Ethics and law

Open disclosure (OD) after adverse health care events is the subject of a national standard that has been implemented in state health policy documents, and is included in the Medical Board of Australia’s code of conduct for doctors. Nevertheless, doctors have been slow to embrace the practice of OD. There is a strong ethical case for implementing OD in the primary interests of ...

Angus J F Finlay · Cameron L Stewart BEc, LLB(Hons), PhD · Malcolm Parker MB BS, MLitt, MD

Are state selection systems for internship positions discriminatory and unconstitutional?

Dev A S Kevat LLB(Hons), MPH · Fiona J Lander MB BS(Hons), LLB(Hons)

Introducing the MJA Ethics series, the series editor outlines some of the ethical challenges for medicine and society in the 21st century. The long-unresolved ethical conflicts surrounding the issue of providing “futile” care are discussed from clinical, ethical and legal perspectives, in this, the first instalment of the series.

Dominic J C Wilkinson MB BS, DPhil, FRACP

Deciding when to stop treatment can be a challenging task for health professionalsWith advances of modern medicine come increased expectations from society, and dilemmas regarding when to stop treatment are becoming increasingly common. The Medical Board of Australia code of conduct explicitly states “you do not have a duty to try to prolong life at all cost. However, you do have a duty to know ...

Bogda Koczwara BM BS, MBioethics, FRACP

We need to pay attention to the reasons why treatment is judged to be futileWhen doctors are confronted with making treatment decisions in the context of a terminally ill patient, the way forward is often difficult and confused. Bringing an ethics perspective to bear on the problem can help to resolve what the essential issues are, in turn enabling a clearer path to appropriate decisions ...

Dominic J C Wilkinson MB BS, DPhil, FRACP

Futility disputes highlight some important legal principles concerning the right to refuse treatment, advance directives and the role of substitute decisionmakersThe need for legal resolution of futility disputes is a rare occurrence in Australia and the jurisprudence is still emerging.1 The legal approach to futility disputes differs in each state jurisdiction, and a full analysis of the Australian law is beyond the scope of this ...

Cameron L Stewart BEc, LLB(Hons), PhD

At a time when increasing use of electronic health records and communication methods has led to increasing use of clinical photography — particularly in visually oriented specialties — this is timely guidance on proper procedure and permissible uses of photographs.

Patrick D Mahar MB BS(Hons), LLB(Hons), MACLM · Peter A Foley MB BS, MD, FACD · Alexander Sheed-Finck BA, LLB(Hons) · Christopher S Baker MB BS, FACD

The 2011 report of the Productivity Commission (PC) recommended the establishment of a no-fault national injury insurance scheme limited to “catastrophic” injury, including medical injury. The report is welcome, but represents a missed opportunity to establish simultaneously a much-needed no-fault scheme for all medical injuries. The existing indemnity scheme based on negligence remains a slow, costly, inefficient, ill targeted and stress-creating system. A fault-based ...

David Weisbrot BA(Hons), JD · Kerry J Breen MB BS, MD, FRACP

A new medical injury scheme will require realistic costing, careful planning and gradual implementationIn his recently published book, The righteous mind, American psychologist Jonathan Haidt makes the observation that “morality is an emotional issue, not a rational one; and in a contest between what we think is reasonable and what we feel in our hearts, emotion always wins”.1 Therefore, recent proposals for national disability and injury ...

Julian L Rait FRACS, FRANZCO, FAICD

Most specialised mental health services in Australia are delivered in community settings and one in six services comprise involuntary treatment. Despite a growing demand for community treatment orders (CTOs) worldwide — and comparatively high rates of use in Australia — the clinical, legal and ethical aspects of CTOs remain contentious. This article examines ...

Edwina M Light BA(Comms), GradCertJournalism, GradCertBioethics · Ian H Kerridge MPhil, FRACP, FRCPA · Christopher J Ryan MB BS(Hons), MHL, FRANZCP · Michael D Robertson MB BS(Hons), FRANZCP, PhD

Findings from a Queensland coronial inquest highlight the complex clinical, ethical and legal issues that arise in end-of-life care when clinicians and family members disagree about a diagnosis of clinical futility. The tension between the law and best medical practice is highlighted in this case, as doctors are compelled to seek family consent to not commence a futile intervention. Good communication between doctors and families, as well as community and professional education, is essential to resolve tensions that can arise when there is disagreement about treatment at the end of life.

