AMA ensures doctors heard on Medicare review

The AMA this week hosted more than 60 leaders from across all medical specialties in Canberra to discuss the medical profession’s participation in the Governments’ Medicare Benefits Schedule (MBS) review, and the recent behaviour of Medibank Private in negotiations with hospitals. Welcoming delegates to the meeting, AMA President, Professor Brian Owler, said it was important that the medical profession was informed and united in its approach to the MBS review.

The AMA has cautiously welcomed the review, led by Sydney University Medical School Dean Professor Bruce Robinson, and supports having a schedule that allows patients access to modern medical procedures, and reflects the modern-day treatments that are provided in our health system.

But Professor Owler has voiced concern that the Government might use the review mostly to remove items from the MBS as part of a cost-cutting exercise, rather than ensuring the schedule is up-to-date and reflects advances in care and medical practice.

“We need to make sure that the Government continues to work with clinicians, that this is a clinician-led process that is based on evidence, and that the process is held in conjunction with the colleges and specialist societies where the knowledge base and expertise lies,” Professor Owler said.

He added that the AMA will continue to work with the Government in the review, and will work with the specialists and colleges in ensuring the best outcome from the review – provided it is not just about cutting costs and provided that doctors maintain access to health care for their patients.

AMA transcript – MBS Review and Medibank Private

This post was first published on GP Network News

Govt needs to relieve strain on health system’s heart

The benefits of co-ordinated care are widely recognised, and worldwide work is progressing to develop and implement systems and models of care that facilitate and support it.

In Australia, improving the continuity of patient care through better co-ordination has been on the agenda for almost two decades. As a GP, it is frustrating when the role of GPs in the co-ordination of patient care is so often undervalued by Governments in their ongoing quest for cost savings.

Despite the Government’s rhetoric acknowledging general practice as being central to the health system and its desire to rebuild it, the indexation freeze and other attempts to cut rebates stand in stark contrast to this intent.

Every time general practice is undermined with a rebate cut, the loss of an incentive, or an indexation freeze, our capacity to provide a higher level of care is compromised.

We have care planning and team care arrangements that recognise the GP’s central role in co-ordinating services to support patients to better manage their chronic and complex conditions. However, these arrangements are limited, inconsistent with established referral practices, and encased in red tape. This impacts on their effective use.

More than $1 billion has been “invested” by the Federal Government in a shared electronic health record to help ensure continuity of care. Unfortunately, most of that investment could have been saved if greater stock had been put in the advice of clinicians and the medical profession. In particular, that it must be an opt-out system and that information uploaded to the shared health recorded needed to be clinically relevant.

In the past decade there have been multiple trials around co-ordinated and collaborative care. We’ve had the Co-ordinated Care Trials in Queensland, HealthPlus in South Australia, the recent Diabetes Care Project trial, and Victoria is currently running the Care Point trial.

To varying extents, these trials recognise the role of general practice. We must build on the lessons learned from them, bearing in mind the recent findings of a report on nurse-led, hospital-based co-ordinated care interventions that found no demonstrated effect. What this shows, I believe, is that the best place for care co-ordination is at the central point of health care, which is general practice.

Private health insurers appear to be slowly coming around to the view that if they want to stem the rise in hospital-based claims (and their resultant payouts), then they need to start looking at supporting primary health care. They need to recognise that general practice holds the key for them, and that the challenge is to develop a funding model that will enable them to support GPs in keeping their patients out of hospital.

As AMA President Professor Brian Owler said in his address to the National Press Club during this year’s Family Doctor Week, there needs to be urgent recognition of the costs of providing high quality care.

If private insurers can recognise that general practice is where they need to be investing, then it is time the Federal Government did so as well.

The current review into primary health care, led by former AMA President Dr Steve Hambleton, provides a vital chance to shift the focus of our health system back to its heart.

Biosimilar drugs – should doctors be concerned?

In June, the Australian Parliament passed legislation allowing prescribed biological medicines to be substituted with biosimilar drugs when they are dispensed by pharmacists.

Under the change, the Pharmaceutical Benefits Advisory Committee (PBAC) will assess on a case-by-case basis whether a specific biological medicine can be safely switched for a biosimilar by a pharmacist. As for all prescribed medicines, doctors can still control what medicine is dispensed to their patients by marking ‘do not substitute’ on the prescription.

Is pharmacist substitution of biologicals a good thing? Or will this pose risks to patient health? And what are biological and biosimilar medicines anyway?

The AMA is satisfied with the regulatory arrangements introduced for biosimilars, but it is important that doctors are aware of the potential implications for their patients. Here’s a summary of the key facts.

What are biologicals?

A biological medicine is made from a living organism, typically extracted from a human cell or tissue-based system. Biologicals include:

hormones used to treat hormone deficiencies, e.g. insulin for diabetes;
monoclonal antibodies for the treatment of autoimmune diseases and cancers;
blood products, e.g. for the treatment of haemophilia;
immunomodulators, e.g. beta-interferon for multiple sclerosis;
enzymes, e.g. to remove blood clots; and
vaccines to prevent a number of diseases.

The manufacturing process for biologicals is complex and sensitive to variations because of the nature of the biological substances used and modified. Subtle variations of a biological substance exist between batch preparations from the same manufacturer.

What is a biosimilar?

A biosimilar is not a generic biological medicine.

