Insurance in the medical & life sciences sector: what is changing for your establishment

Emmanuele Viano

Analyses

5 minutes

23 September 2026

Medical devices: a tense market

The medical professional liability insurance market remains tight in 2026.

The claims ratio on premiums reached 92% in the last exercise published by the ACPR. In other words, for every €100 of premium received, insurers pay out €92 in claims, once other costs are taken into account, leaving little margin.

In addition, there is an inflationary context that increases the final cost of claims, especially those that are settled several years after the events.

After a restructuring phase between 2023 and 2025, a form of rebalancing is emerging for institutions with a more favorable risk profile. However, insurers remain cautious towards the most exposed structures, especially those with international activity.

Public institutions: pressure on bonuses is increasing

The situation remains particularly tense on the side of public hospitals. The most recent reports indicate an average increase of 16.5% in all-risk premiums in one year, with some contracts even doubling.

A situation of tension is developing, as we witnessed in the case of the Regional Hospital Group of Mulhouse Sud-Alsace (GHRMSA) brought before the Senate by Senator Ludovic Haye, who questioned the Minister of Health about the consequences of these increases for the financial management of hospitals (question published in the Official Journal of the Senate, March 12, 2026).

This situation is partly explained by the requirement to go through calls for tenders to subscribe to insurance, which limits competition. The main historical insurers in the sector maintain a strict selection of risks, even if their premiums increase moderately.

Mutualization is progressing

The hospital territorial groupings continue to consolidate their entities under a single insurance contract. This movement is accelerating with the consultations launched in 2025 and 2026, a sign of increasing professionalization of insurance purchases in the public sector.

This pooling also helps insurers, who are themselves subject to the European prudential regulation Solvency II To better measure and control their exposure to risk. However, consultants who work with the public sector remain cautious and recommend high levels of security.

Franchises remain underutilized.

Public institutions are gradually incorporating franchises into their contracts. However, the average level remains too low to truly hold the institution accountable for the risk, even though the trend is progressing under the effect of budget constraints and observations from the Court of Auditors.

Few public hospitals today accept high levels of retention. However, a more active financial management, combined with a better provision method for medium-term losses, would allow for better control of this expense.

Private establishments: a stable market, but not very innovative.

The private sector does not face the same difficulties as the public sector. The insurance market remains stable, but the offer remains little renewed, despite the recent arrival of new players, including specialized MGAs (managing general agents delegated by an insurer to underwrite and manage certain niche risks).

Retention mechanisms remain underdeveloped among local insurers. Captive insurance structures remain rare and are limited in practice to the three largest private clinic groups. However, the implementing decree of 2023 makes this type of arrangement more accessible to medium-sized companies in the health sector.

For medium-sized establishments, whether independent or grouped, contracts still largely rely on zero or very low franchises. The directions remain cautious in the face of a change in approach, while an evolution would allow for the release of financial margins useful for the development of healthcare services, in a context where private practice in private clinics is increasingly attracting young doctors.

Hôpital

Life sciences: three European texts to anticipate

Unlike the traditional medical sector, the life sciences sector remains dynamic, driven by innovation, the internationalization of players, and the arrival of new health technologies. However, this growth is accompanied by a regulatory environment undergoing profound changes. Three texts will particularly structure the coming months:

  • The European directive on liability for defective products (2024/2853)

    It comes into effect on December 9, 2026 and modernizes the rules of responsibility applicable to products, especially in the context of connected products and software integrated into medical devices.

  • The European Regulation on Artificial Intelligence (AI Act)

    Its obligations for so-called "high-risk" systems, a category that concerns some medical software, become applicable and create new compliance requirements.

  • The MDR and IVDR regulations on medical devices and in vitro diagnostic devices.

    The backlog of certification remains significant: over 33,000 requests have been submitted for 17,500 certificates issued to date, delaying the market release of certain products.

The transformations to monitor

Today, it is the blind spot of many analyses on health insurance, even though it is a major source of tension for both healthcare facilities and insurers.

"The recent incidents are limited to the large university hospitals."

