Healthcare and Life Sciences

Overview

Healthcare and life science focused organisations operate in a regulated environment. Patient safety, public funding, scientific integrity and commercial outcomes are all impacted by overlapping legal frameworks.

A single decision, whether an approval, a registration, a recall or an audit finding, can determine whether a product reaches market, a trial proceeds or an institution maintains its licence to operate.

Thomsons advises participants across the healthcare and life sciences sector including hospitals and health service providers, pharmaceutical and medicinal cannabis companies, biotechnology and medical device enterprises, research institutions, universities and clinical trial sponsors. The work is defined by strict regulatory oversight, material commercial consequence and, in many matters, direct public accountability.

The team operates across the full product and service lifecycle: discovery and development, regulatory approval, commercialisation, market entry and governance. Corporate, transactional, regulatory and disputes capability is integrated, not siloed.

Areas of expertise

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Therapeutic goods regulation operates on strict statutory criteria with narrow exceptions. A registration, advertising or supply issue can move quickly from compliance question to civil penalty or criminal exposure.

Thomsons advises on compliance with the Therapeutic Goods Act and related legislation, including product registrations and listings, labelling, advertising restrictions, import and export requirements, and TGA audit responses. The firm acts in regulatory investigations and civil penalty proceedings (including enforcement actions initiated by the TGA) and in section 60 internal reviews contesting TGA decisions. This is contested regulatory work where the stakes are commercial, reputational and, in some matters, criminal.

Software and AI-enabled tools sit within the medical device framework only if their intended use meets the statutory test. Classification determines the regulatory pathway, and classification turns on intended use, clinical claims and data architecture.

Thomsons advises on the classification and regulation of software as a medical device, AI-enabled diagnostic tools and digital health technologies under the Therapeutic Goods framework and, where relevant, equivalent international regimes including the FDA. The firm determines product type, advises on conformity assessment and essential principles, and structures cross-border commercial arrangements for companies entering Australian and international markets.

Hospitals and pharmaceutical companies operate within tightly defined accreditation, safety and reimbursement settings. Commercial arrangements must hold under those constraints, not around them.

Thomsons advises public and private hospitals, health service providers and pharmaceutical companies on major clinical contracts, governance and funding structures. Commercial arrangements are structured to reflect accreditation, patient safety obligations and regulatory requirements. The firm engages directly with the TGA, state health departments and, where relevant, the PBAC on pricing and reimbursement matters.

Clinical trial structures sit at the intersection of regulatory law, contract, ethics and privacy. Each element is reviewed by a different body, on a different timeline, against different criteria.

Thomsons advises clinical trial sponsors on trial governance, HREC compliance, investigator-led study structures and participant privacy obligations. Sponsorship arrangements, indemnification structures and data governance frameworks are drafted and negotiated to withstand regulatory scrutiny.

Life sciences value is held in intellectual property and regulatory approvals long before it is held in revenue. Deal structures, licence terms and capital raises turn on how those assets are characterised, protected and transferred.

Thomsons advises on IP strategy, technology transfer, commercialisation licences, research collaboration agreements, joint ventures and early-stage deal documentation. Important work includes data breach response and cyber insurance review work.

The firm also acts on M&A and capital markets transactions for listed and private life sciences companies, including ASX IPOs, dual schemes of arrangement and cross-border acquisitions.

Health information is among the most tightly regulated categories of personal data. Patient privacy, regulatory disclosure obligations and competitor access through FOI operate in tension and must be managed together.

Thomsons advises on health data protection, patient privacy and information governance obligations under the Privacy Act and applicable state legislation. The firm engages with the OAIC on FOI applications, investigations and privacy complaints, including matters involving competitor attempts to obtain confidential regulatory and IP information.

A device failure can trigger civil proceedings, regulatory investigation, coronial inquest and recall obligations in parallel. Each forum applies a different test and a different standard of evidence.

Thomsons represents medical device manufacturers in product liability proceedings, coroner's inquests and regulatory investigations. The firm advises on recall obligations, mandatory reporting requirements and defence strategy where device performance is in dispute.

Health infrastructure is procured against clinical, public sector and regulatory requirements that operate concurrently. Project structures must deliver against all three.

Thomsons advises on health infrastructure projects (including hospitals and research facilities) covering procurement, funding arrangements, project structuring and compliance with public sector and health-specific regulatory frameworks.

