Health services administration

To the Editor: I compliment Dunbar and colleagues on their analysis of the systematic problems underlying whistleblowing “scandals” at four Australian hospitals.1 I disagree totally, however, with their major conclusion. I refer to their endorsing the recommendation from the President of the General Medical Council of the United Kingdom that “... if there’s a risk to patients ... we expect people to pipe up, but pipe up locally”. Attempting to put this recommendation into practice is itself the root cause of the problem. The many and varied obstacles to locally notifying one’s concerns about a colleague’s performance are almost insurmountable; any permutation or combination might apply in a particular location. On the part of the whistleblower, obstacles might include fear of their confidence being breached, being suspected of professional envy or of being a troublemaker, a concern for job security or about failure to be promoted, a reluctance to rock the boat in their own working environment, or fear of being victimised at work. On the part of the chief executive officer or equivalent local person to whom the report is made, obstacles might include their potential affront at a slight on their responsibility for overall management or for having appointed the person to whom the notification refers, personal friendships and even family relationships (especially in smaller centres), reluctance to have to inquire into a senior staff member’s work, or financial implications (as in the case of Bundaberg Hospital1). I suggest that, instead of trying to overcome such awkward and off-putting obstacles locally, performance concerns should be taken directly to a statutory body with responsibility for overall standards of health care and with absolutely no “conflicts of interest” in specific local situations. In New South Wales, at least, and specifically in relation to doctors, Section 86E of the Medical Practice Act 1992 provides that persons may notify the medical board of professional performance matters, namely “any matter that the person thinks indicates that the professional performance of a registered medical practitioner is unsatisfactory”. This avenue avoids all the pitfalls involved in attempting to resolve the matter locally, affords the potential whistleblower a recognised means of having their concerns given serious consideration, and reassures the whistleblower that the matter is in the hands of a responsible body with statutory authority and with tried and tested methods of dispassionately assessing the situation. The whistleblower would then have no need to “go public”, with the devastating results so well described by the authors.

Peter C Arnold

In reply: Dr Arnold raises the difficulties involved in bringing poorly performing colleagues to notice and proposes that reporting doctors to a medical board is the best option. There are difficulties in relying solely on medical boards. First, doctors have a very high threshold for referral to a medical board, so poor performance may not be reported. Even serious cases of poor performance can go unreported for many years.1 Second, there are many cases of remediable poor performance2 that require a different approach. In the United Kingdom, local procedures are managed by medical directors as part of their contract. The Good Medical Practice guidelines issued by the General Medical Council make it clear that all doctors have a responsibility to report poorly performing colleagues.3 If the medical director then fails to act, the hospital’s insurance could be invalidated and the medical director would appear before the General Medical Council. A number of Australian jurisdictions, including the Australian Capital Territory, New South Wales and Queensland,4,5 have made substantial progress in developing local procedures that offer the best opportunity for remediation of doctors where possible, and for discipline by the medical board where not. With these procedures, we can assure patients of safety while maintaining as many doctors as possible in the workforce.

James A Dunbar · Prasuna Reddy · Bill Beresford · Wayne P Ramsey · Reginald S A Lord

To the Editor: We refer to the study reported by Correa-Velez and colleagues, which found lower hospital utilisation rates among patients from refugee-source countries compared with the Australian-born population in Victoria.1 As noted by the authors, there is a dearth of evidence on the use of health services by refugees. Their 6-year investigation stands as a singular study of its kind in Australia, and we recognise its potential to inform policy on refugee health care. However, we argue that the authors’ conclusion that “the Refugee and Humanitarian Program does not currently place a burden on the Australian hospital system” cannot be drawn from the data collected in the study. Refugee groups have health needs related to histories of torture and trauma, and associated somatic symptoms.2 Furthermore, refugees have often been exposed to diseases that are infrequently encountered in the general Australian population. Considerable time is required to train health professionals to diagnose and treat such complex clinical presentations. In addition, adequately servicing the special needs of this patient group requires the provision of appropriately qualified interpreters. When an interpreter is required during a clinical consultation, additional time is often needed to gain clarity. Interpreters can also be difficult to source, which places added time and resource pressures on health care administrative staff and budgets. Correa-Velez et al do refer to the “multiple barriers that prevent refugees from adequately accessing health care services”. Further research is required to comprehensively assess the reasons why, given the complexity of their health care needs, refugees are not accessing the hospital system at the same rate as other Australians. The authors suggest that reasons for an increase in service utilisation by refugees in recent years may include an increased level of familiarity with services, or poorer health status of recently arrived refugees. Previous reports have indicated that refugees tend not to utilise health care services where fundamental issues of access, such as language barriers and lack of education about the availability of health care services, have not been addressed.2,3 Since Correa-Velez and colleagues’ data were collected, several states, including Victoria, have developed primary health care programs for refugees, with varying degrees of success. As the Queensland Government considers a new statewide model for refugee health,4 it is essential to ensure adequate resources are allocated for refugee and staff education programs and interpreting services.

Joy L Mendel · Claire E Brolan

Objective: To determine the risk of occurrence and recurrence of postpartum haemorrhage (excessive bleeding after childbirth) among women having at least two consecutive pregnancies.Design and setting: Population-based study using longitudinally linked hospital discharge and birth records from New South Wales for the period 1 January 1994 to 31 December 2002.Participants: All 125 295 women having at least a first and second pregnancy resulting in a singleton birth at > 400g or ≥ 20 weeks’ gestation in the study period.Main outcome measures: Risk of occurrence of postpartum haemorrhage (PPH) in any pregnancy, and of recurrence of PPH in subsequent (second and third) pregnancies.Results: 5.8% of women (7327/125 295) had a PPH in their first pregnancy, and 4.5% (5318/117 968) had a first PPH in their second pregnancy. Among the 23 095 women who had three pregnancies in the study period, 4.4% (908/20 839) had a first PPH in their third pregnancy. The risk of recurrence in a second consecutive pregnancy was 14.8% (1082/7327), and in a third consecutive pregnancy (after two previous PPHs) was 21.7% (43/198); even with an intervening pregnancy with no PPH (ie, PPH in the first and third pregnancies only), the risk for the third pregnancy was 10.2% (111/1085).Conclusions: These consistently elevated risks of recurrence highlight the need for women with a history of PPH to have active management of the third stage of labour and to give birth in a hospital that has onsite blood cross-match facilities.

