The 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 legislative frameworks, regulatory procedures, advertising regulations, restrictions and compliance standards governing the Australian life sciences landscape.

The life sciences sector in Australia is a diverse and dynamic industry that encompasses biotechnology, medical technology, pharmaceuticals, digital health, and research and development. The sector contributes to the nation’s economy, health, and innovation. The industry has grown 43% since 2019,[1] has an estimated value of $250 billion and there are over 2,600 organisations operating in the sector.[2]

The laws, regulations, codes and programs applicable to the Australian life sciences sector landscape are frequently revisited. This ensures such laws and regulations keep pace with technical and medical developments, and the needs of the community. For instance, the Efficient Funding of Chemotherapy program was recently reviewed for its relevance to how cancer medicines are handled, and whether improvements could be made. And negotiations for the agreement governing how community pharmacies supply medicines on the Pharmaceutical Benefits Scheme commenced earlier this year.

The Australian chapter of the Life Science Comparative Guide is a helpful roadmap for life sciences companies, researchers and healthcare professionals to navigate legal and regulatory compliance in Australia. It summarises everything from the regulation of medicinal products, medical devices and food supplements by the Therapeutic Goods Administration, to the privacy laws applicable to data arising from clinical trials, through to restrictions on patents and trade marks.

Read our full chapter below:

Authored by:

Kelly Griffiths, Partner
Dudley Kneller, Partner
Raisa Blanco, Special Counsel
Clare Smith, Associate

[1] AusBiotech, ‘Australian Biotechnology Sector Snapshot 2022’ (2022) <https://www.ausbiotech.org/documents/item/707>,

[2] Health and Life Sciences: Australia’s Health and Life Sciences Industry | Global Australia