Life sciences & biotech

Insurance for life sciences and biotech businesses

Yes — Apex arranges insurance for UK life sciences and biotech businesses: professional indemnity for research, consultancy and CRO work, products liability for therapeutics, diagnostics and medical devices, and clinical trials liability for trial sponsors. We place the specialist elements through the Lloyd’s market via wholesale, with the cyber cover that connected devices and trial data now demand.

Part of: Commercial insurance

In short

Life sciences and biotech is a blended risk that one off-the-shelf policy rarely covers well. A therapeutics developer, a diagnostics or device company, a contract research organisation and a laboratory consultancy each need a different mix: professional indemnity for the research and advice, products liability for what is sold or supplied, and clinical trials liability for anyone running a trial. The MHRA regulates medicines and medical devices in the UK, devices carry UKCA marking (with CE marking recognised during the transition), and product liability sits under the Consumer Protection Act 1987. A sponsor must have insurance in place before HRA and ethics approval, which for commercial trials means no-fault compensation on ABPI lines. We place the programme through the Lloyd’s market via wholesale, so it meets your regulators, investors and contracts.

Who this is for

‘Life sciences and biotech’ spans many UK businesses, and the cover that leads depends on what you do:

Therapeutics and pharmaceutical developers — from early discovery to taking a compound through trials.
Diagnostics and medical-device companies — designing, making or supplying a product for clinical or laboratory use.
Contract research organisations (CROs) and consultancies — research, analysis and advice for others.
Laboratory and testing businesses — method development, analysis and scientific services.
Health-tech and digital-health startups — software, apps and connected devices between clinical and technology risk; see insurance for health-tech startups.

Most are a blend, so the professional, products and trials sides belong together. For individual professional advice, see professional indemnity for clinical and scientific researchers and pharmacists and indemnity.

The covers life-sciences firms actually need

The programme usually pulls from a familiar set of covers:

Cover	What it protects
Professional indemnity	Putting right a mistake in research, consultancy, CRO or laboratory work.
Clinical trials liability	Injury to trial subjects, including no-fault compensation a sponsor must arrange.
Products and efficacy liability	Liability for injury or damage caused by a therapeutic, diagnostic or device in use.
Product recall	Identifying, withdrawing and replacing an affected batch or product line.
Public and employers’ liability	Injury or damage to third parties, and the cover required once you employ people.
Cyber	Trial and patient data, connected devices and the systems the business depends on.
Property, equipment and business interruption	Laboratories, equipment, samples and stock, and income lost when research stops.
Directors’ and officers’	Personal liability of directors — often asked for by investors in funded biotech.

Professional indemnity and products do the heavy lifting; most firms need several together.

Clinical trials: insurance, HRA approval and no-fault compensation

If you sponsor a clinical trial, insurance is not optional, and it is checked first. A trial of a medicine is regulated by the MHRA, and it needs a favourable opinion from a research ethics committee through the Health Research Authority (HRA) before it can run; both expect appropriate insurance or indemnity in place.

The sponsor arranges it. Insuring a trial is the sponsor’s responsibility, and cover must be in place before participants are enrolled.
No-fault compensation. For commercial trials, UK practice follows the Association of the British Pharmaceutical Industry (ABPI) guidelines, which compensate a participant harmed by taking part even where no negligence is shown.
The wording must match the protocol. Ethics review looks at whether the insurance actually covers the study, not merely that a policy exists.

This is specialist territory, written in the Lloyd’s market. We place it through wholesale and issue the certificate your ethics committee needs.

Devices, diagnostics and therapeutics: products and regulation

For firms that make or supply a product, products liability leads, against a specific regulatory backdrop:

The regulator. The MHRA regulates medicines and medical devices in the UK, including market surveillance and oversight of the assessment bodies.
Device marking. Devices carry UKCA marking, with CE marking recognised during the current transition; the conformity route is part of what an insurer will ask about.
Strict product liability. Under the Consumer Protection Act 1987, a producer can be liable for damage caused by a defective product without a claimant proving negligence — which is why products and efficacy cover, with recall alongside, matters here.

