Insuring Global Clinical Trials: Navigating Risks Across Borders

By Linda Van Fossen, Camellia Baker, and Tiffany Purcell, Woodruff Sawyer, a Gallagher Company

Foreign clinical trials insurance is a critical component in the global expansion of clinical research. As pharmaceutical companies and research organizations conduct trials across borders, they face a myriad of risks and regulatory requirements that vary by country. This specialized insurance provides coverage for liability that may arise during a clinical trial, ensuring compliance with local laws and protecting both the trial sponsors and participants.

For sponsors, such as pharmaceutical companies and contract research organizations, foreign clinical trials insurance is indispensable. It not only mitigates financial risks but also demonstrates a commitment to participant safety and ethical research practices. For participants, it provides reassurance that they will be compensated in the event of an injury or adverse reaction.

Key Features Of Foreign Clinical Trials Insurance

Foreign clinical trials insurance offers specialized protections to meet the legal, logistical, and safety needs of trials conducted outside your home country. They provide:

1. Liability Coverage: This includes protection against claims arising from injuries or adverse effects experienced by trial participants. In some jurisdictions, no-fault compensation is also required.
2. Regulatory Compliance: Different countries have unique insurance requirements for clinical trials. Policies must be locally admitted and compliant with the specific regulations of the trial's location.
3. Global Reach: Many insurers offer worldwide coverage through a network of affiliates, ensuring seamless support for multinational trials.
4. Tailored Solutions: Policies may be customized to address the specific risks associated with the trial's protocol, the investigational product, and the trial's location.

Challenges In Foreign Clinical Trials Insurance

Securing insurance for foreign clinical trials comes with unique hurdles:

• Regulatory Complexity: Navigating the diverse and evolving regulations across countries can be daunting.
• Timely Documentation: Certificates of insurance may need to be approved before a trial can commence, requiring speed, accuracy, and efficient coordination.
• Risk Assessment: Insurers evaluate factors such as the trial's design, participant demographics, and the nature of the investigational product to determine coverage terms.

When launching clinical trials, precision and timing are everything. It’s essential to work with a life sciences specialist broker who understands the intricate processes, regulatory complexities, and critical deadlines involved.

What Is The Process To Obtain Clinical Trials Insurance Coverage?

Each country requires different policies, terms, limits, and conditions — you can think about local clinical trial placements as visas, in that every country has its own entry requirements.

A few countries accept non-admitted product liability/clinical trials insurance (insurance written from the United States) for international clinical trials. However, most countries have their own laws and regulations that require local, compliant, admitted insurance coverage to be provided, and special policies need to be obtained. Reach out to your insurance broker at least 30 days in advance of the date you begin needing clinical trial coverage.

The basic information the insurance company will need is:

• A copy of the protocol and informed consent documents
• Duration of the trial
• Information on which countries the trials will take place in
• Number of participants
• Name of the clinical research organization

Some additional information may be required, such as translations and other data, depending on the countries in which the trials will take place. Work with your insurance broker to determine what information you need to provide for a quote. They can provide a form to gather this information, or they may use a spreadsheet or tool to help manage information for multi-country or multiple clinical trials.

For many European countries, there can be a very fast turnaround of quotes, and once the quote is approved, fast delivery of the policy and certificates of insurance. Typically, local admitted clinical trials insurance is written for the overall anticipated period of the clinical trial, unlike U.S. products policies, which are written for an annual period. Some countries, including India and Japan, require premium payment to be made before coverage can begin, so these take longer to finalize. In some countries, things move more slowly, and it takes a longer time to secure a quote. Your broker will assist in clarifying the estimated time to complete the placements.

The local admitted clinical trial policies will be compliant with the laws in the local jurisdiction, including no-fault coverage, if needed, in that country. The limits of coverage for these local policies are often lower than the coverage level purchased in the United States, and your U.S. policy will act as excess coverage to the local admitted clinical trial coverage, providing you with an additional layer of protection.

New International Rules Impacting Clinical Trials Coverage

Several countries and the European Union have new laws that affect clinical trials insurance:

• Switzerland extended its reporting period from 10 to 20 years and also extended its data retention period to 20 years for trials ending after March 1, 2025. Additionally, when adding a Swiss entity as the first named insured on a policy, life sciences companies must now involve a licensed local Swiss broker.
• In Brazil, non-admitted insurance coverage is now an option. The policy must be in Portuguese, there must be documented attempts to place the risk with at least 10 insurers, and it must be accepted by the SUSEP (Government of Brazil).
• Poland has updated its limits structure based on the study type — whether it's for a drug or device — with limits based on the number of patients.
• The European Union has implemented a new framework mandating that all clinical trials must comply with one of the following regulatory frameworks: Clinical Trials Regulation (CTR) for drugs, Medical Devices Regulation (MDR) for devices, and In Vitro Diagnostic Regulation (IVDR) for diagnostic tools.

Hot Topics In Clinical Trials Insurance

Staying ahead of insurance trends in clinical trials is crucial for ensuring smooth placements and comprehensive coverage. Here are some key topics to keep on your radar:

• Medical expenses are now a hot topic during clinical trial placements. Medical expenses should be sublimited within your clinical trials insurance policy, but if you don't think the limits are sufficient, supplemental coverage is available.
• We are also seeing an increased request for pregnant partner extensions, especially after binding. This is becoming more common in Argentina, Brazil, Colombia, and Belgium. It can cause a slowdown in the submission process, so find out beforehand whether or not pregnant partner extensions are needed.
• Finally, travel accident coverage is being increasingly requested — particularly in Austria and Germany — and we expect an increase in these types of requests.

Safeguarding Stakeholders

Foreign clinical trials insurance is a cornerstone of ethical and compliant global clinical research. Addressing the unique challenges of conducting trials across borders ensures that innovation in medicine continues to advance while safeguarding the interests of all stakeholders involved.

To obtain the necessary coverage in compliance with international regulations, work with a broker that understands your critical timelines and knows how to place compliant coverage quickly and efficiently to meet those needs.

A version of this article was first published by Woodruff Sawyer. It is republished here with permission.

About The Authors:

Linda Van Fossen, vice president, brings more than three decades of expertise in commercial insurance to her role, where she specializes in providing comprehensive risk management consulting to her clients. Throughout her career, she has worked extensively with businesses across industries such as technology, biotechnology, pharmaceutical, nutraceutical, and medical devices, as well as non-profits and construction.

Tiffany Purcell, team lead, healthcare and life sciences, has extensive experience managing complex life sciences property and casualty programs for Woodruff Sawyer. With more than a decade in insurance, Tiffany is experienced in medical technology, biotechnology, medical devices, and pharmaceuticals. She has placed products/clinical trial policies, and clinical trials in various countries, for various stages, as well as international property and casualty coverages.

Camellia Baker, vice president, life sciences practice, is responsible for managing global risk management needs of life sciences companies. Over the last 20 years, she has specialized in serving life sciences companies and has developed a deep expertise in managing exposures for this industry sector and providing customized risk management solutions for clients.