Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

Guidelines on building design and operation to minimize air quality impacts from major roads in transit oriented development

Poor air quality has a huge detrimental effect, both economic and on the quality of life, in Australia. Transit oriented design (TOD), which aims to minimise urban sprawl and lower dependency on vehicles, leads to an increasing number of buildings close to transport corridors. This project aims at providing guidelines that are appropriate to include within City Plan to inform future planning along road corridors, and provide recommendations on when mitigation measures should be utilised.

Governance and effectiveness in regional planning: an analysis of North American, European, and Australasian practice

Over the past several years, there has been resurgent interest in regional planning in North America, Europe and Australasia. Spurred by issues such as metropolitan growth, transportation infrastructure, environmental management and economic development, many states and metropolitan regions are undertaking new planning initiatives. These regional efforts have also raised significant question about governance structures, accountability and measures of effectiveness.n this paper, the authors conducted an international review of ten case studies from the United States, Canada, England, Belgium, New Zealand and Australia to explore several critical questions. Using qualitative data template, the research team reviewed plans, documents, web sites and published literature to address three questions. First, what are the governance arrangements for delivering regional planning? Second, what are the mechanisms linking regional plans with state plans (when relevant) and local plans? Third, what means and mechanisms do these regional plans use to evaluate and measure effectiveness? The case study analysis revealed several common themes. First, there is an increasing focus on goverance at the regional level, which is being driven by a range of trends, including regional spatial development initiatives in Europe, regional transportation issues in the US, and the growth of metropolitan regions generally. However, there is considerable variation in how regional governance arrangements are being played out. Similarly, there is a range of processes being used at the regional level to guide planning that range from broad ranging (thick) processes to narrow and limited (thin) approaches. Finally, evaluation and monitoring of regional planning efforts are compiling data on inputs, processes, outputs and outcomes. Although there is increased attention being paid to indicators and monitoring, most of it falls into outcome evaluations such as Agenda 21 or sustainability reporting. Based on our review we suggest there is a need for increased attention on input, process and output indicators and clearer linkages of these indicators in monitoring and evaluation frameworks. The focus on outcome indicators, such as sustainability indicators, creates feedback systems that are too long-term and remote for effective monitoring and feedback. Although we found some examples of where these kinds of monitoring frameworks are linked into a system of governance, there is a need for clearer conceptual development for both theory and practice.

Applying an equity lens to tobacco-control policies and their uptake in six western-european countries

We identified policies that may be effective in reducing smoking among socioeconomically disadvantaged groups, and examined trends in their level of application between 1985 and 2000 in six western-European countries (Sweden, Finland, the United Kingdom, the Netherlands, Germany, and Spain). We located studies from literature searches in major databases, and acquired policy data from international data banks and questionnaires distributed to tobacco policy organisations/researchers. Advertising bans, smoking bans in workplaces, removing barriers to smoking cessation therapies, and increasing the cost of cigarettes have the potential to reduce socioeconomic inequalities in smoking. Between 1985 and 2000, tobacco control policies in most countries have become more targeted to decrease the smoking behaviour of low-socioeconomic groups. Despite this, many national tobacco-control strategies in western-European countries still fall short of a comprehensive policy approach to addressing smoking inequalities.

What shapes attitudes toward paying taxes? Evidence from multicultural European countries

Objectives. Considerable evidence suggests that enforcement efforts cannot fully explain the high degree of tax compliance. To resolve this puzzle of tax compliance, several researchers have argued that citizens' attitudes toward paying taxes, defined as tax morale, helps to explain the high degree of tax compliance. However, most studies have treated tax morale as a black box, without discussing which factors shape it. Additionally, the tax compliance literature provides little empirical research that investigates attitudes toward paying taxes in Europe. Methods. Thus, this article is unique in its examination of citizen tax morale within three multicultural European countries, Switzerland, Belgium, and Spain, a choice that allows far more detailed examination of the impact of culture and institutions using data sets from the World Values Survey and the European Values Survey. Results. The results indicate the tendency that cultural and regional differences affect tax morale. Conclusion. The findings suggest that higher legitimacy for political institutions leads to higher tax morale.

Improving ICT integration in today’s AEC industry: recommendations & guidelines

The Cooperative Research Centre (CRC) for Construction Innovation research project 2001-008-C: ‘Project Team Integration: Communication, Coordination and Decision Support’, is supported by a number of Australian industry, government and university based project partners including: Queensland University of Technology (QUT); Commonwealth Scientific Industrial Research Organisation (CSIRO), University of Newcastle; Queensland Department of Public Works (QDPW); and the Queensland Department of Main Roads (QDMR). Supporting the various research aims and objectives of the 2001-008-C (Part B) QUT / Industry Partner agreements, and as a major deliverable for the project, this report is not intended as a comprehensive statement of Architectural, Engineering and Contractor (AEC) industry best practice recommendations. Rather it should read as a set of research and industry recommended guidelines, based on extensive literature reviews and two years worth of investigative activities examining both public and private industry uptake of innovative information and communication technology (ICT) solutions, whilst highlighting the overall need for culture change.

Final report : task 2 : design guidelines for delivering high quality indoor environments

This report is for one of the four Tasks of the CRC project ‘Regenerating Construction to Enhance Sustainability’. The report specifically addresses Task 2 ‘Design guidelines for delivering high quality indoor environments’.

Comparison between ACI 440 and FIB 14 design guidelines in using CFRP for strengthening of a concrete bridge headstock

This paper compares and reviews the recommendations and contents of the guide for the design and construction of externally bonded FRP systems for strengthening concrete structures reported by ACI committee 440 and technical report of Externally bonded FRP reinforcement for RC structures (FIB 14) in application of carbon fiber reinforced polymer (CFRP) composites in strengthening of an aging reinforced concrete headstock. The paper also discusses the background, limitations, strengthening for flexure and shear, and other related issues in use of FRP for strengthening of a typical reinforced concrete headstock structure such as durability, de-bonding, strengthening limits, fire and environmental conditions. A case study of strengthening of a bridge headstock using FRP composites is presented as a worked example in order to illustrate and compare the differences between these two design guidelines when used in conjunction with the philosophy of the Austroads (1992) bridge design code.

Comparative study of guidelines and practices for building infrastructure asset management

This paper presents a comparative study of primarily Australian (and limited international) practices and guidelines on Buildings Asset Management (BAM). The objective of this study was to identify potential gaps in current practices and potential areas of research for further improvement. The paper starts with an overview of BAM. Later sections cover current BAM practices and guidelines across different states of Australia; give a limited overview of international practices and concludes with the authors’ observations.

Electronic Tendering : Guidelines and Recommendations for Successful Implementation and Uptake

This publication, summarising outcomes of an investigation into eTendering as a part of a CRC Construction Innovation research project, presents guidelines and recommendations to be considered when implementing eTendering systems, procedures and policies.