More than 80% of Australians over the age of 16 are now fully vaccinated but the impacts of the pandemic are far from over. Three COVID-19 vaccines are being used in the national rollout: AstraZeneca, Pfizer and Moderna, but, globally, researchers are currently testing more than 100 vaccines in clinical trials on humans. These trials require clinical trial liability insurance.
Honan Insurance Group is involved with at least five pandemic related trials. One of the COVID vaccine trials involves 20,000 participants and is nearing completion.
“There’ll be more to come I think as the different needs pop up in terms of the way the insurers and clients are looking at what they can actually bring to the marketplace and what advantages they can see with their own research,” said Daniel Reid (pictured), client manager and practice leader for Honan’s life science and biotech division, based in Melbourne.
There are a range of insurance needs around the COVID-19 healthcare response.
“A lot of that style of risk has really escalated as businesses and countries try to grapple with the pandemic so that’s definitely an area where we’ve experienced a pretty significant uplift,” he said.
Nearly two years after a COVID-19 outbreak was first identified in the Chinese province of Wuhan, Reid said vaccine trials still have a long way to go.
“I think, from memory, there was at one point over 250 vaccines being tested around the world. As we know there’ve been a lot that have been commercialized and are in use but given the various stages different countries are at and the various strains of COVID I think there will be a lot more testing to go in terms of getting vaccines and getting certain solutions in certain countries for particular needs,” said Reid.
It’s not a one size fits all solution, he said, partly because of the particular strengths and weaknesses of each vaccine.
“You’ve got people with certain health conditions, you’ve also got minors and different ranges of people with varying needs, so I think getting solutions around those sorts of issues is going to take a lot more research,” he said. “The organizations who are participating in this process are still working through those issues.”
Honan provides insurance coverage for a number of research and development clients. Many of these clients are involved in pharmaceuticals and bringing new products and devices to the market.
“Often these clients start from a new idea or a new development they’re researching and then they grow the company from there and quite often they need assistance around insurance requirements and regulatory compliance,” he said.
The need to expedite COVID-19 vaccine trials has contributed to the growth in this market. Reid said the pandemic related insurance and risk assessment work he’s involved with includes vaccine trials, PPE and testing equipment.
The Honan client undertaking clinical testing of a COVID-19 vaccine with 20,000 participants is conducting the trials across five or six countries, said Reid.
“They’re almost at the end of their phase three clinical trial testing of patients. From then on, they’ll be able to potentially roll out another vaccine on to the market for COVID, which is pretty exciting,” he said.
Honan has been assisting this company with their clinical trial insurance requirements around the globe.
“As soon as they’ve reached the point where they can actually test the drug on humans then they have to go through this pretty stringent compliance process where they work with clinical research companies and they start to recruit participants in different regions and different areas and then they go about testing the vaccine on these participants,” said Reid.
He said the process can be slow and is highly regulated.
“But that part of the risk is where we work on an insurance solution, which is essentially if any claim or any adverse reaction comes from the testing of the drug in terms of affecting any participants of the trial then the insurance would respond to cover any claim associated with that occurring,” he said. “So particularly around adverse events after the participants have had the test.”
Reid said the trial protocol and patient consent form are two key factors that determine how to price this sort of insurance.
“We’re looking at essentially the type of study which is really outlined in the study protocol. So, every clinical trial has a clinical trial protocol which outlines in detail the parameters of the trial. So the insurers will review the clinical trial protocol in detail. They’ll also have a look at the consent forms that the patients sign up to,” he said.
Another major rating factor is the number of participants involved in the study.
“Obviously the more participants essentially, the higher the premium will be, because they normally set the premium at a per participant rate,” said Reid.
Then there’s the duration of the study, which can be as short as a number of months or years long. There’s also the limit of cover.
“So, there’s a policy limit, essentially in Australia, the TGA [Therapeutic Goods Administration] stipulate that the client must carry a $20 million legal liability limit so that will be a standard coverage parameter that the clients have to take out as well,” he said.
