Damage to property and personal injury
- Injury to third parties
- Damage to other people's property
- Also during visits to clients' sites
Product liability · clinical trials · long tail
Liability insurance for life sciences
A claim in this sector rarely arrives in the policy year in which the product was supplied, which is why the duration of your cover matters more than the sum insured.
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- 9.5 customer rating for a new policy
- AFM licence 12016589
- Personal 072 - 509 24 56, weekdays 9–17
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The calculator and the quote form below are in Dutch. Prefer to do this in English? Email info@finassverzekert.nl or call 072 - 509 24 56 and we will take it from there.
Work out for yourself what it would cost.
Enter your details; you will receive a proposal within one working day.
- We compare the offerings of several insurers
- An adviser checks whether the cover suits your activities
- We arrange the switch, including cancellation
A premium indication, not personal advice. Prefer to talk it through? Call 072 - 509 24 56.
In brief
For medical devices, pharmaceutical products, diagnostics and laboratory services, product liability applies under Article 6:185 of the Dutch Civil Code: liability for a defect, regardless of fault. Anyone who places a product on the market under their own name or imports it into the European Union is regarded as the producer under Article 6:187 DCC, even without a production line of their own.
The distinguishing feature of this sector is the long tail. A side effect, material fatigue in an implant or contamination in a batch of raw material can come to light years after supply. The question is then not whether you were insured at the time, but whether you still are at the moment the claim comes in. That difference lies in the basis of cover of the policy.
If you carry out clinical trials, separate requirements also apply to the insurance of trial subjects. That cover is separate from your product liability and from your professional indemnity cover as a research institution; do not confuse the three.
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What does liability insurance for life sciences cover?
The structure of the cover in three parts, with an overview per situation below.
Employers' liability
Accidents at work and occupational illnesses.
- Article 7:658 of the Dutch Civil Code
- Hired-in staff as well
- Not in traffic
Extensions
What is excluded as standard.
- Care, custody and control
- Work after completion
- Environmental damage
What is covered
| Situation | AVB | Another policy |
|---|---|---|
| Injury to a visitor or customer | Yes | No |
| Damage to a client's property | Sometimes | No |
| An accident at work involving an employee | Yes | No |
| Injury to staff in traffic | No | Yes |
| Damage to property in your care | No | Sometimes |
| Pure financial loss caused by a professional error | No | Yes |
This overview is general in nature and is not personal advice. What is actually covered, including exclusions, limits and the excess, is set out in the policy conditions and the insurance card (verzekeringskaart) of the insurer; you receive both before you take out cover. Taking out cover without advice? Then read what execution only means for you.
Where things go wrong in practice
Four points that make the difference between a policy that pays out and one that does not.
Retroactive and run-off cover determine whether you have cover
If your policy works on a claims-made basis, what is decisive is when the claim is made, not when the product was supplied. If you change insurer, arrange retroactive cover for supplies made in the past. If you stop a product line or wind up the company, buy run-off cover for a period that matches the life of the product. After the first claim it can no longer be bought.
Traceability down to batch level
If one batch of raw material or one production batch turns out to be non-conforming, your records determine whether you approach a hundred customers or the whole market. Keep a record for each batch of which raw material went into it, which release parameters applied, who supplied it and to whom you supplied it. That documentation is also the foundation of any defence that the product met the state of scientific knowledge when it was placed on the market.
Contract research is a service, not a product
If you carry out analyses, validations or research for others, the loss from a mistake is usually financial: a failed study, a rejected registration application, a lost development programme. That is pure financial loss and falls not under product liability but under professional indemnity insurance. Businesses with both a product arm and a services arm need both covers, aligned with each other.
Where the cover ends
The cost of a recall is not a third party's loss and calls for separate recall cover. Administrative fines from a regulator are not insurable. Supply to the United States and Canada is excluded on many European policies or arranged separately because of the claims climate there. The value of the defective product itself and the cost of replacing it also remain for your own account.
Care, custody and control is excluded as standard
Damage to property that you have in your care: borrowed, hired, being worked on or held in safekeeping: is not covered by the standard cover. For professions where this is the core of the work, a separate care, custody and control module with its own limit is essential.
The traffic gap
Your AVB excludes damage caused with or by motor vehicles. It is precisely there that the Hoge Raad (the Dutch Supreme Court) recognised a separate liability based on the duty to act as a good employer: an employer must arrange proper insurance for employees who take part in traffic for work. A WEGAS insurance policy fills that gap.
What does your premium depend on?
- Product category and risk class. Implants, injectable products and diagnostics weigh more heavily than excipients.
- Stage of the life cycle. Research, the clinical phase, market introduction and mature production each carry their own risk.
- Sales area. Supply outside the European Union, and North America in particular, is assessed separately.
- Run-off period chosen. The longer the tail you cover, the more heavily that weighs in the premium.
- Quality system and batch records. Demonstrable traceability limits the scale of a loss considerably.
- Share of services. Contract research and advice bring pure financial loss into play alongside product risk.
Insurers weigh these details differently. That is where your saving is.
How we arrange it
- You request a quoteWe take stock of your situation, your risk and your wishes.
- We compareseveral insurers, on premium as well as conditions.
- You receive a proposalWith an explanation of the differences and the exclusions.
- We arrange the switchIncluding cancellation, so there is no gap in cover.
9.5New policy
9.8Claims handling
Customers rate our service on four aspects: personal service, service delivery, availability and the outcome. The reviews are collected and published by NH1816 and come from customers who have actually taken out a policy with Finass Advies B.V. or reported a claim.
Frequently asked questions
This is what people ask us most.
What does the long tail mean for my policy?
That the claim comes long after the product left your door. Under a claims-made policy there must still be valid cover at that point. If you stop the activity, that cover falls away while the risk continues. Run-off cover bridges that period and must be bought before the policy ends, not afterwards.
We only import; does that make us the producer?
If you place a product from outside the European Union on the market here, you are regarded as the producer under Article 6:187 DCC. The same applies if you sell it under your own name or brand. The manufacturer's liability then rests with you, including the burden of proof about design, composition and instructions.
Does this policy also cover our trial subjects?
No. Research on human subjects requires separate compulsory insurance for trial subjects, with its own conditions and statutory amounts. It covers loss caused by taking part in the trial. Your product liability insurance relates to the product itself, and professional indemnity insurance to errors in your research and reporting. All three are separate policies.
When do I have to report a possible claim?
As soon as you know of a circumstance that could lead to a claim: a cluster of adverse event reports, a non-conforming test result from a batch or a customer complaint about a defect. Article 7:941 DCC requires timely notification and the provision of all relevant information. A timely notification of circumstances keeps the claim within the current policy year.
Read more
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Ready to compare?
Request a quote without obligation. We will look at which insurer best matches your activities and your risk.
Prefer to call? 072 - 509 24 56, weekdays 09:00–17:00.
Claim on the road? Emergency line 06 - 55 20 40 72.
About our service
Finass Verzekert is a trading name of Finass Advies B.V. We advise on and arrange non-life insurance on the basis of an objective analysis of several insurers, and receive commission for this from the insurer, which is included in the premium. You pay no separate advice fee. Before you take out cover, we establish your wishes and needs.
You will find our licence, KvK and Kifid details and our complaints procedure at the foot of every page.
This page was written and checked by an adviser at Finass Verzekert. Last updated on .
The information on this page is general in nature and is not personal advice.