Ethics

Human fetal tissue is a scarce resource that has been used in Australia for biomedical research since 1980. From 1994 to 2002, it has been used for research by 19 biomedical researchers at 12 separate Australian institutions (four universities, six major teaching hospitals and two research institutes). With an average of 265 samples distributed annually, researchers have conducted experiments in biomedical research with the approval of their Human Ethics Committees, and published 74 manuscripts in peer reviewed journals over the past decade. The tissue is obtained from therapeutic termination of pregnancies at 8–20 weeks’, but mostly 14–18 weeks’, gestation. The average number of fetuses obtained over the past 10 years was 108 per annum. Our understanding of the pathogenesis of human diseases such as diabetes, multiple sclerosis, retinopathy of prematurity and osteoporosis has been advanced because of such experiments, and better drug treatment of disorders such as osteoarthritis has been made possible with the use of human fetal tissue. The benefits of human fetal tissue research need greater recognition.

Bernard E Tuch FRACP, PhD · Hayley Scott BScAg · Muhammad T Tabiin PhD · Liping P Wang MSc · Patricia J Armati PhD

A recent editorial in the New York Times makes disturbing reading. It says, in part: . . . the number of Americans without insurance . . . stood at 39 million even at the end of the booming 1990s . . . more than 2 million Americans lost their insurance last year. The soaring costs are driven, in part, by the biomedical revolution of the past decade, which has produced an array of expensive new treatments for an ageing population, from drugs to fight osteoporosis to high-tech heart pumps. The result is a health care system filled with great promise and inequity — such as wonder drugs that many of the nation’s elderly must struggle to afford. Dr Janelle Walhout sees the paradox every day at the community clinic in Seattle where she works. “I’ve been thinking lately about the mismatch,” Dr Walhout said, “between how very high-tech medicine has become, with all these genetic tests for everything, mixing your medicines like fine cocktails, and our patients, who can’t afford them, can’t understand it, can’t get interpreters to explain it and are just not accessing those things.”1 This is a newspaper editorial from the world’s wealthiest country — the country that is the paradigm for development in the Western world. If the United States leads, can we be far behind? I have been asked to speak broadly about the ethics of healthcare, as a background to a discourse of healthcare reform. There seem to be good grounds to pursue reform; and yet there’s been so much that is good that has happened in the last 50 years. To take but one example, cancer survival overall has risen from 30% to 50%. Some malignancies, such as Hodgkin’s disease and some kinds of testicular cancer, are curable, even when they’re quite advanced. Prevention and early detection have changed the whole history of malignant melanoma, that most Australian of cancers. The genetic basis of a few cancers has been determined, and that may lead to preventive or even curative approaches. However, there is an obdurate residue that we cannot shift. Advanced bowel cancer is common and generally unresponsive. Lung cancer still has a poor outlook. We will all die of something, and strokes, heart disease and cancer remain the three most common causes. These are the sad facts that govern our lives, but my concern here is to talk about the social and political systems in which healthcare is embedded, and why progress in science and technology masks deep social and ethical problems. My view of the future for Western health and medicine is bleak. The gaps between rich and poor, between their health, wealth, welfare, access to justice, education and pleasure, will widen. The burgeoning technology that promises so much will prove to be of inestimable benefit to those who can afford it, and who, in many ways, need it least. Commercial interests will prevail increasingly over moral commitments, and multinational companies will continue their course to replace nation states as the centres of political and economic power. Global issues, such as pollution, environmental destruction and global warming, will be endlessly discussed, and endlessly dismissed. Spiritual and aesthetic issues will decline in importance still further, and money will become almost the sole criterion of worth. Universities, healthcare systems, churches and cults will be judged, and will appraise themselves, by their capacity to make profits rather than prophets. All these things will happen in Australia and in most of the Western world. Indeed, this pattern of development is seen to be the criterion of successful development. Those countries that can’t make it in such an environment will be marginalised, and seen as “opportunities for investment” or as “sources of cheap labour”. These things are happening now, and I see nothing that is likely to change this progression. At its root are two closely linked things — the science of economics (if it is a science) and the colonisation of values by money.2,3 Economics defines itself as the branch of knowledge that deals with the distribution of wealth on one hand, and (in its more idealistic moments) as “the study of how men [sic] and society end up choosing, with or without the use of money, to employ scarce productive resources . . . It analyses the costs and benefits of improving patterns of resource allocation”.4 Unfortunately, these definitions represent conflicting priorities. The distribution of wealth ties economics to money, to a utilitarian calculus, and to commercial values. The domain of scarce resources is communitarian and socially oriented. The dominant paradigm, however, is that of handling wealth and managing the monetary economy, a “neo-classical” model. It is economists of this persuasion who advise and influence heads of state, who determine whether interest rates will inflict “necessary pain” in order to adjust the national inflation figures or “limit the blow-out in the balance of trade”. There are, of course, economists of the communitarian or socially conscious persuasion,5-8 but they work for social change at the margins of both mainstream politics and mainstream economics. They have their apparent victories, as John Deeble did with Medicare in Australia. However, at the end of the day, some form of “economic rationalism” dominates, because it is money management that influences politicians. And it is money that is the problem. Money presumably began life as a convenience, as a portable means of trading that put an exchange medium in the place of barter. It began life as a symbol of value, but has become an abstraction against which value is measured. Money thus colonises our moral space. It has also colonised political space almost completely. In Australia, for example, there’s effectively only one viable political party. We might call it the Economic Realist Party. Like the recognised parties, it has its factions. Just to the left of centre is a faction which insists on emphasising a (heavily qualified) social awareness. To the right, a counterfaction espouses a (qualified) free-market philosophy. Both factions woo the corporate sector; both make gestures toward social welfare. Both temper their ideals with appeals to the central reality of economic restraints. Inevitably, this determines policy for all public services, whether they be in education, transport, housing, roads, defence or health. Levels of services are determined by what we can afford rather than what we can transact between each other. It’s scarcely realistic to suggest going back to some kind of barter system in any westernised country — although Argentina’s recent social credit experiment suggests that the idea isn’t dead — but we do need to understand how money alienates us from the sustaining, foundational values which underlie the provision of any services. The effective colonisation of morals and politics by money and commerce has far-reaching consequences. Commercial values and the notion of the legally binding contract have replaced trust in many relationships, including those between patients and their families, and doctors. The ideal of service has been replaced by the legally nuanced “duty of care”. Our adversarial legal system has entered the space of health services more and more intrusively, so that “defensive medicine” is now an established (and very expensive) part of healthcare practice.9,10 The costs of healthcare services have inevitably demanded that commercial and economic ideas, such as “best practice”, “efficiency”, “cost-effectiveness”, “outcomes”, and “evidence-based medicine” have become more important than human relationships and the nature of the processes of healthcare. Compassion and time to talk return no dollars that can be easily identified on a balance sheet, yet they’re as fundamentally important in healthcare as any technology. Healthcare services are essentially moral endeavours. Western governments and other agencies are obliged to provide them because people generally value human life in both quantity and quality.11 Each person wants to be protected from illness, and, when illness strikes, to be looked after. Each wants some sort of bulwark against the risks and sufferings that illness threatens. This is the value that underpins the ethics of healthcare. If we didn’t value human life to a significant extent, societies wouldn’t permit the expenditure that governments put into healthcare services. Huge amounts of money are committed. Individuals and corporations can become immensely wealthy by supplying goods and services within the healthcare sector. Science and technology continually promise more and better ways to diagnose and cure disease. Life expectancy in Australia was 78.2 years in 1997.12 It has increased by more than 20 years in the US in the last 100 years.13 The last gains have been the hardest and the most expensive, and that’s a common pattern of technological advance.14 It’s time to recognise that we are in the phase of diminishing returns,13 and to re-examine what more we can achieve. Although we are told by some that economics is the science of distributing scarce resources, it’s not really the resources which are scarce in themselves. It’s the scarcity of money that is the problem. If there were more money, we could train and employ any number of doctors, buy computed tomography scanners for every town, and have oncology services and palliative care distributed widely. We could provide sophisticated services for outback towns, public health programs for Indigenous communities, and we could endlessly fund molecular and genetic research in cancer. Whether this increased expenditure would translate into better public health is another question. It would probably make little difference. The public health parameters for Australia, the United Kingdom and the US are very similar, despite differences in expenditure from more than 14% of gross domestic product in the US to about 7% in the UK.12 Speaking ethically, it’s quite likely we could achieve greater health gains by concentrating on improving the health of those with the greatest health needs — the poor, the elderly, the unemployed, Indigenous groups — but it is far more likely that medical research will continue to be funded for the advancement of “high-end” technology, such as molecular genetics and gene therapy. These technological wonders may produce some benefits, but it is extremely unlikely that they will produce the revolutions confidently predicted by scientists at the start of the Human Genome Project. Further, we must ask ourselves who might reap those benefits — the already wealthy (and statistically more healthy), or the poor and needy? As the medical technology corporations inevitably think in terms of profit rather than public service or morality, each advance will come at a price that will be beyond the reach of the disadvantaged, and beyond the reach of most governments to subsidise. Healthcare, then, is underpinned by two imperatives — the relief of suffering and the prevention of death. The massive expenditure of effort and money that Western societies commit to prolonging life has become a defining characteristic of our culture and our times. We fear death, and no amount of stoical rationality can remove that intuitive fear.15,16 When our lives are threatened, we struggle to survive. It’s not surprising, therefore, that our community wants access to healthcare that defends us and our loved ones against the reality and inevitability of death. Medical technology, health systems, medical research — all are sustained and justified, in major part, by our intuitive desire to oppose death and dying with systems that ensure our security and hold out hopes for our flourishing. This is all perfectly good and appropriate — up to a point, but there are some awkward consequences, and we are already in the midst of some of them: It seems unlikely that death can ever be entirely eliminated. That means that, somewhere along the line, we’ll all have to accept that there is a stopping point, a point at which we must call a halt. There is an old law of technological development that says that the last gains are the hardest.14 In other words, we must enter a phase of diminishing returns, waiting for a paradigm shift that moves us away from the established models. In watchmaking, for example, the invention of the quartz movement suddenly made accuracy cheap. No such paradigm shift is on the horizon for medicine. The genetic revolution is immensely expensive, and genetic interventions — exciting though they promise to be — are not likely to be available at bargain prices nor free of patents. Further prolongation of life, beyond, say, an average of 80 years or so, will be increasingly costly. In a global context, the endless prolongation of average life-span is irrelevant. Most of the world’s populations live in what the Western world defines as poverty, with health statistics that are unthinkable in “advanced” countries. Even within wealthy nations — like Australia — there are subpopulations of the Indigenous, the poor, the handicapped, whose health is poor and whose deaths occur at significantly younger ages. World health, in which we are all involved whether we like it or not, doesn’t depend on cutting-edge technological advances, but on moral awareness and political commitment. The indefinite prolongation of life raises practical and moral issues of great complexity and profound significance. Say that scientists find ways to prolong average life span to 100 years. In Western cultures, the 80 years of average life causes problems enough. We’ve scarcely begun to manage the problems of the ageing population. We lack facilities, personnel and funds to care for the aged. Those same scientists will have to find ways to reduce the impact of ageing, so that less care is needed for the elderly. And then, should they succeed in that endeavour, they create another problem. Fit, mentally active people aged 70–80 years will need some way to occupy their time, not just playing bingo or lawn bowls, but working and using their skills and their great experience. How will we achieve this while remaining fair towards younger people wanting to secure and advance their own careers? And how will we manage the population pressures? If the mean duration of life increases, populations will increase, unless birth rates fall even further. And what will a further fall in birth rate do to the balance of ages within our community, to the rights of younger people, to their capacity to earn? Medical research is a wonderful thing, and it does much to increase the sense of security we all feel in our societies, but perhaps it addresses too much the ambition of endless prolongation of life. Perhaps it should turn more to an understanding of suffering,17 to ways of making the average life-span more enjoyable, more secure. Maybe we should do more qualitative research, which is relatively cheap to fund and produces insights that can help healthcare deliverers, educators and policy makers. In our knowledgeable, paternalistic way, we seem to be always prescribing “appropriate” or “sustainable” technology for the Third World. Perhaps we need to listen to our own advice, to curb our ambitions for immortality. Perhaps we need to decide, as a community, how much we’re prepared to spend on healthcare and medicine, and then determine — as they did in the state of Oregon in the US18,19 — just what priorities consumers want. We need, in other words, to decide what it is appropriate for us to do. Community consultation is a part of Danish life. We’ve even done it in Australia at the Constitutional Convention and the Community Jury on Genetically Modified Food. Recently, Gabbay and colleagues in Southampton described the formation and successful function of facilitated groups called Communities of Practice, which assemble stakeholders to examine available evidence and formulate policy suggestions.20 It is not impossible to consult communities, and it sometime produces results that surprise us all. Medical research and the advance of technology will continue, as indeed they should, but we must stop seeing research and technology as ends in themselves, or as directed solely toward the conquest of death. Healthcare is justified just as much by its capacity to limit suffering. If the thrilling advances of cutting-edge science are available only to the few who can afford them, we face some real moral dilemmas. They’re dilemmas which should prompt us to think about the values we might want for ourselves and our children. There are limits to growth, and limits to what we can afford. Here, then, is the message from ethics; a call for action rather than an appeal to theory. It’s time to look at the society in which we live, and to ask ourselves “Is this a society in which there’s real justice? Is this a society where I and my loved ones, in our time of trouble, can be sure to access care which is compassionate, thoughtful and appropriate?” I don’t know what conclusions you’ll reach in this Summit, but I do know that you’ll have wasted your time, and failed the constituency of the ill, if you fail to think deeply about these questions, and to suggest plans of action which will let us answer “yes” to both.