Sean Lawrence MB BS, FACEM · Lindy Willmott BCom, LLB(Hons), LLM · Eleanor Milligan PhD, BA(Hons), BSc · Sarah Winch BA(Hons), PhD · Ben White LLB(Hons), DPhil · Malcolm Parker MB BS, MHealth

Futility assessments, which are unavoidable in end-of-life settings, need to be procedurally fair. This necessitates communication between health professionals and substitute decisionmakers regarding the decision to define treatments as futile. The common law test for whether treatment should be withheld or withdrawn is the best interests test. A futile treatment is not in any patient’s best interests. While it is rare for the law to disagree with a futility determination made by health professionals, if a determination has been made without consultation and fails to reflect the patient’s best interests, the courts will overturn it. The best regulatory regimes provide for a balance between the powers of health professionals and substitute decisionmakers to make decisions for incompetent patients, and for clear and efficient dispute resolution. The Queensland law and its requirement for consent to withhold or withdraw futile treatment represents a good model of futility determination, with clear powers given to substitute decisionmakers and health professionals. Disputes concerning the treatment of incompetent patients automatically trigger the appointment of the adult guardian as the decisionmaker, and there are avenues for appeal.

Cameron L Stewart BEc, LLB(Hons), PhD

Recent federal trade policy commitments could protect Australia’s tobacco control legislation and the Pharmaceutical Benefits Scheme in the Trans-Pacific Partnership Agreement negotiations In its Trade Policy Statement of April 2011, the Australian Government committed to “preserve the right of Australian governments to make laws in important public policy areas” and to reject provisions in trade agreements that could “limit its capacity to put health warnings or plain packaging requirements on tobacco products or its ability to continue the Pharmaceutical Benefits Scheme”.1 One forum in which this resolve is likely to be tested is the Trans-Pacific Partnership Agreement (TPPA) negotiations. The TPPA is a proposed regional free trade agreement between Australia, Brunei, Chile, Malaysia, Peru, Singapore, New Zealand, the United States and Vietnam — a diverse assortment of countries from several continents around the Pacific rim. The TPPA differs from existing bilateral and regional free trade agreements in its sheer size and geographic diversity. It has the potential to restrict national policy space — “the freedom, scope and mechanisms that governments have to choose, design and implement public policies to fulfil their aims”2 — on an unprecedented scale. This article explores the potential for the TPPA to constrain Australia’s national health policy space through two illustrative case studies: tobacco plain packaging and the Pharmaceutical Benefits Scheme (PBS). Investor–state dispute settlement and plain packaging of tobacco productsDuring 2011, the Australian Government introduced legislation requiring tobacco products to be packaged in plain paper (with graphic health warnings, but minimal branding). This represents an important assault on one of the last bastions of tobacco marketing — the appeal to personal identity.3 Strong tobacco control policies such as Australia’s tobacco plain packaging laws are consistent with a substantial body of scientific literature and the World Health Organization’s Framework Convention on Tobacco Control, but they can be challenged under international trade and investment agreements, which are driven by economic rather than public health goals. Philip Morris Asia (PMA) — a subsidiary of Philip Morris International (PMI) — has launched an investor–state dispute against the Australian Government over its tobacco plain packaging legislation. While several tobacco companies have taken their complaints to the High Court, PMA has also been able to pursue its case in international arbitration (where it has a greater chance of success) through an investor–state dispute settlement (ISDS) clause in a bilateral investment treaty signed between Australia and Hong Kong in the early 1990s. This is the second investor–state dispute to arise over tobacco labelling; PMI is bringing a similar case against Uruguay through a Swiss subsidiary.4 PMI has also been prominent in calling for an ISDS provision in the TPPA.4,5 Ironically, the corporate restructuring that has allowed PMI to access the Hong Kong bilateral investment treaty (PMA was made the sole shareholder in Philip Morris Australia in February 2011) has also significantly weakened its claims. This is because the investment was made with the company’s full knowledge that the plain packaging legislation was being developed.6 The government has a strong case. Nevertheless, the dispute with PMA highlights broader problems of including ISDS provisions in trade treaties, and demonstrates why it is important that they be excluded from the TPPA. The arbitration rules that govern PMA’s dispute with the Australian