Jane B Ford BA(Hons), PhD · Christine L Roberts MPH, DipObs, DrPH · Jane C Bell BDS, MAppEpid, MPH · Charles S Algert BA, BSc, MPH · Jonathan M Morris MB ChB, FRANZCOG, PhD

Objectives: To investigate the correlation between the publication “track record” score of applicants for National Health and Medical Research Council (NHMRC) project grants and bibliometric measures of the same publication output; and to compare the publication outputs of recipients of NHMRC program grants with those of recipients under other NHMRC grant schemes.Design: For a 15% random sample of 2000 and 2001 project grant applications, applicants’ publication track record scores (assigned by grant assessors) were compared with bibliometric data relating to publications issued in the previous 6 years. Bibliometric measures included total publications, total citations, and citations per publication. The program grants scheme underwent a major revision in 2001 to better support broadly based collaborative research programs. For all successful 2001 and 2002 program grant applications, a citation analysis was undertaken, and the results were compared with citation data on NHMRC grant recipients from other funding schemes.Main outcome measure: Correlation between publication track record scores and bibliometric indicators.Results: The correlation between mean project-grant track record scores and all bibliometric indicators was poor and below statistically significant levels. Recipients of program grants had a strong citation record compared with recipients under other NHMRC funding schemes.Conclusion: The poor correlation between track record scores and bibliometric measures for project grant applications suggests that factors other than publication history may influence the assignment of track record scores.

Marcus B Nicol BSc, MPH, PhD · Kumara Henadeera PhD · Linda Butler BEcon

To the Editor: Two recent articles in the Journal touch on the current plight of medical academics. Hays emphasises the need to reassert the role of teaching in academic medicine — otherwise, “our aim to produce safer, more efficient doctors will be under threat”.1 Joyce and colleagues outline the projected increase in the number of graduates from Australian medical schools, although their concern is more for the post-graduate careers of these young doctors than for their initial clinical training.2 In 2006, Van Der Weyden warned that not only do new ways of teaching medical students need to be rapidly explored but also that more skilled teachers must be found and trained.3 Medical students themselves believe that more clinical teachers are required to ensure that the increasing numbers of students are taught effectively.4 From personal experience we know that, while many full-time clinicians are both willing and inspiring teachers at undergraduate level, a core of permanent academics is needed to direct teaching during these clinical years. But why would anyone choose to be a medical academic today? Certainly not for the money — a recently qualified obstetrician/gynaecologist, starting at senior lecturer level after about 15 years of training, is looking at an income of less than half that of a staff specialist at the same level, and a quarter of that possible in private practice. One day of private practice per week does not help — obstetrics is a full-time commitment, and even in gynaecology the need to pay practice and indemnity costs outweighs any financial benefits. Is it the kudos? Adjunct academic titles are easily gained by non-academics: hospitals are awash with adjunct associate professors and lecturers. The adjunct appointment system often lacks regular and critical appraisal, and in some cases titles are used to the professional or financial gain of the recipient, with little reciprocal input into teaching at the institution concerned. (However, there are indications of attempts to crack down on such practices.)5 The lifestyle then? Academics may have a less frenetic clinical schedule, but the continuing pressure to produce quality research and to jump increasingly higher hurdles to obtain grants can mean that the limits of the working week are much less defined than for our staff specialist colleagues. We have seen many colleagues depart academia in the past few years for the more verdant pastures of full-time clinical practice. While we are in agreement with Hays about the need for more research into how best to design medical education, we believe that, unless there are urgent improvements in the remuneration, career structure and professional regard for clinical academics, the core workforce of skilled teachers so clearly needed for incoming students will just not be there to deliver that education.

