29 September 2016

Chewing gum and string fixes for Privacy

In another instance of reactively fixing Australia's privacy regime with chewing gum and string (and offsetting news of another health data breach) the national Attorney-General has announced that the Privacy Act 1988 (Cth)
will be amended to improve protections of anonymised datasets that are published by the Commonwealth government". 
No news, alas, about improved protection for non-government data.

The media release states
The publication of major datasets is an important part of 21st century government providing a great benefit to the community. It enables the government, policymakers, researchers, and other interested persons to take full advantage of the opportunities that new technology creates to improve research and policy outcomes.
Our ability to deliver better policies and to solve many of the great challenges of our time rests on the effective sharing and analysis of data. For this reason, the Coalition Government has promoted the benefits of open government data, in accordance with the Australian Government Public Data Policy Statement, and published anonymised data on data.gov.au.
Minister Porter recently drew attention to the benefits of research with anonymised data for identifying risks of long-term welfare dependency and to help break the cycle of dependency.
In a unanimous report, the Senate Select Committee on Health drew attention to the opportunities for research and policy design from the government's data holdings, and recommended that open access to de-identified datasets should be the default position.
In accepting the benefits of the release of anonymised datasets, the Government also recognises that the privacy of citizens is of paramount importance.
It is for that reason that there is a strict and standard government procedure to de-identify all government data that is published. Data that is released is anonymised so that the individuals who are the subject of that data cannot be identified.
However, with advances of technology, methods that were sufficient to de-identify data in the past may become susceptible to re-identification in the future.
The amendment to the Privacy Act will create a new criminal offence of re-identifying de-identified government data. It will also be an offence to counsel, procure, facilitate, or encourage anyone to do this, and to publish or communicate any re-identified dataset.
The legislative change, which will be introduced in the Spring sittings of Parliament, will provide that these offences will take effect from today's announcement.

26 September 2016


In Flori v Queensland Police Service [2016] QCA 239 the Supreme Court of Queensland  has upheld the decision of the Queensland Civil and Administrative Tribunal Appeals (QCATA) regarding Sch 1 of the Information Privacy Act 2009 (Qld).

QCATA affirmed QCAT's decision that the state's privacy principles did not apply to the appellant's personal information published in a news bulletin.

That personal information was obtained during an investigation of his misconduct regarding leaked CCTV footage of the arrest of a man at the police station where undue force was used.

The judgment states that the appellant, Mr Flori, a police officer in the Queensland Police Service, is
aggrieved by the publication of certain personal details contained in an Executive Briefing Note concerning him. The information was about a search warrant which was executed at his home address.
On 16 March 2012 the Executive Briefing Note (EBN) was prepared. An EBN is a document used to communicate important information to other officers in the QPS. The EBN was distributed to other officers in the QPS.
Mr Flori complained that the personal information in the EBN was released to a journalist, in breach of Privacy Principles 4 and 11 of the Information Privacy Act 2009 (Qld) (Privacy Act). The personal information was then the subject of a published article.
His complaint was dealt with initially by the Information Commissioner. The complaint was then referred to the Queensland Civil and Administrative Tribunal. It determined that the EBN was not subject to the privacy principles under the Privacy Act. Mr Flori appealed to the appeal division of QCAT.
QCATA dismissed the appeal, holding that on the proper construction of item 3 of schedule 1 to the Privacy Act, the EBN was a document which contained personal information arising out of a complaint, or an investigation of misconduct, under the Crime and Misconduct Act 2001.
Mr Flori seeks leave to appeal to this Court from the decision of QCATA.
The issue raised is whether the EBN is a document which contains personal information arising out of a complaint, or an investigation of misconduct, under the Crime and Misconduct Act 2001.
That is a question of the statutory construction of item 3 of schedule 1 of the Privacy Act. Section 16 of that Act provides that the documents mentioned in schedule 1 are not subject to the information privacy principles in the Act.
The respondent approached the hearing on the basis that if an error by QCATA could be established, leave was warranted.

25 September 2016

Response to the Review of Medicines and Medical Devices Regulation

In reading the Commonwealth Government's response to the reports of the Expert Panel Review of Medicines and Medical Devices Regulation noted here observers might be forgiven for believing that the Government has once again deferred difficult decisions about the Therapeutic Goods Administration (TGA) and that the Medical Technology Association of Australia (MTAA) has escaped calls for a more coherent registration regime.

The response is described as presenting "a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia [with] ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia".