A biosimilar medicine is highly similar to a biological medicine that has already been approved but for which the patent has expired. Unlike a generic medicine, which is made from the same chemical compounds and has the same chemical structure as the original brand medicine, a biosimilar is not a generic copy of the reference biological medicine.

While a biosimilar’s manufacture is based on the same active ingredient as the original biological, by their nature they cannot be identical.

Before a biosimilar can be approved for sale in Australia, any differences between the biosimilar and its reference medicine must have been shown not to affect quality, safety or efficacy through a robust clinical trial process.

Biosimilars, like generic medicines, will be significantly cheaper than the original biological medicine, although not to the same extent given the higher costs needed to invest in clinical trials, manufacturing and post-approval monitoring programs.

There are already biosimilar versions of medicines listed on the Pharmaceutical Benefits Scheme (PBS) being prescribed to patients.

What are the issues?

Biologicals are more likely to cause an immune reaction than chemical medicines.

In turn, small changes in the manufacturing process or composition of a biological may result in the emergence of immune reactions, even if the agent had previously been well tolerated. For example, in one instance a minor alteration in the manufacturing process of erythropoietin alpha triggered acquired pure red blood cell aplasia in a small cohort of patients.

It is therefore important that effective adverse event reporting mechanisms are in place to ensure that any patterns of adverse events are quickly identified and tracked to the specific biological brand.

Because of the documented variability between biologicals and biosimilars, it is conceivable that adverse reactions may increase with substitution.

Some consumer groups and pharmaceutical companies have argued that allowing biologicals to be switched at the dispensing point will make it more difficult to identify the specific brand if an adverse event occurs.

Government regulation

The Therapeutic Goods Administration (TGA) will remain the regulatory body responsible for assessing and approving a biosimilar as a safe and equally effective treatment compared to another medicine before it can be sold in Australia. The TGA is currently reviewing its assessment guidelines.

Once the biosimilar has been approved by the TGA, the PBAC will also consider if the biosimilar medicine should be listed to allow substitution by a pharmacist under the PBS.

The PBAC has stated that it will not recommend a biosimilar as suitable for substitution unless it is sure of its equal safety and effectiveness.

The PBAC’s assessment will include consideration of whether there is available data to support safe switching between the original product and the biosimilar product, and whether it can be safely substituted by a pharmacist at the point of dispensing.

Examples of biosimilar brands available in Australia include:

Aczicrit, Grandicrit and Novicrit with the active substance epoetin lambda – all have been approved by the TGA but only Novicrit is listed on the PBS; and
Nivestim, Tevagrastim and Zarzio with the active substance filgrastim – all have been approved by the TGA and all are listed on the PBS.

No biosimilar has yet been approved for substitution by a pharmacist.

What should doctors do?

When prescribing biological medicines, doctors should ensure they mark the prescription as ‘do not substitute’ if they have any concerns about the impact on their patients of switching to another brand;
doctors should discuss this decision with their patients so that patients are also aware they must not allow their pharmacist to substitute the medicine;
doctors who find out that a pharmacist has substituted a medicine ignoring the ‘do not substitute’ mark on the prescription should report the behaviour. Under PBS related legislation, this can attract a $2000 fine or 12 months in gaol. Report breaches to the Department of Human Services by phoning 132 290 or emailing pbs@humanservices.gov.au;
Any suspected adverse event should be reported to the TGA:
- by phone on 1800 044 114
- by email at adr.reports@tga.gov.au
- online at https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase

The AMA welcomes members’ views on this issue to president@ama.com.au. Member comments help inform AMA advice and activities.

AMA takes stand against racism, backs Indigenous constitutional recognition

The AMA has thrown its support behind constitutional recognition for Indigenous Australians and combating racism, condemning its insidious effects on social and emotional wellbeing.

As the on-field treatment of Indigenous AFL star Adam Goodes intensifies the focus on racism in the community, AMA President Professor Brian Owler said racist attacks were not only immoral but had all-too-real detrimental effects on the health of those who were its targets.

Professor Owler, who attended the Garma Festival at the Northern Territory town of Nhulunbuy in early this month, said the experience of Adam Goodes, who was badly shaken by the incessant booing directed at him by AFL crowds in recent weeks, showed that racism could have real consequences for individual mental health, as well as overall social and emotional wellbeing.

He said this was why the AMA viewed racism as a health issue and was committed to Indigenous constitutional recognition.

“The Aboriginal concept of ‘health’ centres on social and emotion wellbeing – a concept that applies to anyone,” the AMA President said. “Indigenous people face racism on a daily basis. The treatment of Adam Goodes raises an important questions for the nation, for non-Indigenous people, and our commitment to issues such as raising the standards of health, education, and economic outcomes of Indigenous people.”

“It comes back to social and emotional wellbeing. It is about respect for Indigenous culture and their place in the community being recognised and valued.”

In light of this, he questioned Prime Minister Tony Abbott’s decision not to support the development of a consensus Indigenous position on constitutional recognition to help inform a proposed referendum on the issue – a decision that deeply disappointed Indigenous leaders.

Professor Owler warned the Federal Government that its risks derailing its headline Indigenous Advancement Strategy and undermining recent progress in closing the gap by neglecting health issues and sidelining Indigenous leaders and communities.

The AMA President said that although Government efforts to improve school attendance, encourage young people to get a job and to make communities safer, were laudable, by themselves they would not bridge the big gap in wellbeing between Indigenous Australians and the rest of the community.