Ajay Rane · Caroline de Costa

Significant similarities between the challenges of lung transplantation in patients of all ages should lead to better access to this life-saving surgery for children and adolescents Lung transplantation (LTx) is firmly established as a therapy for end-stage lung and pulmonary vascular diseases in patients aged over 18 years and into the seventh decade of life.1,2 However, for those under the age of 18, be they child or adolescent, the role of LTx is less clear.3,4 In Australia, this has contributed to a perception that the risk of undertaking LTx in children and adolescents does not warrant the reward. Indeed, presently in this country, there is no major paediatric hospital offering a lung transplant program, likely recognising the complexity of treating such patients coupled with the potential risk of achieving poor results with a low case load — the reality is that the projected case numbers will only be of the order of four to eight per year across Australia and New Zealand. Thus, by focusing on successful LTx outcomes for an adolescent population, the article by Morton and colleagues in this issue of the Journal5 highlights a number of the key issues regarding the efficacy and utility of LTx for younger Australians (→ Successful lung transplantation for adolescents at a hospital for adults). Although adolescence refers to a transitional state from childhood to adulthood, patients 15 years and younger are generally excluded from adult hospitals and those 18 years and above excluded from paediatric hospitals. Two-thirds of the patients in the study by Morton et al could have been “routinely” treated in adult hospitals. Notwithstanding this limitation, the report gives important insight into the issues, experience and successful outcomes that can be achieved in younger lung transplant recipients. From this article, it is apparent that in Australia, a well developed, large adult LTx unit is able to use its highly specialised services to overcome some of the problems and deficiencies that can limit a stand-alone service for such a small population as children and adolescents requiring LTx. However, the age of any potential Australian lung transplant recipient is critically important — at this time, this technology is not being routinely offered to younger children. Indeed, at present, Australia’s youngest ever lung transplant recipient was aged 9 years at the time of LTx.6 The improved outcomes for LTx now described in adolescents5 should provide an impetus to provide access for younger potential LTx recipients. In looking to achieve this advance, we need to keep in mind that the transplant recipient’s age can matter in several different ways. Fortunately, severe lung disease warranting consideration of LTx in children and adolescents is relatively rare, although interestingly, it does have a bimodal distribution. The International Society for Heart and Lung Transplant (ISHLT) Registry 2005 paediatric report notes about 65 procedures performed worldwide each year.7 In older paediatric patients, typically over 12 years of age, about 70% will have cystic fibrosis as the primary indication for LTx, whereas in infants aged less than 3 years, the indication in about 60% is congenital heart disease or pulmonary hypertension. Despite the perception that transplant recipients fare worse if they are younger, the recent ISHLT Registry reports a half-life of around 5 years after LTx, and no significant survival difference between adults, adolescents and the very young.7 Rates of early graft dysfunction and late graft dysfunction (ie, bronchiolitis obliterans syndrome [BOS]) are also similar. However, causes of death are quite different, with adults and adolescents dying from respiratory failure related to BOS, and younger children dying from infection. The functional status of survivors is excellent, with over 80% reporting no activity limitations at 5 years,7 although morbidity related to the obligatory immunosuppressant drugs is very common across all age groups. Further, there are some specific issues (medical, psychosocial and legal) associated with LTx in adolescents and children compared with adults. Post-transplant lymphoproliferative disorders, growth retardation, respiratory tract infections and medical non-adherence appear much more commonly in children.8 As discussed by Morton and colleagues, facilitating compliance with therapies and medication are particularly challenging areas when working with adolescents.5 As an example, immunosuppressive protocols need to reflect potential concerns about physical appearance. Also, a particular “at risk” period arises when paediatric LTx recipients transition from paediatric to adult care.9 Performing major surgery with substantial short-term and long-term mortality risks in a patient unable to give consent presents ethical and legal dilemmas. For paediatric patients with severe lung disease, recent technological advances provide the potential to build on the excellent results of LTx in adolescents presented by Morton et al.5 Minimal waiting list mortality is a critical component of any assessment of the efficacy and utility of organ transplantation. Thus, the management of severe lung disease by experienced teams, with appropriate use of newer therapies such as bi-level positive airway pressure (BiPAP), dornase alfa and azithromycin in patients with cystic fibrosis, may lead to a successful “bridge to transplant”. Similarly, intravenous epoprostenol, oral bosentan and sildenafil may provide a bridge to transplant for patients of all ages with severe pulmonary hypertension. The study by Morton et al included several terminally ill individuals transplanted after support with mechanical ventilation or extra-corporeal membrane oxygenation.5 Morton and colleagues are to be commended for their successful endeavour, but we contend that further detailed discussion about excessive early mortality10 and resource use is needed before bridging in this fashion is routine in any age group. Such bridging has become increasingly used in the United States (11% of all LTx in 200611) and we believe that many, including ourselves, would argue that Australia does not have the intensive care facilities and staff to routinely bridge in this manner. There are also other developments that should increase transplant opportunities and access to LTx for children and adolescents, hopefully shortening waiting times, thereby further decreasing waiting list mortality, and potentially allowing at least the possibility of retransplantation in the event of late graft dysfunction. One possibility is that large-volume LTx transplant centres (typically not small-volume paediatric-only centres, as yet) might increase organ availability by using extended donor lungs (eg, where there are secretions or an abnormal chest x-ray, etc),12 or cadaveric or living-related lobar transplants (eg, so-called “cut-down lungs”).13 The use of cut-down lungs typically involves transplanting one lobe from each of two adults to make a bilobar transplant for a child or smaller adolescent. Although this resource-intensive and challenging operation is possible, some question the philosophy of undertaking the only known procedure to have a “potential 300% mortality”.13 Donation-after-cardiac-death (DCD) retrieval of lungs for transplantation (as distinct from the usual donation-after-brain-death retrieval) is also now a viable prospect being used to acquire adult lungs for LTx,14 and will soon be extended to paediatric DCD lung donation.15 Thus, evidently, expanding the complexity and extent of LTx offered to children and adolescents might consume significant resources, so LTx results must be carefully considered and evaluated to ensure continued successful outcomes. In this regard, we note with great interest the recent institution of a complex mathematical lung allocation score model by the American United Network for Organ Sharing (UNOS).16 This model uses disease-relevant clinical and physiological variables to predict who will get the most significant improvement in survival with LTx and, therefore, who should be preferentially transplanted. Although historically based, the model will evolve with ongoing clinical experience and should be able to provide new evidence to guide future practice. Interestingly, because of differences in diagnostic categories and post-LTx outcomes in younger lung transplant recipients, the UNOS lung allocation score is only to be applied to those aged over 12 years.16 So, although there are important differences to consider when evaluating the efficacy and utility of LTx across the wide age-spectrum of disease and physiology in the very young, adolescents and adults with terminal lung disease, there is also significant overlap. Medical and allied health experts in paediatric and adolescent medicine have much to offer adult LTx programs venturing into adolescent transplantation; their involvement should be routine. Similarly, units experienced in adult LTx bring knowledge and technology to paediatric and adolescent LTx that can only benefit the small number of critically ill young Australians previously without local access to LTx expertise.

Gregory I Snell MB BS, FRACP, MD · Glen P Westall MB BS, FRACP · Trevor J Williams MB BS, FRACP, MD