Government are those of the United Nations Commission on International Trade Law. The case will be decided by a tribunal made up of three members: one chosen by PMA, one chosen by Australia, and a third, mutually agreed upon, which will act as president. This method of appointing arbitrators has been described as neither independent nor impartial.7 In sharp contrast to domestic forms of adjudication, individuals can serve as a legal representative in one ISDS case and an arbitrator in another, further undermining their ability to act without bias. Furthermore, although the arbitrators will be experts in international investment law, they may have little or no experience with specific fields of public policy such as tobacco control. While the public has a stake in investor–state disputes, confidentiality is a dominant principle in investment arbitration. Hearings are rarely opened to the public unless both parties agree, and investors have opted for closed hearings in several recent cases concerning public policy. In this regard, it is commendable that the Australian Government has adopted a high standard of transparency in advance of the commencement of formal proceedings by posting PMA’s claims and their response on a public website.8 The arbitration will be expensive for Australian taxpayers, although the government may be able to recoup some of the costs if it prevails. In several investor–state disputes to date, legal fees alone have amounted to over US$4 million and in one case have exceeded US$13 million.9 There are also arbitrator’s fees, administration fees and additional costs for involving experts and witnesses. Even more significant are the awards in investor–state cases, which are widely enforceable.7 The Czech Republic was obliged to pay more than US$350 million in compensation to a Dutch investor, which according to one report meant a near doubling of the country’s public sector deficit.10 It can readily be seen how insertion of a TPPA ISDS mechanism into Australia’s national health policy space might skew legislation away from the public interest towards supranational corporate interests. This is why it is significant that the government has vowed to no longer include provisions on ISDS in the bilateral and regional trade agreements that it signs.1 Australia’s refusal to consent to ISDS in the TPPA is a significant step towards limiting the encroachment of international trade agreements into our national health policy space and retaining our sovereign right to regulate significant areas of public health policy. US proposals for medicines policy in the TPPAChallenges to Pharmaceutical Benefits Advisory Committee processesThe PBS is another area of domestic health policy that the Australian Government has committed to protect in international trade agreements. However, US TPPA negotiators are seeking substantial changes to Australia’s laws and administrative processes. Certain draft TPPA provisions relate to the PBS directly and also indirectly, by seeking to prolong pharmaceutical patents and minimise exceptions to them made in the public interest. We examine these proposals as another instance of how the TPPA may promote incursions into our national health policy space. In October 2011, a draft annex to the transparency chapter of the TPPA was leaked.11 Under the rubric of transparency and procedural fairness, this TPPA annex seeks to impose new restrictions on the operation of national pharmaceutical reimbursement and pricing schemes (Box 1). It is an annex because it is not designed to apply to the US, as it would if it was in the body of the treaty. Clause (d) of paragraph X.3 of the draft annex would require countries to reimburse pharmaceutical companies based on “competitive market-derived prices in the Party’s territory”, or other benchmarks that “appropriately recognize the value” of the patented product. This wording represents a shift away from the more science-based standard in Annex 2-C of the Australia–United States Free Trade Agreement (AUSFTA), which refers to the “objectively demonstrated therapeutic significance” of the new patented pharmaceutical (http://www.dfat.gov.au/fta/ausfta/final-text). This provision includes no mechanism for proving that prices are derived from “competitive” markets. It undermines the world-class science-based mechanisms used by the Pharmaceutical Benefits Advisory Committee (PBAC) to determine whether a new patented medicine has sufficient health innovation to be listed on the PBS (based on a determination of cost-effectiveness, as well as efficacy, quality and safety). Paragraph X.3 of the draft annex seeks to impose a new independent appeals process on determinations by government bodies such as the PBAC (Box 1). This is contrary to what was decided (after prolonged and acrimonious negotiations) under Annex 2-C of the AUSFTA, which only provides for independent expert review as a quality improvement exercise for the PBAC. The threat and the use of an independent appeals process would increase the capacity of the pharmaceutical industry to lobby against PBAC decisions and undercut