Life Sciences Bulletin - COVID-19 & Clinical Trials Insurance
The challenges of responding to an already rapidly evolving environment
With the pandemic causing major economic disruption and uncertainty, the biggest problem still being that there is no real solution to treat it, nor is there an approved vaccine that exists to prevent it. Time is of the essence with Pharmaceutical and Biotech companies around the globe all in the research race to identify effective treatments.
Cover which is both risk-appropriate and comprehensive is vital when it comes to organising clinical trial insurance. Whilst clinical trial participants are not insured parties, this insurance provides a safeguard that an institution or sponsor is able to utilise to compensate those who are harmed whilst participating in trials.
When obtaining cover for a clinical trial, the provision of specific and detailed information to the insurer is critical. This includes the relevant insurance proposal form with attaching information such as the Protocol, PICF, SOP’s and Study Trial Register. It is this information that is reviewed and the risk is then accepted by your insurer and a ‘Contract of Insurance’ is arranged accordingly.
Given the moving parts to clinical trials risks, many brokers overlook the need for medical malpractice coverage particularly for Phase I and Phase II, this is because at pre-clinical stage there is no real exposure.
Those responsible in managing and arranging the contracts for a trial need to be aware that healthcare providers and clinicians entering into contracts to provide clinical research services generally are not covered by their individual professional or medical indemnity insurance for exposures related to clinical trials, experimental procedures, and/or research-related activity. This means there is a potential that the contracted provider may have not any insurance coverage for alleged errors they may make in administering their services within the trial or study.
When to consider medical malpractice?
- Are invasive procedures being undertaken, or are they only drawing participants’ blood?
- Is there a patient-healthcare provider relationship?
- How are adverse findings handled?
- Is there a procedure in place ensuring that the reporting of findings is always undertaken and given to the patient and his/her primary care physician?
- Is coverage required for physicians, assistants, nurse practitioners, and other high-level medical providers and in what, if any, medical circumstances is coverage needed for independent contractors?
TIP: What if the injury to a participant is caused by an error in administering the product by a contracted healthcare provider and not the product itself? This is an area of a potential gap in your liability, and it’s not likely going to be defended or indemnified by your insurance policy.
COVID-19 and the ongoing management of current clinical trials will require continuous review and implementation of contingency planning to address the potential impact of this pandemic, particularly around trial priority, participation and capacity.
The decisions and actions in response to COVID-19 need to be communicated with key stakeholders, one possibly being your insurers. Keeping in mind the decisions are made with the safety and well-being of trial participants, other patients, family members, researchers, other clinical and support staff.
In the event that a trial can proceed without modification then you do not need to notify your insurers and can continue as per your protocol.
Trial modifications resulting in amendments or deviations to protocol must to be advised to insurers for their review and acceptance prior to incorporating any amendments and/or deviations and continuance of the trial.
Protocol amendments in response to COVID-19 may include;
• employ virtual visits, telehealth, electronic consent or otherwise implement tele-trials
• change the ‘site’ to a location outside of a hospital or clinic or permit referral to another hospital or clinic
• extend protocol timeframes for visits, procedures, trial medication delivery or follow-up to accommodate isolation periods or other disruptions
• Trial put on temporary hold or has been cancelled altogether
Getting the coverage right is a risk, given coverage issues already posed by clinical trials are many and varied. Generally, the exposures associated with your trial falls into four major categories: errors and omissions, medical professional liability, general liability and product liability. At the time of placement your coverage would have been structured around the understanding of the services performed and conducted around the clinical trial. Amendments and Deviations could change the scope and therefore need to be reviewed and accepted in order to ensure continuation of appropriate cover.
The Upshot is that amendments to existing protocols are designed to limit exposure to participants, researchers or staff, and if such changes are made and reported to us in accordance with the usual disclosure process we can work with your insurer to ensure continuation of cover. For those looking to continue trials remotely, you must ensure you review the medical malpractice exposure to ensure all participating healthcare providers are adequately covered and you are not leaving your trial exposed to severe losses.
IN BRIEF: Genevieve Mathews, your Lockton Life Sciences broker is always available to help guide you with your insurance particularly around the context of your trial exposures given probable amendments and deviations are being made. For sites looking to continue trials remotely, you must ensure you review the medical malpractice exposure to ensure all clinicians both employed and contracted are adequately covered. COVID-19 has caused an extraordinary challenge to the health and research sectors and is a significant game-changer in an already constantly evolving environment or sector.
Authored By: Genevieve Mathews – Senior Associate, Life Sciences Broker for Lockton Companies Australia
Reference Guide: National Health and Medical Research Council www.nhmrc.gov.au/research-policy/COVID-19-impacts
Therapeutic Goods Administration www.tga.gov.au