Ethics

Legislation has the potential to reduce chronic disease, but political will and leadership are essential If the law required restaurants to tell you the total calories and the grams of saturated fat, trans fat, carbohydrates and salt in the food you order, would it make a difference to your food choices? The California legislature thought so. In September 2007, it passed a law requiring food facilities with 15 or more outlets to prominently display nutritional information for all fixed-menu food items, together with the statement: “Recommended limits for a 2000 calorie daily diet are 20 grams of saturated fat and 2300 milligrams of sodium”.1 The Bill was hotly contested by the food industry and subsequently vetoed by Governor Schwarzenegger.2 New York City, meanwhile, recently reintroduced its own restaurant labelling law, which requires calorie information to be displayed in a typeface as large as the price.3 Although governments are increasingly using legislation in innovative ways to support the prevention of chronic disease, the law’s role remains controversial. The food, tobacco and alcohol industries have lucrative markets to protect, and there is a pervasive assumption that the solution to galloping rates of obesity, diabetes and other lifestyle diseases lies in individuals exercising greater self-control. But preaching self-control will not work if healthy choices are constantly being undermined by other, more powerful influences. While the law is not a complete answer, it can help to create supportive environments for changing the average behaviour of populations. Successful tobacco control programs illustrate this point. Success has not come by merely insisting that smokers exercise more willpower. Nor have laws been drafted with the aim of persecuting smokers or seeking to micromanage their lives. Instead, tobacco control laws have taken a population focus: addressing the price of tobacco through taxation and regulating businesses through laws that dictate smoke-free environments, point-of-sale controls, advertising restrictions and warning labels. This has resulted in conditions that discourage people from starting smoking and better support of individual attempts to quit (eg, the Quitline). The law and behavioural risk factorsLaws can influence the behavioural risk factors for chronic disease at three distinct levels: First, by better supporting interventions led by health care providers. Although Medicare now covers a range of allied health services aimed at improving care for chronic diseases,4 the challenge remains to design incentives for preventing such diseases in primary care,5 building on Lifescripts (tools for general practitioners to use when providing lifestyle advice to patients)6 and the new Medicare item for a health check for chronic disease risk factors at age 45 years (Medicare Benefits Schedule item 717).7 Laws can seek to change behaviour directly. In the United States, federal regulations permit health insurance premium discounts for people who control their weight and other lifestyle risks.8-11 In Australia, this approach would have the risk of creating disincentives to private health coverage and increasing the burden on Medicare. Laws can influence risk factors by addressing the social, economic and environmental influences on lifestyle choices (Box 1).12,13 While this is where we see the best opportunities for the law, the combined weight of multiple legal interventions will be needed if our aim is to slowly reverse broad population trends. Information policiesInformation is a powerful tool for fighting chronic disease. Laws can mandate the provision of information to consumers and, more controversially, can restrict advertising to consumers. Consumers have difficulty understanding the significance of nutrition information. Despite this, we still lack nationally agreed and standardised criteria for a front-of-pack, readily understandable labelling scheme to flag products that are high in saturated fat, salt and sugar. The United Kingdom’s “traffic-light” labelling system uses visual signposts (red, amber and green) to flag these levels in food (Box 2).14 This approach is simple to use, in real time, in supermarket aisles. Food labels can also support healthy choices by showing the amount of fat, sugar and salt as a proportion of the daily recommended intake for a normal adult. In takeaway food outlets, appropriate labelling might alert customers that the “large meal deal” delivers 52% and 77%, respectively, of the average daily energy intake for men and women.15 A “child protection” model is evident in the UK, where the Office for Communications has banned the advertising and promotion of foods with high levels of salt, sugar and fat in television programs likely to appeal to children. Some states in the US are using the law to improve the nutritional quality of food sold in schools. Any serious attempt at regulation in this area must also confront the increasing complexity of food advertising, encompassing television, the Internet, mobile phones and print media.16 The built environmentWhile improvements in the built environment could facilitate and encourage physical activity, the legal processes for making these changes are not well understood.17-19 Many aspects of the built environment are shaped by zoning and planning policies and laws, and all levels of government have a role to play. The possibilities go well beyond using the law to create mixed-use neighbourhoods that encourage walking and cycling and that are well integrated with public transport. For example, in the US, zoning laws have been used to “thin out” the density of fast food outlets. Economic policiesThe workplace is an important setting for interventions to reduce lifestyle risks. In the US, employer-funded health insurance coverage, which includes chronic disease prevention, is seen as central to reducing rising care costs.20 There are proposals before Congress to deepen this trend by partial tax relief for companies offering prevention programs that meet specified criteria.21 While Australian employers do not have the same responsibility for employees’ health insurance, the opportunity remains for Australian companies to improve productivity and reduce absenteeism by investing in workplace health promotion and disease prevention programs.22 Tax relief for companies that invest in employee wellbeing could encourage this. Other economic policies include taxing unhealthy foods to raise revenue for health promotion initiatives or to create price disincentives for overconsumption of these foods. How can this come about?Successfully addressing the broader influences on lifestyle will require policies that engage with the food production system, address public health nutrition, the built environment, transport and urban development, key settings such as schools and the workplace, and issues like food advertising and taxation. No health department, state or federal, is currently mandated to begin doing this. Successful coordination of policies across multiple sectors requires governance structures that can rise above the boundaries and entrenched cultures of existing bureaucracies and agencies, and a clear legal mandate to get things done. The central choice is between politically owned structures with cabinet-level leadership and independent-of-government agencies with clear powers and cross-sectoral reach. Either could work, but the point is that current structures are failing.23,24 Australia has a brand new federal government with a clear mandate for policy change. Will it maintain the reactive model of its predecessors — directing all its resources to disease treatment by the health care sector — or opt for a more preventive approach that engages with the socioeconomic and environmental determinants of health and illness? Most importantly, will it grasp the nettle and establish a national overarching structure — with adequate funding, support and leadership from the highest levels — to make effective intersectoral and interagency action a reality? Or will we be left, yet again, with only the rhetoric? 1 How the law can improve the health of populations10,11 The law can influence behavioural risk factors for chronic disease through: health infrastructure and governance: improving the quality and implementation of public health policies and programs through agencies that have a clear mandate to follow the evidence and to engage with stakeholders across all sectors; shaping the information environment and creating “information assets”; taxing, spending, making grants, subsidising and creating economic incentives; designing and altering the physical and built environment; economic policies addressing the socioeconomic gradient: confronting and addressing health inequalities; and command and control regulation: directly regulating persons, professionals, businesses and other organisations. 2 Traffic-light food labelling14 This traffic-light label shows the shopper, at a glance, that the labelled food is high in fat (> 20%), particularly saturated fat (> 5%), but low in sugar (< 5%) and moderate in salt (0.3–1.5%).

