Legal scholar says clinical-trial patients need better protection

Currently, commercially-sponsored trials have only “a moral commitment” to compensate injured patients

Legal scholar says clinical-trial patients need better protection

A legal scholar and health law expert is pushing for better protection of New Zealanders harmed during clinical trials.

Professor Jo Manning of the University of Auckland Law School is highlighting what she calls a glaring gap in current NZ laws – a gap that makes it hard for New Zealanders to get compensation – if they get it at all – after being hurt in clinical trials. Describing current laws as “inequitable and discriminatory,” the professor said that only people injured in publicly-sponsored trials are covered by the country’s no-fault accident compensation (ACC) scheme.

To participate in a commercially-sponsored trial, people must agree to consent forms that usually state they are not eligible for ACC coverage, Manning said. These forms state that compensation would be provided by the commercial sponsor under industry guidelines.

These Compensation Guidelines developed by the pharmaceutical industry will take effect only if the sponsor agrees to them. Moreover, while they do provide for compensation for otherwise healthy participants who were hurt in a trial, the obligation is categorised as “without legal commitment” which means the sponsor has only a moral obligation to pay compensation.

“Clinical trials benefit society, yet participants who are injured in commercially-sponsored drug trials lack a legal right to compensation without having to prove a sponsor’s or researcher’s negligence in a court action. The chances of that are very low and the process is expensive, gruelling and protracted,” Manning said.

“People considering taking part in commercially-sponsored clinical trials need to know that if they are injured, there is no legal entitlement to compensation from the company involved,” she added.

 
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