Personalised Medicine Production Manufacturing Insurance (UK): A Practical Guide

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Personalised Medicine Production Manufacturing Insurance (UK): A Practical Guide

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Personalised Medicine Production Manufacturing Insurance (UK): A Practical Guide

Introduction: why personalised medicine changes the insurance conversation

Personalised medicine production (including patient-specific therapies, companion diagnostics, and bespoke medical devices) is transforming healthcare. But for manufacturers, it also changes the risk profile in ways traditional “medical manufacturing” insurance doesn’t always capture.

Instead of long, stable production runs, you may be producing small batches or even single-patient products. You may be handling sensitive health data, operating under tight chain-of-custody requirements, and relying on specialist suppliers and cold-chain logistics. A single deviation can trigger product loss, regulatory scrutiny, and reputational damage.

This guide explains the core insurance covers UK personalised medicine producers typically need, how underwriters assess the risk, and how to structure a policy that actually responds when something goes wrong.

What counts as “personalised medicine production” for insurance purposes?

Insurers and brokers usually group personalised medicine production into a few practical categories:

  • Patient-specific therapies (e.g., autologous cell therapies, bespoke biologics, batch-of-one manufacturing)

  • Advanced therapy medicinal products (ATMPs) and related manufacturing steps (where applicable)

  • Companion diagnostics and testing workflows that determine patient eligibility

  • Custom medical devices (e.g., patient-matched implants, 3D-printed components)

  • Software-driven personalisation (e.g., algorithms that tailor dosing, device settings, or treatment pathways)

Even if you don’t manufacture the final therapy in-house, you may still be exposed through:

  • Contract manufacturing arrangements

  • Packaging, labelling, or sterile processing

  • Quality assurance, release, and distribution responsibilities

The risk profile: what can go wrong (and why it’s different)

Personalised medicine manufacturing tends to amplify certain risks:

  • Higher consequence of error: a mistake can directly impact a specific patient.

  • Traceability and chain-of-custody: if documentation is incomplete, you can face compliance and liability issues even if the product is clinically sound.

  • Cold-chain and time sensitivity: temperature excursions or delays can destroy product value.

  • Data dependency: patient data and diagnostic results can be integral to the product’s design and safe use.

  • Supplier fragility: specialist reagents, single-source components, and limited alternatives can create business interruption.

Insurers want to understand not just what you make, but how you control variability.

Core insurance covers for personalised medicine manufacturers

Below are the covers most UK personalised medicine production businesses consider “core.” The right mix depends on your role in the supply chain and whether you’re manufacturing a medicinal product, a medical device, software, or a combination.

1) Product liability (including completed operations)

What it covers: Claims alleging bodily injury or property damage caused by your product after it leaves your control.

Why it matters here: Patient-specific products can create complex causation questions. Even if the issue originates upstream (e.g., diagnostic input), you may still be pulled into a claim.

Key points to check:

  • Territorial limits (UK, EU, worldwide)

  • Whether the policy includes or excludes the USA/Canada

  • “Products supplied” definition (does it include software, instructions for use, labelling?)

  • Contractual liability (how far it follows your customer contracts)

2) Clinical trials liability (if applicable)

If you sponsor or participate in clinical trials, you may need clinical trials insurance separate from standard product liability.

Common triggers:

  • Trial participant injury

  • Protocol deviations

  • Informed consent disputes

Practical note: Underwriters will ask about trial phase, number of participants, geographies, CRO involvement, and ethics approvals.

3) Professional indemnity (PI) / errors & omissions (E&O)

What it covers: Financial loss claims arising from professional services, advice, design, or errors in documentation.

Why it matters: In personalised medicine, the “product” is often inseparable from the process—specifications, batch records, release decisions, and technical files can be central to a dispute.

PI/E&O can be especially relevant if you:

  • Provide manufacturing consultancy

  • Design patient-matched devices

  • Provide software or algorithms used in treatment decisions

  • Provide validation, testing, or quality services

4) Product recall / withdrawal and remediation

What it covers: Costs to recall, withdraw, or remediate products when there is a safety issue or regulatory requirement.

Why it matters: A recall can be financially devastating even without a liability claim.

