EMERGO SUMMARTY OF KEY POINTS:

• The Australian Therapeutic Goods Administration (TGA) is seeking additional sanction and penalty powers against medical device and drug companies violating advertising rules.
• Proposed sanction and penalty tools would allow punishments more commensurate with severity of advertising violations.

The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, is proposing expanded powers for itself to levy sanctions and penalties against market registrants found to be in noncompliance with the Therapeutic Goods Act 1989.

A new consultation seeks comment on recommendations for increased TGA enforcement powers particularly regarding health product advertising requirements and noncompliance. Specifically, the TGA is seeking to adopt new powers related to monitoring, investigations, infringement notices and injunctions to create a “tiered offence” system for medical device manufacturers that violate advertising requirements:

• Fault-based offenses with “aggravating elements, “ which the TGA defines as conduct that has already or has the potential to cause harm; these offenses carry maximum penalties of 4,000 penalty units and/or five years imprisonment.
• Strict liability offenses without aggravating elements, incurring maximum penalties of 100 penalty units and no jail time.
• Fault-based offenses with no aggravating elements, penalties for which the TGA already has at its disposal.

Currently, Australian law does not provide for tiered sanctions and penalties for the TGA to utilize against manufacturers noncompliant with advertising rules; the regulator is essentially proposing varying degrees of civil along with criminal penalties depending on the severity of a manufacturer’s violation.

Proposed tools at the TGA’s potential disposal would include the ability to issue substantiation notices to manufacturers requiring proof of advertising claims; public warning notices in cases where advertising violations may pose public health threats; and infringement notices to levy penalties more commensurate with violations.

Penalties for existing aggravated criminal offences would also be strengthened according to the TGA consultation.

What the TGA proposal means for Australian medical device registrants

Although Australian regulators are still seeking industry and stakeholder input regarding these proposed sanction and penalty powers, TGA registrants should proactively ensure that they can substantiate all advertising claims for their medical devices to avoid violations.

More Australian regulatory resources from Emergo:

• Australian TGA registration support for medical device companies
• Australian TGA Sponsor Representation for foreign manufacturers
• Australian medical device regulatory process chart
• Whitepaper: Medical device registration in Australia and New Zealand