Australia is well placed to again lead the world in health technology assessment Australia led the world in 1993 when it introduced the so-called “fourth hurdle” of economic evaluation into the approvals process for drugs (in addition to the usual regulatory “hurdles” of quality, safety, and efficacy).1 We are among the dozen or so developed countries that had invested in health technology assessment (HTA) since the early 1980s, but it was the requirement of a favourable economic evaluation that attracted international attention to HTA in Australia.2 While economic evaluation had always been considered a component of HTA, a policy requiring evidence of cost-effectiveness was groundbreaking.3 In 1998, the federal Minister for Health created a parallel HTA process for new medical services. Evidence of sufficient safety, effectiveness and cost-effectiveness to be included in the Medicare-subsidised benefits package now forms the basis for coverage recommendations to the Minister by the Pharmaceutical Benefits Advisory Committee (PBAC) for drugs, and the Medical Services Advisory Committee (MSAC) for medical services and technologies (Box).5 In contrast to most other countries, HTA in Australia has been woven into the fabric of health services funding, giving it greater impact on the introduction of new treatments. Our approach is similar to that of the United Kingdom’s National Institute for Health and Clinical Excellence6 but differs from Canada’s more “hands off” implementation approach,7 both described in this issue of the Journal ("Health technology assessment in England: assessment and appraisal" and "Health technology assessment in Canada: diversity and evolution", respectively). Most other countries have structured their HTA processes to be “advisory” to doctors and health care services. It is unclear whether this separation of advice from funding is more effective than the direct application of HTA to coverage decisions seen in Australia and the UK, but a common lament from academics and policy-makers in such systems is that HTA findings are not “taken up” by health care providers.8,9 Separating HTA from coverage decision making may lead to less contention with professional groups and the biotechnology industries, but perhaps also reduces the impact of the HTA effort. Because of their direct impact on government coverage decisions, and the still novel requirement for an acceptable incremental cost-effectiveness ratio, both the PBAC and MSAC have been subject to industry and political scrutiny. The most comprehensive inquiry was a 2005 Productivity Commission report on advances in medical technology in Australia.10 The PBAC was a major focus of negotiation leading to the Australia–United States Free Trade Agreement,11 and the MSAC has conducted an internal review and consultation process,12 in part as a response to industry criticism of delays in the assessment process.4 A third article in this issue of the Journal by Petherick and colleagues (→ An evaluation of methods used in health technology assessments produced for the Medical Services Advisory Committee) examines the evolution and shortcomings of systematic reviews in published MSAC assessment reports since 1998.13 Although the Australian system is apparently fragmented (medicines versus services, federal versus states, public versus private systems), differing characteristics of each may justify separate approaches. It is clear that the longer history of drug safety regulation makes pharmaceutical evaluation more straightforward than evaluation of medical services.10,14 Surgical interventions provide their own unique challenges to evaluation methods, and the Australian Government has funded ASERNIP-S (Australian Safety and Efficacy Register of New Interventional Procedures — Surgical) to conduct HTAs under the sponsorship of the Royal Australasian College of Surgeons.15 Funders at each level of the system (federal and state) have differing responsibilities and interests, probably best served by dedicated evaluation efforts, but there has been considerable synergy in the development of HTA among these stakeholders. The Productivity Commission report highlighted a number of recent developments that fill gaps and reduce friction between the needs of different HTA users.10 Through the Australian Health Ministers’ Advisory Committee (AHMAC), the states pool funds to sponsor HealthPACT (Health Policy Advisory Committee on Technology) which performs “horizon scanning” for state health departments,16 and shares secretariat and other functions with MSAC. This mechanism alerts the funders of public hospitals to emerging medical technologies with potential to influence their health care systems. The states together determine HealthPACT’s budget and work program. In addition, AHMAC has delegated to MSAC a role in advising on Nationally Funded Centres (NFC). These are services where the volume of relevant cases is not sufficient to justify more than one or two units in the country — historically, these have been transplant units. The NFC designation ensures that all states contribute to funding of such units, thus guaranteeing access for residents of all states. State health departments are developing their own HTA capabilities. For example, the Victorian Policy Advisory Committee on Clinical Practice and Technology17 was set up in 2004 to undertake a variety of HTA activities, including horizon scanning, assessment and monitoring for the Victorian Department of Human Services. State-based committees commonly consider applications for high-price and/or high-volume drugs, devices and procedures, and create a mechanism to approve funding for novel or statewide specialty services outside normal hospital funding arrangements. Hospitals and regional health services in Queensland, Western Australia, South Australia and Victoria have established internal HTA committees to oversee the introduction of new drugs and medical procedures, with examples from Bayside Health and Southern Health in Victoria cited by the Productivity Commission in its report.10 Public hospitals, with their role in medical education and research, may need to focus on different technologies at different stages of the product development cycle than do private hospitals and health insurers. In contrast to Australia, the HTA efforts of Canada and the UK have a unified approach to drugs and other technologies. The UK National Institute for Health and Clinical Excellence has an advantage over MSAC and PBAC in setting its own agenda, the so-called “needs-led” prioritisation of HTA topics. Canadian HTA organisations seem to balance the needs of the system as a whole against those of particular interests, including those of funders,7 but probably come closer to HealthPACT’s user-led prioritisation. All jurisdictions grapple with the politically charged problem of “disinvestment” — that is, ceasing to support therapies whose effectiveness (and/or cost-effectiveness) cannot be demonstrated. Both the UK and Canada have successfully pioneered “rapid response” methods for HTA users requiring timely answers to tightly framed clinical questions, an approach not yet common in Australia. Clinical evidence for HTA is derived from systematic reviews, and these in turn rely on randomised controlled trials (RCTs). Evidence-based medicine has refined the tools available for evaluating evidence of clinical benefit; basic physiological evidence of efficacy can come from trials in any country. However, evidence of real-world effectiveness is dependent on the medical culture, workforce and referral patterns of a particular health system, and economic evaluation is even more dependent on the organisational forms of health care, including the skills mix and relative wages of different professional groups. Generally economic assessments use decision–analytic models, with key outcomes costed locally to determine the cost-effectiveness of an intervention in each health care system. None of the national HTA processes described has the capacity to commission new clinical research, and there is little articulation with existing medical research priority-setting processes. This often results in rejecting new technologies because there is no RCT evidence of their efficacy or effectiveness, rather than evidence that they are ineffective.4 Both the UK and the US are trialling “coverage with evidence” approaches to funding new medical technologies as a way of bridging current gaps in evidence.18 These allow introduction of new services or biotechnologies on the condition that patients are entered into rigorous clinical trials, and with the understanding that continued funding will depend on the evidence from these trials. The coming of molecular medicine with its individualised and gene-based therapies will exacerbate the lack of clinical evidence from RCTs.19 The “demise of the blockbuster” drug will demand a new research-intensive paradigm for evaluation and regulation of therapies in developed countries.20 Monitoring drug safety21 and funding the collection of randomised evidence22 are possible in Australia, even with current evaluation tools. However, we will need focused effort to develop more “fine-grained” clinical epidemiology techniques to identify patient characteristics that mediate response to treatment and define which subgroups are likely to derive how much benefit from new treatments at what cost. The phrase “rapid learning health system” has recently been coined to characterise the ways in which computerised medical information can be used to inform health care decision making from the bedside to national HTA efforts.23 With Australia’s large health information technology investment, well established disease registries and systematic metadata specifications, we are in a position to pioneer rapid learning strategies that can be used earlier in the evaluation process, and at an acceptable research cost. The challenges then are to manage the inevitable tensions that arise when HTA directly influences funding decisions, to tailor HTA methods to the needs of different stakeholders with differing timelines, to focus HTA strategically to meet national needs including the capacity to disinvest from ineffective treatments, and to supplement RCT efficacy evidence with real-world evidence of effectiveness and cost-effectiveness. Australia could once again claim leadership of international HTA by creating the evaluative and funding mechanisms to rise to these challenges. Requirements for Medicare subsidy of drugs and medical technologies in the Australian health care system Drugs Applicants are required to prepare detailed evidence-based submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), once drug safety has been assessed by the Therapeutic Goods Administration (TGA). Applications are rigorously assessed by health technology assessment (HTA) organisations contracted to PBAC, which then provide confidential reports to PBAC. All documentation for PBAC recommendations is considered “commercial in confidence”, and only brief reports on decisions and deferrals are published. Medical services and technologies The Medical Services Advisory Committee (MSAC) undertakes its own assessments, also by contracted HTA organisations. MSAC reports are published once the Minister has made a determination about listing on the Medical Benefits Schedule. About a third of the work program of MSAC comes as referrals from the federal Department of Health and Ageing.4

Terri J Jackson PhD

The Health Technology Assessment (HTA) Programme in England is a government-funded but independent research program. It is “needs-led”, identifying technologies of most importance to the National Health Service and commissioning research to provide answers on these technologies useful to policymakers, clinicians and patients. It is “science-added”, refining problems to researchable questions and working with researchers to ensure that the question is addressed, and disseminating the findings to key audiences. There is a clear distinction in England between assessment (a scientific process and the role of the HTA Programme) and appraisal (the role of policymakers, like the National Institute for Health and Clinical Excellence). There are many features common to HTA in Australia and England, but also differences, as HTA in each country has to adapt to its own environment.

