Stakeholders hold own hearing on TGA Bill

A proposed bill which aims to protect consumers from medicines which lack a solid evidence base fails to do so, says Friends of Science in Medicine

Introduced with the Therapeutic Goods (Charges) Amendment Bill 2017, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 makes a number of amendments to the Therapeutic Goods Act 1989.

Friends of Science in Medicine said in a statement that the Government is trying to “bypass” safeguards.

The Bill is “anything but non-controversial,” says spokesperson John Dwyer.

This is particularly the case for changes suggested for the regulation of advertising of complementary medicines, he says.

Friends of Science in Medicine and other stakeholders say they are concerned about certain aspects of the Bill, including:

  • the Bill removes pre-approval of advertisements for therapeutic goods in favour of self-regulation;
  • there are plans for the TGA to take over the advertising complaint system without ensuring ongoing stakeholder input and transparency of complaint outcomes, and
  • the Bill will endorse an industry-submitted list of ‘permissible indications’ for complementary medicines.

A number of stakeholders have arranged for a public hearing regarding the Bill, scheduled for 24 January 2018.

This follows requests for a public hearing on the Bill over the Christmas – New Year period, which Friends of Science in Medicine says was rejected because “Senators were on holiday”.

However submissions were sought over the period and have now closed.

“There are a number of readily supported amendments in the Bill,” says Alastair MacLennan from the University of Adelaide.

“But leading experts in regulation policy, public health, and civil society all agree that it is important to have three very contentious aspects excised so they can receive better consideration.”

Monash University’s Ken Harvey also criticised the Bill.

“The current pre-approval process reviews over 2000 advertisements per year with an average turnaround time of seven days,” says Prof Harvey.

“But it takes a very long time after marketing for inappropriate advertisements to be removed.

“Vetting advertisements before publication is economically efficient because fraudulent therapeutic claims create unnecessary health expenditure and divert scarce health resources from remedies that work, to ones that don’t,” he says.

“Random post-marketing reviews by the TGA consistently find 80-90% of advertisements breach the mandated Code,” he said.

“We want pre-approval of advertisements to continue until the other measures being introduced (increased post-marketing reviews and more stringent penalties for regulatory violations) have shown pre-approval is no longer necessary.”

The public hearing will be held at the Australian National University on 24 January 2018, from 2 to 5pm.

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