Safety through reporting

Using a medicine or medical device has inherent risks. Based on current medical knowledge, not all adverse events can be prevented, underscoring the importance of continuous evaluation and monitoring of harms associated with the use of therapeutic products.

An estimated one in 10 patients have had an adverse reaction to a therapeutic product in the past 6 months. Of these reactions, half would have been moderate to severe, and most are not reported. Around 400 000 general practitioner consultations each year involve a medicine-related problem, yet the Therapeutic Goods Administration (TGA) received only 17 500 reports in 2013, of which only 700 (4%) were from GPs.

Reporting adverse events is a crucial part of ensuring the safety and effectiveness of therapeutic products in Australia. This reporting triggers meaningful actions by regulatory agencies, manufacturers and sponsors. Sometimes just a single report can initiate action.

NPS MedicineWise and the TGA have developed two online learning modules to support health professionals to report adverse events associated with therapeutic products (http://learn.nps.org.au/mod/page/view.php?id=5551) and contribute to the TGA’s ongoing safety monitoring activities. Key features include a detailed explanation of the importance of reporting adverse events in an increasingly active health system, how to build reporting into practice, and what happens to reports once they are submitted to the TGA.

These modules build skills to actively participate in continuous safety monitoring by identifying, documenting and reporting adverse events. They also promote a culture of adverse event notification in clinical practice.

Reporting adverse events relating to the use of medicines, vaccines or medical devices to the TGA is one way health professionals can contribute to safer use of therapeutic goods across the health system and reduce the threat to patient safety. Everyone shares in this responsibility.

Australian Early Psychosis Research Network: national collaboration, international competitive advantage

An expansion of clinical infrastructure for early psychosis intervention offers new possibilities for research, treatment and service development

Over the past three decades, Australian researchers have pioneered a conceptual model of the clinical stages underpinning progression of potentially serious mental disorders, including psychosis. This approach, supported by growing evidence, has informed the development of new service models focusing on the mental health needs of young people.

By shifting the focus of the health sector to intervention during the early and less specific stages of mental disorders, substantial conceptual and practical progress has been made.1 This progress has generated optimism, buttressed by growing evidence of the effectiveness and cost-effectiveness of early intervention in psychosis from clinical trials and health services research conducted in Australia and around the world.2–4

Early intervention has demonstrated potential to reduce the effects of illness on age-specific developmental and occupational goals. It can also improve social and economic participation and productivity. Programs such as headspace have been scaled up across Australia, and have already improved access and engagement in stigma-free, youth-friendly settings.5 The federal government’s planned expansion of comprehensive early psychosis programs in every state and territory6 offers an unprecedented opportunity to promote innovative large-scale, multicentre research into the early stages of psychotic illness.

Against the backdrop of this expansion of innovative service delivery models, we face ongoing challenges. We have an incomplete understanding of what causes psychosis. Even when the best available treatments are delivered early and with precision, longer-term clinical and functional outcomes remain suboptimal. People with long-term psychotic illness die up to 20 years earlier than others.7 Our patients and their families expect better results.

However, the situation we face is not too different from that seen in oncology in previous years, when many standard treatments were associated with substantial toxicity, delivery systems were variable and most patients presented in the later stages of illness. Yet, breakthroughs aside, strategies such as early detection, timely intervention and sustained delivery of high-quality care throughout “critical” illness periods can substantially improve outcomes.

Stimulated by the federal government’s investment in comprehensive clinical infrastructure for early psychosis intervention, a large group of Australian psychosis researchers formed the Australian Early Psychosis Research Network (Appendix). At a recent meeting of this group, research priorities were discussed.

The group agreed that there is an urgent need for novel treatment strategies that are safer, more effective and more acceptable to patients and their families. Current candidates include omega-3 fatty acids, aspirin, N-acetylcysteine, sodium benzoate, cannabidiol and oestrogen. In the early stages of illness, there is a greater degree of clinical equipoise: the risk–benefit ratio can be unclear, with more evidence required on the effectiveness and safety of treatments. This situation creates momentum for a sequence of stepwise clinical trials, as follows:

The study of biomarkers to guide the use of such therapies using a strategy in which “target engagement” is assessed as a predictor of treatment response. This means demonstrating not only whether novel therapies work, but also how they work. This approach directly tackles the problem of heterogeneity within clinical samples assembled using current syndromal diagnostic criteria. Personalised medicine is the ultimate goal.
The further development of novel psychosocial interventions, including online platforms, which focus predominantly on functional recovery. These are particularly promising in terms of consumer engagement, clinical effectiveness and cost-effectiveness. Their integration with biological therapies and linkage with stages of illness require exploration.
The examination of how to reduce the elevated risks of premature mortality (from both cardiovascular disease and suicide) from the time of onset of psychotic illness.

There is also a need for health services research to determine not only which interventions are effective and cost-effective, but in what context. Treatment fidelity in the real world has not been studied well, and the range and quality of clinical interventions vary between and within services. Studying the effect of culture of care and model fidelity is also critical.

The ultimate goal of the Australian Early Psychosis Research Network is substantial improvement in health and social outcomes for people living with psychosis. We have an opportunity to develop a new culture in mental health that has the capacity for large-scale clinical trials with embedded biomarker research, on a par with what exists elsewhere in medicine. Federal government reform and investment gives Australia a unique competitive advantage in this. We do not intend to let this opportunity pass.

Choosing wisely: the message, messenger and method

Insights to guide Choosing Wisely activities in Australia, based on a South Australian Clinical Senate exercise

International movements are seeking to identify and reduce the use of health care services that provide little or no benefit, whether through overuse or misuse. England’s National Institute for Health and Clinical Excellence commenced a formal policy agenda in this area in 2005;1 however, the first truly physician-driven exercise commenced in 2009 in the United States.

The American Board of Internal Medicine Foundation invited professional societies to step forward as “stewards of finite health care resources”.2 Initially, groups of volunteers from three primary care specialties developed top-five lists. These lists described specialty-specific practice changes that would improve patient outcomes through better treatment choices, reduce risks and, where possible, reduce costs.

In 2012, the program was formally launched as the Choosing Wisely campaign, involving lists from nine specialty societies and including a patient-education component. In 2014, about 50 additional specialty societies joined, and clinicians put forward hundreds of health care practices as being interventions of limited value.2

The US Choosing Wisely campaign is unique in how it has framed its message, who has stepped forward as the messenger, and the proposed optimal methods for developing lists of inappropriate health care practices. In this article, we reflect on the relevance of this campaign for Australia.

The message and the messenger

The lists, entitled Five things physicians and patients should question, set an explicit premise to “spark discussion about the need — or lack thereof — for many frequently ordered tests and treatments”.2 These lists are freely available to the public via the internet, have been endorsed by consumer organisations and are supported by educational resources for consumers and health care professionals. The main objective of Choosing Wisely is one of improved safety and quality through a reduction in practices that are, at best, of little to no clinical utility and, in certain situations, harmful. The campaign recognises that the opportunity costs of expending scarce resources on low-value care means they are foregone and cannot be used in other areas where high-value care could have been delivered.

