Ethics

The new genetics: legal and ethical implications for medicine Community discussion and informed guidelines for medical practitioners are needed MJA 1996; 165: 301-303 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - Register to be notified of new articles by email - - ©MJA1996 The achievements and potential of "the new genetics" were recently described as follows: The human genome has now been completely mapped and by the year 2000, virtually all genes will have been isolated and sequenced . . . The technology exists to allow analysis of all persons for mutations causing single gene disorders, probably very early in pregnancy or using IVF . . . [Next] will be predicting risk of multifactorial, common diseases of later life, including cancer. (Professor Bob Williamson, Director of the Murdoch Institute of Research into Birth Defects. The new genetics -- for good or ill , Dean of Medicine's Lecture Series, University of Melbourne, 1996.) These developments have enormous potential for good. About 8000 currently recognised single gene defects 1 afflict at least 1% of the population, more than half with serious consequences. In addition, links have been increasingly recognised between genetic factors and conditions such as cancer and heart disease. Many people are already affected by genetic testing. However, genetic testing raises important legal and ethical issues that must be investigated and resolved expeditiously. Information and consent: General legal principles dictate that genetic testing should be voluntary and based on appropriate information. The High Court of Australia stated in Rogers v Whitaker that a patient is entitled to be informed of "material risks" of a procedure and that a risk is "material" if "a reasonable person in the patient's position . . . would be likely to attach significance to it". 2,3 A patient having a genetic test should obviously be told the purpose and nature of the test, the implications of a positive result and other diagnostic options. As test results may affect other family members, discussion and counselling need to be wider and to include explanations of the information implicit in the family pedigree, as well as who will be told the results and by whom. If information from medical records or genetic test results is needed from relatives (living or dead), permission should be sought, even if tissue is already available for testing. Although there may be no legal requirement, this respects their autonomy and right to privacy. Prenatal screening: Prenatal screening of pregnant women for genetic abnormalities such as Down's syndrome is now routine in Australia. However, there is a chance of both false positives and false negatives and, even if a genetic abnormality exists, there are no tests for severity of impairment. As termination itself is a subject of debate, testing and termination of pregnancy should remain voluntary, and a woman who chooses not to terminate a pregnancy should not be penalised by health or social welfare providers. Confidentiality and access to information: Genetic information may have serious consequences, not only for patients, but also for their families. Although pretest counselling would encourage most patients to share results with their family, some may refuse permission for disclosure. An amendment to the Australian Medical Association Code of Ethics in February 1996 acknowledged that "Exceptions [to the obligation of confidentiality] may arise where the health of others is at risk . . . ". 4 The law also recognises that it may be lawful to breach confidentiality where there is a serious risk to others (note that the law requires the risk to be "serious"). 5 Thus, it is arguable that a doctor who knows a patient carries a harmful genetic mutation would be justified, both ethically and legally, in advising a relative who could take measures to avoid or minimise disease, or who is about to start a family, to undertake testing for the mutation. Indeed, it may be argued that genetic information is "common" to the family, rather than "belonging to" the individual alone, so that a doctor might be justified in always telling family members that the genetic mutation exists in the family (but not that a particular person has, or does not have, the gene). Of course, even people who have been tested may not wish to know the result. For example, many people do not want to know that they will develop a late-onset illness for which there is no treatment, such as Huntington's disease. Both ethics and law support this; patient autonomy entitles people not to know, just as much as to know. Use of genetic information: Life and disability insurers may require that genetic test results be disclosed for risk classification before cover is granted; currently, they do not initiate genetic tests. The Life, Investment and Superannuation Association of Australia states: "Effective underwriting relies upon an assessment of all factors that impact upon the life to be insured." 6 The Association considers that an applicant for insurance who has information that the insurer does not have (such as genetic test results indicating a high risk of premature death) should not be permitted to "anti-select" against the insurer by taking out a very large insurance policy. Denying insurers genetic information could cause a "shift in the risk profile of people taking out insurance". 6 However, others may be concerned that the "genetically handicapped", who are perhaps in most need of disability cover, will find it unobtainable or very expensive. Perhaps, people seeking genetic tests should be warned that they will have to supply results to an insurer if they apply later for insurance; they may be better advised to obtain insurance before rather than after the test. Employers and government agencies, such as the police, may also seek access to genetic information, so it is essential that it be held securely, with strict controls on its potential applications. How to resolve these issues: In Australia, various recommendations have been made 7-12 or are being considered. The Cancer Genetic Ethics Committee of the Australian Cancer Network and the Anti-Cancer Council of Victoria, chaired by Professor Emeritus Richard Lovell, is currently preparing guidelines for genetic testing in relation to cancer. The Australian Research Council has given a three-year grant for research and report on legal issues related to the Human Genome Project, and many conferences have been held on related issues (e.g., Community and the New Genetics, convened by the Human Genetics Society of Australasia in 1995). However, more thought should be given to developing integrated Australia-wide policies and to involving patients and the general community in decision-making. Traditionally, new medical research has been regulated through ethical guidelines prepared by the National Health and Medical Research Council (NHMRC). Although these do not have the force of law, they are generally observed and are flexible, being readily amended in the light of experience and community opinion. The guidelines being prepared by the broadly based Cancer Genetic Ethics Committee, informed by detailed legal and ethical research, could provide the foundation for NHMRC guidelines and community discussion. It is important to get the ethics right first. If legislation is needed on specific topics, it can be developed later. Loane Skene Associate Professor and Director of Studies, Health and Medical Law, Law School, University of Melbourne, Melbourne, VIC. Max Charlesworth Emeritus Professor of Philosophy, Deakin University, Geelong, VIC. On-line Mendelian Inheritance in Man, OMIM (TM). Baltimore (MD): Center for Medical