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.

Efficiently capturing large, complex cultural heritage sites with a handheld mobile 3D laser mapping system

Accurate three-dimensional representations of cultural heritage sites are highly valuable for scientific study, conservation, and educational purposes. In addition to their use for archival purposes, 3D models enable efficient and precise measurement of relevant natural and architectural features. Many cultural heritage sites are large and complex, consisting of multiple structures spatially distributed over tens of thousands of square metres. The process of effectively digitising such geometrically complex locations requires measurements to be acquired from a variety of viewpoints. While several technologies exist for capturing the 3D structure of objects and environments, none are ideally suited to complex, large-scale sites, mainly due to their limited coverage or acquisition efficiency. We explore the use of a recently developed handheld mobile mapping system called Zebedee in cultural heritage applications. The Zebedee system is capable of efficiently mapping an environment in three dimensions by continually acquiring data as an operator holding the device traverses through the site. The system was deployed at the former Peel Island Lazaret, a culturally significant site in Queensland, Australia, consisting of dozens of buildings of various sizes spread across an area of approximately 400 × 250 m. With the Zebedee system, the site was scanned in half a day, and a detailed 3D point cloud model (with over 520 million points) was generated from the 3.6 hours of acquired data in 2.6 hours. We present results demonstrating that Zebedee was able to accurately capture both site context and building detail comparable in accuracy to manual measurement techniques, and at a greatly increased level of efficiency and scope. The scan allowed us to record derelict buildings that previously could not be measured because of the scale and complexity of the site. The resulting 3D model captures both interior and exterior features of buildings, including structure, materials, and the contents of rooms.

Intellectual Property Laws Amendment Bill 2013

This submission relates to the proposed amendment of the Crown Use provisions in the Patents Act 1990 (Cth) (“the Patents Act”),which are contained in Intellectual Property Laws Amendment Bill 2013 (“The Bill”). Specifically, the submission relates to the method of calculation of the remuneration payable to the patent applicant/owner in circumstances where the Crown exercises its rights under Chapter 17 of the Patents Act.

The Proposed Commonwealth Personal Property Securities Act 2008

Inspired by similar reforms introduced in New Zealand, Canada and the United States, the Commonwealth, with the co-operation of the States, seeks in the Personal Property Securities Bill 2008 (the Bill) to introduce a central repository of recorded information reflecting particular security interests in personal property in Australia. Specifically, the interest recorded is an interest in personal property provided for by a transaction that in substance secures the payment or the performance of an obligation. In addition to providing a notification of the use of the personal property as collateral to secure the payment of monies or the performance of an obligation, the Bill proposes to introduce a regime of prioritising interests in the same collateral. Central to this prioritisation are the concepts of a ‘perfected security interests’and ‘unperfected security interests’. Relevantly, a perfected security interest in collateral has priority over an unperfected security interest in the same collateral. The proposed mechanisms rely on the fundamental integer of personal property, which is defined as any property other than land. Recognising that property may take a tangible as well as an intangible form, the Bill reflects an appreciation of the fact that some property may have a tangible form which may act as collateral, and simultaneously the same property may involve other property, intangible property in the form of intellectual property rights, which in their own right may be the subject of a‘security agreement’. An example set out in the Commentary on the Consultation Draft of the Bill (the Commentary), indicates the practical implications involving certain property which have multiple profiles for the purposes of the Bill. This submission is concerned with the presumptions made in relation to the interphase between tangible property and intangible property arising from the same personal property, as set out in s 30 of the Bill.

The game of clones and the Australia tax : divergent views about copyright business models and the willingness of Australian consumers to infringe

