Life Sciences Strategic Risk Signals Report

2 minute read  09.06.2026 Simone Mitchell,  David Taylor, Jonathan Kelp, Sonja Read, Zeina Millicevic, Kemsley Brennan, Chelsea Gordon

How life sciences leaders stay ahead of disputes in Australia.


Key takeouts


  • This report brings together insights from MinterEllison’s multidisciplinary life sciences team, including disputes, IP, privacy, insurance and regulatory specialists to help leaders anticipate risk, strengthen governance and make confident decisions.
  • US product liability litigation is a leading indicator for Australia. Part 1 draws on US and Australian proceedings to highlight how pharmaceutical, biotechnology and medical device companies can manage class action exposure.
  • AI, health data and third-party ecosystems are the fastest-growing sources of new dispute risk. Parts 2 and 3 of the report equip legal and executive teams with practical frameworks to assess governance gaps, close insurance blind spots and build dispute readiness into strategy.

Leaders of Australian life sciences organisations face a rapidly changing dispute landscape. Class actions, regulatory enforcement, data breaches and the deployment of AI are creating exposures that many boards and legal teams have yet to fully map. This report draws on the survey results of 50 Australian health and life sciences leaders, analysis of Australian and international proceedings, and insights from former Minister for Health, Prof the Hon Greg Hunt to help organisations anticipate and prepare for what’s next. 

 

As innovation accelerates, organisations must ensure governance, compliance and risk management evolve at the same pace as scientific and technological change.”
Strategic Risk Signals Report 

 

What do Australian life sciences leaders actually think about emerging risks and their preparedness for disputes or regulatory action? We surveyed more than 50 Australian health and life sciences leaders, including General Counsels and company owners to capture their perspectives.

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79% expect class action exposure to increase over the next 3-5 years.

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32% have material readiness gaps in responding to a class action.

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75% are at least moderately concerned about increased OAIC scrutiny.

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81% agree reform is necessary for timely resolution of IP disputes,

Executive summary and insights

Part I – Disputes reshaping the life sciences sector

Class action exposure in Australia is rising. TGA enforcement is intensifying. Patent injunctions are becoming harder to obtain. Part I examines the dispute trends already reshaping the sector, drawing on Australian and international proceedings.

Part II – Emerging dispute risks

The next wave of disputes in the Australian life sciences sector will be driven by AI and data. Part II examines the specific legal exposure organisations face as they deploy AI in R&D, handle large-scale health datasets, and rely on complex third-party technology ecosystems - including the insurance gaps organisations discover too late. 

Part III – Strategic considerations for life sciences organisations

Dispute readiness is not just a legal function - it is a strategic and governance priority. Part III translates the report's findings into practical frameworks for identifying early warning signals, stress-testing governance structures, and ensuring that dispute risk is embedded in investment and innovation decisions. 

References and contacts

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If you’d like to discuss the insights in this report or explore how these trends may affect your organisation, our team is ready to help.

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https://www.minterellison.com/articles/strategic-risk-signals-report