Australia: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

Artificial Intelligence In Healthcare: Navigating Legal And Regulatory Challenges

Artificial intelligence (AI) is revolutionising healthcare, offering transformative potential in diagnostics, treatment planning, and patient care. However, its rapid integration into health practice presents significant legal, regulatory, and ethical challenges. This article explores emerging technologies and provides insights into the current regulatory landscape and key risk areas associated with AI in healthcare.

Australia Technology

BN

Barry Nilsson

Research Integrity Risks In Health And Life Sciences

Health and life sciences continue to rapidly emerge as a major sector in Australia’s economy, driving innovation, medical advancement and scientific understanding. As the sector grows, however, it is increasingly exposed to scrutiny around integrity and the consequences that follow when confidence in research and quality is questioned.

Australia Healthcare

BP

Bartier Perry

From Lab To Market: How Data Integrity Failures Translate Into Legal Liability

Australia’s health and life sciences sector is growing rapidly, and with that growth comes a more complex web of legal exposure for the organisations that operate within it. The recent Bartier Perry panel event, Health and Life Sciences: Research Integrity Under the Microscope, explored how failures in data and research integrity translate into real-world risk.

Australia Healthcare

BP

Bartier Perry

Prisoners Not Entitled To Egg Extraction And Freezing During Jail Time

A prisoner made an application to Queensland Corrective Services seeking to have some of her eggs extracted and frozen so that she may undergo ‘assisted reproductive technology’ upon her release from imprisonment.

Australia Healthcare

BN

Barry Nilsson

Safeguarding Research Integrity And Managing Fraud Risks In The Health And Life Sciences Sector

Australia Healthcare

BP

Bartier Perry

Patents In Australia: Manner Of Manufacture

PA

Piper Alderman

Tragedy Befalls Family After Homebirth Results In Newborn’s Avoidable Death

Australia Healthcare

BN

Barry Nilsson

Australia | Post-filing Data And Synergy Claims: Lessons For Patent Drafting

SF

Spruson & Ferguson

Safer Care Victoria Releases The Respectful Maternity And Newborn Care Framework

Australia Healthcare

K

Kennedys

Don’t Let Australia’s R&D Tax Incentive Trigger Unintended US International Tax Cost Sharing Issues

W

WilmerHale

Medical Council’s Misuse Of Emergency Power Against Experienced Surgeon

Australia Healthcare

BN

Barry Nilsson

TGA Intensifies Regulatory Oversight: Industry Implications For 2026-2027

Australia Healthcare

BN

Barry Nilsson

Managing Risk In IVF: Lessons From The Monash IVF Settlements

Australia Healthcare

BN

Barry Nilsson

IP Australia Releases Consultation Paper On IP Reforms

KL

Herbert Smith Freehills Kramer LLP

14 September 2026 M&A Review: Market insights and outlook for 2027

Australia Commercial

HR

Holding Redlich

Australia Pauses Work And Holiday Visa Applications From 24 Countries

Australia Immigration

IL

Interstaff Immigration Agency

Navigating Australian Immigration Through Policy Uncertainty

Australia Immigration

IL

Interstaff Immigration Agency

Australia Renews Its Immigration And Tax Data Matching Program

Australia Immigration

IL

Interstaff Immigration Agency

Current Visa Processing Times: June 2026

Australia Immigration

IL

Interstaff Immigration Agency

High-stakes reform: IVF, surrogacy and organ donation under sharper regulatory focus

Recent legislative developments in WA & Qld signal a heightened regulatory focus on assisted reproductive technology, surrogacy and organ donation in Australia.

Australia Healthcare

K

Kennedys

Advancement in assisted reproductive technology: Mitochondrial donation

Mitochondrial donation is an evolving assisted reproductive technique which may assist women to avoid transmitting mitochondrial disease to their child.

Australia Healthcare

K

Kennedys

Review Of Eligibility And Access Criteria Under The Victorian Voluntary Assisted Dying Regime

Finding into death without inquest: Geoffrey Paul McConachy. Coroners Court of Victoria [COR 2023 005213]

Australia Healthcare

K

Kennedys

MAC Disputes, The Takeovers Panel And FIRB – Reflections On Mayne Pharma's Battle With Cosette

The Mayne Pharma/Cosette battle provides a rare example of how things can go awry in a public company transaction.

