Devicemakers Support TGA’s Approach to Beefing Up Sanctions and Penalties

Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance.

The agency asked for comments on its proposals to strengthen post-market regulations and to deter misleading advertising of devices and diagnostics by imposing graduated penalties. The consultation was part of a broader review of Australia’s device regulations that began in 2015.

The Medical Technology Association of Australia (MTAA) said in its comments that it supports the proposed three-tiered system of graduated penalties that would impose strict liability and civil penalties for non-compliant advertising.

The proposed amendments would align regulatory provisions with other Commonwealth regulators, the TGA said, and would give the agency “an expanded suite of possible regulatory actions to address the severity of a compliance breach.”

Some proposed amendments introduce substantiation notices and public warnings, and others would enhance sanctions and penalties and introduce the ability to seek an injunction to quickly address serious cases of non-compliant advertising.

The proposed tiered structure for advertising non-compliance would comprise the following alternative offenses:

• A new fault-based offense with an aggravating element (conduct that has or will result in harm or injury, or conduct likely to result in harm or injury) — maximum penalty of 4,000 penalty units and/or five years imprisonment; or
• A new strict liability offense with no aggravating element — maximum penalty of 100 penalty units with no imprisonment; or
• The existing fault-based offense.

The amendment also proposes civil penalties that would allow courts to impose either a maximum 5,000 penalty units for an individual or 50,000 penalty units for a corporation.

MTAA said it supported the proposed changes that include an “additional circumstance of aggravation of ‘likelihood of harm or injury to any person.’” The association said the change should better differentiate aggravated criminal offenses from strict liability offenses.

Compliance and enforcement actions should only be taken against those that “persistently or deliberately operate outside the regulatory scheme,” MTAA said.

The Australian Dental Association also supported the TGA’s proposals, but expressed concern that the TGA would have discretion over whether or not to issue an infringement in cases where illegal supply could be demonstrated. It pointed to language in the proposal that says, “in deciding how to deal with a non-compliance matter, we first consider education, guidance material or additional training for those who show a willingness to comply with the regulatory scheme.”

ADA said that this language implies that even in instances where illegal supply can be proven, “the TGA may fail to take enforcement action.”

The dental equipment association stressed that the TGA should not forgo issuing an infringement notice in favor of a warning, education requirement or other measures when illegal supply can be proven.

Accord Australasia, a raw material and service provider, said it supported most of the reforms, but took issue with proposed provisions that would allow certain authorized persons to enter any premises without a warrant.

“We believe that obtaining a warrant is a necessary and transparent action to demonstrate that reasonable grounds exist to enter premises and seize goods,” Accord said.