Roger S Magnusson BA/LLB(Hons), PhD, GDipManDev · Ruth Colagiuri BEd, GradCertHlthPolMgnt

To the Editor: The recent editorial by Penington and Mitchell1 unreservedly supports the Victorian Government’s legislation allowing “therapeutic cloning” by somatic cell nuclear transfer (SCNT) — generating an embryo by transferring an adult somatic cell nucleus (skin, muscle, etc) from an individual into a donated ovum from which the nucleus has been removed. State and federal support for therapeutic cloning has clearly been dependent upon belief in the therapeutic benefits to be obtained — a belief that the editorial does nothing to dispel. Since the licensing system for embryo research (Research Involving Human Embryos Act 2002 [Cwlth]) was introduced, there have been no discoveries in animal or human embryonic stem (ES) cell research that support an urgent need for therapeutic cloning. This includes references 3–8 in Penington and Mitchell’s editorial, all of which fall far short of providing proof of concept of efficacy of ES cells in treatment. A number of major problems need to be resolved before any remotely credible scientific case could be made for the need for therapeutic cloning. These include achieving prolonged, effective, safe therapy in an animal model of disease, and safe transplantation of ES cells in animals, without any tumour formation — a problem that occurs commonly,2,3 not on the “rare occasions” claimed in the editorial. We need to understand how stable the fully differentiated phenotype is when ES cells are used to generate specialised cells. This can be explored in animal ES cells, but also in human ES cells that do not need to be prepared by therapeutic cloning. If stability is indeed shown, these cells must die eventually — how will they then be replaced? Will this require a compromise of using less “mature” cells and incurring an even greater risk of tumour formation? If cells derived by SCNT are to be used to find “new approaches to ... hitherto unyielding diseases”, proof of this concept could readily be provided by studying animal examples. Crucially though, that will require resolution in animal studies of the effect of SCNT on genetic controls and epigenetic effects in the derived ES cells. These are all scientific requirements. Proceeding to therapeutic cloning provides no scientific advance without them — and of course it should be noted that no one anywhere in the world has ever made human ES cells by SCNT. Penington and Mitchell’s editorial provides a limited view of these matters. It acknowledges the long lead times required if there is ever to be success in ES cell therapies, but does not advance even a single compelling argument in support of SCNT now.

T John Martin

To the Editor: I read with interest the editorial by Penington and Mitchell1 in which they briefly discussed the recent legislative developments with regard to human embryonic stem cells. As a medical student, I delight at the complexity and passion that surround the stem cell debate. How is a student to proceed through this ethical minefield? At the Australian National University, we are taught that international human rights are likely to become more important in professional regulation than classical medical ethics born of the Hippocratic Oath.2 The International Covenant on Civil and Political Rights (ICCPR)3 and the Universal Declaration of Human Rights (UDHR)4 are currently used as the cornerstone for building ethical arguments and controversial legislation. However, problems with these international human rights documents include their relevance and applicability to the 21st century. The medical and technological advances made since they were introduced are mind-numbing; I doubt that stem cell research was a consideration when they were drafted. Both Article 6 of the ICCPR and Article 3 of the UDHR state that every human being has the right to life. An individual’s ethical principles must shape his or her interpretation of this statement. Moreover, ethical argument should not be confused with religious views. Australian society and its belief systems are more than ever moving further away from religion, and medical ethics should incorporate the views of the community at large. An example of religion and international human rights opposing society’s position is the termination of pregnancy. In Australian medicine there is an ethical obligation to uphold a woman’s right to autonomy and wellbeing, while the exact wording of the ICCPR and UDHR is ignored to achieve a currently socially acceptable outcome. We are seeing a similar rationale with stem cell research, in that there is an ethical responsibility to “the greater good”, regardless of the requirements of the UDHR and ICCPR. I am a strong supporter of both stem cell research and a woman’s right to choose. I am simply suggesting that we stop looking to international human rights covenants to be the cornerstone of legislation or to answer ethical dilemmas. I just don’t think current international human rights documentation incorporates all the ethical considerations required of modern medicine. A new alternative is just what the medical student ordered.

Jeffrey J Flaherty

The federal Privacy Act 1988 (Cwlth) has recently been amended to permit the disclosure of genetic information to an at-risk relative when there is a serious (although not necessarily imminent) threat to that person’s life, health, or safety. This represents a significant exception to the statutory obligations to maintain the privacy of a patient’s health information. However, its scope of operation is limited in that it applies only to doctors and other health professionals working in the private sector, and does not cover those working in State public hospitals or for Commonwealth Government agencies.

Margaret F A Otlowski PhD

To the Editor: Gerber’s article1 about the case Royal Women’s Hospital v Medical Practitioners Board of Victoria raises important issues but contains significant errors. The Medical Practice Act 1994 (Vic) states that the main purposes of the Act are “to protect the public by providing for . . . investigations into the professional conduct . . . of registered medical practitioners” — Section 1(a). Section 22(1) makes it clear that any person may notify the Board if they believe a person may have engaged in unprofessional conduct. Section 25(1) states that the Board must investigate notifications unless they meet certain criteria, which the Board did not believe were met in this case. Gerber is not correct in stating that the Board made no attempt to question the medical practitioners involved. In the absence of the patient’s consent, all but one of the doctors refused to provide any information in response to the complaint. Gerber’s statement that the subcommittee of the Board that conducted the preliminary investigation concluded that the complaint was “frivolous and vexatious” is wrong. The subcommittee recommended that the matter be closed. Later, the full Board chose not to accept this recommendation, as the investigation had been hampered by lack of information, including access to the original hospital records. While formal hearing panels have the power to subpoena documents or persons, this power does not extend to the Board’s preliminary investigations. The Board does have the power to apply to a magistrate for the issue of a search warrant. Gerber refers to the powers of the Board under Section 48 and Section 49 of the Act. These powers only come into play if the Board has determined that it will conduct a formal hearing. He is also incorrect when he states that the Board can compel medical practitioners to appear before the Board. This power is not available during preliminary investigations. The considerable delay in the matter being finalised was due to the legal appeals mounted by the Royal Women’s Hospital against the decision of the Magistrate to allow the Board access to the hospital records. Another issue raised by Gerber requires clarification: the Board does not currently have the power to conciliate disputes or conduct mediations. The Board did not ultimately dismiss the matter as frivolous and vexatious. When the subcommittee, having been provided with the records, reported to the Board that it did not find evidence of unprofessional conduct, the Board closed the investigation. I trust that this information will correct the public record on this important matter.