“Health is essential to learning, to going to school, for training and employment,” he said. “Health must underpin these strategies. The lack of focus on health is one of the reasons why I struggle to understand the Government’s Indigenous Advancement Strategy.”

Professor Owler said there had been real progress in addressing Indigenous disadvantage, including reducing infant mortality, but cautioned the disruption and uncertainty created by last year’s decision to slash $500 million from Indigenous services and programs put recent gains at risk.

“There is clearly a lot of good things that are being done, but we still have an enormous problem, and Indigenous health is one of those areas where you cannot take the foot off the pedal, because the moment you stop you can lose all the gains you have won,” he said.

Last year’s Budget cuts are continuing to resonate. An analysis of the 2015-16 Federal Budget by Menzies Centre for Public Policy Adjunct Associate Professor Dr Lesley Russell found that the share of total health funds being directed to Indigenous health programs will fall to 1.07 per cent this financial year before a minor improvement to 1.13 per cent in 2016-17.

Dr Russell said Commonwealth funding for Indigenous policies as a percentage of total outlays and of GDP was in decline, and that Indigenous organisations were losing out in the competition for funds to deliver Indigenous programs.

Adrian Rollins

GP pay up for grabs in primary health overhaul

Set fees and performance payments are among changes to GP remuneration being considered as part of efforts to remodel the primary health system to improve the care of patients with chronic and complex conditions.

The Federal Government’s Primary Health Care Advisory Group, led by immediate-past AMA President Dr Steve Hambleton, has canvassed a number of GP payment options in a discussion paper outlining potential reforms to address the rising chronic care challenge.

While the current fee-for-service model worked well in the majority of instances, the Better Outcomes for People with Chronic and Complex Health Conditions through Primary Health Care Discussion Paper said it did not provide incentives for the efficient management of patients who required ongoing care.

Instead, it suggested alternatives included capitated payments, where GPs, health teams, practices or a Primary Health Network receive a set amount to provide specified services over a given period of time; or pay-for-performance, where remuneration is tied to the achievement of particular care outcomes; or some combination of all three.

The discussion paper also suggests ideas about how care is organised and managed, including the creation of medical homes, GP-led team-based care, improved use of technology and upgrading techniques to monitor and evaluate care.

AMA President Professor Brian Owler welcomed the release of the discussion paper, but warned the Government that reform would not succeed without significant investment in general practice.

Professor Owler said several of the options for reform canvassed by Dr Hambleton’s Group had long been supported by the AMA, including GP-led team-based care, the improved use of technology, care coordinators, and an expanded role for private health insurers.

He said the new payment models outlined were a challenge for the medical profession, and would need ongoing discussion.

But he warned that the Government needed to support general practice if it was genuine in seeking to improve care.

“What is missing from the discussion paper is an explicit statement that we need to better fund and resource general practice if we are to meet the health challenges of the future,” Professor Owler said. “The final outcome from this Review must be more than simply re-allocating existing funding.”

Dr Hambleton emphasised that the paper had been developed to encourage discussion, but warned that things needed to change.

He said increasing life expectancy meant more patients were presenting with multiple chronic and complex health complaints, and current arrangements were increasingly struggling to meet their care needs.

More than a third of Australians have a chronic health condition and the discussion paper said that because the system was not set up to effectively manage long-term complaints, many were turning up unnecessarily in hospital and emergency departments, adding millions of dollars to the nation’s health bill.

Health Minister Sussan Ley said it was “essential” to review the provision of chronic care, because Medicare benefits for chronic care were soaring – up almost 17 per cent to $587 million in 2013-14 alone.

“We are committed to finding better ways to care for people with chronic and complex conditions and ensure they receive the right care, in the right place, at the right time,” Ms Ley said. “This discussion is a real opportunity to cater for the increase in chronic and complex conditions, and this approach ensures that health professionals and patients continue to be central to this process.”

But Professor Owler said the reality was that primary health review was being undertaken at a time when general practice was under sustained attack from the Government, and a “more positive” attitude was urgently needed.

“General practice has been the target of regular Budget cuts that undermine the viability of practices, and threaten the long term sustainability and quality of GP services,” he said. “The freeze on Medicare patient rebates is the prize example. It is causing great harm to GPs, their practices, and their patients.

“If the Government is genuine about improving how we care for patients with chronic and complex disease in primary care, greater investment and genuine commitment to positive reform is needed,” Professor Owler said.

As part of its consultation process, the Primary Health Care Advisory Group is conducting an online survey that will be open until 3 September. To access the survey and discussion paper, visit www.health.gov.au

In addition, the Group is holding a series of public meetings in major cities and regional centres around the country, and will host a nationwide webcast on 21 August.

It is due to present its final report to the Government by the end of the year.

Adrian Rollins

Higher drug price fears in trade deal fall-out

Health groups remain concerned the massive Trans-Pacific Partnership trade deal will push up the cost of medicine and hamper public health initiatives despite indications United States negotiators are prepared to give ground on controversial intellectual property protections.

While the future of the controversial trade pact is clouded following the failure of officials from 12 nations to seal an agreement in Hawaii last month, reports have emerged that the US is willing to back down on demands that data used to produce biologic medicines be subject to a 12-year exclusivity clause.

The clause would delay the competition pharmaceutical companies would face from cheaper generics, adding billions of dollars to their bottom line.

