Clinical Trials Insurance

Clinical Trials are vital and important for finding new, better & more effective medicine. Whenever any new medicine/therapy is to be launched, it must first be tested in lab on animal or human cells. If the results are encouraging than it is tested on human beings. There is commercial advantage to the firms that produce the first approved drug for a disease. That being the situation, there is dramatic increase in clinical trials. India has now become a favourable destination for clinical trials because of availability of expertise, infrastructure and availability of patient/research subjects at low costs. Although significant worldwide drug and medical device R&D activity remains within the United States, representing close to 50% of total worldwide expenditure, over the last 10-15 years a clear trend towards globalization has emerged. As a result of these and other factors, many drug and medical device companies are looking overseas to supplement or substitute for U.S. based studies, and Western Europe is no longer the only preferred destination for it. New countries including China, India and various South American countries are emerging as preferred foreign site locations. These countries offer ample patient populations, faster enrolment rates and less stringent regulatory environments necessary to initiate and complete effective clinical drug testing. In any case, in today's litigant society, parties are sued regardless of who or what caused injury or death. Recently in India, the Supreme Court said uncontrolled clinical trial of drugs on humans by multinational companies was creating "havoc" in the country and slammed the Centre for failing to stop the "rackets" which has caused a number of deaths. The apex court asked the government to handle the problem on an "urgent basis" and protect health of citizens of the country and instructed that illegal trials must be stayed,"

Products Liability Insurance does not normally include the liability of an unproven, unregulated product in its testing stages. Usually, this isn't a problem for manufacturers, since products aren't distributed until the company and regulators feel the products are safe under normal use circumstances. In the case of pharmaceuticals, medical devices or diagnostics, this isn't correct. Testing is normally conducted in phases that can span years. Especially in the later phases of testing, when clinical trials testing are being conducted, there may be significant, uninsured liabilities incurred by the manufacturer. These potential liabilities have created the need for clinical trials liability insurance. From a risk management perspective, a sponsor company must take its clinical trials loss avoidance very seriously. While your company may be covered for general liability, it is probably not covered for clinical trials liability. A company needs to purchase additional liability insurance specifically designed to cover clinical trials. This is a specialty area in the insurance industry and all clinical trial policies are different. It is important to make certain that your policy is specifically written to cover all of the exposures for anticipated trials.

This being the ground reality, insurance must form part of any risk management philosophy of all pharmaceutical companies. As such any company conducting clinical trials, needs proper monitoring and adequate insurance cover. So in spite of all precautions being there, liabilities may arise due to the human error element and other factors and these can be only be countered with the help of insurance.

UNISON as your broker, will assist you in understanding best clinical trials insurance coverage options available, including various countries regulation and requirement of admitted insurance coverage, certificate of insurance, modification in policies and can also help you to arrange annualised master cover rather than 'trial based' policy.