Generic drugs: international trends and policy developments in Australia

Public and private third-party payers in many countries encourage or mandate the use of generic drugs. This article examines the development of generics policy in Australia, against the background of a description of international trends in this area, and related experiences of reference pricing programs. The Australian generics market remains underdeveloped due to a historical legacy of small Pharmaceutical Benefits Scheme price differentials between originator brands and generics. It is argued that policy measures open to the Australian government can be conceived as clustering around two different approaches: incremental changes within the existing regulatory framework, or a shift towards a high volume/low price role of generics which would speed up the delivery of substantial cost savings, and could provide enhanced scope for the financing of new, patented drugs.

An integrated information strategy for ecommerce for export : enhancing networking in an international business context

Companies using electronic commerce to facilitate their export activities (EC4X) need information and support at all stages of their export development and eCommerce adoption. This need is especially pressing for small and medium enterprises (SMEs). This paper reports the findings of a study of EC4X information and support needs among a sample of Australian companies. Evidence from SMEs, business associations and the Victorian state government suggests that governments need to develop a strategy for cost-effective on-line EC4X material that incorporates both generic and specific information. On-line provision of information is an effective way to meet the needs of SMEs and is increasingly the preferred channel for government bodies seeking to promote EC4X capability. However, personal contacts and networks are still an essential part of international business. Thus, an effective government strategy will support the business networking and personal contacts so important to help SMEs develop both eCommerce and export activities.

International strategy : is it meeting the challenge?

International strategy (IS) is the approach by which an organisation's capabilities and resources are directed to generate value utilising the global market's opportunities (and risks). Many of the largest multinationals invest significant resources in their IS, however, the literature does not offer any substantive model for the process. This paper presents a model of the IS process which comprises two parts, the first part is made up of inputs, development and outputs and the second comprises a feedback loop based on organisational performance measurement and its interpretation which impacts on the first part stages of inputs and development. The content of the model is explained and justified using examples of practice. Inputs are comprised of market information, human resources, diversity and value creation and host country environmental factors. Development is comprised of preparation and learning, planning and scrutinising partnerships, anticipating impacts of globalisation, anticipating impacts of technology, location, experience effects, planning competencies, planning for cost effectiveness, scenario planning, planning structures and operations, leadership and ethics. Outputs are comprised of structure, scope of operations, target countries, facility location and positioning. Performance interpretation explains rapid and major changes in IS outputs, such as structure
and business unit portfolios, whilst process complexity explains observed output similarities for organisations reacting to similar inputs and suggests an evolutionary approach in their determination.

Managing academic support for international students: the appropriateness of a learning support unit in an Australian tertiary institution

The higher education environment in Australia has undergone a radical change since the 1980s with the phenomenal increase in the intake of international students, particularly from what are referred to as Confucian Heritage Cultures (CHC): China, Korea, Japan, Malaysia and Singapore. Students from these countries view the Australian higher education system very favourably. The present increase in the proportion of full-fee paying students at Australian universities is also a result of decreasing government funding to the Australian higher education sector, which has now risen to be one of the most important elements of the Australian economy. These push-pull factors have drawn more Australian tertiary institution providers into the market place, as they seek more international student enrolments for their domestic campuses and also establish campuses overseas. Potential higher education students are becoming more discerning in their choices and are choosing learning environments that offers them both relevant and stimulating educational experiences and good qualifications, along with a range of both IT and academic support services that cater to their individual learning needs. Increasing competition, both within Australia and internationally, calls for a focus on student satisfaction in order to sustain the existence of the providers. This paper addresses the issue of what international students seek in terms of academic support and demonstrates that present levels of cost efficient services by Australian higher education providers, generally characterized by IT and language support services, are inadequate and do not meet the specific needs of the students.