Tom Walley MD, FRCP, FRCPI

Canada has health technology assessment programs at national, provincial and local levels. The programs have been complementary in providing advice to decisionmakers in health care. A national strategy for the management of health technologies is expected to strengthen communication with policy areas.

David M Hailey MSc, PhD

Objective: To examine the methods used in health technology assessments (HTAs) produced for the Medical Services Advisory Committee (MSAC) reviewing the effectiveness of a technology or procedure.Design and setting: Data were extracted from the effectiveness section of HTA application assessment reports published between 1 January 1998 and 17 July 2006 and available on the MSAC website. Only HTAs of effectiveness interventions were examined, as the methods used to undertake such reviews are well established.Main outcome measures: Variables reflecting methods used in the HTAs to evaluate the effectiveness of health technologies or procedures.Results: Of 56 MSAC HTA reports available, 31 met the inclusion criteria. Considerable variability was shown to exist between the various indicators of quality and the methodology used within the HTAs. Reports did not describe potential conflicts of interest of participants. The majority of reports (19/31) did not formally state the research question that the assessment was attempting to answer. Just over half of the reports (18/31) provided details of validity assessment of the included studies.Conclusions: Minimum and consistent standards of methodology and reporting are required in Australian HTAs, using international recommendations of best practice to increase the transparency and applicability of these reports.

Emily S Petherick BSc(PhysEd), MPH · Elmer V Villanueva MD, ScM · Jo Dumville MSc, PhD · Emma J Bryan BSc, PhD · Shyamali Dharmage MD, PhD

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

As practice continues to evolve, there will need to be concurrent changes in undergraduate and postgraduate medical education on skin cancer Over the past two decades, preventive health programs about the need for sun protection have alerted patients to the significance of increased rates of skin cancer in white Australians. Skin checks of both affected people and the “worried well” have become daily medical practice. This public demand has resulted in changes to medical practice and an increase in associated health costs, as touched on in two other articles in this issue.1,2 In this editorial, I argue that, as practice continues to evolve, there will be a need for concurrent changes in undergraduate and postgraduate medical education on skin cancer. Each year over 300 000 Australians are diagnosed with melanoma or non-melanoma skin cancer.3 However, on clinical examination, it is not always easy to tell the difference between benign lesions and skin cancer, even with specialist training. Both patients and medical practitioners feel the pressure to excise lesions if there is doubt about their malignancy. In this issue of the Journal, Youl et al report that a quarter of the number of lesions removed were as a result of patient insistence.1 For every melanoma excised, about 20–25 benign pigmented lesions are excised,1,4 amplifying surgical and pathology costs — nearly 300 000 benign naevi were excised over the period July 2005 to June 2006.5 Further, Askew et al demonstrate that skin cancer excisions are increasingly associated with complex and expensive surgical repairs.2 Medicare Australia statistics show that procedural cryotherapy for 10 or more solar keratoses was performed 595 568 times between July 2005 and June 2006.5 Skin cancer has been reported as the costliest of all cancers to treat.6 Traditionally, actinic lesions were initially managed by general practitioners, with appropriate referral to dermatologists, surgeons and radiotherapists. If GPs were uncertain about skin cancer diagnoses, they would refer patients to specialist dermatologists, who often had long waiting lists, were variably accessible, and charged higher fees. The Australasian College of Dermatologists (ACD) has long recognised the skin cancer “epidemic” in Australia, but has had difficulty meeting patient demand for dermatologists’ services, even with a trebling of the number of trainees from 20 in 1976 to 65 in 2006 (ACD, unpublished data). With a minimum 4-year training scheme, the number of practising Australian dermatologists has only risen from 136 in 1976 to about 350 in 2006 (ACD, unpublished data). Most people in metropolitan areas will have to wait for weeks or months to see a dermatologist, while access to dermatologists in rural and regional Australia is variable. The College’s state facilities have created regional outreach clinics with rostered dermatologists, but services still need to be improved. The two-tier relationship between GPs and specialists has been challenged recently by the rapid growth of skin cancer clinics that bulk-bill patients and are staffed by non-specialist medical practitioners.7 There are no regulations about who can set up these clinics — some are part of large commercial corporations. Nor are there any particular requirements for training of the clinicians who work there. Thus, an under-regulated three-tiered system of skin cancer management has developed. From the patient’s point of view, the convenience, accessibility and billing arrangement of these clinics may be appreciated. But, patients may also be incorrectly assuming that the attending medical practitioners have had “specialist training” and be unaware that their usual GP may be just as competent.1 From a professional perspective, some skin cancer clinicians, realising that they may have a “credibility” issue with their colleagues, have started to form liaisons with universities to establish accreditation courses. These clinicians are the “standard bearers”, but we need to know the competence of all clinicians in all skin cancer clinics, which should be open to examination by the public and professional peers. In my view, the rise of skin cancer clinics and the partial “sidelining” of GPs in skin cancer management is due not only to the relative shortage of specialist dermatologists but also to a failure in undergraduate and postgraduate education on skin cancer. In the 1980s and 1990s, I believe there was a profound, long-term underinvestment in the number of Australian medical schools, accompanied by variability in the breadth and quality of teaching on skin cancer. Over the next few years, owing to the development of new medical schools, the number of medical students graduating each year will almost double.8 Ensuring that skin cancer education is adequate will be an enormous challenge. Given the high prevalence of skin cancer in Australia, the Australian Medical Council should ensure that universities can sign off their graduates as competent in clinical recognition of skin cancers, as all interns will need this skill. This education needs to be significantly patient-based, to ensure that medical students have the chance to develop an appreciation of subtle clinical features. Available resources, including teachers as well as patients, are limited. New paradigms, educational technologies and collaborations will need to be established quickly.9,10 Going beyond basic recognition of lesions, skin cancer management is a complex issue, involving both procedural and pharmaceutical interventions. This requires supervised training, which should be undertaken by postgraduate clinicians who want to manage skin cancer. At the moment, further training for non-dermatologists who wish to increase their skills in this area is extremely ad hoc. Some universities have recently capitalised on the interest in skin cancer management by establishing skin cancer courses for medical postgraduates.7 These vary from weekend diagnostic certificate courses to year-long masters degrees, but, critically, may lack a significant component of face-to-face clinical contact with patients. While such courses may form an important part of future postgraduate skin cancer education, I believe the first priority of universities must remain the provision of undergraduate education. A different approach would be to look at more “hands-on” clinical training to achieve clinical competence in skin cancer management. The Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, and the ACD are working on a unique training and education scheme that will provide supervised clinical attachments and assess competence, but this program will take years to provide enough certified GPs. In the meantime, other GPs are establishing and publishing their credentials to manage skin cancer.2,3 There may be little difference in outcomes between competent experienced GPs and skin cancer clinicians.1 Public health studies have ensured that we are now aware that skin cancers are five times more common than all other cancers combined.6 Now the public needs to be assured that new medical graduates are able to recognise skin cancers and that postgraduate education institutes will ensure that clinicians who choose to treat skin cancer are appropriately trained and competent.

