TGA's Legislative Amendments Don't Go Far Enough

The Australian Dental Industry Association (ADIA), the peak representative body for suppliers of quality dental product, has taken their review of the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 as an opportunity to continue to push for the enhancement of the Therapeutic Goods Administration (TGA)'s regulatory enforcement mechanisms.

"The proposed amendments to the Therapeutic Goods Act are broadly supported by the dental industry. However, these amendments do not address the Act's fundamental flaw – that it is largely unenforced and unenforceable," said Troy Williams, ADIA Chief Executive Officer.

ADIA has tendered a detailed submission to the Senate Community Affairs Legislation Committee which is currently reviewing the Bill that proposes amendments to the Therapeutic Goods Act (Cth) 1989. ADIA noted that the TGA has its hands tied when it comes to importation of products via the internet with the TGA lacking the legislative backing to effectively police its legislation.

"Enforcement of the Act is growing in importance, especially given an environment where an increasing volume of dental products are imported directly by patients and individual healthcare professionals in a manner inconsistent with the Act, thereby circumventing the necessary safeguards," Mr Williams said.

"As well as safety concerns, this direct importation also adversely affects local jobs as Australian suppliers of medical devices that face high regulatory compliance costs. Overseas suppliers selling to Australia don't face the same burden thus receive an unfair cost advantage," adds Mr Williams.

In addition to a call for a review of the TGA's enforcement activities, ADIA's submission to the Senate Community Affairs Legislation Committee supports all but one proposed amendment that allows the option of publishing information about various regulatory decisions made under the Act on the Department's website rather than in the Australian Government Gazette.

"The team at the TGA are doing a good job in difficult circumstances. In this context, we broadly support the reforms and note that more still needs to be done to ensure that the TGA administers a regulatory framework that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing the dental industry from an unnecessary regulatory burden," Mr Williams concluded.