Genetics, Johns Hopkins University, and National Center for Biotechnology Information, National Library of Medicine, 1996 [cited 1996 Aug 5]. OMIM Statistics. World Wide Web URL: http://www3.ncbi.nlm.nih.gov/omim/ Rogers v Whitaker (1995) 109 ALR 625 at 634. Nuffield Council on Bioethics. Genetic screening: ethical issues. London: the Council, 1993. Australian Medical Association. AMA Code of Ethics. Canberra: AMA, 1996. W v Egdell [1990] 1 All England Reports 835. Life, Investment and Superannuation Association of Australia. Draft policy regarding genetic testing. Sydney: LISA, 1996. Medical Research Ethics Committee of the National Health and Medical Research Council. Report to the NHMRC. Ethical aspects of research on human gene therapy. Canberra: AGPS, 1987. National Health and Medical Research Council. Statement on human experimentation. Supplementary Note 7, Somatic cell gene therapy and other forms of experimental introduction of DNA and RNA into human subjects. Canberra: NHMRC, 1982: 21-22. Medical Research Ethics Committee of the National Health and Medical Research Council. Report to the NHMRC. Guidelines for the use of genetic registers in medical research. Canberra: AGPS, 1991. Victorian Law Reform Commission. Genetic manipulation. Melbourne: the Commission, 1988. Report No 26. House of Representatives Standing Committee on Industry, Science and Technology. Genetic manipulation: the threat or the glory? Canberra: AGPS, 1992. Federal Privacy Commissioner. Privacy implications of genetic testing. Exposure Draft 1995. Sydney: Human Rights and Equal Opportunity Commission. 1996 . - Register to be notified of new articles by email - - To top of article - ©MJA1996 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Loane Skene · Max Charlesworth

The clinical and ethical implications of hepatitis C for organ transplantation in Australia Ian H Kerridge, Peter Saul and Robert G Batey Current Australian policy prohibiting transplantation of organs from hepatitis C-infected donors raises questions about patient autonomy and medical paternalism. MJA 1996; 165: 282-285 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Introduction - HCV infection - Transmission of HCV by organ transplantation - Implications of HCV infection after organ transplantation - Ethical issues - Conclusions - Acknowledgements - References - Authors' details - Register to be notified of new articles by email - - ©MJA1996 Case 1 A 42-year-old man presented to a liver clinic for assessment as he had recently been found to be hepatitis C virus antibody (anti-HCV) positive. Liver function test results had been normal in the two years preceding this appointment, and the patient felt perfectly well. There were no signs of chronic liver disease, and a liver biopsy (undertaken at the patient's request) 12 months earlier had shown minimal inflammatory damage and no fibrosis. One of the main points for discussion at the outpatient clinic was that this patient had been rejected as an organ donor by the transplantation service. He was indignant that his offer of organs was rejected, particularly as he felt that it would be appropriate in the event of his death for his liver to be made available to another HCV-positive patient. He asked for advice as to why HCV-positive patients were unable to donate organs for transplantation. Case 2 A 48-year-old man presented with advanced alcohol-related liver disease and is awaiting liver transplantation. His clinical progress had improved slowly after cessation of alcohol intake but his liver function had deteriorated in the preceding six months. He had been advised that liver transplantation might be required within 12 months but had not yet been placed on the active transplantation list. This patient asked if he could have a liver transplant earlier if he agreed to accept an HCV-antibody positive liver. This request was motivated by his frustration at being unable to work and his awareness that patients with hepatitis C were receiving transplants and apparently doing well. He was advised, that at present, there is a policy banning the use of organs from all HCV-positive donors in Australia. He agreed to abide by these rules but insisted that this issue be investigated further. Introduction D uring the past decade, advances in immunosuppression and transplantation technology have increased the demand for organ transplantation without a corresponding increase in the number of donors. In June 1995, 1869 Australians were on waiting lists for solid-organ transplantation, with a further 1435 awaiting corneal transplants. Waiting-list numbers increased by 17% in the first six months of 1995, while the Australian organ donation rate continued to fall. 1 The relative donor shortage and its impact on both waiting lists and the length of time patients wait for transplantation highlights the importance of efficient and effective organ procurement and use. 2 Viruses which may be transmitted by organ transplantation (such as cytomegalovirus, herpes simplex virus, Epstein-Barr virus, human immunodeficiency virus, hepatitis A virus, hepatitis B virus, hepatitis D virus and human T-cell lymphotropic virus type 1) have become one of the major causes of morbidity and mortality in organ transplant recipients. 3 For this reason, potential organ donors are routinely screened for the presence of viral infection. After the identification of the hepatitis C virus, and the recognition that it may be transmitted by organ transplantation, transplantation organisations have restricted the use of organs from anti-HCV-positive organ donors. 4 There is no international consensus about the use of HCV-positive organs in transplantation. Three recent studies from the United States highlight the variation in policies for the transplantation of organs from HCV-positive donors. Milfred et al. 5 found that, for heart and lung transplantation, 22% of the centres studied would accept organs from anti-HCV-positive donors irrespective of recipient HCV status, 45% would accept such donors only for anti-HCV-positive recipients, 27% would never accept these donors, 2% did not screen donors, and 4% did not have a defined policy. 5 By contrast, studies by Ramos et al. 6 and Schweitzer et al. 7 found that most US transplant centres would not accept organs from anti-HCV-positive donors for renal transplantation. Part of the reason for the lack of consensus is that the consequences of transplantation of organs from anti-HCV donors (including the degree of HCV transmission, the prevalence of liver disease and the impact of HCV infection on survival) remain unclear. 8-11 Furthermore, any guidelines must incorporate ethical considerations relating to resource allocation, prognostic uncertainty, medical paternalism and limitation of patient autonomy. In New South Wales, the Transplant Advisory Committee policy currently excludes transplant of all HCV-positive organs and tissues, including transplant to known HCV-positive recipients. The implications are that one in 50 potential organ donors are lost to the transplant program and that certain individuals therefore lose the right to choose potentially life-sustaining organ transplantation with an organ they know to be infected with HCV. These cases raise questions about the current Australian policy of excluding transplantation of HCV-positive organs and whether this constitutes unjustifiable paternalism. As with many questions of ethics in clinical practice, further understanding depends upon a number of factual issues concerning the transmission of HCV during transplantation and the consequences of HCV infection for the graft recipient. HCV infection HCV infection is now the most frequently reported notifiable disease in Australia. 