Joanna M Flynn

In reply: Flynn points to some minor technical differences in my historical recount of the handling, by the Medical Practitioners Board of Victoria, of the complaint against the medical specialists involved in a late-term abortion.1 None requires a reply, save for Flynn’s assertion that “the Board does not currently have the power to conciliate disputes or conduct mediations”. The Board does not require statutory power to approach a hospital in a conciliatory manner so as to explore whether an impasse, involving confidentiality, can be resolved without recourse to litigation. Was the Board’s only remedy to raid the hospital, trawling for evidence to decide whether there were grounds for the possible suspension or cancellation of registration of the doctors involved in the complaint? We both agree that the relevant legislation mandated the Board, on the material before it, to investigate the charge of serious professional misconduct. Where we disagree is that, having overruled its own subcommittee’s recommendation that the matter be closed, the Board failed (I maintain) in its statutory duty to promptly institute a formal hearing. Had the various specialists been subpoenaed, this would have cleared them of professional misconduct, thereby preventing the considerable and unnecessary stress to these witnesses over a period of 5 years.

Paul Gerber

To the Editor: Breen’s timely call for a reality check on medical professionalism noted major global changes that affect contemporary doctor–patient relationships: new technology, changing market forces, evidence-based treatment protocols, and resource-driven health services and policies.1 The call by our colleagues in the United States and United Kingdom to restore “trust that the public used to have in the profession” was urgent. Breen’s thesis posits that lost trust is due to an “altered balance” of ethical issues faced by doctors because of a generational shift from the ethical principle of “beneficence” to “autonomy” to “justice” and “distributive justice”. This view contrasts with Green and Bloch’s analysis of the mental health care system’s ethical concerns arising from an adherence to “efficiency-driven” policies that started in many countries during the 1980s.2 They suggest the system itself is flawed. Green and Bloch suggested that the legacy of efficiency-driven policies created two current moral compromises for our profession: first, a threat to the “ethic of agency”; second, the constraints those policies imposed on ethical principles precisely because they were not based on justice, instead being created to meet wider socioeconomic and political considerations. Their views point to the heart of the matter, beyond Breen’s suggested remedy to be found in “stronger leadership”, which may be necessary, but is not sufficient without an urgent update on personal medical ethics. At the individual doctor’s experience, Green and Bloch locate conflict arising from competing interest when doctors’ “principle of fidelity is juxtaposing their financial interests alongside patients’ needs”. In the US, a study found 28% of physicians receive direct payment for consulting, lectures or enrolling patients in trials, and 94% report “some type of relationship with the pharmaceutical industry”.3 To avoid the conundrum posed by the ethics of conflict of interests we face when confronted by these physician–industry relationships, or by efficiency-driven policies, risks perpetuating the very loss of trust that we need to restore. Breen’s analysis, an important step in the needed debate on medical professionalism, should account for not merely shifts in the ethical balance, but also the incremental erosion of trust. As it stands, he expressed our very Australian attitude “she’ll be right”. Our overseas colleagues, as well as locals, have suggested that “she won’t be right, mate” when it comes to managerialism eroding the ethical foundations of medicine.4

George Halasz

In reply: My recent article was submitted under the category of “For Debate”, so it is pleasing that Halasz has joined the debate. I am disappointed that he interprets my view as “she’ll be right”. My point is that revising or repackaging existing ethical codes will not, on its own, fix any of the perceived problems of “managerialism eroding the ethical foundations of medicine”. Working constructively, consistent with existing ethical codes, within our health care system, as is also suggested by Green and Bloch,1 is more likely to achieve better outcomes for our community. As I stated and as Green and Bloch imply, this will not always be a simple matter. I am in fierce agreement with Halasz over steps to reduce erosion of trust,2 but that was not the focus of my article.

Kerry J Breen

Reform is needed, but will the current Bill enact the best options? Two articles in this issue of the Journal1,2 comment on a complex but important piece of legislation put forward by the Minister for Health and Ageing — the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 (the Bill).3 The Bill splits the Pharmaceutical Benefits Schedule into two formularies: “one part for single brand drugs [F1], the other part for drugs that have multiple brands or that are interchangeable at the patient level with drugs with multiple brands [F2]”.3 The Bill allows reference pricing of drugs within each formulary but disallows an ongoing link in the price of drugs between formularies. The Bill institutes progressive mandatory price reduction and price disclosure by the sponsors of multiple brand (generic) medicines for drugs on F2. The aim of this is to ensure that the price the government pays for Pharmaceutical Benefits Scheme (PBS) medicines more closely reflects discounted prices paid by pharmacists and international prices for generic medicines. A support package will be provided to help community pharmacists adjust to the new arrangements. Authority approvals will be streamlined, a public awareness campaign is promised to promote the use of generic medicines, and a working group will be established to consider issues of continued access to innovative medicines through the PBS. The government argued in the Bill that dual delinked formularies were required to tackle a problem caused by reference pricing: price reductions imposed on multiple brand generic medicines that were being discounted to pharmacies would, in many cases, flow directly on through price linking to single brand patented medicines that were not being discounted. This was said to cause difficulties for the innovative pharmaceutical industry and to place patients at risk of losing subsidised access to many worthwhile medicines.4 The government believes patients will not be disadvantaged by the proposed changes, as out-of-pocket costs to patients would remain unchanged. In some cases, patients should pay less. It is estimated that the mandatory price reductions for drugs in the F2 formulary will result in patients paying between 20 cents and $4.65 less for about 400 drugs that will fall below the current copayment amount of $30.70 (for general patients), or that were already below this amount. The articles by Searles et al1 and Faunce2 raise three concerns about the Bill. First, eliminating global reference pricing could result in Australia paying more for a new medicine in F1 that is no better than those already available in F2. Second, these changes appear to reflect ongoing pressure from the United States through the Medicines Working Group established by the Australia–US Free Trade Agreement to weaken the PBS system of evidence-based reference pricing. Third, mandatory price reductions and price disclosure for drugs on the F2 formulary, while saving the government money, provide little financial relief to patients and are unlikely to stimulate the Australian generic medicine industry. Reference pricing is a means of negotiating a lower price by tying the subsidy to the differential effectiveness of the drug — its comparative clinical outcome rather than its cost of production. This principle applies both at the time of initial subsidy and later, when new competitors arrive on the scene. The proposed changes may not change the initial pricing mechanism, which will continue to use comparative effectiveness as a criterion for pricing. What they will do is lessen the “downward pressure” on single brand (patented) drug prices over time. With the new dual formulary system, there will no longer be an automatic price reduction when different drugs of similar effectiveness for the same condition are listed on the PBS at a lower price. The problem with the current system, as Searles et al make clear, is that we are paying too much for drugs that are out of patent, where the company has already made its profit on the initial investment. We need a means to reduce the price of generic drugs in a system where fixed out-of-pocket costs to consumers and historic negotiated prices with suppliers provide no incentive to switch to generics, and where there are no competitive forces to reduce prices to government. The Bill does provide one mechanism to do so. It will mandate price reductions to government for out-of-patent medicines over time. This will lower the cost of generic drugs in Australia — a much needed reform. The problem is that it relies on annual administrative rule changes that do little to encourage the generic medicine industry and may have the effect of maintaining high prices for patented medicines, even when similar non-patented drugs are falling in price. The unforeseen result might be that we will pay more for the health gains from many new expensive medicines over time. Searles et al suggest one alternative — maintain a single formulary, but have closed-bid, competitively tendered contracts with generic medicine suppliers to provide key drugs outside of the PBS. Another option would be to increase competition for generic drugs (within a single or dual formulary) by allowing generic drug manufacturers to discount to government rather than wholesalers or pharmacies. A generic-brand price discount to consumers could be seen as an extension of the current brand price premium scheme — instead of consumers paying more than the regular copayment for a particular brand, they could pay a lower price if they choose a particular generic. Using a market price signal of a copayment reduction for consumers is likely to be more effective in stimulating generic medicine use than the proposed government advertising campaign, possibly a lot cheaper, and is consistent with the aim of the National Medicines Policy to provide timely access to the medicines that Australians need, at a cost patients and the community can afford. Fine-tuning such a system so that the expected increase in market share would be enough to encourage a local industry, or to ensure the kind of continuous price reductions that the Bill imposes, is something that the government could experiment with — without serious disruption to the system. A Senate Committee inquiry into the Bill held a public hearing on Friday 15 June 2007, and was required to report the following Monday. The Committee recorded that this provided insufficient time to analyse specific concerns raised in evidence, especially in relation to possible long-term impact of these reforms. The Senate Committee recommended that the Minister report to the Senate 12 months after implementation of the reforms on their impact, par-ticularly on the cost of medicines to consumers.5 The Bill was amended accordingly.

