New Zealanders injured in commercially-sponsored drug trials are not covered by ACC legislation, leaving them financially exposed, Auckland University Law School Professor Jo Manning says.

Professor Manning says the current laws are inequitable and discriminatory as they only provide compensation to people injured in publicly-sponsored drug trials, who are covered by our no-fault ACC scheme.

She says commercially-sponsored drug trials are undertaken by the pharmaceutical industry. By agreeing to take part in a commercially-sponsored trail, participants surrender their rights to ACC cover if injured, and must look to the sponsor for 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. This refers to Compensation Guidelines drafted by the pharmaceutical industry, which apply if the company sponsor agrees to abide by them in the specific trial. 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” and hence is a moral obligation only.

“Patients need to be better protected," Professor Manning says. "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.

“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 says. The information given to potential subjects before they agree to participate needs to be changed to make this crystal clear to them.

Professor Manning recommends that ethics committees look hard at and consider declining ethical approval for commercial trials where the risk is more than minimal in the absence of a legally enforceable no fault compensation arrangement put in place by the company.

However, she says that ultimately 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.