12 Its true prevalence is unknown, but studies of Australian blood donors demonstrate a prevalence of 0.3%-0.7%. 13,14 Most estimates suggest that there are at least 100 000 cases in Australia. International studies reporting the incidence of HCV in cadaveric organ donors have shown wide variation (1.5%-16.7%), 15-17 probably reflecting both geographical variation in HCV prevalence and the different testing methods used for HCV identification. Second generation enzyme-immunoassays used to detect anti-HCV have a sensitivity and specificity of about 90% and 99%, respectively, resulting in a positive predictive value in Australian blood and organ donors of less than 50%. 18 Confirmatory assays (e.g., radioimmunoblot assay [RIBA-2] and polymerase chain reaction techniques) can provide further evidence of actual HCV infection but may also give false positive or false negative results. 19 Genotyping assays are now available and may prove to be important for prognosis, determining epidemiological research and monitoring response to treatment. Most cases of hepatitis C in Australia can be traced to a history of parenteral exposure through intravenous drug use (50% of cases) 20 or blood products (10%-15% of cases). 21 Since the introduction of routine donor screening for hepatitis C, the risk of transmission by infected blood products has reduced substantially. 22 Accurate information about the natural history of hepatitis C is extremely limited because diagnoses of acute hepatitis are rarely made, serum transaminase levels are poor predictors of liver disease and most studies of long-term outcome are limited to a 10-year follow-up. It is estimated that 50%-80% of infected patients develop chronic hepatitis C and 20%-30% of these will progress to cirrhosis. An unknown number (varying from 10%-75%) will develop hepatocellular carcinoma (HCC). 23 The mean interval between infection and diagnosis of cirrhosis is estimated to be 20 years. The cornerstones of managing hepatitis C virus infection are education about its natural history and counselling to prevent transmission or worsening of the disease (e.g., avoiding the sharing of needles, restricting alcohol intake and practising "safe-sex"). Interferon alfa is available for treatment of chronic HCV under the Pharmaceutical Benefits Scheme but is extremely expensive; the long term response rate after a standard six-month course is approximately 20%-25%. 24 End-stage liver disease in patients with HCV can be managed medically or by liver transplantation. Reinfection of the graft is almost universal. Despite the need for immunosuppressive therapy, the resultant liver disease is generally benign and graft survival in the medium term (up to five years) is equivalent to that of other causes of liver disease requiring transplantation. Hepatitis C is now the most frequent indication for liver transplantation in Australia. 25 Transmission of HCV by organ transplantation There is conflicting evidence about the risk of transmission of HCV with organ transplantation. 26-30 Retrospective studies indicate that hepatitis is evident in approximately 50% of recipients of HCV-antibody-positive kidney transplants. 31 The type of solid organ transplanted (heart, lung, liver or kidney) does not appear to influence the transmission of HCV from an infected donor to a recipient. Recent studies have also demonstrated the transmission of HCV through bone marrow transplantation 32 and bone, ligament and tendon allografts. 33 Given the likely high degree of HCV transmission by organ transplantation, there is considerable interest in the work of Zucker et al., which suggests that washing donated kidneys can remove 99% of the viral burden. It is not known whether this has any significant impact on the transmission of HCV. 34 Implications of HCV infection after organ transplantation There is evidence that liver disease is more frequent in recipients of anti-HCV-positive organs, 35 that immunosuppression may enhance HCV replication 36 and that immunocompromised patients infected with HCV may have a more aggressive course of infection. 37 A number of studies have also shown that, when HCV infection develops after renal transplantation, it will become chronic in approximately 85% of recipients and may progress to cirrhosis. 38 There is also evidence to suggest that HCV infection may increase the risk of rejection and infection; 39,40 however, no study has consistently demonstrated a significantly increased rate of mortality or graft loss in recipients of anti-HCV-positive organs. 41 The effects of HCV infection on transplanted livers in immunocompromised hosts can be partly surmised by examination of HCV-positive patients who receive HCV-negative liver transplants -- early reinfection occurs almost uniformly 42 and may range in severity from asymptomatic viraemia to cirrhosis and hepatic failure. A small number of patients develop fulminant hepatic failure after organ transplantation, but reinfection is usually not clinically significant, producing only mild inflammation. In general, primary infection with HCV and reinfection in a transplanted patient follow a similar course. 43 Growing awareness of the heterogeneous nature of HCV genotypes has led to suggestions that anti-HCV-positive organs could be safely made available for transplantation into anti-HCV-positive recipients. 44 Unfortunately, a number of studies have suggested that patients may become infected with multiple viral genotypes, 45 and there may not be sufficient cross-immunity between different HCV subtypes. 46 Furthermore, there is some evidence to suggest that repeated exposure to the virus may result in repeated bouts of hepatitis. 47,48 Thus, host seropositivity for HCV may provide no absolute assurance that a patient receiving an HCV-positive organ will have less risk of infection and liver disease. In general terms it seems likely that transplant-related infection may follow a similar course to primary infection with hepatitis, 43 but the long term implications of HCV infection after organ transplantation remain unclear. Importantly, the use of interferon alfa for chronic hepatitis C does not appear to increase the risk of graft rejection. 49 Ethical issues With the increasing scarcity of organs, maximum use of donors is essential to realise the full potential of organ transplantation. However, in attempting to meet the health needs of both individuals and society, all attempts must be made to maximise the benefit and minimise the risks of transplantation to the recipient. The high probability of transmitting HCV by organ transplantation and the uncertain long term consequences of HCV infection in immunocompromised hosts have led the Transplantation Advisory Committee to ban the transplant of HCV-positive organs in New South Wales. This policy is clearly medical paternalism; the question is, is it justifiable paternalism? Should informed patients be able to request transplantation of HCV-positive organs, in the light of their own wishes, beliefs and values, or do policies such as these constitute justifiable limits of autonomy? The uncertain risks of HCV may add to the mortality and morbidity associated with organ transplantation, but this is not in itself sufficient reason for preventing patients from choosing an HCV-positive organ. It is well accepted that competent patients may have the right to choose medical interventions which have significant or uncertain side effects, provided they are aware of the nature and likelihood of such complications. This is especially the case when alternative forms of therapy are associated with high rates of morbidity and mortality. For example, young patients with