their expert-informed determinations. Paragraph X.4 of the draft annex requires parties to permit pharmaceutical companies to disseminate information to health professionals and consumers via the internet — a practice that is not permitted for prescription drugs in Australia due to concerns about overprescribing. This is also contrary to Annex 2-C of the AUSFTA, which makes the direct advertising of pharmaceuticals subject to Australia’s domestic laws, regulations and procedures. There is a consensus against such advertising in the Australian national policy space, chiefly because of its capacity to increase lobbying of the medical profession for purposes of corporate gain rather than public health benefit. While the effect of US TPPA proposals on Australia’s PBS would be economically damaging and reduce the affordability of medicines in Australia, the effects on access to medicines in other TPPA countries could be far more severe, particularly for developing countries and those required to make greater changes to their domestic laws.12 Extending intellectual property rightsUS TPPA proposals on intellectual property applying to patents13,14 (Box 2) would also add to the cost of medicines overall, affecting the sustainability of the PBS. Non-government organisations have undertaken extensive analyses of these proposed provisions,12,15 and have shown areas where TPPA provisions extend patent protection beyond comparable AUSFTA patent provisions and existing Australian law.15 For example, proposed article 8.1 of the intellectual property (IP) chapter of the TPPA provides patent protection for new forms, uses or methods of using a known product, whereas article 17.9.1 of the AUSFTA does not require patent protection to be provided for new forms of existing drugs.15 Although, in practice, new forms are sometimes patented, the TPPA proposals would restrict efforts to tighten patenting standards in future. Proposed IP article 8.2 requires patenting of diagnostic, therapeutic and surgical methods, whereas article 17.9.2 of the AUSFTA allows for its exclusion.15 This change could restrict expeditious patient access to new clinical developments and substantially add to health care costs. Proposed IP article 8.7 would also eliminate pre-grant opposition to patent applications by third parties, a safeguard provided for in the Australian Patents Act 1990, which is designed to prevent unwarranted patents from being granted.15 Most concerning are the provisions for data exclusivity periods — where generic manufacturers cannot use clinical trial data to prepare and register their products for springboarding after patent expiry. Proposed IP article 9.214 provides an additional 3 years of data exclusivity for new uses of existing pharmaceutical products, on top of the 5 years of data exclusivity already permitted under article 17.10.1 of the AUSFTA. There is also a placeholder for specific provisions for biologics (medicines produced from biological products, which are not currently dealt with separately in Australia). US pharmaceutical companies are reportedly lobbying for 12 years of data exclusivity for biologics. If adopted, these proposals would lead to higher costs to the PBS (as drugs stay under patent for longer periods) and delayed entry of cheaper generic medicines into the market. The US TPPA proposals for extended intellectual property rights and data exclusivity for pharmaceutical companies would require changes to Australian laws and administrative processes. They would also conflict with the spirit of the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, which is currently before the Senate and seeks to raise patent standards and facilitate faster regulatory approval for generic medicines. ConclusionRecent Australian trade policy commitments to exclude ISDS and provisions that would affect the PBS from the TPPA are a positive step towards preserving sovereign, democratic and science-based control over our national health policy space. It is important that Australia continues to insist that future trade agreements, including the TPPA, do not extend the intellectual property privileges of patent holders, interfere with the operation of the PBS or provide foreign corporations with ISDS rights to challenge domestic public health policies. 1 Leaked United States demands for changes to schemes such as Australia’s Pharmaceutical Benefits Scheme Pharmaceutical Benefits Advisory Committee (PBAC) recommendations to be based on competitively derived market forces or systems that appropriately value patented pharmaceuticals (no mention of “objectively derived therapeutic significance” as in the Australia–United States Free Trade Agreement) Appeals process able to challenge PBAC recommendations Heightened capacity for direct-to-patient pharmaceutical advertising 2 Some United States proposals for extensions to intellectual property rights applying to patents Patent protection for new forms of existing drugs Patenting of diagnostic, therapeutic and surgical methods Elimination of pre-grant opposition Extensions to data-exclusivity periods for some drugs