Christopher A Commens MB BS, FACD

Objective: To measure and compare the casemix and diagnostic accuracy of excised or biopsied skin lesions managed by mainstream general practitioners and doctors within primary care skin cancer clinics.Design, setting and participants: Prospective comparative study of 104 GPs and 50 skin cancer clinic doctors in south-eastern Queensland, involving 28 755 patient encounters. The study was conducted in 2005.Main outcome measures: Prevalence of each type of skin lesion; sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the clinical diagnosis against histology; number needed to excise or biopsy (NNE) for a diagnosis of skin cancer.Results: GPs excised or biopsied 3175 skin lesions (mean 2.5/week) including 743 basal cell carcinomas (BCCs) (23.4%), 704 squamous cell carcinomas (SCCs) (22.2%) and 49 melanomas (1.5%). Skin cancer clinic doctors excised or biopsied 7941 skin lesions (mean 34/week), including 2701 BCCs (34.0%), 1274 SCCs (16.0%) and 103 melanomas (1.3%). Overall, sensitivity for diagnosing any skin cancer was similar for skin cancer clinic doctors (0.94) and GPs (0.91), although higher for skin cancer clinic doctors for BCC (0.89 v 0.79; P < 0.01) and melanoma (0.60 v 0.29; P < 0.01). The overall NNE was similar for skin cancer clinic doctors (1.9; 95% CI, 1.8%–2.1%) and GPs (2.1; 95% CI, 1.9%–2.3%). This did not change after adjusting for years of clinical experience.Conclusions: GPs and skin cancer clinic doctors in Queensland treat large numbers of skin cancers and diagnose these with overall high sensitivity. The two groups diagnosed skin cancer with similar accuracy.

Philippa H Youl MPH · Peter D Baade PhD · Monika Janda PhD · Christopher B Del Mar MD · David C Whiteman PhD · Joanne F Aitken PhD

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

Objective: To investigate the prevalence and format of medical morning handover report (MMHR) in Australian hospitals.Design, setting and participants: Questionnaire survey faxed to 76 Australian hospitals accredited for basic physician training by the Royal Australasian College of Physicians (RACP). The survey was conducted in 2005.Main outcome measures: Use of MMHR; structure and format of meetings.Results: 53 of 76 (70%) hospitals responded. However, some data (1.7% of possible responses) were missing or illegible. Prevalence of the use of MMHR in respondent hospitals was 58% (31/53). Analysing the data by RACP accreditation level, 18/24 Level 3 hospitals (75%) conducted MMHR compared with 5/9 Level 2 hospitals (56%) and 7/18 Level 1 hospitals (39%) (odds ratio [OR] for trend, 2.17; 95% CI, 1.12–4.23; P = 0.023). 44 of 53 respondents reported their Rural, Remote and Metropolitan Areas (RRMA) classification. MMHR is less likely to be held in hospitals in regions classified as RRMA 2–4 (8/21 [38%]) than those in capital cities (RRMA 1) (16/23 [70%]) (OR, 0.27; 95% CI, 0.08–0.95; P = 0.042). In 62% of hospitals, MMHR was chaired by a consultant, and at most hospitals (23/31 [74%]), meetings were 15–30 minutes long.Conclusions: In spite of RACP accreditation requirements, the use of MMHR in Australian hospitals accredited for basic physician training is low.

Matthew J Fassett BInfoSys(Hons) · Terry J Hannan MB BS, FRACP · Iain K Robertson MB BCh, MPH · Steven J Bollipo MB BS, FRACP · Robert G Fassett MB BS, FRACP

The obesity epidemic and global warming are linked through energy use. A personal carbon trading scheme aimed at reducing fossil fuel usage could act as a “stealth intervention” for reducing obesity by increasing personal energy use. Such a scheme would complement a corporate “cap and trade” system for carbon emissions, which should increase the relative price of processed, energy-dense foods. The scheme would work by reducing global carbon emissions to a sustainable level (contraction), while offering potential for trade of emission rights between frugal and profligate users of non-renewable energy (convergence). A key goal would be changed attitudes to conspicuous (and obesogenic) consumption. Adoption of the scheme would make healthy choices the easy choice.