On the eve of the Hawaii talks, Trade Minister Andrew Robb told Fairfax Media he was pushing for the data exclusivity period to be slashed to five years, and it is understood the United States’ chief negotiator, US Trade Representative Michael Froman, was considering a counter-proposal for a base period of five years, followed by a three-year extension contingent on “certain circumstances”.

The secretive nature of the talks has meant that most observers have had to rely on information gained by websites like Wikileaks for information about the direction of negotiations on the deal which, if concluded, will encompass about 40 per cent of the global economy.

Mr Robb said that although the deal was not concluded at Hawaii, “we are definitely on the cusp”.

“While nothing is agreed until everything is agreed, I would say we have taken provisional decisions on more than 90 per cent of issues,” the Minister said.

But he admitted data protection for biologic medicines was among a number of “big outstanding issues” to be resolved: “You’ve got to set a balance somewhere between people getting a return on innovation on investment, and enabling competition to bring prices down for the rest of the community.”

Biologic medicines are derived from biological sources, and though they comprise only a fraction of drugs listed on the PBS, many are extraordinarily expensive, with a course of treatment often costing hundreds of thousands of dollars. In 2013-14, they accounted for a quarter ($2.3 billion) of PBS spending in 2013-14.

While the US may have given ground on access to biologic data, the AMA and other health groups remain concerned that other clauses in the proposed trade deal, including provisions allowing pharmaceutical companies to “evergreen” drug patents and giving investors scope to block governments taking public health measures, could undermine health care.

The AMA Federal Council has called on the Federal Government to reject “any provisions in trade agreements that could reduce Australia’s right to develop health policy and programs according to need”.

The Association said it was concerned that aspects of the proposed TPP could be used to attack key health policies and measures including the PBS and the cost of medicine, food labelling and tobacco control laws, restrictions on alcohol marketing, the operation of public hospitals and the regulation of environmental hazards.

Among the most controversial provisions are investor-state dispute settlement (ISDS) procedures that would enable corporations to mount legal action against government policies and laws they felt harmed the value of their investment or future profits.

Tobacco giant Philip Morris Asia used just such provisions in a 1993 investment agreement between Australia and Hong Kong to challenge Australia’s world-first tobacco plain packaging legislation in the courts and seek compensation, arguing that the policy undermined the value of its investment by ‘expropriating’ its trademarks and branding.

It is understood that Australia is arguing that health and environment policies, as well as the Pharmaceutical Benefits Scheme, be made exempt from ISDS provisions.

In addition, the TPP includes proposals demanding the removal of technical barriers to trade – provisions which companies have used to challenge regulations such as alcohol warning labels, alcohol excise, and front-of-packet food labelling.

There are also concerns market access rules in the TPP may be used to restrict government support for public hospitals and other health services by requiring that there be competitive neutrality between such entities and private health providers.

Medical charity Medecin Sans Frontieres is also apprehensive about the deal.

It said that without major changes in the Hawaii talks, the deal would have a “devastating impact” on global health.

MSF was particularly concerned about provisions it warned would “strengthen, lengthen and create new patent and regulatory monopolies for pharmaceutical products that will raise the price of medicines and reduce the availability of price-lowering generic competition”.

It said some of the most concerning provisions centred on patent evergreening, which would force governments to grant drug companies additional patents for changes they made to their medicines, even if these were of no therapeutic benefit.

Adrian Rollins

Discrimination, bullying and sexual harassment: where next for medical leadership?

Sexual harassment, the perceived career damage that can result from reporting such behaviour, and inconsistent standards of response by medical colleges and health services hit the headlines in early 2015.1 A background briefing paper published by the Royal Australasian College of Surgeons (RACS) in June 2015,2 as well as several articles in this issue of the Journal3–6 confirm these concerns are real.

Discrimination, bullying and sexual harassment (DBSH) occur in many workplace environments internationally, despite having been prohibited by law for decades. Trainees, medical students and female staff and colleagues are identified as the most likely targets. Proceduralists are particularly likely to offend. Some offenders unwittingly reproduce behaviours they have learned from role models of previous generations. Others are more deliberate or determined perpetrators, often with a reputation for misbehaviour that frequently goes unchecked. Observers who are aware of such behaviour may be covictims or coperpetrators, or both. Hospitals and professional associations sometimes foster a culture of abuse through covert sanctions against complainers, or by providing tacit approval by failing to act or by discouraging change.

There is little doubt of the perception among medical students and trainees that complaining can damage a career because “the hierarchy is too high and too strong”.7 Underreporting of abuse is prevalent across the entire health sector.8 Despite explicit professional values being taught, these seem to be overlooked, and there is a perceived disconnection between organisations’ stated values and their responses in individual cases of alleged abuse.9,10

Significant cultural change is necessary to make perpetrators aware that their behaviour will no longer be tolerated. The leadership required includes the following:

understanding what constitutes DBSH;
taking responsibility for proactively improving workplace culture and eradicating DBSH;
providing training in appropriate behaviour, including resilience, performance under pressure and speaking up when DBSH occurs;
recognising the right of victims to be able to report abuse or complain without fear of retribution;
providing appropriate timely responses to allegations, that include various levels of sanction for perpetrators; and
providing confidential counselling and support for those who have been affected.