J Miles Little MD, FRACS

James E Fielding,* Heath Kelly† * Epidemiology Registrar, Communicable Disease Control Branch, Department of Human Services, PO Box 6, Rundle Mall, Adelaide, SA 5000; † Head, Epidemiology and Surveillance Division, Victorian Infectious Diseases Reference Laboratory, North Melbourne, VIC. james.fieldingATdhs.sa.gov.au To the Editor: In addition to a complicated ethical approval process, new privacy laws have presented challenges for multicentre research studies.1 In Victoria, an amendment to the Guardianship and Administration Act 1986 came into effect on 1 January 2003. We wish to highlight its unanticipated ramifications. We proposed to conduct a pilot study on the feasibility of ascertaining cases of Murray Valley encephalitis (MVE) in Victorian hospitals. Currently, there is no routine human surveillance for MVE, and we intended to perform diagnostic tests for several encephalitis aetiological agents on routinely collected samples. A study protocol was developed and submitted in November 2002 to five Human Research Ethics Committees (HRECs), one at the Department of Human Services and four at hospitals where the study was to be conducted. The case definition for encephalitis included the criterion that the patient had an “altered conscious state”, and could not therefore give informed consent. Informed consent was to be provided by the patient’s next-of-kin, but, in late December, an HREC representative alerted us to an imminent amendment to the Act which stipulated that only a guardian appointed by the Victorian Civil and Administrative Tribunal (VCAT) could provide consent to participate in “any procedure carried out for the purposes of medical research” on behalf of a disabled patient (in this instance, a patient with an altered conscious state). The Act does not further define medical research. Surveillance involves no intervention, and it is unclear to us (and some ethics committees) whether surveillance was considered a “procedure”. We indicated our uncertainty in a letter to VCAT in January 2003. If an application to VCAT were required for each patient we wished to enrol, then the study became unworkable. Under legislative requirements, VCAT is only obliged to “commence to hear” an application within 30 days of its receipt, which would prevent surveillance being conducted in a timely manner. Awareness of the legislative amendment differed between HRECs. In December 2002, two committees gave full approval for the study without reference to the amendment, while the remainder gave conditional approval, subject to complying with the amended Act. VCAT wrote to HRECs in February 2003 to clarify the amendment, and directly indicated to us that it did not apply to our proposed study. In May, despite the correspondence from VCAT, one HREC reaffirmed its position that applications must be made to VCAT for consent for studies such as this one. Despite attempts at clarification, a legislative amendment in Victoria has created ongoing confusion about obtaining consent on behalf of disabled patients. Researchers planning studies involving invasive procedures (eg, blood chemistry or seroprevalence studies) need to be aware of the amendment’s potential impact. Differences in interpretation of the amendment by the tribunal and various ethics committees highlight the need for further clarification of the Act, as well as for centralised and consistent assessment of HREC applications.

James E Fielding · Heath Kelly

Martin B Van Der Weyden Editor, Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. editorialATampco.com.au Comment: Fielding and Heath raise two issues. The first is the increasing barriers to the conduct of research as the law and Human Research Ethics Committees (HRECs) quite rightly ensure the safety of participants in human research. In the words of Cicero, salus populi suprema est lex (“the welfare of the people is the highest law”),1 but the law is not immutable. The confusion uncovered by Fielding and Heath over the implications of the amendment to the Guardianship and Administration Act 1986 may prompt legislators to re-examine the purpose of the Act in the context of research involving patients with “altered conscious state”. The second issue raised is more general. The plurality of HRECs’ interpretations of the amendment may be difficult to fathom by ordered scientific minds: data are data, so why the differences in HRECs’ opinions? These frustrating differences are the bane of researchers involved in multicentre research.2,3 The 1999 National statement on ethical conduct in research involving humans4 empowers HRECs to minimise duplication and allows for ethical and scientific assessments made by one HREC to be accepted by others.5 Nevertheless, HRECs value their independence and are unlikely to relinquish it to others easily.6 Various states are considering the feasibility of centralised ethical bodies,5 but bureaucracy moves cautiously and change is always slow.

Martin B Van Der Weyden

Ethical eye: Transplants. Peter Morris (editor). Strasbourg: Council of Europe, 2003 (258 pp). ISBN 92 871 4779 5. Through its Ethical eye series, the Council of Europe has addressed a number of recent developments in science and technology, including cloning and the human genome. The series aims to outline the ethical issues relating to each topic and to make these topics accessible to as wide an audience as possible. The most recent volume, edited by the eminent transplant surgeon, Sir Peter Morris, addresses the ethics of solid organ transplantation. The organisation of this collection is anachronistic and this provides a clue to its strengths and weaknesses. It begins with a historical review of transplantation and then considers a series of ethical issues raised by transplantation, including threats to identity, xenotransplantation, brain death, rights and duties, the media, conflict between individual benefit and the “common good”, and the appropriate limits of transplantation. The remaining sections cover transplantation practices in Europe, including religious perspectives. While the division of chapters according to national boundaries may seem of little relevance to non-European readers, the format actually provides tangible local exempla of many of the topical issues in transplantation, including presumed consent, cultural determinants of organ donation and organ commerce. The section dealing with religion and transplantation is excellent in its philosophical depth and practical clarity. The book discusses organ donation and transplantation in terms of issues relevant to Christianity, Buddhism, Islam and Judaism. This is invaluable and often lacking in other texts. As with all multiauthored works there is some unevenness in the contributions. A practitioner, not a patient, wrote the chapter called “Patients’ perspective” (a problem common to many medical texts), and several chapters lack references for further reading. Perhaps the weakest of the contributions is the chapter entitled “Agnostic ethics”, which is almost completely lacking in logical and philosophical substance. This book does not provide a comprehensive coverage of the ethics of transplantation, but it does provide a fascinating overview of the ethical, cultural and sociopolitical context of transplantation using examples from contemporary European practice. It is written in an engaging and accessible style that will be of interest both to the professional and the lay reader. Ian H KerridgeAssociate Professor of Bioethics Centre for Values, Ethics and the Law in Medicine University of Sydney, NSW