The engagement of about 60 US colleges and professional societies in the program is an acknowledgement by frontline clinicians that in some areas of care, less is more. Clinician leadership by specialty societies and engagement of consumer organisations greatly increase the likelihood of success. The US campaign has, however, been criticised for the variability of methods employed by the specialty groups, and the potential bias this has introduced to the process.3

The method

International programs such as Choosing Wisely have focused on creating momentum for clinicians to reflect on their work practices and take individual and collective responsibility for selecting health practices of limited value. They aim to change behaviour, rather than rely on policymakers or administrators to achieve similar outcomes.

Although the aims of the US Choosing Wisely campaign have been consistent, the methods employed for list development have not. Some services included on US lists have fallen under scrutiny for varying widely in terms of their potential impact on care and spending without a consistent approach in terms of cost, volume or potential for harm. Some societies’ lists have been criticised for including low-impact items while excluding high-impact items.4 Furthermore, some participating societies have named other specialties’ services as low value, avoiding their own.

A recent analysis4 showed the most common service types listed by the first 25 Choosing Wisely participants: 29% of listed items target radiology; 21%, cardiac testing; 21%, medications; 12%, laboratory tests or pathology; and 18%, other. It is clear from the numbers that some interventions have been double counted. It is also feasible that groups (eg, primary care, emergency medicine) are reflecting on the tests they order (eg, radiology, pathology) rather than carry out (and vice versa).

The broadest criticism is that most societies have not detailed the methods by which their lists were created. This has led to one particularly harsh comment,

In some cases, it is clear that the lists were developed without much input from frontline practitioners, using a process that was not transparent and without clear criteria for inclusion …3

At the other end of the spectrum, the method employed by the American College of Emergency Physicians (ACEP)5 has been held up as the gold standard3 because it:

used existing work of the ACEP Cost Effective Care Task Force;
surveyed the entire ACEP membership and grouped results into domains which were prioritised using serial voting;
reviewed the literature to establish a solid evidence base that specifically sought to include available cost data; and
made panellists’ disclosures and conflicts of interest publicly available.

The contribution of the ACEP list is as much about methodology (broad college discussion, practitioner surveys, transparency, clinician engagement, modified Delphi technique and solid scientific foundations) as it is about the final recommendations.3

A fundamental consideration is to ensure item development is evidence-based. As suggested by existing lists, services that are inappropriate for all patients and indications are rare. Typically, a service has safety and effectiveness profiles that depend on the characteristics of the patient to whom it is provided; a service that is of low value in certain clinical circumstances might be of high value in others. It is precisely for this reason that understanding of the local health care context is critical to identifying practices whose reduction is achievable and will have an impact in terms of quality improvement.6

An Australian experience in choosing wisely

In October 2013, the South Australian Clinical Senate met to consider health care quality improvement. The Senate is a diverse group of practising clinical experts who provide advice to the Minister and Chief Executive of the SA Department of Health and Ageing. The meeting was divided into a morning meeting of emerging clinical leaders and an afternoon session of the full (senior) Clinical Senate. Both groups had the opportunity to hear the case for quality improvement and economic reform of the health system.

As leaders of this clinical consultation group, including an invited content expert (A G E), we asked all senators (junior and senior) to provide, anonymously, their individual list of top-five items in line with the objectives of the Choosing Wisely campaign. Summary results (of the full report7) are presented in the Box. We provided all participants with a range of preparatory materials, which included an evidence-based list of low-value health care practices. The top-five identified were:

computed tomography pulmonary angiography for low-risk pulmonary embolism;
routine inpatient blood tests, electrocardiograms, medical imaging and preoperative screening investigations;
antibiotics, including prophylactic use;
arthroscopies in general; and
duplication of diagnostic testing with change of care teams or between health care contexts.

As might be expected, there was a high level of sensitivity (many selections) and poor specificity (focus). Further, while we often think of bias as reflecting perverse individual interests (and the protection of these), bias can also merely reflect an awareness of services based on one’s own exposure or proximity to their occurrence. Our results showed that relative temporal exposure can affect perceptions of services. This was particularly stark in our findings of differences in choice of top-five items between the emerging and established clinical leadership groups. Junior senators, while offering many purely clinical items, were far more likely to nominate work practices, protocols and processes of care as contributing to areas of low-value care; their senior colleagues focused on therapeutic and diagnostic practices. The role that experience plays is not explored in any Choosing Wisely literature that we have been able to identify, and points to a methodological nuance that any group devising similar initiatives might find valuable.

Conclusions

Existing lists of low-value services vary in level of cross-representation of items from Choosing Wisely.1,6,8 If Australian specialty colleges sought to replicate this initiative, how might they go about maximising list validity while minimising the limitations raised in the US?

We recommend the following steps.

Consider the methodological principles set out by the ACEP. What constitutes a gold-standard approach is debatable, but it should be transparent and inclusive.
Consider using existing lists to compile a mega-list1,2,6,8 of items, adding any others nominated by group members.
Seek explicitly to capture the views of emerging as well as experienced clinicians before working towards prioritisation with (for example) methods employed by the ACEP, and informed as necessary by complementary prioritisation tools.9
As a novel element, establish two top-five lists: one for clinical services and another reflecting administrative, policy and process waste.
Consider including other health care providers so that all clinical staff are surveyed for their unique, evidence-based perspectives of waste.

Finally, consumer representative organisations must also step forward, as they did in the US, to ensure any campaign complements the role of clinical autonomy while empowering and incorporating patients as partners in choosing wisely.

Summary results for the South Australian Clinical Senate Choosing Wisely items

Health care practice

Emerging leaders

Clinical senators

Evidence-based list8

Overuse or use not indicated under current guidelines or funding models

Routine inpatient blood tests, electrocardiography and diagnostic imaging for preoperative screening*

CT pulmonary angiography for low-risk pulmonary embolism*

−

CT of the brain without CNS signs

−

CT, MRI and x-ray for back pain

C-reactive protein

D-dimer testing

−

Antibiotics, including prophylactic use*

−

Proton-pump inhibitors

−

Statins

−

Stenting of non-critical coronary arteries

−

Physiotherapy

−

Sleep studies

−

Caesarean section

−

Bariatric surgery

−

Tonsillectomy

−

Prostate-specific antigen testing

−

Arthroscopy*

Steroid joint injections

−

Vitamin D testing

Grommets

Cardiac MRI

−

Surgery for chronic back pain

−

Robotic surgical techniques

−

CT = computed tomography. CNS = central nervous system. MRI = magnetic resonance imaging. + Identified by clinicians for inclusion in lists of low-value health care practices. − Not identified by clinicians for inclusion in lists of low-value health care practices. * One of five most commonly identified interventions of potentially limited value.