The response indicates that  
The Expert Panel identified several significant trends in the regulation of medicines and medical devices internationally. In particular, the Panel noted international trends towards allowing earlier access to medicines and medical devices through the development of provisional approval pathways. Additionally, the Panel commented on the benefits of harmonising international regulatory frameworks, noting that there are benefits for consumers and efficiencies for industry from greater harmonisation.
After considering the current regulatory framework for therapeutic goods, the Panel found that the TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators. However, the Panel found that while the TGA performs well there are opportunities for reform and improvement in the regulation of therapeutic goods.
The Panel concluded that allowing for greater flexibility in approval pathways for medicines and medical devices (including greater use of overseas assessment reports and provisional approvals in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices.
The Panel also identified areas of regulation where a more risk-based approach could be adopted to more appropriately align regulation with the risk posed by regulated products. The Panel was also of the view that the use of data was essential in assessments of therapeutic goods, and that better utilising existing data sets could lead to system enhancements and provide greater information for the regulator to base decisions upon.
The Panel’s recommendations considered the following issues: the role of the Australian Government to make sovereign decisions regarding therapeutic goods; the medicines regulatory framework; the medical devices regulatory framework; enhancements to post-market monitoring; the complementary medicines framework; and the framework for advertising therapeutic goods to the public.
In considering the Panel's recommendations the Government’s "plan for reform" is described thus
Of the Review's 58 recommendations, 56 are supported by the Government. The majority of these recommendations are supported in full, while for some, the Government supports the intention of the recommendation but proposes to implement them in a different manner to that suggested by the Review.
Of the 56 supported recommendations, the Government has decided to defer two recommendations namely the:
establishment of registries for all high-risk medical devices (recommendation 22);
review of the Therapeutic Goods Administration's (TGA) funding arrangements (recommendation 32).
The two recommendations that the Government has rejected relate to the decision-making and governance arrangements of the regulator (recommendations 29 and 30). These recommendations were primarily rejected due to widespread stakeholder concerns that they would result in significant approval delays for new medicines and medical devices. In addition, the intention of these recommendations can be achieved through the implementation of the broader suite of reforms recommended by the Review.
The response states
The Government recognises that streamlining access to medicines and medical devices, including access to novel and life-saving therapies, offers significant benefits to consumers, health professionals and industry. The proposed reforms reflect the Government’s plan to boost competitiveness and lessen unnecessary regulatory burden through the Industry, Innovation and Competitiveness Agenda and encourage innovation through the National Innovation and Science Agenda.
The Panel has provided a strong case for the reform of the regulation of therapeutic goods in Australia - one that strikes a balance between supporting consumer choice, the safe and effective use of therapeutic products, creates flexibility for industry and ensures that regulatory settings are appropriately aligned to risk. The proposed programme of reform involves:
• increasing use of overseas assessments with comparable regulators, while maintaining sovereignty of regulatory decisions;
• increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approval and allowing the operation of commercial assessment bodies in Australia for medical device assessments;
• taking a risk-based approach to variations to medicines and medical devices and access to products not listed in the Australian Register of Therapeutic Goods (ARTG);
• enhancing post-market monitoring and improving integration of administrative arrangements relating to pre- and post-market processes for subsidy and other purposes;
• simplifying processes by which advertising of therapeutic products to the public is regulated;
• working across government to consider incentives for innovation to improve the competitiveness of the Australian complementary medicines industry and increasing information available to consumers; and
• conducting further reviews on the Scheduling Policy Framework for substances in consultation with states and territories and on the appropriateness of the application of the therapeutic goods regime to a range of low-risk products.
Moving into Yes, Minister territory, the response states
 In order to progress this important programme of reform, the Government will take a strategic and systems-based approach. This will involve implementation of recommendations in a staged approach over the next three years in order to maintain continuity of business. The Department of Health will collaborate and consult across government and with consumers, health professionals and industry in order to progress these reforms. The TGA, where necessary, will cost recover from industry so as to ensure that it is adequately resourced to implement these reforms and undertake the ongoing work without interrupting business as usual. The Government understands that consumer, professional, and industry groups are looking for immediate action. Accordingly, the Department of Health will commence work on designing implementation of the recommendations, with a view to implementing early opportunities in 2016-2017. Implementation of this important programme of reform will deliver significant benefits for the Australian public and to the Australian medicine and medical device industries. ...
The reforms outlined in this response will improve access to therapeutic goods for Australian consumers, including the potential for expedited access to innovative and life-saving products, without compromising the integrity and safety of medicines and medical devices available in Australia. These benefits include:
• access to life-saving and innovative medicines and medical devices will be improved through the introduction of new, expedited pathways for approval. This will lead to earlier access to vital, life-saving therapies for patients with serious conditions;
• faster access for Australian consumers to certain medicines and medical devices that are approved based on assessments from comparable overseas regulators. This will reduce duplication of effort, leading to efficiencies, while ensuring Australian consumer protection is maintained through retention of oversight by the TGA as the final decision-making authority;
• consumer protection will be enhanced through the development of a more comprehensive system of post-market monitoring which will provide the TGA with better information about emerging safety issues. This will ensure that therapeutic goods in Australia continue to be safe for use, efficacious and of a good quality;
• access to products under the Special Access Scheme and the Authorised Prescriber Scheme will be streamlined, reducing burden for healthcare professionals and enabling ease of access to products not on the ARTG for individual patients who meet the relevant criteria;
• the process for managing complaints relating to advertisements of therapeutic goods directed at consumers will be simplified and streamlined, but with stronger compliance powers against misleading advertising;
• the regulation of complementary medicines will be reformed to provide new pathways where evidence of efficacy will be reviewed by the TGA prior to market and compliance powers strengthened, whilst recognising the low-risk nature of complementary medicines.
As Recommendation 22 the Panel recommended that:
1. All high-risk implantable devices are included in a registry that is compliant with the requirements for registries established by the Australian Commission on Safety and Quality in Health Care (ACSQHC).
2. Responsibility for ensuring that registries are operated consistent with the ACSQHC requirements should rest with the NRA [ie the TGA as Australian National Regulatory Authority].
3. Data collected by device registries should be made available to the NRA in a timely manner to inform post-market monitoring.
4. The NRA should implement an active programme of analysis and reporting on adverse events, and associated data, collected through registries or by other means.
5. The NRA should continue collaborative activities with overseas medical device regulators to actively share registry and other monitoring data, with a view to facilitating timely identification of emerging safety concerns and to inform better clinical practice. 
The Government's response is
The Commonwealth defers consideration of Recommendation Twenty-Two, as establishing and maintaining registries requires careful consideration of the range of registries managed by a variety of organisations and how they could be sustainably managed and funded in the future. Further consultation with stakeholders is required to adequately assess the risks and benefits of establishing registries, and to determine appropriate mechanisms to enable access to data. 
As Recommendation 32  the Panel recommended
 that the Australian Government review and enhance the NRA’s funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and operation are achieved. 
The Government's response is
The Commonwealth defers consideration of Recommendation Thirty-Two. The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 2017/18. A review of the regulator’s funding arrangements should not be conducted in isolation. Deferring consideration under the Portfolio Charging Review will ensure funding arrangements are fully considered and aligned within a whole-of-portfolio perspective.
As recommendation 29 the Panel recommended that:
1. The decision making process for the inclusion of medicines and medical devices in the ARTG be changed to provide for:
A. The Australian Government’s Chief Medical Officer to be the delegate for decisions.
B. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about registration of a medicine in the ARTG (Advisory Committee on Medicines).
C. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about inclusion of a medical device in the ARTG (Advisory Committee on Medical Devices).
2. Both Committees be composed of experts across relevant fields and consumer representation and have the authority to:
A. Consider information submitted by the product sponsor.
B. Consider evaluation reports prepared by or for the Australian NRA and comparable overseas NRAs.
C. Take evidence from sponsors, the Australian NRA, and any other parties which the committees consider may have a reasonable interest in the registration of the medication or medical device. D. Take into account any other information that the committees consider may be material in their deliberations. 
The Government's response is that
The Commonwealth rejects Recommendation Twenty-Nine. In consultation on the review recommendations, all stakeholders (industry, health professionals and consumer groups) strongly opposed this recommendation, as there was a consensus that delegating decision-making to a single person would slow approval processes and lead to a significant backlog of applications, thus potentially undermining efficiencies gained by implementing other recommendations in the Review. The Commonwealth notes that the stated purpose of the recommendation (which is to increase dialogue between the TGA and sponsors), will be achieved through implementation of the broad range of reforms the Commonwealth proposes to adopt, such as improving transparency of decision-making, developing an SME support function to provide regulatory advice and facilitating increased engagement between sponsors and the regulator.

22 September 2016

Human Services Competition

The Productivity Commission's preliminary report on Human Services echoes the Harper Review in concluding that competition will cure most, if not all, ills.

