Insurance for healthcare and pharmaceutical companies
The one sector where insurance is not only compulsory by law, but where its minimum amount per person is set in a statute and the burden of proof runs, for a year, against whoever is doing the research.
What it is
In healthcare, being insured is a condition of operating rather than a management decision. Spain's Health Professions Act requires liability insurance, a bank guarantee or another financial guarantee both from professionals practising privately and from private legal entities providing any kind of health service. And the autonomous regions set the essential conditions of that cover, so the framework is not identical across the country.
The second particularity is that the sector answers along three separate routes at once. For the professional act, with its individual claim. For the product —a medicine or a medical device— under the defective-products regime. And for the service, because the law expressly places health services under a special liability regime with a cap of its own.
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At a glance
- Minimum guaranteed in a clinical trial
- €250,000/subject
- Presumption of causation
- 1 year
- Special-regime cap
- €3,005,060.52
- Broker registered with the DGSFP
- J0140
In healthcare, insurance is a condition of operating. And one detail sets the sector apart from every other: the same activity can answer along three routes at once — the professional act, the product and the service — and each has its own regime, its own timescale and its own cap.
The duty reaches the entity, not only the professional
Article 46 of Act 44/2003 requires liability insurance, a bank guarantee or another financial guarantee from health professionals in private practice and also from private legal entities providing any kind of health service.
That is where the sector's commonest gap comes from: the claim goes against the provider and the clinician at the same time, and if the provider's policy does not cover the professionals by name — including those collaborating without an employment relationship — the exposed point is exactly where the claim concentrates. The detail is in the professional indemnity page.
It is also worth checking the region: the same article leaves the essential conditions of the cover to the autonomous communities.
In clinical trials, the statute sets the figures
Royal Decree 1090/2015 is unusually specific. Its article 9 makes the sponsor responsible for insurance or a financial guarantee being in place covering the sponsor, the principal investigator and collaborators, and the site, documented before the trial starts.
And its article 10 sets the rest: a presumption that harm came from the trial during the trial and the year that follows — after which the burden of proof shifts to the subject — a minimum guaranteed amount of €250,000 per person, and the option to set a maximum of €2,500,000 per trial and year.
Health services have a regime of their own
Less well known: article 148 of the consolidated Consumer Protection Act places under a special liability regime those services carrying a guarantee of set levels of effectiveness or safety, and names health services expressly, with a cap of €3,005,060.52.
And there is a route to a claim that does not dispute the technique at all: informed consent. Article 8 of Act 41/2002 requires it in writing for surgery and for invasive diagnostic and therapeutic procedures. Impeccable clinical work with defective consent is still a viable claim.
Why through a broker
As a broker registered with the Spanish Directorate-General for Insurance and Pension Funds under reference J0140, New Brokers works on the client's mandate, not on behalf of any insurer.
In healthcare the work concentrates on things that do not show when comparing premiums: who is named as insured alongside the company, how the retroactive date lines up with the real life of claims, and whether the programme covers all three routes — act, product and service — without leaving a stretch between them. It is an alignment reviewed alongside the professionals' contracts and the consent protocols, not just the policy wording.
What this sector is exposed to
Liability for the clinical act
The claim over diagnosis, treatment or follow-up, brought at once against the provider and against the professional who signed the care.
Defective information and consent
The claim that does not dispute the technique but whether the patient was informed and consented in writing where the law requires it. It is a standalone route to liability.
Harm in a clinical trial
Harm suffered by the subject during the trial and in the year that follows, with a presumption of causation in their favour and minimum amounts fixed by statute.
Defective medicine or medical device
Manufacturer and importer liability under the defective-products regime, with its deductible, its long periods and its overall cap.
Health data breach
Compromise of clinical records, which are a special category of data and raise regulatory and reputational exposure directly.
Cold chain failure and critical equipment breakdown
The storage failure that ruins stock or samples, and the outage of a diagnostic device the provider's activity depends on.
Cross-contamination and batch recall
The manufacturing incident that forces a product withdrawal, at a cost that does not travel with ordinary liability cover.
Directors' liability in healthcare groups
Decisions of the governing body in providers with a board or investors, distinct from clinical error towards a patient.
What the law requires of you
The obligations that, in this sector, trigger the purchase of a specific cover.
