Australia's Life Sciences industry spans biotechnology, pharmaceuticals, complementary medicines, medical technology (devices and diagnostics), food, agriculture and veterinary health, and represents a key driver for future economic growth.

However, life sciences companies operate in an increasingly complex and regulated environment. New scientific advances occur daily. 

Australia has a strict (i.e., no fault) product liability regime and an established class action regime, requiring you to be ever vigilant. High-profile recalls of pharmaceuticals and devices, resulting in class actions in recent years, has caused increased scrutiny by regulators. Pressure on government budgets has resulted in an examination of reimbursement arrangements for pharmaceuticals and medical devices. The heavily regulated environment, as well as the long product commercialization timeframe between research, development, clinical testing through to regulatory approval and sale, presents challenges in negotiating and structuring transactions. Long product commercialization timeframes mean that life sciences companies require significant capital with no guarantee of return, which can make capital raising difficult.

To meet these and other challenges, you need a law firm that understands your issues and your business. We are that firm.

We are acknowledged leaders in the biotechnology law, intellectual property law, life sciences regulatory and product liability space, and drive innovative solutions to the legal, commercial and practical challenges you face. Our clients range from start-ups to global companies.

Our multi-specialty practice provides a wide array of services across the spectrum of the Life Sciences industry. This includes:

• Assisting with regulatory matters such as product approvals, acting in relation to regulatory investigations and disputes, and finding solutions to regulatory problems
• Defending product liability claims including the defense of cross-border litigation involving conflict of laws
• Resolving issues arising in human research and clinical trials, including consent issues and matters arising from adverse events
• Acting in the product recall of goods
• Protecting and licensing intellectual property
• Advising on privacy and data security matters
• Drafting material transfer agreements, collaboration agreements, manufacturing, supply and distribution agreements and other contracts and resolving contractual disputes
• Assisting start-ups with venture capital, capital raising and finance documentation, and supporting them through every step of commercialization
• Pursuing anti-bribery, corruption and fraud claims
• Advising on corporate transactions including sale and purchase of IP assets, M&A, corporate structuring, capital raising, IPOs and corporate governance-related matters
• Advising in relation to marketing and promotion issues including regulatory and intellectual property matters
• Advising in relation to the requirements of, and compliance with, the Australian Consumer Law, including consumer guarantees and consumer protection provisions
• Litigation and mediation
• Employment and safety-related matters

Insights

Legal professional privilege in cybersecurity incident reports – mere ‘incantations’ are not sufficient

April 13, 2025

Australia: A recent Federal Court decision in the Medibank data breach class action highlights the limits of legal professional privilege in respect of third party reports prepared in connection with a cybersecurity incident. 

Australia's competition regulator targets return, exchange and refund policies

March 7, 2025

Australia: Australia’s competition and consumer protection regulator, the ACCC, has audited over 2,000 retail websites and flagged concerns about widespread potential contraventions of the Australian Consumer Law in online terms and conditions regarding the right to exchange, refund or return goods. This sweep reflects the ACCC’s enforcement priorities in 2025.

Australia expected to regulate dark patterns and other unfair trading practices in 2025

January 13, 2025

Australia: Late in 2024, Australia’s Commonwealth Government sought feedback on proposals to prohibit unfair trading practices.  Being targeted are certain practices relating to subscriptions, or drip pricing, dynamic pricing, requiring online accounts (instead of guest checkouts for online transactions), erecting barriers to accessing customer support and other types of practices known as “dark patterns”.  Reforms are expected in 2025 – and they will be impact most businesses – especially online businesses carrying on business in Australia who transact with consumers or small businesses. 

View all insights for Life Sciences in Australia