acute myeloid leukaemia will always be offered bone-marrow transplantation, despite its significant risks, because other treatments for this condition have such poor outcomes. This is not to suggest that patient autonomy is, or should be, unrestricted. Patients may not request treatment that is ineffective, that endangers others, or that is judged by health care professionals and, ultimately, by society to be of insufficient value to be allocated scarce health resources. It may well be that current policy should continue for non-life-threatening conditions (such as renal transplantation in chronic renal failure) because of the uncertain long-term consequences of HCV infection and the small number of donor organs that would be gained from relaxing the prohibition on the use of HCV-positive organs. On the other hand, for patients awaiting heart, lung or liver transplantation, the risk of liver disease after organ transplantation from an HCV-positive donor may well be more acceptable than the risk of death or poor quality of life without transplantation. A further difficulty is that, whereas the transplantation of an HCV-positive organ may benefit the individual, this may be to the detriment of the wider community. The use of HCV-positive organs would clearly generate a potential source of preventable infection which may impact significantly on the lives of others (such as sexual partners) and inevitably demand further expensive treatment. The cost of a six-month course of interferon alfa is $3200 and the cost of liver transplantation for end-stage liver disease is $120 000, plus $7000-$10 000 per annum postoperatively. A conservative estimate of the cost of treating a patient with chronic hepatitis C (including hospitalisations) over five years is approximately $100 000. The effects on the present system of waiting-lists of a separate pool of "sub-standard" HCV-positive organs may also become increasingly complicated. Should a patient be able to "jump the queue" to a position higher up the waiting list if they are willing to accept such an organ? Should a patient at the top of the queue have the right to refuse an HCV-infected organ? Should there be a separate list of patients who are eligible only for HCV-infected organs? Conclusions Much of the uncertainty about the significance of hepatitis C infection in organ transplantation will only be resolved by further research. Until then, the obligations suggested by the ethical principles of autonomy, non-maleficence, beneficence and justice suggest a number of alternative approaches to the management of HCV-positive donors, shown in the Box. The decision to transplant an HCV-infected organ remains a complex issue in which benefit must be weighed against harm and individual choice against the wider demands of society and scarce health resources. Ultimately, such issues may only be resolved through an approach based on shared and informed decision-making between doctors and patients, recognising the many clinical and epidemiological uncertainties involved in these circumstances. That there are organ recipients willing to accept HCV-positive organs, but prevented from doing so by current policy, reflects tension between professional guidelines and individual needs or between medical paternalism and patient autonomy. We believe that there are circumstances in which transplantation of HCV-infected organs may be indicated, particularly in the case of life-saving transplantation. Decisions that deny choice to informed, competent patients are the subject of increasing scrutiny by the medical and legal professions and the community at large. If patients who are aware of the risks and complications are to be denied the choice of an HCV-infected organ, such denial must be carefully considered and explicitly justified. Acknowledgements We acknowledge the contributions of Dr Michael Lowe for his editorial assistance and of members of the John Hunter Hospital Clinical Ethics Committee for advice on the formulation of this paper. References Australian Coordinating Committee on Organ Registries and Donation (Gladesville, Sydney, NSW). Newsletter, October 1995 (distributed to all intensive care and renal transplant units). Shiener PA, Mor E, Schwartz ME, Miller CM. Use of hepatitis C-positive donors in liver transplantation. Transplant Proc 1993; 25: 3071. Aswad S, Mendez R, Weingart RG, Mendez R. Expanding organ availability by using hepatitis C antibody-positive donors. Transplant Proc 1993; 25: 2270-2271. Public Health Service inter-agency guidelines for screening donors of blood, plasma, organs, tissues and semen for evidence of hepatitis B and hepatitis C. MMWR Morb Mortal Wkly Rep 1991; 40: 1-17. Milfred SK, Lake KD, Anderson DJ, et al. Practices of cardiothoracic transplant centers regarding hepatitis C seropositive candidates and donors. Transplantation 1994; 57: 568-572. Ramos EL, Kaiske BL, Alexander SR, et al. The evaluation of candidates for renal transplantation: the current practice of US transplant centers. Transplantation 1994; 57: 490-497. Schweitzer EJ, Bartlett ST, Keay S, et al. Impact of hepatitis B or C infection on the practice of kidney transplantation in the United States. Transplant Proc 1993; 25: 1456-1457. Tesi RJ, Waller K, Morgan CJ, et al. Transmission of hepatitits C by kidney transplantation -- the risks. Transplantation 1994; 57: 826-831. Aeder MI, Shield CF, Tegtmeier GE, et al. The incidence and clinical impact of hepatitis C virus (HCV) positive donors in cadaveric transplantation. Transplant Proc 1993; 25: 1469-1471. Diethelm AG, Roth D, Ferguson RM, et al. Transmission of HCV by organ transplantation. N Engl J Med 1992; 326: 410-411. Triolo G, Squiccimarro G, Baldi M, et al. Antibodies to hepatitis C virus in kidney transplantation. Nephron 1992; 61: 276-277. Commonwealth Department of Human Services and Health. Hepatitis C. Commun Dis Intell 1994; 18: 533. Archer GT, Buring ML, Clark B, et al. Prevalence of hepatitis C virus antibodies in Sydney blood donors. Med J Aust 1992; 157: 225-227. McGuinness PH, Bishop GA, Lien A, et al. Detection of serum hepatitis C virus RNA in anti-HCV seropositive (RIBA positive) volunteer blood donors with normal ALT levels. Hepatology 1993; 18: 485-490. Aeder MI, Shield CF, Tegtmeier GE, et al. Incidence and clinical impact of hepatitis C virus-positive donors in cadaveric transplantation. Transplant Proc 1993; 25: 1469-1471. Pereira BJ, Wright RL, Schmid CH, et al. Screening and confirmatory testing of cadaveric organ donors for hepatitis C virus infection: a US National Collaborative Study. Kidney Int 1994; 46: 886-892. Candinas D, Joller-Jemelka HI, Schlumpf R, et al. Hepatitis C RNA prevalence in a Western European organ donor pool and virus transmission by organ transplantation. J Med Microbiol 1994; 41: 220-223. Talley NJ. Internal medicine. Sydney: Maclennan and Petty, 1990: 288. Strasser SI, Desmond PV, Watson KJR, et al. The value of routine hepatitis C PCR in clinical practice. Gastroenterology 1994; 106: A991. Bell J, Batey RG, Farrell GC, et al. Hepatitis C virus in intravenous drug users. Med J Aust 1990; 153: 274-276. Strasser SI, Watson KJR, Lee CS, et al. Risk factors and predictors of outcome in an Australian cohort with hepatitis C infection. Med J Aust 1995; 162: 355-358. Donahue JG, Munoz A, Ness PM, et al. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med 1992; 327: 369-373. Ikeda K, Saitoh S, Koida I, et al. A multivariate analysis of risk factors for hepatocellular carcinogenesis: a prospective observation of 795 patients with viral and alcoholic cirrhosis. Hepatology 1993; 18: 47-53. David GI, Balart LA, Schiff ER, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicentre randomised controlled trial. N Engl J Med 1989; 321: 1501-1506. Ascher NL, Lake JR, Emond K, Roberts J. Liver transplantation for hepatitis C virus related cirrhosis. Hepatology 1994; 20: 245-275. Roth D, Fernandez JA, Babischkin S, et al. Detection of hepatitis C virus infection among cadaver organ donors: evidence for low transmission disease. Ann Intern Med 1992; 117: 470-475. Pereira BJ, Milford EL, Kirkman RL, Levey AS. Transmission of hepatitis C virus by organ transplantation. N Engl J Med 1991; 325: 454-460. Wreghitt TG, Gray JJ, Allain JP, et al. Transmission of hepatitis C virus by organ transplantation in the United Kingdom. J Hepatol 1994; 20: 768-772. Maple PA, McKee T, Desselberger V, Wreghitt TG. Hepatitis C virus infections in transplant patients: serological and virological investigations. J Med Virol 1994; 44: 43-48. McDonnell WM, Lucey MR. Hepatitis C virus transmission during organ transplantation. Hepatology 1993; 17: 162-164. Morales JM, Munoz MA, Castellano G, et al. Impact of hepatitis C in long-functioning renal transplants: a clinicopathological follow-up. Transplant Proc 1993; 25: 1450-1453. Shuhart MC, Myerson D, Childs BH, et al. Marrow transplantation from hepatitis C virus seropositive donors: transmission rate and clinical course. Blood 1994; 84: 3229-3235. Conrad EV, Gretch DR, Obermeyer KR, et al. Transmission of the hepatitis-C virus by tissue transplantation. J Bone Joint Surg Am 1995; 77: 214-224. Zucker K, Cirocco R, Roth D, et al. Depletion of hepatitis C virus from procured kidneys using pulsatile perfusion preservation. Transplantation 1994; 57: 832-840. Weir MR, Kirkman RL, Strom TB, Tilney NL. Liver disease in recipients of long-surviving renal allografts. Kidney Int 1985; 28: 839-844. Chazouilleres O, Kim M, Combs C, et al. Quantitation of hepatitis C virus RNA in liver transplant recipients. Gastroenterology 1994; 106: 994. Pereira BJG, Milford RL, Kirkman RL, et al. Liver disease and HCV infection after transplantation of organs from hepatitis C antibody-positive donors. Transplant Proc 1993; 25: 1458-1459. Huang CC, Lai MK, Lin MW, et al. Transmission of hepatitis C virus by renal transplantation. Transplant Proc 1993; 25: 1474-1475. Roth D, Zucker K, Cirocco R, et al. The impact of hepatitis C virus infection on renal allograft recipients. Kidney Int 1994; 45: 238-244. Fritsche C, Brandes JC, Delaney SR, et al. Hepatitis C is a poor prognostic indicator in black kidney transplant recipients. Transplantation 1993; 55: 1283-1287. Ynares C, Johnson HK, Kerlin T, et al. Impact of pretransplant hepatitis C antibody status upon long-term patient and renal allograft survival -- a 5 and 10-year follow-up. Transplant Proc 1993; 25: 1466-1468. K"nig V, Bauditz J, Neuhaus P, et al. Follow-up of hepatitis C virus (HCV) reinfection in liver allograft recipients. J Hepatol 1991; 13: 540. Wright TL, Ferell L, Donegan E, et al. Impact of hepatitis C viral (HCV) infection on the allograft following liver transplantation. J Hepatol 1991; 14: 51A. Morales JM, Andres A, Campistol JM. Hepatitis C virus and organ transplantation. N Engl J Med 1993; 328: 511-513. Preston FE, Jarvis LM, Markis M, et al. Heterogeneity of hepatitis C virus genotypes in haemophilia: relationship with chronic liver disease. Blood 1995; 85: 1259-1262. Farci P, Alter HJ, Govindarajan S, et al. Lack of protective immunity against reinfection with hepatitis C virus. Science 1992; 258: 135-140. King P. Renal transplantation. N Engl J Med 1994; 331: 1719. FŽray C, Gigou M, Samuel D, et al. Direct evidence for a more pathogenic effect of HCV type II: the model of liver transplantation. J Hepatol 1993; 28 Suppl 1: 54. Shorrock C, Neuberger J. The changing face of liver transplantation. Gut 1993; 34: 295-298. Authors' details Faculty of Medicine and Health Sciences, The University of Newcastle, NSW. Ian H Kerridge, BMed(Hons), MPhil, Lecturer in Clinical Ethics, Health Law and Ethics Programme, and Haematology Registrar, John Hunter Hospital. John Hunter Hospital, Newcastle, NSW. Peter Saul, FANZCA, FFICANZCA, Intensive Care Specialist; Robert G Batey, MD, FRACP, Associate Professor and Director, Department of Gastroenterology. No reprints will be available. Correspondence: Dr I H Kerridge, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW 2305. - Register to be notified of new articles by email - - To top of article - ©MJA1996 < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Ian H Kerridge · Peter Saul · Robert G Batey

Is a general practitioner legally bound to render assistance to a stranger? Paul Gerber The finding that a general practitioner has a duty to attend any person in a medical emergency, in the absence of any previous professional relationship, is brand new law MJA1996; 165: 159-161 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Register to be notified of new articles by email - - ©MJA 1996 The case of Woods v. Lowns and Procopis (decision of the Court of Appeal of NSW, handed down 5 February 1996: unpublished to date) is likely to have wide implications for the future practice of medicine in Australia. The trial involved two main issues: (i) should judges decide cases of medical negligence by acting on unproven scientific evidence contrary to the weight of expert medical opinion; and (ii) is there a legal obligation upon a general practitioner to attend a person with whom he or she has no professional relationship? I have dealt in the Journal with the first aspect of the case, 1 involving Dr Procopis. I was highly critical of the trial judge's finding against this specialist, concluding that his Honour had misconceived his role, and predicting that the "Procopis" component of his judgment would be reversed on appeal. My analysis did not meet with universal approval. 2 My criticism of the judge's handling of the evidence against Dr Procopis proved justified -- the verdict against the specialist was set aside on appeal. A majority of the Court of Appeal of the Supreme Court of New South Wales held that, while it is for the courts to decide the content of the duty of care which a medical specialist owes to a patient, it does not follow that a judge "will simply or readily put aside the considered judgment and/or experience of those skilled in the field and their opinion of what the care of the patient warranted" ( Woods v. Lowns and Procopis on appeal ). This concession has come some way toward attenuating the more extreme view generally ascribed to the decision in Rogers v. Whitaker 3 (i.e., that, generally speaking, the answer to the question whether the patient has been given all the relevant information to choose between undergoing and not undergoing the proposed treatment does not depend on medical standards or practice). Here I deal with the case against Dr Lowns, the general practitioner, who, at first instance, was held liable in negligence for failing to attend the plaintiff when allegedly requested to do so. The finding against him was upheld by majority of the Court of Appeal of the Supreme Court of New South Wales (Kirby P and Coles JA), who concluded that Dr Lowns, albeit a stranger to the plaintiff, was nevertheless liable for the unfortunate medical misadventure which resulted in the case, all said to be attributable to Dr Lowns' failure to attend the plaintiff at his home when requested to do so. The plaintiff, a boy aged ten years at the time, had a history of epilepsy and suffered an attack of status epilepticus in 1987 while on vacation with his family. Briefly, the relevant facts, taken from the trial judge's findings, were these: when the boy's mother -- after some considerable delay -- discovered that her son was fitting, she directed her older son "to go for an