Proposed Changes to Therapeutic Goods Advertising Criticised

Thursday 1 February 2018 @ 8.47 a.m. | IP & Media | Trade & Commerce

The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 (Cth) (the Bill) was introduced into the Federal Parliament last year (14 September 2017) and is currently at second reading stage in the Senate (4 December 2017). Generally, the Bill make a large number of amendments which follow from the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation (the Review). One particular area of amendment, that makes changes to the way in which therapeutic goods are approved for advertising, has met with criticism from professional and consumer groups.

About the Bill

The Bill makes amendments to the Therapeutic Goods Act 1989 (Cth) (the Act) which the government claims will:

  • support the implementation of a number of important recommendations of the Review;
  • provide clarity regarding issues raised in relation to the processing of applications by the Department of Health, through the Therapeutic Goods Administration (the TGA), by the Federal Court’s decision in Nicovations Australia Pty Ltd v Secretary  of the Department of Health [2016] FCA 394; and
  • amend the Act, principally with respect to ensuring greater consistency across the regulation of different kinds of therapeutic goods.

The Bill is part of the government's continuing response to the Review which the government says was undertaken to:

". . .identify unnecessary or ineffective regulation and propose opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods".

A previous Bill has already been enacted supporting the implementation of eight key recommendations of the Review, namely, the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 (assented on 19 June 2017 and commencing 20 June 2017 and 1 July 2017).

The current Bill supports the implementation of key recommendations of the Review, theses are:

  • the introduction of a scheme for the granting of "provisional marketing approval" of medicines, 
  • reforms to the advertising of therapeutic goods, changes to the regulation of complementary medicines, and 
  • streamlined sanctions and penalties under the Act. 

Advertising Requirements and Changes Made

On the matter of the advertising of therapeutic products the government has accepted and sought to implement the following recommendations of the Review:

Recommendation 52 - in which the Review recommended that the advertising of therapeutic products to the public continues to be regulated by the Secretary under a legislative framework that includes an advertising code. 

Recommendations 55 and 56 - in which the Review further recommended that the process of vetting and pre-approval of the advertising of therapeutic products to the public should cease and the handling of advertising complaints should be the responsibility of a single agency.

Recommendations 54 and 55 - where the Review recommended that future requirements for advertising therapeutic goods to the public be consistent for all medicines and medical devices, and that the whole process of vetting and pre-approval of the advertising of therapeutic products to the public cease in favour of a more self-regulatory regime.

The recommendations are supported and implemented in the Bill by removing the distinctions in the Act between advertisements for therapeutic goods for which an approval is, or is not, required, with effect from 1 July 2018.

A further recommendation of the Review was that consideration be given as to whether the current range of investigation and enforcement powers needed to be broadened (Recommendation 57). The government's view is reported as being that the implementation of Recommendation 57 is critical to the management of any consumer or healthcare professionals concerns that might arise as a result of accepting Review Recommendation 55 - the cessation of the process of vetting and pre-approval of the advertising of therapeutic products to the public. The Bill supports Recommendation 57 by broadening the enforcement options available to deal with breaches of advertising requirements.

Reaction and Comment

The SMH has reported that while supporting many elements of the Bill, groups such as Choice and the Consumers Health Forum have, criticised the Bill for abandoning the "pre-approval process" for advertisements for complementary and alternative medicines. These groups say amendments abolishing the pre-approval process in favour of self-regulation and larger penalties is ". . . worrying and should be reconsidered".

The SMH reports Professor John Braithwaite, a regulatory expert at the Australian National University as pointing out that the gap between shutting down the current system and the new penalty based system taking effect could be dangerous:

"People could die in the period between the shutdown of pre-approval of advertisements and the post-marketing prosecutions replacing them . . ."

It is reported that some of the critics of the changes want the advertising amendment to be reviewed, or at least, the pre-approval system to be maintained until it can be shown the new rules are successful at stopping companies from misleading advertising of ineffective and potentially harmful products.

It should also be noted that the Bill was referred to a Senate inquiry but that inquiry rejected calls for a public hearing on the basis that the Christmas and New Year period would make such difficult to carry out. As a result those wanting a public forum on the matter held, according to the SMH a  "civil society hearing" at ANU where concerned stakeholders spoke. Stake holders included former deputy chair of the Australian Competition and Consumer Commission Allan Asher and the Public Health Association of Australia.

In favour of the advertising changes it is argued by Carl Gibson, chief executive officer of Complementary Medicines Australia that:

"Pre-approval is not required today for advertising on the internet, social media or subscription television and yet the sky hasn't fallen in, ... pre-approval is not the last line of defense, because even if it is axed, advertising will still be subject to the Therapeutic Goods Advertising Code and the ACCC rules on false and misleading claims."

SMH reports a spokesperson for the Health Minister Greg Hunt saying the Bill would

". . . help patients get earlier access to new medicines in cases where they address an unmet clinical need, while also providing more informed product choices and stronger consumer protections through tougher penalties."

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