Ken J Harvey MB BS, FRCPA · Anthony H Harris MA, MSc · Liliana Bulfone BPharm, MBA, GradCertHealthEco

The concept of “loss of chance” as an alternative cause of action in cases of medical negligence has succeeded in recent cases where actions based on causation have failed. The plaintiff must prove negligence and loss of a chance of a better outcome. The quantity of loss of chance must be more than “speculative” (1%). Damages are awarded as a proportion of the total injury commensurate with the loss of chance. More claims may be expected, although damages will generally be less than those awarded under causation. Doctors’ insurance premiums may rise.

James Tibballs MD, MHlth

Draft legislation introduced to Parliament on 24 May 2007 proposes changes to the Pharmaceutical Benefits Scheme (PBS), including the creation of two formularies. The F1 formulary will contain single brand drugs that are not considered “interchangeable on an individual patient basis”, while the F2 formulary will contain mainly older drugs (many of them generic) for which there is at least one alternative product considered to be clinically interchangeable. Drugs in F1 will not be compared with those in F2 for pricing purposes, even if clinical trial data show them to be equivalent (or even inferior) for the same clinical indication. This undermines the evidence-based approach to reference pricing currently used in the PBS. Other changes require compulsory price disclosures and price cuts for generic medicines. While positive, these amendments are unlikely to deliver generic medicine prices as low as those in other developed countries. This is important, in view of growing evidence of the unaffordability of prescription medicines in the Australian community.

Andrew Searles BEc, DipEd, MMedStat · Susannah Jefferys BA LLB(Hons) · Evan Doran BA, GradDipHealthSocSci, PhD · David A Henry MB ChB, MRCP, FRCP