The Commission's "key points" are
  • Greater competition, contestability and informed user choice could improve outcomes in many, but not all, human services. 
  •  The Commission’s preliminary finding is that there are six priority areas where introducing greater competition, contestability and informed user choice could improve outcomes for people who use human services, and the community as a whole. – The Commission’s view is that reform could offer the greatest improvements in outcomes for people who use social housing, public hospitals, specialist palliative care, public dental services, services in remote Indigenous communities, and grant-based family and community services. – Well-designed reform, underpinned by strong government stewardship, could improve the quality of services, increase access to services, and help people have a greater say over the services they use and who provides them. – The purpose of this report is to seek participant feedback on the Commission’s findings before the public release of its study report in November 2016. 
  • Introducing greater competition, contestability and informed user choice can improve the effectiveness of human services. – Informed user choice puts users at the heart of service delivery and recognises that, in general, the service user is best-placed to make decisions about the services that meet their needs and preferences. – Competition between service providers can drive innovation and create incentives for providers to be more responsive to the needs and preferences of users. Creating contestable arrangements amongst providers can achieve many of the benefits of effective competition. – For some services, and in some settings, direct government provision of services will be the best way to improve the wellbeing of individuals and families. 
  • Access to high-quality human services, such as health and education, underpins economic and social participation. – The enhanced equity and social cohesion this delivers improves community welfare. 
  • Government stewardship is critical. This includes ensuring human services meet standards of quality, suitability and accessibility, giving people the support they need to make choices, ensuring that appropriate consumer safeguards are in place, and encouraging and adopting ongoing improvements to service provision.
  • High quality data are central to improving the effectiveness of human services. – User-oriented information allows people to make choices about the services they want. – Data improves the transparency of service provision, making it easier for users to access the services they need, and increases accountability to those who fund the services. – Governments are better able to identify community needs and expectations, and make funding and policy decisions that are more likely to achieve intended outcomes.
The preliminary report goes on to state
Public and private expenditure on human services is significant — almost $300 billion in 2013/14  — with demand projected to grow as people live longer, incomes grow and technological breakthroughs increase the range and number of services available to users. Expenditure provides an indication of costs but does not measure the benefits of human services to an individual or to the community — the social and economic benefits when a person at risk of homelessness, for example, finds their way to stable accommodation, better health care and, ultimately, fulfilling employment. ...
The Commission has been asked to examine whether the efficiency and effectiveness of human services could be improved by introducing greater competition, contestability and informed user choice. The terms of reference request that the inquiry be undertaken in two parts: the first is to identify services that are best suited to reform by introducing greater competition, contestability or informed user choice. For the services identified as best suited, the second part is to make reform recommendations that help to ensure all Australians have timely and affordable access to high-quality services that are appropriate to their needs, and that those services are delivered in a cost-effective manner. The final inquiry report will be submitted to the Australian Government in October 2017.
It notes that
The terms of reference for this inquiry do not define ‘human services’, or provide a definitive list of which human services are within scope. Instead, the terms of reference list examples of human services — health, education, community services, job services, social housing, prisons, aged care and disability services — that serve as a guide to the scope of the inquiry. Potential reform to existing government ‘back office’ systems that support the delivery of human services, such as payments systems, is beyond the scope of this inquiry. ...
Governments take an active role in the funding, provision and stewardship of human services. This recognises that markets, as price and quality-setting forums, often struggle to deliver an appropriate level or distribution of these services across the community. The level of funding assistance from governments to service users varies — up to 100 per cent of the cost of provision for some services and for some users — as can the way the funding flows to service providers and users. The nature of funding flows from governments — who receives the funding, when and on what basis — is a significant driver of outcomes from the provision of human services. Some services are funded through payments to suppliers, while for others funding is placed in the hands of the consumer. Funding can be based on meeting outcomes agreed between governments and providers, or on the basis of activity. Careful design is needed to ensure the incentives of providers and users are aligned; and that government objectives are met. Care is needed, for example, to avoid overconsumption of services that are ‘free’ to users.
Governments’ stewardship role in the delivery of human services is broader than overseeing the ‘market’. Stewardship encompasses almost every aspect of system design, including identifying policy priorities and intended outcomes, designing models of service provision, and ensuring that services meet standards of quality, accessibility and suitability for users. Some recipients of human services can be vulnerable, with decisions often being taken at a time of stress. The need to ensure the development and implementation of appropriate consumer safeguards is an important aspect of the stewardship role and will be a key focus for the Commission in the second part of this inquiry. With governments’ involvement in the provision of human services comes the expectation from the community that those services meet a minimum standard. If governments do not adequately discharge their stewardship function, the effects can be damaging to service users, providers and governments. ... Stewardship of human services also includes evaluating outcomes to identify effective practices, and making ongoing improvements to policies and programs to disseminate innovations and improve service outcomes. This aspect of stewardship is challenging. The ability to accurately define and measure outcomes varies significantly across the different human services. These difficulties mean that models of service provision and programs for evaluation need to be carefully designed and appropriately resourced. ...
Competition, contestability and user choice
Informed user choice places users at the heart of human services delivery. With some exceptions, the user of the service is best-placed to make choices about the services that match their needs and preferences. Putting this power into their hands lets individuals exercise greater control over their own lives and can generate incentives for service providers to be more responsive to users’ needs. Competition between multiple service providers for the custom of users can drive innovation and efficiencies. Competition and user choice are already common across a range of human services including general practitioners (GPs) and private dental services, and childcare centres. More competition and user choice is being introduced in other human services, such as disability services. It will not always be the case that users are well-placed to make decisions on their own behalf. People vary enormously in their ability to make informed choices about the services they need or want, as does the level of assistance and user-oriented information needed to support user choice. Not everyone can, is willing to, or should exercise choice. The very young or those with severe cognitive impairment, for example, may not be well placed to make decisions There are also circumstances when a user’s agency is explicitly removed, such as being placed under a court order to attend drug rehabilitation. Competition between multiple service providers is not always possible or desirable. As an alternative, where there would be net benefits, governments can seek to mimic competitive pressures through contestable arrangements to select providers. These providers could be from within government (ideally separated from the commissioning body) or from outside government, with contractual arrangements specifying the terms under which the service should be provided. A contestable market (including one with a single provider), with the credible threat of replacement, can enable the better performing service providers to expand their service offering and keep current providers on their toes. Under the right conditions, contestability can deliver some, or even many of, the benefits of effective competition. Competition, contestability and informed user choice can be part of a system that encourages providers (and governments) to be more effective at achieving outcomes for service users by improving service quality, using innovative delivery models (box 2), expanding access so more people get the support they need, and reducing the costs to governments and users who pay for those services. Competition, contestability and user choice do not have to be applied simultaneously. User choice can be introduced where services are commissioned using contestable processes to select multiple providers. Competition to provide a service may be used when there are sufficient suppliers, while contestability can be used for the same service where competition would be ineffective due, for example, to thin markets in regional and remote areas. The introduction of greater competition, contestability and user choice may not always be the best approach to reform. One size does not fit all and redesigning the provision of human services needs to account for a range of features, including: the rationale for government involvement; the outcomes the services are intended to achieve; the nature of the services and the dynamics of the markets in which the services are provided; the characteristics and capabilities of users; and the diversity in purpose, size, scale and scope of providers. Not all of these features are clear cut or measurable, and all change over time. Further, reforms may raise or lower government expenditure on the provision of human services and different design options will have different fiscal implications for government. ... Many, but not all services, are suited to greater competition, contestability and user choice Non government provision has been a feature of many human services for a long time. Non government provision has increased in some sectors since the mid-1990s, including schools, vocational education and training, residential aged care, employment services and childcare. In many cases, increased non government provision has been accompanied by greater access, with users having choice over the service they receive, who provides it or perhaps both. Participants pointed to the benefits of this, for individuals and the community as a whole.
The government and non-government provision of human services has also involved instances of controversy or failure. Many participants expressed concern about service provision being subject to greater competition and contestability, and, to a lesser extent, user choice. The reasons for participants’ concern included that:
• competition, contestability and user choice risks bidding down the cost of delivery and will lead to a reduction in the quality of services — especially where for profit providers are involved
• the users of human services are among the most disadvantaged in the community with vulnerabilities arising from very low incomes, mental or physical illness, frailties due to older age, low numeracy and literacy skills, or a lack of access to the resources and support needed to exercise informed choice
• some providers of human services have taken advantage of vulnerable people (and poor government stewardship), exposing weaknesses in the system and undermining confidence that competition, contestability and user choice can be beneficial to users, and to the community more broadly
• not for profit, community based organisations are better placed to provide human services — they are closer to the communities they serve and, because they are mission (rather than profit) driven, will reinvest any surplus back into services to support less profitable areas. However, they are disadvantaged by the time and resource consuming administrative processes used to commission services
• introducing greater contestability creates incentives for providers to focus their attention on tender applications and for governments to focus on contract management rather than on ‘what works’ for those in need of support.