In March this year, the RACS established an Expert Advisory Group to provide well grounded, informed and independent advice. The college published the background briefing paper, above, reviewing the evidence,2 and an issues paper11 that will cover the areas described above as well as equity between the sexes. It has also commissioned a prevalence survey of college fellows, trainees and international medical graduates, and qualitative research that captures the stories, effects and outcomes of individual cases. On the recommendations of the Expert Advisory Group, the RACS mounted an improved complaints process, and partnered with an independent external agency to provide the RACS Support Program for those affected.

Medical colleges have a vital role to play in honouring the “societal contract” that exists between the profession and the public,12 ensuring that DBSH are never tolerated and championing professionalism and standards.

Not so innocent bystanders

It’s time for all of us to accept responsibility

“The standard you walk past is the standard you are prepared to accept.” With this wake-up call in June 2013, Lieutenant General David Morrison challenged all those serving in the Australian Army to take responsibility for the culture and reputation of the army and the environment in which they work.1 He made this call in response to an emerging scandal of sexual abuse and harassment in the army. At the 2015 Australian Medical Association national conference in May, James Lawler, President of the Australian Medical Students’ Association, named bullying, harassment, sexual harassment and their mental health as the biggest problems affecting medical students.2 He explained that he could not tell his peers to take a stand against the perpetrators because “the hierarchy is too high and too strong”. Quoting David Morrison, he called on those present to help change the culture of medicine.

Discrimination, bullying and sexual harassment are illegal and breach both published and implicit codes of ethics and professional standards in medicine.3 Yet they are prevalent in medicine and health care, not only in Australia, but in many other countries and cultures and in other professions, notably law.4 Both men and women perpetrate this behaviour, but the most common pattern is a male perpetrator and female victim. The behaviour affects the individuals involved and the organisations they work in, reducing individual and team morale and performance and, in health care, ultimately diminishing patient safety.5

Most incidents are not reported. Reasons for this include lack of confidence in complaint processes, fear of adverse consequences, reluctance to be viewed as a victim and cultural minimisation of the problem.6

Hierarchies lend themselves to misuse of power. Our profession remains hierarchical, and the further one advances up the hierarchy in many parts of the profession, the greater the imbalance between the sexes. This is particularly so in surgery, where only 10% of fellows are female, and few women hold office.7

In this issue of the Journal, Walton points to the profound power imbalance that exists for junior medical staff8 and Mathews draws attention to the system of patronage where trainees depend on powerful senior colleagues for advancement.3 These articles go some way towards explaining why victims cannot be expected to solve the problem or even to take primary responsibility for identifying and naming it.

What can the rest of us, the bystanders, do?

How can peers and colleagues not notice inappropriate behaviour going on around us? Or do we notice but feel disinclined to become involved or reluctant to act? And how do we respond if a student or trainee comes to us for help and support? Or if we are part of a formal complaints mechanism?

Those who are perpetrators, whether their behaviour is deliberate or unconscious, need to know that their peers do not accept and will not tolerate it. The behaviour needs to be recognised and condemned as and where it occurs.

The lack of confidence in complaint processes and fear of reprisals is a sad reflection of the hidden curriculum in medicine, the cultural norms and expectations that run counter to the explicit curriculum of professionalism.

The way forward

“Good medical practice”, the code of conduct issued by the Medical Board of Australia outlines the professional values on which all doctors are expected to base their practice.9 These values include integrity, truthfulness, dependability, compassion and self-awareness. Bullying, discrimination and sexual harassment are incompatible with these qualities.

Problems of discrimination, bullying and harassment are not new, but they are increasingly at odds with the standards expected in the 21st Century. Other institutions are facing up to the darker aspects of their history and culture, bringing them into the light of day and committing to eliminating abuse and exploitation. It is time for all of us to accept responsibility for the culture and reputation of our profession and work to create environments in which respect is the dominant quality of relationships with our colleagues, trainees and patients.

It is not appropriate to dismiss inappropriate care

Personalised care does not justify use of therapies that have been shown to lack benefit

Will you be disbelieving, dismissive, disheartened or alert to the dangers after reading the study in this issue of the MJA that identified potentially inappropriate care in Australian hospitals?1 Using routine hospital admissions data, Duckett and colleagues found that five procedures not supported by clinical evidence happen more than 100 times a week and there is great variation in hospital-specific rates of procedures that should not be done routinely.

Disbelieving

Confirmation that inappropriate care continues to occur challenges to the core the optimal, ethical and patient-centred medical care that medical professionals strive to provide.2 To disbelieve the findings would be human,3 as “evidence contrary to our personal beliefs tends to be dismissed as unreliable, erroneous or unrepresentative”.4

To counter the discomfort these findings provoke, we may rationalise, arguing that the appropriateness of care is quintessentially where the art and science of medicine merge, where balancing the logic of evidence with the personal values of each individual patient leads to variation in care. However, personalised care does not justify inappropriate care.

Or we may argue that this is to be expected when there is a vacuum of evidence about what is appropriate (eg, the established and widespread practice of off-label use of medications5), or that today’s radical ideas may become standard practice in another era.6,7 However, neither of these are valid counterarguments to Duckett et al’s findings.1

Instead of disbelieving, we should consider how we respond to consumers who will react to the results of the study with incredulity — and perhaps even outrage — that a contemporary health care system continues to deliver therapies with clinical research evidence showing they are of no benefit to patients. Patients should be receiving care that is appropriate and, ideally, based on evidence of benefit. Robust research evidence from testing the merits of a therapy and demonstrating a lack of benefit identifies inappropriate care. This is different to a lack of research evidence of benefit.

