The Unique Complexities of Clinical Trials

As the global focus looks to pharmaceutical companies for a vaccine to combat the transmission of coronavirus, it is worth reflecting upon the intricacies of clinical trials and the often complex nature of clinical trials insurance.

Before a pharmaceutical drug becomes available in the market, it goes through several phases of research and development, followed by extensive clinical trials for various testing phases. Clinical trials are often conducted in multiple markets worldwide and involve collaboration between many different organisations, including research institutions, universities, hospitals, contract research organisations, pharmaceutical and biotechnology companies.

The insurance of clinical trials has its unique complexities. Clinical trials are subject to a high degree of regulation, and each country is governed by its own strict rules to ensure the protection of its citizens. Since organisations face potential liability from their involvement in clinical studies, it is necessary to have a specialised insurance program to anticipate and mitigate the various risk exposures.

There are several key points to be considered when addressing clinical trials insurance coverage:

• Is local insurance required?
• What information is required on the policy document/certificate?
• Is an insurance certificate required for each clinical trial or is a generic certificate sufficient?
• Is cover on a no-fault basis?
• Do the limits of liability vary from a local sponsor to that of a foreign sponsor? 
• Does the policy compensate the injured directly or indemnify the sponsor for its liabilities?
• Do the sponsor’s vendors (CRO, clinics, healthcare providers and investigators) need their own insurance?
• Is medical malpractice insurance required for the medical staff involved in a study?
• Are there any additional ethics committee or regulatory requirements for additional cover for patients travelling to and from study site?

The answers to these questions can vary from territory to territory.

For example, in the Netherlands, non-admitted is not allowed, except where prior approval has been obtained from the regulator, though insurers from EU/EEA members may write business under FOS legislation and subject to the appointment of a claims representative responsible for the handling and settlement of claims established in the Netherlands.

Kenyan regulators stipulate the following compulsory insurance: Clinical trials liability, Professional indemnity for investigators involved in clinical trials, liability insurance for clinical trials host institutions covering investigators, those acting on behalf of the investigators, and its research members.

For trials in Germany, the named insured does not have to be a Local Entity, however, the clinical trial must be started in Germany.

In Italy, the Standard Extended Reporting Period is 36 months; 10 years is required for trials involving children, gene therapy, cell therapy and radio-pharmaceutical.

Compulsory minimum limits vary between Australian states: Vic: AUD 10mn (specific legislation applies) but in NSW: it is AUD 20mn. Other states and territories normally specify a minimum of AUD 10mn.

For more information on these and other territories, contact us about Axco's Clinical Trials service that focuses on the insurance regulatory requirements for Clinical Trials in over 170 countries. With key information presented in a simple Q&A format, you can quickly access the answers to the compliance questions that matter most.