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.

Succession law keeping pace with changes in technology and community expectations – informal wills

Purpose - The purpose of this paper is to provide insights into recent developments in the way the law of succession allows people to use new technologies to document their testamentary intentions in an informal way. Design/methodology/approach – This article considers one area in which the law has arguably kept good pace with advances in society’s expectations and technological change – the law of succession. This article examines the legislative reforms in Queensland and other jurisdictions permitting the recognition of informal wills and the decided cases in the area. In particular, the article examines the decision in a Queensland Supreme Court case in which the court recognised the validity of a will made on an iPhone. Research limitations/implications – This is a doctrinal analysis, not an empirical study, and accordingly is limited to providing details specific to the legislation and the court cases selected.

Vulnerability : an issue for law and policy in pandemic planning?

The 2009 H!Nl 'swine flu' pandemic was the first influenza pandemic of the twenty-first centmy. Unlike the first influenza pandemic of the twentieth century, the so-called 'Spanish flu' which killed millions of people worldwide, the 2009 pandemic was relatively mild. While the mildness of the 2009 pandemic meant that the 'Yorld was spared from the impact of a high-mortality event that would cause widespread social and economic disruption, the 2009 pandemic did provide an opportunity to road-test pandemic readiness. In other work we have assessed Australia's pandemic plans and emergency management legislation, finding that both provide flexible and adaptive forms of regulation that are capable of adapting to the scale and severity of a pandemic or other public health emergency. 1 In this chapter we consider whether pandemic planning adequately addresses the needs of vulnerable individuals and groups, both within countries and between them. Central to this is the question of whether vulnerability is itself a useful concept for both law and policy, and if so, the implications of expressly incorporating the concept of vulnerability into pandemic planning.

Australian Environmental Law : Norms, Principles & Rules, 3rd Edition

Australian Environmental Law: Norms, Principles and Rules, 3rd Edition provides a detailed examination of the fundamental concepts and principles of the environmental legal system in Australia. This new edition updates relevant State, Territory and Commonwealth legislation and case law and expands on the themes set out in the 2nd edition, namely:the origins and contexts of environmental governance; the movement toward ecologically sustainable development; the relevance and function of ecologically sustainable development today in the legal system; and the range of instrumental rules supporting environmental governance. The 3rd edition in particular expands upon the range of instrumental rules by analysing through the case law the emerging sets of rules of competence and limitation on the one hand and the emerging sets of purposive, deliberative, methodological, strategic, liability and market rules on the other hand. This thematic and principled approach adopted in Australian Environmental Law: Norms, Principles and Rules, 3rd Edition presents the reader with coverage of the important issues surrounding this area of the law in a clear and concise way.

Testing the effects of the Japanese vehicle emission-control law on the international palladium futures market

This paper tested the effects of the 2005 vehicle emission-control law issued in Japan on the market linkages between the U.S. and Japanese palladium futures markets, To determine these effects, we applied a cointegration test both with and without break points in the time series and found that the market linkages between the two countries changed after the break in October 2005. Our results show that the 2005 long-term regulation of vehicle emissions enacted in Japan influenced the international palladium futures market.

Promoting law student well-being through the curriculum

The Australian tertiary sector is becoming increasingly concerned about the psychological well-being of its students.Empirical research in Australia indicates that more than one-third of law students suffer from psychological distress, and the competitive, isolated, adversarial learning environment at law school has been suggested as partly responsible (Brain and Mind Research Institute, 2009). This fellowship program has mobilised strategic change to improve the psychological health of law students. It has lead and stimulated advancement in the legal curriculum, its pedagogy, and assessment practice to better engage, motivate and support student learning of law, focussing on the potential of non-adversarial legal practice. A new conceptual framework for legal education has been developed, demonstrating the pursuit of excellence in the teaching of law, and raising the profile of learning and teaching in Australian law schools. In addition the fellowship has created a national community of practice around this issue through the Wellness Network for Law, and made significant contributions to research and scholarship in the field.

Doctors' knowledge of the law on withholding and withdrawing life-sustaining medical treatment

Objectives To examine the level of knowledge of doctors about the law on withholding and withdrawing life-sustaining treatment from adults who lack decision-making capacity, and factors associated with a higher level of knowledge. Design, setting and participants Postal survey of all specialists in emergency medicine, geriatric medicine, intensive care, medical oncology, palliative medicine, renal medicine and respiratory medicine on the AMPCo Direct database in New South Wales, Victoria and Queensland. Survey initially posted to participants on 18 July 2012 and closed on 31 January 2013. Main outcome measures Medical specialists’ levels of knowledge about the law, based on their responses to two survey questions. Results Overall response rate was 32%. For the seven statements contained in the two questions about the law, the mean knowledge score was 3.26 out of 7. State and specialty were the strongest predictors of legal knowledge. Conclusions Among doctors who practise in the end-of-life field, there are some significant knowledge gaps about the law on withholding and withdrawing life-sustaining treatment from adults who lack decision-making capacity. Significant consequences for both patients and doctors can flow from a failure to comply with the law. Steps should be taken to improve doctors’ legal knowledge in this area and to harmonise the law across Australia.