Summary results for the South Australian Clinical Senate Choosing Wisely items (continued)

Health care practice

Emerging leaders

Clinical senators

Evidence-based list8

Work practice protocols and processes of care

Duplication of diagnostic testing with change of care teams or between contexts*

Excessive outpatient referrals and follow-up

Excessive hospital delivery of care

−

Duplication of or excessive documentation; process duplication on electronic platforms

−

Delays in assessment for and discharge to placement

−

Clinical care delivery by inappropriate health care professional

−

Innovations in care such as acute medical units, clinical networks, hospital at home

Medical emergency teams

−

Use of locum and agency health care workers

−

Time and cost associated with excessive packaging (unpacking, disposing of)

−

Interventions in the context of limited life expectancy

Cataract surgery

−

Cardiac surgery

−

Surgery while on life support

−

Intensive care

Chemotherapy for advanced malignancy

−

Implantable cardiac devices

Hip replacements and surgery for fractures

Percutaneous enteric gastrostomy feeding

−

Faecal occult blood testing

−

Blood transfusions

−

Drugs such as statins and vitamin D replacement

−

na = not applicable. + Identified by clinicians for inclusion in lists of low-value health care practices. − Not identified by clinicians for inclusion in lists of low-value health care practices. * One of the five most commonly identified interventions of potentially limited value.

Surveyors’ perceptions of the impact of accreditation on patient safety in general practice

To the Editor: Finally! Abou Elnour and colleagues have done something different and looked at accreditation in general practice from the perspective of the surveyors.1 Previous studies have solely focused on accreditation as a process and how it improves patient safety in the acute health care setting.2

Sure, the sample size was meagre, with only 10 Australian General Practice Accreditation Limited surveyors taking part, but between them, they had accredited 2022 general practices over 15 years.1 As a health care consumer, I was horrified to discover that only 80% of Australian general practices have opted to become accredited.3 This is especially disturbing when “errors and harms” have been well documented in general practices1,4 and we know that the accreditation process improves patient safety.1,2

Abou Elnour et al highlighted that clinical risk management of patient safety is poorly done throughout general practices in Australia.1 It was alarming to realise that my first port of call when unwell may not have a process or structure to effectively manage any adverse events that may occur.3 I agree with the surveyors that it is time for the Australian Primary Care Collaboratives (APCC) Program, which has been successful in improving quality,5 to broaden its horizons and implement a clinical risk management system in general practices. I support Abou Elnour et al’s recommendation for the APCC Program to add patient safety to its agenda.

Additionally, I think it is time for the accreditation process to be mandated among all general practices, to ensure a high level of patient safety. If those 2022 practices had not undergone accreditation, we would not be having this much-needed discussion about improving patient safety in a setting where it is underestimated.1 Patients go to general practices when they are vulnerable and need help the most. We need to maintain general practice’s reputation by providing excellent patient care.

Surveyors’ perceptions of the impact of accreditation on patient safety in general practice

In reply: We appreciate Philip’s interest in our article and share her concern for the efficiency of clinical risk management — 45%–76% of adverse events in primary care are avoidable.1 There have been attempts to describe near misses, errors and harm in general practice, through accreditation using well evolved Royal Australian College of General Practitioners Standards, but there is no systematic mechanism to report, analyse and prevent adverse events in general practice.

Based on interviews with general practice staff2 and accreditation surveyors,3 literature review, and consultations with international and national experts on patient safety,4 a patient safety collaborative manual with an automated trigger tool has now been developed.5 This manual is intended to be used by the Australian Primary Care Collaboratives Program to improve patient safety in Australian general practice. It covers the major change concepts of engaging the team, data quality, identifying harm and preventing harm.

With this manual available, now is the time for action in a journey towards safer care through changing culture and creating a systematic approach to capturing, analysing and preventing harm in general practice.

A bowel cancer screening plan at last

To the Editor: The National Bowel Cancer Screening Program (NBCSP) sees general practitioners as “critical partners”,1 but has not really involved or supported GPs, who have personal frequent contact with a large proportion of the NBCSP’s target population. GP endorsement increases uptake,2,3 but the NBCSP does not fund GPs to send reminder letters to their patients.

The NBCSP informs GPs about who has used a faecal occult blood test (FOBT) kit and returned samples, but it sends these reports on paper, which creates extra work of scanning results into patients’ electronic clinical records and, more importantly, prevents GPs’ clinical software from automatically generating appropriate reminders. Automated reminders can be displayed onscreen to GPs during consultations, and now can also be given to patients when they arrive for consultations, as printed prevention summaries based on current data in the patient’s electronic clinical record.4,5

Uptake of bowel cancer screening is likely to be greater if general practice is a true partner in the process, as occurs in the cervical screening program. Following this model, the NBCSP would perform a back-up function to notify the person’s usual GP or usual general practice if an FOBT result has not been received within 3 to 6 months of it becoming due. We concur with the statement: “it will become increasingly important to consult closely with the primary care sector and provide support to GPs to facilitate their role in the expanded NBCSP”. General practice must be made more central in the NBCSP for it to succeed.

Frequency and quality of mental health treatment for affective and anxiety disorders among Australian adults

Each year, 6% of Australian adults meet criteria for an affective disorder and 14% for an anxiety disorder.1 These disorders accounted for 52% of the burden of mental and substance misuse disorders and 7% of the overall burden of disease in Australia in 2010.2 Despite efficacious pharmacological and psychological interventions, this burden persists, partly because treatment coverage and quality are suboptimal.3 Monitoring treatment quality for these disorders may identify opportunities to improve health system performance and highlight populations at risk of inadequate care.

Reports from Australia’s first National Survey of Mental Health and Wellbeing (NSMHWB) showed that, in 1997, 60% of adults with affective disorders and 35% with anxiety disorders had consulted a health professional for mental health in the previous year. Just over half of consultees reported receiving medicine or tablets (not further defined) or cognitive behaviour therapy (CBT).3 One-third of consultees saw a general practitioner only.4 Sociodemographic factors including male sex, socioeconomic disadvantage and rurality were shown to influence the likelihood and type of mental health care received, independent of diagnosis.4–8

In the decade following 1997, two major mental health reforms designed to improve treatment access and quality were introduced: in 2001, the Access to Allied Psychological Services (ATAPS) program; and, in 2006, the Better Access to Psychiatrists, Psychologists and General Practitioners through the Medicare Benefits Schedule (Better Access) initiative. These programs provide government subsidies for evidence-based psychological services delivered mainly by psychologists and other allied health providers. Information-based initiatives such as beyondblue were introduced to improve mental health literacy and demand for necessary mental health services.9 Reports from the second NSMHWB in 2007 documented a shift in provider mix since 1997, notably a doubling of psychologist care,10 and increased levels of met and perceived need, suggesting improvements in treatment access or effectiveness and willingness to seek treatment.11 However, population mental health did not improve, possibly due to inadequate treatment.9

Population levels of minimally adequate treatment (a “dose” of an evidence-based intervention above a minimum threshold consistent with treatment guidelines) for affective and anxiety disorders have been measured elsewhere,12–14 but Australian estimates are lacking. Using 2007 NSMHWB data, we examined the frequency, type and adequacy of mental health treatment among Australian adults with affective and anxiety disorders; how these estimates differ across the health sectors consulted; and the factors associated with treatment.

Methods

We analysed data from the 2007 NSMHWB,1,15 a nationally representative household survey of 8841 Australians aged 16–85 years conducted in late 2007. Respondents were selected from a stratified, multistage area sample of private dwellings. Face-to-face interviews of 90 minutes average duration were conducted by trained lay interviewers. The response rate was 60%.

