439 resultados para Pharmaceutical policy.


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This article considers the origins and the development of the defence of experimental use in patent law - the ’freedom to tinker'. It explores the impact of such an exemption upon a number of important industries - such as agriculture, biotechnology, and pharmaceutical drugs. This article takes a comparative approach in its analysis of patent law and experimental use. It highlights the competing norms, and lack of harmonization between a number of jurisdictions - including the United States, the European Union, and Australia. Section 2 provides a critique of the development of the common law defence of experimental use in the United States. It considers a series of precedents - including Roche Products Inc v Bolar Pharmaceuticals, Madey v Duke University, Integra Lifesciences I Ltd v Merck KgaA, and Applera v MJ Research. Section 3 explores the operation of patent law and experimental use in European jurisdictions. It looks at a number of significant precedents in the United Kingdom, the Netherlands, France, Italy, and Germany. Section 4 considers the policy debate in a number of forums over the defence of experimental use in Australia. It examines the controversy over Genetic Technologies Limited asking research organisations to obtain a licence in respect of its patents associated with non-coding DNA and genomic mapping. It also considers the inquiries of the Australian Law Reform Commission and the Advisory Council on Intellectual Property, as well as the impact of the TRIPS Agreement and the Australia-United States Free Trade Agreement. The conclusion contends that there is a need for a broad-based defence of experimental use for all the member states of the Organisation for Economic Co-operation and Development.

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Biophilic urbanism, or urban design that reflects humanity’s innate need for nature, stands to make significant contributions to a range of national, state and local government policies related to climate change mitigation and adaptation, by investigating ways in which nature can be integrated into, around and on top of buildings. Potential benefits of such design include reducing the heat island effect, reducing energy consumption for thermal control, enhancing urban biodiversity, improving well being and productivity, improving water cycle management, and assisting in the response to growing needs for densification and revitalisation of cities. This report will give an overview of the concept of biophilia and consider enablers and disablers to its application to urban planning and design. The paper will present findings from stakeholder engagement and a series of detailed case studies, related to a consideration of the economics of the use of biophilic elements (direct and indirect).

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The paper critiques the focus of creative industries policy on capability development of small and medium sized firms and the provision of regional incentives. It analyses factors affecting the competitiveness and sustainability of the games development industry and visual effects suppliers to feature films. Interviews with participants in these industries highlight the need for policy instruments to take into consideration the structure and organization of global markets and the power of lead multinational corporations. We show that although forms of economic governance in these industries may allow sustainable value capture, they are interrupted by bottlenecks in which ferocious competition among suppliers is confronted by comparatively little competition among the lead firms. We argue that current approaches to creative industries policy aimed at building self-sustaining creative industries are unlikely to be sufficient because of the globalized nature of the industries. Rather, we argue that a more profitable approach is likely to require supporting diversification of the industries as ‘feeders’ into other areas of the economy.

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In October 2009, Professor David Nutt, eminent neuropsychopharmacologist and world leading expert on drugs, was dismissed as Chair of the UK government’s Advisory Council on the Misuse of Drugs for comments he made at the Centre for Crime and Justice Studies’ Eve Saville lecture. This article considers the role of evidence in political decision-making through the case of David Nutt. It is argued that the status of expert knowledge is in crisis for both the natural and the social sciences. We examine the role of the criminological advisor within emerging discourses of public criminology and suggest that high-stakes political issues can open up unprecedented opportunities for critical voices to engage in unbridled critique and to mobilise movements of dissent.

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This paper examines the global policy convergence toward high-stakes testing in schools and the use of test results to ‘steer at a distance’, particularly as it applies to policy-makers’ promise to improve teacher quality. Using Deleuze’s three syntheses of time in the context of the Australian policy blueprint Quality Education, this paper argues that using test scores to discipline teaching repeats the past habit of policy-making as continuing the problem of the unaccountable teacher. This results in local policy-making enfolding test scores in a pure past where the teacher-as-problem is resolved through the use of data from testing to deliver accountability and transparency. This use of the database returns a digitised form of inspection that is a repetition of the habit of teacher-as-problem. While dystopian possibilities are available through the database, in what Deleuze refers to as a control society, for us the challenge is to consider policy-making as a step into an unknown future, to engage with producing policy that is not grounded on the unconscious interiority of solving the teacher problem, but of imagining new ways of conceiving the relationship between policy-making and teaching.