Each of these concerns is legitimate but may be minimised or removed by designing appropriate systems to provide human services. Even with these concerns, measures to empower service users and increase competitive pressures could lead to better outcomes for some service users and communities. The question is when is it possible to design service delivery models that capture one of the clearest benefits of markets — the emphasis on putting power into the hands of individual service recipients through choice. The NSW Disability Council explains this in the context of the National Disability Insurance Scheme (NDIS): Choice is empowering and can facilitate greater independence and improve overall quality of life, particularly for people with disability that may have been denied choice and opportunities for self-determination. A strong theme in submissions was the need to consider how reforms to introduce greater competition, contestability and user choice could contribute to the effectiveness of the service. Effectiveness is best considered in the context of human services as an overarching concept, incorporating the attributes of quality, equity, efficiency, accountability and responsiveness to determine whether the service is achieving its intended outcomes. Introducing greater competition, contestability or user choice might not improve all of these attributes at the same rate, or in equal measure, for all service users. Many, but not all, human services are suited to this type of reform and options that generally offer improvements across this range of attributes will be examined in the inquiry report. ...
For a number of the services considered by the Commission, competition, contestability or user choice reform could improve service provision for users, and benefit the community as a whole. The services identified reflect the Commission’s preliminary view of where well-designed reform could offer the greatest improvements in community wellbeing. The assessment has identified six priority areas:
• social housing
• public hospital services
• specialist palliative care
• public dental services
• human services in remote Indigenous communities
• grant-based family and community services.
These priority areas are diverse — in the type and number of users and providers, the settings and circumstances under which services are provided, their reform history, the current application of competition, contestability and user choice, and the level of expenditure contributed by governments and users. The policy design challenge in each will be unique.
 The Commission states
There are six priority areas for reform identified in this report. These reflect the Commission’s preliminary views on the highest priorities for the Commission’s current task. However, many other services could also benefit from reform. For example, there is considerable scope to improve outcomes by promoting competition, contestability and user choice in the provision of residential aged care services. The Commission’s inquiry into the aged care sector in 2011 made recommendations, such as replacing the system of discrete care packages across home-based and residential care with a single integrated and flexible system of care entitlements. If implemented, these reforms would improve outcomes for users of residential aged care services, and the community as a whole.
Reforms are underway to introduce greater competition, contestability or user choice to other services included in the scope of this inquiry. For example, in home-based aged care, reforms are being implemented to offer greater choice for service users. Other areas, such as the NDIS and early childhood education and care, are also under reform. All warrant continued scrutiny and evaluation to ensure the potential net benefits of those reforms are captured.
The Australian Government has also committed to reforming the provision of mental health services, including making the delivery of mental health services more contestable, evidence-based and person-centred. The Commission supports the intention of these important reforms, but notes that it is too early to evaluate their effectiveness.
Services identified for reform
Social housing
Shelter is a basic human need. Housing assistance provides a safety net for those that are experiencing homelessness, or who face high barriers to sustaining a tenancy in the private rental market, and plays an important role in increasing their quality of life. About 400 000 households live in social housing. Recipients of social housing support, who are also likely to access a number of other human services (box 3), have reported through the National Social Housing Survey that they are in better health, are better able to improve their employment situation and have better access to the services and supports they need once settled in stable accommodation. Compared with the general population, tenants of social housing are more likely to be female, Indigenous, Australian-born, from single-person households and to have a disability. Tenants are likely to access a number of other human services, most commonly health and medical services (two thirds of all tenants), and mental health services (one fifth of all tenants).
Three out of four working-age social housing tenants who are in receipt of an income support payment (such as Newstart Allowance or Youth Allowance Job Seeker) have severe or significant barriers to employment. Employment participation rates are low — nationally in June 2013, about 10 per cent of working-age public housing tenants in receipt of an income support payment were employed, compared to 20 per cent for other working-age recipients of an income support payment.
Over time, there has been a shift in the demographics of people receiving support through the social housing system — from working families to recipients of income support who have additional barriers to entering the private housing market. This, combined with the long-lived nature of housing assets, has resulted in a growing mismatch between the characteristics of the social housing stock and those receiving support. It has also resulted in funding pressures on the system. The disconnect between the level of subsidy social housing tenants receive and that received by tenants in the private rental market through the Commonwealth Rent Assistance payment has also increased over time.
Making judgments on the number of households assisted through the social housing system depends on a range of factors, and international evidence suggests that there is no ‘right’ level of social housing. The level of social housing needed will depend on interactions with broader government policy, including the level of income support provided, the objectives of the state and territory governments that have responsibility for the policy area, and the amount of affordable housing available for people to rent in the private market.
Most social housing is provided by government entities
Government entities manage four out of five social housing properties, with the remainder managed by not-for-profit community housing organisations. About 20 per cent of social housing managed by governments (public housing) is not in an acceptable condition, property underutilisation is high, and prospective tenants face long waiting times before they receive housing (figure 3). Limited data on tenant outcomes restrict the ability of governments to monitor service providers and make informed decisions about which providers — including both government and non government providers — would be best-placed to manage social housing.
Offering more choice to social housing tenants
The current social housing system limits the ability of tenants to choose the home they would like to live in. Once applicants reach the top of the social housing waiting list, they are generally allocated an available home based on their preference for the area in which they would like to be housed and their broad characteristics. The suitability of an allocated property can be a question of timing and luck. Tenants cannot ‘hold out’ for a preferred property, because those that reject two (or sometimes one) offers of housing are relegated to the back of an already long waiting list, and often must take what is offered. Many people who enter social housing are likely to be capable of exercising choice over their housing options — although some may need additional support to be able to exercise informed choice and maintain a tenancy. Efforts to improve users’ choice of home have led to a range of benefits overseas. Tenants are more likely to stay in the same area, invest in the local community, and have stable accommodation. Data collected from choice-based systems has been used to identify the housing characteristics that tenants prefer, and to target areas of high demand and need.
Under the current social housing system, demand for social housing far outstrips supply, limiting the properties available for prospective tenants to choose from. Approaches have been implemented overseas that provide a choice of home, even where there are supply constraints. Reform options could also be explored in Australia to address supply constraints and increase the housing options available for prospective social housing tenants.
Preliminary Finding 3.1
Introducing greater competition, contestability and user choice could improve the effectiveness of the social housing system in meeting tenant needs.
• There is substantial room for improvement in the current social housing system. There are long waiting lists, poorly maintained and underutilised properties, and a lack of information available to allow governments to select and monitor the performance of service providers.
• Four out of five social housing properties are managed by government entities, yet there are a large number of housing providers — both not-for-profit and for-profit — that could perform this service. Community housing providers outperform public providers on some indicators, including tenant satisfaction and property maintenance.
• There are currently not enough social housing properties to meet demand, limiting the housing choices available to social housing tenants. Nonetheless, approaches implemented internationally allow social housing tenants greater choice of home. Reform options could be explored in Australia to address supply constraints and increase the housing options available for prospective social housing tenants.
Public hospital services
The term ‘public hospital services’ refers to healthcare that (mostly public) hospitals provide to public patients. This covers many different types of care and can be provided in a range of settings, including specialised units in large hospitals, outpatient clinics, day procedure centres, and hospital-in-the-home care. Almost 60 per cent of expenditure is on admitted services, with the vast majority of this being acute care to cure a condition, alleviate symptoms or manage childbirth. Even a small percentage improvement in outcomes from public hospital services, including quality, could deliver significant benefits in aggregate, given the scale of service provision.
There is scope to improve outcomes for patients
On average, Australian public hospitals perform well against those in comparable countries in terms of health outcomes and costs. Nevertheless, there is scope to improve. Equitable access is an ongoing concern for some groups, particularly those in remote areas. Moreover, benchmarking within Australia suggests that many public hospitals could increase their service quality and efficiency by matching best practice among their domestic peers. There are many policy levers that governments already use to improve patient outcomes, including quality standards and professional training requirements. Greater contestability and user choice could place indirect pressure on hospitals, as part of a broader suite of reforms, to improve outcomes.
User choice could be greater
The good health outcomes that Australia generally achieves compared to other countries indicate that, from a clinical perspective, public hospitals are typically responsive to the needs of patients. However, public patients are often given little or no choice over who treats them and where. Overseas experience indicates that, when hospital patients are able to plan services in advance and access useful information to compare providers (doctors and hospitals), user choice can lead to improved service quality and efficiency (box 4).
As was the case overseas, potential reforms to introduce greater user choice in Australia would need to be supported by user-oriented information. Without it, low levels of health literacy would reduce the willingness and ability of public patients to make informed choices. Providing greater choice at the point where individuals are referred to a specialist by their GP might be another way of supporting choice for people with low levels of health literacy. This is broadly the model that has existed in England (although not the rest of the United Kingdom) since 2006.
The most common planned (elective) surgical procedures in Australian public hospitals include cataract surgery, removal of skin cancers and knee replacements. Overall, public hospitals account for about one-third of elective surgical admissions but almost 50 per cent for patients in the most disadvantaged quintile (figure 4). Thus, greater choice in public hospital services could disproportionately benefit disadvantaged groups that up until now have had fewer choices than other Australians. In England, patients referred to a specialist by their GP have a legal right to choose the hospital or clinic and consultant-led team they attend. They can access a useful website to compare alternatives, and use an online booking service when they have chosen. Quantitative studies have found that following these reforms:
