Health complaints and regulatory reform: Implications for vulnerable populations?

Complaints and disciplinary processes play a significant role in health professional regulation. Many countries are transitioning from models of self-regulation to greater external oversight through systems including meta regulation, responsive (risk–based) regulation, and “networked governance”. Such systems harness, in differing ways, public, private, professional and non-governmental bodies to exert influence over the conduct of health professionals and services. Interesting literature is emerging regarding complainants’ motivations and experiences, the impact of complaints processes on health professionals and identification of features such as complainant and health professional profiles, types of complaints and outcomes. This paper concentrates on studies identifying vulnerable groups and their participation in health care regulatory systems.

Leading Digital Transformation: Building Technology and Information Governance Capability in Boards of Directors and the C-Suite

Information and technology and its use in organisation transformation presents unprecedented opportunities and risks. Increasingly, the Governance of Enterprise Information and Technology (GEIT) competency in the board room and executive is needed. Whether your organization is small or large, public, private or not for profit or whether your industry is not considered high-tech, IT is impacting your sector – no exceptions. But there is a skill shortage in boards: GEIT capability is concerningly low. This capability is urgently needed across the board, including those directors who come from finance, legal, marketing, operations and HR backgrounds. Digital disruption also affects all occupations. Putting in place a vision will help ensure emergency responses will meet technology-related duty of care responsibilities. When GEIT-related forward thinking and planning is carried out at the same time that you put your business strategy and plan in place, your organization has a significantly increased chance of not only surviving, but thriving into the future. Those organizations that don’t build GEIT capability risk joining the growing list of once-leading firms left behind in the digital ‘cloud of smoke’. Those organizations that do will be better placed to reap the benefits and hedge against the risks of a digital world. This chapter provides actionable, research-based considerations and processes for boards to use, to build awareness, knowledge and skills in governing technology-related organization strategy, risk and value creation.

Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

Traps for the unwary : reform stories of private sector managers entering public service

The purpose of this research is to capture and interpret the stories of “outsider” managers who make the transition to the public sector. These experiences are considered in the context of efforts to shift public management culture in a direction consistent with meeting contemporary demands placed on public sector organisations. It is often noted that an important strategy for changing culture is the infusion of outsiders. Outsiders are thought to bring new perspectives that, through a dialectical process (Van de Ven 1995), create the potential for change. While there have been cross-sector comparisons (Broussine 1990; Silfvast 1994; Redman 1997), little attention has been given to the experience of those who make the transition in the context of efforts to reform public sector management culture. Not only is the infusion of private sector managers into the public sector a potential culture change strategy, it is also a personal experience for those who make the transition. Boundary crossing is typically an anxiety provoking experience (Van Maanen & Schein 1979) and the quality of this experience influences decisions to commit, engage, disengage or exit. The quality of the experience is likely to be affected by how the public organisation responds to people making this transition, that is, their investment in people processing (Saks 2007). The cost of recruitment and selection processes at middle and senior management levels warrants a greater research focus on this transition. In this paper we argue that the experiences of those who make the transition from private to public sectors has much to tell us about the traps that transition managers experience in making this change, the implications for injecting outsider managers as a strategy for achieving public management culture change, and how reform-oriented public organisations can manage the transitions of outsider managers into the public sector in order that best value might be achieved for both the individual and organisational change goals.

At work or play : a comparison of private property vehicle crashes with those occurring on public roads in north Queensland.

Objective: To define characteristics of vehicle crashes occurring on rural private property in north Queensland with an exploration of associated risk factors. Design: Descriptive analysis of private property crash data collected by the Rural and Remote Road Safety Study. Setting: Rural and remote north Queensland. Participants: A total of 305 vehicle controllers aged 16 years or over hospitalised at Atherton, Cairns, Mount Isa or Townsville for at least 24 hours as a result of a vehicle crash. Main outcome measure: A structured questionnaire completed by participants covering crash details, lifestyle and demographic characteristics, driving history, medical history, alcohol and drug use and attitudes to road use. Results: Overall, 27.9% of interviewees crashed on private property, with the highest proportion of private road crashes occurring in the North West Statistical Division (45%). Risk factors shown to be associated with private property crashes included male sex, riding off-road motorcycle or all-terrain vehicle, first-time driving at that site, lack of licence for vehicle type, recreational use and not wearing a helmet or seatbelt. Conclusions: Considerable trauma results from vehicle crashes on rural private property. These crashes are not included in most crash data sets, which are limited to public road crashes. Legislation and regulations applicable to private property vehicle use are largely focused on workplace health and safety, yet work-related crashes represent a minority of private property crashes in north Queensland.