Dismissive

Those who would be dismissive will point to the inherent limitations in the study; for example, reaching conclusions about health care interventions with the use of a secondary analysis of hospital discharge data instead of clinical registries.8 The use of cross-sectional data, describing clinical practice from 5 years ago, provides no insight into temporal trends and whether these inappropriate procedures have tapered and are now eradicated. Further, a very small number of interventions were examined; and the highest volume of inappropriate care, also referred to as “do not do” treatments, involved hyperbaric oxygen therapy. This highly specialised therapy is only available in a small proportion of health services in Australia and accounted for 79% (4659/5888) of all procedures included. The remaining do-not-do interventions affected a very small but important number of patients.

Disheartened

The true believers who sought a revolution to improve patient safety and quality of health care will be disheartened. Unexplained variation in care was first reported over 5 decades ago9,10 and there was a flurry of activity throughout the world11 to improve the quality of health care, which generated considerable momentum from the evidence of patient harm.12

Duckett and colleagues’ study reminds us that we still do not have answers about how to ensure a high quality of care, that the impacts of most interventions to improve care remain incompletely understood, and the potential for inadvertent adverse consequences is ever present.

Alert to the dangers ahead

Inappropriate care is a “wicked problem”13 — difficult to resolve and requiring a fundamental change across the health care system. The danger ahead is we become mired in negative emotions. Now is the time to be interested, somewhat trusting and encouraged. Be interested in understanding and contributing to solving a complex problem, and put to use the natural inquisitiveness and skills of inquiry required in any consultation to make a diagnosis. Be somewhat trusting of the data, given there is substantial other robust empirical evidence showing inappropriate use of common procedures (coronary angiography, carotid endarterectomy, caesarean section) in health care.14 Be encouraged that this important aspect of quality health care continues to receive attention.

These findings call for action and we should all be interested in the outcome. However, we need to be only somewhat trusting of the recommendations for addressing inappropriate care through pay for performance, the use of rewards or sanctions as these may be premature, are conventional and provide at best a partial solution.

What should happen next?

Instead of dismissing, we should consider that for any inappropriate care to occur, complicit action on a large scale is required. To deliver a do-not-do procedure a medical practitioner must first be credentialled, have a defined scope of practice and operate within their clinical team alongside support services and the governance structures of an organisation. Start counting how many people are involved. Therefore, the question we should be asking is: how is it possible for inappropriate care to occur? And what systems-level agreements perpetuate this situation?

Instead of feeling disheartened we should embrace this opportunity to address appropriateness of care, which is integral to all six domains of quality.15 Our approach to this situation will be far more sophisticated because of the collective experiences and lessons on how to improve practice from the past 25 years.

Instead of merely feeling alert to the dangers ahead, we must be engaged and encouraging in our efforts to seek out the underlying factors and new solutions. This requires a change in thinking16 and incorporating the science of performance measurement with the science of human factors (a branch of applied science that draws on psychology, engineering, computing science, education, ergonomics and anthropology to improve patient care).

Prudent policy makers, medical practitioners and patients expect community resources to focus on efficacious and effective provision of health care. The ideas and concepts presented by Duckett et al1 are worthy of heated debate and concerted action to explore what we must do to eradicate inappropriate care.

Sexual harassment in the medical profession: legal and ethical responsibilities

Sexual harassment in medicine became a national concern after a senior surgeon warned that trainees who complain about these incidents are not well supported, and advised trainees that the safest action to protect their careers was to comply with unwanted requests.1 The surgeon referred to the case of Dr Caroline Tan, who was found by a tribunal to have been sexually harassed by a neurosurgeon who was involved with her surgical training. While Dr Tan successfully sued for sexual harassment,2 she reportedly faced substantial career detriment after pursuing her rights.1

While the prevalence of sexual harassment in Australian medicine is unknown, reports suggest it is an entrenched problem for both trainees3 and specialists.4,5 This is consistent with surveys in Australia, the United Kingdom, the United States, Sweden and Canada that have found between a quarter and three-quarters of women experienced sexual harassment in training or practice.6–9

Sexual harassment is an umbrella term covering a range of behaviour, from everyday exchanges communicating derogatory messages (“micro-aggressions”), through to direct acts of physical sexual assault.10

As we will show, some forms of harassment also constitute criminal sexual assault. Sexual harassment can adversely affect women’s safety and wellbeing, choice of specialty11 and career progression. The vast majority of incidents are unreported due to: lack of confidence that reporting would help; fear of adverse consequences; reluctance to be viewed as a victim; complicity of senior staff; and cultural minimisation of the problem.12 Men also experience harassment, but women are more frequently targeted.6,7

While sexual harassment occurs across professions, women in medicine are at particular risk because of male dominance of senior positions13 and the “patronage” system of training, whereby trainees depend on a small group of powerful senior colleagues for entry into training, assessment, job opportunities and career progression.

In this article, we review four dimensions of legal responsibilities owed by individuals and employers across Australia, and analyse professional standards and ethical frameworks. There are compelling legal, reputational and economic reasons for medical schools, hospitals, colleges and other organisations to create cultural change to reduce sexual harassment. These interests are further supported by an ethical and professional duty to promote gender equality and equal opportunity.

Four legal dimensions of sexual harassment

Criminal law

Criminal laws in every Australian jurisdiction make it an offence to commit sexual assault and more serious acts such as rape. Other criminal offences include indecent exposure, obscene communications and stalking.

