TGA To Keep Cash From Bungled Deregulation Attempt

The Therapeutic Goods Administration (TGA) looks set to keep the cash it will earn as a result of a bungled attempt to reduce regulatory compliance costs according to the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products.

The TGA maintains the Australian Register of Therapeutic Goods (ARTG), which is a list of medicines and medical devices that can be lawfully supplied in Australia, and the TGA levies a charge to businesses to place a product on the ARTG.  A business can apply for an exemption to this charge if the value of products sold is fifteen times or less the charge that would have been payable to the TGA; however, the threshold where a business is eligible to claim an exception for the charge will drop to $0 from 1 July 2015.  The trade-off is a reduction in compliance paperwork; however this does not take into account the significantly increased charges that many small businesses in the dental industry will pay.

“The TGA’s own assessment was unambiguously clear.  Many small businesses in the dental industry will face an overall 30% increase in charges to place products on the ARTG,” said Troy Williams, ADIA Chief Executive Officer.

Of concern is that the Regulatory Impact Statement (RIS) prepared by the TGA in support of the changes omitted its own assessment that the ARTG listing charges paid by the dental industry will rise. 

“The regulatory changes were claimed to reduce compliance costs, an assessment which does not include the TGA’s own assessment of the adverse impacts on many small businesses in the dental industry,” Mr Williams said.

In last week’s evidence to an estimates hearing of the Senate Community Affairs Legislation Committee, the TGA admitted that it will only be next year that an adjustment to TGA charges will be discussed.

“This is a ludicrous proposition.  The TGA introduces reforms based upon the premise that businesses’ compliance costs will fall, yet omits to include in the Regulatory Impact Statement any reference to the higher charges to be paid by small businesses in the dental industry.  To add insult to injury the TGA gets to profit by keeping the higher charges it looks set to collect,” Mr Williams said.

Given that the RIS underpinning the reforms cannot be relied upon in order to fully assess the impacts of the new ARTG charges on small businesses in the dental industry, ADIA continues its efforts to secure a full assessment of the reforms.

“Most suppliers in the dental industry are small, family-run businesses and they deserve better than to pay increased TGA charges simply because the RIS is deficient and omits the TGA’s own assessment as to how these reforms will impact businesses in the dental industry,” Mr Williams said.