Federal Court has bone to pick with Medtronic, awards largest ever penalty under Therapeutic Goods Act 1989 (Cth)
The Federal Court of Australia in New South Wales has hit medical devices giant Medtronic with a $22 million penalty and a $1 million costs order in its decision of Secretary, Department of Health v Medtronic Australasia Pty Ltd [2024] FCA 1096, which was handed down last week. Pursuant to its originating application dated 31 […]
ReadmoreThe Legal 500 Life Sciences Comparative Guide 2024 – Australia
The inaugural edition of the Legal 500 Life Sciences Comparative Guide examines the current challenges facing organisations operating in the life sciences sector within specific countries. Gadens Life Sciences sector experts – Kelly Griffiths, Dudley Kneller, Raisa Blanco and Clare Smith – have co-authored the Australian chapter for this global guide, providing insight into the […]
ReadmoreConsumer gains – The regulation of sports supplement pills
Consumers of sports supplements stand to gain from increased oversight of sports supplements in medicinal dosage form through regulation of such supplements as therapeutic goods (ie medicines). The sports supplement industry has been regulated for some time now. For instance, oral sports supplements that contain certain high-risk substances, and claim to improve or maintain performance […]
ReadmoreDigital Tools and Medical Devices used for mental health – is yours a regulated medical device?
The Therapeutic Goods Administration (TGA) recently released guidance on digital tools and medical devices for the mental health sector (Guide).[1] The Guide aims to clarify whether software-based medical devices, products, services and tools used in the mental health sector (collectively, digital mental health products) are regulated by the TGA. Prior to the Guide, information about […]
ReadmoreHigher Education Research Commercialisation Intellectual Property Framework – a tool to increase collaboration and partnerships between industry and universities
Most Australians are aware of the strength and quality of our nation’s research sector, particularly in fields such as life sciences and medical research. Never has this been more evident that during the COVID-19 pandemic, when Australians could, quite rightly, be proud of the role that Australians researchers played in the global efforts to develop […]
ReadmoreCOVID-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 […]
Readmore‘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 […]
ReadmoreCOVID-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 […]
ReadmoreFMCG 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 […]
ReadmoreWhen 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 […]
ReadmoreCOVID-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 […]
ReadmoreCOVID-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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