| Rule | What it requires |
|---|---|
| Act 44/2003, on health professions, art. 46 — View the legislation | It requires health professionals practising in private healthcare, and private legal entities providing any kind of health service, to take out liability insurance, a bank guarantee or another financial guarantee covering the compensation arising from any harm to people. The autonomous regions set the essential conditions of that cover. |
| Royal Decree 1090/2015, on clinical trials, art. 9 — View the legislation | It makes the sponsor responsible for insurance or a financial guarantee being in place covering harm to the subject and the liabilities of the sponsor itself, the principal investigator and collaborators, and the hospital or site where the trial runs, documented before it starts. Low-intervention trials fall outside it where the site's own policy already covers them. |
| Royal Decree 1090/2015, on clinical trials, art. 10 — View the legislation | It presumes, unless proven otherwise, that harm to the subject's health during the trial and in the year after treatment ends was caused by the trial; once that year passes, proving the link falls to the subject. It sets a minimum guaranteed amount of €250,000 per person and allows a maximum of €2,500,000 per trial and year. |
| Consumer Protection Act (consolidated text), art. 148 — View the legislation | It places under a special liability regime those services that by their nature carry a guarantee of set levels of effectiveness or safety, and expressly names health services among them. Liabilities arising under this article are capped at €3,005,060.52. |
| Act 41/2002, on patient autonomy, art. 8 — View the legislation | It requires the patient's free and voluntary consent, which is generally verbal but must be given in writing for surgery, invasive diagnostic and therapeutic procedures and, in general, those carrying risks or drawbacks with a notorious and foreseeable negative impact on health. |
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Claim over missing informed consent
The patient does not dispute the technique used but says they were not properly informed before an invasive procedure.
What it means
It is a standalone route to liability: it can succeed even where the clinical work was correct. Article 8 of Act 41/2002 requires written consent for surgery and for invasive diagnostic and therapeutic procedures, so the defence rests on a document as much as on the clinical record.
Harm appearing eleven months after the trial
A trial subject presents a health problem within the year following the end of treatment.
What it means
Article 10 of Royal Decree 1090/2015 presumes the harm came from the trial unless proven otherwise, and that presumption lasts a year. It is the sponsor who must prove otherwise; after the year, the burden reverses. The minimum guaranteed amount is €250,000 per person.
Provider and clinician sued together
The claim is brought against the clinic and against the specific professional who treated the patient.
What it means
Article 46 of Act 44/2003 requires cover both from the private-practice professional and from the entity providing the service. If the provider's policy does not name the clinicians —including those collaborating without an employment relationship— an uncovered zone appears exactly where the claim concentrates.
The covers that structure your programme
Professional indemnity / E&O
The central line: it answers for the clinical act and for defective information, and it instruments the duty in article 46 of Act 44/2003.
General, employer's and product liability
It answers for damage on the premises and for a defective medicine or medical device, which follows the products regime.
Cyber risk
Clinical records are a special category of data: a breach here weighs more, in regulatory and reputational terms, than in any other sector.
Property damage and business interruption
It covers diagnostic equipment, stock and the cold chain, and the stoppage of activity when critical equipment fails.
D&O — Directors' and officers' liability
A management decision in a healthcare group with a board or investors is its own territory, distinct from clinical error towards a patient.
International programmes
Multicentre trials and marketing in several countries expose the company to very different liability regimes.
Frequently asked questions
What insurance does a clinic or healthcare provider need?
The core is medical professional indemnity, which is not optional: article 46 of Act 44/2003 requires insurance, a bank guarantee or another financial guarantee both from private-practice professionals and from private entities providing health services. On top of that come general liability for the premises, cyber risk for clinical records, property damage with business interruption for equipment and the cold chain, and D&O where there is a governing body. The scope of each is governed by the specific terms of each policy.
Is medical liability insurance compulsory?
Yes in the private sphere. Article 46 of Act 44/2003 applies to health professionals practising in private healthcare and to private legal entities providing any kind of health service. The same article leaves the essential conditions of that cover to the autonomous regions, so it is worth checking what the region where you practise requires.
What insurance does a clinical trial require, and for how much?
Article 9 of Royal Decree 1090/2015 makes the sponsor responsible for insurance or a financial guarantee being in place covering the sponsor itself, the principal investigator and collaborators, and the site where the trial runs, documented before it starts. Article 10 sets a minimum guaranteed amount of €250,000 per person taking part, and allows a maximum of €2,500,000 per trial and year.
For how long is harm presumed to come from the trial?
During the trial and the year following the end of treatment, harm to the subject's health is presumed to come from the trial unless proven otherwise. Once that year ends, it is the subject who must prove the link between the trial and the harm. That reversal of the burden of proof is what makes the cover period, and how it lines up with the trial calendar, so decisive.
Does a medicine manufacturer answer in the same way as a healthcare provider?
No, they are different regimes that can run together. A defective medicine or medical device follows the products liability regime, with its deductible, its overall cap and its long periods. The health service is additionally subject to the special regime in article 148 of the consolidated Consumer Protection Act, which names it expressly and caps liability at €3,005,060.52.
What documentation do you need to prepare a proposal?
The service portfolio and specialties, the number of professionals and how they are engaged, annual activity by type of procedure, whether clinical trials are sponsored or participated in and at what phase, critical equipment and its value, the volume of clinical records and the security measures in place, and the claims history with its procedural status.
This information is for guidance only and is not binding. Covers, limits and exclusions are governed in all cases by the specific terms of each policy. New Brokers Correduría de Seguros, S.L., registered with the DGSFP under reference J0140.