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 Yet, while more than 40 experimental COVID-19 vaccines are being
tested on humans, the insurance companies with decades of experience
in assessing the risks of clinical trials don't see anything to be
unduly concerned about.
Executives at insurer Allianz and brokers Gallagher and Marsh, among
the leading players in clinical trials insurance, told Reuters that
premiums had only marginally increased so far in the current
pandemic.
They argued there was little structural difference to trials carried
out in the past, despite drugmakers around the world competing to
shatter the fastest time in history for developing a vaccine, which
stands at around four years.
"Rates have been relatively stable. Even this year we have so far
seen only moderate price increases on average, with higher price
jumps for particularly exposed COVID-19 trials," said Mark Piazzi,
senior underwriter liability at Allianz Global Corporate & Specialty
(AGCS).
This was echoed by David Briggs, managing director, life sciences
practice at Gallagher, who said every trial was rated on its methods
and the kinds of patients involved.
Gallagher said premiums in Britain, for example, started at about
5,000 pounds ($6,500) per trial.
Total claims limits in policies were typically set at roughly $6-12
million, depending on the country's rules, according to several
insurance companies interviewed by Reuters.
In Britain, for instance, claim limits were usually set at no lower
than 5 million pounds, while in Germany the figure was around 10
million euros ($11.8 million).
'LOSS EXPERIENCE NOT DRAMATIC'
However part of the reason why premiums have not risen as sharply as
some people might have expected is that claims from trial are
generally uncommon, according to executives. This is because
patients have often signed so-called informed consent agreements,
they said.
Jim Walters, managing director of Life Sciences & Chemical Group at
broker Aon, said such agreements outlined the risks that patients
were taking by participating in the trial.
"So, you know, everything from you could have a sore spot on your
arm. To you could potentially die. And you know, they would
literally go that far in some of these protocols," he added.
"Those generally tend to hold up in courts and in legal systems
around the world. That means that the loss experience coming out of
clinical trials is not very dramatic."
Claims are often limited to circumstances linked to the improper
conduct of trials or any wrongdoing, rather than side-effects of the
treatment, executives said.
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Such have been the worries about the vaccine race among some members
of the public, who fear safety standards could slip, that nine
developers issued a joint pledge last month to "uphold the integrity
of the scientific process".
ASTRAZENECA TRIAL SUSPENSION
AstraZeneca and Oxford University's suspension of global Phase III
trials of their experimental COVID-19 vaccine early last month due
to a participant's illness brought the risk of side effects in
clinical trials to the public fore.
But the insurers said such delays were not unexpected, and could
even reflect the extra caution of vaccine developers given the lack
of data about COVID-19.
"Side effects always happen with clinical trials, but these are
typically mild and expected. It is not very common to delay or
suspend trials, it does happen though," said Piazzi at AGCS, whose
main peers in underwriting trials include Chubb, HDI and Fairfax's
Newline.
"Pharma companies and insurers alike are even more careful than
usual with COVID-19 trials because there is so much at stake,
particularly for the patients' safety."
All trials of the vaccine candidate have resumed, with the exception
of the U.S. study.
There have been examples in recent memory of drug trials going
catastrophically wrong, though.
In 2016, for instance, one participant died and five were
hospitalised in a Phase I trial run by French company Biotrial in
the city of Rennes, testing an experimental mood brightener made by
Portuguese drugmaker Bial.
In 2006, six patients required intensive care after receiving a
potential treatment against leukaemia and auto-immune disease in
London. One was described as looking like "the elephant man" after
his head swelled. Another lost fingertips and toes. Germany's
TeGenero, the initial developer of the medicine, folded.
But insurance executives stress such disasters are rare, given the
thousands of clinical drug trials being carried out every year.
Walters of Aon, speaking about the 2016 trial, said it was
"obviously a horrible situation".
"But that's one of very few incidents of really bad loss experience
that the industry has faced. So, clinical trial insurance is not
hugely expensive. Let's put it that way."
(Reporting by Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger;
Editing by Pravin Char)
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