Life Sciences Insurance

The usual starting point is a combination of Professional Indemnity (for advisory and research work), Public Liability (for third-party injury and property damage), and Product Liability (if a physical product is manufactured, imported, distributed or hired). Clinical trial sponsors and CROs also need Clinical Trials Liability. Biotech startups with investors typically add Management Liability and D&O cover. The right stack depends on what the business actually does. We build it around the occupation, not around a generic bundle.

There's no single answer because premium depends on turnover, the limit required, the product type, the distribution channel and the geography of sale. As a rough guide, we've recently placed $20M Public and Product Liability for a Sydney children's consumer products importer at around $1,200 annual premium, and smaller consumer chemical placements (like a baby skincare brand) at around $2,900. The biggest variable is usually whether the main panel declines and a specialist market is required. See our children's products importer case study for a real example.

Many biomedical R&D consultants carry Professional Indemnity as their core cover. If the work involves technical advice, design input, biocompatibility guidance, materials recommendations or R&D consulting to medical device developers, PI is the cover that typically responds when a client alleges that advice caused a loss. Whether it's right for a specific business is something to work through with a broker. Mainstream insurers often decline biomedical R&D on occupation alone, which is why it's one of the more difficult placements in this sector. Read how we placed combined PI and PL for a biomedical R&D consultant at around $1,900 through a specialist underwriter.

AICIS registration is a strong compliance signal, but it doesn't remove the need for Product Liability insurance. Any business selling a consumer chemical product in Australia needs Product Liability cover to respond to claims of bodily injury or property damage caused by the product. Retailers will typically ask for a certificate of currency before listing the product. For a real example, see our baby skincare product liability case study.

Three reasons, usually all at once. First, occupation codes. Terms like 'implantable device', 'biotech', 'medical device' or 'clinical trial' trigger automatic declines in most underwriter systems. Second, overseas exposure. Any link to the United States, Europe or international distribution can push the risk outside mainstream appetite - particularly the US. Third, product and downstream risk. Even a small product business can carry a long tail of claims exposure that standard business pack insurers aren't set up to price. The answer is almost never 'you're uninsurable'. It's that the submission needs to reach a specialist market.

Clinical trials liability is a specialist cover for trial sponsors, CROs and research organisations running studies on human participants. It responds to trial-related bodily injury and, where relevant, can include no-fault compensation arrangements often expected by human research ethics committees and referenced in good clinical practice frameworks. Any business sponsoring or running a Phase I, Phase II or Phase III trial typically carries this cover, often alongside legal liability on clinical trials as part of a complete trial programme.

Standard product liability responds to third-party bodily injury and property damage caused by a defective product. Product recall costs, which include notifying customers, shipping product back, disposing of affected stock and managing reputational damage, are typically handled by a separate Product Recall extension or endorsement. Specialist life sciences policies can often include this feature, subject to the underwriter and the territory. We'll tell you up front whether it's being offered on your specific placement.

Retailers and online marketplaces often require $20M combined Public and Product Liability for children's products before they'll stock or list the goods. Anything below that limit and you risk being declined by the retailer, not the insurer. We've placed $20M combined cover for a Sydney children's products importer at a commercially workable premium, so the answer exists even when the main market panel declines. See the full case study.

It can, but only if the policy is placed through a market that specifically writes biomedical and implantable device advisory work. Many standard PI policies carry exclusions or restrictions around medical device advisory work. A specialist placement can include R&D advice, biocompatibility guidance and materials recommendations, subject to clear documentation of scope. We've placed exactly this cover for a biomedical R&D consultant through a specialist underwriter, in an occupation where mainstream appetite is limited.

This is the most common pattern in Australian life sciences, and it's where mainstream markets usually fall over. The placement needs to cover Australian liability exposure plus distribution in overseas jurisdictions, which typically means a worldwide jurisdiction extension including North America where relevant. Specialist life sciences markets can offer this, subject to clear evidence of the overseas manufacturer's compliance status, the distribution channels and the territory breakdown.

Professional Indemnity is the anchor cover. Research and data consulting is pure advisory work, and the exposure is professional negligence (incorrect analysis, flawed statistical work, errors in data collation that flow through into client decisions). Where the consultant also visits client sites or handles client equipment, Public Liability is added. International clients require overseas exposure to be built into the wording. We've placed exactly this cover for a sole-trader consultancy supporting research teams across four countries at around $900 annual premium. See the case study.

Yes, subject to underwriter appetite. These are all niches that specialist life sciences markets will typically consider, though appetite shifts over time and some markets prefer specific sub-categories. Medical cannabis in particular requires a specialist market that writes the class. FemHealth and nutraceuticals (food, supplements, TGA-regulated goods) are more broadly written but still sit outside mainstream appetite. We'll go to the market that makes sense for your occupation rather than forcing it through a generic panel.