Garry Egger MPH, PhD

An Australian GP’s pilgrimage to Rome to sound the voice of primary care Rather than finishing paperwork after a busy Monday in a Katoomba general practice, I (A W K) found myself sitting (jet-lagged) in a marble auditorium in Rome within the Istituto Superiore di Sanità (Institute of Public Health; Box 1) with about 200 other conference participants from the United States, Australia, and more than 22 different European Union (EU) and non-EU member states. We were waiting for an announcement by the Honourable Livia Turco, the Italian Minister of Health. An article I co-authored, which was published in the Journal in July 2006,1 had led to an invitation to participate in the 2-day International Rare Disease Conference (IRDC) and the subsequent 3-and-a-half-day NEPHIRD (Network of Public Health Institutions on Rare Disease) conference organised by Dr Domenica Taruscio, Director of the Centro Nazionale Malattie Rare (National Centre for Rare Diseases) in Rome, together held from 18–23 September 2006. The Ministry of Health announcement confirmed the Italian Government’s commitment to rare diseases and to orphan drugs research and development. The IRDC proceeded with an overview of initiatives in rare diseases in Italy and some of the more than 22 countries represented. The NEPHIRD involved morning presentations and afternoon small-group work, with the first day devoted to prevention and epidemiology, and the second to diagnosis and treatment. The third day dealt with the social aspects of rare diseases and, on the final morning, we heard plenary sessions on specific rare diseases such neurofibromatosis, Prader–Willi syndrome, myasthenia gravis, Cornelia de Lange syndrome and Rett syndrome. Plenary presenters were significant people in the field of rare diseases from Europe and the US, including Dr Kerstin Westermark, Chair of the Committee for Orphan Medicinal Products of the European Medicines Agency, Dr Ségolène Aymé, the Chair of the European Rare Disease Task Force, and Dr Marlene Haffner, Director of the Office of Orphan Products Development, which is part of the US Food and Drug Administration. The patient voiceAs the week unfolded, a striking theme was the presence of patients. Patients and carers dealing with Ehlers–Danlos syndrome, cystic fibrosis, narcolepsy, multiple endocrine cancers, Sjögren syndrome, chronic fatigue syndrome, fibromyalgia, fibrodysplasia ossificans, muscular dystrophy, cyclical vomiting, neurofibromatosis, and many others disorders, participated in and presented sessions. Specific sessions were devoted to patient groups to allow them to present the problems they face. In one moving contribution, Claudio Buttarelli, President of the neurofibromatosis support group Ananas (Italian for pineapple — rough on the outside but sweet on the inside), described the impact of this rare and misunderstood disease on every aspect of his life from socialisation in his teenage years through to the limitations imposed by nerve palsies on playing soccer with his children. Such sessions kept presentations on genetic research, new compounds, and public health initiatives grounded in the everyday experience of patients. However, the presence of patients should have been no surprise, as patient voices were instrumental in bringing the problem of rare diseases to the attention of governments. In the 1980s in the US, a peak patient group, the National Organization for Rare Disorders (NORD),2 was established to lobby for funding and research that no single rare disease could attract (Box 2). Eurordis (the European Organisation for Rare Diseases) fulfils a similar function. Notably, there is no peak patient body for rare diseases in Australia. Different storiesThe USDr Stephen Groft, Director of the Office of Rare Diseases (ORD) of the US National Institutes of Health,4 spoke at both conferences, describing ORD and some of its activities. ORD was set up in 1993 to stimulate and coordinate research on rare diseases and to support research to respond to the needs of patients with rare diseases. ORD supports a grants program to establish a network for research on rare diseases; grants are provided for such activities as the training of rare diseases researchers and programs to stimulate clinical research on rare diseases. Of particular interest to Australians because of its online accessibility is an information centre aimed at the public, researchers, and health care providers (http://rarediseases.info.nih.gov/asp/resources/rardis_info.asp). ORD also supports a national scientific conferences program to stimulate research and regional workshops to help patient support groups obtain assistance through the National Institutes of Health. EuropeIn April 1999, the EU Parliament set forth Decision No. 1295/1999/EC, adopting a program of community action on rare diseases within the framework for action in the field of public health (1999–2003). Many projects were funded under this program, and important initiatives that continued in the 2003–2008 European public health program5 include ORPHANET, a database for the general public on rare diseases (http://www.orpha.net/consor/cgi-bin/home.php?Lng=GB), and EUROCAT (http://www.eurocat.ulster.ac.uk/), which surveys more than one million births per year in 19 countries to provide epidemiological information on congenital abnormalities. We heard about innovative Italian initiatives, including the national network for the prevention, surveillance, diagnosis and therapy of rare diseases made up of certified centres expressly identified by the regions (decentralised administrative units) and the National Registry of Rare Diseases. This registry is established at the Centro Nazionale Malattie Rare,6,7 led by Dr Domenica Taruscio. The centre carries out a wide range of activities including genetic research into rare diseases, quality assurance of genetic testing, primary prevention projects, maintenance of the rare disease registry, dissemination of information, development of guidelines, involvement and coordination of EU projects such as NEPHIRD, qualitative research on patients’ quality of life, narrative medicine, and training of health professionals. Lessons for an Australian GPA need for coordinated activityThe relative lack of coordinated activity in rare disease in Australia compared with the US and Europe is striking — we believe there is a need for a peak patient group (such as NORD or Eurordis) in Australia to lobby for patients with rare diseases. Australia’s small population (with consequent small numbers of patients with any given rare disease) and geographic dispersal presents particular challenges in connecting patients with rare diseases with each other and with expert care. Presentations at the rare diseases conference covered a number of potentially useful strategies for connecting and empowering patients. Of particular note is Ågrenska in Sweden,8 which organises week-long camps at which families and patients with similar problems receive intensive education and establish connections with each other, and hear about specialist services. Ågrenska has been able to demonstrate better outcomes and cost savings through its strategy.8 Europe is establishing networks of excellence in which researchers and institutions with expertise in particular diseases are linked. We wonder whether Australian patients and clinicians with interests in particular diseases could join these networks, perhaps even participating in e-medicine consultations. The role of primary careThe specialists and scientist researchers at the conferences expressed frustration about the supposedly “low” level of skills of their primary care colleagues in identifying the rare disease in which they were expert. One specialist exclaimed that some GPs had never even heard of neurofibromatosis type 1. Some sessions at the conference presented this as an equity issue — surely, a patient with Prader–Willi syndrome has as much right to prompt diagnosis and evidence-based treatment as a patient with type 2 diabetes? The natural reaction is to call for more education of primary care clinicians in individual rare diseases. However, we do not think it would be realistic or even wise for GPs to use their time learning all the details of the 6000 identified rare diseases.4 We do believe that primary care has a neglected but important role in rare diseases. To date, progress in rare diseases has been driven by patients through their specialist clinicians and through public health institutions. Primary care clinicians provide a key link between patients in our community and the very specialised services those with rare diseases require. The Australian proposal of a generic model of general practice care1 was presented and discussed at the IRDC. One important and simple strategy identified during the week was careful monitoring of infant development as a generic strategy to screen for many rare congenital diseases. A voice from the perspective of primary care seemed to be quite strange to this very specialised community. In the main, they welcomed the general practice contribution and were excited by the possibilities of adding a primary care perspective to the rare disease agenda. Patients at the conference in particular confirmed the need to continue to develop the role of primary care clinicians in rare disease. Future connectionsThe pursuit of an idea (the common problem of rare disease in general practice) through to publication in the Medical Journal of Australia has led to a number of connections which have been professionally stimulating, satisfying and helpful. One of them was the IRDC in Rome 2006, which highlighted the international agenda on rare diseases. This conference has stimulated one Australian GP (A W K) to think further about and conduct more research into the role of GPs in rare disease. Policymakers, other clinicians, and patient groups in Australia also have the opportunity to reflect on the way forward. In particular, a funded initiative to establish a peak patient body for rare diseases seems long overdue. 1 The Istituto Superiore di Sanità (Institute of Public Health), conference venue, Rome 2 Rare disease facts Rare diseases are life-threatening or chronically debilitating diseases that have such a low prevalence (not more than 5 per 10 000) that specially combined efforts are needed to prevent morbidity and perinatal or early mortality, and to address quality-of-life and equity issues. There are approximately 6000 defined rare diseases. It is estimated that up to 6%–10% of the community have a rare disease.2 Patients with rare diseases have common experiences — including delayed diagnosis, wrong diagnosis, inappropriate surgery, lack of access to evidence-based care, and social consequences — because their diseases are rare.3 Orphan drugs are pharmaceuticals developed to treat diseases that affect relatively few people.

