Life Sciences Liability Insurance

The Life Sciences industry is defined by rapid advancement and rigorous regulatory requirements. We help provide comprehensive liability solutions tailored to the unique risks faced by businesses involved in research, development, and the distribution of medical products.

Unified Protection for the Life Sciences Lifecycle

Our Life Sciences Liability insurance is specifically designed to address the complex exposures of the pharmaceutical, biotech, medical device and medical consumable sectors. We understand that in this industry, a single error in research or a product defect can have significant global consequences. We provide a seamless approach to protection, bridging the gap between clinical trial risks and general product liability.

- Damages arising from bodily Injury or, property damage caused by your products or services
- Product recall expenses
- Claims arising from bodily injury or property damage to Clinical Trial Participants
- Financial loss arising from your acts, errors or omissions
- Claims arising from contact with or exposure to Biological Agents in your products or materials
- Privacy and data breach expenses
- Analytical Device importers, manufacturers and distributors
- Bioengineering
- Biologic companies
- Dietary supplement companies
- Drug discovery technology
- Laboratories
- Life science product testing
- Life science product development
- Medical consumables importers, manufacturers and distributors
- Medical device / product importers, manufacturers and distributors
- Medical drug importers, manufacturers and distributors
- Medical food importers, manufacturers and distributors
- Research institutions and organisations
- Service organisations
- Therapeutic cosmetic companies
- Biotechnology
- Brain and spinal implants
- Gene therapy products
- General anaesthesia drugs
- Genetic testing products
- Industrial, marine or agricultural
- Medical records software
- Products with significant off-label use
- Products intended for pregnant women or persons under 18 years of age
Life Sciences Liability Insurance - Information Sheet
Life Sciences Liability Insurance - Proposal Form
Life Sciences Liability Insurance - Policy Wording
Life Sciences - Claims Examples

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Claims Examples

Contract Research Organisation (CRO)

A pharmaceutical company (sponsor) hired a CRO to manage the distribution of drugs for a double-blind clinical trial. Due to a distribution error, the CRO allegedly caused too many participants to receive the placebo instead of the active ingredient under investigation. The regulatory authority deemed the trial’s resulting data flawed. This prevented the sponsor from obtaining market approval for the drug. The sponsor was also required to incur additional unexpected costs as the trial had to be re-run.

Contract Manufacturing Organisation (CMO)

A pharmaceutical firm hired a CMO to manufacture epinephrine mist. A Class III product recall resulted from the CMO’s alleged failure to test the mist for all microbial specifications. The pharmaceutical firm sought damages for breach of contract and negligent misrepresentation.

University, Medical Center or Hospital

A dental device company retained a university to conduct a dental implant clinical trial. The university allegedly breached the clinical trial contract by failing to provide information required, such as the implantation date, the date the patient was examined, and a description of the implant tissue quality and the amount of bone growth. Additionally, the university allegedly failed to follow the protocol: one patient exceeded the age limit, one implant was too close to the patient’s sinus cavity, and in one instance the wrong cement was used.

Bodily Injury to a Clinical Trial Participant

A biotechnology company sponsors a Phase II clinical trial for an investigational oncology drug being conducted at multiple hospitals. The protocol has been approved by the relevant ethics committee and regulatory authorities.

A 52-year-old participant enrols in the study after signing an informed consent form and passing all screening requirements. During the third treatment cycle, the participant develops a severe and unexpected immune-mediated reaction that was not identified in earlier studies.

The participant is hospitalised with acute respiratory distress syndrome (ARDS), requiring intensive care treatment for 10 days. Although the participant survives, they suffer permanent impairment to lung function and are unable to return to their previous employment.

Important Notice

These are examples only. You should read them only as a guide. They do not form part of any policy. Every claim is different. We always determine indemnity decisions and claim payments on an individual basis, after we have assessed the claim. Information provided is general only and has been prepared without taking into account any person’s particular objectives, financial situation or needs. Insurance cover and whether a policy responds to a claim is subject to the terms, conditions, limits and exclusions of the policy. When making a decision to buy or continue to hold a financial product, you should review the relevant policy wording and any applicable endorsements.