Simultaneous gene silencing and supressing gene silencing in the same cell

The present invention relates to genetically modified cells that are capable of optimal transgene expression by co-expressing a silencing suppressor whilst at the same time are also capable of silencing a gene, such as a naturally occurring gene of the cell. The present invention also relates to methods of producing the modified cells, as well as relates to processes for obtaining a genetically modified cell with a desired property.

A QUM partnership approach to regulating biosimilars in Australia

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

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.

Interrupting malaria transmission: quantifying the impact of interventions in regions of low to moderate transmission

Malaria has been eliminated from over 40 countries with an additional 39 currently planning for, or committed to, elimination. Information on the likely impact of available interventions, and the required time, is urgently needed to help plan resource allocation. Mathematical modelling has been used to investigate the impact of various interventions; the strength of the conclusions is boosted when several models with differing formulation produce similar data. Here we predict by using an individual-based stochastic simulation model of seasonal Plasmodium falciparum transmission that transmission can be interrupted and parasite reintroductions controlled in villages of 1,000 individuals where the entomological inoculation rate is <7 infectious bites per person per year using chemotherapy and bed net strategies. Above this transmission intensity bed nets and symptomatic treatment alone were not sufficient to interrupt transmission and control the importation of malaria for at least 150 days. Our model results suggest that 1) stochastic events impact the likelihood of successfully interrupting transmission with large variability in the times required, 2) the relative reduction in morbidity caused by the interventions were age-group specific, changing over time, and 3) the post-intervention changes in morbidity were larger than the corresponding impact on transmission. These results generally agree with the conclusions from previously published models. However the model also predicted changes in parasite population structure as a result of improved treatment of symptomatic individuals; the survival probability of introduced parasites reduced leading to an increase in the prevalence of sub-patent infections in semi-immune individuals. This novel finding requires further investigation in the field because, if confirmed, such a change would have a negative impact on attempts to eliminate the disease from areas of moderate transmission.

Mandatory reporting laws

As part of the effort to protect children from significant abuse and neglect, each state and territory in Australia has enacted legislation commonly known as "mandatory reporting laws". There is much confusion about the nature and effects of these laws, both generally and within each jurisdiction. Accordingly, the main aim of this chapter is to review and explain the legislative principles across Australia. In doing so, the chapter will identify differences between the state and territory laws and will situate the laws as part of a system of responses to the whole spectrum of child abuse and neglect. We will also highlight the need for effective reporter training and public awareness, especially given the tension between the widely perceived need for a community response to child abuse and neglect and the simultaneous concern to avoid unnecessary reporting of innocuous events and situations.

Changes to commercial service provision among sex workers from Queensland, Australia

Introduction: The role of commercial sex in facilitating infection transmission is a subject of ongoing empirical enquiry, with little attention to the variety and extent of ‘non-traditional’ commercial services that pose a lesser risk of infection. This study sought to examine the supply and demand of a wide range of traditional and non-traditional commercial sexual services among sex workers and their clients from Queensland, Australia. Methods: Cross-sectional convenience sampling was used to compare female sex workers in 1991 (n=200, aged 16-46 years) and 2003 (n=247, aged 18-57 years) and from male clients in 2003. The client sample comprised 160 male clients aged between 19 and 72 years. Results: Over the comparison period there was a significant increase in the provision of ‘exotic’ or non-traditional sexual services. In 2003, the availability of bondage and discipline, submission, fantasy, use of sex toys, golden showers, fisting and lesbian double acts had increased dramatically, while ‘traditional’ services had mostly remained at similar levels. Moreover, the proportion of sex workers in some industry sectors providing ‘exotic’ commercial services seem to have risen over time. Conclusion: Undoubtedly, the sex industry has professionalised and now includes more sophisticated and specialized suppliers. As with any commercial business, the diversification of services is largely driven with client demand, with the ‘menu’ being generally broader than the majority of client preferences. However, although clients demands for particular commercial sexual services seems to have been met, with regard to anal sex and anal play, supply has failed to meet client demand. Disclosure of Interest Statement: Funding for the 2003 study was provided by the Prostitution Licensing Authority. Acknowledgement and sincere thanks to the men and women who participated in this study.

Effectiveness of policy against illegal disposal of waste

Our objective is to analyze the effectiveness, against the illegal disposal of waste, of a licensing system that has been introduced in a waste management policy. We theoretically find enforcement leverage in the licensing system, and then examine the theoretical result empirically. The results suggest that extending liability to disposers, which forms the basis of the enforcement leverage, deters illegal disposal more effectively than increasing penalties for illegal disposal. We also obtain evidence of transboundary movement of illegal disposal, and find how the court determines penalties for illegal disposal.