Andrew W Knight FRACGP, MMedSci(Clin Epid) · Domenica Taruscio MD

Objective: To understand how multidisciplinary care plans are being used in the management of patients with diabetes, and to explore the role of collaboration in care planning.Design: Grounded theory interview study.Setting: Primary care, June 2005 to October 2006.Participants: Thirty-eight people from three New South Wales Divisions of General Practice: 19 general practitioners, eight diabetes-related allied health providers, two endocrinologists, and nine adults with type 2 diabetes. Sampling was purposeful then theoretical.Results: GPs use care plans to organise clinical care and help patients access allied health providers. Written plans are used to educate patients about their care and to motivate change. GPs rarely discuss care plans with other providers, and providers are unlikely to change their approach to patients on the basis of care plans. Patients do not expect to participate in care planning.Conclusions: Care planning may increase evidence-based multidisciplinary care for patients with diabetes, but it rarely results in genuine collaboration between providers and patients. This suggests a difference may exist between Australian policymakers’ and providers’ definitions of patients with complex needs. Care plans could facilitate patient self-management by including more personalised information. Further research is needed to clarify which patients would benefit from a truly collaborative approach to their care.

Timothy D Shortus MB BS, MPH, FRACGP · Suzanne H McKenzie MMSc(ClinEpid), GradCertULT, FRACGP · Lynn A Kemp BHSc, PhD · Judith G Proudfoot BEd, MA, PhD · Mark F Harris MD, DRACOG, FRACGP

Objectives: To describe the patients seen and the clinical activity undertaken by general practitioners during encounters at residential aged-care facilities (RACFs), and to ascertain how these differ from all GP encounters in Australia as a whole.Design and participants: A secondary analysis of encounter data from the Bettering the Evaluation and Care of Health (BEACH) study, April 2004 to March 2006, comparing RACF consultations (identified by Medicare item numbers) with all BEACH study encounters in Australia. Participants were a random sample of GPs who had claimed at least 375 general practice Medicare items in the 3 months prior to the study.Main outcome measures: Differences in the characteristics of GPs and patients at RACF consultations, morbidities managed, and treatments provided to patients.Results: Over the study period there were 2310 RACF encounters out of a total of 197 000 BEACH encounters; 360/1970 GPs (18.4%) recorded at least one RACF consultation. GPs aged ≥ 45 years were more likely to record at least one RACF consultation than those aged < 45 years. Patients were predominantly women (70.7%), and 83.4% were aged ≥ 75 years. At RACF consultations, problems managed significantly more often included chronic problems, as well as psychological, neurological, urological, circulatory, eye and musculoskeletal problems. Dementia was the most common problem managed, at 33 times the usual management rate in everyday practice. Significantly fewer medications, non-pharmacological treatments, referrals, pathology and imaging tests were recorded at RACF consultations.Conclusion: GP encounters at RACFs involve the management of chronic and complex conditions, including some not frequently seen in everyday general practice. The provision of additional education and resources where required may assist with workforce shortages in this setting.

Julie O’Halloran BAppSc(HIM)(Hons) · Helena Britt BA, PhD · Lisa Valenti BEc

Objective: To examine the effect of Divisions of General Practice on various measures of primary care performance.Design and setting: Regression analysis using longitudinal data across Australia.Participants: All Divisions of General Practice between 2002 and 2004.Main outcome measures: Fourteen indicators of primary care performance in the areas of general practice infrastructure, access, multidisciplinary working, chronic disease, and measurable aspects of quality of care.Results: Between 2002 and 2004, Divisions and the activities they performed were associated with a number of measures of primary care performance, particularly measures of general practice infrastructure. Of the total variation in each performance indicator, between 19% and 64% can be attributed to the influence of Divisions while controlling for remoteness, health needs, and general practitioner characteristics. In all regression models, these effects were significant (P < 0.05). Divisions that provided support in electronic communication and electronic transfer of data were associated with: a 0.56 (95% CI, 2 0.04 to 1.2; P = 0.07) percentage point increase in the proportion of Practice Incentives Program (PIP) practices; a 0.73 (95% CI, 2 0.09 to 1.5; P = 0.08) percentage point increase in the proportion of PIP practices with electronic prescribing software; and a 0.66 (95% CI, 0.05 to 1.3; P = 0.03) percentage point increase in the proportion of PIP practices with a modem. Divisions providing activities with an asthma focus were associated with a 0.84 (95% CI, 0.02 to 1.5; P = 0.01) percentage point increase in the proportion of PIP practices receiving the asthma sign-on payment. There were no significant effects of Division activities on clinical aspects of care, such as GP claims for Service Incentive Payments for asthma, diabetes or cervical screening.Conclusions: Divisions of General Practice had an effect on primary care performance in a difficult health system context.

Anthony Scott BA(Hons), MSc, PhD · William Coote MB BS, BA(Econ), FRACGP

Almost 60% of general practices now employ at least one practice nurse. Australian Government initiatives to support the expansion of practice nursing are not consistently based on strong evidence about effectiveness, outcomes or efficiencies. Reviews from other countries suggest that practice nurses can achieve good health outcomes, but there is little information about the Australian practice-nurse workforce, funding models to support their work, scope of their practice, or its outcomes. Australian practice nursing lacks a career structure and an education framework to advance nurses’ skills and knowledge. To maximise the contribution of nurses in primary care, a more systematic approach is needed, with a stronger evidence base for policy to support effective outcomes.

Helen Keleher PhD · Catherine M Joyce BA(Hons), MPsych, PhD · Rhian Parker BScEcon(Hons), MSc, PhD · Leon Piterman MRCP, FRACGP, MAFOM

General practitioners face the challenge of developing a career path and credentialling pathway for doctors working in special interest areas to ensure safe practice and to develop a professional profile for these groups. Breast physicians are one example. They care for women with benign and malignant breast disease and work in multidisciplinary teams in hospitals, clinics, private practice, and the breast screening program. The training and credentialling of breast physicians has recently been formalised by the Australasian Society of Breast Physicians with the introduction of a training program and fellowship in breast medicine.

Meagan E Brennan FRACGP, FASBP · Andrew J Spillane MD, FRACS

An attractive strategy to meet the increasing need for medical education is teaching in community general practice. General practice will be in a position to meet and sustain this need only if various conditions are met, including: Teaching is undertaken in general practice at all levels of medical education (medical student, postgraduate years 1–3 and GP vocational training); Standards and quality of teaching are maintained while the number of sites involved increases; Further Australian research is conducted into innovative models of general practice teaching and their cost-effectiveness; and Appropriate remuneration and infrastructure is available to support practices and general practitioners involved in teaching.

Rod Pearce MB BS, FAMA · Caroline O Laurence BA(Hons), MHSM · Linda E Black BA(Psych), DipApplPsych, MAPS · Nigel Stocks MD, FRACGP, FAFPHM