The Therapeutic Goods Administration has been accused of being too friendly to the industry it is meant to regulate.

The TGA has been criticised over two recent decisions – allowing transvaginal mesh implants to continue be used despite safety concerns, and allowing a herbal remedy to be marketed as relief for the symptoms associated with an enlarged prostate, despite a lack of scientific backing.

Ken Harvey, a professor of public health and preventive medicine at Monash University, says the TGA is “very helpful to industry while being ineffective from a consumer protection point of view”. 

TGA released a statement saying it “totally rejects claims” of a “too close relationship between regulator and industry because of this funding model”.

“While fees received, for example, for the evaluation of a product are used to fund staff time on evaluation of that product, they are not refunded if the application is rejected or withdrawn,” the statement said.

“Industry has no say whatsoever in how TGA spends the revenue it receives from other industry charges. This system has been in place for more than 20 years and there has been no evidence of any sort of regulatory capture.”

On the matter of transvaginal mesh implants, the TGA says it decisions are based on evidence available at the time.

Its expert committee found the reported rate of complications from the meshes was low in a ruling 2008, linking complications to the skill and training of the surgeon and patient selection.

“So at that time it would have been inappropriate to implement some of the measures that have been introduced more recently,” the TGA said.

The TGA reclassified transvaginal meshes as “high risk” earlier this year, and says the new classification and additional regulations will come into effect in December next year.

“Other medicines and device regulators internationally also are fully or significantly funded by industry fees and charges and operate in the same way,” the TGA statement said.

“This takes the burden off the taxpayer for such time-consuming scrutiny.”

Dr Harvey said the regulator is being “disingenuous”.

“Regardless of whether the regulator is funded by industry fees or the government, the consumer pays, either through higher prices on therapeutic goods or increased taxation,” he said.

“Second, how many other therapeutic goods regulators are 100 per cent funded by industry?

“The benefits of industry funding are that the regulator is not constrained by cutbacks in government budgets, efficiency dividends and other constraints. The downside is that industry has a greater say in how its fees are used and there is an increased risk of regulatory capture.”