Implementing voluntary assisted dying laws in healthcare: Exploring beliefs to identify implementation hurdles.

The number of countries introducing voluntary assisted dying (VAD) laws is increasing. Actively taking steps to end a person's life is contentious so implementing these laws into healthcare services presents unique challenges. Theoretically underpinned by the Advocacy Coalition Framework, this study identified the beliefs of classes of stakeholders who engaged with the parliamentary process associated with the introduction of VAD laws in Queensland, Australia. Submissions about VAD made to a parliamentary inquiry were allocated to a class and qualitatively analysed to identify underlying beliefs. The data were then subjected to statistical analysis including nonmetric dimensional scaling and one-way analysis of similarity. Data visualisation techniques were used to generate a chord map and heatmap, to identify the belief types, as well as similarities and differences between beliefs and among classes. Fourteen different beliefs were identified in the 91 reviewed submissions. Six were deep core beliefs and eight were policy core beliefs. Beliefs could be associated with a positive or negative sentiment toward VAD. In this study, the class of Health Services expressed more negative sentiments to VAD than neutral or positive sentiments. The sentiments expressed by the class of Health Professionals were equally divided between positive, neutral and negative. These findings provide important insights for implementors as laws become operational. In particular, for organisations that provide health services, clear articulation of their stance in relevant policy and guidance documents is recommended.

Is Intellectual Property the COVID-19 Bad Guy? Lessons We Could Learn from the Pandemic.

At the time the COVID-19 pandemic was declared there was no vaccine and other medical products were insufficient to meet demands. At the time intellectual property was considered a limitation to an effective pandemic response and the World Trade Organization considered a waiver of intellectual property addressed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The lesson from the COVID-19 pandemic and TRIPS waiver is that given enough time sufficient medical products will be delivered, albeit there remain some complicated delivery challenges and vaccine hesitancy issues. This column addresses the moment before that medical product saturation and the inherent limitation imposed by industry policies. The column concludes that the private sectors' motivating factors need to be integrated into the design of global public health pandemic responses from the start.

The COVID-19 Pandemic and the TRIPS Waiver: Patents and Flexibility.

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for global minimum standard patents. These patents potentially limit access to products and processes for the surveillance, tracking, diagnosis and treatment of COVID-19. A possible solution currently under consideration is a TRIPS waiver of the implementation, application and enforcement for the prevention, containment or treatment of COVID-19. This article addresses the ways that TRIPS patents might be mediated including through TRIPS flexibilities. The article argues that there are sufficient means of derogating from patents (and potentially copyright, industrial designs and undisclosed information), although they alone will not resolve the access problems. The article concludes that the key patent problem is the transfer of know-how and that developing new ideas about addressing these patent know-how transfers is the presently unaddressed challenge.

Provenance and risk in transfer of biological materials.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

COVID-19 Tests the Limits of Biodiversity Laws in a Health Crisis: Rethinking "Country of Origin" for Virus Access and Benefit-sharing.

The COVID-19 pandemic raises serious questions about the operation of international agreements for accessing and sharing viruses potentially delaying emergency responses. The access and benefit-sharing (ABS) frameworks under the United Nations' Convention on Biological Diversity and its Nagoya Protocol apply to the collection and use of the COVID-19 pathogen SARS-CoV-2. These frameworks aim to ensure countries of origin reap some of the benefits from the use of their resources. Using real-world examples, we demonstrate conceptual and definitional ambiguities relating to "country of origin" that make not only operationalising the ABS scheme for biodiversity conservation and sustainable use objectives difficult but may also undermine public health emergency responses. Understanding how COVID-19 fits (or does not fit) within ABS laws is a valuable exercise for international policy-makers trying to determine how best to operationalise pathogen ABS, an issue currently under examination at the World Health Organization and critical to responding to pandemics.

Patenting Nucleic Acid Sequences: More Ambiguity from the High Court?

