A host of pharma companies have opted to buy insurance covers from domestic general insurers for their clinical trials to develop such vaccines in the country. Some of the general insurers who have provided these covers include New India Assurance, ICICI Lombard General Insurance and Raheja QBE General Insurance, sources said.
The insurance cover, known as ‘Clinical Trial Liability Insurance’, seeks to indemnify the insured, including institutions or organisations conducting clinical trials, against legal liability arising out of clinical trials on claim-made basis, said Atul Sahai, CMD, New India Assurance, the largest general insurance company in the country.
The policy covers serious adverse event on the volunteers. The legal liabilities may arise out of death and bodily injury or disease to volunteers while undergoing clinical trials of product specifically named and insured. The policy provides cover for legal liability arising out of lack of care or negligence resulting in injury or death of the subject participating in the trial, said Pankaj Arora, MD & CEO, Raheja QBE General Insurance.
The cover is taken till the particular medical product or vaccine for which the cover has been given is completed. Once the product is launched in the market, the cover ceases to operate. “The policy indemnifies the insured for legal costs, damages and compensation for injury or death caused to a research subject participating in a trial. The policy also provides cover for medical expenses in respect of such subjects who sustain injury arising out of their participation in a trial,” Arora said.
The cover is taken till the particular medical product or vaccine for which the cover has been given is completed. Once the product is launched in the market, the cover ceases to operate. The policy indemnifies the insured for legal costs, damages and compensation for injury or death caused to a research subject participating in a trial.
Raheja QBE General insurance has issued 119 ‘Clinical Trial Liability Insurance’ policies including 53 covers exclusively for the “Covid-19 Clinical Trials’’ from April till November 2020. Of the 53 new policies given for clinical trials for developing Covid-19 remedies, some companies have taken more than one policy.
Sources said the premium for a ‘Clinical Trial Liability Insurance’ is based on the risk exposure and depends on a wide range of factors. It may range anywhere from less than Rs 1 lakh for simple trials for limit of liability as low as Rs 50 lakh to over Rs 1 crore for complex trials for high limits of liability ranging from Rs 50-70 crore.
While most of these are Indian companies, some foreign companies and joint ventures/partnerships have also taken this cover, he said without disclosing the names of these pharma companies. Indian companies such as Zydus, Bharat Biotech and Gennova are developing indigenous vaccines, other domestic companies are collaborating with companies such as Serum Institute with AstraZeneca, Dr Reddys with Sputnik and Biological E with J&J.
Insurers have already received some claims against Covid-19 policies. Clinical trial cover market has grown at 30 per cent in India, but, this year, growth has been substantially higher due to Covid-19, Arora said.
India has a large pharma industry and some pharma companies have taken ‘Clinical Trial Liability Insurance’ for developing Covid-19 vaccine, said Sanjay Datta, chief–underwriting, claims, Reinsurance and Actuarial, ICICI Lombard General Insurance. “We have also issued some Covid-19 policies and have received some claims against these policies,” he said.
Although the domestic clinical trial cover market is Rs 400-500 crore, despite growing demands and claims, the premiums for clinical trials haven’t gone up post-Covid-19. Insurance officials said clinical trial premium is more expensive than other liability products. “We estimate the insurance market size to be about Rs 50 crore and our market share in the industry is around 10 per cent,’’ said an official.
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