Alarm sounded over new complaints system for pharma ads

Medical politics

By Tessa Hoffman

6 Jun 2018

A planned overhaul of the system for handling advertising complaints for therapeutic goods will not result in better protection for consumers, public health experts claim.

In July, the TGA will take over the role of handling complaints and doling out punishments for breaches to the TGA’s advertising code, a role that was until now handled by the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council.

The move – recommended by a review – is meant to reduce complexity and ensure more consistency and timeliness for regulatory action against advertisers who breach the code, potentially posing a public safety risk.

But while public health experts have welcomed the move to a single body with tougher powers, they are now voicing concerns the system proposed by the TGA will be less transparent and accountable than the old one.

Associate Professor Ken Harvey, from Monash University’s School of Public Health and Preventive Medicine, says flaws in the proposed new system include:

The new system triages complaints into low and high priority but complainants will not be told where theirs is ranked

Details on whether Code breaches alleged by the complainant were upheld or not will not be made public

There will be no routine evaluation on whether regulatory action undertaken by the TGA achieves the desired compliance

“Experience with the current complaints resolution panel shows that many sponsors assert they will fix the problem or correct the breaches but then create new ones,” A/Prof Harvey said.

“Unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system,” he said.

He is also concerned that hundreds of outstanding complaints could be delayed or lost in the transition over to the new system.

However, the TGA maintains the new system “will be more transparent than the previous one”.

This will be achieved by measures such as publication of its performance against KPIs for handling complaints and information on individual medium, serious and critical level complaints, along with publication of the numbers and frequency of low- level complaints and complaint trends in bi-annual reports.

“This information will inform the identification and prioritisation of compliance risks, and the targeting of our education and compliance work,” a TGA spokesperson said, adding that a new group had been formed to provide advice on policy issues.

The TGA will use an educative approach for low-level breaches and “where compliance cannot be achieved through assistance and education, formal enforcement actions will be undertaken,” the spokesperson said.

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