knowledge that a genetic test had been carried out would be unreasonably intrusive into the privacy of the tested individual - even to the point of potential harm.
4-6 Privacy protection of genetic information can only sensibly be provided on a consistent national basis. The mobility of individuals and the provision of health, insurance and other services on an interstate basis would make any significant differences in regulation between jurisdictions a nonsense. We offer no view as to whether consistency is best achieved by federal legislation or by uniform state and territory legislation.
The creation of a central national database of genetic information (not suggested in the Issues Paper other than in the context of electronic health records (9-3)) would allow access to be controlled according to a single set of rules. It might be possible to vest management of such a database in a disinterested third party, with no stake in any potential uses, but we doubt if even this arrangement would be able to resist the inevitable pressure for new uses and access. On balance, we favour the maximum dispersion and de-centralisation of human genetic information, amongst purpose specific and preferably geographically limited databases. The trusted third party concept could however be applied at this level as an additional protection.
7-5 The idea of giving individuals a form of property right in their genetic information is superficially attractive but seems to fall foul of the `familial nature' of the information.
Question 9-4 belongs in a general section as it applies outside the health administration context as well. We believe that the penalties for misuse of genetic information, and for breaches of whatever rules are put in place, need to be severe. The existing regimes of complaint based sanctions for breaches of general privacy principles are not adequate. A graded range of administrative sanctions, civil penalties and criminal offence provisions is required. The regulatory authority also needs to have the full audit and inspection powers already available to the Privacy Commissioner in relation to Commonwealth agencies, tax file numbers and consumer credit (but not in relation to the NPPs).
As a general principle, we do not think that allowing employers and insurers to differentiate the way they deal with individuals on the basis of their genetic makeup can be justified. Individuals have no control over their genetic inheritance, and the community as a whole should bear any risks that arise from genetic differences. While these applications of genetics raise largely ethical issues drawing on human rights and anti-discrimination theory and law, there is a privacy dimension. The less differentiation is allowed, the less testing there will be, and the less genetic information will be collected and stored. This is both intrinsically protective of privacy, and also minimizes the difficulties of reconciling competing privacy rights as between related persons. Therefore from a privacy perspective, prohibitions or restrictions on genetic testing use of genetic information in employment and insurance are a good thing.
A general principle that should apply in all forms of testing in an employment context is that tests should be aimed at assessing ability to perform the required tasks - not to surrogate `conditions' that may or may not have some bearing on ability or competence. Just as drug testing is often used as an unnecessarily intrusive surrogate for safety standards, genetic testing could all too easily come to be a `lazy' alternative to more specific testing or assessment.
In the insurance context, insurers should not be allowed to require applicants for cover to take genetic tests - confirming the interim policy currently in effect. Individuals should only be required to provide genetic test results already obtained for other purposes where the test result could have a direct bearing on the underwriting decision using existing health criteria. Any pressure to introduce new criteria based on more specific information about an individual's genetic make-up should be resisted - it would pose too much of a threat to the community rating principle and could make some individuals effectively un-insurable.
It may be desirable to review the appropriateness of allowing general family health history information and criteria in insurance, if the community is serious about community rating and sharing risk. The suggestion of a basic level of cover, to be available to all independently of any genetic information (Q 11-12) could be extended.
We are concerned that there was inadequate public debate around the amendment of the forensic procedures section of the Crimes Act in 2000. It has also been widely acknowledged, including in the Parliamentary debates, that the effectiveness of some of the safeguards in the Commonwealth Act is undermined by weaker State legislation - pointing to the urgent need for consistent regulation.
We understand that the operation of the CRIMTRAC system, and of the Commonwealth legislation, is to be reviewed later this year under s.23YV of the Crimes Act. Among the matters that we hope that both that review and your inquiry will address are:
We have only been able to address a few of the issues that arise. We welcome the Inquiry's comprehensive identification of privacy issues in the Issues Paper and rely on the ALRC and AHEC to use their resources to thoroughly pursue the privacy implications of current, proposed or likely applications of genetic analysis, even where these may challenge established or powerful interests.
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