Australian Dental Industry Calls for Medical Device Regulatory Framework Overhaul

Australia's Therapeutic Goods Administration (TGA), the regulatory body in charge of approving medical devices and medicines for sale in the country, needs stronger enforcement powers to stem the flow of substandard medical devices entering the country. That's the call according to the Australian Dental Industry Association (ADIA) after receiving reports about escalating incidences of illegal importation and use of substandard products.

“Not a day goes by where a healthcare professional doesn’t receive emails inviting them to buy therapeutic products directly from overseas manufacturers. There are genuine questions as to whether these products are safe and effective as this method of obtaining goods makes it far too easy for the importer to circumvent the regulatory framework that protects patients from inferior products,” said Troy Williams, ADIA chief executive officer.

According to ADIA, the TGA’s ability to effectively enforce the Therapeutic Goods Act (Cth) 1989 stems from structural problems in the legislation. Mr Williams said the fault lies not with the TGA which is doing what it can to address the concern, but with a regulatory framework that is inadequate.

“The TGA’s regulatory framework is designed to deal with one individual importing ten thousand products, not ten thousand people importing one product,” Mr Williams said.

ADIA will ask the next Parliamentary Secretary to strengthen the TGA’s powers by overhauling the infringement notice system. Regulatory amendments introduced in 2009 allowed the TGA National Manager, and certain other persons, to issue an infringement notice to a person alleged to have committed a strict liability offence or contravened a civil penalty provision of the Act to pay a penalty, as an alternative to being taken to court.

“Unfortunately this option is seldom employed in practice as, according to advice received by ADIA, the administrative arrangements associated with issuing an infringement notice are overly complex. ADIA believes however, that infringement notices can be effective in protecting consumers from inferior products if it were made easier to issue them,” Mr Williams said.

Discussions between ADIA and the TGA have highlighted that medical devices across the entire spectrum are being imported and used by healthcare professionals. The reports include healthcare professionals purchasing surgical instruments, dental implants and event heart defibrillators and using them on patients in direct contravention of the TGA’s regulatory framework.

“We look forward to working with the TGA in order to strengthen its powers in order to protect public health and safety by regulating the supply of therapeutic goods in Australia,” Mr Williams said.