Unless the federal government changes the course of our medicines policy with intention, Australia’s pricing of patented pharmaceuticals is likely to follow inequitable US trends Proposed amendments to the National Health Act 1953 (Cwlth) are currently being considered by the Australian federal government. The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 (the Bill) includes several changes that will limit reference pricing under the Australian Pharmaceutical Benefits Scheme (PBS). Here, I argue that these amendments have been influenced by the Australia–United States Free Trade Agreement (AUSFTA) and, further, that if US influence on Australian medicines policy continues, there are likely to be adverse consequences for all Australians, involving the erosion of scientific objectivity and equity in PBS processes and, eventually, the end of public-funded medicines. What is reference pricing?The PBS is an internationally respected system under which the federal government uses public funds to reimburse pharmacists (and thence manufacturers) the “health innovation” value of listed medications, as proven by scientific evidence assessed by pharmacoeconomic experts on the Pharmaceutical Benefits Advisory Committee (PBAC). This allows Australian patients to generally pay a relatively low standardised copayment (currently $30.70 for non-concessional patients) for all PBS medicines, patented and generic alike. Under the current PBS system, once expert assessment has established that a new patented drug has better efficacy or safety than a different off-patent comparator for the same clinical indication, it is recommended by the PBAC for listing. The submission price is then further negotiated by the Pharmaceutical Benefits Pricing Authority (PBPA). If the PBAC’s analysis merely establishes equal effectiveness, then, in a fundamental cost-minimisation process, the newly listed drug’s initial reimbursement price is linked to the lowest in the relevant price reference group. Reference pricing, in its most fundamental sense however, applies post-listing when new competitors (with lower prices) enter six groups presently established under the Therapeutic Group Premium (TGP) Policy. In this TGP system, the unusual criterion of “individual interchangeability” assists patients wishing to obtain an alternative to a drug in one of these groups whose price has a high additional premium. Readily expanding categories of TGP reference pricing are a fundamental institutional manifestation of the evidence-based distributional justice — seeking a fair balance between price and proven community benefit — required to underpin public expenditure on medicines under section 101(3B[a]) of the National Health Act, as well as the principle of equity of access under the Australian National Medicines Policy.1 What are the amendments influencing reference pricing? The Bill proposes amendments (new sections 85AB, 85AC) to the National Health Act that will divide the current PBS formulary into two. Medicines will be listed on the F1 formulary if there are no “bioequivalent” brands or drugs in reference pricing groups subject to the TGP Policy — these will mostly be patented or “innovative” medicines. The F2 formulary will cover generic medicines. Once adopted, specific price cuts and disclosures will be imposed only on F2 generic medicines. New reference pricing groups subject to the TGP (in addition to the existing six) will have to meet the additional high standard (undefined in legislation) that they are “interchangeable on an individual patient basis” (proposed sections 84AG and 101[3BA]). Reference pricing — as it now operates after PBS listing to produce “flow-on” price drops — will be problematic when the trigger drug is in the F2 formulary (although the latter’s existence may cause the F1 comparator to be redefined as an F2). What lies behind these changes?I am concerned that at least some of the impetus for this alteration of PBS fundamentals may have come from multinational patented-pharmaceutical companies through mechanisms established by the AUSFTA. Annex 2C of the AUSFTA,2 which focuses on the PBS and pharmaceuticals, has led to some positive changes, including public summary documents of PBS drug-listing decisions.3 However, it also produced a new review mechanism that is triggered after PBAC rejection decisions,4 with increased opportunities for industry pre-hearings and consultations with technical staff, as well as a Medicines Working Group (MWG) comprising high-level officials on medicines policy from both Australia and the US.5 Further, in the past few months policies have been produced for full PBS cost-recovery from industry6 — despite such “user fees” and increased liaison mechanisms being criticised as creating conflicts of interest for the US Food and Drug Administration that significantly endanger public safety.7 Perhaps most significantly with respect to the Bill, Annex 2C.1 of the AUSFTA emphasises the principle of valuing pharmaceutical innovation through either the operation of “competitive markets” (the US position) or by “adopting or maintaining procedures that appropriately value the objectively demonstrated therapeutic significance of a pharmaceutical” (the Australian position).8 The potential importance to Australian medicines policy of this ambiguous definition of innovation has been highlighted in this Journal9 and elsewhere.10 We should not forget that the US negotiators to the AUSFTA, who previously worked very closely with senior members of the US patented-pharmaceutical industry on the Industry Functional Advisory Committee on Intellectual Property Rights for Trade Policy Matters, had an explicit legislative mandate to seek the “elimination” of PBS reference pricing (see Box).11 The same legislation also required the US Department of Commerce to investigate the possible future dismantling of reference pricing in OECD (Organisation for Economic Co-operation and Development) countries.12 In December 2005, in Paris, the US sought to implement this agenda through the OECD Project on Pharmaceutical Pricing Policies and Innovation.13 Australian AUSFTA negotiators provided reassurances about the Annex 2C.1 innovation principle before a Senate Select Committee on 21 June 2004: ... we went into these negotiations with an absolutely clear mandate to protect and preserve the fundamentals of the PBS. That is what this agreement does ... there is nothing in the commitments that we have entered into in Annex 2C or the exchange of letters on the PBS that requires legislative change.14 However, when the AUSFTA MWG met for the first time in Washington, DC on 13 January 2006, Australia’s Minister for Trade, Mark Vaile, stated that: . . . the core principle that we both agree on in this area . . . is recognising the value of innovation . . .15 To my way of thinking, this represents a restatement of Australia’s position on objective, evidence-based assessment of health innovation, in accord with the National Medicines Policy. Documents obtained under a Freedom of Information application (organised by Pat Ranald, Australian Fair Trade and Investment Network, 2007) reveal almost nothing of what was said at the first AUSFTA MWG meeting. One disclosed document, presumably discussed, was an opinion editorial in The Australian, which argued that: “Truly innovative cures should be referenced against innovation in other classes, rather than against generics”16 — an approach that seems to reflect the US “competitive markets” method of valuing innovation. The second meeting of the MWG on 30 April 2007 discussed the new F1 category, which had now been structured along the same lines proposed in the editorial the MWG had discussed at their previous meeting (International Trade Law Symposium, Canberra, 4 May 2007, personal communication). The official Australian Government website only disclosed that the MWG “discussions were constructive and informative”.17 I believe this evidence suggesting a possible, non-transparent link between the definition of innovation in AUSFTA Annex 2C.1, the MWG, and the new F1 PBS category, with its sequestration from post-listing reference pricing against generic medicines, has disturbing implications for sovereignty over Australian public health policy. The PBS beyond AustraliaIn its recent free trade negotiations with the US, the South Korean Government demanded a process similar to Australia’s current system of evidence-based cost-effectiveness and reference pricing.18 Article 5.2 of the Republic of Korea–United States Free Trade Agreement, after recognising each nation’s differing approach to medicines policy, indicates that if South Korea establishes a reimbursement system for pharmaceuticals or medical devices where the amount paid is not based on “competitive market-derived prices”, then it has to “appropriately recognize the value of patented pharmaceutical products” (Article 5.2 [b][i]). Article 5.1 (c) and (e) respectively mention PBS-type “sound economic incentives” as a method of facilitating access to patented medicines and PBAC-style “transparent and accountable” procedures as a means of promoting health innovation. However, Article 5.7 creates a Medicines and Medical Devices Committee, similar to the AUSFTA MWG. Will the parallels continue? The end of public-funded medicines?In Australia, it is likely that creating an F1 PBS category where patented drugs are insulated from post-listing reference pricing against generics and required price drops may, in the short term, tempt governments to increase the extent of patient cost-sharing (perhaps through differential means-tested copayments) for high-cost patented medicines. If the proposed amendments are adopted, the incentives for pharmaceutical products to remain within the price-protected F1 class are likely to lead to much more aggressive pharmaceutical patent battles in Australia (taking advantage of intellectual property changes introduced by Chapter 17 of the AUSFTA) that could delay the introduction of cheaper generic medicines.19 The consequent widening discrepancy between initial listing prices for patented medicines and their therapeutically equivalent generic comparators may become unconscionable. The evolving higher prices for F1 patented medicines could also provide additional arguments for patented-pharmaceutical industry lobbyists to claim that the PBS is “unsustainable” and that we need to move to a privately financed prepaid insurance system, such as medical savings accounts (a form of medicines superannuation).20 If, however, a future Australian government wants to retain public funding of patented medicines and contain PBS expenditure, it could remove, or rigorously define according to established PBAC records, the criteria of “interchangeable on an individual patient basis”. It also needs to be clarified that this concept will not interfere with the initial choice of cost-effectiveness comparator, initial cost-minimisation, or the creation of therapeutic relativity sheets that are used by the PBPA to assess post-listing industry requests for price rises. Without such clarification, and a robust mechanism for shifting F1 drugs to the F2, the proposed changes to the PBS threaten a shift away from the fundamentally evidence-based method of valuing the health innovation of a patented pharmaceutical after listing. They may, instead, push it more towards valuing F1 products through the operation of markets that are nominally competitive, but readily distorted by collusion and advertising. Much will depend on whether the government protects and supports the independence of officials involved in pharmacoeconomic analysis and vigorous price negotiations with patented pharmaceutical manufacturers (both at first listing and over time), in the MWG and, if necessary, in AUSFTA Chapter 21 dispute resolution procedures. My concern is that the haste with which this legislation is progressing might lead to this policy choice being delegated to technical experts in finance, or working groups with private interests, rather than being made part of a systematic public debate about the kind of health care system all Australians want to have, and the trade-offs they are prepared to make against strategic objectives of trade or international public policy. If the Australian regulatory and policy environment for medicines continues to further resemble the inequitable US system, we will similarly have unaffordable innovative products and worse health outcomes (despite low-cost generics) for citizens lacking private insurance with extensive coverage. United States AUSFTA negotiators’ instructions on Pharmaceutical Benefits Scheme reference pricing The US Trade Representative, the Secretary of Commerce, and the Secretary of Health and Human Services were obliged to: Bear in mind the negotiating objective set forth in the Bipartisan Trade Promotion Authority Act of 2002 to achieve the elimination of government measures such as price controls and reference pricing which deny full market access for United States products. In so doing, the agencies shall provide periodic and timely briefings for the Committees of the House and Senate listed above, with an interim briefing no later than 90 days after enactment to address negotiations to establish a US–Australia Free Trade Agreement and, as appropriate, other current negotiations.11 [emphasis added] AUSFTA = Australia–United States Free Trade Agreement.

