pexels-mart-production-7089401.jpg

Insights

Case study: Involved in commercial clinical trials or clinical research?

If so, you may not be protected by ACC or by your current indemnity provider.




Six years ago, Dr Richard Stubbs spotted a gap in his professional indemnity cover that had the potential to cost a substantial sum of money.


New Zealand’s Accident Compensation Corporation (ACC) provides compensation to patients and protection for medical professionals where treatment injury has occurred. However, if you are one of the more than 700 doctors employed in the NZ clinical trial sector, treatment injury in this setting may not be covered by ACC. Furthermore the mutual society providing professional indemnity for most NZ doctors would not normally meet the cost of any awards of compensation.


Dr Richard Stubbs, Chairman of Medicus and managing director of P3 Research Ltd, one of New Zealand’s biggest clinical trial research companies, joined Medicus to ensure that no such gap existed in his professional indemnity cover. He received guaranteed professional indemnity cover while performing medical trials.


Dr Stubbs’ main reason for joining Medicus was to ensure that he would be protected while performing clinical trials.


P3 Research has five clinical research sites which are capable of performing studies from small scale Phase 2 trials to large scale, longer term Phase 3 studies.


Since 2001 they have been trusted to perform over 200 clinical studies on behalf of worldwide pharmaceutical companies, contract research organisations and individual researchers.


Normally if a treatment injury occurs in the course of medical treatment, patients will receive support and compensation under ACC.


For example, if a patient experiences a stroke as the result of a medical intervention and is unable to work for the next 25 years ACC will provide compensation in the form of salary and other expenses.


But if something serious goes wrong during a commercial clinical trial, ACC may provide no support or compensation at all, Dr Stubbs said.


“Pharmaceutical companies are required to carry insurance that will provide equivalent cover to that normally provided by ACC. If a serious problem occurs in the course of a clinical trial and this relates to the drug under investigation being given correctly and in accordance with the protocol, then the pharmaceutical company’s insurance would be expected to provide support and compensation to the injured party.


“But if the problem came about because I failed to follow the protocol correctly, for example I gave double the dose by mistake, then the insurer might say no, sorry, that is your fault, Dr Stubbs. In that case the liability for compensation would fall to me.”


In such rare circumstances where the fault lies not with the drug company, but with the doctor conducting the trial, then compensation for such an injury would fall to the doctor or their indemnity provider.


Dr Stubbs said that prior to switching to Medicus it had taken some 18 months to establish that his previous provider would be unlikely to cover him in such circumstances.


“Answers were not initially forthcoming and in the end, I found such cover would only be discretionary cover. At the discretion of the Board in the UK.


“You can be fairly sure if they were confronted with a hefty bill for compensation, such discretion would not be exercised in my favour.”


As his previous provider was a mutual society and not an insurance company they were not required to hold the reserves that insurance companies hold.


“Under my policy with Medicus, I would be covered, and this is expressly stated in the policy. That is why I believe doctors who are involved in clinical trials should be aware they have a vulnerability.”


Medicus is managed by New Zealand's leading insurance broker, Aon New Zealand. The insurance is underwritten by NZI, a division of IAG New Zealand Limited.


Dr Stubbs said the issue of discretionary cover could become very relevant in the context of doctors conducting commercial clinical trials.


“The chance of a medical professional having to pay is very small, but it could happen, and if it did happen, it could cost a very large sum. Where would that leave you when you are paying indemnity insurance every year thinking that you would be okay?


“That would certainly take people's homes and reputation and affect their family. Their way of life could be seriously impacted.”


In 2018 there were 753 people in New Zealand working directly in the clinical trials sector. Dr Stubbs said a lot of doctors employed by medical schools and large hospitals who do clinical trials, could be at risk.


He said doctors who are conducting trials regularly are probably much less likely to make a mistake than those who just do it occasionally.


“The clinical trial protocol is not a one-page document, it’s more like 100 pages so if you don't have systems in place, it might be very easy for a protocol deviation to occur.”


Dr Stubbs recommends Medicus, for certainty around cover and for peace of mind.