Thought Leadership

The Prescription

By Ben Miller, Stephen Rohl

• 17 June 2021 • 0 min read

The Prescription is a biannual publication addressing legal developments and trends in the healthcare and life sciences spaces in Australia. 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

  • We review the High Court’s decision to adopt the doctrine of patent exhaustion and consider the implications for both patentees and purchasers of patented products.

  • We discuss the Federal Court’s decision in Merck v Wyeth, which is the first detailed judicial consideration of the new support requirement for Australian patents.

  • We consider the reforms for restrictive practices in aged care recommended by the Royal Commission into Aged Care.

    • We discuss the implications of the Federal Court’s dismissal of Pfizer’s application for preliminary discovery from Sandoz regarding its etanercept biosimilar.

    • We consider the Full Court’s dismissal of Johnson & Johnson’s appeal in the representative class action regarding its transvaginal mesh products.

    • We review the new mandatory active ingredient prescribing rules and the impact on prescribers of medicines.

      • Following our article regarding the TGA’s active enforcement of the therapeutic goods advertising framework during the COVID-19 pandemic, we provide an overview of the ACCC’s ability to enforce consumer protection laws over the same products.

      • We discuss the new Software as a Medical Device (SaMD) Framework, which offers greater clarity and reduces the regulatory burden on low-risk software, as well as the transitional requirements that existing sponsors and manufacturers of SaMDs should be aware of.

      • We discuss whether a person can seek access under the Health Records and Information Privacy Act 2002 (NSW) (HRIPA) the health records of a deceased person.

        • We review the National Safety and Quality Digital Mental Health Standards which were released on 30 November 2020. An independent assessment scheme for the voluntary standards will be implemented in late 2021.

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