Thomas A Faunce BA LLB, BMed, PhD

Religions, culture and healthcare Susan Hollins. Oxford: Radcliffe Publishing, 2006 (ix + 115 pp). ISBN 1 85775 755 6 Written by the lead chaplain of the UK National Health Service’s National Chaplaincy Strategy, this handbook is designed to serve as an accessible reference for health care professionals seeking to understand various practices and beliefs associated with a range of faiths. As the book was produced in the United Kingdom, it focuses on faiths which are most widely practised there (Christianity, Judaism, Hinduism, Sikhism, and Islam), but also includes less familiar traditions such as Jainism, Zoroastrianism, Mormonism, Baha’i, and even paganism. The bulk of the book is devoted to detailed examinations of each religious tradition, presented in an easy-to-use format. Sections provide basic information on the history of the faith and core tenets, and outline beliefs associated with key areas related to care, including attitudes toward illness; gender and privacy; naming, diet, and hygiene; birth, dying, and death; contraception and assisted reproductive technologies; and organ/tissue donation. The author is careful to note the diversity of beliefs within faiths where relevant (for instance, within Islam, Judaism, and Zoroastrianism there are debates over the permissibility of organ donation). The book includes a thoughtful set of introductory chapters that explore cultural and religious diversity in health care, as well as spiritual care for patients. They promote the idea that health care professionals must maintain open minds with regard to patients, and to avoid stereotyping on the basis of religion or culture, in order to provide sensitive and appropriate care. Hollins notes in her preface that this book should be placed at nursing stations and other places where it can be easily accessed for quick answers. It must be noted that there are some local differences in belief systems between the UK and Australia, but as a preliminary guide to religious beliefs in health care, this is an excellent resource.

Rachel A Ankeny

Organ donation after cardiac death increases organ availability, but raises several legal and ethical issues, including consent. Medical interventions for people who are unconscious usually require guardian consent and must meet patients’ best-interests standards. Antemortem procedures can improve the success of organ transplant after cardiac death, but do not serve the patient’s medical interests, and it is contentious whether consent for antemortem interventions is legal under current Australian guardianship legislation. We argue that consent decisions should take patients’ wishes as well as their medical interests into account. Antemortem interventions are ethically and legally justified if the interventions are not harmful and the person concerned wished to be an organ donor.

Bernadette Richards BA, DipEd, LLB(Hons) · Wendy A Rogers BM BS, FRACGP, PhD

Mifepristone (RU486), which is used for early medical abortion, can only be obtained in Australia under the Authorised Prescriber legislation (Section 19[5] of the Therapeutic Goods Act 1989 [Cwlth]); two of the authors have permission to obtain, prescribe and administer this drug in Cairns, Queensland. From July 2006 to April 2007, 10 women who fulfilled the Therapeutic Goods Administration (TGA) criteria of “life-threatening or otherwise serious” indications underwent medical abortion with mifepristone/misoprostol, and 12 women conforming with abortion requirements of Queensland law, but not TGA legislation for mifepristone administration, had medical abortions with the less preferable methotrexate/misoprostol combination. Although it is now more than a year since the cross-party vote in federal Parliament in February 2006 confirmed wide support for the right of Australian women to a medical abortion, we believe we are at present the only medical practitioners in Australia with permission to use mifepristone. Obtaining Authorised Prescriber status from the TGA is of necessity a complex and protracted process, involving ethics committee approval and auditing, and regular reporting to the TGA. Because of the current restrictions, we believe that women seeking medical abortion in Australia face barriers not experienced by women in other comparable countries, and that drug manufacturing and distributing companies may be discouraged from seeking to market mifepristone in Australia.

Caroline M de Costa FRANZCOG, FRCOG, MPH · Darren B Russell FRACGP, DipVen, FAChSHM · Naomi R de Costa LLB(Hons), GradDipLegalPrac · Michael Carrette MB BCh, FRANZCOG · Heather M McNamee MB ChB, FRACGP

