Thought Leadership

The Prescription

By Ben Miller, Stephen Rohl

• 26 May 2020 • 0 min read

The Prescription will be published in April and October of each year addressing legal developments and trends in the healthcare and life sciences spaces in Australia over the previous 6 months. In addition to this publication, we will continue to publish regular alerts which focus on current trends and issues within the healthcare and life sciences sectors as they arise.

In this edition of The Prescription

  • What are the immediate legal and regulatory measures implemented by the Australian government and regulatory agencies for access to pharmaceuticals, testing kits and medical devices in light of the Coronavirus

  • We provide an overview of the recent developments in the Australian private hospital and private health insurance environments and identifies a number of implications for this sector arising from the COVID-19 pandemic.

  • We look at the Federal Court’s decision at first instance in Sequenom Inc v Ariosa Diagnostics Inc [2019] FCA 1011, which held that claims to a gene-based diagnostic method involving the practical application of a natural phenomenon are patentable in Australia.

    • We outline the progress of the Royal Commission into Aged Care Quality and Safety, including the Commissioners’ Interim Report titled 'Neglect'. The Royal Commission hearings are continuing through 2020, with the final report due on 12 November 2020.

    • We review a recent decision of the Full Federal Court which emphasises the limits on the availability of additional damages for patent infringement in Australia. The case should be welcome news to medical device, pharmaceutical and biologics developers navigating complex patent landscapes to bring products to market in Australia.

    • What are the issues arising from requests for the installation and use of surveillance devices in residential aged care facilities? Careful consideration of not only a number of complex regulatory issues is required but also, as the Royal Commission hearings have made clear, of the expectations of families and communities.

      • We discuss the important decision of the Federal Court in the representative class action against Johnson & Johnson regarding its transvaginal mesh products.

      • We review a recent decision of the Full Federal Court regarding comparative advertising of pharmaceutical products. Companies considering a comparative advertising campaign should ensure there is adequate scientific basis to do so, in particular where claims of superior efficacy are put forward as supported by data.

      • Lawyer Joanne Chenn lays out a compliance roadmap for providers of residential aged care services to navigate the complexities of the Aged Care Act 1997 (Cth) and the National Disability Insurance Scheme Act 2013 (Cth).

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