ambulance", and told her daughter (then nearly 15 years of age) "to go and get a doctor". The girl insisted that she went to Dr Lowns' surgery and spoke "to a man who answered the door". She claimed that she told that man that her mother had sent her because her brother was having a bad fit, that they had called for an ambulance, and "that we needed a doctor and could he come up?". The girl identified this man in Court as Dr Lowns, and claimed that he had refused to come, telling her instead to bring her brother to the surgery. By the time the ambulance arrived and took the boy to another medical practice (where he was injected with diazepam) and then to hospital (still fitting), he had suffered severe brain damage. The boy sued both Dr Procopis and Dr Lowns (as well as the two doctors who injected him with diazepam, a claim later withdrawn). At first instance, both Dr Procopis and Dr Lowns were found to have been negligent: Dr Procopis for having failed to instruct the parents in the use of rectal diazepam, and Dr Lowns for failing to attend the plaintiff at his home. At the trial, Dr Lowns denied that the girl had ever been to his surgery. His case was that the alleged conversation had never occurred. However, he made a number of fatal concessions: (i) that if he had been requested to attend the boy, he would -- and should -- have gone, (ii) that if he had attended the boy, he would have injected him with diazepam, and (iii) that if the boy had been treated at that point in time, it is probable that the tragic consequences would have been avoided. The identification of Dr Lowns by the boy's sister must be treated with considerable scepticism: she alleged that Dr Lowns was smoking a pipe (he does not), and there is little doubt that the doctor is not easily recognisable from her initial description of him. For good measure, the girl's ex- planations of these discrepancies lack conviction. This notwithstanding, the judge chose to believe her and rejected Dr Lowns' denial. (This finding was not challenged on appeal.) In the result, the judge entered a verdict in favour of the plaintiff in excess of $3 million. The finding that a general practitioner has a duty to attend any person in a medical emergency, in the absence of any previous professional relationship, is brand new law. With a stroke of a pen, the Court "discovered" a duty which did not previously exist. The origin of this so-called duty is found in the seminal speeches in Donoghue v. Stevenson, 4 where a majority of the House of Lords held, some 60 years ago, that a soft-drink manufacturer was liable in negligence to a plaintiff who claimed to have suffered an attack of gastroenteritis as a result of drinking the defendant's ginger beer (alleged to have contained the decomposed remnants of a snail). This case discovered the "neighbour" principle, "based upon a general public sentiment of moral wrongdoing for which the offender must pay" (per Lord Atkin, at p 580). 4 This "general public sentiment", excavated from the Old Testament, commanding that you are to love your neighbour, has mutated into law that you must not "injure" your neighbour. The legal question "who is my neighbour?" receives the restricted reply "persons so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts and omissions which are called in question" (per Lord Atkin, at p 580). 4 This "neighbour" principle had never previously been applied to doctor and stranger. Indeed, the trial judge himself (in Woods v. Lowns and Procopis ) noted: Something other than the foreseeability of harm is required before the law imposes a duty to intervene. It has been held in other common law jurisdictions that a doctor is under no duty to attend upon a person who is sick, even in an emergency, if that person is one to whom the doctor has not and never has been in a professional relationship of doctor and patient: see Jones, Medical Negligence , Sweet and Maxwell 1991 at p 24, par 2.21; Kennedy & Grubb, Medical Law , Butterworths (2nd ed) 1994 at p 79. His Honour cited a number of United States decisions, all of which held, firstly, that there can be no liability to attend to members of the public and, secondly, that there can be no negligence unless and until the relationship of doctor and patient has been established. How, then, did the majority impose this hitherto unknown legal obligation? The answer is that their Honours confused a moral duty with a legal one. The Medical Practitioners Act 1938 (NSW) s 27 (1) (now re-enacted in s 37 of the Medical Practice Act 1992 [NSW]) does state that "professional misconduct" in a registered medical practitioner is, inter alia: (h) refusing or failing, without reasonable cause, to attend, within a reasonable time after being requested to do so, on a person for the purpose of rendering professional services in the capacity of a registered medical practitioner in any case where the practitioner has reasonable cause to believe that the person is in need of urgent attention by a registered medical practitioner. However, while the legislation describes the contents of professional misconduct which will attract professional sanction, there is nothing in the Act which imposes a statutory obligation to attend a stranger, and it would be quite wrong to elevate "professional misconduct" to a breach of statutory duty, thus giving rise to an independent cause of action. It follows that those who maintain that the decision in Woods v. Lowns and Procopis is relevant only to medical practitioners in New South Wales are on shaky ground. I believe that, on appeal, only the dissenting judge (Mahoney AJ) correctly summarised the position when he stated: "We are concerned with whether the moral obligation to which (as I assume) the doctor was subject should be a legal obligation" ( Woods v. Lowns and Procopis, at p 13). His Honour noted that: Counsel have not been able to find any case in support of the present existence of such an obligation. Nor has any member of the Court. No case has been put to the contrary. I am conscious of the fiction that what the law creates has always been the law. But the implications of this case are great. . . . In this, as in other areas of law, the Court now faces squarely the nature of its decision: it prefers reality to fiction. Therefore, it is not inappropriate that I describe what the Court is here asked to do is imposing a legal obligation which presently does not exist ( Woods v. Lowns and Procopis, at p 15). I suggest that both the trial judge (Badgery-Parker J) and the majority of the Court of Appeal of the Supreme Court of NSW have not only "discovered" a relationship of proximity between doctor and stranger hitherto unknown to the law, but that they were wrong to hold that a doctor is under a legal duty to attend a person with whom he or she has had no previous professional relationship, a duty said to be based on the "proximity" or "neighbour" test, so that the only remaining question was whether the damage in suit was reasonably foreseeable if a doctor, otherwise in a position to do so, refused to render medical assistance. I submit that this is not only bad law; it is a blatant usurpation by the Court of what is solely the function of Parliament. If the Legislature wants to impose such a duty, so be it. It is not the business of judges to do so. While this is not the place to examine the history and development of the law of negligence, it is with no disrespect to the majority of the Court of Appeal to say that in the case Woods v. Lowns and Procopis Homer nodded,* and that the majority's reasoning was simplistic. It has long been held that the tort of negligence does not include -- save in a special relationship -- an obligation of