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Non-oncologic orphan drug approvals across the world: Types of evidence required and time to approval Open
Large time gaps are frequently observed between approvals of orphan products by different jurisdictions. A retrospective review of publicly accessible information for new orphan medicines approvals between 2021 and 2022 was performed to qu…
View article: Opportunities for a national genomic data governance framework in Australia: a systematic review.
Opportunities for a national genomic data governance framework in Australia: a systematic review. Open
Our synthesis of the current literature on genomic data governance suggests that the current focus on individual consent as the primary mechanism for protecting data subjects and different priorities in clinical and research governance nee…
View article: Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort
Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort Open
MAbs real-world data over a 2-year changing pandemic landscape showed the feasibility of the intervention, although the hospitalization rate was not negligible. Immunosuppressed subjects remain more at risk of clinical worsening.
From speculative to real: community attitudes towards government COVID-19 vaccine mandates in Western Australia from May 2021 to April 2022 Open
Many governments employed mandates for COVID-19 vaccines, imposing consequences upon unvaccinated people. Attitudes towards these policies have generally been positive, but little is known about how discourses around them changed as the ch…
Restricted Philanthropic Gifts: Paradigm Clash between Law and Practice or Simply a Muddle? Open
Restricted philanthropic gifts are becoming more common, yet their legal characterisation is unsettled. Moreover, other than from anecdotal evidence, it is unclear how charities treat such gifts in practice. This article investigates the p…
Giving Bad Science the Stamp of Approval: Policy and Legal Consequences of a Vaccine Scare in Italy Open
Twelve years ago, a decision by an Italian court catalyzed a series of events leading to new mandatory childhood vaccination laws in 2017. As vaccine misinformation and mandates continue to animate public debates globally, Italy’s experien…
No-Fault Compensation Schemes for COVID-19 Vaccines: Best Practice Hallmarks Open
International audience
Vascular graft infections caused by Mycobacterium bovis BCG after BCG immunotherapy for non-muscle-invasive bladder cancer: Case report and review of literature Open
Bacillus Calmette-Guerin (BCG) immunotherapy (i.e., intravesical instillation of live attenuated strain of Mycobacterium bovis) is a standard of care for non-muscle-invasive bladder cancer (NMIBC). The risk of infective adverse events is g…
Consolidating a research agenda for vaccine mandates Open
A workshop on mandatory vaccination was pitched to the World Public Health Congress in 2019 and the resultant special issue was pitched to Vaccine in 2020. During this project, the COVID-19 pandemic pushed vaccine policy to the forefront o…
Predictive analytics and governance: a new sociotechnical imaginary for uncertain futures Open
In an era of global sanitary, economic and ecological crisis, beliefs in the predictive power of artificial intelligence (AI) progressively penetrate the legal and political spheres, in search of new ways to anticipate and govern the futur…
All Bets on the Executive(s)! The Australian Response to COVID-19 Open
This chapter examines the response of the Australian Federal and State governments to the COVID-19 pandemic. While successful in limiting the spread of the virus, the response caused significant challenges from a rule of law perspective. E…
Motion Estimation and Compensation in Automotive MIMO SAR Open
With the advent of self-driving vehicles, autonomous driving systems will have to rely on a vast number of heterogeneous sensors to perform dynamic perception of the surrounding environment. Synthetic Aperture Radar (SAR) systems increase …
Legitimising a ‘zombie idea’: childhood vaccines and autism – the complex tale of two judgments on vaccine injury in Italy Open
The impact of ‘bad’ science on judicial decision-making is a thorny aspect of the relationship between science and law. This study employs doctrinal and empirical analysis to explore two Italian judgments that asserted a causal link betwee…
Residual Motion Compensation in Automotive MIMO SAR Imaging Open
This paper deals with the analysis, estimation, and compensation of trajectory errors in automotive-based Synthetic Aperture Radar (SAR) systems. First of all, we define the geometry of the acquisition and the model of the received signal.…
Multi-Beam Automotive SAR Imaging in Urban Scenarios Open
Automotive synthetic aperture radar (SAR) systems are rapidly emerging as a candidate technological solution to enable a high-resolution environment mapping for autonomous driving. Compared to lidars and cameras, automotive-legacy radars c…
Consent in Posthumous Reproduction: Giving the Deceased a Voice without Drowning out the Living in Cases of Unexpected Death Open
One of the most controversial issues in the legal regulation of artificial reproductive technology is how to approach posthumous reproduction (PR). Typically, this involves a cisgender woman seeking to use her deceased cisgender male partn…
Inaction, under-reaction action and incapacity: communication breakdown in Italy’s vaccination governance Open
This article explores why governments do not respond to public compliance problems in a timely manner with appropriate instruments, and the consequences of their failure to do so. Utilising a case study of Italian vaccination policy, the a…
Coronavax: preparing community and government for COVID-19 vaccination: a research protocol for a mixed methods social research project Open
Introduction Ahead of the implementation of a COVID-19 vaccination programme, the interdisciplinary Coronavax research team developed a multicomponent mixed methods project to support successful roll-out of the COVID-19 vaccine in Western …
The Australian Response to COVID-19: A Year in Review Open
Australia’s legal and political response to the outbreak of COVID-19 has been marked by the formation of a new intergovernmental forum, the National Cabinet, to lead a coordinated national response to the pandemic, and the declaration of s…
Bergamo and Covid-19: How the Dark Can Turn to Light Open
The novel coronavirus, SARS-CoV-2, continues to spread rapidly. Here we discuss the dramatic situation created by COVID-19 in Italy, particularly in the province of Bergamo (the most severely affected in the first wave), as an example of h…
Inferring Necessary Conditions: The Enduring Paradox of the 'But For' Test in Factual Causation Open
The Court of Appeal of Western Australia engaged with the issue of factual causation recently in East Metropolitan Health Service v Ellis (by his next friend Christopher Graham Ellis) (‘Ellis’). Quinlan CJ, Mitchell and Beech JJA took the …
Rethinking Vaccine Development as an Integral Part of Preparedness in the European Health Union Open
This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Vaccines being the universally recognised prime method of prevent…
Communication breakdown in Italy’s vaccination governance Open
Background In 2017, Italy rebooted its mandatory vaccination regime, following a series of unfavourable court decisions placing vaccination in disrepute. Vaccination rates had steadily declined for half a decade, culminating in a measles e…
“Transfer, Contestation and Conflict”: How Italian regional and national governments claim and challenge authority in mandatory vaccination policies Open
Background This paper explores conflictual policy transfer in Italian vaccination policy 2007-2018. The region of Veneto formally suspended mandatory vaccination in 2007. Soon after, declining vaccination rates across the country sparked a…
Legitimising a ‘Zombie idea’: childhood vaccines and autism Open
Background In June 2017 the Italian government made childhood vaccination mandatory following a drop in immunization rates. In the years preceding, two court judgments affirmed a causal link between vaccines and autism. Studies have linked…
Health Professionals’ Standard of Care and Breach of Duty in Western Australia: A requiem for the ‘peer professional’ test at a time of uncertainty Open
In late September 2019, the Court of Appeal of Western Australia, comprising Quinlan CJ, Murphy and Pritchard JJA, handed down a significant judgment that sheds a measure of light over some intricate aspects of medical liability in WA. The…