Building a successful partnership to increase affordable rental housing supply in Queensland

Accessibility to housing for low to moderate income groups in Australia has been experiencing a severe decline since 2001. On the supply side, the public sector has been reducing its commitment to the direct provision of public housing. Despite high demand for affordable housing, there has been limited supply generated by non-government housing providers. One possible solution to promote an increase in affordable housing supply, like other infrastructure, is through the development of multi-stakeholder partnerships and private financing. This research aims to identify current issues underlying decision-making criteria for building multi-stakeholder partnerships to deliver affordable housing projects. It also investigates strategies for minimising risk and ensuring the financial outcomes of these partnership arrangements. A mix of qualitative in-depth interviews and quantitative surveys has been used as the main method to explore stakeholder experiences regarding their involvement in partnership arrangements in the affordable housing sector in Queensland. Two sets of interviews were conducted following an exploratory pilot study: one set in 2003-2004 and the other in 2007-2008. There were nineteen respondents representing government, private and not-for-profit organisations in the first stage interviews and surveys. The second stage interviews were focussed on twenty-two housing providers in South East Queensland. Initial analyses have been conducted using thematic and statistical analyses. This study extends the use of existing decision making tools and combines the use of a Soft System Framework to analyse the ideal state questionnaires using qualitative thematic analysis. Soft System Methodology (SSM) has been used to analyse this unstructured complex problem by using systematic thinking to develop a conceptual model and carrying it to the real world situations to solve the problem. This research found that the diversity of stakeholder capability and their level of risk acceptance will allow partnerships to develop the best synergies and a degree of collaboration which achieves the required financial return within acceptable risk parameters. However, some of the negativity attached to future commitment to such partnerships has been found to be the anticipation of a worse outcome than that expected from independent action. Many interviewees agree that housing providers' fear of financial risk and community rejection has been central to dampening their enthusiasm for entering such investment projects. The creation of a mixed-use development structure will mitigate both risk and return as the commercial income will subsidise the affordable housing development and will normalise concentration of marginalised low-income people who live in a prime location with an award winning design. In addition, tenant support schemes and rent-to-buy incentive programs will encourage them to secure their tenancies and significantly reduce the risk of rent arrears and property damage. There is also a breakthrough investment vehicle offered by the social developer which sells the non-physical but financial product to individual and institutional investors to mitigate further financial risk. Finally, this study recommends modification of the current value-for-money framework in favour of broader partnership arrangements which are more closely aligned with risk minimisation strategies.

Differences in Treatment and Management of Indigenous and Non-Indigenous Patients Presenting with Chest Pain: Results of the Heart Protection Partnership (HPP) Study

BACKGROUND: Indigenous patients with acute coronary syndromes represent a high-risk group. There are however few contemporary datasets addressing differences in the presentation and management of Indigenous and non-Indigenous patients with chest pain. METHODS: The Heart Protection Project, is a multicentre retrospective audit of consecutive medical records from patients presenting with chest pain. Patients were identified as Indigenous or non-Indigenous, and time to presentation and cardiac investigations as well as rates of cardiac investigations and procedures were compared between the two groups. RESULTS: Of the 2380 patients included, 199 (8.4%) identified as Indigenous, and 2174 (91.6%) as non-Indigenous. Indigenous patients were younger, had higher rates hyperlipidaemia, diabetes, smoking, known coronary artery disease and a lower rate of prior PCI; and were significantly less likely to have private health insurance, be admitted to an interventional facility or to have a cardiologist as primary physician. Following adjustment for difference in baseline characteristics, Indigenous patients had comparable rates of cardiac investigations and delay times to presentation and investigations. CONCLUSIONS: Although the Indigenous population was identified as a high-risk group, in this analysis of selected Australian hospitals there were no significant differences in treatment or management of Indigenous patients in comparison to non-Indigenous.

Sapporo World Window : urban interaction through public and private screens

This paper introduces Sapporo World Window, a screen-based application that is currently under development for the new underway passage at the centre of Sapporo City. There are ten large public screens installed in the space, displaying user-generated videos about various aspects of the city and a real-time map that visualises users’ interaction with the city. The application aims to engage the general public by functioning as a unique ‘point of connection’ for socio-cultural and technological interactions, making the space a lively social place where people can have meaningful experiences of interacting with people and places of Sapporo through mobile phones (keitai) and the public screens in the space. This paper first outlines the contextual background and key concept for the application’s design. Then the paper discusses the user interaction processes, technical specifications, and interface design, followed by the conclusions and outlook.