The University of Queensland Behavioural and Social Sciences Ethical Review Committee approved this study.

Clinical measures

As defined by the International Classification of Diseases, 10th revision (ICD-10), affective disorders (depression, dysthymia and bipolar affective disorder) and anxiety (panic disorder, agoraphobia without panic, social phobia, generalised anxiety disorder, obsessive–compulsive disorder and post-traumatic stress disorder) experienced in the past year were assessed using a modified World Mental Health Survey Initiative Composite International Diagnostic Interview 3.0. Severity of disorder (mild, moderate or severe) was determined via an algorithm that incorporated disorder-specific role impairment and other clinical information. Past-year substance misuse disorder(s) and chronic physical conditions were also assessed.

Health care sectors consulted

Respondents were asked whether they had consulted a health professional for mental health in the past year. Those who had were interviewed further about the types of professionals consulted, and the frequency, average duration and means of payment for these consultations. Using this information, past-year consultations for mental health were grouped into sectors relevant to Australia’s mental health care system:

GP only (seeing a GP but no other health professional);
primary care allied health (seeing a psychologist or a professional such as a social worker, occupational therapist or counsellor providing specialist mental health services, except those whose services were provided within public sector mental health services — with or without a GP or other providers);
specialised mental health (seeing either: a psychiatrist or mental health nurse, or a psychologist or other professional providing specialist mental health services, whose services were provided within public sector mental health services — with or without a GP or other providers); or
other health (seeing: a professional such as a social worker, occupational therapist, counsellor providing general services; a specialist doctor or surgeon other than a psychiatrist; or a complementary or alternative medicine provider — but not seeing a GP only, a primary care allied health provider or a specialised mental health provider).

Sectors were largely mutually exclusive, other than 55 respondents who consulted both of the second two sectors.

Interventions received

Respondents who reported past-year consultations for mental health were asked to identify interventions received in those consultations from a list including: information; medicine or tablets (not further specified); talking therapies including CBT, psychotherapy and counselling; social intervention; and skills training. Respondents were also asked to name up to five medications they had taken in the previous 2 weeks for mental health and how long they had been taking each; interviewers checked available medication packaging.

Levels of treatment

We defined three levels of treatment received in the past year:

any consultation — one or more consultations with any health professional for mental health, regardless of the interventions provided;
an evidence-based intervention — either pharmacotherapy, specifically an antidepressant or mood stabiliser, or psychological therapy, namely CBT or psychotherapy;
minimally adequate treatment12 — either: taking an antidepressant or mood stabiliser for 1 month or longer, plus four or more consultations with any medical practitioner for mental health; or receiving CBT or psychotherapy, plus six or more consultations of 30 minutes or longer average duration with any health professional (except a complementary or alternative medicine therapist) for mental health. We adapted existing minimally adequate treatment criteria12 that were based on treatment guidelines and considered appropriate to the Australian health care system.

Sociodemographic measures

The survey elicited information about respondents’ age, sex, marital status, employment status, education, main income source, country of birth, urbanicity and relative socioeconomic disadvantage.

Statistical analysis

We analysed 2007 NSMHWB Basic Confidentialised Unit Record File (April 2009) data using Stata, version 11 (StataCorp). Replicate weights were applied to the data to account for the differential probability of survey selection and to ensure conformity to known population distributions. Standard errors and 95% confidence intervals were calculated using jackknife repeated replication to accommodate the complex survey design. In the subsample who met criteria for past-year affective and/or anxiety disorders, multivariate logistic regression analyses were used to identify clinical, sociodemographic and health sector correlates of each of the three levels of treatment. Of the 8841 respondents, 10 with missing data were excluded, leaving 8831 respondents in our analysis.

Results

Treatment of past-year affective and/or anxiety disorder

In the 2007 survey, 17% of Australian adults met criteria for a past-year affective and/or anxiety disorder. Of these, 39% had consulted a health professional for mental health in the past year (Box 1). The proportion of participants who consulted a health professional varied by disorder. For example, there was a 2.5-fold variation between those with anxiety disorder(s) only (27%) and those with comorbid affective and anxiety disorders (67%), and a threefold variation between those with mild (20%) and severe (64%) disorders.

Of those who consulted a health professional, two-thirds (67%) received an evidence-based treatment but only 41% received minimally adequate treatment. This equates to 26% and 16%, respectively, of all consultees with a past-year affective or anxiety disorder. There was a gradient in the likelihood of receiving an evidence-based treatment according to disorder type, and in the likelihood of receiving adequate treatment according to disorder type and severity.

Of the consultees who received an evidence-based treatment, about two-thirds received a psychological therapy and two-thirds received pharmacotherapy. The likelihood of receiving an evidence-based psychological therapy was lower among people with affective disorder(s) only (Appendix 1).

Of the consultees who received minimally adequate treatment, about equal proportions (two-thirds) received an adequate “dose” of psychological therapy and/or of pharmacotherapy (Appendix 1).

Health sectors consulted

Of those who consulted a health professional (620), 28% consulted only a GP, 43% consulted the primary care allied health sector, 31% consulted the specialised mental health sector, and 9% consulted the other health sector. Consultation with the specialised mental health sector was significantly more common among people with severe, relative to mild or moderate, disorders. Further details are shown in Appendix 2.

Treatment level by sector

Among people consulting the primary care allied health sector, receipt of an evidence-based intervention was more common among people with severe disorders and receipt of adequate treatment was more common among people with severe or comorbid disorders. Further details are shown in Appendix 3.

Correlates of treatment

In analyses controlling for clinical factors including type and severity of disorder, the odds of all levels of treatment were lower for younger, compared with middle aged, adults (Box 2). The odds of receiving an evidence-based treatment were lower among married compared with never married respondents. The odds of receiving an evidence-based treatment or minimally adequate treatment were two and six times greater, respectively, among those consulting the primary care allied health and/or specialised mental health sector(s) compared with those consulting only a GP.

Discussion

In the 2007 NSMHWB, of all people with past-year affective and/or anxiety disorders, 39% sought professional help for mental health, 26% received an evidence-based intervention, and 16% received minimally adequate treatment. Younger adults were less likely to receive any treatment, and people who consulted a GP only were less likely to receive evidence-based or minimally adequate treatment than those who consulted a mental health professional.

Potential sources of bias should be considered. First, treatment quality indicators are not universally agreed and vary across studies. In this study, adequate psychological therapy required six sessions of treatment to best fit the grouped consultation data in the NSMHWB. Although lower than the threshold of eight sessions commonly used,12 both a meta-regression and a patient-level analysis have shown little increase in benefit beyond seven sessions.16,17 Adequate pharmacotherapy relied on reports of medications taken in the past 2 weeks and required at least 1 month of medication use to fit the grouped duration data available, rather than the 2-month threshold commonly used.12 Medication dose was not available. We were able, to some extent, to specify types of psychological therapy, although psychotherapy is an umbrella term and may have included some therapies that are not evidence-based. Notwithstanding methodological and service system differences, studies have generally returned similar findings regarding the shortfall in treatment quality and variations between health sectors.12–14

Second, cross-sectional data have limitations for this purpose. The temporal relationship between clinical and treatment variables could not be established. As detail was gathered only about past-year consultations, adequate treatment for respondents who commenced treatment before, or late in, the past year may be underestimated. However, there is no reason to believe this would bias the patterns or correlates of treatment quality.13 It was not possible to examine the validity of the indicators of treatment quality; however, positive associations between similarly derived indicators of treatment quality and outcomes have been reported.18

Third, the criteria for minimally adequate treatment represent a minimum threshold for adequacy, but do not necessarily equate to optimal, individually tailored care. The criteria will require revision as the evidence base for interventions evolves.

