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Calls for protection of med trial patients

NZ Newswire logoNZ Newswire 31/01/2017

Volunteers in commercial medical tests are at risk of not getting compensation if something goes wrong under current laws and the government needs to step in, a health law expert says.

University of Auckland law professor Jo Manning says while participants in publicly funded medical trials are currently covered by ACC if they're hurt, those taking part in commercially sponsored tests often waived their rights to compensation.

"Participants sign consent forms that usually state that they are not eligible for ACC cover, but that compensation would instead be provided by the sponsor in accordance with industry guidelines," she said.

"These provide that the sponsor 'should pay compensation' to healthy patient-volunteers suffering bodily injury. But that obligation is clearly stated to be 'without legal commitment'.

Prof Manning said those injured in commercial drug trials had to take court action and prove negligence in order to get payment.

"The chances of that are very low and the process is expensive, gruelling and protracted," she said.

"If you were injured and unable to work for an extended period of time you are unlikely to be able to advocate for yourself with a large company or their insurance company, especially knowing that you have no legal entitlement to compensation unless you can prove negligence in a court."

While specific examples were difficult to come across due to confidentiality agreements, Prof Manning said there was public information about a case in which a man in a gout trial didn't get compensation for three years after a complication, and another that had yet to be settled.

She said while ethics committees could look at declining approval for trials that risked leaving subjects in the lurch, ultimately law changes were needed.

"Government needs to intervene either to insist that the compensation guidelines are made legally enforceable by subjects, or to change the ACC scheme so as to cover all participants injured in clinical trials," she said.

"Clinical trials benefit society yet participants who are injured in commercially sponsored drug trials lack a legal right to compensation."

Comment has been requested from the Minister of Health.

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