Public regulatory reform and management earnings forecasts in a low private litigation environment

We examine the impact of continuous disclosure regulatory reform on the likelihood, frequency and qualitative characteristics of management earnings forecasts issued in New Zealand’s low private litigation environment. Using a sample of 720 earnings forecasts issued by 94 firms listed on the New Zealand Exchange before and after the reform (1999–2005), we provide strong evidence of significant changes in forecasting behaviour in the post-reform period. Specifically, firms were more likely to issue earnings forecasts to pre-empt earnings announcements and, in contrast to findings in other legal settings, those earnings forecasts exhibited higher frequency and improved qualitative characteristics (better precision and accuracy). An important implication of our findings is that public regulatory reforms may have a greater benefit in a low private litigation environment and thus add to the global debate about the effectiveness of alternative public regulatory reforms of corporate requirements.

On location : the imagined private interior in public life

This paper reveals the interior landscapes of selected contemporary Australian films, such as The Caterpillar Wish and Bad Boy Bubby, to develop a number of thematic influences on the manner in which domestic and private lives are constructed through filmic imagination. The research uncovers the conditions that contribute to particular scenographic representations of the humble interiors that act as both backdrop and performer to subtle and often troubled narratives. Such readings are informed by the theoretical works of writer Gertrude Stein, among others, who explore the relationships between the scenographic third dimension and the fourth dimensional performance in the representation of narrative space. A further theoretical thread lies in Giuliana Bruno’s work on the tension between private and public filmic space, which is explored through the public outing of intensely private spaces generated through narratives framed by the specificities of found interiors. Beyond the interrogation of qualities of imagined filmic space is the condition whereby locations, once transformed by the event of movie making are consequently forever revised. These altered conditions subsequently reinvest the lives of those who return to the location with layered narratives of occupation. Situationally, the now reconverted interior performs as contributor to subsequent private inhabitation, even if only as imagined space. The possibility here is that the qualities of the original may be superimposed and recontextualised to invest post-produced interiors with the qualities of the other space as imagined. This reading of film space explores new theoretical design scenarios for imagined and everyday interior landscapes.

Going public : do risk and choice explain differences in caesarean birth rates between public and private places of birth in Australia?

Background: Women who birth in private facilities in Australia are more likely to have a caesarean birth than women who birth in public facilities and these differences remain after accounting for sector differences in the demographic and health risk profiles of women. However, the extent to which women’s preferences and/or freedom to choose their mode of birth further account for differences in the likelihood of caesarean birth between the sectors remains untested. Method: Women who birthed in Queensland, Australia during a two-week period in 2009 were mailed a self-report survey approximately three months after birth. Seven hundred and fifty-seven women provided cross-sectional retrospective data on where they birthed (public or private facility), mode of birth (vaginal or caesarean) and risk factors, along with their preferences and freedom to choose their mode of birth. A hierarchical logistic regression was conducted to determine the extent to which maternal risk and freedom to choose one’s mode of birth explain sector differences in the likelihood of having a caesarean birth. Findings: While there was no sector difference in women’s preference for mode of birth, women who birthed in private facilities had higher odds of feeling able to choose either a vaginal or caesarean birth, and feeling able to choose only a caesarean birth. Women had higher odds of having caesarean birth if they birthed in private facilities, even after accounting for significant risk factors such as age, body mass index, previous caesarean and use of assisted reproductive technology. However, there was no association between place of birth and odds of having a caesarean birth after also accounting for freedom to choose one’s mode of birth. Conclusions: These findings call into question suggestions that the higher caesarean birth rate in the private sector in Australia is attributable to increased levels of obstetric risk among women birthing in the private sector or maternal preferences alone. Instead, the determinants of sector differences in the likelihood of caesarean births are complex and are linked to differences in the perceived choices for mode of birth between women birthing in the private and public systems.

Property : a regulatory instrument for protecting private and public interests in the environment

Property in an elusive concept. In many respects it has been regarded as a source of authority to use, develop and make decisions about whatever is the subject matter of this right of ownership. This is true whether the holder of this right of ownership is a private entity or a public entity. Increasingly a right of ownership of this kind has been recognised not only as a source of authority but also as a mechanism for restricting or limiting and perhaps even prohibiting existing or proposed activities that impact upon the environment. It is increasingly therefore an instrument of regulation as much as an instrument of authorisation. The protection and conservation of the environment are ultimately a matter of the public interest. This is not to suggest that the individual holders of rights of ownership are not interested in protecting the environment. It is open to them to do so in the exercise of a right of ownership as a source of authorisation. However a right of ownership – whether private or public – has become increasingly the mechanism according to which the environment is protected and conserved through the use of rights of ownership as a means of regulation. This paper addressed these issues from a doctrinal as well as a practical perspective in how the environment is managed.