• consumers sought out better-performing providers — hospitals with lower pre-reform mortality rates and waiting times had a greater increase in elective patients post-reform than those with higher mortality rates and waiting times. Among people seeking a coronary artery bypass graft, choices made by sicker patients were more sensitive to reported mortality rates
• hospitals in more competitive locations improved service quality the most — death rates for patients admitted after a heart attack fell the most in hospitals that had more nearby competitors. Hospitals located in more competitive areas also had larger declines in mortality from other causes and lower lengths of stay for elective surgery.
Studies of other countries — including Canada, Sweden and the United States — have also found benefits following the public release of information on service quality. For example, the adoption of public performance reporting in Sweden was followed by a decline in the share of patients requiring an artificial hip repair or replacement to among the lowest rates in the world.
More contestable approaches to commissioning public hospital services
In most cases, services are provided by state and territory governments through local health networks. These networks regularly renegotiate service agreements with their government and this could be used as an opportunity to test more contestable approaches to commissioning services. Such a reform should not be taken lightly — public hospitals and the services they provide are very heterogeneous, with many submarkets, and there are complex links between public hospitals and the rest of the health system, including private patients and private hospitals. There have been difficulties in the past commissioning non government providers and the lessons from these attempts should not be forgotten. Workforce issues can also pose particular challenges to changing providers. As a result, it may be more feasible to implement contestability as a more transparent mechanism to replace an underperforming public hospital’s management team (or board of the local health network), rather than switch to a non-government provider. Another option is to focus on introducing greater contestability for a subset of services.
Preliminary Finding 4.1
Introducing greater user choice and contestability in public hospital services could, as part of a wider range of reforms, lead to better outcomes for patients.
• Australian hospitals generally perform well against those in other countries. There is still scope for many to improve outcomes for patients, and to lower costs, by matching the practices of better-performing hospitals within Australia.
• Greater user choice in public hospital services could disproportionately benefit disadvantaged groups that up until now have had fewer choices than other Australians.
• Other countries have shown that user choice can benefit patients when they have access to useful consumer-oriented information on services and referring practitioners support them in making decisions.
• There is an opportunity for state and territory governments to test more contestable approaches to commissioning services when they regularly renegotiate service agreements with local health networks. More transparent arrangements for replacing senior management of government-operated hospitals (or local health network boards) in cases of underperformance could also increase contestability. This would not require switching to a non-government provider.
Specialist palliative care
Specialist palliative care refers to medical care that focuses on relieving the symptoms of a life-limiting illness, rather than treating the underlying causes of that illness. It is provided to patients whose physical, social, emotional and spiritual needs exceed the capabilities of primary care providers. This covers both inpatient care provided to patients admitted to a hospital or a standalone palliative care facility, and community-based care provided in the home or in a residential aged care facility. In 2015, more than 40 000 people across Australia accessed specialist palliative care services. Management of symptoms, including relief from pain, and support provided by social workers, counsellors and volunteers, can make a significant difference to the wellbeing of patients and their families at a time of high stress.
There is scope to improve outcomes
Australia’s palliative care services are well-regarded internationally and, on at least some measures, patient outcomes have improved over recent years. Yet there remains scope for improvement. The range and quality of services available varies across jurisdictions, and between urban and non-urban areas. Indigenous Australians, and people from culturally and linguistically diverse backgrounds are likely to be underserviced, as are people suffering illnesses other than cancer even though they have many of the same palliative care needs.
A lack of comprehensive, publicly available national data about expenditure, patient activity and patient outcomes hampers accountability. Coordinating services, determining costs of care, appropriately allocating funding and evaluating measures designed to improve service provision are all made more difficult by the lack of adequate data.
Increasing user choice about the setting, timing and availability of care
The development of a chronic life-limiting illness is emotionally taxing and psychologically distressing for patients, carers and loved ones. In this environment, making choices about palliative care arrangements may be difficult.
Much has been made of survey findings that consistently show that most people would prefer to receive care and die comfortably at home, yet most palliative care patients die in hospital. The reality is more complex than this and, as death approaches, a person’s preferred place of death can change. Palliative care patients can become concerned about the effect that the caring task has on their loved ones and may choose to use inpatient services closer to the end of life. These changing preferences highlight the importance of user choice as to the setting, time and availability of care.
The characteristics of users can pose challenges to implementing user choice for palliative care patients. While patients with cancer tend to have fairly predictable disease trajectories, often with full cognitive and communicative capacity until close to death, other patients have less predictable trajectories of deterioration in cognitive and physical functioning. While some patients receive months of palliative care and repeated episodes of care, others may have no contact with specialist palliative care services until their last days of life. This limits the ability of some patients (and their families) to plan ahead and express preferences for care. The inability of users to express preferences directly would, to some extent, be addressed if carers, relatives and medical professionals were well informed about user preferences and engaged in discussions about palliative care from the early stages of illness. Taboos about discussing death can prevent this from happening. Patients often rely on medical professionals to initiate conversations about palliative care, many of whom are inadequately trained about, and intimidated by, holding such conversations.
Greater user choice between providers would need better supports
Greater user choice between providers raises additional challenges. As with other forms of healthcare, patients receiving specialist palliative care services can have difficulty judging the quality of services available to them. Palliative care does not involve a single transaction of a well-defined service and making like-for-like comparisons between providers is difficult.
Information asymmetry between palliative care users and providers could be lessened through the provision of high-quality, consumer oriented information about the availability and quality of services. While some information on patient outcomes is currently available, it is not provider-specific and is not designed to be consumer-oriented.
Introducing greater competition or contestability
There is substantial variation in the quality of palliative care services across Australia. Despite this, there has been little focus on whether better service models exist. In these circumstances, introducing greater competition, contestability and user choice could improve outcomes. The preferred reform option may vary across regions. Introducing greater user choice through contestability or competition would require careful design to ensure that the interests of patients and their families are well served. Special measures for consumer protection may be needed given the vulnerability of many palliative care users and the potential magnitude of harm should a service provider act without due care. Arrangements would need to be in place to ensure continuity of care between providers. More extensive data collection and improved monitoring and benchmarking of provider performance would also be required. Introducing greater contestability could, however, make providers more accountable for their performance and spur the innovation required to lift patient outcomes among poor performers.
Preliminary Finding 5.1
Placing greater emphasis on user choice could help to better satisfy patient preferences regarding the setting, timing and availability of palliative care.
• The quality of specialist palliative care services is highly variable, there are concerns about patients not being able to access services and there is limited performance reporting, particularly in community settings.
• There is little evidence that service providers are being held to account for relatively low service quality. Introducing greater contestability could make providers more accountable for their performance and spur the innovation required to lift patient outcomes among the poor performers.
• The potential to increase user choice through greater competition between providers or through more contestable arrangements would depend on market size and the ability to cost-effectively provide user-oriented information, among other things. The preferred reform option will likely vary across regions.
Public dental services
Publicly-funded dental services play an important role in improving access to care for people who face financial and other barriers. In 2013-14, public dental services accounted for about 14 per cent ($1.2 billion) of Australian expenditure on dental care. Of those people (aged 5 and over) who saw a dental professional in 2013, about 84 per cent visited a private practice at their last visit, while most of the remaining 16 per cent last visited a public (including school) practice.
There is scope to improve outcomes
Most public dental services are provided in clinics (and dental hospitals in some jurisdictions) operated by state and territory governments. While users can sometimes choose between different public dental clinics, there can be few of these located close to a patient’s residence compared to private dental practices that could potentially provide the service. Access outside major cities is also a concern, particularly for Indigenous Australians, many of whom live in regional and remote areas. The continuity of care that public clinics provide can be an issue because patients may be treated by a different person each time. Without continuity of care, users could be discouraged from maintaining a favourable visiting pattern, which can eventually lead to more extensive remedial care being required. People from low socioeconomic backgrounds, who are the predominant users of public dental services, are more likely to have an unfavourable visiting pattern. For some people, an extended period on a waiting list means that a potentially preventive or restorative treatment becomes an emergency case. Dental conditions were the second-highest cause of acute potentially preventable hospitalisations in 2013/14.
A further concern is the lack of published evidence on the efficiency of public dental services. This is symptomatic of a lack of accountability to those who fund public dental services (governments and users through co-payments). It is also evident in the lack of performance reporting on service quality and patient outcomes.
Competition, contestability and user choice could be greater
The most appropriate approach to introducing greater competition, contestability and user choice could vary between regions due to differences in characteristics of the population and geographic dispersion of dental professionals.
Service provision could be made more contestable by inviting bids from non-government providers to operate public dental clinics. This could facilitate the development of more flexible and responsive service models. Innovative service delivery may be particularly important in remote areas, which have less than half the number of dental professionals per person than major cities.
More competition and choice could involve using delivery mechanisms that allow users to choose between competing private dental practices. Such mechanisms are already used to some extent in all jurisdictions and this has shown that private dental practices can supply good quality services to public patients. As part of any shift to more choice in the provision of public dental services, governments would need to ensure that they support disadvantaged groups to choose a dentist, possibly through a combination of information provision and person-to-person advice.
Preliminary Finding 6.1
Introducing greater competition, contestability and user choice in public dental services could lead to better outcomes for patients and the wider community.