Because a single product can reach many users, the limit, territory and wording deserve attention. Where a product is sold into, or a trial runs in, the United States, cover usually includes US jurisdiction — see professional indemnity with US jurisdiction.

Why place life-sciences cover through Apex

Apex Insurance Brokers is an independent commercial insurance broker established in 2009 and based in Bristol — in the South West’s life-sciences, health-tech and diagnostics cluster, from university spin-outs and incubators to the med-tech and laboratory businesses across the region. We are owned entirely by our directors and directly authorised by the FCA since 2016. We are not tied to any single insurer, and we have access to over 30 markets, including the Lloyd’s market — via wholesale — where clinical trials, life-science products and efficacy risks are written. Every client has a named broker who understands what a sponsor, investor or supply contract asks the insurance to do.

Owned by its directors, not for sale. No consolidator, no private-equity owner, no external shareholders — and we have declined approaches to buy the firm. Read the Apex Independence Charter.
Independent, not tied. No single-insurer scheme, no in-house policy, no placement quotas — the recommendation is the one that fits, not the one we are paid to push.
Over 30 markets, including Lloyd’s. Specialist UK PI insurers and Lloyd’s syndicates via wholesale, so a risk that one underwriter dislikes can still be placed properly with another.
Usually three or four competing quotes, laid out side by side — limit, excess, retroactive date, exclusions and premium — with a plain-language note on the trade-offs.
The stay-put letter. If your existing cover is right, we say so in writing, free and without obligation. How the stay-put letter works.
A named broker all year. The person who places your cover is the person who picks up the phone at renewal, on a mid-term change, or when a letter of claim lands.
Director-level attention on claims. We help you notify circumstances early and in the right form, stay involved once the insurer’s panel solicitors are appointed, and tell you plainly where you stand.
Directly authorised by the FCA since 2016, not an appointed representative trading under someone else’s permissions.

Frequently asked

Does my biotech need professional indemnity or products liability?

It depends on what you do. Research, consultancy, CRO and laboratory work needs professional indemnity — correcting a mistake in advice or analysis. Firms that make or supply a therapeutic, diagnostic or device need products and efficacy liability. Many do both, and a trial adds clinical trials liability.

We are about to start a clinical trial — what insurance needs to be in place?

The sponsor is responsible for insuring the study, and cover must be in place before it starts. A trial of a medicine is regulated by the MHRA, and the ethics committee reviewing it via the HRA will expect appropriate insurance; for commercial trials, UK practice follows the ABPI no-fault compensation guidelines. We place it through the Lloyd’s market and issue the certificate the committee needs; if a start date or tender is close, see business insurance at short notice.

Do medical devices need special cover because of MHRA and UKCA rules?

The regulation drives the exposure, not the policy. The MHRA regulates medical devices in the UK, devices carry UKCA marking (with CE marking recognised during the transition), and under the Consumer Protection Act 1987 a producer can be liable for a defective product without negligence being proved. Products and efficacy liability, with recall alongside, responds. This is general information, not regulatory advice.

Can you arrange cover for US trials or sales, and do you handle other specialist sectors?

Yes. Where a product is sold into, or a trial runs in, the United States, cover usually needs US jurisdiction — see professional indemnity with US jurisdiction. We place other specialist classes too; where the work overlaps engineering or aerospace, see aerospace and aviation insurance.

Working in life sciences or biotech?

Tell us what you research, develop, make or trial — and any requirement an investor, an ethics committee or a supply contract has set — and we’ll place it through the specialist market with the cover and certificates you need. Or call 0117 325 0027.

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Apex Insurance Brokers Limited is authorised and regulated by the Financial Conduct Authority. Registered in England and Wales, company number 07014570. This page is general information about life sciences and biotech insurance, not advice on your individual circumstances, and it does not guarantee that cover will be available or on what terms.