Public hearing on TGA amendments – January 24, Canberra

Concerns about the promotion of pseudoscience and industry capture with a proposed new TGA regime has led to the launch of a public hearing to discuss amendments to the Therapeutic Goods system. The meeting will be held at the Acton Theatre, Crawford Building at the Australian National University campus, Canberra, on January 24.

Late last year the Commonwealth Senate referred the Therapeutic Goods Amendment (2017 Measures No.1) Bill to the Senate Community Affairs Legislation Committee for inquiry and report. The reporting date is 2 February 2018.

The Bill abolishes the need for TV and print advertising for therapeutic goods to be verified before publication (currently 70 per cent need to be corrected), exposing consumers to a welter of false, misleading or dangerous claims. The Bill also abolishes the only transparent and publicly accountable complaints body for therapeutic goods.

Prof John Braithwaite of the School of Regulation and Global Governance at ANU says that “There are many positive aspects of this Bill. It has the potential to provide a more responsive approach to regulatory enforcement with more teeth.

“But there are also concerns about whether, in practice, the new regime is vulnerable to industry capture that takes us closer to a US culture of a pill for every ill.

“In this regulatory culture, misrepresentation of commercial claims for therapeutic effects of medicines, food and medical devices have become rife, dangerous and have distorted precious health spending toward ineffective remedies.”

“There is a case for moving cautiously in deregulating existing mechanisms for pre-approval of marketing claims until there is evidence that the new post-marketing and complaint enforcement provisions are robust enough to be effective. There is also a need to assist informed decision-making by consumers by mandating clear advisory statements that ‘traditional’ medicines lack scientific proof of efficacy.”

A public hearing was requested, but rejected because of the short time-frame encompassing Christmas and New Year.

“Regardless, various colleagues and civil society groups in our networks believe it is crucial that a public hearing be held on the provisions of the Bill that deal with the regulation of advertising and complementary medicines,” Braithwaite said.

“It is a last minute opportunity to give civil society voices some hope of participating in discussion on sensible amendments to this regulatory reform.

“While the Therapeutic Goods Administration has been assiduous in communicating industry views to members of parliament, we are concerned that civil society views have been poorly communicated to our elected representatives.”

The public hearing will be held on from 2:00 – 5:00 pm. Representatives of various groups, including Australian Skeptics and the media, will be attending.

Those interested in attending should know that, while it will be possible to turn up on the day (capacity permitting), the organisers suggest prospective attendees register via Eventbrite to enable them to prepare accordingly.

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