There are many possible reasons why people who seek professional help might not receive an adequate dose of treatment. In this study, the attrition between the frequency of evidence-based and minimally adequate treatment suggests a need for strategies to improve treatment adherence. Options include quality improvement strategies to support systematic and proactive monitoring of patient adherence and outcomes.19 Little is known about the content of interventions in office-based practice; professional bodies could take a role in monitoring and providing education regarding effective practices. Educating consumers regarding the benefits of psychological therapies and what constitutes an adequate course may be helpful.13 Dissemination of psychological treatments via the internet may help reduce barriers to care and increase treatment fidelity. Most work in this area has occurred since 2007 so could not be included in our model. Internet therapies are efficacious and effective for mild, moderate and severe anxiety and depression, acceptable to patients and providers, and probably more cost-effective than face-to-face therapies.20,21

The frequencies of evidence-based and adequate pharmacotherapy and psychological therapy were similar across disorder and severity groups, except that fewer people with affective disorder(s) only received adequate psychological treatment. These patterns are inconsistent with treatment guidelines that, generally, recommend psychological therapy as first-line treatment for anxiety disorders and milder depression, and medications as an adjunct to psychological therapies for more severe depression. Further investigation of the patterns of treatment according to individual disorders is needed, but these initial findings are concerning given that CBT (face-to-face or internet) can achieve improvements for one in 2–3 patients (depending on disorder) within 6 weeks, and has about 80% adherence.20 In contrast, selective serotonin reuptake inhibitors (the most commonly prescribed antidepressants) take up to 6 weeks to reach potency and require continuation for 6 months to reduce relapse, and adherence is poor.22

In our study, as elsewhere,14 frequency and type of treatment received varied by health sector. People with more complex and/or severe disorders were most likely to receive all levels of treatment and to consult the specialised mental health sector. This suggests that treatment resources are being allocated according to need, although coverage and quality could be improved. The relatively lower frequency of evidence-based and adequate treatment among those who only consulted a GP, compared with those consulting a mental health professional, may reflect provider factors (competing demands, lack of specialised training or experience) and patient factors (poorer adherence and acceptability of mental health treatments among patients consulting this sector).4,12,13 In Australia, the 20-minute average duration of GP encounters for depression or anxiety,23 reflecting the Medicare Benefits Schedule item structure, limits GPs’ capacity to meet the threshold for adequate psychological treatment. Onsite psychotherapy and use of treatment algorithms in primary care settings have been associated with higher-quality care for depression14,24 but not improved outcomes.18 It has been suggested that the gap in treatment quality overall is more important than the differences between sectors,19 and that quality improvement strategies19 and improved collaborative care models4 should be prioritised. Research to identify the treatment elements (eg, number or duration of sessions) that contribute to poorer adequacy, within each sector, is indicated.

Further research is needed to investigate the reasons for the age-related differentials in treatment that occur along the pathway to adequate treatment; these likely involve patient and provider factors.7

Data for this study were collected in 2007. Direct evidence of changes in treatment quality is lacking, and there have been no major reforms since 2007 likely to have affected quality at a population level. A previous study estimated that treatment access for any mental disorder may have improved by 23% between the 2006–07 and 2009–10 financial years, primarily due to uptake of Better Access services.25 Applying our estimates of minimally adequate treatment to the estimated proportions of people consulting various health sectors in 2009–10,25 we might speculate that 19% of consultees with affective and/or anxiety disorders received adequate treatment in 2009–10, compared with 16% in 2007 (details upon request). A proposed third NSMHWB should allow an updated assessment of mental health treatment access and quality.

1 Prevalence of past-year affective and/or anxiety disorder among 8831 adult participants of the 2007 Australian National Survey of Mental Health and Wellbeing, and level of treatment received, by disorder type and severity

Percentage of [b] who received:

Distribution of past-year affective and/or anxiety disorders in the Australian population [a]*

Percentage of [a] who consulted for mental health [b]†

An evidence-based intervention [c]†

Minimally adequate treatment [d]†‡

% (95% CI)

Any affective and/or anxiety disorder

1517

17% (16%–18%)

39% (35%–42%)

67% (61%–72%)

41% (35%–47%)

Disorder type

Anxiety only

966

11% (10%–12%)

27% (23%–32%)

61% (53%–69%)

31% (21%–41%)

Affective only

226

3% (2%–3%)

46% (36%–56%)

61% (48%–74%)

30% (19%–41%)

Comorbid affective and anxiety

325

4% (3%–4%)

67% (60%–75%)

77% (69%–84%)

59% (51%–67%)

χ2 (P)§

67.7 (< 0.001)

10.0 (0.01)

25.1 (< 0.001)

Severity

Mild

570

7% (6%–8%)

20% (15%–25%)

61% (48%–75%)

25% (10%–40%)

Moderate

580

6% (6%–7%)

43% (37%–48%)

66% (58%–75%)

36% (28%–45%)

Severe

367

4% (3%–5%)

64% (56%–73%)

71% (62%–79%)

55% (47%–62%)

χ2 (P)§

73.7 (< 0.001)

1.7 (0.44)

19.3 (0.003)

All percentages are weighted. na = not applicable. * As represented by the study population (n = 8831). † Percentage of respondents within each disorder type or severity group. ‡ Because data on the frequencies of consultation with each type of professional were only available in grouped form, minimally adequate treatment status was deemed for 55 respondents with affective or anxiety disorders using available data regarding their possible range of eligible consultations. § df = 2.

2 Multivariate analysis* of predictors of consultation for mental health among adult participants with past-year affective and/or anxiety disorder, 2007 Australian National Survey of Mental Health and Wellbeing

	Consulted for mental health†		Received an evidence-based intervention if consulted for mental health‡		Received minimally adequate treatment if consulted for mental health‡§
	AOR (95% CI)	P¶	AOR (95% CI)	P¶	AOR (95% CI)	P¶