It is often said that Australia is a world leader in rates of copyright infringement for entertainment goods. In 2012, the hit television show, Game of Thrones, was the most downloaded television show over bitorrent, and estimates suggest that Australians accounted for a plurality of nearly 10% of the 3-4 million downloads each week. The season finale of 2013 was downloaded over a million times within 24 hours of its release, and again Australians were the largest block of illicit downloaders over BitTorrent, despite our relatively small population. This trend has led the former US Ambassador to Australia to implore Australians to stop 'stealing' digital content, and rightsholders to push for increasing sanctions on copyright infringers. The Australian Government is looking to respond by requiring Internet Service Providers to issue warnings and potentially punish consumers who are alleged by industry groups to have infringed copyright. This is the logical next step in deterring infringement, given that the operators of infringing networks (like The Pirate Bay, for example) are out of regulatory reach. This steady ratcheting up of the strength of copyright, however, comes at a significant cost to user privacy and autonomy, and while the decentralisation of enforcement reduces costs, it also reduces the due process safeguards provided by the judicial process. This article presents qualitative evidence that substantiates a common intuition: one of the major reasons that Australians seek out illicit downloads of content like Game of Thrones in such numbers is that it is more difficult to access legitimately in Australia. The geographically segmented way in which copyright is exploited at an international level has given rise to a ‘tyranny of digital distance’, where Australians have less access to copyright goods than consumers in other countries. Compared to consumers in the US and the EU, Australians pay more for digital goods, have less choice in distribution channels, are exposed to substantial delays in access, and are sometimes denied access completely. In this article we focus our analysis on premium film and television offerings, like Game of Thrones, and through semi-structured interviews, explore how choices in distribution impact on the willingness of Australian consumers to seek out infringing copies of copyright material. Game of Thrones provides an excellent case study through which to frame this analysis: it is both one of the least legally accessible television offerings and one of the most downloaded through filesharing networks of recent times. Our analysis shows that at the same time as rightsholder groups, particularly in the film and television industries, are lobbying for stronger laws to counter illicit distribution, the business practices of their member organisations are counter-productively increasing incentives for consumers to infringe. The lack of accessibility and high prices of copyright goods in Australia leads to substantial economic waste. The unmet consumer demand means that Australian consumers are harmed by lower access to information and entertainment goods than consumers in other jurisdictions. The higher rates of infringement that fulfils some of this unmet demand increases enforcement costs for copyright owners and imposes burdens either on our judicial system or on private entities – like ISPs – who may be tasked with enforcing the rights of third parties. Most worryingly, the lack of convenient and cheap legitimate digital distribution channels risks undermining public support for copyright law. Our research shows that consumers blame rightsholders for failing to meet market demand, and this encourages a social norm that infringing copyright, while illegal, is not morally wrongful. The implications are as simple as they are profound: Australia should not take steps to increase the strength of copyright law at this time. The interests of the public and those of rightsholders align better when there is effective competition in distribution channels and consumers can legitimately get access to content. While foreign rightsholders are seeking enhanced protection for their interests, increasing enforcement is likely to increase their ability to engage in lucrative geographical price-discrimination, particularly for premium content. This is only likely to increase the degree to which Australian consumers feel that their interests are not being met and, consequently, to further undermine the legitimacy of copyright law. If consumers are to respect copyright law, increasing sanctions for infringement without enhancing access and competition in legitimate distribution channels could be dangerously counter-productive. We suggest that rightsholders’ best strategy for addressing infringement in Australia at this time is to ensure that Australians can access copyright goods in a timely, affordable, convenient, and fair lawful manner.

Finding country

The Finding Country Exhibition seeks a pluralist contest between the traditions of aboriginal space (Country), and European space (property) in Australia. Aboriginal Country is excluded from the Australian city. The city of Brisbane, located on the aboriginal Country of the Turrbal people, is the common ground of this confrontation. It is the show Australia rejected. Despite the 1992 landmark Mabo case High Court decision, a decision that struck down the doctrine of terra nullius (an empty land belonging to no-one), architecture in Australia continues its 18th century European tradition of drawing on empty paper. The aboriginal position is that this paper is not empty, but is full of what can’t be seen. The aboriginal map of Australia reveals a continent with many Countries and many spaces. The prevailing spectrum of architectural positions, bookended by decorated sheds and metaphysical decks, continues to bring aboriginal Country into decline. If the opposite position is considered it is possible to find something lost. Cities historically enter states of decline, frequently associated with some form of catastrophe. Others end in a whimper. It is not unreasonable to imagine an opportunity for the recovery of Country through decline. The central exhibit is an 8×3m drawing of the city of Brisbane consisting of approximately 50 individual grid submissions emptied by half to find something special. Each grid is an explicit architectural negotiation with decline, whilst carrying an implicit personal challenge to non-aboriginal architects to engage Country. Since 2006, the Finding Country project has endeavoured to assert an aboriginal origin for architecture in Australia. It is led and directed by Kevin O’Brien a descendent of the Kaurareg and Meriam people of north-eastern Australia, and an architect working in Brisbane.

Commercial Leases in Australia [7th ed.]