rescue. The claim against Dr Lowns was argued in negligence and only in negligence; no breach of any other civil obligation was, or could have been, demonstrated. The answer to the plaintiff's claim must surely be that the tort of negligence does not extend to a failure by a doctor to attend a stranger. If there is such a duty, it must be sought elsewhere and, in this area, none of the cases to date have ever suggested that a person having goods or skill must provide them for the benefit of another. In this case, the majority sought to make a great deal of Dr Lowns' concession that, had he been requested to do so, he would and should have attended the plaintiff. The doctor went further, admitting in cross-examination that he could well foresee harm to a fitting child if he did not attend immediately and administer treatment. But that concession could not amount to an admission that he was under a legal obligation to attend the plaintiff, as the majority appear to have thought. After Dr Lowns indicated that he would seek special leave to appeal the decision to the High Court of Australia, the parties settled their claim. The medical profession is thus deprived of obtaining a more definitive pronouncement on a controversial decision in which, in my opinion, the majority of the New South Wales Court of Appeal came to a wrong conclusion, "bending" the law to reach a socially compelling result. References Gerber P. Has informed consent become a legal nightmare? Med J Aust 1995; 163: 262-264. Bates PW. Social and legal changes in medical malpractice litigation. Med J Aust 1995; 163: 264-268. Rogers v. Whitaker (1992) 175 CLR 479. Donoghue v. Stevenson [1932] AC 562 . Author's details 6 Devaney Lane, Corinda, QLD 4075. Paul Gerber, LLB, DJur, Adjunct Professor of Law, University of New South Wales. < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Paul Gerber

The Professional Indemnity Review: what did it accomplish? Charlotta Blomberg In a previous article,* Richard Tjiong criticised the Professional Indemnity Review's specific recommendations for reform of professional indemnity insurance. But the Review covered many other issues, particularly to do with identifying, evaluating and reducing adverse outcomes of medical procedures. Charlotta Blomberg highlights some of the key findings (and failings) of the Review's Final Report. MJA 1996; 164: 502 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Introduction - New research into health outcomes - Preventing adverse outcomes - Litigation crisis? - Compensation schemes - Drawing together medicine and law - In conclusion ... - References - Authors' details - - ©MJA1997 Introduction The Review of Professional Indemnity Arrangements for Health Care Professionals (chaired by Fiona Tito) was established against a background of increasing litigation, or fear of litigation, among health care professionals (see Box). Its purpose was to report to the then Minister for Health, Housing and Community Services on: the arrangements for patients injured through health care negligence or misadventure; the means of funding these arrangements; any problems with these arrangements; and proposed solutions and recommendations on the feasibility, appropriateness and estimated costs and benefits of these proposals.11 The last duty remains largely unfulfilled in the Final Report. Despite 168 detailed recommendations for changes of varying degrees, there is little discussion of feasibility, appropriateness or, more importantly, estimated costs and benefits. New research into health outcomes The Review embarked upon a 41/2-year investigation of the health care system and produced 19 publications (listed in Appendix C of the Report) in addition to the Final Report. The Review looked at the incidence and nature of health care injuries, compensation and structured settlements for personal injuries, facilities for the disabled, professional indemnity arrangements, "defensive" medicine and informed consent, birthing issues and information guidelines for patients and providers. At the start of the Review there was no information on the nature and extent of adverse outcomes, no readily available information on the number and types of health-related compensation claims and little publicly available information on the business operations of the medical defence organisations. The Report argues that lack of information on the issues under review required several individual studies to obtain the information required for decision making. Therefore, a major part of the Review was information gathering. It commissioned the Quality in Australian Health Care Study, which investigated the nature and extent of injuries suffered by patients in Australian hospitals. The preliminary results of this study were released in June 1995 and provoked considerable media attention. After peer review, the results were recently published in the MJA.12 With this study and others, the Review produced the first detailed analysis of the system of compensation for personal injury resulting from health care in Australia. The Final Report attempts to tie this considerable research work together with far-reaching recommendations which, if implemented in full, would radically alter the delivery and funding of health care in Australia. Preventing adverse outcomes The Quality in Australian Health Care Study defined an adverse event as "an unintended injury to a patient which resulted in a temporary or permanent disability, prolonged length of stay or death, and which was caused by health care management not by the patient's underlying disease".11 Under this broad definition the study found that hospital-based care produced over 400 000 adverse outcomes, with an estimated 230 000 of these being preventable. As a result, a considerable part of the Final Report concentrates on proposals aimed at preventing adverse outcomes. The solutions proposed involve the development of clinical practice guidelines based on evidence gained through the Cochrane Collaboration (which focuses on evidence derived from randomised controlled trials, conducted around the world and collectively analysed at the Cochrane Centre, Oxford University, UK). Medical services will be assessed on their efficacy and cost effectiveness. The Review recommends review of current services under the Medicare Benefits Schedule to establish their efficaciousness and cost-effectiveness. Commonwealth funding for those that fail these tests should cease (see Report recommendations 16, 19, 23, 28, 29 and 33).11 The emphasis on the development of clinical practice guidelines appears to stem from one of the findings of the Quality in Australian Health Care Study that system errors account for 16% of all adverse outcomes, with 53% of these due to the absence of or failure to use a policy, protocol or plan.12 However, the Study also concluded that "half of all AEs [adverse events] are deemed to have low or no preventability" and that this should be remembered "to avoid an inappropriate presumption of culpability when things go wrong".12 The Review does not address the difficulties associated with implementing a guidelines-based system of health care. The cost or cost-effectiveness of implementing these recommendations is not discussed, and no mention is made of what is involved (such as time and resources) in evidence-based reviews. There appears to be an underlying assumption that, if evidence-based guidelines are developed and followed, adverse outcomes will, in the main, be prevented. This "cookbook" approach to medicine has been criticised elsewhere.13 Without further debate of the issues, the Final Report fails to convince that strict adherence to evidence-based practice