• Users could benefit from having greater choice over the timing and location of treatment. Greater continuity of care may lead to fewer people delaying dental treatment until more painful and costly care becomes necessary.
• The uncontested provision of services in government-operated clinics results in limited responsiveness to user needs and preferences. Minimal public performance reporting limits accountability to those who fund services.
• Service provision could be made more contestable by inviting bids from non government providers to operate public dental clinics. More competition and choice could involve using delivery mechanisms that allow users to choose between competing private dental practices.
Human services in remote Indigenous communities
About 85 per cent of Australia is classified as remote or very remote — the physical distance to the nearest town or service centre can be in the hundreds of kilometres. A lack of transport infrastructure, coupled with extreme seasonal conditions, makes travelling those distances uncomfortable and time consuming at best or impossible at worst. Just over 2 per cent of Australia’s population, including about one fifth of Indigenous Australians, live in remote areas.
Physical isolation underpins many of the challenges to providing high quality human services to the over 1000 discrete Indigenous communities in remote areas. The cost of providing services in remote Australia can be several times the cost in urban areas due to long distances and travel times, and the lack of scale (more than three quarters of the remote Indigenous communities have a population under 50). Only 36 per cent of remote Indigenous households, for example, have an internet connection (compared to 73 per cent of remote non Indigenous households). Service providers also face barriers such as difficulty accessing infrastructure, and recruiting and retaining staff.
The remoteness of Indigenous communities is a major reason why these communities typically cannot access the range of human services that are provided elsewhere, but it is not the only reason. Indigenous Australians living in these communities may also interact with services differently to other Australians. One area of significant difference is language. About 40 per cent of Indigenous Australians living in remote areas speak an Australian Indigenous language as their main language, compared to 2 per cent for Indigenous Australians living in non remote areas. Another area of difference is culture. Indigenous Australians tend to relocate more frequently than other Australians, which can lead to significant variability in the level and nature of demand for services in communities and can be challenging for providers to respond to. The Australian Government’s 2014 Mental Health Review found that Indigenous Australians had poorer access to mental health services, in part because services designed for the broader population are not culturally appropriate. The NDIS trial in the Barkly region also identified the importance of providing services in a culturally appropriate way, including through building relationships and trust, and providing tailored information to those accessing support.
Outcomes in remote Indigenous communities are not meeting expectations
Indigenous Australians living in remote communities are more likely to experience poor outcomes than other Australians, including Indigenous Australians living in non remote areas (figure 5).
The Commission’s early investigations suggest that current arrangements for purchasing and delivering human services are not fully meeting the needs and preferences of Indigenous Australians living in remote communities. Responsibility for service provision is split across governments and departments, and funding is delivered through numerous programs. Problems arise from a lack of coordination across services, including duplication in some areas, gaps in others, and unclear lines of responsibility across and within governments for identifying and achieving the intended outcomes for people who are receiving the services. In its submission to this inquiry, the Aboriginal Medical Services Alliance NT gave the example of a remote community in Central Australia where around 400 people receive social and emotional wellbeing programs from 16 separate providers, mostly on a fly in fly out or drive in drive out basis. The Alliance described what happens on the ground.
There was little in the way of communication or coordination with the local ACCHS [Aboriginal Community Controlled Health Service], with providers often turning up unannounced and demanding information on and assistance with locating clients, use of buildings and vehicles etc. The resulting fragmentation and duplication of service delivery, lack of coordination, waste of resources and suboptimal outcomes for clients is totally counter to the improved outcomes sought by this inquiry.
A way forward
There are many economic and social factors that drive outcomes in remote Indigenous communities. The nature of service provision and the characteristics of users mean that the service models that work in other parts of the country will not necessarily work in remote Indigenous communities. For example, introducing greater competition, when there are at best one or two providers, is unlikely to be the most effective model for improving service outcomes for users. This also suggests that governments may need to be more flexible in their approach to service models and providers, to allow for better ways of working and achieving governments’ intended outcomes.
Expectations of a quick fix are unrealistic. More promising, given the issues with current service delivery arrangements used by governments, is the scope to improve outcomes over the long term through better design and implementation of policies to purchase services in remote Indigenous communities. Many services are (at least nominally) contestable, but the arrangements are not delivering the benefits of contestability to the communities themselves, or to governments and service providers. Many of the ideas discussed in the next section on grant based family and community services also apply to services to remote Indigenous communities. Outcomes should be defined holistically, rather than being narrow and program driven. Better service provision could involve better coordination, place based service models, increased community voice in service design and delivery, and stable policy settings.
Preliminary Finding 7.1
Current arrangements for purchasing and delivering human services are not fully meeting the needs and preferences of Indigenous Australians living in remote communities.
• Improving the quality of services and providing services in a more culturally appropriate way could improve outcomes for Indigenous Australians living in remote communities.
• Better coordination of services to address people’s needs could overcome some of the problems that arise from service fragmentation.
• Place based service models and greater community voice in service design and delivery could lead to services that are more responsive to the needs of people in these communities.
• More stable policy settings and clearer lines of responsibility, could increase governments’ accountability for improving the wellbeing of Indigenous Australians living in remote communities.
Grant-based family and community services
Family and community services offer a range of supports to build people’s capacity and resilience. Examples include services for people experiencing homelessness, alcohol and other drug abuse, and family and domestic violence. While often grouped under the banner ‘community services’, government funded services generally focus on improving outcomes through the provision of specific services for individuals and families, rather than being directed to community level projects. Hundreds of thousands of people receive these services every year for a variety of reasons and with diverse needs — some need emergency relief, while others have multiple, ongoing and complex needs.
Providers of family and community services are similarly diverse. Some services are provided directly by governments, but the majority are provided by mission-driven not for profit organisations. Providers vary in size. Many small organisations operate in a single location, often with the help of volunteers, and focus on a single service. Some larger organisations provide a range of services across many locations, and receive funding through numerous grants from several governments. Government funding for family and community services runs to billions of dollars each year. At July 2016, the Australian Government Department of Social Services reported that it had about 7000 grant funding agreements in place for ‘families and communities’ programs, with a combined value of about $2.8 billion. Each state and territory government also allocates hundreds of millions of dollars (and billions in the larger states).
Flawed commissioning processes
Current approaches to commissioning family and community services constrain the ability of these services to meet the needs of many people. People outside of metropolitan areas, culturally and linguistically diverse groups and Indigenous Australians can face significant barriers to accessing family and community services that meet their needs. People who have multiple, ongoing and complex needs require coordinated assistance across several services, but are inadequately served when the system is fragmented and difficult to navigate.
Funding to deliver family and community services is usually contested through tender processes that entail at least a nominal threat of replacement by an alternate provider. In practice, commissioning processes are often flawed and do not consistently deliver the benefits from contestability that should flow to governments and providers and, importantly, they are not effective at delivering outcomes for users.
• There is generally a lack of an overarching framework based on improving outcomes for service users to inform service planning and determine how objectives should be achieved (figure 6). Governments need to undertake systematic analysis of community needs, gaps in service delivery and risks. Commissioning agencies need to specify policy priorities and the program outcomes that are consistent with achieving these objectives.
• Government engagement with service providers is inconsistent and does not always take advantage of providers’ experience and expertise in program delivery. It is uncommon for providers to be invited to participate in the program design stage. Instead, programs are designed by government agencies that are often remote from the realities of ‘what works’ in family and community services, and the costs of providing effective services. Often what looks good on paper does not translate to the real world.
• Service providers that are funded on relatively short contracts (three years or less), face ongoing uncertainty about their future operations, and have to devote excessive resources to applying for further funding at the expense of delivering frontline services.
• Contract terms often limit providers’ ability to develop flexible responses to the needs of service users. Although governments promote the virtues of innovation, when it comes to family and community services they often set highly prescriptive terms that are focused on managing funding flows, rather than on achieving outcomes for users. Some governments have experienced a loss of corporate knowledge of how these services work and instead have developed expertise in managing contracts. At the same time, they have created incentives for service providers to become experts in tender writing.
• The current approach to information collection, performance monitoring and reporting can create excessive burdens on service providers but does not deliver the information that is needed to understand how services contribute to achieving outcomes. Better access to data could contribute to governments and providers developing more effective programs and services, coordinating assistance for users with complex needs, and providing user oriented information to support choice.
Better system design
The scope for improving the effectiveness of family and community services largely relates to the way they are commissioned by governments, rather than the use of contestable processes. Governments need to take a stronger stewardship role to design and coordinate a system of provision that is helped, rather than hampered, by shared interests across jurisdictions. They also need to develop an outcomes framework against which individual services could be planned, and their performance benchmarked and monitored.
Preliminary Finding 8.1
Improving the way governments select, fund, monitor and evaluate providers of family and community services could improve outcomes for the users of those services.
• Governments could deliver a better mix of services if they took a systematic approach to identifying what the community needs.
• Engagement with service providers and users at the policy design stage could increase the quality and efficiency of services.
• Contract arrangements that are focused on outcomes for service users could increase the incentives for service providers to deliver services that meet people’s needs and provide more scope for innovation in service delivery.
• Better use of data could help service providers and governments identify and disseminate effective practices.
• Measures to support user choice and introduce greater competition between service providers could create incentives for providers to improve services in some areas.