Commercial Leases in Australia is a comprehensive guide to understanding and drafting commercial leases agreements in Australia and to managing disputes when they arise.

Electronic conveyancing in Australia : is anyone concerned about security?

We have previously suggested that three proof requirements are essential for a sustainable land registration system. These were proof of identity, proof of ownership and authority to deal. Our attention in this article is drawn to the security framework that surrounds these requirements. We will ask whether the introduction of the Property Exchange of Australia (PEXA), and its underpinning regulatory regime will meet the concerns that we have in relation to them. In drawing out some problems with PEXA, we then offer an innovative idea, sourced from the transfer of equities that could serve to generate discussion on how we can ensure the Torrens system of land registration is sustainable for another 160 years. We also canvass some more incremental suggestions that evolve out of what we currently do, as well as outlining some comparative externally sourced ideas as to how the transfer and ownership of land can be made safer for all citizens. Such a goal is imperative when land transfer and secure property ownership is a critical component of the economic infrastructure of a modern society.

The ethics, aesthetics and practical politics of ownership in co-creative media

What is ‘best practice’ when it comes to managing intellectual property rights in participatory media content? As commercial media and entertainment business models have increasingly come to rely upon the networked productivity of end-users (Banks and Humphreys 2008) this question has been framed as a problem of creative labour made all the more precarious by changing employment patterns and work cultures of knowledge-intensive societies and globalising economies (Banks, Gill and Taylor 2014). This paper considers how the problems of ownership are addressed in non-commercial, community-based arts and media contexts. Problems of labour are also manifest in these contexts (for example, reliance on volunteer labour and uncertain economic reward for creative excellence). Nonetheless, managing intellectual property rights in collaborative creative works that are created in community media and arts contexts is no less challenging or complex than in commercial contexts. This paper takes as its focus a particular participatory media practice known as ‘digital storytelling’. The digital storytelling method, formalised by the Centre for Digital Storytelling (CDS) from the mid-1990s, has been internationally adopted and adapted for use in an open-ended variety of community arts, education, health and allied services settings (Hartley and McWilliam 2009; Lambert 2013; Lundby 2008; Thumin 2012). It provides a useful point of departure for thinking about a range of collaborative media production practices that seek to address participation ‘gaps’ (Jenkins 2006). However the outputs of these activities, including digital stories, cannot be fully understood or accurately described as user-generated content. For this reason, digital storytelling is taken here to belong to a category of participatory media activity that has been described as ‘co-creative’ media (Spurgeon 2013) in order to improve understanding of the conditions of mediated and mediatized participation (Couldry 2008). This paper reports on a survey of the actual copyrighting practices of cultural institutions and community-based media arts practitioners that work with digital storytelling and similar participatory content creation methods. This survey finds that although there is a preference for Creative Commons licensing a great variety of approaches are taken to managing intellectual property rights in co-creative media. These range from the use of Creative Commons licences (for example, Lambert 2013, p.193) to retention of full copyrights by storytellers, to retention of certain rights by facilitating organisations (for example, broadcast rights by community radio stations and public service broadcasters), and a range of other shared rights arrangements between professional creative practitioners, the individual storytellers and communities with which they collaborate, media outlets, exhibitors and funders. This paper also considers how aesthetic and ethical considerations shape responses to questions of intellectual property rights in community media arts contexts. For example, embedded in the CDS digital storytelling method is ‘a critique of power and the numerous ways that rank is unconsciously expressed in engagements between classes, races and gender’ (Lambert 117). The CDS method privileges the interests of the storyteller and, through a transformative workshop process, aims to generate original individual stories that, in turn, reflect self-awareness of ‘how much the way we live is scripted by history, by social and cultural norms, by our own unique journey through a contradictory, and at times hostile, world’ (Lambert 118). Such a critical approach is characteristic of co-creative media practices. It extends to a heightened awareness of the risks of ‘story theft’ and the challenges of ownership and informs ideas of ‘best practice’ amongst creative practitioners, teaching artists and community media producers, along with commitments to achieving equitable solutions for all participants in co-creative media practice (for example, Lyons-Reid and Kuddell nd.). Yet, there is surprisingly little written about the challenges of managing intellectual property produced in co-creative media activities. A dialogic sense of ownership in stories has been identified as an indicator of successful digital storytelling practice (Hayes and Matusov 2005) and is helpful to grounding the more abstract claims of empowerment for social participation that are associated with co-creative methods. Contrary to the ‘change from below’ philosophy that underpins much thinking about co-creative media, however, discussions of intellectual property usually focus on how methods such as digital storytelling contribute to the formation of copyright law-compliant subjects, particularly when used in educational settings (for example, Ohler nd.). This also exposes the reliance of co-creative methods on the creative assets storytellers (rather than on the copyrighted materials of the media cultures of storytellers) as a pragmatic response to the constraints that intellectual property right laws impose on the entire category of participatory media. At the level of practical politics, it also becomes apparent that co-creative media practitioners and storytellers located in copyright jurisdictions governed by ‘fair use’ principles have much greater creative flexibility than those located in jurisdictions governed by ‘fair dealing’ principles.

