With the COVID-19 pandemic dominating headlines across the globe now for the best part of the last year, our health has never been more at the forefront of our minds. In recent months, meanwhile, the stories have pivoted away (somewhat) from the lockdowns and infection rates towards something a little more hopeful – the vaccines that will get us all out of this mess.

These vaccines have been developed at lightning speed by some of the most innovative scientists and  pharmaceutical companies in the world and the pace of vaccine development has relied on a multitude of new clinical trials.

Clinical trials have been a part of medical science for decades now and some of the greatest advances in medicine couldn’t have been made without them. There are, however, always going to be risks associated with such trials. If a participant has an adverse reaction to the as-yet untested medicine, for example, what kind of liability does the pharmaceutical company behind the trial have for the health and safety of the patient?

Volunteers are always protected by a high-spec framework of risk management, of course, but there’s always an element of risk. This is why it’s imperative all institutions that undertake clinical trials have specialist clinical trials liability insurance in place.

With new EU regulations set to change the landscape further, with which the UK is likely to align, and the pandemic moving the goalposts every step of the way, clinical trials insurance has never been a more vital piece of the puzzle.

What does clinical trials insurance cover?

Negligent harm – Harm caused during a clinical trial as a direct result of alleged negligence.

Non-negligent harm – Harm that occurs as a result of the trial but with no specifically definable cause. Policy wording here should always work in accordance with the guidelines for regulators in each territory.

Who needs clinical trials insurance?

In the majority of cases, it will be the sponsor of the clinical trial that arranges the insurance and this can be anyone from a pharmaceutical company to a University or a biotech company. In short, if you are an institution that uses clinical trials to further your development then it’s a cover you can’t operate without. You should also sort out insurance ASAP, as you often need the certificate of insurance to hand when you submit to the ethics committee.

The evolution of clinical trials insurance

Clinical trials were once solely about drug development. However, today the landscape has changed. Modern clinical trials might involve testing new equipment or procedures and these trials come with their own risks that need to be covered by more specific lines of cover.

Say, for example, that a software error occurs when uploading medical imaging software. This error then means the patient has to have multiple images retaken, causing added emotional and physical distress. Years ago, this wouldn’t have been covered but insurers have had to adapt to changing technologies and changing trends.

We also live in an increasingly litigious world, where medical lawsuits are distressingly common and can lead to reputational damage and financial loss too. Then there are the latest EU regulations on clinical trials (from 2019) which affect both the limit of cover stipulated and the way the insurance is structured.

Finding a clinical trials insurance broker

Any broker offering a specialist life science policy should be able to arrange clinical trials insurance, either as an extension of existing cover or a separate policy. If it’s part of a broader insurance portfolio then it’s more likely to cover every base.

All specialist brokers should have genuine expertise in life science insurance, be agile enough to respond rapidly, understand country-specific requirements and have foreign and domestic capabilities.

Ultimately, it’s up to each trial sponsor to ensure they have an open and honest partnership with their insurance broker. In a fast-moving, competitive environment. it’s always the human beings at the centre of the trial that should come first. Without these volunteers taking their own risk, there would be no trial.

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