Regulation of human stem cell research in Australia

Australia is currently well placed to contribute to the global growth of human stem cell research. However, as the science has progressed, authorities have had to deal with the ongoing challenges of regulating such a fast moving field of scientific endeavour. Australia’s past and current approach to regulating the use of embryos in human embryonic stem cell research provides an insight into how Australia may continue to adapt to future regulatory challenges presented by human stem cell research. In the broader context, a number of issues have been identified that may impact upon the success of future human stem cell research in Australia.

Stem cell technologies : regulation, patents and problems

Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.

Commercialisation of regenerative human tissue : Regulation and reform in Australia and England, Wales and Northern Ireland

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.

Performance Benchmarking of Australian Business Regulation : Submission to the Productivity Commission

The need to “reduce red tape” and regulatory inconsistencies is a desirable outcome (OECD 1997) for developed countries. The costs normally associated with regulatory regimes are compliance costs and direct charges. Geiger and Hoffman (1998) have noted that the extent of regulation in an industry tends to be negatively associated with firm performance. Typically, approaches to estimation of the cost of regulations examine direct costs, such as fees and charges, together with indirect costs, such as compliance costs. However, in a fragmented system, such as Australia, costs can also be incurred due to procedural delays, either by government, or by industry having to adapt documentation for different spheres of government; lack of predictable outcomes, with variations occurring between spheres of government and sometimes within the same government agency; and lost business opportunities, with delays and red tape preventing realisation of business opportunities (OECD 1997). In this submission these costs are termed adaptation costs. The adaptation costs of complying with variations in regulations between the states has been estimated by the Building Product Innovation Council (2003) as being up to $600 million per annum for building product manufacturers alone. Productivity gains from increased harmonisation of the regulatory system have been estimated in the hundreds of millions of dollars (ABCB 2003). This argument is supported by international research which found that increasing the harmonisation of legislation in a federal system of government reduces what we have termed adaptation costs (OECD 2001). Research reports into the construction industry in Australia have likewise argued that improved consistency in the regulatory environment could lead to improvements in innovation (PriceWaterhouseCoopers 2002), and that research into this area should be given high priority (Hampson & Brandon 2004). The opinion of industry in Australia has consistently held that the current regulatory environment inhibits innovation (Manley 2004). As a first step in advancing improvements to the current situation, a summary of the current costs experienced by industry needs to be articulated. This executive summary seeks to outline these costs in the hope that the Productivity Commission would be able to identify the best tools to quantify the actual costs to industry.

Economics and preventing healthcare acquired infection

The evolution of organisms that cause healthcare acquired infections (HAI) puts extra stress on hospitals already struggling with rising costs and demands for greater productivity and cost containment. Infection control can save scarce resources, lives, and possibly a facility’s reputation, but statistics and epidemiology are not always sufficient to make the case for the added expense. Economics and Preventing Healthcare Acquired Infection presents a rigorous analytic framework for dealing with this increasingly serious problem. ----- Engagingly written for the economics non-specialist, and brimming with tables, charts, and case examples, the book lays out the concepts of economic analysis in clear, real-world terms so that infection control professionals or infection preventionists will gain competence in developing analyses of their own, and be confident in the arguments they present to decision-makers. The authors: ----- Ground the reader in the basic principles and language of economics. ----- Explain the role of health economists in general and in terms of infection prevention and control. ----- Introduce the concept of economic appraisal, showing how to frame the problem, evaluate and use data, and account for uncertainty. ----- Review methods of estimating and interpreting the costs and health benefits of HAI control programs and prevention methods. ----- Walk the reader through a published economic appraisal of an infection reduction program. ----- Identify current and emerging applications of economics in infection control. ---- Economics and Preventing Healthcare Acquired Infection is a unique resource for practitioners and researchers in infection prevention, control and healthcare economics. It offers valuable alternate perspective for professionals in health services research, healthcare epidemiology, healthcare management, and hospital administration. ----- Written for: Professionals and researchers in infection control, health services research, hospital epidemiology, healthcare economics, healthcare management, hospital administration; Association of Professionals in Infection Control (APIC), Society for Healthcare Epidemiologists of America (SHEA)

Creative clusters and universities : the cluster concept in economics and geography

This paper considers the history of the cluster concept in urban economic geography, and its relationship to recent debates about creative cities. It then looks at the role that universities can play in the development of a creative cluster, as well as some of the potential pitfalls.

Obesity in pregnancy : outcomes and economics

Maternal obesity is an important aspect of reproductive care. It is the commonest risk factor for maternal mortality in developed countries and is also associated with a wide spectrum of adverse pregnancy outcomes. Maternal obesity may have longer-term implications for the health of the mother and infant, which in turn will have economic implications. Efforts to prevent, manage and treat obesity in pregnancy will be costly, but may pay dividends from reduced future economic costs, and subsequent improvements to maternal and infant health. Decision-makers working in this area of health services should understand whether the problem can be reduced, at what cost; and then, what cost savings and health benefits will accrue in the future from a reduction of the problem.