Risk Partners Life Sciences Roundtable 2024, thank you very much! Already for the 26.06.2025 >
Risk Partners Life Sciences Roundtable 2024, thank you very much! Already for the 26.06.2025 >
How to properly insure clinical trials to protect subjects and satisfy the ethics committee.
Clinical trials are required to test non-approved drugs or new medical devices. The trial subject insurance discussed on this page is mandatory and serves to protect the trial participants, irrespective of any contractual or tortious basis for liability. The insurance is taken out in favor of the trial participant with a special insurer approved within the scope of the German Medicinal Products Act (AMG) or Medical Devices Implementation Act (MPDG) or Medical Device Regulation (MPG) - usually with the help of a special insurance broker such as us as your risk partners.
In contrast, it is not mandatory to take out test person insurance if it is not a clinical trial to test a medical device or a medicinal product. Therefore, scientific studies or clinical trials of food supplements, for example, which are often carried out for marketing purposes, are not subject to compulsory insurance. However, voluntary insurance to protect the test subjects should be considered.
This is due to the Declaration of Helsinki. In 1964, the World Medical Association committed itself for the first time to strict compliance with ethical standards in medical research in a self-declaration. Principles:
A challenge for governments around the world
In Germany, insurance for test persons has been mandatory since 1978. Across Europe, corresponding laws were only introduced after 1985(introduction of the EU directive on product liability).
Subject insurance must cover damage caused by the conduct of a study or other clinical trials in which a person is killed or physically injured or their health is impaired in any way. The insurance must also provide benefits in cases where no one else is responsible for the damage. The main promise of trial subject insurance to trial subjects applies, for example, in the event of permanent disability or death.
Sponsors of clinical trials for medicinal products or medical devices are required by law to provide evidence of subject insurance in order to obtain official approval to conduct the trial. Ethics commissions therefore also prescribe a corresponding insurance policy for trial subjects. For other types of clinical trials for which there is no statutory insurance requirement (such as new examination and treatment methods), many sponsors also take out appropriate insurance to protect the test subjects. We are also increasingly seeing that a corresponding promise of insurance can be helpful in recruiting trial subjects and that voluntary benefits such as accident insurance for trial subjects on the way to and from the study center are now commonplace.
Possible additional cover
From a risk management perspective, it is essential to create a common risk awareness in the first step, which is largely supported by the risk strategy. Convince your investors in the due diligence process of your next financing round with a risk report and a deep understanding of your risks, thereby safeguarding against risks that could threaten your company's existence.
On the basis of sound risk and insurance management, we develop a decision-making basis for your company. You decide what to insure and what not to insure. Because not every risk is worth insuring. Here is our basic approach:
Your added value through active risk and insurance management:
The importance of this for young growth companies was demonstrated not least by the Silicon Valley Bank case, which was identified as part of a risk management process and - if necessary - would have led to an adjustment of the banking/treasury strategy.
If a clinical trial falls under the German Medicinal Products Act (AMG), according to § 40a General requirements for the clinical trial.
Beyond the requirements of Regulation (EU) No. 536/2014, a clinical trial may only be conducted as long as:
in the event that a human being is killed or the body or health of a human being is injured during the conduct of the clinical trial, insurance exists which also provides benefits if no one else is liable for the damage, in accordance with the following provisions:
What many companies only become aware of in discussions with the notified bodies is the obligation to provide insurance in accordance with MDR Article 10, Paragraph 16 (2), which is worded as follows:
"Manufacturers shall take precautions appropriate to the class of risk, the nature of the product and the size of the undertaking to ensure adequate financial coverage of their potential liability under Directive 85/374/EEC, without prejudice to more stringent protective measures under national law."
"Thanks to the partnership with our subsidiary "Atrialis GmbH - experts in clinical trial insurance", we are one of the leading specialists in the market. Thanks to our many years of experience, we offer you competent support in the risk structuring and risk transfer of complex international trials as well as in the event of claims for trial subject insurance."
The insurance premium for subject insurance cannot be quantified across the board, but is usually between 30 and 400 euros per subject. Pure screening subjects are usually included without a premium, as is the placebo cohort. The following criteria are taken into account in the insurer's risk assessment:
The last point can become very important, for example, if you have to cover the very high sums insured required by the German Ethics Commission for a particularly risky study project (see also the following section on the special features of international studies). This is where a national provider can reach its limits - in case of doubt, even if it continues to purchase capacity from its (expensive) reinsurers. We discuss this problem, which is particularly common in the insurance of multinational clinical trials, with you at an early stage after we have studied the trial project, as experience has shown that, in addition to the fulfillment of requirements, an insufficient sum insured can become a problem at the end of the trial. In order to avoid uneconomical emergency solutions, we structure this for you at the outset, e.g. by adding 2-3 insurers (keyword: co-insurance & excess liability insurance).