A new approach to assessing the health benefit from obesity interventions in children and adolescents: the assessing cost-effectiveness in obesity project

OBJECTIVE: To report on a new modelling approach developed for the assessing cost-effectiveness in obesity (ACE-Obesity) project and the likely population health benefit and strength of evidence for 13 potential obesity prevention interventions in children and adolescents in Australia. METHODS: We used the best available evidence, including evidence from non-traditional epidemiological study designs, to determine the health benefits as body mass index (BMI) units saved and disability-adjusted life years (DALYs) saved. We developed new methods to model the impact of behaviours on BMI post-intervention where this was not measured and the impacts on DALYs over the child's lifetime (on the assumption that changes in BMI were maintained into adulthood). A working group of stakeholders provided input into decisions on the selection of interventions, the assumptions for modelling and the strength of the evidence. RESULTS: The likely health benefit varied considerably, as did the strength of the evidence from which that health benefit was calculated. The greatest health benefit is likely to be achieved by the 'Reduction of TV advertising of high fat and/or high sugar foods and drinks to children', 'Laparoscopic adjustable gastric banding' and the 'multi-faceted school-based programme with an active physical education component' interventions. CONCLUSIONS: The use of consistent methods and common health outcome measures enables valid comparison of the potential impact of interventions, but comparisons must take into account the strength of the evidence used. Other considerations, including cost-effectiveness and acceptability to stakeholders, will be presented in future ACE-Obesity papers. Information gaps identified include the need for new and more effective initiatives for the prevention of overweight and obesity and for better evaluations of public health interventions.

Integrating cost-effectiveness evidence into clincal practice guidelines in Australia for acute myocardial infarction

 A teaching hospital is working with the Victorian State Government and universities, integrating cost-effectiveness evidence into clinical practice guidelines (CPGs), protocols and pathways for respiratory and cardiology interventions. Acute myocardial infarction (AMI) findings are reported. Results will stimulate cost-effective practice and inform medical associations, federal and state governments and international organisations developing CPGs. Published CPGs by the American College of Cardiology/American Heart Foundation for AMI in 1999 are reviewed by a large interdis- ciplinary hospital-based committee given cost-effectiveness evidence. Levels of evi- dence criteria rating on methodological rigor for effectiveness and costs are applied. National Health and Medical Research Council (NHMRC) grades of recommendation criteria for combinations of relative effectiveness versus relative costs and cut-off points are used. Extrapolating results between countries was addressed by applying the OECD's health purchasing power parity series. Recommendations for revisions to United States guidelines and for local application are formulated. United States Guide- lines require updating: Regarding angioplasty, percutaneous transluminal coronary angioplasty (PTCA) is cost-effective for men aged 60 years relative to recombinant tissue plasminogen activator (tPA),with additional cost per life year saved of 274 ecu. PTCA with discharge after 3 days is cost-effective in low-risk AMI. Regarding GP llb/Illa drugs, Abciximab during intervention incurred equal mean hospital costs for placebabciximab bolus, and abciximab bolus+ infusion with incremental 6-month cost for the latter treatment costing US$ 293 per patient. Agent recouped almost all initial therapy costs with significant benefits. Incre- mental cost of abciximab per event prevent- ed is US$ 3,258.Tirofiban was compared to placebo after high-risk angioplasty for AMI or unstable angina.Tirofiban decreased the rate of hospital deaths, myocardial infarc- tion, revascularisation at 2 days by 36% relative to placebo (8% vs. 12%) without increased cost. Clinical benefits were similar at 30 days.Tirofiban+heparin+aspirin was compared to heparin+aspirin.Tirofiban arm resulted in net savings of 33,418 ecu per 100 patients for the first 7 days of treatment. Regarding thrombolytics,tPA is more cost- effective than streptokinase. Incremental costs for each life saved when streptokinase is substituted by recombinant tissue plasmi- nogen are 31%,45%, 97% higher in Germa- ny, Italy and the United States than in the United Kingdom. Regarding anticoagulants, enoxaparin is a promising alternative to unfractionated heparin for hospitalised patients with non-Q-wave myocardiai infarc- tion or unstable angina, saving C$ 1,485 per patient over 12 months with 10% reduction in 1 year risk of death, myocardial infarction or recurrent angina. Regarding anti- arrhymics, the cost-effectiveness of no amiodarone, amiodarone for patients with depressed heart rate variability (DHRV),and amiodarone for patients with DHRV plus positive programmed ventricular stimula- tion (PPVS) for high-risk post-AMI was investigated. Amiodarone for DHRV+PPVS patients was dominated by a blend of the two alternatives. Compared to no amioda- rone, the incremental cost-effectiveness of amiodarone for DHRV patients was US$ 39,422 per quality adjusted life year gained. Amiodarone for DHRV is the most appropriate. Other CPG updates concern serum markers, for example, cardiac troponin I assay (c-Tnl), cost advantages of ad hoc angioplasty and secondary prevention through antioxidants and pravastatin. Australian costs are reported later in the paper.