Australia Commercial

KL

Herbert Smith Freehills Kramer LLP

ART In Focus: Choosing Life – Embryo Selection, Ethics And The Law

Australia Healthcare

BN

Barry Nilsson

Piercing The Limits | Patenting In The Age Of Needle-free Vaccines

Australia Healthcare

SF

Spruson & Ferguson

ART In Focus: The Donor Conception Minefield

Australia Healthcare

BN

Barry Nilsson

Reforming Australian human tissue laws: Implications for healthcare practitioners and product manufacturers

Australia Healthcare

BN

Barry Nilsson

AHPRA guidelines on medicinal cannabis

Australia Healthcare

BN

Barry Nilsson

Woman gives birth to stranger's baby – Monash IVF's error after error causing mistrust in the industry

Australia Healthcare

BN

Barry Nilsson

Governance in Agriculture

Australia Healthcare

MO

Mellor Olsson Lawyers

Guidance when Dealing with the Department of Agriculture and Food

Australia Healthcare

HL

HHG Legal Group

Biotechnology and the R&D tax incentive – current issues

Australia Healthcare

PA

Piper Alderman

Biosecurity management plans for mining and resource companies and landowners

Australia Government

CG

Cooper Grace Ward

Governance in Agriculture

The impact of international tariffs means farmers and growers across the country are under immense pressure.

Australia Healthcare

MO

Mellor Olsson Lawyers

Guidance when Dealing with the Department of Agriculture and Food

Guidance when dealing with the Department of Agriculture regarding breaches of regulations

Australia Healthcare

HL

HHG Legal Group

Biotechnology and the R&D tax incentive – current issues

Biotechnology companies need to be aware of recent developments in the RDTI regulatory space.

Australia Healthcare

PA

Piper Alderman

Biosecurity management plans for mining and resource companies and landowners

The importance of biosecurity laws. What is a BMP? Who must make a BMP? Compliance. Recent case on point.

Australia Government

CG

Cooper Grace Ward

ToolGen Incorporated v Fisher (No 2) – Lessons In Entitlement To Priority From The Australian Federal Court

DC

Davies Collison Cave

International Biosimilar Market Updates

Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe.

Global Healthcare

GP

Goodwin Procter LLP

Near Enough Is Good Enough: Full Federal Court Of Australia Revisits Construction Of "About" In Patent Claim

In the area of patent law, clarity is king. Where precision of language is essential for defining the limits and scope of legal rights, the acceptance within Australia of unbounded terms...

HS

Herbert Smith Freehills Kramer LLP

Not What The Doctor Ordered: Authorisation Application Withdrawn For Pharma Patent Settlement In Australia

Pharmaceutical manufacturing group, Celgene Corporation and Celgene Pty Ltd (together, "Celgene"), and generic drug companies, Juno Pharmaceuticals ("Juno") and Natco Pharma ("Natco")...

Australia Anti-trust

BB

Bird & Bird

Pfizer Files Lawsuit In Australia To Halt Sales Of BRENZYS (Etanercept)

Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept).

GP

Goodwin Procter LLP

First Things First: Full Federal Court Clarifies The Law On Patent Term Extensions

HS

Herbert Smith Freehills Kramer LLP

Australian IPO Review 2021: Pre–IPO Capital Raises

Australia Finance

HS

Herbert Smith Freehills Kramer LLP

Australian patent box regime one step closer: Bill introduced into Australian parliament

SF

Spruson & Ferguson

Australian patent box takes shape

BP

Bennett & Philp Lawyers

Agricultural and veterinary chemicals legislation streamlined

Australia Healthcare

HR

Holding Redlich

Prior Art In The Age Of COVID

DC

Davies Collison Cave

The Nexus Between IP And Clinical Trials: An Australian Perspective

DC

Davies Collison Cave

Diagnostic methods patentable in Australia

CC

Corrs Chambers Westgarth

Federal Government To Introduce A "Patent Box" Tax Regime In Australia

DC

Davies Collison Cave

Women In STEM 2021 – Lessons Learnt During A Pandemic With Dr Sarah McDonald

Australia Healthcare

DC

Davies Collison Cave

DCCL Resource Centre: Issue 10

DC

Davies Collison Cave

COVID-19 and the new digital clinical trial era

Australia Technology

MR

McCullough Robertson

COVID-19 Australia: Weekly Briefing (1 June 2020)

Australia Coronavirus

CC

Clyde & Co

DCCL COVID-19 Resource Centre: Issue 5

Australia Coronavirus

DC

Davies Collison Cave

Switching from biologic to biosimilar: Unique approach in Australia

Australia Healthcare

SF

Spruson & Ferguson

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