Deborah H Gleeson BSc(MLS), MPH, PhD · Kyla S Tienhaara PhD · Thomas A Faunce BA LLB(Hons), BMed, PhD

When a patient’s wishes conflict with “best practice” The question of whether a person has the capacity to make decisions for him- or herself is one that has increasing relevance throughout clinical practice. It is especially relevant in palliative medicine, where practitioners often pride themselves on offering patient choice, particularly when it comes to selecting a venue for receiving care. Patients seen by palliative care services frequently have impaired cognition, often due to delirium.1 Such cognitive impairment places patients at risk of not understanding the ramifications of the decisions that they make. This is likely to become an increasing problem, as palliative care services care for an ageing population, with a significant comorbid burden, who are more at risk of diminished capacity due to the prevalence of illnesses such as dementia. The four ethical principles of health care — non-maleficence (doing no harm), beneficence (doing good), respect for autonomy, and justice2 — remain the foundation for ethical clinical practice. However, in the course of our duties, these principles may come into conflict. Deciding to act in the patient’s best interestsAn 85-year-old man with metastatic rectal cancer, who received domiciliary palliative care support following an “unsafe discharge” from an inpatient palliative care unit, was readmitted against his express wishes and subsequently died in hospital. This article explores the resulting sense of unease among the responsible clinicians, arising from our decision to act with beneficence and, arguably, humanity, in overriding a patient’s dying wishes. The patient was diagnosed with a stenosing rectal cancer, with lung and bone metastases, following presentation with advanced cachexia and symptomatic anaemia. The diagnosis came as a shock to the patient, who denied any previous major health issues and had infrequent contact with his family doctor. He had been a lifetime smoker of 60 pack years, and smoking was one of the few passions of his now-isolated existence. The patient was a worldly man, born in Malta, who had travelled extensively in his youth before settling in metropolitan Melbourne and raising a family. Unfortunately, his wife’s death in 1989 heralded a slow withdrawal from his friends and family. By the time of his presentation, he was living a squalid existence and reluctantly came to hospital at the insistence of his adult children. Options for palliative surgery, chemotherapy and radiotherapy were discussed and declined by the patient. A brief period at home resulted in a further presentation with symptomatic anaemia due to ongoing rectal blood loss and faecal incontinence. He was referred and admitted to inpatient hospice care, but again asked to be discharged almost immediately following blood transfusion. His insistence on discharge and refusal to discuss options to improve his physical care and safety at home led his palliative care providers to organise an assessment of his decision-making capacity by a neuropsychologist and consultation liaison psychiatry team. He was found to have decision-making capacity during these assessments, although it was noted that he was an avoidant historian and lacked some insight into the ramifications of his decisions. Plans were made to support the patient at home, as was his wish, with extra community services, community palliative care and family involvement. Unfortunately, the situation unravelled quickly at home. He refused many of the services that had been organised. He was reluctant to let his family help him more and they felt powerless to compel him. The community palliative care team attempted to act as mediator but made little progress. During this time, he became progressively frail until no personal care or safe use of medications was deemed possible. He had a fall at home 6 weeks after discharge, and an ambulance was called when he was found on the floor, unable to rise. Despite his frail condition, he remained both vocally and physically resistant to paramedic attempts to transfer him to hospital, and he finally sent them away. He was also left alone by his family, who felt both unable to provide care for their father at home and powerless to compel him to go to hospital. He remained on the floor for several hours, until urgent re-review by the community palliative care physician. By this time, the sun had set, and his home was shrouded in darkness and cold. He told the physician that he was lying on the floor only because he wished to do so and that he wished to remain where he was, although he was intermittently not orientated to place or person. Under Victorian legislation, he was assessed by the palliative care physician as being incompetent due to delirium3 and was transferred to hospital as an involuntary patient. This required police attendance and the ambulance service to transport him safely. His involuntary status was upheld for a further 48 hours by subsequent independent psychiatric review. No reversible cause of delirium was found on investigation when he was hospitalised, although his cognition did improve. He deteriorated over a course of weeks and died comfortably in hospital without requesting discharge again. Weighing up the ethical issuesThe decision that led to the patient’s removal from his home against his wishes, and his subsequent death in hospital, continues to rest uneasily on the team, given that clinical decisions are usually made not only for the benefit of the patient, but are also informed by respect for patient autonomy, non-maleficence and justice. In this instance, less invasive interventions, including enlisting family support, appointing a guardian, or urgent review by community-based psychiatric services were considered but judged to be inadequate or not possible within the time frame required. Subsequent peer-review discussions raised the probability of similar situations of isolated people living and dying without support in poor conditions. While this is likely true, there is a clear distinction between knowing the detail of a specific unfolding clinical scenario and not intervening, and theoretical events outside our direct knowledge. In the end, the contention returns to the dilemma that this patient had decided not to comply with what we would regard as “a good death”. In doing this, the consequences of his actions were detrimental not only to his comfort and condition but to the physical and psychological wellbeing of his family and carers, who were placed in the unenviable situation of having to provide inadequate care in an inappropriate environment. The clinical decision was made that drastic action was necessary, even to the point of forcing his compliance against his will. At the time of the decision to compel his removal from his home, it became less about his competence to make decisions, and more about our recognition of his humanity. To leave him to die alone, cold and probably in pain, in the midst of one of our well resourced cities, with medical and health care professionals in full awareness of his predicament, without acting, would have been a betrayal of our responsibility as his medical carers. We would have been inappropriately allowing respect for his autonomy to outweigh all other ethical considerations, despite his changed circumstances and limited realistic choice to remain as he was. While this is a pragmatic principlist approach, other ethical theories, such as virtue ethics, accord with our decision, which was guided by compassionate interest in the patient’s wellbeing. Was this an act of excessive medical paternalism, resulting in the denial of a person’s last wish to die at home? Undoubtedly there are those who would argue on both sides. However, even with the passage of time, we remain comforted that, after acknowledging the patient’s autonomy, our intervention was carried out in his best interests.