Estimating the increasing cost of commercial buildings in Australia due to greenhouse emissions trading

The ratification of the Kyoto Protocol by most industrial nations will result in an international greenhouse emissions trading market by or before 2008. Calculating the quantity of embodied energy in commercial buildings has therefore taken on added significance because it is in the creation of energy that most greenhouse gas that causes global warming is released. For energy efficient commercial buildings in Australia, the embodied energy can typically represent between 10 and 20 years of operational energy. When greenhouse emissions trading is introduced in Australia the cost of energy will rise significantly, particularly electricity which relies primarily on burning fossil fuels for generation. This will affect not only the operating energy costs of buildings (light, power & heating/cooling) but also the cost of building materials and construction. Early estimates of the potential cost of future greenhouse emission permits in Australia vary between $IO/tonne to $180Itonne. This cost would be imposed primarily on the producers of energy and passed on by them to consumers via higher energy costs. For a typical commercial building this could lead to an increase in the total procurement cost of buildings of up to 20% due to the energy embodied during the construction or refurbishment of the building. To assist in evaluating these potential cost increases McKean & Park, Sinclair Knight Merz and Deakin University have developed a web-based Carbon Cost Calculator for commercial buildings.

Theories of international relations

This collection of essays demonstrates the continuing importance of the work of Michael Polanyi for the understanding, not only of the great events of the 20th century, but also of the problems that face us in the 21st century. Polanyi moved liberalism away from a negative, sceptical and rationalist basis towards an acceptance of trust, tradition and faith in transcendent values. His conception of the free society is not one merely of doing as one pleases nor vacuously 'open', but one of individual and communal self-dedication to those values and ideals.These essays, authored by a distinguished international and interdisciplinary panel of invited contributors, examine Polanyi's specific insights in the theory of knowledge, the nature and source of social order and the philosophy of economics and science and draw relevant comparisons between Polanyi and related thinkers such as Popper, Hayek and Mises. This book shows the sources of Polanyi's ideas and his distinctive contribution to philosophy generally, to social and political thought and to economics.

Challenges in health services and health systems research

The relationship between emerging trends in healthcare systems and the consequent research priorities will be explored.

Governments and policy makers in developed countries are increasingly focused on the management of chronic disease, reflecting demographic changes and shifts in the burden of disease. Systems of quality improvement and reward are increasingly based on performance in chronic disease management. There is some evidence that countries with well-developed systems of primary care, such as Australia, achieve better health outcomes at less cost. In the past 15 years, almost all developed countries have undergone some type of health care reform. There has been a major focus on reducing costs; often involving shifting services from secondary to primary care. While there are few international comparisons, most suggest a complex relationship between the strength of primary care within the overall health services system and good performance, particularly with regard to lower costs of care and particularly relevant measures of health.