guidelines will achieve perfect outcomes. Litigation crisis? In the Final Report, the issues of professional indemnity, negligence actions and adverse outcomes were described as surrounded by myths and assertions supported by little hard data. Much of the information relating to the "litigation crisis" was anecdotal: "evidence for a so-called claims crisis is scant", said the Report, concluding that a crisis mentality has been fostered by some medical defence organisations to deflect attention from their own "irresponsible financial management".11 Although an increase in the rate of incident reporting was noted, the Final Report held that this did not appear to be reflected in an increase in claims filed in courts. It did acknowledge that there is often a considerable time lag between the reporting of an incident and the filing of a claim in court, which may imply recognition that the crisis may yet eventuate. The Review has rightly identified a lack of readily available information on common law negligence cases. A database of common law personal injury cases would be a valuable tool for monitoring the nature and frequency of legal claims, patterns of claims, the frequency of settlement and the amounts of awards and settlements. Such a project would require Commonwealth-State cooperation, as common law matters fall outside the Commonwealth's jurisdiction. The Report cites the register currently operating in South Australia and the National Practitioner Data Bank in the United States as models, but does not estimate the amount or nominate the source for funding of such a project. It does recommend that such a register would provide "a positive quality link between the tort system and the [practitioner] registration system" (Report, pages 154-155).11 This proposal must be studied further. It could mean registration would be subject to the frequency or value of claims incurred each year. It could mean a type of peer review that may establish that common law negligence is not to be equated with medical negligence. Unfortunately, the Report is not clear on what is meant. Compensation schemes In relation to compensation for those who have suffered personal injury as a result of health care, the Review recommended against the introduction of a "no-fault" scheme of compensation. Such a scheme would remove the need to prove negligence (fault) to receive compensation; proof of injury would suffice. It was rejected on grounds of inequity. The public interest is served by those who cause injury paying compensation. A no-fault scheme would mean that the full burden of assistance for injured persons would fall on the community as a whole through increased taxes and an overall reduction in resources available to those suffering injury as a result of health care.11 While recognising that there is inequity between the allocation of resources for those with compensable injuries and those with non-compensable injuries, the Report suggests that the overall public interest would be better served by the retention of the current system. The Review did investigate means of compensation other than the current lump sum awards. In many cases these, although seemingly generous, have proved to be inadequate when taken over the lifetime of a severely disabled person. Structured or serial payments in the place of lump-sum awards were offered as a solution. This is an alternative worthy of further consideration as it may provide security of assistance for those with severe permanent disabilities and solve the problem of awards being dissipated, eventually leaving the injured party relying on the public system. Drawing together medicine and law The Review has made useful recommendations in relation to the medicolegal system. Incorporating the study of legal issues into the training for health care professionals (Report recommendation 8), introducing a system of peer support for health professionals involved in negligence litigation (recommendation 89) and accrediting specialist health negligence lawyers (recommendation 94) are all worthy of further investigation. Greater positive and cooperative interaction between law and medicine is a desirable goal. Both professions would benefit from greater understanding and appreciation of each other's workings. Often people injured during medical procedures say that their main reason for pursuing legal actions is to find out what went wrong.14 This suggests that many potential actions may be prevented through appropriate advice at an early stage. A key factor in this process is access to expert opinions. The Review recommends a college-based system of encouraging high quality health professionals to provide expert opinions in medicolegal cases (Report recommendation 98). This type of system, along with appropriate legal training for medical experts, has been under review by the Australian Medical Association since last year. The existence of a pool of peer-recognised medicolegal experts available to give advice to plaintiffs, defendants and even the court itself may well have a positive effect on reducing litigation and delays inherent in the current system. Judges are keenly aware of the delays and costs attaching to civil actions and actively consider means to speed up their progress. The public interest is not served by lengthy delays and costly litigation. In conclusion . . . it's inconclusive The Final Report of the Review has not lived up to its high expectations. It has identified and investigated issues and proposed recommendations which raise more questions than they answer. There is little real assessment of the financial effect of the recommendations or the impact on current medical practice. The focus is on providing information for more effective decision-making. The legacy of the Review will be even more extensive consultations and reviews to develop practical solutions to the problems it has identified. References Tjiong R. The American litigation crisis is already here. Australian Medicine, 5 June 1995: 4. Bailie RS, Douglas RM. The future role and operation of Australian general practice survey results. Canberra: National Centre for Epidemiology and Population Health, 1995. Komesaroff PA, Keaney MA, Niselle P, Dunn IM. Is there a medical litigation crisis? MJA 1996; 164: 178-182. Keaney MA. Is litigation increasing? MJA 1996; 164: 178-179. Rogers v Whitaker (1992) 175 CLR 479. Lowns v Woods, by his next friend the Protective Commissioner & Ors Court of Appeal (NSW), unreported, 5 February 1996. O'Shea v Sullivan & Macquarie Pathology Services Pty Ltd (1994) Aust Tort Reports 81-273. Talbot & Anor v Lusby (1995) unreported, Supreme Court of Queensland, 14 July 1995. Litigation fears increase health bill. Australian Doctor, 1 September 1995: 48. Breen v Williams (1994) 35 NSWLR 522. Review of Professional Indemnity Arrangements for Health Care Professionals [Tito F, chairman]. Final Report. Compensation and professional indemnity in health care. Canberra: Commonwealth Department of Human Services and Health, 1995. Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. MJA 1995; 163: 458-471. Arnold P. The Tito Report -- medical practice re-invented. Australian Medicine, 19 February 1996: 6. Vincent C, Young M, Phillips A, et al. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994; 343: 1609-1613.* See: Tjiong RTT. The Professional Indemnity Review. A lost opportunity for reform. MJA 1996; 164: 371-374. Authors' details Australian Medical Association, Canberra, ACT. Charlotta Blomberg, BA(Hons), LLB, Legal Advisor. Reprints: Ms Charlotta Blomberg, AMA, 42 Macquarie Street, Barton, ACT 2600. E-mail: cblombergATama.com.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Charlotta Blomberg