A welcome alternative to the current cumbersome and inefficient system Australia’s system of ethical review of human research is based on a National Health and Medical Research Council (NHMRC) publication, the National statement on ethical conduct in research involving humans.1 This statement requires all research involving humans to be reviewed by an appropriately constituted human research ethics committee (HREC), whose primary role is to protect the welfare, rights and dignity of human research participants. It is also a requirement of Australian therapeutic goods legislation that all clinical trials that use unapproved therapeutic goods obtain approval from an HREC.2 There are currently 59 HRECs in New South Wales registered with the NHMRC, of which 23 are within the public health sector. Historically, HRECs were established by institutions or organisations to review research proposals conducted solely within their facilities, or involving only their researchers (single-site research). The ethical and scientific review of multicentre research, whereby a single research protocol is conducted at numerous sites, presents unique difficulties for HRECs, researchers, industry and governments.3-5 Under the current system, multicentre research projects are reviewed regularly by the HREC at each site where the research will be conducted, resulting in multiple reviews of the same project. As multicentre research grows, this process is becoming increasingly untenable. In 2005, the NSW Department of Health undertook a review of all research projects submitted to HRECs within the public health sector. In 2003, 148 multicentre research projects were reviewed 491 times, and in 2004, 196 projects were reviewed 607 times. It is clear that the current system has resulted in a number of inefficiencies, including the duplication of effort for HRECs and researchers, an increased burden on HRECs to provide reviews of adequate quality in a timely manner, and increased time from conception of a project to completion of recruitment of participants. In addition, the system is expensive to administer and hinders Australia’s international competitiveness in attracting quality research activities. Researchers, industry and HRECs have been calling for reform of the current system for many years.6,7 In response to these observations and after exhaustive consultation, at the end of 2006, the NSW Department of Health finalised a model for single ethical and scientific review of multicentre research, which will be implemented in July 2007. Further information can be found at: http://www.health.nsw.gov.au/healthethics/multicentre_research.html. The aim of the model is to provide for a single review of multicentre research projects within the NSW public health system, so that every research project is ethically and scientifically reviewed once only. There are three key points which underpin the model: the separation of research governance from the scientific and ethical review of a research project; the notion of a lead HREC; and the concept of a coordinating investigator. Research governance refers to the administrative aspects of research, including: support of department managers; the financial and human resources required to undertake the research project; and ensuring appropriate levels of insurance and indemnity. As many of these issues are site-specific, each site where the research is to be conducted will undertake their own site-specific assessment. A standardised six-page site-specific assessment form will need to be completed by the principal investigator at each site and assessed by a Research Governance Officer at the site. Lead HRECs will be accredited by the NSW Department of Health to conduct a single ethical and scientific review on behalf of all sites within the NSW public health system at which a research project is to be conducted. The actual process used by a lead HREC to undertake the ethical and scientific review remains the decision of each committee. The lead HREC will be responsible for overseeing the research project at all sites, including handling complaints from research participants. An HREC may be a lead HREC in relation to all types of research or in specific research areas only. These areas of research include clinical trials and interventional clinical research and general research including epidemiology, population health, health services, and qualitative and clinical research of a non-interventional nature. In line with the European Directive on the implementation of good clinical practice in the conduct of clinical trials on medical products for human use,8 lead HRECs should take no more than 60 days to reach a decision and communicate that decision to the coordinating investigator. The 60 days does not include time during which the HREC is awaiting a response from the investigator. Lead HRECs will retain the right to limit the number of applications reviewed at each meeting. However, as a number of lead HRECs will be accredited to conduct single ethical and scientific reviews, there will always be more than one lead HREC available to consider a multicentre research project. Under the new model, the research team will appoint a coordinating investigator. This person will be responsible for submitting the research project to the lead HREC. He or she will be able to choose the lead HREC to which to submit the ethics application, provided the HREC is accredited to review that area of research. Use of the NHMRC’s National Ethics Application Form (NEAF) will be mandatory for submission of all multicentre projects. While the site-specific assessment and lead HREC review may occur in parallel, the decision to authorise or not authorise the commencement of a research project at a particular site will only be made by the chief executive or delegate of the public health organisation when the lead HREC has granted approval and the site-specific assessment has been satisfactorily completed. This new model will be effective within NSW Health facilities only. Similar models to streamline ethical and scientific review by HRECs are being developed for the public health sector in Victoria and Queensland.9 The health departments in these states and in NSW have been cooperating to standardise the mechanisms that will be used in their various systems. This is in preparation for the introduction of a national system of single review, currently being examined by the NHMRC, and having been allocated $5.6 million in the 2007–08 federal budget.10 It is hoped that the new NSW model will achieve its goals of efficiency, effectiveness, timeliness, cost-effectiveness, reduction in workloads and transparency.

Helen E Fraser RN, BN, MPH · Ainsley E Martlew BMSc, MM · Deborah J Frew BA, LLB(Hons)

Objective: To determine the relationship between compensable status in a “no-fault” compensation scheme and long-term outcomes after orthopaedic trauma.Design and setting: Prospective cohort study within two adult Level 1 trauma centres in Victoria, Australia.Participants: Blunt trauma patients aged 18–64 years, admitted between September 2003 and August 2004 with orthopaedic injuries and funded by the no-fault compensation scheme for transport-related injury, or deemed non-compensable.Main outcome measures: 12-item Short Form Health Survey (SF-12) and return to work or study at 12 months after injury.Results: Of 1033 eligible patients, 707 (68.8%) provided follow-up data; 450 compensable and 247 non-compensable patients completed the study. After adjusting for differences across the groups (age, injury severity, head injury status, injury group, and discharge destination) using multivariate analyses, compensable patients were more likely than non-compensable patients to report moderate to severe disability at follow-up for the physical (adjusted odds ratio [AOR], 2.0; 95% CI, 1.3–2.9), and mental (AOR, 1.6; 95% CI, 1.1–2.5) summary scores of the SF-12. Compensable patients were less likely than non-compensable patients to have returned to work or study, even after adjusting for injury severity, age, head injury status and discharge destination (AOR, 0.6; 95% CI, 0.3–0.9).Conclusions: Patients covered by the no-fault compensation system for transport-related injuries in Victoria had worse outcomes than non-compensable patients.

Belinda J Gabbe BPhysio(Hons), MAppSc, PhD · Peter A Cameron MB BS, FACEM · Owen D Williamson GradDipEpi, FRACS, FAOrtho · Elton R Edwards MB BS, FRACS, FAOrthA · Stephen E Graves DPhil, FRACS, FAOrthA · Martin D Richardson MS, FRACS, FAOrthA

In an age that features technologically sophisticated medical interventions, patients still desire spiritually nurturing health care. Attention to patients’ spiritual needs and resources in the clinical setting may raise a number of ethical questions. Five ethical guidelines are offered as illustrations of norms that respect patients’ preferences and preserve health care professionals’ integrity.