Female	1.5 (1.0–2.4)	0.08	1.3 (0.7–2.4)	0.46	1.3 (0.6–2.5)	0.52
Age group
16–29 years (reference)	1.0		1.0		1.0
30–39 years	1.6 (1.0–2.6)	0.04	2.7 (1.1–6.3)	0.03	2.8 (1.2–6.3)	0.02
40–59 years	1.5 (0.8–2.6)	0.11	2.8 (1.1–7.1)	0.03	2.7 (1.1–6.3)	0.03
60 years and over	1.0 (0.5–1.9)	0.89	2.0 (0.6–6.4)	0.23	1.8 (0.5–6.2)	0.36
Marital status
Never married (reference)	1.0		1.0		1.0
Married	0.9 (0.6–1.5)	0.78	0.5 (0.2–1.0)	0.04	0.9 (0.4–1.8)	0.70
Previously married	1.2 (0.7–2.2)	0.46	0.7 (0.3–1.5)	0.37	0.7 (0.3–1.7)	0.41
Employed	1.1 (0.7–1.7)	0.61	1.8 (0.6–5.3)	0.27	1.9 (0.7–5.0)	0.21
Post-school qualification	0.9 (0.6–1.4)	0.65	1.3 (0.7–2.5)	0.37	1.4 (0.8–2.7)	0.27
Main source of income, government benefit	1.4 (0.9–2.2)	0.10	0.8 (0.3–2.0)	0.57	0.8 (0.3–2.0)	0.64
Disorder type
Comorbid affective and anxiety (reference)	1.0		1.0		1.0
Anxiety only	0.4 (0.2–0.6)	< 0.001	0.5 (0.3–0.9)	0.03	0.4 (0.2–0.8)	0.01
Affective only	0.6 (0.3–1.0)	0.04	0.5 (0.2–1.1)	0.07	0.4 (0.2–0.8)	0.02
Comorbid substance use disorder	0.8 (0.5–1.4)	0.50	0.9 (0.4–2.1)	0.82	1.2 (0.5–2.9)	0.66
Two or more chronic physical disorders**	1.4 (1.0–2.0)	0.08	0.8 (0.4–1.4)	0.35	1.2 (0.8–2.0)	0.38
Severity of disorder
Mild (reference)	1.0		1.0		1.0
Moderate	2.2 (1.4–3.5)	0.001	1.2 (0.6–2.4)	0.64	1.6 (0.7–3.8)	0.28
Severe	3.8 (2.1–6.7)	< 0.001	0.8 (0.3–2.0)	0.63	1.8 (0.7–4.6)	0.22
Sector consulted
General practitioner only (reference)	na		1.0		1.0
Primary care allied health and/or specialised mental health sector(s)			1.9 (1.1–3.5)	0.03	6.0 (3.0–12.0)	0.001
Other health			0.4 (0.2–1.2)	0.09	1.2 (0.4–3.3)	0.79

AOR = adjusted odds ratio. na = not applicable. * Country of birth, urbanicity, and relative socioeconomic disadvantage were assessed for inclusion in the models but did not reach P = 0.05 in univariate analyses. † Denominator is 1517 respondents with past-year affective or anxiety disorders. ‡ Denominator is 620 respondents with past-year affective or anxiety disorder who consulted for mental health in the previous 12 months. § Because data on the frequencies of consultation with each type of professional were only available in grouped form, minimally adequate treatment status was deemed for 55 respondents with affective or anxiety disorders using available data regarding their possible range of eligible consultations. ¶ P for Wald χ2 test of association. ** Chronic physical disorders in past year included musculoskeletal conditions, cardiovascular conditions, respiratory disorders, diabetes, cancer, stroke, emphysema, anaemia, epilepsy, fluid problems, hernias, kidney problems, migraine, psoriasis, gastrointestinal ulcer, thyroid problems and tuberculosis.

Until the pips squeak

Freezing the price of Medicare benefits will be more effective than the ill fated copayment

An amendment to our constitution after the 1946 referendum (s51 [xxiiiA]) gave the Australian Government the power to set prices for medical services.1 This amendment has often been incorrectly interpreted as the power to set doctors’ fees. It is frustrating to see old misunderstandings distorting current considerations of health financing policy.

In reality, the federal government has no control over whether a doctor charges $5 or $500; nor to whom such a fee is charged. Doctors can charge what they choose, provided it can be justified as “fair and reasonable”.

Dabbling in price signals

For the best part of a year, the health debate has swirled around a proposed copayment for general practice services.2 All the government needed to do, if it was seeking to reduce Medicare outlays on general practice services, was to reduce the price it pays for those services. That was the apparent basis for the ill fated initiative in January 2015, directed at the short consultation. Getting into an area of price signals by unnecessarily flagging a copayment simply complicates matters.

When, in 2005, the government removed the disincentives for bulk-billing by allowing these services to be priced at 100% (ie, the Medicare rebate for those services was set at 100% rather than 85%), an effective price signal was removed. This was done to serve a political agenda — to increase bulk-billing rates — which removing the price signal certainly did.

When the first attempt at codifying the doctors’ various charges was made after the publication of the Nimmo report in 1969,3 the concept of the value of one service compared with another emerged. This then formed the basis of the prices that are set out in the Medicare Benefits Schedule (MBS). The MBS is one of the pillars of Australian health financing. Within the MBS, there is a clear scale of relativities, which means, for instance, that Medicare benefits are higher for consultations with specialists than general practitioners.

There are two factors besides the relative value of services that are considered in setting the Medicare benefit. One is the descriptor of the actual service, which defines the service. The other factor is time. Time-tiering, confined to consultation items, is used to further differentiate price. The longer the service takes, the higher the price.

One of the most controversial MBS items has always been the Level B general practitioner consultation, which is described as a consultation of “less than 20 minutes”. Thus, a 2-minute consultation attracts the same benefit as a 15-minute consultation. The government, in now trying to cut costs, has belatedly recognised that the price signal for 6 minutes or less is the most profitable way of exploiting the MBS, and the current Level B consultation allows this by not establishing a minimum time.

So, the government now has the correct target for reducing costs, but the way the change was introduced in January with a Queensland election in the offing was not politically smart. It enabled all the populists, who now are rampant in federal parliament, to jump all over the decision, trumpeting how much the community will suffer. However, this is not a debate about caring for the health of the populace; it is about doctors’ incomes.

The Medicare price freeze

As proposed and then withdrawn, the decision to reduce the price the government would pay for a Level B consultation by $20 is a blunt instrument. However, an even blunter instrument is a price freeze on the MBS until 2018. The government could also tighten descriptors or exclude certain service items from attracting a benefit, and remove the requirement for prescriptions for some drugs, thus reducing the need for doctor visits.

The government can toy with copayments for consultations, but there is a “complete absence of evidence that copayments have a particularly significant quantitative effect or that they can explain even a fraction of the post-war inflation of health costs”.4 In a recent issue of the Journal, Keane, lecturer in public health at Monash University, was more circumspect, but essentially agrees that there is little or no evidence that copayments work.5

The bellwether for the success of the price freeze and its selectiveness will be bulk-billing practices that depend on throughput to make profits. How far can the profit margin be squeezed before these types of “for-profit” practices have to start charging to stay solvent?

If the government is resolute, freezing the price until 2018 is the most effective way to curb Medicare outlays, especially if the general practitioner consultation descriptors are rewritten to specify an expected length of consultation. If that descriptor restricts the Level B MBS benefit to a consultation of a minimum of 15 minutes, it removes all “time” ambiguity In other words, the government price would be based on four consultations an hour. This is harder to argue against as the government has already priced a brief consultation (Level A), the price of which could be renegotiated given that no time is specified.

In the end, all the palaver about copayments is unnecessary. The government can squeeze price, and then wait until the pips squeak — especially among practices owned by private corporations. If one is used to getting a service for nothing, instituting a cost will send an eruption of squeaking pips into the political troposphere, as happened with the most recent government announcement.