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In May 2011, the Australian Federal Education Minister announced there would be a unique, innovative and new policy of performance pay for teachers, Rewards for Great Teachers (Garrett, 2011a). In response, this paper uses critical policy historiography to argue that the unintended consequences of performance pay for teachers makes it unlikely it will deliver improved quality or efficiency in Australian schools. What is new, in the Australian context, is that performance pay is one of a raft of education policies being driven by the federal government within a system that constitutionally and historically has placed the responsibility for schooling with the states and territories. Since 2008, a key platform of the Australian federal Labor government has been a commitment to an Education Revolution that would promote quality, equity and accountability in Australian schools. This commitment has resulted in new national initiatives impacting on Australian schools including a high-stakes testing regime 14 National Assessment Program 13 Literacy and Numeracy (NAPLAN) 14a mandated national curriculum (the Australian Curriculum), professional standards for teachers and teacher accreditation 14Australian Institute for Teaching and School Leadership (AITSL) 14and the idea of rewarding excellent teachers through performance pay (Garrett, 2011b). These reforms demonstrate the increased influence of the federal government in education policy processes and the growth of a 1Ccoercive federalism 1D that pits the state and federal governments against each other (Harris-Hart, 2010). Central to these initiatives is the measuring, or auditing, of educational practices and relationships. While this shift in education policy hegemony from state to federal governments has been occurring in Australia at least since the 1970s, it has escalated and been transformed in more recent times with a greater emphasis on national human capital agendas which link education and training to Australia 19s international economic competitiveness (Lingard & Sellar, in press). This paper uses historically informed critical analysis to critique claims about the effects of such policies. We argue that performance pay has a detailed and complex historical trajectory both internationally and within Australian states. Using Gale 19s (2001) critical policy historiography, we illuminate some of the effects that performance pay policies have had on education internationally and in particular within Australia. This critical historical lens also provides opportunities to highlight how teachers have, in the past, tactically engaged with such policies.

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I must admit that I approached the European Union-supported educational research 1995-2003: Briefing papers for policy makers with a sense of trepidation. As a researcher who defines himself as socially critical, I wondered about the dynamics of a policy document that was published by the bureaucracy that has, in some form, a vested interest in the structure and operation of education in its various guises. In turning my attention to this review, I decided to focus my attention on the third guiding question that argues education and training "are strongly interconnected with concerns that include citizenship and democratic participation, inequalities and social justice, cultural diversity and quality of life" (Millei, 2005). The Briefing Papers include recommendations on democracy and citizenship, social exclusion and equality, gender and dealing with mental illness in schools...

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Unlike US and Continental European jurisdictions, Australian monetary policy announcements are not followed promptly by projections materials or comprehensive summaries that explain the decision process. This information is disclosed 2 weeks later when the explanatory minutes of the Reserve Bank board meeting are released. This paper is the first study to exploit the features of the Australian monetary policy environment in order to examine the differential impact of monetary policy announcements and explanatory statements on the Australian interest rate futures market. We find that both monetary policy announcements and explanatory minutes releases have a significant impact on the implied yield and volatility of Australian interest rate futures contracts. When the differential impact of these announcements is examined using the full sample, no statistically significant difference is found. However, when the sample is partitioned based on stable periods and the Global Financial Crisis, a differential impact is evident. Further, contrary to the findings of Kim and Nguyen (2008), Lu et al. (2009), and Smales (2012a), the response along the yield curve, is found to be indifferent between the short and medium terms.