Sexual assault is defined as an “unlawful and indecent assault” punishable by maximum prison terms of 5–21 years (Box 1). An assault is “indecent” if it has a sexual connotation and is “contrary to the ordinary standards of morality of respectable people within the community”.14 The acts found by the civil tribunal to have been committed without consent in Tan v Xenos2 (paragraphs 15–16 and 532–546) included embracing the complainant, kissing her on the lips, touching her breast, pinning her against a desk, and asking for oral sex. Such acts would constitute sexual assault if proved beyond reasonable doubt in a criminal prosecution.

Criminal laws in every state and territory set clear principles. Importantly, consent must be “freely and voluntarily given” for any sexual act to be lawful (Box 1). Consent is invalid if obtained by threat or intimidation, or by abuse of a position of authority (Box 1). Mere lack of physical resistance does not prove consent (Box 1). Therefore, sexual acts committed without any agreement will be criminal; as will sexual acts where a medical practitioner obtained “agreement” through threats, intimidation or reliance on a position of authority.

Anti-discrimination law

Legislation in all jurisdictions prohibits discrimination in the workplace. This legislation imposes two duties: individuals must not sexually harass a colleague; and employers must provide work environments free of sexual harassment.

The legislation prohibits unwelcome conduct of a sexual nature in circumstances where a reasonable person would have anticipated the other person would be offended, humiliated or intimidated (Box 2). Prohibited conduct includes inappropriate comments, sexual propositions, indecent exposure and sexual assault. Circumstances relevant in determining whether the other person would be offended, humiliated or intimidated include each person’s sex and age, and the relationship between the individuals. The concept of “unwelcome conduct”, with the element of offence, humiliation or intimidation, distinguishes unlawful harassment from lawful interactions between consenting adults. Therefore, even forms of harassment which are apparently more minor are serious and cannot be dismissed as trivial or justified as banter.

Sexual harassment under anti-discrimination legislation has consequences for individual offenders and employers. Individuals may face civil proceedings and be ordered to pay damages (Box 2). Employers are vicariously liable for an individual’s acts unless reasonable steps were taken to prevent them (Box 2). It is insufficient for an employer to merely respond after a complaint. Proactive steps include making policies, educating staff, establishing grievance procedures and monitoring workplace environments.

Where sexual harassment is proved, damages are awarded to approximate the hurt caused to the victim. In Tan v Xenos, the award was $100 000.2

Tort law

Tort law gives individuals a further range of rights enforceable in civil law, separate from their rights in anti-discrimination law and the state’s capacity to bring criminal proceedings. Some of these rights can be pursued in civil lawsuits against individuals and employers for sexual harassment. For example, an individual may be liable for battery for intentionally causing harmful or offensive physical interference with another’s body. An individual may also be liable for breach of duty, enabling a victim to sue for compensation when further losses have crystallised, such as the nature and extent of psychological injury, and the victim’s economic loss.15

Employers have a positive obligation to provide a safe workplace for employees, including an environment free of sexual harassment.16 In the branch of tort law known as negligence, employers owe employees a duty of care to prevent damage being suffered. An employer will be liable for breaching its duty of care to a harassed employee if the employer knows, or ought to know, of an employee’s propensity to harass other employees, does not take reasonable steps to prevent further offending, and the individual offender subsequently causes damage to the harassed employee.

Contract law

Employment contracts contain an implied duty requiring the employer not to engage in conduct likely to damage the relationship of trust between employer and employee.17 Connected with this is an implied term to provide a safe work environment free of sexual harassment.17 These terms may support an action for breach of contract against the employer where an employee experiences sexual harassment by another employee.

Where a person resigns because sexual harassment makes the workplace intolerable, a court or the Fair Work Commission may find the person has been subject to “constructive” dismissal. That is, workplace conditions gave the employee no reasonable alternative but to resign. Such indirect forced dismissal warrants compensation from the employer for lost remuneration. Finally, if an employee complains about harassment and resigns because of subsequent pressure or victimisation, this may constitute an additional contractual breach and a separate breach of anti-discrimination legislation (Box 2).

Professional standards

Professional codes of conduct establish clear professional and ethical responsibilities to treat colleagues with fairness and respect. These responsibilities are established for all doctors in the code of conduct of the Medical Board of Australia (Box 3).18 Other codes reinforce these profession-wide duties. The code of ethics of the Australian Medical Association urges doctors to recognise that their conduct may affect the profession’s reputation, and encourages reports of colleagues’ unprofessional conduct (clause 2.1).19

Many professional colleges address harassment in their codes of conduct. For example, the Royal Australasian College of Surgeons’ code of conduct requires surgeons to “eradicate bullying or harassment from the workplace” (clause 4.1.6).20 This code states that surgeons, by virtue of their position, should be role models for those they supervise and teach (clause 10) and are prohibited from seeking intimate relationships with trainees under their supervision (clause 10.1). Sexual harassment is prohibited by other colleges’ codes of conduct, including those of the Royal Australasian College of Physicians21 and the Australian and New Zealand College of Anaesthetists.22

Serious breaches of standards may result in notifications to the Medical Board. Under the Health Practitioner Regulation National Law, which has been enacted in every Australian state and territory, practitioners and employers must notify cases where a practitioner engages in “sexual misconduct in the practice of the profession”. Although this usually arises when practitioners breach boundaries with patients, sexual assault of colleagues has been reported to the Australian Health Practitioner Regulation Agency under these provisions or the voluntary notification provisions for unprofessional conduct.