A recent article made the point that “healthcare, if publicly provided, inevitably has to be constrained”, but what people are fearful of is that “once the service is driven by market principles, the rationing will cease to be fair.”6

Wise words! The new Health Minister, Sussan Ley will need to be very wise, so intense will be the lobbying given the enormous increase in the number of vested interests.

After the fiasco in January, she promised to consult with stakeholders. Perhaps she should also look to an independent umpire, as Nimmo and his eminent colleagues were 40 years ago, when their report formed the basis of Medicare as we now know it. Sustaining a freeze over 4 years with an election in between and with a populist Senate will be nigh impossible.

The serious challenge of medical research

Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution. It is, strictly speaking, a real factor in scientific research.

Albert Einstein

Two emails that landed on my computer screen recently gave clues to the amazing pace and reach of medical research. Both advertised conferences: one planned for Boston in July, and the other in San Diego in March this year.

The Boston meeting, entitled the Organ-on-a-Chip World Congress, is rather breathlessly described as concerning “assemblies of cell clusters using microfluidics that mimic in vivo organ structure”. Technology options to be reviewed at the congress resemble a fast-food menu — Lung-on-a-Chip, Brain-on-a-Chip and Gut-on-a-Chip.

The San Diego conference, Biomarker Summit 2015, will consider “all aspects of the biomarker and diagnostic development process from discovery to translation to commercialization”, with topics covering “big data analytics and management, regulatory and reimbursement trends, companion diagnostics development, and much more”.

In contemplating the future of medical research in Australia, the international context, typified by what lies behind these two meetings, is critical. Two features stand out.

Biology — make way for IT

First, wherever you look, the massive contributions to medical research by non-biological sciences are paramount. Craig Venter, a gene scientist who sequenced the human genome, states in his book Life at the speed of light that genetic research and information science are so interwoven as to be inseparable. His book takes its title from his suggestion that if a sophisticated probe found life in deep water below the surface of Mars, an on-board sequencer could decipher and digitise its genome and radio the code at the speed of light to a laboratory on earth (presumably his), to be reconstituted to build a Martian organism.

In neuroscience also, technology not thought of as medical is now thoroughly integrated with biology. Workers studying changes in brain function as they relate to behaviour depend heavily on such technology. Denis Le Bihan, a French neuroscientist and major inventor of imaging techniques, extols the contribution of magnetic resonance imaging to our understanding of brain function in his new book Looking inside the brain.

Neuroscience leapt forward in the 1970s when computerised neuroimaging became available to the research and clinical communities. Physics underpinned the development of the electroencephalograph. New levels of neurological and psychiatric understanding are leading to new therapies, such as deep brain stimulation. Depression, Bihan suggests, may soon be seen as a feature of many abnormalities, just as the once-solid disease called “fever” broke apart when its multiple causes were found. In all these discoveries, engineering, information science and mathematics are deeply embedded.

Medical research is good economics

Second, we need to see research much more clearly, as others are doing, as a major economic opportunity for government and the private sector alike. The two conferences I mentioned are almost entirely private sector-sponsored. Medical research is an intellectual industry. Smart, future-oriented economic thinking would be seeking ways to position Australia at the head of the pack. Pedalling happily in the Alpine sunshine at the back of the peloton is just plain dumb economics. The oft-repeated (appalling) mantra that we are “punching above our weight”, based on publications, seriously mistakes past achievement for future opportunity. Research is a fierce competition. Winners do well. They need expensive support teams.

How is it that our major project grants scheme — the National Health and Medical Research Council — supports fewer than one in five applicants? If one in five missed out, the arrangements would be credible.

It is among the project grants that bright, risky and imaginative ideas are often found. Imaginative questions are the essence of research: yes, it does require high-tech and massive investment to prosper, but if the intellectual electricity is missing, the wheels do not turn. Were the Medicare levy raised by 0.5%, the $3 billion raised each year could be applied to medical research — an amount much larger, and more equitably procured, than was to be raised through the proposed copayment for Medicare services. There would be no sitting and waiting for a future fund to bear fruit.

A big increase in our present fund also makes investment sense, so that we can more appropriately match the achievements of our economic peers and grow the world’s best research community, fit for future purpose, from our large talent pool. Channelling Henry Ford, we may say that what’s good for research is good for Australia.

While no one should promise that medical research will find a cure for cancer or Alzheimer’s disease, at least not in the next few years, it is certain that we will not find a cure any other way. Fortunately we live in a gilded age of science, and all of it — not just the disciplines classically seen as medical — has a contribution to make to medical achievement. It requires political and private enterprise and vision to enable it, through generous, imaginative funding.

Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement

Intellectual property (IP) provisions being pursued by the United States in the 12-country Trans-Pacific Partnership Agreement (TPPA) negotiations have generated widespread alarm since the initial US proposals were leaked in 2011.1–5 Subsequent leaks of composite drafts of the IP chapter have shown ongoing resistance by most countries to many of the US proposals that would delay access to generic medicines.6,7 But while the most recently leaked draft suggests some modifications in the US position,7 major concerns related to medicines access remain unresolved.

This article focuses on three particular problems for Australia that remain in the 2014 draft. These are provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms, and extend data protection for certain medicines. If agreed by negotiating countries, these provisions would future-proof existing low standards that are antithetical to promoting access to, and affordability of, medicines. These will not only extend monopolies over expensive new treatments, but will also make subsequent reform efforts increasingly difficult.

For each of the problems identified, we examined existing public domain data, drawn primarily from the 2013 Pharmaceutical Patents Review (PPR) and submissions to it, to identify the costs to Australian taxpayers of existing patent and data protection provisions, as well as those likely to accrue to taxpayers if the Australian Government accedes to US ambitions on these matters.

Secondary patents and evergreening

The pharmaceutical industry uses a practice known as evergreening to extend monopoly periods for medicines. Secondary patents are patents of very low inventiveness based on an original inventive patent for a new molecule. Evergreening patents are secondary patents held by the owner of the original patent. Evergreening presents a particular problem in countries with low patentability standards, such as Australia and the US.8,9

US researchers examined patents granted for two HIV drugs (ritonavir and lopinavir/ritonavir) and found that Abbott owned 82 secondary patents and had a further 26 pending applications in the US, all of which involved small variations on the original patents for these drugs.9 They found that these evergreening patents could delay generic competition for 19 years beyond the date from which generic entry would have been anticipated.9 This problem is largely due to low standards for patent grant, together with barriers to the challenge and revocation of questionable patents.

A study in Australia found an average of 49 secondary patents for each of the 15 highest-cost drugs over a 20-year period.10 One-quarter of these secondary patents were evergreening patents.

Evergreening delays generic market entry and imposes large unnecessary costs on the health care system — and on consumers. When a patent on a medicine expires and the first generic version is listed on the Pharmaceutical Benefits Scheme (PBS), a statutory reduction of 16% is applied to the PBS price and it is moved from the F1 to the F2 formulary. There, it becomes subject to the application of price disclosure,11 which further lowers prices over time.