Brian H Le MPH, FRACP, FAChPM · Michael D Chapman MB BS

Forensic medical practitioners urgently require credentials and national guidelines Across Australia, health professionals from differing disciplines provide health care for victims of suspected assault, which may include collection of samples for forensic analysis. Although some have been trained to collect forensic samples, few hold professional qualifications in forensic medicine. The current lack of standards and credentialled training for collection of forensic samples (in a manner that minimises the risk of contamination) poses an unacceptable risk to individual doctors and nurses, the profession and to the criminal justice system. During the past decade, several high profile cases involving DNA contamination of evidence have been reported in the medical, legal and popular media. These cases highlight the costs in economic terms and in terms of human suffering, injustice and loss of confidence in the criminal justice system when errors occur because of DNA contamination. A swab, and materials collected onto a swab, for forensic DNA identification might become contaminated at any time from the collection stage to the final stage of DNA identification. The process of DNA identification is a lengthy one that involves a number of people operating at different locations, at different times. There are many opportunities for a swab, or the genetic material obtained from the swab, to become contaminated with another person’s DNA. It could be argued that there are two levels at which we should consider the need to avoid DNA contamination of swabs. First, there is a need to avoid contamination of a swab with DNA from a member of the public who might be inculpated in a crime. These individuals cannot easily be excluded as suspects. Second, there is a need to avoid contamination of a swab by DNA shed from a professional who has handled the swab or worked in the environment in which the swab was collected. By virtue of their employment, these individuals have a valid reason for their DNA being in the proximity of the swab. They might more easily be excluded as suspects, and most would readily volunteer to donate a reference sample to enable their DNA to be identified for the purpose of excluding them from further consideration in a criminal investigation. The compelling reason to avoid contaminating a swab with DNA from a medical professional or laboratory scientist is that the presence of any extraneous DNA affects the DNA scientists’ ability to interpret electropherograms. When mixed profiles are obtained, confidence in the scientists’ interpretation of the results is reduced. Some laboratories will not provide an interpretation of DNA results when a mixed profile of four or more individuals is obtained. What are the consequences when DNA contamination of a forensic swab occurs?Wrongful convictions of innocent individuals have occurred because of DNA misidentification and other DNA-related errors in Australia and other countries — an outcome regarded as intolerable in a civilised society. Examples of wrongful convictions that appear to have resulted from DNA contamination are shown in Box 1. Wrongful convictions have far-reaching consequences. In regions of the world where the death penalty exists, the outcome can be lethal. How has the legal system responded?As new case law increases everyone’s awareness of the phenomenon of secondary transfer of DNA, and techniques such as low-copy-number DNA amplification increase the risk of amplification of traces of contaminating DNA,6 defence lawyers are demonstrating greater willingness to challenge DNA evidence in court. In the United Kingdom, at Terence and David Reed’s unsuccessful appeal ([2009] EWCA Crim 2698) against their 2006 conviction for the murder of Peter Hoe, the defence counsel argued that shards of plastic said to be from a knife handle and found near the victim were contaminated with the brothers’ DNA. Prosecutors argued that the DNA connected the brothers to the murder weapon. (The appeal was dismissed as there was sufficient evidence for conviction beyond the doubts over the DNA evidence.) In 2008, the UK police conducted a review of the use of low-copy-number DNA amplification techniques in light of the increased risk of erroneous interpretation of DNA identification results.7 In Australia, Canberra man Steven Hillier was acquitted of his ex-wife’s murder at a retrial in April 2010 (R v Hillier [2010] ACTSC 33). He had been convicted of murder in 2004. The conviction was quashed in 2006, and the Australian Capital Territory Director of Public Prosecutions subsequently challenged the appeal and sought a retrial. Hillier’s counsel successfully argued that a possibility existed that his DNA had been secondarily transferred onto his estranged wife’s clothing and doona.2 Prominent Australian lawyers8-10 have provided advice for barristers and judges on matters to consider during cross-examination and guidelines for determining admissibility of DNA evidence in Australian courts. How have forensic scientists responded?Quality assurance activities within laboratories minimise the risk of DNA contamination. National standards exist (National Association of Testing Authorities [NATA]) and DNA laboratory scientists must be credentialled. Most scientists remain alert to the possibility of DNA contamination and openly acknowledge when