Page 43 - Insurance Times June 2021

CLINICAL TRIAL

PROCESS &

CLINICAL TRIAL

LIABILITY

INSURANCE

What is this Clinical Trial Requirement? History of litigation against the Clinical
It is obvious that- Trials Industry:
1. Commercial advantage to the firm that produces the
1. There has been significant increase in such litigation
first approved Vaccine/ Drug for a disease.
during the recent past.
2. There is thus dramatic increase in the number of clinical 2. The most well known suit was filed against the
trials worldwide to fight against this pandemic.
University of Pennsylvania by the family of Jesse
3. Hence, the demand for risk management measures and Gelsinger, an 18 year old man who died participating
availing the Clinical Trial Liability Insurance has been in 1999 in a gene therapy trial.
amplified.
3. These are not isolated incidents.
4. The clinical trials have largely been sheltered from 4. In the days to come, we may expect such litigations in
liability suits unlike other industries.
India also connected to trials for vaccines.
5. The norms are changing now for the immense & urgent
requirements for the vaccines. The opportunity & potential in India:

1. India has become a favourable outsourcing destination
About the author for IT and host of other activities and the latest to join
is clinical trial industry with the targeted populace of
Anabil Bhattacharya 136.64 Crores to be served for vaccination phase by
B.M.E. (Honours), F.I.I.I., phase.
Risk Inspecting Engineer & Insurance 2. India has to alter its drug and cosmetics rule under
Counselor, Retired Chief Manager, H.O., pressure from WTO, multinational drug companies and
National Insurance Co. Ltd., Kolkata.
clinical research organization.

The Insurance Times, June 2021 43