Costs that may be covered (policy-dependent):

  • Notification and communications

  • Shipping and logistics

  • Disposal and destruction

  • Replacement product costs

  • Consultant and crisis management fees

Watch-outs: Some policies require a “reasonable probability of bodily injury” trigger; others may respond to regulatory action. The wording matters.

5) Employers’ liability (EL)

In the UK, EL is typically compulsory if you employ staff.

Personalised medicine angle: Exposure can include:

  • Handling biological materials

  • Chemical and solvent exposure

  • Cleanroom and sterilisation processes

  • Repetitive strain injuries in lab environments

Insurers may want evidence of training, PPE, COSHH assessments, and incident reporting.

6) Public liability (PL)

What it covers: Third-party injury or property damage arising from your premises/operations (not your product).

This is relevant for:

  • Visitors to your facility

  • On-site audits and inspections

  • Demonstrations, training, or site tours

7) Property damage and business interruption (BI)

What it covers: Damage to buildings, plant, equipment, and stock, plus loss of gross profit due to an insured event.

Why it matters: Personalised medicine facilities can be capital-intensive, and downtime can be catastrophic.

Key considerations:

  • Cleanroom rebuild times

  • Specialist equipment lead times (bioreactors, freezers, isolators)

  • Dependency on utilities (power, water, HVAC)

  • Increased cost of working (e.g., outsourcing production temporarily)

8) Equipment breakdown (engineering insurance)

Standard property insurance may not fully cover sudden mechanical/electrical breakdown.

This can be crucial for:

  • Ultra-low temperature freezers

  • HVAC and environmental controls

  • Sterilisation equipment

  • 3D printers and CNC machines

9) Stock deterioration / temperature-controlled goods

If you rely on cold storage, consider specific cover for:

  • Temperature excursions

  • Refrigeration failure

  • Power outage

For patient-specific products, the value of a single unit can be extremely high, and replacement may not be possible within clinical timelines.

10) Cyber insurance and data protection

What it covers: Data breaches, ransomware, business interruption from cyber events, forensic and legal costs, and sometimes regulatory support.

Why it matters: Personalised medicine often involves special category data under GDPR (health data). A cyber incident can halt production, compromise chain-of-custody records, and trigger notification obligations.

Underwriters commonly ask about:

  • MFA and access controls

  • Backups and recovery testing

  • Supplier and cloud dependencies

  • Incident response plans

  • Staff training and phishing controls

11) Management liability (Directors’ & Officers’ / D&O)

If you have investors, a board, or rapid growth plans, D&O can protect directors and the company against claims alleging mismanagement.

This can be relevant for:

  • Fundraising disclosures

  • Regulatory investigations

  • Employment practice claims

12) Cargo / transit insurance (including cold-chain)

If you ship materials, samples, or finished product, transit cover can be essential.

Important features to discuss:

  • Temperature monitoring requirements

  • Approved couriers and packaging standards

  • International shipments and customs delays

  • Chain-of-custody documentation

The “grey areas” that cause claim problems

Personalised medicine claims often become complicated because responsibility is shared across multiple parties. Common friction points include:

  • Contract manufacturing vs. brand owner responsibility: Who is legally responsible for the product?

  • Software and data inputs: If a diagnostic input is wrong, is it a product defect, a professional error, or a data issue?

  • Labelling and instructions: Small-batch production increases the risk of labelling errors.

  • Deviation handling: How you document and respond to deviations can influence liability.

A good insurance programme aligns policy wording with your contracts and your real-world workflow.

What underwriters want to see (and how to present your risk well)

Insurers are more comfortable when you can demonstrate control, traceability, and governance. Expect questions on:

  • Quality management system (e.g., ISO 13485 for devices, GMP alignment where relevant)

  • Batch records and traceability (including chain-of-custody)

  • Supplier qualification and single-source dependencies

  • Validation and calibration of equipment

  • Environmental monitoring for cleanrooms

  • Change control processes

  • Complaint handling and CAPA processes

  • Recall plan and mock recall testing

  • Cyber controls and business continuity planning

If you’re preparing for renewal or a new placement, having a concise underwriting pack can reduce premiums and improve terms.

