COVID-19 | Mandatory vaccination in the healthcare sector in Victoria

The Acting Chief Health Officer has issued updated directions making mandatory COVID-19 vaccinations a requirement for staff to work in healthcare facilities in Victoria (the Directions). Who do the Directions apply to? The Directions apply to ‘healthcare operators’, being those who own, control or operate a healthcare facility, whether public, private or denominational. A ‘healthcare […]

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‘A reasonable and commercial construction?’ Patent time extensions after Ono Pharmaceuticals

The Federal Court of Australia has ordered the Commissioner of Patents to grant Bristol Myer Squibb (BMS) a patent term extension (PTE) for cancer drug Opdivo until 2031, providing certainty to industry around Australia’s intellectual property regime. Background BMS and Ono Pharmaceutical sought judicial review by the Federal Court of Australia after the Australian Patents […]

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COVID-19 | TGA updates guidance for advertising of COVID-19 vaccines to Australian public

In February 2021, we provided an update on the guidance issued by the Therapeutic Goods Administration (TGA) regarding the advertising of COVID-19 vaccines to the Australian public. That update is available here: COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public. Under the previous guidance, advertisers were restricted to republishing materials […]

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FMCG Express | May 2021 Edition

2021 certainly started with a bang; we are seeing a significant boost in appetite for advice right across our FMCG client base, including a lot of M&A activity, and we are excited to see how the year ahead unfolds. In the May 2021 edition of FMCG Express, editor Hazel McDwyer and the Gadens team provide […]

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When software delivers a therapeutic benefit: regulation of digital therapeutics

Digital therapeutics are defined as evidence-based therapeutic interventions that are driven by software programs to prevent, manage or treat a medical disorder or disease. As medical technological innovation continues at pace, more software applications and devices are under development to inform, drive or replace clinical decisions or directly provide therapy to a patient. The Therapeutic […]

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COVID-19 | Medicines dispensing emergency measures extended

At the commencement of the COVID-19 pandemic, the Australian Government introduced a range of measures to take the pressure off Australia’s health care system, such as the introduction of TeleHealth and E-Prescribing. Another measure was to extend the Continued Dispensing rules to enable pharmacists to supply medicines without prescription to certain patients. These emergency measures […]

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COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public

The roll out of the COVID-19 vaccine in Australia this week brings both excitement and questions about how healthcare services may advertise or promote the vaccines to the general public. The Therapeutic Goods Administration (TGA) has issued guidance to enable vaccine providers, and the broader healthcare sector, to confidently navigate a highly regulated environment, whilst balancing […]

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COVID-19 | COVIDSafe update: legislation and source code

The Commonwealth Parliament has now passed legislation to regulate the collection and use of COVID app data. In addition, the Commonwealth Digital Transformation Agency has now released the source code for the app, which has allowed independent analysis of how the app operates. This update discusses the legislation and the commentary in relation to the […]

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COVID-19 | COVIDSafe – An update: what do the experts think?

As expected, the COVIDSafe app has spurred debate, and has resulted in a sharp increase in the number of “data privacy experts” (including politicians) who are willing to publicly express their views! Since our earlier article, there have been a number of developments, including those discussed below. While there are those who have enthusiastically installed the […]

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COVID-19 | Contact tracing? There’s an app for that!

Effective and widespread contact tracing is considered to be a critical step in managing and containing the spread of COVID-19. The Commonwealth has released COVIDSafe, a mobile app to assist in determining who may have been exposed to the virus. Additionally, a contact tracing protocol is being developed by Apple and Google which will be […]

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COVID-19 | Is your policy register current?

The highly infectious nature of COVID-19, the ability of the virus to kill, and the disastrous impact the virus has shown it can have on a national economy all lead to one certain point.  Once a vaccine for COVID-19 is available every employer will need to consider whether they are doing enough in their workplace […]

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COVID-19 | Is your organisation ready for the business and operational impact of the COVID-19 in aged care?

Updates from the Department of Health The Guidelines for the Prevention, Control and Public Health Management of Influenza Outbreaks in Residential Care Facilities in Australia (Influenza Outbreak Guidelines) and the Series of National Guidelines (SoNGs) provide aged care providers with best practice guidelines for, preparing for, preventing, identifying and managing outbreaks of influenza in residential […]

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