In serious cases, tribunals can suspend or deregister practitioners for misconduct, including for repeated instances of unprofessional conduct or conduct inconsistent with being a fit and proper person to hold registration.

Conclusion

Sexual harassment is illegal and unethical. Prohibitions in Australian laws and codes of conduct are clear. Practitioners face serious consequences for committing sexual harassment, and employers can be liable for failing to take preventive action.

Nonetheless, sexual harassment of women in medicine remains a serious concern in training and clinical settings, but complaints are rare. This suggests that the problem requires cultural change rather than legal reform. A potent alloy of gender inequality, normalisation of inappropriate conduct, professional monopolies and powerful hierarchies combine to create a culture that shields offenders and silences victims.

We suggest that culture change requires a five-pronged approach. First, we need a clearer understanding of the nature and scope of the problem, its effects and potential impacts on clinical care. Many acknowledge the gravity of the problem, but others contend that concerns are infrequent and historical. The establishment of the new Royal Australasian College of Surgeons Advisory Group, which will review policies, establish a reporting framework for harassment and explore problems of gender balance, is a welcome development.

Second, we need to educate students, practitioners, employers and boards about their responsibilities. Improved knowledge can influence attitudinal and behavioural change: the goal is for doctors to cease the sexual harassment of students and colleagues. In designing educational programs, Australia may benefit from the experience of Canadian colleges, which have provided sexual harassment training for 2 decades.23 Other helpful tools may include the Victorian Equal Opportunity and Human Rights Commission’s recommendations for reform of the legal profession, directed partly at preventing sexual harassment.24

Third, health practitioners should have access to a sound complaint mechanism. However, this alone is insufficient and does not mean that victims are responsible for resolving the problem. Victims should not simply be ordered to “speak up”, as this ignores factors that impede disclosure, and leaves undisturbed the power imbalances, gender discrimination and tolerance of inappropriate conduct which foster the problem.

Fourth, we should recognise and support individuals and employers who promote respectful work environments. It takes courage for victims and bystanders to speak up about sexual harassment. Employers who set new standards of conduct demonstrate leadership and integrity. An environment that unequivocally supports women and rejects harassment can powerfully influence the behaviour of perpetrators, the careers and wellbeing of women, and the “hidden curriculum”25 communicated to students and trainees.

Finally, the medical profession can nurture wider efforts to promote women’s rights through its status in society and its broad interaction with the population. By modelling a commitment to gender equality and women’s rights to safety and dignity in the workplace, the medical profession can embody what should be core aspirations in contemporary Australia.

1
Sexual harassment as a criminal offence in Australian states and territories

The offence of sexual assault or indecent assault exists in each state and territory, with substantial penalties: Crimes Act 1900 (ACT) s 60 (7 years); Crimes Act 1900 (NSW) s 61L (5 years); Criminal Code (NT) s 188(2)(k) (5 years); Criminal Code 1899 (Qld) s 352 (10 years); Criminal Law Consolidation Act 1935 (SA) s 56 (8 years); Criminal Code Act 1924 (Tas) s 127 (21 years: s 389); Crimes Act 1958 (Vic) s 39 (10 years); Criminal Code Act Compilation Act 1913 (WA) s 323 (5 years).
Consent only exists if freely given and will not be present if obtained by threat, force or abuse of position: ACT s 67; NSW s 61HA; NT s 187(a); Qld s 348; SA s 46; Tas s 2A; Vic s 36; WA s 319.
Consent is not shown simply by lack of physical resistance: ACT s 67(2); NT s 192A(a); Vic 37AAA(e); WA s 319(2)(b).

2
Sexual harassment as discrimination in Australian states and territories

Sexual harassment can be constituted by a single act. It is generally defined as unwelcome sexual conduct in relation to the other person, committed in circumstances where a reasonable person would have anticipated the other person would be offended, humiliated or intimidated: Discrimination Act 1991 (ACT) s 58(1); Anti-Discrimination Act 1977 (NSW) s 22A ; Anti-Discrimination Act 1992 (NT) s 22; Anti-Discrimination Act 1991 (Qld) s 119; Equal Opportunity Act 1984 (SA) s 87(9); Anti-Discrimination Act 1998 (Tas) s 17(3); Equal Opportunity Act 2010 (Vic) s 92; Equal Opportunity Act 1984 (WA) s 24(3-4).
Sexual harassment is prohibited, with substantial penalties for the individual offender: ACT s 58; NSW s 22B; NT s 22(2); Qld s 119; SA s 87(1); Tas s 17(2); Vic s 93; WA s 24(1).
Substantial penalties can also be imposed on an employer, who will be vicariously liable unless appropriate preventive steps were taken: ACT s 121A; NSW s 53; NT s 105; Qld s 133(2); SA s 91; Tas s 104; Vic ss 109-110; WA s 161.

3 Sexual harassment as a breach of good medical practice

Under Good medical practice: a code of conduct for doctors in Australia,18 “good medical practice” includes:

Communicating professionally, respectfully and courteously with colleagues (clause 4.2)
Understanding the nature and consequences of harassment, and seeking to eliminate such behaviour in the workplace (clause 4.4)
Acting as a positive role model and supporting students and practitioners (clause 4.4)