The High Court in D'Arcy v Myriad Genetics Inc (2015) 258 CLR 334; [2015] HCA 35 addressed patent claims under the Patents Act 1990 Cth to deoxyribonucleic acid (DNA) sequences set out in tables listing nucleotides as As, Ts, Gs and Cs finding they are unpatentable. This was a significant development given DNA sequences have been patentable for decades. This article reviews the High Court's judgments in D'Arcy v Myriad Genetics Inc highlighting the introduction of ambiguities to the current subject matter standards and providing a critique of the High Court majority's assessment of DNA sequence as information. The article concludes that the High Court majority has introduced an unhelpful conception of information as a standard for patentability. While this will limit claims to DNA and other nucleic acid sequences, the broader effect of the decision is uncertain because the High Court majority's conception of information could be applied to any matter (including all molecules) and eviscerate the patent system.

Open Access DNA, RNA and Amino Acid Sequences: The Consequences and Solutions for the International Regulation of Access and Benefit Sharing.

This article addresses how open access to DNA, RNA and amino acid sequences might be reconciled with the benefit-sharing obligations under the United Nations' Convention on Biological Diversity and its Nagoya Protocol, the Food and Agriculture Organization of the United Nations' International Treaty on Plant Genetic Resources for Food and Agriculture, and the World Health Organization's Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. Tracing the evolution of open access databases, the article posits models for reconciling open access and benefit sharing; the article concludes, however, that none of the proposed solutions ­ monitoring and tracing, the contract model, and the copyright and database right model ­ provides a perfect solution. Each model does, however, suggest that open access to these sequences might be at least partially reconciled with benefit sharing.

Patenting genetic diagnostic methods: NGS, GWAS, SNPs and patents.

This article reviews the problems posed by patent claims to genetic diagnostic methods associated with genome-wide association studies (GWAS) adopting methodologies using next-generation sequencing (NGS) and single nucleotide polymorphisms (SNP). These problems are essentially about experimental reproducibility and the credibility and veracity of reported developments. An analysis of the relevant law demonstrates that the current Australian and United States laws about suitable patentable subject matter differ, and that the current reproducibility (sufficiency, enablement and inutility) standards are unlikely to address these problems. The article concludes that following the United States approach excluding these genetic diagnostic method claims from patenting is one solution. Failing this, improving analysis and quality controls that are now being adopted in the basic research will reduce the nature of the problems, although this will remain problematic for patent examiners and the broader public.

How are pharmaceutical patent term extensions justified? Australia's evolving scheme.

This article examines the evolving patent term extension schemes under the Patents Act 1903 (Cth), the Patents Act 1952 (Cth) and the Patents Act 1990 (Cth). The analysis traces the change from "inadequate remuneration" to a scheme directed specifically at certain pharmaceuticals. An examination of the policy justification shows there are legitimate questions about the desirability of any extension. The article concludes that key information provisions in the Patents Act 1990 (Cth) that might assist a better policy analysis are presently not working and that any justification needs evidence demonstrating that the benefits of patent term extensions to the community as a whole outweigh the costs and that the objectives of extensions can only be achieved by restricting competition.

Miniature swine model of phototoxicity testing.

BACKGROUND/PURPOSE: This study determined the threshold doses for 'solar erythema' and for phototoxic responses to 8-methoxypsoralen (8-MOP) in white skin Hanford and grey skin Yucatan miniature swine. METHODS: For threshold erythema determinations, the UVR exposures included both UVA (315-400 nm) and UVB (290-315 nm) radiation by positioning one fluorescent 'sunlamp' among 10 'PUVA' lamps. With this configuration the UVR exposures ranged from 0.5-2.8 times the 'instrumental MED' (MEDi) for Hanford and from 1.0-5.6 times the MEDi for Yucatan. For phototoxicity determinations (i.e., with and without topically-applied graduated concentrations of 8-MOP), the UVB component was minimized by extinguishing the sunlamp, thus permitting higher UVA exposures. RESULTS: The Hanford had the lower UV erythema dose threshold (1.0-1.4 times the MEDi) and the erythema that developed was readily observable. The exposure doses for the phototoxicity test were 5 J/cm(2) of UVA in 35 minutes or 10 J/cm(2) in 70 minutes. The phototoxic (vascular) response to 8-MOP was observed in the two highest concentrations (0.01% and 0.1%) in Hanford pigs, in a dose-related manner. Microscopic evidence of a dose-related response was also observed as the concentration of 8-MOP increased. CONCLUSION: This verified that the Hanford miniature swine is the preferable strain for phototoxic effects. In contrast, UVR exposure of the Yucatan pig skin produced tanning rather than erythema, confirming that the Yucatan is the more appropriate strain for studying the melanization response. Thus, Hanford and Yucatan miniature swine have cutaneous photobiological responses that reflect their respective strain differences.