Generic medicines manufacturer Alphapharm (a subsidiary of US-based Mylan) stated in its public submission to the PPR that:

In the case of Plavix (clopidogrel) the cost to the PBS of a near 3-year delay in the generic market entry caused by the grant of an interim injunction over an evergreening patent that was subsequently revoked has been estimated to be about $60 million. However, the total cost to the PBS attributable to the revoked patent has been estimated to be about $644 million (p. 6).12

The Australian Generic Medicines Industry Association analysed the costs to the health system for 39 PBS-listed medicines for which generic competition was delayed after the patent on the active pharmaceutical ingredient expired, as a result of secondary patenting.13 In the 12 months to November 2012, the cost of delayed generic launch was calculated at $37.8–$48.4 million. This estimate does not include subsequent price reductions due to price disclosure.

An illustration of how this affects consumers comes from the patents associated with an antidepressant, venlafaxine (Efexor). Two additional patents support the extended-release form, Efexor-XR. One of these was so broad that it delayed generic entry by two and a half years. By the time this patent was eventually declared invalid, the delay to generic market entry had cost Australian taxpayers $209 million.14

Pfizer also successfully patented desvenlafaxine (marketed as Pristiq), the active metabolite of venlafaxine. Not only was a patent granted for desvenlafaxine, it was also given a term extension until August 2023. There is no evidence that Pristiq offers any clinical benefit over venlafaxine.15,16 But the cost to taxpayers of doctors prescribing Pristiq in preference to off-patent Efexor-XR has been estimated at more than $21 million per year.14

The problem of evergreening in Australia is likely to be entrenched further by the provisions of the TPPA. A footnote to draft TPPA article QQE1 sets the current very low inventiveness approach in stone, making it difficult, if not impossible, to prevent further evergreening.17 Australia is supporting a provision that commits countries to make patents available for “any new uses, or alternatively, new methods of using a known product” (Art. QQE1.4(a)),7 as this is current Australian practice. But acceding to this provision in the treaty text will limit Australia’s options for much needed patent reform in future.

Patent term extension

Australia is obliged to provide 20-year patents under the World Trade Organization’s Agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights). In 1998, patent term extension provisions were introduced, allowing up to 5 years for delays in processing patent applications or in the regulatory approval process. These provisions were later locked in by the obligations of the Australia–US Free Trade Agreement (AUSFTA).3

The PPR found that about 58% of new molecules listed on the PBS from 2003 to 2010 received extensions of term. Of the term extensions granted since 1999, 47% received the full 5 years.18 The cost of these extensions to the PBS in 2012–13 was estimated at about $240 million in the medium term and about $480 million in the longer term.18

The PPR found that, contrary to claims by the pharmaceutical industry, there was no evidence that the public investment in extensions of term had led to a commensurate increase in investment in research and development.18 The PPR concluded that patent term extension was not in Australia’s interests, and recommended reducing the maximum length of extensions or the maximum effective patent life.

The most recent draft TPPA IP text includes provisions for term extensions for delays in the processing of patents and in the regulatory approval process.7 While the leaked text indicates opposition by Australia to the former, and the latter is consistent with the AUSFTA, patent term extension has been widely reported as an area where the US has little support from other countries. Moreover, the Therapeutic Goods Administration (TGA) regulatory approval process for medicines is subject to a statutory time limit of 255 working days, after which the TGA forfeits 25% of the evaluation fee (Therapeutic Goods Regulations 1990 [ss. 16C; 43AA]). Thus, the routine granting of extensions to compensate for rare delays in the marketing approval process makes little sense.

Earlier leaked TPPA negotiating documents show that the US was seeking to mandate patent term extensions not just for new molecules, but also for new uses and new methods of using existing products.6 This extension of scope for term extensions seems to have been dropped from the 2014 draft,7 a likely result of opposition by other countries. No evidence presented to the PPR indicated that extending the scope of patent term extensions would be in the national interest.18

Data protection

Data protection refers to preventing or delaying the reliance, by a generic manufacturer, on clinical trial data produced by the originator to support marketing approval of its product. Under the Commonwealth Therapeutic Goods Act 1989 (s. 25A), the TGA may not consider an application for a generic medicine where that application relies on undisclosed evidence of safety and efficacy submitted in support of the originator product for 5 years from the date of first registration. Data protection confers a monopoly that is distinct from that provided by the patent system, and is effective even where a patent has not been granted, or has expired. Unlike a patent, data protection cannot be subject to legal challenge.

We are not aware of any analyses of the financial impact of data protection on the Australian health system, but studies in other countries have shown that its introduction leads to increased costs. Oxfam International found that data protection introduced in Jordan in 2001, together with other TRIPS Plus measures, delayed generic entry for 79% of medicines launched between 2002 and 2006.19 A later, more comprehensive study found that between 1999 and 2004 there was a 17% increase in total medicines expenditure in Jordan, equating to additional costs of US$18 million in 2004.2 0 The study concluded that data protection had the most significant effect on this price increase.

In addition to its effects on medicines expenditure, data protection also presents a potential barrier to compulsory licensing — a TRIPS-compliant strategy that countries may use to bypass patents where this is necessary for public health purposes.2 1

Proposals for the TPPA include 5 years of data protection for new products, an additional 3 years for data produced to support new uses of existing products, and a longer period of data protection for biologics (possibly up to 12 years).7 Biologics are produced through biotechnology processes involving living organisms; these include many new cancer, anti-rheumatic and multiple sclerosis medicines.

In the 2014 TPPA draft, data protection is limited to undisclosed data and data required by regulatory agencies, representing a narrowing of the scope in comparison with earlier drafts.7 However, extending data protection to new uses of existing products and allowing longer periods of protection for biologics are likely to lead to significant delays in the market entry of cheaper generics and biosimilars in Australia. Additional periods of 3 years of data protection for new indications were previously rejected by Australia in the AUSFTA negotiations.3

The PPR found that “data protection appears to have little impact on the levels of pharmaceutical investment in a country” (p. 160).18 It concluded that there was no evidence to indicate that current data protection provided insufficient incentives to innovate and bring biologic products to market, and recommended against extending data protection for biologics. In the US, the Federal Trade Commission also concluded that lengthy data protection for biologics was not warranted.2 2

A useful example of the costs of delaying market entry of competitors for biologics is adalimumab (Humira), a drug for rheumatoid arthritis and other autoimmune conditions. This drug represented the third-highest cost to government in 2013–14, costing Australian taxpayers $272.7 million.2 3 When the first biosimilar version is listed on the PBS, it will trigger a 16% statutory price reduction on all versions of the product. This means savings to taxpayers of $43.6 million in the first year (based on 2013–14 expenditure data), and with flow-on effects resulting from price disclosure likely to lead to further savings in subsequent years.

Conclusions

Pharmaceutical monopoly protections already cost the Australian health system hundreds of millions of dollars each year. US ambitions for the TPPA IP chapter in the most recently leaked draft would expand and entrench costly monopolies in Australia, with no evidence of any countervailing benefit to the Australian public.

The PPR warned that the current Australian patent system was not well designed to serve Australia’s interests. The government’s stated concern about the need to ensure the sustainability of the PBS can hardly be credible if it ignores this warning in the final stages of the TPPA negotiations.