Ian H Kerridge

Ethics and evidence-based medicine. Fallibility and responsibility in clinical science. Kenneth W Goodman. Cambridge: Cambridge University Press, 2003 (xii + 168 pp). ISBN 0 521 79653 9. Goodman explores the links between scientific knowledge, clinical practice and ethics in this well-written and enthusiastic book. The main argument of the book is that practitioners are constantly faced with clinical decisions characterised by uncertainty — decisions with serious implications for patients. This uncertainty about the right course of action can be reduced through the use of evidence, making it morally blameworthy not to use evidence. For Goodman, an uninformed practitioner is a negligent practitioner, whose patients are “no longer seeing a physician, but visiting a museum”. A series of well-informed chapters engage with some of the major criticisms of evidence-based medicine (EBM). Issues such as flawed research, redundant publishing, publication bias, and the shortcomings of research synthesis are tackled squarely. Despite these problems, argues Goodman, the use of research is well founded both conceptually and practically, creating the imperative to improve the quality of research production and synthesis rather than abandon EBM. The only weakness in his reasoning is the lack of evidence that using EBM leads to better patient outcomes, or discussion of how this might be demonstrated. The author’s expertise in philosophy and computing are evident in the discussion of ethical issues raised by internet use in research, for data collection and for recruiting. As well as a chapter on clinical EBM and guidelines, the relationship between policy and evidence is explored through three case studies, providing concrete examples of the promises and problems of evidence-based public health. Overall, this is a thoughtful and sympathetic exploration of the moral imperative to use EBM. The detailed analyses are supplemented with practical suggestions, making the book of interest to academics and practitioners alike. This is a valuable early contribution on the ethics of EBM; no doubt further contributions will engage with some of the wider ethical issues that were beyond the scope of this text. Wendy A RogersNHMRC Research Fellow Flinders University, Adelaide, SA

Wendy A Rogers

Balancing commercial patent rights and public interest is a complex matter In this issue of the Journal, Walpole and his colleagues (page 203) squarely raise the difficult issue of balancing public access to genetic health services with enforcement of gene patents.1 They explore this issue using the case study of the hereditary breast cancer gene patents (the BRCA patents).1 This timely and important article coincides with the work of the Australian Law Reform Commission (ALRC). On 5 June 2003, the ALRC released the final report of its joint inquiry with the Australian Health Ethics Committee on the protection of human genetic information.2 The report proposes that access to genetic testing for healthcare should be better regulated, and emphasises the need for ongoing development of ethical standards, particularly in relation to consent and counselling (Recommendations 11-1 to 11-4). The ALRC has now turned its attention to the separate, but related, issue of gene patenting and human health.3 The ALRC will soon be releasing its Issues Paper and calling for submissions. It is likely that limitations on the use of disease gene patents will feature prominently in the submissions and in the ALRC’s responses. The ALRC is required to report its findings by 30 June 2004. The issues associated with gene patents and genetic services are complex and warrant detailed consideration. The role of patents is to encourage innovation, but this needs to be balanced against other values, including equitable access to healthcare. The ALRC may decide that the balance needs to be adjusted. However, a simple prohibition on gene patents is unlikely, of itself, to achieve this end. More comprehensive reform options may need to be considered, including changes to the requirements for obtaining a patent and restrictions on how patents are used. One option might be to include a requirement that the usefulness of the invention be fully examined. At present, the applicant only needs to show that the invention has some commercial value. It may be appropriate to follow the United States’ lead of requiring the applicant to prove “specific, substantial and credible utility”, and restricting the scope of the patent to proven uses.4 Even if patent law is reformed, it will not necessarily assist in dealing with gene patents that are already in existence. As patents have a 20-year life, the effect of the BRCA patents and others could be felt for many years, unless their validity is challenged in the Federal Court. In Europe, L’Institut Curie started proceedings in October 2001, challenging the validity of the BRCA patents.5 Since then, other individuals and organisations across Europe have joined in, including research institutes, hospitals, ministries of health, and human genetics societies. They raise a number of grounds for invalidity, including that the invention is neither new nor inventive. Genetic service providers in Australia could challenge the equivalent Australian patents. However, the costs and risks of such litigation are such that this course of action should not be embarked upon lightly. It is equally important to consider limitations to the ways in which patents may be used. The Patents Act 1990 (Cwlth) grants patent holders the exclusive right to make, hire and sell the invention for the life of the patent. There are few controls on how this right may be used, but the controls that do exist warrant consideration. Sections 133 and 135 of the legislation allow applications to be made for compulsory licences when “the reasonable requirements of the public” have not been met. Although subject to certain limitations, a compulsory licence protects a person from infringement action for using a patented invention without the patent holder’s permission. Perhaps surprisingly, there have been few compulsory licensing applications to date. The Act also provides protection from infringement for “Crown use”: use of the patented invention “for the services of the Commonwealth or State” where “necessary for the proper provision of those services” (section 163). Examples of the applicability of this provision include use of an invention by a state rail authority for construction of rail carriages,6 and use by a local government authority of a meter for measuring water supply.7 It is debatable whether Crown use extends to the provision of public genetic services. In addition to these provisions, the Patents Act 1990 prohibits arrangements that tie use of the invention to use of other products or processes. The role of this provision and of the competition law provisions in the Trade Practices Act 1974 (Cwlth) both need further examination. Although a “research exemption” is often relied on for non-commercial research use of a patented invention, there is no specific law in Australia to support it. The ALRC may recommend that patent legislation should be amended to incorporate this exemption, perhaps together with an exemption for non-commercial clinical use, or it may recommend changes to the other limitations on use discussed above. It may be preferable to adopt the suggestion of Walpole et al and empower an expert body to require broad licensing of patented tests. In making its recommendations, the ALRC has to be mindful of Australia’s international obligations. Australia is a signatory to the World Trade Organization Agreements, one of which is the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS).8 TRIPS lays down fairly stringent requirements for the patent laws in member countries. One stumbling block may be the requirement that there should be no discrimination in the applicability of patent rights between technologies (Article 27). Clearly, there are no simple answers to questions about what patents should be granted and what restrictions should be imposed on the ways in which granted patents are used. The ALRC faces a challenging year.

Dianne Nicol PhD, LLM

The patent system has been seen as a critical factor driving innovation in clinical medicine, particularly in medical devices and diagnostic assays. The licence terms and business model proposed by Myriad Genetics Inc. for testing the hereditary breast cancer susceptibility genes BRCA1 and BRCA2 could stifle innovation (particularly if other companies adopt similar business models), and are likely to limit the ability to provide high quality public genetic testing services in Australia. Under the Myriad model, testing for the BRCA1 gene would be undertaken by an organisation removed from the integrated public healthcare system. Based on overseas experience, Australia can expect a 2–3-fold increase in the cost of this testing, which will provide only partial information on the hereditary breast cancer status of the patient. Commercial exploitation of gene patents needs to be regulated to balance the patent holders’ right to profit from their inventions (necessary to drive further innovation) and the public policy objective of high quality, equitable healthcare.

Ian R Walpole FRACP · Hugh J S Dawkins PhD, Senior Project Officer · Peter C O’Leary PhD · Peter D Sinden LLM

With release of the ALRC/AHEC inquiry report, we are now in a position to develop sound policies The report Essentially yours: the protection of human genetic information in Australia,1 launched in May this year, represents the first comprehensive exploration in this country of the ethical, legal and social implications of the emerging revolution in genetic science and technology. The report is the outcome of a major, two-year, public inquiry conducted by the Australian Law Reform Commission and the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC). Although the central themes of the inquiry were ethical standards, privacy protection and protection against unlawful discrimination, the final report examines the impact of the “new genetics” across a very wide range of social and professional contexts — accounting for the “super-sized” 1200-page document, presented in two volumes and containing 144 recommendations for reform. The inquiry covered obvious issues such as the ethical oversight of genetic research and the increasing use of DNA collection and testing by law enforcement authorities. Other questions considered by the inquiry included: the regulation of genetic testing in the workplace; the collection and use of genetic information by the insurance industry; genetic testing by immigration authorities; DNA parentage testing; the use of genetic testing as an element in the construction of kinship and identity; and the use of genetic testing to identify potential sporting champions. This may sound like the stuff of science fiction, but the report documents contemporary cases and controversies in all these areas. In the course of its extensive community consultation effort, the inquiry found significant optimism in Australia about the promised benefits of genetic science for improved diagnostics and therapies. However, there is also an underlying anxiety about the rapid pace of change and the capacity of our institutions to regulate science effectively in the public interest. Thus, the centrepiece of the recommendations is the establishment of a standing Human Genetics Commission of Australia (HGCA). The role of the HGCA would be to provide independent, high-level, technical and strategic advice to Australian governments, industry and the community generally about current and emerging issues in human genetics, and to provide a consultative mechanism for the development of policy statements and national guidelines in this area. One of the threshold questions for the inquiry was whether to accept arguments in favour of “genetic exceptionalism”. This is the idea that genetic information is so fundamentally different from, and more powerful than, all other forms of personal health information that it requires different or higher levels of legal protection. In contrast, genetic “inclusivists” argue that genetic information is neither distinctive nor unique in its ability to predict an individual’s health, but indicates only a rough range of probabilities. The inquiry concluded that an exceptionalist approach would be unhelpful to the extent that it would divorce genetic information from the principles, processes and institutions that have been developed over time to provide ethical oversight of research and ensure best practice in clinical medicine. However, the inquiry accepted that genetic information has some special features and issues that necessitate a thorough inspection of existing principles, practices and safeguards, and of the legal, ethical and regulatory landscape, to ensure these are all adequate to the task. The inquiry concluded that “big law” — an omnibus genetic regulation act — is inappropriate at this time. Nevertheless, the report makes a large number of recommendations for careful fine-tuning of existing legislation in the areas of privacy, discrimination, industrial law, and occupational health and safety, to meet the challenges of the new genetics. For example, it recommends that the federal Disability Discrimination Act 1992 be amended “to clearly prohibit unlawful discrimination based on a person’s real or perceived genetic status”, and that the federal Privacy Act 1988 be amended to cover genetic samples as well as data. The report also strongly emphasises that we need not only adequate protection against the unlawful use of genetic information, but also measures to ensure that, where genetic information may be used lawfully, it will be used fairly and intelligently. As a consequence, the inquiry’s recommendations go beyond simply changing laws — they involve a broad mix of strategies and approaches, including the promulgation of ethical codes, codes of practice and official standards (eg, by the NMHRC and the Federal Privacy Commissioner); industry codes and best practice standards; community and professional education; and better coordination of governmental and intergovernmental programs. Medical practitioners are well aware of how difficult it is to keep abreast of all the implications of the genetic information explosion. The report calls for all the parties involved in medical education (initial and continuing) to work collaboratively to greatly enhance genetics education for all doctors. The report also makes plain the increasingly important role that genetic counselling will play in everyday clinical practice. For some genetic tests, counselling will be adequately provided by medical practitioners; nevertheless, the report recommends that Australian healthcare authorities give urgent priority to assessing and responding to the need for increased, adequately resourced, genetic counselling services. The inquiry recognised the powerful “familial dimension” of genetic information — that is, the extent to which an individual’s genetic information can also reveal information about, and therefore have implications for, that person’s relatives, including those in preceding and succeeding generations. This leads to a recommendation that, despite the traditional importance of confidentiality to the doctor–patient relationship, there may be exceptional circumstances in which doctors (and familial cancer registries) should be permitted to disclose confidential information to genetic relatives without the patient’s consent, if such a disclosure is necessary to lessen or prevent a serious threat to an individual’s life, health or safety. In this sensitive area, the inquiry asks that guidelines be developed to assist healthcare professionals in this task. Some other recommendations of particular interest to the scientific and medical communities are summarised in the Box. The inquiry’s findings and recommendations have been presented to the two relevant federal Ministers — the Attorney-General and the Minister for Health and Ageing — and the government is expected to respond and outline its plans for implementation soon. However, the pervasive influence of genetic science means that recommendations for change have been addressed to more than 30 bodies across the public and private sectors — many of these organisations do not need to wait for the federal government before they can take action. We have an excellent opportunity in Australia now to develop policy based on sound principle, rather than managing emerging problems on the run. The area of genetic testing and information is so personal and so sensitive that it is critical we get this right — and do so now — to avoid the crisis of confidence and the public backlash that would inevitably follow from the revelation of poor or unethical practices. Some specific recommendations of the Australian Law Reform Commission/Australian Health Ethics Committee inquiry National ethical and privacy guidelines should be developed specifically to cover the use of genetic information held in tissue banks, research databases and genetic registers (including “inchoate” databases, such as Guthrie card collections). The support and guidance given to human research ethics committees when reviewing proposals dealing with genetic issues should be significantly strengthened. Laboratories that conduct genetic tests for medical, diagnostic or treatment purposes (rather than for research purposes) should be accredited by the National Association of Testing Authorities, and accreditation requirements should be strengthened to deal more broadly with ethical standards in genetic testing, such as proof of consent. The Therapeutic Goods Administration should be empowered to more effectively regulate medical devices used in genetic testing, as well as DNA test kits provided directly to the public, whether such kits are marketed for health purposes or for identification (such as for parentage testing). Nationally consistent standards should be developed in relation to population genetic screening programs, covering such matters as informed consent, testing standards, quality assurance, cost–benefit considerations, and reporting and data collection. Employers should not be permitted to collect or use genetic information in relation to job applicants and employees, except in rare and compelling circumstances. Such circumstances might be when this is necessary to protect the health and safety of workers or third parties, and the action complies with stringent standards developed for this purpose by the HGCA and occupational health and safety authorities.