Developing a Cross-cultural Law Curriculum

This work makes the case that cross cultural issues are central to the purposes of legal education, and no longer can such issues be seen as an add-on to the traditional curriculum. The authors argue instead for a critical multiculturalism that is attuned to questions of gender, class, sexuality and social justice, and that must inform the whole law school curriculum.

Current status and future trends of school counseling in Australia

School counselling in Australia is presently in a state of flux and adaptation. Within this period of change and adjustment, three key points are acknowledged. First structural and organisational change is a constant in the field of school counselling in the Australian context. Second, despite this, the nature of the school counselling role tends to remain the same but with new areas of need being added, such as self harm and cyberbullying. Third, each state and territory in Australia has differing role statements and training requirements for its school counsellors. This paper initially reviews the historical context of school counselling in Australia, including changes and developments in qualifications and training programs. A description is then provided of the current status of school counselling including the differences among the state systems. Issues such as work intensification, uncertainty of tenure, supervision, ethical issues and online counselling are discussed. The scant research into the effectiveness of the profession is outlined, followed by future recommendations.

Subprime agriculture, and Australia?

Today, Australian agriculture is not where we hoped it would be. Despite being highly productive and the nation's only 'strongly competitive industry', it is struggling across the country. There are successes, as there always will be, but the bulk of our food and fibre production is from enterprises with minimal profitability and unstable or unsound finances. A debt-deflation spiral and subprime mortgage crisis are now being fuelled by property fire sales while leading bankers proclaim no problem and governments dance at the edges. However, it is not just the bush that has problems. National economic conditions are deteriorating with per capita incomes falling and real interest rates still high. Well-informed policy strategies and effective responses are needed quickly if Australians are to avoid needless losses of capacity and wealth destruction in the cities and the bush.

The impact of infrastructure charges on house prices in Australia

Developer paid fees or charges are a commonly used mechanism for local governments to pay for new infrastructure. However, property developers claim that these costs are merely passed on to home buyers, with adverse effects to housing affordability. Despite numerous government reports and many years of industry advocacy, there remains no empirical evidence in Australia to confirm or quantify this passing on effect to home buyers. Hence there remains no data from which governments can base policy decision on, and the debate continues. This paper examines the question of the impact of infrastructure charges on housing affordability in Australia. It presents the findings of a hedonic house price model that provides the first empirical evidence that infrastructure charges do increase house prices in Australia. This research is consistent with international findings, that support the proposition that developer paid infrastructure charges are passed on to home buyers and are a significant contributor to increasing house prices and reduced housing affordability.

Fostering digital participation in regional and rural Australia

The deployment of high speed broadband around Australia offers opportunities to extend digital participation among and between regional and rural communities. Full realisation of these opportunities requires a greater understanding about community members’ current digital participation and development needs, to underpin innovative community-driven initiatives. This paper outlines the Fostering Digital Participation Project’s initial undertakings to determine current digital participation and the future digital aspirations of a number of regional and rural communities.

Competition Law in Australia [6th ed.]

Competition Law in Australia, 6th edition provides a comprehensive discussion of the provisions of the Competition and Consumer Act 2010 (Cth) (CCA) dealing with the regulation of competition and markets in Australia. This book covers disparate topics, such as restrictions in horizontal and vertical agreements, horizontal mergers and acquisitions, misuse of market power, and access to services necessary to compete in upstream or downstream markets. However, the unifying theme of this text is that it is not possible to use a formalistic approach in applying the CCA. The decisions of the courts, and the competition authorities responsible for implementing and enforcing the CCA, underline the need to undertake a detailed substantive economic analysis of the effect of the agreement or conduct at issue on competition, efficiency and consumer welfare.