The rise and fall of the international law of maritime terrorism : the ghost of piracy is still hunting!

Maritime terrorism is a serious threat to global security. A major debate in this regard is the treating of acts of maritime terrorism as piracy by some scholars and a rejection of this view by others. Moreover, the international law of maritime terrorism suffers from fundamental definitional issues, much like the international law of terrorism. This article examines the current international law of maritime terrorism with a particular emphasis on the debate regarding the applicability of the international law of piracy in the case of maritime terrorism. It argues that the international law of piracy is not applicable in the enforcement and prosecution of maritime terrorists on the high seas. International treaties on terrorism and the post-September 11 developments relating to international laws on terrorism have created a workable international legal framework for combating maritime terrorism, despite some bottlenecks.

Social turkey

Social Turkey is a short digital dance video developed over a series of weekly meetings with a group of sprightly and defiant sixty-plus year olds resident in Limerick. Very early in the process artist Ciara Finnegan and choreographer Jenny Roche found each individual expressing a wonderful enthusiasm for dance, an eagerness to perform and a healthy refusal to conform to stereotypes of aging. Finnegan was keen that this project should support an exchange of ideas rather than employ a top-down directorial structure. While Roche devised the fundamentals of the dance and Finnegan manned the camera, each participant contributed thereafter - improvising on a step sequence and collaborating on patterns that ultimately determined much of the look of the result. The work seeks to amplify the represented interests of a wider community while celebrating the vivacity of the particular group and the sheer fun of the collaboration.

Islamic project financing in Indonesian infrastructure development

It is reasonable to expect that Islamic project financing may be a suitable option of infrastructure financing in Indonesia. This research explored the conditions necessary for the implementation of Islamic project financing for Indonesian infrastructure development. It is important that all infrastructure project stakeholders understand the concept comprehensively. This study identified reforms through which the government could more directly support the implementation of Islamic project financing. This research has led to the realisation that Islamic project financing can be implemented in all sectors, in both public and private sector domains, and across Muslim and non-Muslim communities.

Repeatability or reproducibility in Australian Patent Law

This article considers the extent to which a claimed process must be repeatable or reproducible in order to be patentable according to Australian patent law. It asks whether a process must yield identical or near-identical results each time the process is invoked, or if not, what degree of repeatability is required. The question is relevant when considering, among other things, the patentability of some methods of medical treatment and diagnosis, biotechnology inventions and business methods.

Labour Law and Labour Market Regulation

The traditional boundaries of labour law are becoming outmoded in a modern world in which active labour market participants vastly outnumber “employees”, and the world of work extends way beyond the workplace gate. There is convergence with labour market regulation. The contract of employment remains central but is no longer the sole object of study.Labour Law and Labour Market Regulation reflects the dramatically different industrial, social, political and legislative contexts in which the law now operates and the intellectual revolution this is generating. Individual chapters contain studies of regulation within prescriptive government schemes, contract networks, specialist labour markets, the intersection between work and family, enterprise policies and practices, and the courts and tribunals. The book provides insights into areas that are, as arbitration declines, becoming increasingly important to their clients' interests. The most recent legislation and jurisprudence is discussed in many chapters including discrimination, dismissals, health and safety, immigration, social security, franchise, volunteer and contract law.

Work Health and Safety Law and Policy

The third edition of Work Health and Safety Law and Policy continues to provide a plain English approach to explaining and analysing the law which regulates work health and safety in Australia. Providing broad coverage, this book focuses on the role that legal regulation plays in preventing work-related injury and disease, as well as the way in which the law contributes to rehabilitating and compensating injured and ill workers. This third edition focuses on the national model Work Health and Safety Bill 2009. The provisions of the model Bill are outlined, along with court decisions and other documentation that help interpret the provisions in new legislation enacting the model Bill. There is also a chapter in the book examining the national model Work Health and Safety Regulations 2011, and model codes of practice. The book includes three chapters on common law, statutory workers’ compensation provisions and rehabilitation. Tables summarising the key legal provisions of the major Australian Commonwealth, State and Territory workers’ compensation statutes have been updated and give quick and easy reference to points of legislation.