Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia

Lumiracoxib (Prexige©) 200 mg was listed in Australia’s Pharmaceutical Benefits Scheme (PBS) schedules on 01 August 2006. The listing was intended as a cost-minimisation strategy, as lumiracoxib 200 mg was deemed equivalent in therapeutic effect to celecoxib (Celebrex©) 200 mg, and was available at a lower cost. By the time of listing on the PBS, a safety re-evaluation of the recommended daily dose of lumiracoxib was being considered in other national regulatory jurisdictions. Within 3 months of listing, the manufacturer revised the recommended dosage to half that of the PBS-listed dosage. However, the PBS listing was neither revoked nor modified. At the time of listing on the PBS, lumiracoxib was known to be 17 times as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons. Safety concerns had already been raised about adverse hepatic outcomes on daily doses of lumiracoxib 200 mg. Communication of information about the risk potential of lumiracoxib was inadequate. Economic and political considerations were prioritised over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality.

Pharmaceutical benefits in Australia and Sweden: welfare policy and the cost of prescription drugs

Pharmaceutical benefits provide a stable framework within which consumers, prescribers, suppliers, pharmacists and other actors undertake transactions. The state in effect delivers a good that enhances individual autonomy. A major reason for the legitimacy enjoyed by pharmaceutical benefits in both Australia and Sweden is that these programs have strong attributes of universalism (rather than targeting). Sweden's predominantly public health system allows greater scope for pharmaceutical policy innovation. Australia's Pharmaceutical Benefits Scheme (PBS), while historically resilient and effective, is now wedged precariously between traditional considerations of equity and public health on the one hand, and constant pressure for increased marketisation on the other.

Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

Performance Septic Systems: Does an Advanced Septic System Provide Adequate Treatment on Black Hammock Island and is there Adequate Regulatory Policy to Ensure Integrity?

This project determined if the performance based septic system, proposed for a development on Black Hammock Island in Jacksonville, Florida, is the best choice to prevent environmental contamination from septic tanks and if adequate regulatory policy exists. Research shows a central wastewater treatment plant provides the most efficient pollutant removal but can be cost prohibitive. This project found performance based systems surpasses conventional septic system performance and are more suited and economical to remote areas without sewer service. This project finds current regulations to be inadequate and supports ordinance changes proposed by the Mayor of Jacksonville to enhance the current policy and provide more adequate and meaningful regulation.

Harmonising procurement policy environment - identifying key themes towards the development of a conceptual model

Capital works procurement and its regulatory policy environment within a country can be complex entities. For example, by virtue of Australia’s governmental division between the Commonwealth, states and local jurisdictions and the associated procurement networks and responsibilities at each level, the tendering process is often convoluted. There are four inter-related key themes identified in the literature in relation to procurement disharmony, including decentralisation, risk & risk mitigation, free trade & competition, and tendering costs. This paper defines and discusses these key areas of conflict that adversely impact upon the business environments of industry through a literature review, policy analysis and consultation with capital works procurement stakeholders. The aim of this national study is to identify policy differences between jurisdictions in Australia, and ascertain whether those differences are a barrier to productivity and innovation. This research forms an element of a broader investigation with an aim of developing efficient, effective and nationally harmonised procurement systems. Keywords: capital works, procurement policy reform Acknowledgement: The research described in this paper carried out by the Australian Cooperative Research Centre for Construction Innovation.

Health and safety regulatory reform in Australia : challenges and issues for smaller ethnic firms

In recent times significant change has occurred to the Australian health and safety regulatory context. In this paper we consider the potential response of smaller firms in general, and ethnic owned and/or operated smaller firms in particular. We draw on literature examining smaller firms' responses to regulation and apply this to what little we know about smaller ethnic firms in Australia in the context of the regulatory change. We highlight the challenges to owner managers and what could be done to engage and support smaller ethnic firms to realise the opportunities resulting from this regulatory change.

Should tax incentives for charitable giving stop at Australia's borders?

Around the world, philanthropic gifts are increasingly crossing borders, driven by globalisation and facilitated by liberalised cross-border tax incentives. Australia is considered to have one of the strictest regimes for the tax treatment of cross-border donations. With bipartisan political support for a significant reduction in the amount and scope of Australian foreign aid, the nation’s international presence through the ‘soft power’ of aid will fall increasingly upon private philanthropy. Are the current tax incentives for Australian cross-border philanthropy and the supervision of those incentives appropriate to both facilitate and regulate international giving? To address this question, this article analyses the amount of Australian cross-border philanthropy and explains the current legislative architecture affecting the tax deductibility of cross-border gifts. It then examines the Australian Government’s proposed ‘in Australia’ reform agenda against the underlying fiscal and regulatory policy imperatives, and makes recommendations for the future tax treatment of Australian cross-border philanthropy.

The new arts leader: the Australia Council and cultural policy change

One consequence of the development of cultural policy has been a demand for more creative leadership in arts organisations. This article provides a case study of how leadership of the Australia Council changed from the 1970s to the beginning of the 21st century. It argues that changes to the way in which Australia Council chairs approached their role was shaped by, and contributed to, the trend towards constructing the arts as an industry. Part of this change sees the Australia Council subjected to aspects of reform, which were widely endorsed by the Australian public sector. The article identifies three styles of leadership exhibited by the chairs over the period: visionary, statesman and reformer, in three phases of the Council's history. It examines the political and social imperatives shaping these leadership styles.