The Gers Hospital Center (cyberattack with suspicion of ransomware, August 2025), the Haute-Comté Hospital Center in Pontarlier (ransomware encrypting some data and causing a temporary return to paper, October 2025), and the attack against the medical software Weda, which paralyzed a tool used by around 23,000 healthcare professionals in France (November 2025). The average cost of a cyber incident in the healthcare sector now exceeds 500,000 euros.

What are the concrete consequences for your insurance contracts?

Insurers now incorporate cyber hygiene requirements (multi-factor authentication, secure backups, regular audits) as conditions for subscribing to or maintaining coverage.

Compliance with the NIS2 directive is becoming an increasingly scrutinized criterion by subscribers for healthcare facilities considered as operators of essential services.

The cyber risk now overlaps with the product risk for connected medical devices, a point that directly relates to the new cybersecurity requirements imposed by regulations on defective products, mentioned below.

The question is no longer just "am I covered in the event of a cyber incident?" but "does my level of cyber maturity still determine access to coverage at the expected rate?"

Driven by artificial intelligence and innovative therapies (gene therapies, GLP-1 class treatments, connected devices), small and medium-sized companies in the sector are increasingly relying on insurance to support their international development. Special attention is paid to product recalls, which are more frequent in ophthalmology and sterile products.

The American litigation surrounding GLP-1 treatments concretely illustrates this risk. More than 3,700 cases were identified in June 2026 as part of a consolidated federal lawsuit (MDL) targeting manufacturers of semaglutide and tirzepatide-based treatments, with allegations including vision problems and gastrointestinal complications.

Some legal analysts evaluate the potential exposure of manufacturers to several billion dollars. This case primarily concerns multinational companies, but it sets a precedent and a level of compensation that all French life sciences companies must take into account when entering into partnerships or joint ventures with American players on comparable molecules or devices.

The number of joint ventures with American partners is also increasing, which requires adapting insurance contracts to the American legal context, marked by a continuous increase in the amount of compensation linked to the proliferation of class actions.

Faced with these changes, the insurance offer is being reorganized around packaged and modular solutions, designed to support the growth of companies in the sector. These offers now include reinforced requirements in terms of cybersecurity and security updates, which have become enforceable under the new regulation on defective products.

What this means concretely for your establishment

Two lines of reflection emerge from this overview, to be adapted according to the size and risk profile of your organization:

  • Reevaluate the level of retention and interest of a captive.  Le cadre fiscal français récemment révisé et la hausse continue des primes hospitalières rendent ces montages plus pertinents qu'auparavant, y compris pour des structures de taille intermédiaire.
  • Secure insurance programs related to clinical trials.  Pour les activités de sciences de la vie, un accord-cadre européen avec délégation de gestion permet d'intégrer plus facilement les nouvelles exigences issues de la directive sur les produits défectueux, de l'AI Act et des règlements MDR/IVDR dans les contrats.
Vélo en montagne

Discover the other trends in the insurance market for 2027

Discover the latest edition of our market report. In it, we analyse the key market trends for you, to help you better understand developments in the sector.

Download the document

Complete your reading

    Frequently asked questions

    From the date it comes into force on 9 December 2026, this directive requires insurance contracts to systematically incorporate requirements relating to cybersecurity, security updates and product compliance - criteria that are now legally enforceable. This comes alongside the implementation of the obligations under the AI Act for high-risk systems and the ongoing increasing complexity of the MDR/IVDR regulations, forcing medical device manufacturers to review their insurance programmes.

    The recommendation is to prioritise European framework agreements with delegated management, incorporating the requirements of the PLD 2024/2853, the AI Act and the MDR/IVDR regulations into the wording from the outset. This is particularly strategic against a backdrop of a growing number of joint ventures with the United States, where ‘social inflation’ and class actions are driving up compensation levels, and where product recalls are on the rise (ophthalmology, sterile products).

    The rise of gene therapies, GLP-1 treatments and connected devices is prompting SMEs in the sector to view insurance as a genuine driver of international growth. This trend is accompanied by increased scrutiny of cover for product recalls – which have risen significantly in the fields of ophthalmology and sterile products – and is driving the market towards packaged and modular solutions capable of supporting the growth of these innovative companies.