Several pharmaceutical companies are acquiring insurance cover from domestic general insurers for their clinical trials to develop vaccines, including COVID-19 vaccines.
Some of the general insurers which have provided these covers include New India Assurance, ICICI Lombard General Insurance and Raheja QBE General Insurance, reported The Indian Express.
Insurers in turn have sought reinsurance support for such coverage from India’s largest reinsurer General Insurance Corporation (GIC Re).
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 a claim-made basis, said Atul Sahai, Chairman and managing director of New India Assurance, the largest general insurance company in the country.
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, managing director and CEO of Raheja QBE General Insurance. The policy also provides cover for medical expenses in respect of such subjects who sustain injury arising out of their participation in a trial.
The insurance is applicable until the trial of the particular medical product or vaccine covered is completed. Once the product is launched in the market, the cover ceases to operate. “
Raheja QBE General insurance has issued 119 Clinical Trial Liability Insurance policies including 53 covers exclusively COVID-19 clinical trials from April till November 2020. Of the 53 new policies extended for clinical trials for developing COVID-19 remedies, some companies have taken more than one policy.
Sources say the premium for a Clinical Trial Liability Insurance policy is based on the risk exposure and depends on a wide range of factors. It may range anywhere from less than INR100,000 ($1,366) for simple trials for limit of liability as low as INR5m to over INR10m for complex trials for high limits of liability ranging from INR500m-700m.
While most of the companies which have bought the cover are Indian companies, some foreign companies and joint ventures/partnerships have also taken this cover, Mr Arora says 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.