David Weisbrot BA, JD · Kerry J Breen MD, FRACP

In Victoria, decisions regarding late termination of pregnancy no longer involve just pregnant women and their clinicians. At two major women's hospitals, committees now govern the decision-making process for approval of a late termination of pregnancy. The legal and ethical implications of clinical decision-making by committee need to be widely debated. decision-making processes for termination of pregnancy after 20 weeks' gestation have recently changed in Victoria. Most late terminations of pregnancy are conducted in the public sector at two major centres for obstetrics and gynaecology: the Royal Women's Hospital, and Monash Medical Centre. Before June 2000, in response to a request for a late termination of pregnancy, the clinicians managing the woman's pregnancy would meet and attempt to reach a consensus as to the appropriateness of a termination in her circumstances. Following the reporting of a late termination of pregnancy to the Victorian Coroner,1 Monash Medical Centre and the Royal Women's Hospital each decided to create a termination review committee (TRC) to deal with the decision-making (Box). The role of each committee is to receive referrals from obstetricians regarding requests for late termination of pregnancy from pregnant women, and to decide whether the request should be approved. Clinical decision-making by committeeThere is a growing belief in the medical community that doctors can no longer make important clinical decisions in isolation. This is particularly evident where clinicians have diverse views about the appropriateness of a late termination. The major dilemmas are whether a clinician views the status of the fetus as secondary to the mother's interests, or whether the fetus is a separate entity with rights that can be in conflict with the rights of the pregnant woman. Clinical decision-making by committee can perform several roles, and these depend on whose interests the committee is intended to serve. Expert ethical and legal guidanceA committee may provide expert guidance in areas in which clinicians need assistance, predominantly in clinical ethics and the law, where clinical requests would be assessed in line with current standards. By obtaining appropriate expert guidance, a TRC may protect the community against possible poor ethical or legal decisions by clinicians. LiabilityA committee may accept the bureaucratic responsibility for the care of the patient, including liability. The clinicians become absolved of legal liability for the decision about a late termination. This would serve the interests of doctors, who give up their clinical autonomy to the committee, and are not responsible for the decisions made by the committee in patient care. An attempt has been made by the Royal Women's Hospital TRC to recognise this role (Guidelines for the termination of pregnancy. Royal Women's Hospital, Melbourne, intramural communication). The Royal Women's Hospital guidelines for termination of pregnancy state that "staff will be strongly supported by the Hospital in patient care which is in accordance with these guidelines." However, "staff will be strongly supported" is a weak legal statement to take on legal liability. It is doubtful whether a doctor can absolve himself or herself from legal responsibility. Nevertheless, many clinicians feel supported by ethics committees in making these difficult decisions. They feel it is helpful if a TRC shares with them the responsibility for the decision-making. Avenue of appealA committee may act as an avenue of appeal for the pregnant woman. That is, if the clinician disagreed with the woman's position, she could seek another opinion. In this case, the committee would be set up to serve the interests of the pregnant woman. If the committee came to a different conclusion, it would be required to facilitate a second opinion — either within the hospital, in another hospital, privately or interstate. However, the Victorian TRCs do not act as an avenue of appeal for pregnant women in their current structure. It is the decision of the obstetrician to put forward her case; the pregnant woman has no right to do so herself. In the case of pregnant women denied a termination by a TRC, it is unclear how to offer a second opinion. Obtaining a second opinion outside the major teaching hospitals is not necessarily straightforward. The pregnant woman may have to request the second opinion of her own volition. Although not impossible, it is unlikely that a doctor in Victoria (or perhaps even interstate) would proceed against the decision of a TRC, even if he or she thought the woman had an ethical and legal reason for a late termination. It may be in the pregnant woman's best interests to inform her of this before the case is put before a TRC. Pregnant women can then exercise their autonomy to pursue private or interstate options before these become "closed". Public accountabilityA committee may act to provide public accountability as well as an educative role for clinicians. Public accountability would require that the committee have appropriate representation from the community. The committee would need to publish its cases or make them accessible to clinicians for general examination. Clinical decision-making, whether by a committee or by clinicians, should be publicly accountable. Clearly, this is not the current role of the Victorian TRCs. Ethical considerations of clinical decision-making by committeeInterestsWhose interests does a TRC serve? The major concerns that have been expressed about ethics committees can be levelled at TRCs.2 If a committee is set up to serve the interests of the hospital, then it tends to err on the side of "conservative" decision-making. In late terminations, where the law is unclear, this is to be expected, but this may not be in the interests of pregnant women. A committee could also come under the influence of a particular constituency or lobby group, which might not serve the best interests of either pregnant women or clinicians. This would depend on how members (and their delegates) are co-opted on to the committee, and whether any external process assesses the committee. The pregnant woman's autonomy and a TRCWho is ultimately responsible for a decision? In Victoria, a pregnant woman has no explicit right to demand a review by a TRC, even if she is aware of the inside workings of the process. She cannot attend personally to put her case forward, nor is she able to send a patient advocate, or even a clinician of her choice, to review the process. It must also be remembered that the obstetrician presenting the case may not agree with the woman's decision for a termination, but may bring the case to a TRC anyway. This raises several issues about patient autonomy and informed consent. All the woman's preferences and circumstances are heard second-hand. How strongly her preferences are advanced will depend on the communication from the obstetrician. Should an obstetrician who disagrees with the patient's preference inform the woman before he or she attends a TRC? As a legal question, this may be extending the disclosure principle to its limit, as patients have no right to demand that a procedure should be provided. However, from an ethical viewpoint, a lack of disclosure may restrict a pregnant woman's autonomy to seek other options. Most members of a TRC do not meet the pregnant woman who is making the request for a termination. This "arm's length" approach may undermine the autonomy of the pregnant woman to argue her case. Anonymity of the membersThe Royal Women's Hospital TRC insists on anonymity for its members. The hospital administration is concerned that if names of the members of the TRC were available outside the hospital, members risked being victimised and stalked, as occurred with a former senior consultant in the 1970s (Review of Royal Women's Hospital TOP [termination of pregnancy] Working Party. Notes of meeting number 1. 17 October 2000, intramural communication). The inconsistency in this defence of anonymity is that the doctor performing the termination of pregnancy is not anonymous, nor are the doctors counselling the pregnant woman. It could be argued that the people most at risk of a political act of violence are the clinicians, not the members of the Royal Women's Hospital TRC. The ethical difficulty is who takes the responsibility for the decision-making if committee members are anonymous. An attempt is made to offer support to the clinician by the Chairman of the Royal Women's Hospital TRC "signing off" on the patient's chart. Third-party considerations The Royal Women's Hospital TRC considers the "desires of the father, other children and familial circumstances" in evaluating the appropriateness of a termination. Third-party considerations for termination of pregnancy have no standing in Australian law. The countries which do have "third-party authorisation" for terminations of pregnancy (eg, Morocco, which requires a husband to authorise his wife's abortion) are considered to have the most restrictive laws on abortion.3 How can a TRC consider the desires of the father or other children without asking them for their opinion? Does this contravene our privacy laws and our commitment to our patient's privacy? The intention of this clause is unclear, but I have reservations that our care for pregnant women may be harmed by third-party considerations. ConclusionWhile we are waiting for a legal solution, women will continue to attend clinicians requesting late termination of pregnancy. Further research needs to be performed on the impact that clinical decision-making by committees has on the effective care of pregnant women. In particular, we need to review the psychological effects on women who were denied a termination by a TRC. Clinicians need support in making controversial and difficult ethical decisions. Clinical ethics committees can provide support and advice, particularly in clinical ethics and the law, but should they take over clinical decision-making? This alienates both the pregnant woman and the clinicians, and may lead to inappropriate clinical care. The committee must not erode the doctor–patient relationship, which provides a framework for mutual decision-making. It is the setting where patients make many of their difficult quality-of-life decisions. Each case is unique and there is no right answer when a pregnant woman asks, "Doctor, what would you do?". We live in a pluralistic society with diverse views on abortion. Why should the decision of a committee, which bears no long-term responsibility for the unborn child, prevail over an informed, conscientious, pregnant woman, especially when there is no sound legal basis for the committee's decision-making? Termination review committees in Melbourne, Victoria Why were they formed? The Royal Women's Hospital Executive created a termination review committee in June 2000, following widespread publicity of a controversial late termination of pregnancy. The hospital created a set of guidelines for late termination to be referred to the TRC as "hospital policy". The TRC was formed to ensure that hospital administration approved all late terminations performed within the hospital. The hospital administration believed that this was the best way to protect itself, clinicians and patients from possible poor decision-making by doctors. A TRC was also formed at Monash Medical Centre in July 2000. The initiative came from clinicians who wished to formalise the process that was already in place for approving a late termination of pregnancy. The clinicians believed that a formal process would improve communication with the hospital administration and lawyers, and ensure all options were explored before a late termination was performed. What are the terms of reference of the committees? The committees deal with the decision-making for approval of all terminations of pregnancy at or after "viability" (22–24 weeks' gestation) to be performed within the hospital. Their role is to assess a request for a termination in line with their interpretation of current Victorian law. The committees are also responsible for ensuring adequate consultation, counselling and documentation before the approval of a late termination. Who are the members? Royal Women's Hospital: A member of the executive (eg, Chief Executive Officer, Executive Director [medical or nursing]), a neonatal paediatrician, two medical divisional directors, one nursing divisional director, and the obstetrician managing the pregnancy. Delegates may be used in some cases. The committee may co-opt non-voting members with relevant clinical, legal and ethical skills. Monash Medical Centre: The clinicians involved in the woman's care (obstetrician, ultrasonologist, geneticist, paediatrician, labour ward midwives, resident staff) and a general practitioner practising outside the hospital. Opinion may be sought from a member of the hospital executive and the hospital lawyer. How do the committees make decisions? Initially, the pregnant woman has a consultation with her clinicians. After comprehensive counselling, she may request a termination of pregnancy. Requests for termination may be in the setting of an obstetric complication, a medical or psychiatric illness, or a fetal abnormality. The clinicians meet to decide if they believe that the request should be upheld and if this requires approval from a TRC. The referral to a TRC comes from the obstetrician, not from the pregnant woman. In arriving at a decision, the TRC needs to compare the consequences for the pregnant woman if she has a termination, if she continues the pregnancy and cares for the child, or if she gives up the child for adoption. Other considerations include the extent and severity of a fetal abnormality, and the physical, psychological and social circumstances of the pregnant woman. At the TRC, an attempt is made at consensus, but if necessary, decisions are made by majority vote. The clinician is bound by the decision of the committee. The Monash Medical Centre model differs from the Royal Women's Hospital model in that opinion from the hospital executive and lawyer is consultative rather than prescriptive in nature. The final decision is made by the pregnant woman, her clinicians and an independent GP. Both committees can be convened and decisions made within days of a request being put forward.