Common exclusions and limitations to watch for

Policy exclusions can vary widely. Areas to scrutinise include:

  • USA/Canada exclusions or restricted limits

  • Clinical trials exclusions (unless specifically covered)

  • Known defects or prior incidents

  • Contractual liability beyond common law

  • Fines and penalties (often excluded, but defence costs may be covered)

  • Cyber exclusions on liability policies (and vice versa)

  • Biological agents exclusions (depending on the insurer and wording)

This is where a specialist broker adds value: negotiating wording that matches your actual risk.

How to choose limits: a practical way to think about it

There’s no universal “right” limit, but a sensible approach is to consider:

  • Worst-case patient harm scenario (severity and legal costs)

  • Number of units/patients impacted in a single event

  • Contractual requirements from NHS trusts, hospitals, distributors, or OEM partners

  • Regulatory and recall costs (including logistics and communications)

  • Your balance sheet and ability to absorb uninsured losses

Many manufacturers start with a baseline and increase limits as they scale production, expand territories, or enter higher-risk indications.

Packaging your cover: what a typical programme can look like

A common structure for a growing personalised medicine manufacturer might include:

  • Product liability (with worldwide territory as needed)

  • PI/E&O for design, documentation, and software elements

  • Product recall/withdrawal

  • Property + BI (including equipment breakdown and stock deterioration)

  • Cyber

  • EL and PL

  • Transit/cargo

  • D&O (where relevant)

The key is avoiding gaps—especially between product liability, PI/E&O, and cyber.

Claims scenarios (realistic examples)

Scenario 1: temperature excursion destroys patient-specific product

A courier delay leads to a temperature excursion. The product is unusable, the patient’s procedure is postponed, and the hospital seeks recovery of costs.

Potentially relevant covers:

  • Transit/cargo

  • Stock deterioration

  • Business interruption (if production is disrupted)

  • Liability (depending on allegations)

Scenario 2: labelling error in a small batch

A batch label is misapplied, leading to a near-miss. The regulator requires withdrawal and investigation.

Potentially relevant covers:

  • Product recall/withdrawal

  • PI/E&O (documentation/process error)

  • Product liability (if harm occurs)

Scenario 3: ransomware halts manufacturing and compromises records

Systems are encrypted, production stops, and chain-of-custody records are inaccessible. You must notify affected parties and restore systems.

Potentially relevant covers:

  • Cyber (incident response, restoration, business interruption)

  • PI/E&O (if customers claim financial loss)

Practical next steps: how to get a quote that reflects your real risk

If you’re seeking insurance for personalised medicine production, prepare:

  • Company overview and activities (what you make, where you sit in the chain)

  • Territories and customer types

  • Quality certifications and compliance framework

  • Claims history and incident logs

  • Contracts and required limits

  • Risk management summary (cold-chain, cyber, supplier controls)

A broker can then approach insurers with a clear narrative, improving the odds of broad cover and competitive pricing.

FAQ

Do personalised medicine manufacturers need product liability insurance?

In most cases, yes. If you manufacture, supply, or brand a product used in patient care, product liability is typically a core requirement.

Is professional indemnity the same as product liability?

No. Product liability focuses on injury/property damage caused by products. PI/E&O focuses on professional errors, design, advice, documentation, and financial loss.

What if we only do R&D and prototypes?

You may still need PI/E&O, public liability, employers’ liability, and potentially product liability depending on what you supply and to whom.

Do we need cyber insurance if we already have IT security?

Cyber insurance doesn’t replace security—it helps fund response, recovery, and liability costs when incidents occur.

Can insurance cover regulatory investigations?

Some policies can cover defence costs for certain investigations, depending on wording. It’s important to discuss your regulatory exposure and ensure the policy aligns.

Conclusion

Personalised medicine production is high-impact, high-complexity manufacturing. The right insurance programme isn’t just a box-tick—it’s a risk-financing strategy that protects patients, contracts, and your balance sheet.

If you want, tell me what you manufacture (therapy, device, software, or a mix), where you sell (UK only vs worldwide), and whether you handle cold-chain logistics—then I can tailor the cover checklist and suggested limits to your exact setup.

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