A systematic policy approach to changing the food system and physical activity environments to prevent obesity

As obesity prevention becomes an increasing health priority in many countries, including Australia
and New Zealand, the challenge that governments are now facing is how to adopt a systematic
policy approach to increase healthy eating and regular physical activity. This article sets out a
structure for systematically identifying areas for obesity prevention policy action across the food
system and full range of physical activity environments. Areas amenable to policy intervention can
be systematically identified by considering policy opportunities for each level of governance (local,
state, national, international and organisational) in each sector of the food system (primary
production, food processing, distribution, marketing, retail, catering and food service) and each
sector that influences physical activity environments (infrastructure and planning, education,
employment, transport, sport and recreation). Analysis grids are used to illustrate, in a structured
fashion, the broad array of areas amenable to legal and regulatory intervention across all levels of
governance and all relevant sectors. In the Australian context, potential regulatory policy
intervention areas are widespread throughout the food system, e.g., land-use zoning (primary
production within local government), food safety (food processing within state government), food
labelling (retail within national government). Policy areas for influencing physical activity are
predominantly local and state government responsibilities including, for example, walking and
cycling environments (infrastructure and planning sector) and physical activity education in schools
(education sector). The analysis structure presented in this article provides a tool to systematically
identify policy gaps, barriers and opportunities for obesity prevention, as part of the process of
developing and implementing a comprehensive obesity prevention strategy. It also serves to
highlight the need for a coordinated approach to policy development and implementation across
all levels of government in order to ensure complementary policy action.

Harmonised procurement policy environment - identifying key themes towards the development of a conceptual model

Capital works procurement and its regulatory policy environment within a country can be complex entities. For example, by virtue of Australia’s governmental division between the Commonwealth, states and local jurisdictions and the associated procurement networks and responsibilities at each level, the tendering process is often convoluted. There are four inter-related key themes identified in the literature in relation to procurement disharmony, including decentralisation, risk & risk mitigation, free trade & competition, and tendering costs. This paper defines and discusses these key areas of conflict that adversely impact upon the business environments of industry through a literature review, policy analysis and consultation with capital works procurement stakeholders. The aim of this national study is to identify policy differences between jurisdictions in Australia, and ascertain whether those differences are a barrier to productivity and innovation. This research forms an element of a broader investigation with an aim of developing efficient, effective and nationally harmonised procurement systems.

The mutual obligation policy in Australia : the rhetoric and reasoning of recent social security policy

Since 1997, the Australian Federal Liberal Government has introduced policies which have sought to reduce rates of unemployment, particularly long-term unemployment. The policy, known as Mutual Obligation, increased the expectations on unemployed people in return for their social security payment. At the same time, previous labour market programmes and government assistance schemes were scrapped or privatised. This article explores the justification of the term 'Mutual Obligation' by examining both the language and the underlying principles of the policy. By defining the problem of unemployment in terms of flaws in the previous social security system, the stage is set for the government to introduce policies which remedy those flaws by emphasising self- reliance in favour of government assistance. Further, by invoking notions of fairness and mutuality, the article argues that the term 'Mutual Obligation' masks both the extent and the strength of the obligations imposed on unemployed people.

Regulating IVF and pre-implantation tissue-typing for the creation of "saviour siblings" : a harm analysis

Scientific discoveries, developments in medicine and health issues are the constant focus of media attention and the principles surrounding the creation of so called ‘saviour siblings’ are of no exception. The development in the field of reproductive techniques has provided the ability to genetically analyse embryos created in the laboratory to enable parents to implant selected embryos to create a tissue-matched child who may be able to cure an existing sick child. The research undertaken in this thesis examines the regulatory frameworks overseeing the delivery of assisted reproductive technologies (ART) in Australia and the United Kingdom and considers how those frameworks impact on the accessibility of in vitro fertilisation (IVF) procedures for the creation of ‘saviour siblings’. In some jurisdictions, the accessibility of such techniques is limited by statutory requirements. The limitations and restrictions imposed by the state in relation to the technology are analysed in order to establish whether such restrictions are justified. The analysis is conducted on the basis of a harm framework. The framework seeks to establish whether those affected by the use of the technology (including the child who will be created) are harmed. In order to undertake such evaluation, the concept of harm is considered under the scope of John Stuart Mill’s liberal theory and the Harm Principle is used as a normative tool to judge whether the level of harm that may result, justifies state intervention or restriction with the reproductive decision-making of parents in this context. The harm analysis conducted in this thesis seeks to determine an appropriate regulatory response in relation to the use of pre-implantation tissue-typing for the creation of ‘saviour siblings’. The proposals outlined in the last part of this thesis seek to address the concern that harm may result from the practice of pre-implantation tissue-typing. The current regulatory frameworks in place are also analysed on the basis of the harm framework established in this thesis. The material referred to in this thesis reflects the law and policy in place in Australia and the UK at the time the thesis was submitted for examination (December 2009).