Our experience

Montu Group / Alternaleaf – Alleged advertising contraventions

Acting for Australia's largest medicinal cannabis wholesaler and telehealth clinic in civil penalty proceedings initiated by the TGA for alleged contraventions of therapeutic goods advertising laws - the largest such action brought against a medicinal cannabis company. The firm secured a non-publication order against The Age and The Sydney Morning Herald preventing publication of affidavit material inadvertently released to journalists. Hearing set for Q4 2026.

DT MedTech – TGA cancellation review

Acting for the manufacturer of the H3 Hintermann ankle device in a section 60 internal review of the TGA's decision to cancel the device from the ARTG. The matter required analysis of data from the Australian and UK Joint Registries, assessment of multiple scientific studies and engagement with the FDA. Strategic arguments based on scientific and statistical evidence were developed to address the TGA's concerns.

Karl Storz Endoscopy Australia – Coroners Court inquest

Acting for a medical device manufacturer in a Coroners Court inquest arising from a patient death during a hysteroscopic procedure. The firm also acts in related product liability proceedings concerning alleged device damage.

Smart Reporting GmbH – Classification and regulatory status advice

Advising on the classification and regulatory status of SmartAssist SummarAIze, an AI-enabled software tool designed to assist documentation of clinical information in radiology reports. The matter required determination of product type under the Therapeutic Goods legislation, classification of the software as a medical device, and advice on conformity assessment.

Valneva – FOI applications

Acting for a specialist vaccine company in opposing FOI applications and related investigations initiated by a competitor seeking access to patent and confidential IP information. The matter spans IP Australia, the TGA and the OAIC.

Artrya Ltd – Cross-border privacy and data security

Advised the ASX-listed AI cardiovascular health company on a SaaS agreement and HIPAA-compliant privacy and data security addendum with a US hospital. The matter required cross-jurisdictional analysis of Australian, federal US and state law, negotiation of limitation of liability and indemnity provisions, and coordination with US counsel on HIPAA compliance and privacy risk.

Care Pharmaceuticals – Advertising and regulatory strategy

Advised on advertising compliance and regulatory strategy in connection with supply of a medical device starter kit, including analysis of advertising restrictions applicable to healthcare practitioners and patients respectively.

QUT Microbial Biobank – Collaboration agreement negotiation

Advised QUT on negotiating a collaboration agreement with a listed biotechnology company for development and maintenance of a microbial biobank.

Compulsory acquisition of Calvary Bruce Public Hospital by the ACT Government

Acted for Calvary across the ACT Government's compulsory acquisition of Calvary Public Hospital Bruce, from re-negotiation of the Calvary Network Agreement, through urgent advice on the Health Infrastructure Enabling Act 2023 (ACT), Supreme Court proceedings challenging the Act's validity, transition and claims work, to settlement on 2 September 2025.

Trustees of the Sisters of Charity of Australia (TSCA) St Vincent's Private Hospital Sydney (SVPHS) St Vincent's Healthcare Ltd (SVHC) – Project structuring and stakeholder agreements

Thomson Geer acted on the sale of TSCA's interest in the medical imaging joint venture which operated the medical imaging business at St Vincent's Private Hospital Sydney and dissolution of that joint venture.

Microba Life Sciences – IPO and regulatory compliance

Acted on the ASX IPO, raising A$30 million, including transaction structuring and regulatory compliance.

QBiotics Group – Company merger

Advised on a A$130 million biotech merger via dual schemes of arrangement, consolidating QBiotics Limited and EcoBiotics Limited into a new holding company.

Incannex Healthcare – Company acquisition

Advised on the acquisition of medicinal cannabis R&D company APIRx, including transaction structuring and regulatory analysis.

SAHMRI – Establishment and commercial matters

Advised on establishment and ongoing commercial matters, including clinical trial agreements, fundraising arrangements and privacy and information governance compliance.

Queensland Ambulance Service

Acting for a QAS ambulance officer in an inquest into the death of an individual who was taken into police custody after paramedics attended.

Aged care coronial investigations and inquests

Acting for aged care providers in coronial investigations and inquests, including acting for:

A not-for-profit aged care provider in relation to a complex coronial investigation into the death of five residents in similar circumstances.
An aged care provider in an inquest into the death of a resident relating to the use of a bed pole.

Overview

Areas of expertise

Regulatory compliance and enforcement

AI, digital health and medical devices

Hospitals, health providers and pharmaceuticals

Clinical trials

Licensing, commercialisation and strategic transactions

Health data, privacy and information governance

Product liability and recalls

Health infrastructure and procurement

Our experience