20 September 2016

Angels and others

'Can There Really Be Law in a Society of Angels?' by Kenneth Einar Himma argues 
Authorized coercive enforcement mechanisms is a feature of every existing institutional normative system we would characterize as a legal system. Indeed, it is so prominent in existing legal practice that it seems also to be a paradigmatic feature of law. Despite this, most contemporary theorists deny that authorized coercive enforcement mechanisms are a conceptually necessary feature of law. These doubts have been grounded in concerns about the conceptual status of international law, as well about whether law exists in a hypothetical society of angels who are motivated always to obey law without any need for authorized coercive enforcement mechanisms.
In this essay, I consider whether this second concern – the “society of angels” example – succeeds in showing that such mechanisms are not a conceptual feature of law. I will argue, in essence, that the society-of-angels argument depends on assumptions about the psychological features of the “angels” that are simply too far removed from what is possible for us (i.e. human beings) in the conditions in which we live to tell us anything of theoretical significance about our legal concepts. Insofar as it is our legal practices, which result from the problems to which our circumstances give rise, that, on Raz’s methodological view, construct the content of our legal concepts, the society-of-angels argument is simply not equipped to do the work it is contrived to do. Otherwise put, I argue that our concept of law explicates a normative institutional system that is distinctively human; as such, society-of-angels thought experiments tell us nothing about the proper content of a conceptual theory of law.
'Historical-sociology vs. ontology: The role of economy in Otto Kirchheimer and Carl Schmitt’s essays ‘Legality and Legitimacy’' by Karsten Olson in (2016) 29(2) History of the Human Sciences 96–112 comments
The pre-1932 writings of Otto Kirchheimer are often described by researchers as the work of a young ‘left-Schmittian’, a radical Marxist who gave the anti-liberal critique and theoretical apparatus of his Doktorvater Carl Schmitt a new purpose for different ‘political ends’. The danger of this approach is that fundamental divisions between the societal conceptualizations of both theoreticians are ignored in lieu of apparent terminological similarity. Through the lens of economy, it is therefore the intent of this article to continue in the tradition of Alfons Sollner and Frank Schale, pushing against this assumed affinity and highlighting Otto Kirchheimer’s unique defense of liberal democracy.
Olson argues
Much of the research on the relationship between Otto Kirchheimer and his Doktorvater Carl Schmitt poses two related questions. To what extent was young Kirchheimer a left- Schmittian? And when did the break occur, that is, when did Kirchheimer free himself of Schmitt’s spell and emerge as a fully independent theorist? One source of these formulations is Ellen Kennedy’s well-known essay ‘Carl Schmitt and the Frankfurt School’, in which Kennedy asserts that Kirchheimer was the ‘legitimate heir and the transmitter of [Schmitt’s] ideas within Critical theory’ (Kennedy, 1987: 47), creating the now familiar formulation of Schmitt and Kirchheimer sharing the same theoretical apparatus to achieve different political goals. Kennedy’s essay has a distinctly polemical quality, strongly asserting Carl Schmitt’s largely secret sway over ‘the Frankfurt School’, as well as his total methodological indoctrination of Kirchheimer prior to 1932. ‘Carl Schmitt and the Frankfurt School’ drew an equally polemic response from Alfons Sollner in ‘Jenseits von Carl Schmitt’, a self-proclaimed ‘Anti-Kritik’ of Kennedy’s article (Sollner, 1986: 504). However, despite its polemical character, ‘Jenseits von Carl Schmitt’ remains one of the most fruitful examinations of early Kirchheimer for two reasons. First, it avoids the problematic formulation of the left’s oft-cited ‘fascination’ with Schmitt, which at times seems to portray Schmitt as a theoretical siren, dashing the stout ships of Marxists on the rocks of accidental fascism. Second, by arguing against an inherent similarity, Sollner is forced to give a detailed account of what concepts are used by Kirchheimer, as well as how and in what context. The question of shared methodology and moments of ‘convergence’ (Kennedy, 1987: 37) between the right and the left is certainly not without interest; however, such an approach runs the risk of masking difference behind the veil of apparent similarity; both Schmitt and Kirchheimer rely, to varying degrees, on concepts of decision, homogeneity, sovereignty and exception within their constitutional theory, but not only do they produce, by all accounts, markedly different ‘political results’,   the foundational understandings of society upon which they are based also stand in direct opposition to one another.
Sollner’s analysis leads to a subtle but significant shift; Kirchheimer is no longer a left-Schmittian implementing anti-liberal critique in the service of a Marxist agenda, but rather his argumentation is ‘historical-sociological’ in direct contrast to Schmitt’s ‘ontological’ democratic critique (Sollner, 1986: 511). Frank Schale argues in a similar vein in ‘Parlamentarismus und Demokratie’ [Parliamentarianism and Democracy], stating that Kirchheimer operated from a ‘sociological-scientific’ perspective, one intrinsically material in orientation, which afforded a knowledge of Weimar ‘from the inside’ (Schale, 2011: 141, 143). In other words, Kirchheimer was from the very beginning not merely adopting but rather critically engaging with Schmitt’s terminology.   It is my hope to continue So llner’s project of conceptual differentiation by examining Schmitt’s and Kirchheimer’s final exchange on the topic of legality and legitimacy within liberal democracy; in 1932 Kirchheimer wrote ‘Legality and Legitimacy’, which was followed later that year by Schmitt’s essay of the same title, which was in turn answered directly by Kirchheimer’s ‘Remarks on Carl Schmitt’s Legality and Legitimacy’. The fundamental nature of the questions posed by both theorists reflects the political instability of the time and also serves to demonstrate the gulf that had always existed between the two, even while they were seemingly operating within the same framework. Central to this division is the role of the economy, and it is subsequently through the lens of the economy that I hope to highlight critical differences between Schmitt and Kirchheimer, and also to sketch a shift within Kirchheimer’s own thought, one which cast a new, hopeful light on the potential of liberal democracy.
‘Hermann Heller and the European Crisis: Authoritarian Liberalism Redux?’ by William E. Scheuerman in (2015) 21(3) European Law Journal 302–312
tentatively buttresses Alexander Somek’s view that Hermann Hel- ler’s 1933 essay, ‘Authoritarian Liberalism’, provides a useful starting point for thinking about the ongoing European crisis, in which European authorities are favouring rigid austerity and pro-business policies while undermining basic liberal and democratic rights. Heller’s unfortunate neglect, especially in Anglophone scholarship, is discussed. Nonetheless, Somek and other recent scholars who have turned to Heller to make sense of the European crisis downplay some of the tough questions raised by any attempt to apply Heller’s analysis of the Weimar crisis to the contemporary setting. In particular, Heller’s theory relied on a robust social democratic statism which has become increasingly unpopular even among theorists on the political left. Contemporary students of European law are most likely to have encountered Hermann Heller in the context of the controversial Maastricht Decision, in which the German constitutional court cited his ideas about social homogeneity to buttress its version of the sceptical ‘no (European) demos’ thesis. As J.H.H. Weiler soon aptly noted in a powerful rejoinder, not only did the German judges misconstrue Heller’s ideas, but there was something shameful about their employment of a ‘Socialist, Anti-fascist, Jew, critic of Schmitt’ as the main source for a notion of homogeneity more reminiscent of Schmitt’s authoritarianism than that of his great Weimar-era social democratic political and intellectual rival.  Although envisioning homogeneity as essential to democracy, Heller dogmatically hypostasised neither national homogeneity nor the nation state, whose defenders, he once sceptically noted, tended to absolutise it into the ‘highest stage of (Hegelian) world spirit’. Although always hostile to politically na├»ve versions of both liberal and Marxist internationalism, in contrast to recent conservative defenders of the ‘no demos’ thesis Heller in fact sympathised with calls for a European federal state.
This context makes the long overdue translation of Heller’s 1933 brilliant jeremiad, ‘Authoritarian Liberalism?’, one of his final essays penned before he tragically passed away in Spanish exile (prematurely at age 42), particularly timely. Like Heller, Alexander Somek shares Heller’s sympathies for robust self-government, social democracy and the rule of law. Although understandably vexed by worrisome trends within the EU, and particularly its leadership’s continuing top-down efforts to ensconce and indeed immunise neoliberal capitalism from democratic politics, he is not opposed in principle to ‘the European project’, as long as it upholds rather destroys democracy and legality. Reminiscent of Heller here as well, who always resisted being sequestered into the standard academic cubbyholes, he creatively synthesises legal scholarship, political theory and the critical social sciences in a fashion that remains depressingly unusual. Finally, he makes a strong case for why Heller’s arguments about ‘authori- tarian liberalism’ remain disturbingly pertinent. Some real theoretical and political distance notwithstanding, he, and not the German Maastricht judges, belongs among Heller’s rightful political heir.
Since Heller today remains an unfairly forgotten figure, I start by providing some general background on him and his ambitions, while also explaining why his work remains so neglected, especially in the Anglophone world. I then comment briefly on the potentially productive recent move to revisit his critique of ‘authoritarian liberalism’