Aims for 21st century health systems
What, then, are the issues which are shaping contemporary general practice in developed countries? There are several imperatives: Safety, effectiveness, patient-centredness, timeliness, efficiency and equity. A study by the Nuffield Trust (Dargie, 1999) projected the shape of healthcare for the first fifteen years of this century. The study identified six issues that need to be addressed in the process of formulating health systems policies:

• Peoples’ expectations and financial sustainability
• Demography and ageing
• Information and knowledge management
• Scientific advance and new technology
• Workforce education and training
• Systems performance and quality (efficiency, effectiveness, economy
and equity)

Each of these six issues requires innovative thinking and priority setting on the part of the health sector, such as the delivery of health services in new and creative ways. Furthermore, there is a clear need for a finely tuned research, development and evaluation strategies to match these goals.

Accounting services and SMEs : an Australian study

Background: The observance of regulation has become a fundamental part of life for the conduct of business around the world. Governments and their duly appointed designates, acting in the interest of the collective public, have relied on regulation to moderate economic and social behaviour through the imposition and enforcement of rules. While it can be commonly accepted that such a prescriptive framework may be necessary for the achievement of desired economic and social outcomes, regulation does impose costs on society and on individual firms. These costs, which can include the costs for government departments to administer, the cost for firms to comply, and the multitude of indirect costs such as lost innovation and productivity or their interrelated opportunity costs, have received ample attention.

Accountants are key advisers to all businesses on all aspects of doing business, including regulation. As such, it is appropriate that ACCA has sponsored this study, which explores the regulatory issues facing SMEs and the critical role that accountants and other organisations play in helping SMEs be aware of, comply with and generally manage effectively the regulations that apply to their business.

ACCA has consistently argued for a balanced view to be taken on regulation, recognising that certain rules are necessary for the fair development of business and for employees’ rights. Yet at the same time, ACCA recognises that SMEs are likely to be disproportionately burdened by regulatory requirements and, as a consequence, it actively campaigns for fairness in regulation, recognising the issue as a significant factor in the success, productivity and growth of small businesses.

Overview: This study complements similar research commissioned by ACCA in the United Kingdom and Canada (Blackburn et al. 2006), with the aim of helping to provide a more international picture of the effects of regulation on adviceseeking by SMEs and how accountants can help SMEs meet their regulatory obligations.

The research commenced in November 2006 and was conducted over the Australian summer period 2006/7, among SMEs and accounting practices, as follows:

* telephone survey among 250 SMEs
* postal survey among 130 accounting practitioner firms.

Key findings: The SME section of this study revealed the following points.

* Most SMEs (between 70% and 80%), agreed that the regulations under review were reasonable, however there were significantly high levels of concern regarding:
* the number of regulations affecting their business (80%)
* staying up to date with changing regulations (80%)
* complexity of regulation or the ease of understanding regulations (77%)
* inequity, or the cost of regulation in proportion to the business (66%)
* duplication, or being required to provide the same information to more than one government department (55%).
* External accountants were the most common source of advice, being used by 72% of SMEs; this was followed by federal government agencies,    62%; trade or industry bodies, 61%; and a lawyer or solicitor, 53%.
* Highest levels of satisfaction with the advice provided were recorded for lawyers/solicitors (94%), banks (91%) and external accountants (90%).
* Overall, 80% of SMEs who had used accountants rated their service as excellent or good. Thirty per cent gave accountants an excellent rating.
* Accountants rated particularly well on the following attributes:
* the potential for a long-term relationship with the business (81% excellent/good)
* technical understanding of the regulatory requirements that apply to the business (79%)
* ability to meet the needs of the business (77%)
* understanding of the business of the SME and its operations (73%).

The survey of accounting practitioners produced the following information.
* The results indicate that SME firms with fewer than 10 employees are the main source of revenue for the respondent accounting practitioners.
* Virtually all accountants provide regulatory advice, primarily in the areas of taxation (particularly Goods and Services Tax, GST), and Do-It-      Yourself (DIY) superannuation requirements. These services provided the accountants with their largest business growth in the two years before the time of the survey.

