Human Clinical Trials Outside the US: How Do You Obtain the Best Insurance?

In the United States, obtaining insurance coverage for human clinical trials is fairly straightforward. However, when these trials are run outside the U.S., as is done frequently, this insurance becomes a complicated matter, to say the least.

If you’re planning to conduct clinical trials internationally, you’ll need to comply with each jurisdiction’s requirements for insurance coverage. While it can take a week or less to secure coverage for a multi-site trial anywhere in the U.S., a comparable trial overseas could take a month when dealing with the different regulations about not only what type of coverage to buy, but also how much.

Interestingly, the claims exposure for these trials is not the biggest insurance risk; clinical trials claims are infrequent. The more challenging issue when dealing with insurance for human clinical trials outside the U.S can be the regulatory hurdles. And the stakes are high: if you don’t obtain the coverage required, the trial won’t start.

The Inefficiencies Plaguing International Clinical Trials Coverage

Today, there are only a couple of ways companies running human clinical trials internationally can obtain insurance coverage. And the solutions are not perfect. The first option is placing coverage with the products liability insurance carrier you’re already working with, and one of two things can happen:

1. If it’s a truly global insurer, they can pursue a policy through either their U.S. home office or their applicable office abroad.
2. If it’s not a global insurer, they might have relationships with other carriers abroad they can work with. But it’s less likely they have relationships everywhere you need to be for any given trial.

In both instances above, however, the insurers are likely limited with respect to the jurisdictions they can provide coverage for, and may also create problems for you in “linking” all the policies they offer.

The other option for obtaining coverage includes having the CRO managing the trial overseas place the coverage on your behalf. This is sometimes convenient but limits the control the trial sponsor has on the coverage terms, including cost.

Purchasing the coverage “outside” of your U.S.-placed products liability policy through separate, internationally based insurers is another option. This can be an ideal solution for sponsor organizations that want to control the terms of their international clinical trials policies, and is part of our recommended solution for many clients.

 A Better Solution

While there may not be a simple solution today for obtaining coverage globally for human clinical trials, we’ve developed one that works quite well here at Woodruff Sawyer, and I’d like to share it with you.

The proprietary solution we’ve created involves using international insurance facilities with both the expertise and capacity for providing clinical trials coverage overseas.

We believe this is a better solution for several reasons:

1. It allows our clients to select the right amount of insurance coverage at the terms that the jurisdiction requires at that point in time. This is a critical point, given the constant change in regulatory requirements for this coverage in many jurisdictions overseas.
2. Our solution meets local regulatory requirements. A number of the “easier to use” coverage placement options are made through online platforms, and do not always meet local regulatory requirements.
3. We access more insurance facilities in the worldwide marketplace, thereby creating more competition for the clinical trials coverage being placed.
4. Our solution provides separate “capacity” from the U.S.-placed products liability program. This avoids the “linking” that some global products liability insurers do to cap their claims exposure and the worldwide limits they offer.

Let’s look at those benefits in closer detail …

Meeting insurance requirements in this area is a must, otherwise, a trial cannot start. This is virtually impossible to do without experts familiar with current regulatory mandates.

We, along with our international clinical trials brokerage partner, do this type of work all day long, so it is a core expertise. This ensures  we know what regulatory issues may come up in India or Brazil, for example, and can build the policy to comply with a regulatory change, or limit increase in a way that the other solutions can’t do as consistently.

It is equally important to purchase coverage from insurers who are also experts in clinical trials liability coverage, with respect to both policy terms and claims payment. Having the broadest available market access allows us to offer this combination of expert insurance facilities at competitive terms.

Finally, when using capacity (coverage limits) from multiple insurance facilities overseas, we insulate the capacity dedicated to your products liability coverage placed in the U.S. This is the “linking” I referred to earlier, and protects you from two potential problems:

1. When global clinical trial limits are linked by a products liability insurer, a claim under an overseas policy will reduce the available limit under the U.S.-placed “global” products/clinical trials liability policy. This is a critical issue, as it reduces the amount of coverage available to companies under their most significant policy in this risk area.
2. If you have multiple trials ongoing and initiate new trials in additional countries with the same drug during your policy period, your U.S. global insurer may run out of the capacity required to place the additional coverage/policies needed for the new trials.

While conducting human clinical trials abroad continues to present challenges to companies that need the right coverage quickly, our solution addresses the regulatory challenges while maintaining the integrity of your critical global coverage limit. Partnering with brokers who have expertise in clinical trials coverage - in the U.S. and abroad -  is a key step in addressing these challenges.