Nicole L Woodrow FRACOG

Roger W Hunt Palliative Care Specialist, 700 Goodwood Road, Daws Park, SA 2041. roger.huntATrgh.sa.gov.au To the Editor: Somerville argues that Resolution 3 passed at the 2002 Australian Medical Association (AMA) Annual General Meeting "might inadvertently go well beyond" a position consistent with current ethics and law and might open a door to euthanasia.1 Resolution 3 states: . . . that the AMA support doctors whose primary intent is to relieve the suffering and distress of terminally ill patients in accordance with patients' wishes and interests, even though a foreseen secondary consequence is the hastening of death. As the mover of this resolution, I wish to comment on Somerville's arguments. Pain versus suffering: Somerville claims the phrase "to relieve their pain" does not open up the possibility of legitimating euthanasia, whereas "to relieve their suffering" does. She suggests better language would be "the relief of pain and other symptoms of serious physical distress of terminally ill patients". This argument is weakened by the fact that powerful analgesics and adjuvant pain medications can be used for euthanasia, but the methods of palliating other suffering cannot so readily be used for this purpose. Furthermore, the concept of purely physical pain has long been discredited. The dimensions of suffering cannot be neatly separated. Existential suffering can be just as agonising as physical discomfort, and there are moral and clinical imperatives to relieve all kinds of suffering. Current law: Resolution 3 is based on the "Care of the Dying" clause in the South Australian Consent to Medical Treatment and Palliative Care Act 1995. This clause codified the common law position. It was overwhelmingly supported in parliament — politicians believed terminally ill patients should not have to suffer pain and distress because clinicians feared prosecution for hastening death. The Act and Resolution 3 are fundamentally similar: both involve the principle of double effect, and both stipulate the need for patient-centred decision-making. Patients' wishes and interests: Somerville is critical of the phrase "in accordance with patients' wishes and interests". She says it justifies rather than excuses life-shortening treatment: "an excuse carries the message that life-shortening is wrong . . . The message of a justification . . . is that the conduct of shortening life is right." I believe it is better for a doctor to provide a valid justification than offer an excuse for a treatment that contributes to a patient's death. An excuse equates with an unsatisfactory attempt at explanation, whereas a valid justification implies ethical and appropriate care. If a doctor aims to act in the patient's interests, and with the patient's informed consent, then the life-shortening consequences of an action may be accepted. The treatment, rather than the outcome, may be seen as "justified". Ethical care involves negotiation with the patient (or representative) to select the treatment that best suits the patient's wishes and interests. Somerville apparently undervalues the principles of patient autonomy and informed consent, but these have a crucial role in medical decision-making. Decision-making about treatments that affect the time of death must be balanced between being doctor-centred and patient-centred. Conclusion: Resolution 3 is consistent with current ethics and law, and with relevant clinical concepts. If a medical treatment results in a patient's death then a valid justification, rather than an excuse, is required. This justification involves the careful consideration of, and respect for, the patient's wishes and interests. Malcolm Parker Senior Lecturer in Ethics and Professional Development, School of Medicine, University of Queensland, Herston, QLD 4006 m.parkerATuq.edu.au To the Editor: Somerville's analysis of the Australian Medical Association's (AMA's) confusion in its recent resolutions concerning death and dying is helpful, but her subsequent anti-euthanasia arguments are inadequate.1 Somerville suggests that the AMA has moved closer to supporting euthanasia by adopting a neutral stance, because being neutral means the AMA has no principled reasons to oppose it. This is incorrect. Taking a neutral stance is to recognise that there are both good reasons to oppose an issue and good reasons to support it. In fact, a neutral stance remains more felicitous to the status quo, because it suggests that the AMA does not contemplate action in regard to the issue, but action is clearly required to legalise euthanasia. Somerville distinguishes the right to have treatment withdrawn from the right to be killed, on the basis of the difference between death caused by the underlying illness, and death caused by a lethal injection. She states that there are "long-established, well understood, profound and important differences between allowing people to die, when it is ethically and legally justified, and making them die", and "respecting people's refusals of life-saving treatment belongs in the former category, euthanasia in the latter". It is difficult to assess what force Somerville thinks these assertions have. They do not constitute arguments for her position. The only reason Somerville appears to offer is that acting with the primary intention of killing another person is inherently wrong, except in justified self-defence or defence of others, and this is a cornerstone of our law and relationships. However, anything that is inherently wrong but admits exceptions is at least open to further argued exceptions. If there are cases in which assisting someone to die would be better than letting nature take its course (and many people believe there are such cases), then there is clearly a case for seriously questioning our "deep moral intuitions", rather than issuing infallible moral proclamations based on tradition. Finally, while Somerville is correct in stating that doctors' secret involvement in euthanasia does not mean that it is right, she makes the stronger empirical suggestion that if doctors are presently ignoring the law against murder, we should expect them to disobey guidelines for voluntary euthanasia. This suggestion is no more than a rhetorical mischief, as doctors who ignore the current law are those who support euthanasia, and they would have no reason to disobey legal guidelines. Rodney A Syme Surgeon, 20 Woodside Crescent, Toorak, VIC 3142 To the Editor: Somerville1 says that language matters, which is why she selects the definition of euthanasia as "a deliberate act that causes death undertaken by one person with the primary intention of ending the life of another person, in order to relieve that person's suffering". This obviously produces a different response compared with the realistic definition (based on the classical understanding of the word) as "an act to cause a peaceful and dignified death on request", or the practical definition (that of the Voluntary Euthanasia Society of Victoria) as "an act, taken by, or at the request of, a rational informed person, whose intention is to relieve their intolerable suffering, by hastening their death in a dignified manner", which incorporates all the components of euthanasia in a medical context. Somerville provides a legal definition, which ignores the simple fact that the primary intention of an act of euthanasia is to relieve suffering — it is an act of palliation. The doctor involved has no desire to end life — that is the intention of the patient. Somerville seems to choke on the word "voluntary", dismissing it in one sentence, despite the Australian Med-ical Association accepting, rightly, that doctors should respect "the patient's wishes and interests". She also, not surprisingly for a lawyer, recognises no suffering other than physical pain, ignoring dyspnoea, paralysis, cachexia, or psychological and existential suffering. She claims, without any evidence, that allowing euthanasia would cause profound damage to society. The Netherlands have openly practised voluntary euthanasia for nearly 20 years, and the Swiss have allowed assisted suicide for 50 years2 without any evidence of societal damage. Medically assisted suicide in Oregon (US) has been closely and officially documented over the past 5 years with positive effects on the use of hospice care, opioid use, and deaths at home rather than in hospital.3 Finally, how long must it take for this debate to focus more intently on physician-assisted suicide? Most patients who wish to relieve their suffering can do this for themselves, with the assistance of a physician for advice, support and prescription. This then places the responsibility for this fundamental decision and action where it should be, with the patient. It also minimises the small possibility of non-voluntary euthanasia. Just because the Dutch adopted direct lethal injection as their principal method of voluntary euthanasia does not mean that we in Australia should allow that method to dominate the debate. Julia M Anaf C/- PO Box 2151, Kent Town, SA 5070 turanaATozemail.com.au To the Editor: In endorsing the Australian Medical Association's (AMA's) reiteration of a negative policy on voluntary euthanasia, Somerville claims that "language is not neutral".1 In discussing the wording of the resolutions, she argues for the term "suffering" to be subsumed within "pain and physical distress", even though "suffering" better reflects the complex physical and psychosocial dimensions of the human condition. This suggested white-out is troubling, but to be anticipated. Defending an unequivocal negative stance on euthanasia inevitably results in conditional compassion, for it must assume the right to control patients, instead of respecting their autonomy. A negative policy has no more credence than a positive one. Neither represents the diversity of opinion that exists within the profession, or the broader community.2 A negative stance takes refuge in, instead of challenging, the problems imposed by the doctrine of double effect as public policy. Although this doctrine offers a (compromised) level of legal and emotional surety for the doctor, it takes no real account of other relevant moral considerations, or the views of the patient. A policy stance which mirrors Somerville's view that "euthanasia is simplistic, wrong and a dangerous response to the complex reality of death" cannot respect the complexities arising