Seventy-nine per cent of accountants referred their SME clients to external professional advisers. Their comments indicate (see Appendix 4) that some accountants consider their role to be as convenors or advisers for their SME clients. Importantly, according to the accountants, SME firms with fewer than 10 employees did not update their knowledge of regulatory requirements; they relied on their accountant for the right advice. The main types of external adviser to whom accountants referred their SME clients were lawyers and financial planners.

* Accountants expressed their concern regarding the complexity and amount of regulations affecting their SME clients.
* The accountants also stated that they would like to provide additional advice to their SME clients.
 
Confidence intervals – SME survey:  The survey sample size was 250 SMEs from the total of 1.2 million Australian SMEs. Any estimate of proportions agreeing or disagreeing with particular statements must be considered with respect to the margin of possible statistical error. Owing to the small sample size, generalising the results from this study to a wider population of SMEs may be constrained.

A 95% confidence interval of the sample mean for the following estimates based on a percentage agreement of 75% to a proposition with a sample size of 250 would be from 69.5% to 80.5%. The 95% confidence interval for estimates of any other value will diverge slightly in magnitude from the numbers given.

In general then we can be highly confident that the actual sample mean will be within approximately ± 5% of the figure given, with a survey of this size. Confidence intervals – acounting practitioner survey IBISWorld estimates reveal a figure of 9,222 accounting practices in Australia as at June 2006 (IBISWorld 2007). The sample size of 133 accounting practitioners gives a 95% confidence limit that the results reported from the mail-out survey are within the ± 5% confidence interval of the reported values.

Conclusions:  This report describes the results of two parallel surveys undertaken on the impact of business regulation on small and medium-sized enterprises in Australia and on the perceptions of accounting firms about the ways in which the regulatory impact on the SME sector drove their business.

The survey of SMEs provides empirical support for many of the concerns raised with the Regulation Taskforce, which reported to the Australian government in 2006. Many businesses are concerned about the volume and complexity of government legislation as it applies to their business. They are concerned that they are unable to keep up with new legislation and that there is apparent duplication of reporting requirements across the various tiers of government.

The survey of accountants revealed that accounting firms derive a significant proportion of their revenue from SMEs. While the SMEs are concerned with regulatory changes, the accountants surveyed reported that the major growth areas in their businesses were in what could be seen as traditional accounting areas of tax and superannuation. Some SMEs sought advice on areas such as employment law, environmental regulation and health and safety but it appears that many accountants refer their clients to specialists in these areas. Recent changes to the laws regarding financial planning in Australia may lead to changes in the market for financial advice in Australia, with many accountants apparently regarding this as a key driver of future business opportunities.

The surveys were conducted using a similar instrument to similar surveys conducted in the UK and Canada and reported in Blackburn et al. (2006). Comparisons of the Australian survey results with those from the UK and Canada seem to support the perception that Australian business is not over-regulated, but the SME sector is concerned with the volume and complexity of regulation. This suggests that the SME sector wants to see improvements to Australia’s regulatory regime as a result of the work of the Regulation Taskforce undertaken in 2005/6. In its response to the work of the Taskforce the government agreed with 158 of the 178 specific recommendations of the Taskforce. This now needs to be followed through at all levels of government.

Accountants in all three countries understand their SME clients’ concerns with the burden of regulation and they are prepared to advise their clients where appropriate or refer them to specialist advisers. Most business growth for accountants has come from the taxation area. Very few accountants in the UK or Australia specialise in providing advice in the areas of environmental regulation or health and safety regulation.

International comparisons show that in all three countries accountants are generally highly regarded by SMEs for their professionalism and competence. The major area of client concern is the value for money offered by the accountant’s service. In an era of rapidly shifting professional and technical boundaries, accountants need to be more strongly attuned to levels of client satisfaction. Lawyers, financial planners and a plethora of specialist advisers operate in the business services market and if they have an opportunity to take business from accountants by competing on price they may well do so. This suggests a stronger role for professional accounting bodies in monitoring the broader business services market for opportunities and threats on behalf of their membership.