Gerald R Winslow PhD · Betty J Wehtje-Winslow PhD

It has long been my practice to write a letter of condolence to the next of kin of any patient of mine who has died. As a thoracic and sleep physician, I share a practice with my wife (a psychiatrist) in rooms attached to a private city hospital. I rarely see patients in their own environment, as most come from outlying suburbs or provincial towns. Nevertheless, I get to know many patients quite well, sometimes over a period of many years. However, unlike my father, who was a solo general practitioner initially in the country and later in Brisbane, I am unfortunate in being cut off from the local community in which patients live. He and my mother, who practised with him as a nurse, knew the patient’s whole family, the parish priest, and the names of their children and dogs, not to mention their full address. They saw three generations pass through their surgery.1 Over the years, I have also noted changes in the doctor–doctor relationship, which often affects our attitudes within the profession, and the fragmentation of services due to specialisation and defensive medical practice. Letters can be dangerous in the hands of lawyers, but surely not the simple letter of condolence. A recent American perspective on doctors’ letters of condolence shows that grieving has changed over the past century in US society, so that such letters from doctors are now infrequent.2 People are expected to “get over it” in a matter of weeks. This is in marked contrast with the custom in my grandparents’ time, when “full mourning” was symbolised by black clothing, followed by a period of “half mourning”, signified by grey. Certain behaviour was proscribed during the mourning period, such as going to parties and balls; any jewellery worn had to be made of jet, with no sparkly diamonds; and so it went on. As a specialist in Australia, there are several reasons why I persist in writing letters of condolence today. The first reason is that it is simply a decent, tangible thing to convey my sympathies in writing to the next of kin and show that the patient was not just a “file” or a Medicare item number. Sometimes it may be possible to explain why the patient died, particularly if relatives are confused or upset about the mode of death, but generally such details are not required. The second reason is for myself as a sort of closure on what may have been a long and pleasant relationship with not only the patient but also the family and friends. I am given the opportunity to express both grief and the positive aspects of this unique doctor–patient relationship. Some may see this as “soppy”, but I believe I have learnt over the years that we neglect our own soul at our peril. The third reason is to convey to my staff my sentiments and to give them, too, some form of closure, as the feelings of staff are often overlooked. They may type, read and send the letter and therefore are an integral part of the process. It also sets a tone for my practice. The helmsman is at the helm leading by example. The fourth reason is that a copy of this final letter is filed in the patient’s record that will go off to the archives for the statutory number of years. This indicates to anyone who recalls the chart that the patient has died. I have seen situations in which a patient’s chart is pulled out of the records and a routine appointment (eg, annual follow-up) made for someone who has long since died. This unwitting contact with relatives may lead to unnecessary distress. I recently did a lengthy medicolegal report about a man who had died of lung cancer. In a mountain of subpoenaed medical notes, including that of his family doctor, I could not find the date or situation of his death, let alone a single letter of condolence. By way of a general example, I recently wrote the following letter to the wife of an elderly ex-serviceman I had had the privilege to treat for many years. He had gone downhill very suddenly. As a former Army medical officer myself, with service in East Timor, I often shared with him reflections about world events.3 Dear [name of wife] I was sorry to hear the bad news this morning that . . . had died from lymphoma. I received the biopsy report yesterday and I was going to telephone you this morning to see how he was going. I always enjoyed seeing him and respected his long military background, which was longer than I have seen in any patient in my career and spanning nearly every conflict we have been involved in, including World War 2. The RSM* is the backbone of the Army. I salute him. I am sure he will be sadly missed by you and your family and I wish to convey my sincere sympathies at his passing. Yours sincerely . . . * RSM = Regimental Sergeant Major. I write this article for all doctors, but most of all for those who are just entering the profession. I commend this practice as we share in this mortal business, as it is also for us “for whom the bell tolls”.

Roger K A Allen MB BS(Hons), FRACP, PhD

In 2001, the Medical Practitioners Board of Victoria received a complaint from an Australian Government Senator regarding a late-term abortion carried out in February 2000 at the Royal Women’s Hospital, Melbourne. Five years later, the complaint of professional misconduct was finally dismissed by the Board as being frivolous and vexatious. The action highlights a number of deficiencies in the way medical practitioner boards deal with complaints against medical practitioners; in particular, the Board’s lack of discretion to deal with complaints lacking substance. Early mediation of the dispute between the Royal Women’s Hospital and the Medical Practitioners Board could have avoided a great deal of suffering and expense. As a result of this case, it is likely that the Victorian Medical Practitioners Board will be given additional powers in the future to deal with complaints without merit.

Paul Gerber LLB, DJur

To the Editor: The recent editorial by White and Whiteford raises the important issue of the need to provide more extensive and more effective mental health services for the prison population.1 However, their discussion of the reasons for the increased level of need does not consider one important problem that often results in the inappropriate imprisonment of people with mental illness. This is the frequent refusal of acute psychiatric units to accept mentally ill people referred by the courts. I recently reviewed a series of 102 referrals for medicolegal assessment from Legal Aid New South Wales between February 1999 and March 2006. The results were presented at the 2006 meeting of the Forensic Section of the Australian and New Zealand College of Psychiatrists.2 Of the 55 patients meeting the criteria for mental illness under section 32 or 33 of the Mental Health (Criminal Procedure) Act 1990 (NSW), 27 (49%) were seen in custody. For 14 of these patients, their incarceration had resulted from the failure of the local area heath service to accept patients for admission if they had drug-related exacerbations of mental illness. Hospital registrars would return patients to court with a certificate saying that they had no mental illness, even though some of them were currently under a community treatment order recommended by other professionals from the same mental health service. To some extent, this may be because of the strict application of the guidelines for compulsory hospitalisation. These are more stringent than the criteria for defining mental illness under the Mental Health (Criminal Procedure) Act, but one is left with anomalous situations such as the one described above. Important issues leading to this situation appear to be the presence of dual diagnoses (10 of the patients reviewed had a combination of psychosis and substance misuse) and violent behaviour. The rejection of violent patients reflects both occupational health and safety considerations in the context of inadequate resources and an industrial stance (usually informal) taken by the nursing staff. It is therefore important that some of the additional resources recently committed by Australian governments to the reform of forensic mental health services be directed towards the provision of acute hospital inpatient services for disturbed patients, so that the incidence of imprisonment in the acutely disturbed psychiatric population is reduced. This is more humane and may be more cost-effective than simply applying all the resources within the prison system.

Gordon R W Davies

Nanotechnology is a revolutionary field of micro-manufacturing involving manipulation, by chemical or physical processes, of individual atoms and molecules. Pharmaceutical and medical device manufacturers, both in Australia and internationally, have significant investments in nanotechnology research and development. It is important that safety regulation of nanotherapeutics keep pace with this growing level of industry interest. A recent senate inquiry recommended the establishment of a working party, including representatives of the Therapeutic Goods Administration, to consider whether bulk materials classified as safe should be routinely reassessed for use at the nanoscale level by a permanent, distinct nanotechnology regulator. Safety regulation of nanotherapeutics may present unique risk assessment challenges, given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic classifications of “medicines” and “medical devices”. Nanotherapeutics is likely to make increasing claims on a particular area of Australian health care regulatory strength: scientific cost-effectiveness assessment of innovation in medical products. Any review of Australian regulation of nanotechnology should include a critical analysis of both safety issues and cost-effectiveness assessment systems for nanotherapeutics.

Thomas A Faunce BA/LLB, BMed, PhD