from each person's very personal meanings and values attaching to life, death and dying. Its adherents must defend against acknowledging the true extent of suffering that some patients are forced to endure. A negative policy also fails to acknowledge that all end-of-life decision-making attracts moral evaluation, including "doing nothing", withdrawing futile treatment, or shortening life by symptom control. Rightly or wrongly, the AMA's policy stance can also be interpreted as a way of absolving itself of any responsibility to face, let alone challenge, the legal and social circumstances under which medicine is practised — circumstances that inevitably lead to the "euthanasia underground" and the horrors of self-deliverance.3 Somerville's implication is that a negative policy stance based upon moral absolutism will resolve difficult moral dilemmas. It will not. Clem F Nommensen Retired General Surgeon, 9 Moorabinda Street, Buderim, QLD 4556 nommensAThotkey.net.au To the Editor: Somerville discussed her perspectives on the debate concerning voluntary euthanasia which took place at the 2002 Australian Medical Association Annual General Meeting.1 This debate arose because of submissions which sought the adoption of a neutral stance on this issue, similar to that taken on abortion.2 The voluntary euthanasia debate (including physician-assisted suicide) has intensified over the past 10 years, fuelled by enabling legislation in Switzerland, the Netherlands, Oregon (US), Belgium, and briefly in the Northern Territory, and by a groundswell of favourable public opinion. The arguments have been rehearsed countless times. Somerville's article adds nothing, but underlines the total failure of consensus. Her initial discussion on definitions and voting patterns seems pointless in the real world. Public opinion polls have shown that more than 70% of Australians support the idea that terminally ill and severely suffering people should be free to make a choice,3 and that palliative care is not always the answer. Some surveys of medical opinions, such as one within the Royal Australian College of Surgeons,4 suggest most doctors probably agree, although many do not approve legalisation. These findings accord with my practice experiences, and contacts with colleagues, throughout a long surgical lifetime. This indicates that voting at the conference did not reflect the opinion of most Australians, or a possible majority of our profession. Unfortunately, much of Somerville's article reads like a homily urging the negative view. Like her opponents, she claims the high moral ground, but opinions have clearly consolidated on the basis of previously accepted philosophical positions. In spite of the published studies, there is no clear and convincing knowledge of what percentage of Australian doctors approves voluntary euthanasia, whether legalised or not. We need a well-conducted poll to determine an appropriate medical community stance on this issue, bearing in mind that community standards are now broadly accepted as the appropriate basis for legal sanctions on behaviour and practice. Frances J Coombe President, South Australian Voluntary Euthanasia Society, 11 Boord Court, Dernancourt, SA 5075 fcoombeATadam.com.au To the Editor: I agree wholeheartedly with Somerville's closing statement "How a society treats its weakest, most in need, most vulnerable members best tests its moral and ethical tone".1 Unfortunately, by preceding this with an argument against choice for euthanasia, Somerville effectively condemns those weakest and most vulnerable people who are suffering intolerably from a hopeless or terminal illness to a horrendous existence. A position statement by Palliative Care Australia acknowledges that, although pain and other symptoms can be alleviated, complete relief is not always possible, even with optimal palliative care.2 The only relief from intractable pain and symptoms comes through death, and the present law perpetuates suffering by denying this release. The moral and ethical tone of our society in this regard is shamefully weak. For too long, end-of-life decisions have centred on a doctor's stated intentions — "double effect". Somerville gives a lengthy justification of this doctrine and tells us that language and doctors' decisions about euthanasia are most important. Where do the needs of suffering people fit here? The moral and legal validity of a doctor's action would be best determined by factors such as: the patient's right to self-determination and bodily integrity; the provision of informed consent; the absence of less harmful alternatives acceptable to the patient; the severity of the patient's suffering; and the requirement that a doctor should work always in the best interests of the patient. Such a patient-focused approach will meet the needs of and protect all vulnerable people, thereby strengthening our society's moral and ethical tone with rationality and unconditional compassion. Margaret A Somerville Samuel Gale Professor of Law, McGill Centre for Medicine, Ethics and Law, McGill University, 3690 Peel Street, Montreal, Quebec H3A 1W9, Canada margaret.somervilleATmcgill.ca In reply: Hunt seems not to understand the reason for distinguishing between life-shortening treatment to relieve pain and physical distress, and that to relieve suffering in general. Whether either type of treatment is likely to be used for euthanasia is beside the point. The doctrine of "double effect" can be used to justify life-shortening treatment to relieve pain, but not to relieve suffering in general. More-over, if an intention of relieving suffering in general became a justification for giving life-shortening treatment, there would be no limits on using such treatment, that is, euthanasia would be legitimised. I disagree that "there are moral and clinical imperatives to relieve all kinds of suffering" (emphasis added). Doctors, like the rest of us, should respond humanely to suffering people. But it is beyond the role of doctors and the mandate of medicine to assume an authority to kill people in the name of relief of suffering in general. I agree with the position taken in the South Australian Consent to Medical Treatment and Palliative Care Act 1995, that patients should not have to suffer "pain or distress", but that is a narrower category than "suffering". Depending upon how the Act and Resolution 3 are interpreted, they might or might not be "fundamentally similar". However, if interpreted to allow life-shortening treatment for the relief of suffering in general, then they go well beyond the accepted common law position on double effect. Parker is wrong in stating that the Australian Medical Association (AMA) adopted a neutral stance; it expressly rejected doing so. However, his misunderstanding makes my point that the resolutions are inconsistent and confusing. He is also wrong to write that a neutral stance on euthanasia is morally neutral. It is not — it means that euthanasia is not morally wrong, which would contradict the AMA's current position. One strategy for legalising euthanasia is to move incrementally towards its acceptance by using ambiguous or confusing language. Whatever Hunt's intention in drafting Resolution 3, it reflects those characteristics. Doctors need to be aware of that strategy. Hunt appears to misunderstand the legal difference between justifications and excuses. These terms apply to the consequences of justified acts. Shortening life as a consequence of a justified treatment should only be excused. Similarly, both Hunt and Syme do not seem to understand how informed consent functions in law and ethics. Consent is necessary but not sufficient to justify potentially life-shortening treatment. That treatment must also be not contrary to public policy. It meets this condition only if needed for pain or symptoms of physical distress. Parker is dissatisfied with my statements on the distinction between killing and letting die. This distinction hinges on ethical and legal doctrines of causation and intention that are too complex to discuss here. There is a further distinction between intention and desire, which Syme confuses. Anaf says I argue for "the term 'suffering' to be subsumed within 'pain and physical distress'". The fundamental point of my article is the absolute opposite. She appears equally confused on other points. One can only be for or against euthanasia, so "diversity of opinion" does not make sense here. Of course, all end-of-life decision-making attracts moral evaluation, but my article was not about all such decision-making. Nommensen implies that "community standards" and "an appropriate medical community stance" necessarily equate to an ethically acceptable one. This is incorrect — majorities can decide to act unethically. Contrary to Parker's final claim, there is evidence that many doctors in the Netherlands who support euthanasia do not follow the guidelines for carrying it out.1 Similarly, experience in the Netherlands contradicts Coombe's assertion that legalising euthanasia will "protect all vulnerable people".1 Some of the most vulnerable — mentally incompetent — people have been subject to euthanasia. The same source challenges Syme's statements on the Netherlands and Oregon (US). Finally, Syme confuses the definition of euthanasia with the justification put forward by advocates of its legalisation. Creating such confusion can be a deliberate advocacy strategy.

Roger W Hunt · Malcolm Parker · Rodney A Syme · Julia M Anaf · Clem F Nommensen · Frances J Coombe · Margaret A Somerville

Although uniquely personal, the information from gene analyses impacts on parents, siblings, children and even entire ethnic groups. Doctors need to carefully balance the right of a patient to privacy against the wider family and society interests, consistent with ethical standards and their legal obligations. Doctors also need to be in a position to advise their patients of potential risks that may result ...

Margaret F A Otlowski LLB(Hons), PhD · Robert Williamson FRS, FAA

To the Editor: I concluded my recent article with a hope that the "recommendations of the Dawson Committee will provide much needed amendment to the Trade Practices Act".1 In the article, I argued that medical rosters ran the risk of illegality as exclusionary provisions under the Trade Practices Act 1974 (Cwlth) because of either a drafting deficiency in the Act or a policy non-appreciation of ...