contamination within a laboratory occurs. On rare occasions, scientists have denied responsibility for contamination or error. For example, the Victoria Police Forensic Services Centre (VPFSC) scientist involved in the contamination of a murdered child’s bib with a rape victim’s DNA suggested that an adventitious DNA match, not laboratory error, was responsible (inquest into the death of Jaidyn Leskie, Coroner Graeme Johnstone, July 2006). At the trial of a man wrongfully convicted of rape, the testimony of a VPFSC scientist suggests that the scientist had limited understanding of the potential for contamination at a site other than the VPFSC laboratory.5 How have clinical forensic medical practitioners responded?Justice Frank Vincent’s conclusions5 about environmental contamination of the swab that led to the wrongful conviction of Farah Jama (Box 1) has been a powerful influence for change in the practice of clinical forensic medicine in relation to suspected sexual assault in Australia. There are a number of areas of improvement driven by the Victorian Institute of Forensic Medicine (VIFM), which has developed, in consultation with others, interim practice arrangements that act as guidelines for the collection of samples for forensic analysis.11 Key areas for improvement include the equipment and procedures used to collect samples and the environment in which samples are collected. Swabs and slides within sexual assault kits should be as free of contaminating DNA as possible. Irradiation of swabs has proven to be an inadequate process for denaturing DNA. An unknown female suspect, linked to several unsolved serious crimes in Germany and Austria between 1993 and 2009, was eventually shown to be a worker involved with the manufacture of the swabs.12 Forensic-supply companies continue to develop and supply swabs, slides and kits that are increasingly easy to use and are designed to minimise the risk that DNA might inadvertently be transferred onto a swab via a swab sheath or equipment used during the procedure. Disposable single-use instruments such as pencils, pens, speculae, forceps and scissors are recommended. Documents for recording samples collected and envelopes used for transporting samples to a laboratory are treated to denature DNA. Currently, there is significant variation between regions in Australia in relation to the design and suitability for purpose of some of the facilities where forensic samples are collected. Some facilities are clearly not “fit for purpose”. The structure of the facility should enable restricted access to a limited number of known individuals, adequate and documented cleaning to DNA elimination standards, furniture and surfaces that are maintained in a DNA-clean state, storage of equipment and supplies that prevents reuse or replacement of supplies that might have been contaminated and appropriate disposal of used supplies. Furniture and equipment within the examining room should be kept to a minimum and all surfaces should be able to tolerate cleaning with bleach. There should be a flow of patients from the entrance area into the examination room then shower facility. Suspects should not be examined in the area where victims are examined. These recommendations were set out in the VIFM submission to the Vincent inquiry. Gloves must be worn and changed regularly, particularly during the interval between collecting samples from different sites and when labelling and packaging samples. In some overseas jurisdictions, medical practitioners shower and change clothing between cases. No agreement has yet been reached about the need for forensic practitioners to wear gowns, masks or hairnets. The requirement to use gowns and masks is likely to meet with opposition from paediatric forensic practitioners who are likely to express concern about the negative emotional impact that this apparel might have on child victims. Cleaning procedures need to be at a standard that will denature DNA. Hypochlorite bleach has been demonstrated in DNA laboratories to denature DNA and is used for routine cleaning of floors and walls, as well as for cleaning work surfaces. Techniques used to collect samples must ensure that material from one site is not inadvertently transferred to another site. Tamper-proof seals are used in some jurisdictions. How have the regulators responded?Following the release of the Vincent report, the Victorian Department of Justice sought to rectify problems within the Victorian centres where sexual assault victims are examined. To date, changes to cleaning practices and modifications to a small number of units have occurred, primarily as a direct request to health services, where most facilities are located. Although it was a clear recommendation in the Vincent report, no reduction in the number of sites where sexual assault victims are examined has occurred. In July 2010, the UK Home Office published the second draft of the Codes of practice and conduct for forensic science providers and practitioners in the criminal justice system.13 The document was informed by a critical review of low-copy-number DNA amplification techniques and the use of this technology within courts. This comprehensive discussion document is regarded to be the first step in a process aimed at achieving better governance and higher standards throughout the sector. In Australia and New Zealand, standards are being developed in line with