A cost-based equity weight for use in the economic evaluation of primary health care interventions: case study of the Australian Indigenous population

Background : Efficiency and equity are both important policy objectives in resource allocation. The discipline of health economics has traditionally focused on maximising efficiency, however addressing inequities in health also requires consideration. Methods to incorporate equity within economic evaluation techniques range from qualitative judgements to quantitative outcomes-based equity weights. Yet, due to definitional uncertainties and other inherent limitations, no method has been universally adopted to date. This paper proposes an alternative cost-based equity weight for use in the economic evaluation of interventions delivered from primary health care services.

Methods : Equity is defined in terms of 'access' to health services, with the vertical equity objective to achieve 'equitable access for unequal need'. Using the Australian Indigenous population as an illustrative case study, the magnitude of the equity weight is constructed using the ratio of the costs of providing specific interventions via Indigenous primary health care services compared with the costs of the same interventions delivered via mainstream services. Applying this weight to the costs of subsequent interventions deflates the costs of provision via Indigenous health services, and thus makes comparisons with mainstream more equitable when applied during economic evaluation.

Results : Based on achieving 'equitable access', existing measures of health inequity are suitable for establishing 'need', however the magnitude of health inequity is not necessarily proportional to the magnitude of resources required to redress it. Rather, equitable access may be better measured using appropriate methods of health service delivery for the target group. 'Equity of access' also suggests a focus on the processes of providing equitable health care rather than on outcomes, and therefore supports application of equity weights to the cost side rather than the outcomes side of the economic equation.

Conclusion : Cost-based weights have the potential to provide a pragmatic method of equity weight construction which is both understandable to policy makers and sensitive to the needs of target groups. It could improve the evidence base for resource allocation decisions, and be generalised to other disadvantaged groups who share similar concepts of equity. Development of this decision-making tool represents a potentially important avenue for further health economics research.

Evaluation of heat stress indices using physiological comparisons in an alumina refinery in a sub-tropical climate

The production of alumina involves the use of a process known as the Bayer process. This method involves the digestion of raw bauxite in sodium hydroxide at temperatures around 250°C. The resultant pregnant liquor then goes through a number of filtering and precipitation processes to obtain the aluminium oxide crystals which are then calcined to obtain the final product. The plant is situated in a sub tropical climate in Northern Australia and this combined with the hot nature of the process results in a potential for heat related illnesses to develop. When assessing a work environment for heat stress a heat stress index is often employed as a guideline and to date the Wet Bulb Globe Temperature (WBGT) has been the recommended index. There have been concerns over the past that the WBGT is not suited to the Northern Australian climate and in fact studies in other countries have suggested this is the case. This study was undertaken in the alumina plant situated in Gladstone Queensland to assess if WBGT was in fact the most suitable index for use or if another was more applicable. To this end three indices, Wet Bulb Globe Temperature (WBGT), Heat Stress Index (HSI) and Required Sweat Rate (SWreq) were compared and assessed using physiological monitoring of heart rate and surrogate core temperature. A number of different jobs and locations around the plant were investigated utilising personal and environmental monitoring equipment. These results were then collated and analysed using a computer program written as part of the study for the manipulation of the environmental data . Physiological assessment was carried out using methods approved by international bodies such as National Institute for Occupational Safety & Health (NIOSH) and International Standards Organisation (ISO) and incorporated the use of a ‘Physiological Factor’ developed to enable the comparison of predicted allowable exposure times and strain on the individual. Results indicated that of the three indices tested, Required Sweat Rate was found to be the most suitable for the climate and in the environment of interest. The WBGT system was suitable in areas in the moderate temperature range (ie 28 to 32°C) but had some deficiencies above this temperature or where the relative humidity exceeded approximately 80%. It was however suitable as a first estimate or first line indicator. HSI over-estimated the physiological strain in situations of high temperatures, low air flows and exaggerated the benefit of artificial air flows on the worker in certain environments ie. fans.