Life Sciences 2026

AUSTRALIA Trends and Developments Contributed by: Suzy Madar, Matthew Swinn, Kate Hay and Scott Bouvier, Mallesons

consent architecture, data-sharing agreements and advisory structures. Effective population health strategies increasingly depend on large-scale data integration, spanning healthcare systems, genomics, wearables and social determinants. These tools enable more sophisticated population-level insights but also raise complex legal questions around consent, secondary use, govern- ance and public trust. Regulators are increasingly focused on whether existing frameworks adequate- ly balance data collection and use with community expectations, privacy and individual rights. Licensing, Transactions and Disputes: Allocating Risk Across the Life Cycle Licensing and collaboration structures continue to dominate life sciences transactions in Australia as parties seek to manage capital constraints, regulatory uncertainty and long development timelines. Rather than full asset acquisitions, staged licensing, options and joint development arrangements are increasingly being implemented to preserve flexibility while defer- ring regulatory, manufacturing and commercialisation risk. While late-stage licensing deals are often pre- ferred due to a perceived lower risk of failure, they are also more expensive than earlier-stage transactions. High demand and competition for assets have given licensees more negotiating power, and relationships frequently evolve into more equal long-term partner- ships, including co-development and co-marketing rights, rather than wholesale out-licensing. Regulatory alignment has become a central deal driv- er. Licensing agreements now tend to specify how regulatory pathways will be pursued, where deci- sion-making sits, and how post-market obligations and compliance risk are to be allocated. In Australia, increased TGA post-market scrutiny and closer inter- action between therapeutic goods regulation and con- sumer protection regimes mean that unclear alloca- tion of responsibility can quickly translate into material exposure. In practice, control of regulatory decisions and their downstream consequences, rather than for- mal ownership alone, is often the critical lever. Data and IP ownership is another recurring pressure point. As products increasingly embed software, AI

tools and real-world data, provisions in agreements relating to improvements, data use rights and con- straints on downstream deployment are increasingly being tested. Where the same datasets underpin reg- ulatory compliance, product claims and commercial differentiation, poorly defined data rights can under- mine value and give rise to technical and legal risk. Disputes activity in the Australian life sciences sector remains steady. Patent disputes continue to be a con- sistent theme, and 2025 also saw greater exposure to regulatory enforcement risk, consumer law claims and challenges to product claims, pricing and promotional conduct – particularly where digital channels, patient programmes and real-world data were involved. These disputes tend to carry reputational consequences that can outweigh underlying legal risk. The authors expect that this is where battle lines will be drawn in 2026. Regulatory Focus for 2026: The TGA’s Compliance Principles In 2026, the TGA is expected to continue to shift focus from assessment of market entry to strengthening oversight across the full product life cycle. This reflects both the maturing of advanced therapeutics and digital health technologies, and the growing policy sensitivity to patient safety, data integrity and public confidence in an increasingly complex healthcare ecosystem. The TGA’s compliance principles for 2026 and 2027 rein- force a whole-of-sector approach to monitoring and enforcement, underpinned by clearer prioritisation, enhanced digital capability and a greater willingness to intervene early where public health risks are identified. The principles emphasise: • safeguarding therapeutic goods; • empowering consumers and healthcare profes- sionals through education; • protecting vulnerable populations; • leveraging digital tools to monitor emerging risks; and • strengthening enforcement action where voluntary compliance falls short. Of particular note is the TGA’s focus on digital envi- ronments, including online advertising activity, e-com- merce and AI-generated content.

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