Warren Pengilley

Virtue ethics and professional roles. Justin Oakley, Dean Cocking. Melbourne: Cambridge University Press, 2002 (xii + 188 pp). ISBN 0 521 79305 X. Authors Oakley and Cocking have spent the past ten years reflecting on which moral theory enables professionals to pursue their work ethically. In this book they offer an incisive argument for selecting virtue ethics over two commonly applied rivals — utilitarianism and Kantianism. The authors believe that this virtue-based model has the advantage of being both theoretical and practical. The novice moral philosopher is given a brief guide to the origins and variants of virtue ethics. We are introduced to the Aristotelian view that a specific set of character traits is needed in order to live a "flourishing life". We are also told that to live the good life we need to acquire phronesis — practical wisdom. The authors then add their own concept of the "regulative ideal" to the Aristotelian argument. People are guided by a "regulative ideal" when they have "internalised a certain conception of correctness or excellence in such a way that they are able to adjust their motivation and conduct so that it conforms — or at least does not conflict — with that standard". The idea is aligned to Aristotle's practical wisdom in that it encompasses an appreciation of what constitutes the general good. The book describes how virtue ethics and the "regulative ideal" apply to medical practice and links the concept of a "flourishing life" to the goals of the medical profession. Consideration is given to what constitutes desirable virtues in a doctor and what character traits enable them to achieve the goal of enhancing health and corresponding human "flourishing". The authors settle on a familiar catalogue of virtues: a deep capacity for compassion, truthfulness, trustworthiness, courage, humility and a consistent inclination to act justly. Does the book convince the reader of the benefits of virtue ethics for the professions? Many would support the view that inculcating and promoting certain character traits in doctors would enable them to make a more positive contribution to their patients and patients’ families — but is this a sufficient basis for good practice? Does virtue ethics provide the means to disentangle the myriad moral dilemmas that doctors encounter in their day-to-day practice? Does virtue-based ethics sort out complex issues like euthanasia, abortion, gene therapy, involuntary hospitalisation, respecting confidences, allocating resources, and many other quandaries? All theories have their limitations. Ultimately, we may find common ground between various theories and achieve an integrative view where their advantages are harnessed. Sidney BlochProfessor of Psychiatry University of Melbourne, VIC

Sidney Bloch

To the Editor: I note with interest the case study of experimental Ancylostoma caninum infection in a 22-year-old student.1 In his accompanying editorial, Van Der Weyden highlights the courage of these researchers, as well as some of the risks and discomforts associated with their participation,2 including in two studies in which he was a co-author. However, it is also worth highlighting some of the ethical issues associated with such experimentation. Larry Altman, who provided many of the quoted examples of self-experimentation, also reflects on Walter Reed's experiments with yellow fever vectors in Cuba. Although later credited with the use of written consent forms, on an earlier occasion Altman alleges that Reed withdrew at the last moment from inoculation experiments in which one of his colleagues died.3 Although not mentioned in the published work, the A. caninum experiment was initiated and undertaken by Landmann under the supervision of Prociv, who has himself self-experimented with both A. caninum and Necator americanus (human hookworm) in previous work (Juergen Landmann, Student; Paul Prociv, Senior Lecturer, Department of Microbiology and Parasitology, University of Queensland, personal communication). In this case, the study was wholly initiated by the student so consent was not an issue, but other such studies raise the potential problem of consent in situations of an unequal power relationship. Students under supervision constitute a "vulnerable" group in that consent may be given under a form of duress.4 Just as special protection is needed for populations for whom research is combined with care, protection is required for students who may feel obliged to participate in such research. There have been recent calls for a fuller discussion of ethical issues in published experimental studies,5 where ethical justification should be accorded the same weight as statistical considerations. The unusual study by Landmann and Prociv highlights the need for such discussion in potentially controversial research protocols.

Allen C Cheng MB BS, FRACP

Obstructive sleep apnoea is associated with an increased risk of sleep-related motor vehicle accidents. Seven recent legal cases of fatal motor vehicle accidents on NSW roads are presented, where the driver who caused the accident was suffering from an unrecognised or under-treated sleep disorder. The legal outcomes in these cases were variable: some of the drivers have been acquitted and others have been jailed. All remained licensed to drive immediately after their accidents. In some of the cases, the driver was cleared of any culpable driving offence because of a defence of sleepiness or a sleep attack without warning ("Jiminez defence"). This appears at odds with current medical research and legal opinion in other countries. More research is needed to understand the relation between sleep disorders and awareness of sleepiness. Medical practitioners need to be aware of current advice and guidelines with respect to obstructive sleep apnoea and driving.

Anup V Desai MB BS, FRACP · Ronald R Grunstein PhD, FRACP · Elizabeth Ellis PhD, MHL · John R Wheatley PhD, FRACP

A "new genetics" has emerged driven by knowledge gained at the DNA level. In clinical practice, a practical application of the new genetics is DNA testing, which can be expected to expand with the completion of the Human Genome Project as the functions of new genes are discovered. Genetic DNA testing scenarios include diagnostic DNA testing, prenatal DNA testing, predictive (presymptomatic) DNA testing and screening DNA testing. The challenge for genetic DNA testing and clinical practice will be to define the roles to be played by the general practitioner, the specialist, and other healthcare professionals. From the patients' and families' perspective, the new genetics will best be implemented if a planned approach is adopted in the ordering of DNA tests and the associated counselling and support processes.

Ronald J A Trent FRACP, FRCPA · Robert Williamson FRS, FAA · Grant R Sutherland FRS, FAA

To the Editor: I am happy to inform Whiteman and colleagues1 that, should they wish to undertake a project in Australian general practices, the Royal Australian College of General Practitioners (RACGP) has one ethics committee which covers the whole of Australia. As a researcher, I have participated in many multicentre trials under the aegis of this committee over the past 8 years. Details of the RACGP national ethics committee may be found at <http://www.racgp.org.au/document.asp?id=523>.

Christopher D Hogan

Medical rosters are not free of trade practices problems, notwithstanding assurances by the Australian Competition and Consumer Commission (ACCC). Neither the ACCC nor the recently convened Wilkinson Committee has applied rigorous legal principles in interpreting the Trade Practices Act 1974 (Cwlth) to reach its conclusions. The Australian law should be changed to bring it into line with that of the United States and New Zealand.

Warren Pengilley LLB, DSc

Pengilley has neatly summarised the long and ongoing disputation between the Australian Medical Association (AMA) and the Australian Competition and Consumer Commission (ACCC).1 The AMA claims that medical roster arrangements are likely to constitute a breach of the primary boycott provisions of the Trade Practices Act 1974 (Cwlth), a proposition vehemently denied by the ACCC (and by the Wilkinson Committee, which came into being as the result of vocal representations made to the federal government by the AMA). Pengilley claims to be on the side of the angels (ie, the AMA) with wings; I prefer to be the devil's advocate. Central to the dispute is to ask what is the meaning of the word "purpose" in any arrangement set out in section 4D(1) of the Trade Practices Act. Is it, as claimed by the ACCC, aimed at — and limited to — an anticompetitive purpose, or, as Pengilley maintains (because the word "purpose" is unqualified), does the section render illegal any roster that has the incidental effect of limiting medical services? The kind of literal reading of the Trade Practices Act applied by Pengilley had already fallen into disuse by the end of the 16th century. In what is now known as the "Mischief Rule", the Court, in Heydon's Case,2 asked itself "what was the mischief for which the common law did not provide and what has Parliament done to remedy it?". Thus, regarding rosters, the mischief for which the common law did not provide was the "combinations" that resulted in public harm. The incidental effect of section 4D is to give an imprimatur to all medical roster arrangements, save those whose "substantial purpose" is to deprive the community of competition. It follows that the roster arrangements entered into in compliance with the AMA's trade practices compliance program are immune from legal challenge. Thus, an arrangement whereby Dr X and Dr Y agree on a roster service which may incidentally deprive a community of 24-hour medical cover (eg, because of a medical manpower shortage) is clearly legal, provided no member of the roster deliberately agrees to withhold his or her services. I am puzzled by Pengilley's statement that "Indeed, no roster could function unless Doctor Y agreed not to provide services during the hours during which Doctor X is rostered on duty". Indeed, any attempt by Dr Y to keep himself or herself "out of service" is not only illegal, but unethical, and deliberately "caught" by the Act, and so it ought to be. In the end, the argument comes down to how many angels can dance on the head of a pin. I am satisfied that Pengilley's argument in support of an amendment to the Trade Practices Act is a counsel of perfection, if only because any attempt by the ACCC to prosecute a bona fide medical roster arrangement would face insurmountable legal and evidentiary hurdles.

Paul Gerber LLB DJur

Rural doctors, like their colleagues elsewhere, are thinking individuals whose main aim is to provide timely, appropriate care to the patients living in their local communities. More often than not, they are small-business operators running a practice which is becoming more complex, both in the clinical sphere and in the myriad requirements associated with accreditation, indemnity, practice incentive payments, vocational registration, the Pharmaceutical Benefits Scheme and Medicare, credentialling at the local hospital, the Privacy Act 1988 (Cwlth), and the Trade Practices Act 1974 (Cwlth). Non-compliance with any of these regulations and requirements can lead to severe penalties — in the case of breaches of the Trade Practices Act, exposure to $500 000 fines for individuals. The Productivity Commission's recent enquiry into red tape in general practice1 and the Wilkinson Review of the impact of Part IV of the Trade Practices Act on the recruitment and retention of medical practitioners in regional Australia are two demonstrable consequences of the general concern. In rural Australia, the medical workforce faces a special subset of challenges in providing a broad range of medical services to small communities with limited resources and support facilities. This is in an environment where there is a relative shortage of medical practitioners and an increased workload.2,3 Administrative and bureaucratic requirements can make the difference between staying in and leaving rural practice.4,5 The size of isolated rural practices does not allow for the management processes, information technology, and support staff required to meet the bureaucratic requirements. Pengilley's article6 is a timely reminder that government reviews may not solve the questions faced by doctors in their everyday work in their efforts to comply with the law. Grey areas of the law will only be resolved by changes in the law itself, not by reviews. Pengilley has given an example of rostering for 16 hours out of 24, which would almost certainly be in contravention of the law and bring the full force of the Australian Competition and Consumer Commission (ACCC) down on those doctors. There are real examples happening in Australia today of doctors struggling to provide services in a sustainable manner so that they do not become exhausted, which may lead to disruption of their family, social and professional life and ultimate cessation of practice in that community. For example, a consensus of opinion is that rural doctors require a one-in-four roster to ensure sustainability. How is this to be achieved in a three-doctor town where it recently took three years to replace a doctor? The doctors may choose to advise their communities that, if they are to have sustainable medical services, it may be necessary for the community to have no doctor available one weekend in four. The trade-off for the community is that their doctors will stay longer. The ACCC has never given a clear opinion in relation to such an arrangement, but, if consumers complained, then almost certainly the ACCC could take the view that the arrangement breaches section 4D(1)(ii) of the Trade Practices Act: "The provision has the purpose of preventing, restricting or limiting the supply of services to particular persons or classes of persons." Similarly, a cluster of four small towns, perhaps 50 km apart, with one doctor each, may not be able to form an after-hours roster, because services would be reduced to three of the communities after hours on any particular night. The result may be that no doctors service such towns. Authorisation under the Act is both costly and complex — from the doctors' viewpoint, why bother when there is work at the larger town 100 km away? Yet, Pengilley argues that even more straightforward rosters may in fact breach section 4D. The rural doctor's job is difficult enough without continued uncertainty over whether the Trade Practices Act will be brought to bear on well-meaning practitioners doing the best for their local communities in difficult circumstances. The persisting uncertainties are likely to hinder further recruitment and may lead to exhausted doctors leaving their communities.