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This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

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In response to scientific breakthroughs in biotechnology, the development of new technologies, and the demands of a hungry capitalist marketplace, patent law has expanded to accommodate a range of biological inventions. There has been much academic and public debate as to whether gene patents have a positive impact upon research and development, health-care, and the protection of the environment. In a satire of prevailing patenting practices, the English poet and part-time casino waitress, Donna MacLean, sought a patent application - GB0000180.0 - in respect of herself. She explained that she had satisfied the usual patent criteria - in that she was novel, inventive, and useful: It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new: I have led a private existence and I have not made the invention of myself public. I am not obvious (2000: 18). MacLean said she had many industrial applications. 'For example, my genes can be used in medical research to extremely profitable ends - I therefore wish to have sole control of my own genetic material' (2000: 18). She observed in an interview: 'There's a kind of unpleasant, grasping, greedy atmosphere at the moment around the mapping of the human genome ... I wanted to see if a human being could protect their own genes in law' (Meek, 2000). This special issue of Law in Context charts a new era in the long-standing debate over biological inventions. In the wake of the expansion of patentable subject matter, there has been great strain placed upon patent criteria - such as 'novelty', 'inventive step', and 'utility'. Furthermore, there has been a new focus upon legal doctrines which facilitate access to patented inventions - like the defence of experimental use, the 'Bolar' exception, patent pooling, and compulsory licensing. There has been a concerted effort to renew patent law with an infusion of ethical principles dealing with informed consent and benefit sharing. There has also been a backlash against the commercialisation of biological inventions, and a call by some activists for the abolition of patents on genetic inventions. This collection considers a wide range of biological inventions - ranging from micro-organisms, plants and flowers and transgenic animals to genes, express sequence tags, and research tools, as well as genetic diagnostic tests and pharmaceutical drugs. It is thus an important corrective to much policy work, which has been limited in its purview to merely gene patents and biomedical research. This collection compares and contrasts the various approaches of a number of jurisdictions to the legal problems in respect of biological inventions. In particular, it looks at the complexities of the 1998 European Union Directive on the Legal Protection of Biotechnological Inventions, as well as decisions of member states, such as the Netherlands, and peripheral states, like Iceland. The edition considers US jurisprudence on patent law and policy, as well as recent developments in Canada. It also focuses upon recent developments in Australia - especially in the wake of parallel policy inquiries into gene patents and access to genetic resources.

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One of the most discussed topics in labour and demographic studies, population ageing and stability, is closely related to fertility choices. This thesis explores recent developments in the fertility literature in the context of Australia. We investigate individual preferences for child bearing, the determinants of fertility decisions and the effectiveness of policies implemented by the government aimed at improving total fertility. The first study highlights the impact of monetary incentives on the decision to bear children in light of potentially differential responses across the native and immigrant population. The second study analyses the role of unemployment and job stability on the fertility choices of women. The final study examines whether the quality-quantity trade-off exists for Australian families and explores the impact of siblings on a child's health and educational outcomes.

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The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology. In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical. After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined. Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA. This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; the definition of piracy is overbroad; the suite of civil remedies, criminal offences and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations and remedies. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

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For a hundred years, since Federation, Australian consumers have suffered the indignity and the tragedy of price discrimination. From the time of imperial publishing networks, Australia has been suffered from cultural colonialism. In respect of pricing of copyright works, Australian consumers have been gouged; ripped-off; and exploited. Digital technologies have not necessarily brought an end to such price discrimination. Australian consumers have been locked out by technological protection measures; subject to surveillance, privacy intrusions and security breaches; locked into walled gardens by digital rights management systems; and geo-blocked.

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The cultural and creative industries are closely intertwined with government. This chapter reviews key economic rationales for public policy interventions for the arts, cultural and creative industries. Market failure justifications depend on the status of arts and culture as non-rival public goods, as ‘merit goods’, or the need to moderate the effects of up-front investment costs or monopoly, and the inherent uncertainty of creative production. ‘Systems failure’ too is a regular rationale for policy intervention. Using the United Kingdom as an example, the chapter shows how emphasis on these rationales has shifted over the last three decades, first in the context of industrial policies for traditional aims such as exports and job growth, which have been joined in recent years by the need for investment in intangibles, knowledge exchange, and spillover effects in the wider economy.