Young driver distraction : state of the evidence and directions for behavior change programs

Adolescent drivers are over-represented in distraction-related motor vehicle crashes. There are a number of potential reasons for such elevated risk with driving inexperience, high adoption of communication technology, increased peer involvement and tendency to take risks, rendering young drivers particularly vulnerable. Major legislative efforts in Graduated Licensing Systems that include passenger restrictions have shown positive effects. Restrictions on cell phone use are also being introduced however enforcement of such regulations is challenging. This paper argues that such contextual, legislative interventions are an essential prevention strategy however there is an unfilled need to introduce behavior change programs that may target adolescents, parents and friends. A theoretical framework is applied in which risk and protective factors are identified from research within community and jurisdiction contexts. In the literature on distraction social context and normative influences are the key elements used to inform program design for adolescent drivers with parental monitoring informing interventions targeting parents. Following from this assessment of the message content assessment, the design of strategies to deliver the messages are reviewed. In the current literature, school-based programs, simulations and web-delivered programs have been evaluated with supplementary strategies delivered by physicians and parents. Such developments are still at an early stage of development and ultimately will need controlled implementation and evaluation studies. There is of course, no likely single approach to prevent adolescent driver distraction and complementary approaches such as the further development of technological interventions to manage phone use are needed. Implications and Contributions The paper describes the intervention design process alongside key research in young driver distraction including selecting target behavior, audience, theoretically-derived strategies and delivery strategies. Currently graduated driver licensing and technology use and acceptance and parent-adolescent and adolescent-peer interactions are opportunities for further research and exploration.

Intellectual Property – What Went Wrong!

In its simplest form the patent system is designed to encourage the disclosure of innovative thought in exchange for a period of exclusivity in which the grantee of the rights may profit from such knowledge. I will attempt in this paper to show that patentees seeking to enforce their patents in Australia will face great difficulty through a number of potentially fatal pitfalls. I also submit that as a result of the decisions in Australia in reported patent cases in the last ten years, legal advisers should place their clients on notice that if they are trying to enforce their patents they are unlikely to succeed...

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.

Submission: Towards a Stronger and More Efficient IP Rights System : Getting the Balance Right

1. In March 2009, the Australian Government, through IP Australia its administrator of Intellectual Property Rights (IPR) acquired by registration or grant, issued two consultation papers for comment by interested stakeholders. 2. The Consultation Papers have invited written submissions directed towards the object of the paper, namely encouraging discussion on certain proposed changes and their impact on business and innovation. 3. I understand the invitation to make written submissions is predominantly in the areas raised by the Consultation Papers and the questions posed. However, I have made a brief reference to several other areas of concern with the current Australian patent law, which in my opinion inhibit innovation and therefore come under the wider agenda of the government to work toward a stronger and more efficient IP rights system. 4. In this regard, the Consultation Papers indicate that if the IPR are less likely to be invalidated and more likely to be enforced, this confidence will reflect in a greater investment in research leading to innovation. 5. This submission relates to the Balance Paper.

Community pharmacy dispensing of prescription medicine sample packs: Changing the business of medicine initiation?

Prescription medicine samples (or starter packs) are provided by pharmaceutical manufacturers to prescribing doctors as one component in the suite of marketing products used to convince them to prescribe a particular medicine [1,2]. Samples are generally newer, more expensive treatment options still covered by patent [3,4]. Safe, effective, judicious and appropriate medicine use (quality use of medicines) [5] could be enhanced by involving community pharmacists in the dispensing of starter packs. Doctors who use samples show a trend towards prescribing more expensive medicines overall [6] and also prescribe more medicines [7]. Cardiovascular health and mental health are Australian National Health Priority Areas [8] and account for approximately 30% and 17%, respectively, of annual government Pharmaceutical Benefits System (PBS) in 2006 [9]. The PBS is Australia's universal prescription subsidy scheme [9]. Antihypertensives were a major contributor to the estimated 80 000 medicine-related hospital admissions in Australia in 1999 [10] and also internationally [11,12]. The aim of this study was to pilot an alternative model for supply of free sample or starter packs of prescription medicines and ascertain if it is a viable model in daily practice.

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.

Assessment of robust autonomy for unmanned systems : progress and challenges

The growing number of potential applications of Unmanned Aircraft Systems (UAS) in civilian operations and national security is putting pressure of National Airworthiness Authorities to provide a path for certification and allow UAS integration into the national airspace. The success of this integration depends not only on developments in improved UAS reliability and safety, but also on regulations for certification, and methodologies for operational performance and safety assessment. This paper focuses on the latter and describes progress in relation to a previously proposed framework for evaluating robust autonomy of UAS. The paper draws parallels between the proposed evaluation framework and the evaluation of pilots during the licensing process. It discusses how the data from the proposed evaluation can be used as an aid for decision making in certification and UAS designs. Finally, it discusses challenges associated with the evaluation.

Best practice in peer-led curriculum content : informing an interactive program to improve passenger safety among high school seniors

Despite ongoing improvements in behaviour change strategies, licensing models and road law enforcement measures young drivers remain significantly over-represented in fatal and non-fatal road related crashes. This paper focuses on the safety of those approaching driving age and identifies both high priority road safety messages and relevant peer-led strategies to guide the development school programs. It summarises the review in a program logic model built around the messages and identified curriculum elements, as they may be best operationalised within the licensing and school contexts in Victoria. This paper summarises a review of common deliberate risk-taking and non-deliberate unsafe driving behaviours among novice drivers, highlighting risks associated with speeding, driving while fatigued, driving while impaired and carrying passengers. Common beliefs of young people that predict risky driving were reviewed, particularly with consideration of those beliefs that can be operationalised in a behaviour change school program. Key components of adolescent risk behaviour change programs were also reviewed, which identified a number of strategies for incorporation in a school based behaviour change program, including: a well-structured theoretical design and delivery, thoughtfully considered peer-selected processes, adequate training and supervision of peer facilitators, a process for monitoring and sustainability, and interactive delivery and participant discussions. The research base is then summarised in a program logic model with further discussion about the quality of the current state of knowledge of evaluation of behaviour change programs and the need for considerable development in program evaluation.