David Mildenhall

Building a patient's trust is just as important as following the letter of the law The cases and discussion in the article by Braunack-Mayer and Mulligan in this issue of the Journal (page 277)1 provide informative examples of legal and ethical dimensions of confidentiality and privacy in doctor–patient relationships. It is important to clarify the foundations and scope of both legal and ethical duties. In law, information provided to a medical practitioner by a patient becomes subject to a statutory duty to protect the patient's privacy and a common-law duty of confidence owed by the medical practitioner to the patient. *A failure to fulfil this duty is not an offence, although it can be the foundation of a complaint to the Office of the Privacy Commissioner. Privacy Act 1988 (Cwlth), section 36. †There is specific legislation in the Australian Capital Territory (Health Records [Privacy and Access] Act 1997), New South Wales (Privacy and Personal Information Protection Act 1998) and Victoria (Health Records Act 2001), and other States are actively considering such legislation, including New South Wales in relation to health information. Statutory duty. The statutory duty* varies according to whether federal or state legislation applies.† The federal Privacy Act 1988 applies to health information used by a private organisation and permits use or disclosure of such information without the patient's consent in a specified list of circumstances.2 Those that relate to the examples given by Braunack-Mayer and Mulligan are (a) disclosure for purposes directly related to the purpose of collection in ways that the patient would reasonably expect;3 and (b) disclosure that is reasonably believed to be necessary to prevent or lessen a serious and imminent threat to a person's life, health or safety.4 The scope of the statutory duty is not yet clear, as guidelines5 and public interest determinations6 issued by the Federal Privacy Commissioner indicate. Common-law duty. The common-law duty arises from a contract between patient and doctor or the presumption that the relationship is one of a class to which the law attaches that obligation. The duty is said to encourage patients to disclose full information so that medical practitioners can provide effective healthcare, a basis for a public interest in such duties of confidence.7 Correctly understood, it is not a duty to keep all information secret, but a duty to use the information only for the purposes for which it was provided and not for any other purpose.8 Medical ethics. In ethics, the duty of confidence in medical practice has strong historical origins in formal statements of medical ethics. Different translations of the Hippocratic oath recognise that the duty applies only to some and not to all information. These statements include "what should not be published abroad",9 "things shameful to be spoken about",10 and "things that should never be blurted out".11 Thus, its scope can be described by reference to the purpose of the disclosure.12 The justifications for this duty include a respect for patient autonomy and an expression of the professional virtue of fidelity.13 In Cases 1 and 2 presented by Braunack-Mayer and Mulligan, Ms X's and Mr Y's information was clearly provided for the purpose of providing diagnosis, advice and/or treatment to them. Their doctors' uses of that information to clarify a diagnosis, confirm decisions about treatment or seek additional advice could fairly be described as uses for that same purpose. As such, those uses would not be breaches of the common-law duty of confidentiality. However, the particular use described in Cases 1 and 2 may not conform to the Privacy Act, as it seems clear that neither Ms X nor Mr Y reasonably expected that use of their information. (There is no suggestion that the disclosure was reasonably necessary to prevent or lessen a serious and imminent threat to their life, health or safety.) The legal and ethical implications of access to Ms Z's test results in Case 3 are less clear, because of the involvement of two medical practitioners and the lack of explanation as to how the second doctor had access to the test results. Clarification of these details is important. However, if there was an explanation of access, it is clear that the information was used for the purpose of diagnosis and treatment, the purpose for which it was provided. Ms Z's being unaware of that use remains relevant for the Privacy Act. Thus, the common-law duty of confidence may not have been breached by any of the doctors in the three cases. The statutory duty to protect privacy may have been breached, depending on clarification of some uncertainties of interpretation. However, what remains important is that the patients all plainly felt that their information had been used in ways that surprised or troubled them. It could be said that the patients thought that an ethical duty had been breached. It seems there were two main causes for their concern, both of which have ethical importance. First, they did not know about (and did not feel that they had consented to) the way their information was used, and, second, that use diminished their trust in their doctors. Consent that is based upon an adequate and clear disclosure of how information will be used is the best response to the first cause of concern. Being given that information and, in turn, giving consent also respects a patient's autonomy. Routine advice as to whom a patient's information will be disclosed in the course of using it for diagnosis and treatment will probably also meet the requirements of the Privacy Act.3 Further, patients can, by their consent, agree to wider uses or disclosures of their information. As to the second cause of concern, acting in order to generate and maintain a patient's trust is the best response. In doing so, a doctor expresses the virtue of fidelity. This lies at the foundation of the doctor–patient relationship: it extends beyond merely keeping promises (eg, to maintain confidentiality) and speaks to character and the establishment, and not the assumption, of a relationship of trust.14 The authors are correct to identify the ethical importance of attending carefully to patients' awareness of and understanding about how their information is used. Exceeding minimal legal duties by doing more than merely making patients aware of how their information will be used is important to building trust and to providing effective healthcare.

Colin JH Thomson BA LLB LLM

Careful consideration of the ethical implications is required before patient information should be shared without the patient's knowledge. Routine and apparently uncontroversial releases of information can be perceived as problematic by patients. The ethics of such "ordinary" breaches of confidence can be explored by considering the patient's autonomy, the patient's best interests, and the public interest in preserving or breaching confidentiality. Patient autonomy can be supported and ethical problems may be avoided when patients are given as much information as possible about foreseeable information disclosures.

Annette J Braunack-Mayer BMedSci(Hons), PhD · Ea C Mulligan BMBS MHAdmin

To the Editor: The recent article by Scott and colleagues1 described a retrospective analysis by postal questionnaire of the attitudes of family members to participation (about a year earlier) in a face-to-face interview about their child's diagnosis of Ewing's sarcoma. This was accompanied by an editorial exposing the complexities of research participation, including the potential risks of interviews as well as the role of altruism.2 Although results derived from the questionnaire have only recently been published (November 2002), the questionnaire was distributed in November 1997, before introduction of the National statement on the ethical conduct of research involving humans.3 Some ethical uncertainties and questions of historical interest arise. First, what was the nature of the original consent obtained for the initial interviews? Presumably it involved written informed consent in which the risks of participation were clearly mentioned, including the possibility of distress associated with the interview. Did it mention a procedure for aborting or complaining about the interview? Second, did the patients (aged up to about 35 years) and their families give permission to be contacted again by the same research group? Third, for the follow-up on research participation, was consent implied simply by return of the questionnaire? Finally, how would the conduct of the initial interviews and the follow-up questionnaire differ in the light of recent developments in the ethics of research involving humans? Importantly, the respondents (84% of those surveyed) indicated that participation in the original study had not "upset them".1 While the attitude of non-responders is unknown, this would seem to confirm that the original process had been sensitive and appropriate. This is supported by the finding that families whose child had died after the initial interview were more likely to respond to the questionnaire. As a long-time member of a university human research ethics committee, I have often been required to evaluate research protocols that involve potentially threatening or distressing interviews. This has occurred more frequently since introduction of the National statement, as much qualitative research previously conducted under different jurisdictions (such as quality control or clinical audit) has been submitted for formal ethical review. The risk of harm to participants in qualitative research cannot be trivialised. Its impact can be minimised by wording the consent form to warn of possible adverse psychological reactions to interviews and questionnaires, using trained interviewers and providing counselling support if needed.

Simon C Gandevia

Objective: To examine doctors' perceptions and attitudes to prescribing within the Authority Prescribing System (APS).Design and setting: Questionnaire survey of Australian doctors' responses to a number of statements and factorial vignettes, conducted between 1 May and 30 June 2001.Participants: A national random sample of 1200 doctors, stratified according to specialist/generalist, rural/urban and high/low prescriber: 669 (56%) responded.Main outcome measures: Self-reported perceptions of the APS and attitudes to prescribing within the APS.Results: 72% of doctors agreed that the APS makes effective medications available to the socioeconomically disadvantaged members of the Australian public and 50% agreed that it compromises patient privacy. Fewer agreed that authority indicators were based on the highest quality of evidence quality (40%) or medication safety (12%). Doctors placed more emphasis on the doctor–patient relationship than on the criteria for authority prescribing in their decisions about prescribing APS medications. Doctors who used computers to prescribe were more likely to agree that computers can improve the authority prescribing process.Conclusions: This study suggests that authority-required prescribing is not achieving the stated aims of the National Medicines Policy in reducing variability in prescribing. Strategies to improve the quality of prescribing must consider the professional and ethical conundrum associated with prescribing outside of PBS/APS approved use for clinical and patient-centred reasons.

Siaw-Teng Liaw PhD, FRACGP · Christopher M Pearce FRACGP, FACRRM, MFM · Patty Chondros MSc · Leone Piggford MB BS, FRACGP · Kay Jones MSW, PhD · Barry P McGrath PhD, MB BS