Who shall live when not all can live? Intellectual property in accessing and benefit-sharing influenza viruses through the World Health Organisation.

This article addresses the development of the World Health Organisation's (WHO) arrangements for accessing viruses and the development of vaccines to respond to potential pandemics (and other lesser outbreaks). It examines the ongoing "conflict" between the United Nations' Convention on Biological Diversity (CBD) and the World Trade Organisation's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in the context of the debates about the paramountcy of intellectual property, and the potential for other (equity and development) imperatives to over-ride respect for intellectual property and TRIPS. The article concludes that the same intellectual property fault lines are evident in the WHO forum as those apparent at the CBD and the WTO fora, and an ongoing failure to properly address questions of equity and development. This poses a challenge for the Australian Government in guaranteeing a satisfactory pandemic influenza preparation and response.

Making clinical care decisions with people living with dementia in hospital: An integrative literature review.

BACKGROUND: As our population ages, the percentage of hospitalised patients diagnosed with dementia is expected to rise. However, there is emerging evidence that people living with dementia may experience discrimination and exclusion from decisions about their clinical care. Although dementia affects cognition, many patients living with dementia want to participate in decision-making processes relating to their clinical care in hospital. OBJECTIVE: Identify the processes associated with making decisions about clinical care with people living with dementia in hospital. DESIGN: An integrative literature review. DATA SOURCES: Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus, EMBASE (Ovid), MEDLINE (PubMED), PsycINFO and HeinOnline. REVIEW METHOD: One author conducted the initial screening of titles, and two authors screened in subsequent rounds for abstracts and full text. The process of making clinical decisions was the outcome of interest. Articles about people with cognitive impairment that did not include dementia, or decisions such as discharge planning or end of life care were excluded. An inductive synthesis of the findings was undertaken. RESULTS: Nine articles were identified for review and included expert opinion or hypothetical discussion (n=5), cross-sectional survey research (n=3), and qualitative research (n=1). Three themes were identified: capacity for decision-making is conceptualised as 'all or nothing'; there are no universal principles for including people living with dementia in decision-making in acute care settings; and autonomy is recognised but superseded by beneficence. CONCLUSIONS: Contemporary hospital practice is focused on determining capacity for decisions, with an all or nothing attitude to capacity, effectively excluding many people living with dementia from participation in decisions. While there is limited evidence to guide clinicians in this complex and situated process of making clinical decisions, emerging models of supported decision-making require further evaluation in the hospital setting.

Macroinvertebrate Communities and Body Condition of Larval Eastern Hellbender Salamanders (Cryptobranchus alleganiensis) in North Carolina.