In certain countries, such as the USA, we are seeing a trend of trial sites demanding a higher limit in trial subject insurance than the pure regulatory requirements of ethics and legislation. In the USA, for example, a USD 5 million limit is sufficient by law, but some trial sites demand a limit of at least USD 10 million per claim and in aggregate as a total amount. This serves to extend their protection against potential liability cases, which can also exceed the regulatory framework. There is no (liability) limit due to the statutory minimum requirements. The solution can be a voluntarily higher sum insured for individual countries or study centers, e.g. in order to win them over in the event of increased recruitment costs and to meet their requirements for participation in the study. Umbrella cover is usually installed for a trial participant insurance policy, which, like an umbrella, offers additional, comprehensive protection if the preceding basic cover of the trial participant insurance is exhausted.
This can also be the case with an extended reporting period (ERP), for example, where an umbrella insurance policy extends the cover in accordance with the desired or required term. The risk carrier of the umbrella cover is usually different from the insurer of the underlying proband insurance. This means that limits and premiums, as well as the content of cover (e.g. term of the ERP) can be negotiated better and more attractively, as "weaknesses" in the proband insurance can be closed and negotiated with the umbrella solution.
Advantages of an umbrella solution for the study sponsor:
Studies in several countries must comply with local laws and regulations, required sums insured and the issuing of policies in the local language, which is why country-specific policies are necessary. This starts with different legal standards and lower or higher prescribed sums insured per test subject. Local policies can also be used to meet the requirements of statutory subsequent liability periods and the special feature that all participants in the study must be able to read the insurance policy in their local language.
It is also advisable to provide a no-fault indemnity for volunteers to ensure the required insurance coverage according to local laws. This no-fault insurance is required by law in many countries where you may be conducting your study.
Or would you have thought that the maximum compensation per test subject is subject to an extreme range within the EU member states? We are therefore seeing an increasing trend towards additional umbrella cover, particularly for multinational studies, in order to make insurance cover uniform, transparent and risk-adequate. For example, the statutory limit can vary significantly from EUR 29,000 to EUR 5,000,000 per subject in other countries. Umbrella cover is therefore available for all study countries and offers protection if the local minimum requirements for proband insurance have been exhausted.
We are familiar with these challenges and, thanks to our many years of intensive contact with leading insurance companies from international projects in almost every country in the world, we can offer you a solution for test person insurance. Even with the most important insurance market in the world Lloyd's of London in order to organize special studies and higher levels of cover if required. Last but not least, we recently joined forces with our experienced colleagues at Atrialis GmbH - experts in clinical trial insurance (formerly Aric Advances Risk & Insurance Consulting, known for its "aric trial insurance approach", among other things) and pool our experience. In future, this will also be reflected in the addition of a medical expert to the team, who we will involve accordingly in the event of a claim.
We are highly specialized, so we can tell you immediately whether this is our area of expertise (e.g. fire insurance for a sawmill is not), but international proband insurance is.
As an independent insurance broker, we work with all insurers relevant to our specializations in the continental European and UK markets to ensure that the study center in Brazil is also covered locally and compliantly. As part of our consultation, we will discuss with you the optimal marketing strategy for your risk for our tender.
Senior Risk Advisor Financial Lines
Depending on the specific requirements, we offer various insurance solutions, whether it is a trial subject insurance for Europe through a single insurer or a structured, worldwide program with excess insurance, which enables sufficient capacity to be secured. Our aim is to present you with a range of options so that you can make the best decision regarding your choice of provider.
It is then ultimately up to you to decide whether we should implement the proposal
Your risk changes (e.g. new study center in Belarus insurable at all?), we discuss with you possible adjustment options or urgent need for changes to the insurance. Claim? You call us first and we will handle the claim for you on an equal footing with the insurers. Risk Partners & Atrialis - experts in clinical trials, your insurance experts!
Request our guides now
Everything you need to know to optimally protect your clinical trial from Risk Partners & Atrialis - experts in clinical trial insurance.