the strategy for 2009–2012 developed by the Australia New Zealand Policing Advisory Agency National Institute of Forensic Science.14 Forensic science centres are assessed according to explicit criteria that test quality and the reliability of results in order to achieve NATA accreditation. Within government in Australia, particularly Departments of Justice, there is an increasing awareness of the need for standards, monitoring and governance of those standards and the need for caution in relation to the use of DNA evidence in courts. The Public Defenders Office in New South Wales offered succinct advice to the legal profession in relation to the use of DNA evidence in court.15,16 In May 2011, the High Court, the highest court of appeal in Australia, dismissed convicted Canberra rapist Benjamin Forbes’ application for an appeal on the basis that he had been convicted on DNA evidence alone.17 This judgement indicates confidence in DNA technology and its use in the Australian criminal justice system. At present, there is no governing or regulatory body for clinical forensic medical practice. Doctors are accountable to their employer and to the Medical Board of Australia. Nurses are likewise accountable to their employer and the Nursing and Midwifery Board of Australia. Most forensic practitioners belong to professional colleges, such as the Royal Australasian College of Physicians, the Royal Australasian College of General Practitioners, and the Australasian College of Legal Medicine. There is no overarching collegiate body to certify successful completion of forensic medical training. The intercollegiate working group that developed guidelines for genital examinations of girls and young women did not provide explicit advice about the collection of samples for forensic analysis when sexual assault is suspected.18 The Australasian Association of Forensic Physicians has demonstrated an interest in developing standards and guidelines for collection of forensic samples, but this work is in its infancy. Where to now?It is unlikely that the medical profession will ever be able to exclude the possibility that a swab has become contaminated with DNA. The task before us is to minimise the risk, and to be seen to be minimising the risk, of DNA contamination. Forensic medical practitioners urgently require national guidelines and standards to guide and govern forensic medical practice (Box 2). We also need: a national collegiate body to certify that practitioners have met training requirements and have demonstrated required competencies; a national group to negotiate across state boundaries with employers and governments to ensure that we are enabled and supported to provide a high standard of forensic medical care and to maintain an effective workforce; police and forensic scientists to share with us the desire to safeguard the integrity of forensic samples and the results obtained from their analysis; a well informed public that has realistic expectations of forensic services; a legal system that challenges, questions and pushes us to consider our failings; and a health system that supports and encourages us to continue to improve. 1 DNA contamination resulting in wrongful identification of suspect Country Year Case Contamination site Criminal charge Consequences for wrongly accused New Zealand 1998 Profile N1 Laboratory Murder × 2 Financial records seized; intense police investigation; no conviction Canada 2001 Gregory Turner2 Laboratory Murder 27 months’ jail Australia 2004 Steven Hillier3 Before collection Murder Conviction; successful appeal Australia 2008 Russell Gesah4 Laboratory cold-case match Murder × 2 Charges dropped Australia 2008 Farah Jama5 Collection Rape 15 months’ jail 2 A multicomponent plan for national clinical practice standards regarding collection of forensic samples for DNA identification Task Responsible group Strategy Authorising body Determine clinical practice guidelines Forensic physicians, paediatricians and nurses Working group evaluation of evidence; consensus; recommendations Currently none; potentially AAFP Develop national standards for handling of forensic samples ANZPAA National Institute of Forensic Science Multidisciplinary working group evaluation of evidence; consensus ANZPAA National Institute of Forensic Science Determine professional training requirements College or university department of forensic medicine Curriculum development and implementation Currently none; potentially VIFM and/or Monash University Certification of competency College or university department of forensic medicine Successful completion of training program; demonstrated competency Currently none; potentially VIFM and/or Monash University or alternative Governance of professional practice clinical forensic medicine Employing organisations Organisational standards; monitoring practice Multiple, such as state centres providing clinical forensic medicine services Monitor and enforce clinical forensic medicine standards across Australia National body A new national college of forensic medicine Currently none; potentially RACP, Australasian College of Legal Medicine or new national college of forensic medicine AAFP = Australasian Association of Forensic Physicians. ANZPAA = Australia New Zealand Policing Advisory Agency. RACP = Royal Australasian College of Physicians. VIFM = Victorian Institute of Forensic Medicine.

J Anne S Smith MB BS, FRACP