TGA Gets Qualified Tick In Transparency Review

The Australian Dental Industry Association (ADIA) has given a qualified tick of approval to the way in which the Therapeutic Goods Administration (TGA) communicates its regulatory processes and decisions. ADIA's endorsement was made in the association's submission to the panel undertaking a review of how the TGA operates and the reasons for its key decisions.

ADIA is the national industry body for the manufacturers and importers of dental product, an industry sector that is heavily regulated by the TGA.

"On balance, ADIA supports the current regulatory framework and the TGA's efforts to develop an understanding of its decision making processes. That said, the dental industry has identified opportunities for the TGA to improve the communication of its regulatory development and enforcement activities," said Troy Williams, ADIA Executive Officer.

One area where ADIA has recommended that there be a greater degree of accountability is when the TGA is making assumptions about the cost of proposed regulatory changes and that its economic modelling be open to scrutiny.

"In late 2010 the TGA proposed changes to the medical devices regulatory framework that the regulator said would have a minimal cost impact. The advice from industry was entirely to the contrary and noted that the TGA's proposed changes would significantly increase the costs of dental care for ordinary Australians," Mr Williams said.

However, ADIA endorsed the consultative mechanisms that are used by the TGA to consult with industry. According to ADIA, they provide ample opportunity for the regulator to engage with the suppliers of dental product to address issues of common concern.

"Having reviewed the TGA's current processes and compared these with processes employed by other government departments and agencies, ADIA advises that in its view the TGA's consultative processes are considered to serve as a model for regulators," Mr Williams said.

Although broadly supportive of the need for the transparency review and the conduct of the same, ADIA noted that the composition of the review panel was flawed owing to a lack of balance in its composition, something that has undermined industry's confidence in the panel.

"The review has adequate representation from the consumer sector and medicines sector and contains only one representative from the medical devices sector – and the dental industry lacks specific representation and this has undermined industry's confidence in the integrity of the review," Mr Williams said.