Salamanders are important biological indicators of freshwater aquatic ecosystems. The Eastern Hellbender, Cryptobranchus alleganiensis, is found primarily in streams across the southeastern, midwestern, and eastern portions of the United States. However, this unique large aquatic salamander is facing numerous threats and declines across its geographic range, including in Appalachia. Moreover, little is known regarding the early life history stages (gilled larvae), particularly regarding food availability (aquatic insects present in streams) and body condition. In this study, we assessed the macroinvertebrate communities of streams sampled for larval C. alleganiensis and report on the body condition index within western North Carolina streams. We found varying levels of diversity across sample locations for macroinvertebrates (total sampled = 3,619, representing over 30 genera), with the most prevalent insects from Trichoptera order, with an overall high percent of Ephemeroptera, Plecoptera, and Trichoptera (EPT) in all streams, ranging from 68.5% to 90.7%. Functional Feeding Groups included 40.5% filterers, 24.3% predators, 17.6% gatherers, 10.7% shredders, and 6.9% scrapers. Shannon Diversity Index in sample streams ranged from 2.101 to 2.698. Body condition or SMI (scaled mass index) ranged from 1.5 to 3.3 2 across sites with a largely consistent and strong linear relationship between log mass and total length (r = 0.910). Our results add to the body of knowledge on the larval ecology of this North American salamander and may aid in future management of hellbender stream habitats.

Grant v Commissioner of Patents and patenting knowledge inventions.

This article reviews the Full Federal Court decision in Grant v Commissioner of Patents (2006) 154 FCR 62; 69 IPR 221; [2006] FCAFC 120 denying patentability to a method for structuring a financial transaction so as to protect an individual's assets from a loss of ownership as a result of a legal liability. The article challenges the distinctions drawn by the Full Federal Court and argues that the decision marks a new development in setting a boundary for the Patents Act 1990 (Cth) "manner of manufacture". The article concludese that important questions now arise in assessing the possible application of the Patents Act 1990 (Cth) to promoting some inventions (and innovations) and not others, and whether there are other classes of inventions that also do not require the Patents Act 1990 (Cth) incentives.

Newborn screening in Victoria: a case study of tissue banking regulation.

The regulation of human tissue collections is increasingly important in maintaining public trust (and legitimacy) for critical practices and resources directed to public health programs and research. This article examines the governance arrangements applying to VCGS Ltd (under its various incarnations as "Genetic Health Services Victoria", "VCGS Pathology", and so on) and the existing collection of population-wide blood samples maintained on newborn screening cards (or Guthrie cards) in Victoria. The analyses reveal a complex web of regulations (and possibly even no regulation) and the limited role of significant statutory schemes that are generally assumed to apply to human tissue collections and the data and information derived from those materials. The article argues that, without a clear regulatory framework (and in particular meaningful consent), there is likely to be a decline in public trust (and legitimacy) with a consequent decreased participation in what is a public health program with immediate and quantifiable benefits and a valuable research resource for the future.

Grant's Application: it's time for a new approach to a "public interest" exclusion from patentability.

This article reviews the recent IP Australia decision in Grant's Application [2004] APO 11 about an innovation patent for a way of protecting assets against a loss of ownership as a result of a legal liability. The significance of this decision was to expose the tortured reasoning necessary to exclude from patentability an invention that was arguably contrary to the "public interest". The article asserts that the effect of the decision revoking the patent was correct, but that the reasoning points to a need to reconsider the "public interest" limits on patentability. The article then considers the approach that should be adopted in formalising a "public interest" exemption from patentability that is practical and generally applicable.

"Sufficiency" for living organism inventions under the Patents Act 1990 (Cth).

The Patents Act 1990 (Cth) requires a complete specification to describe the invention. This description is central to the policy objective that the statutory rights under the Patents Act 1990 (Cth) are exchanged for disclosure of the invention, including how to make the invention. In addressing these requirements for "micro-organisms", the Patents Act 1990 (Cth) adopted the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure (Budapest Treaty) recognising that the "invented" organism itself may be necessary to make and use the invention, and that a formal description may be of limited value or practicability. The scope of the Budapest Treaty does not, however, extend to a significant class of living organisms outside the class defined by the term "micro-organism". This article reviews the application of the description requirements for living organism inventions under the Patents Act 1990 (Cth) and concludes that some form of public availability or deposit requirements are necessary for invented living organisms that are outside the scope of the Budapest Treaty's "micro-organisms".