Biobanks, Biodata and Bodyhackers

'Biobank Research and Privacy Laws in the United States' by Heather Harrell and Mark Rothstein in (2016) 44(1) Journal of Law, Medicine and Ethics comments 
Privacy is protected in biobank-based research in the U.S. primarily by Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research and therefore neither applies to all biobank based research. Not only is it challenging to determine when the HIPAA Privacy rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. U.S. law also does not directly address international sharing of data or specimens outside of the EU - US Safe Harbor Agreement, which only applies to receipt of data by certain U.S. entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking.
'Leviathan in the Commons: Biomedical Data and the State' by Jorge L. Contreras in Katherine Strandburg, Brett Frischmann and Michael Madison (eds) Governing Medical Knowledge Commons (Cambridge University Press, 2017 Forthcoming) analyzes 
the role that the state has played with respect to the generation and management of large repositories of scientific data, situating it within the context of commons theory and the organization of common pool resources. Extending beyond the traditional “big science” conception of the state as creator/provisioner of large-scale scientific data pools, and the literature of state-based innovation incentives, this chapter identifies nine distinct but interdependent roles that the state has played in assembling and maintaining scientific data sets. It uses as a case study the U.S. federal government’s engagement with genomic research projects beginning with the Human Genome Project and encompassing a range of federally-funded, public-private and private sector projects. It then assesses the potential roles that the state may play in the formation and maintenance of new pools of biomedical data, namely data from clinical trials. The analytical framework described in this chapter offers a means by which state engagement with data-intensive research projects may be compared across agencies, fields and national borders. This framework may be used to assess the effectiveness of state engagement in such research programs and to configure state engagement in new data commons in a manner that can enhance the efficiency and effectiveness of data sharing arrangements and improve overall social welfare.
'The Right to Try and the Future of the FDA in the Age of Personalized Medicine' (Mercatus Center, Working paper Series, 2016) by Adam D. Thierer asks 
Do citizens have the right to determine their own courses of treatment and to use medicines and devices that they think could improve their health? And, to the extent regulators seek to restrict that freedom, what is the practicality and cost of doing so? These questions animate the debate over the so-called “right to try,” a growing movement to allow terminally ill individuals to experiment with alternative medical treatments, therapies, and devices that are tightly controlled by the Food and Drug Administration (FDA). This essay argues that such an expansion of the right-to-try notion may be happening already as technological innovation decentralizes and democratizes medical decisions. This expansion does not mean that all FDA regulation will fade away, but it will necessitate a move away from the agency’s command-and-control methods of the past and toward a new focus on patient empowerment through enhanced choice, improved risk education, and clearer consent mechanisms.


Vito Zepinic, whose career raises questions about vetting, certification and identity crime, has featured in previous posts. He's in the news - and in court - again.

The SMH, in reporting on Zepinic v Chateau Constructions (Aust) Limited [2016] NSWSC 1254, comments
Despite having no medical or psychiatric qualifications, Zepinic worked as a psychiatrist at Toowoomba Hospital for almost two years from April 2000 to March 2002 before he was unmasked.
After he was deregistered by Queensland authorities, he moved to the inner western Sydney suburb of Burwood where he once again passed himself off as a psychiatrist. In 2008 he was convicted in the Burwood Local Court on six counts of falsely describing himself as a psychiatrist. He was released on a good behaviour bond.
Undeterred, Zepinic moved to London and in October 2009 he once again falsely claimed to be a psychiatrist, landing a prestigious position as a senior lecturer in psychiatry at Queen Mary, University of London (QMUL). During his job application, QMUL had asked Zepinic if he had any criminal convictions. He lied about his convictions in Australia.
Five months later, Zepinic's past caught up with him but once again he lied to hospital authorities claiming he had documents that proved he had won the case against him in Australia. No such documents existed. In 2013 he was convicted of three counts of fraud in London over his QMUL position, but again escaped a jail term.
The battle over his renovations on his Turramurra Avenue home started in December 2006 when Zepinic's $1.1 million makeover was almost complete. But Zepinic refused to pay the builders the last $223,000. Chateau took him to the Consumer, Trader and Tenancy Tribunal, where Zepinic cross-claimed, saying the building work was defective. He was unsuccessful.
After nine further unsuccessful court actions, in 2014 the NSW Supreme court ordered that Zepinic's house be sold and that Chateau was entitled to collect more than $1 million from the proceeds of the sale, having incurred almost $700,000 in legal costs on top of its original claim. Since then Chateau has incurred further legal expenses fighting Zepinic, who having been through seven lawyers, is currently representing himself.
The Court is unimpressed, stating
This proceeding is the latest in a farrago of unnecessary and wasteful litigation that derives from Dr Zepinic’s dissatisfaction with the adverse result that he achieved in the CTTT.
Following the CTTT decision, Dr Zepinic initiated the following unsuccessful appeals:
(a) District Court of New South Wales proceeding 2009/335054, being an appeal against the decision of the CTTT (the District Court Appeal Proceeding);
(b) Court of Appeal proceeding 2010/45208, being an application for leave to appeal against the decision in the District Court proceedings (the 2010 Court of Appeal Proceeding).
Following the commencement by Chateau of proceeding 2009/290598 in this court to enforce its charge over the property, and to obtain an order for the appointment of a trustee for sale, Dr Zepinic initiated three separate appeals to the Court of Appeal and a special leave application to the High Court of Australia. They were:
(a) Court of Appeal proceeding 2013/302149 in respect of orders in the charge proceeding (the 2013 Court of Appeal Proceeding);
(b) Court of Appeal proceeding 2014/130563 in respect of orders in the charge proceeding (the 2014 Court of Appeal Proceeding);
(c) Court of Appeal proceeding 2015/326487 in respect of orders in the charge proceeding (the 2015 Court of Appeal Proceeding);
(d) Application for special leave to appeal to the High Court of Australia No S86/2016 in respect of orders in the 2013 Court of Appeal Proceeding (the 2016 Special Leave Application).
In addition, Dr Zepenic initiated the following proceedings relating to his original allegations that had been ventilated and dismissed in the CTTT, namely that there were defects in the building work carried out by Chateau:
(a) Supreme Court proceeding 2013/132492 (the 2013 Supreme Court Proceeding);
(b) Court of Appeal proceeding 2013/345739 (the Second 2013 Court of Appeal Proceeding);
(c) Court of Appeal proceeding 2014/130569 (the Second 2014 Court of Appeal Proceeding);
(d) Application for special leave to appeal to the High Court of Australia No S230/2015 (the 2015 Special Leave Application).
Dr Zepenic has failed at every turn. Every one of his actions has been determined against him. Eventually, after numerous appearances before other judges of this court, he came before me on 5 September 2016. On that date, I made orders and gave short reasons finally disposing of Chateau’s proceeding number 2009/290598. I also made orders on that date finally disposing of this proceeding. These are the reasons for those orders. ...
I have no hesitation in concluding that the issues that Dr Zepinic seeks to raise by his statement of claim in this proceeding not only fail to raise an arguable issue, but that they represent an indulgent, wasteful and repetitive exercise in going over old ground. The contention that Nina was the true owner of the property may be new but as I have said, it cannot avail Dr Zepinic . It has been superseded by subsequent events. And he only has himself to blame. But there was never anything in it, in any event.
Dr Zepinic appears to have out-distanced, and probably exhausted, all of his legal advisors. At various times, he has had legal representation including from LAC Lawyers, (January 2007 to March 2007); Schreuder Partners Compensation Lawyers, (March 2007 to October 2007); Gray and; Perkins Lawyers, (December 2007 to 18 September 2008); Makinson and d'Apice Lawyers, (December 2008 to February 2009); Macquarie Lawyers, (5 March 2009 to 11 September 2009); Hancock Alldis and Roskov Lawyers and Notaries, (14 September 2009 to 28 September 2009 and from 7 October 2009 to November 2009) and Stacks Goudkamp Lawyers, (8-11 October 2013). This proceeding, in which he is representing and advising himself, appears to be a last desperate throw of the dice. But it is pointless and doomed to fail.
The costs incurred by Chateau in this litigation have been horrifying. All because Dr Zepinic has not been prepared to accept the initial decision of the CTTT. Chateau’s assessed costs in the CTTT proceedings and the subsequent assessment process were in excess of $417,000. Its costs in all of the other failed litigation initiated by Dr Zepinic must also be extensive.
Subject to giving Dr Zepinic an opportunity to be heard, I will entertain appropriate applications by Chateau for an indemnity costs order and an order pursuant to the Vexatious Proceedings Act 2008 (NSW). It is pertinent to observe that Dr Zepinic has already recently been warned by the Court of Appeal.
Zepinic appears to have fared better than Dusan Milosevic.