By Dr Teresa Nicoletti, Partner, Helaena Short, Lawyer and Seasonal Clerk, Isabella Boag Taylor

Complementary medicine sceptics attended a forum last Wednesday to voice their concerns about proposed changes to the regulation of OTC and complementary medicine advertisements in Australia. With the TGA and representative industry bodies noticeably absent from the forum, it seems that its purpose was to broadcast an anti-complementary medicines agenda without canvassing the substantive issues that have already been considered by the Government and the Sansom Review.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (Bill) is expected to be considered by the Senate early next month and, if passed, will introduce a series of changes to the advertising framework for OTC and complementary medicines in Australia.

The Bill was referred to the Senate Community Affairs Legislation Committee in November last year, but due to the proximity of the Christmas break, the Committee elected not to hold any public hearings.  Notwithstanding this arrangement, sceptics of the proposed changes organised a “civil society hearing” last Wednesday to voice their arguments against implementing the Bill.

The Bill

At its heart, the Bill will have the effect of changing the advertising framework for OTC and complementary medicines by:

1. abolishing the Complaints Resolution Panel (CRP), being the body currently responsible for handling advertising complaints, in favour of a centralised process through the Therapeutic Goods Administration (TGA); and
2. removing pre-approval requirements for advertisements but, in turn, introducing more stringent penalties and sanctions for sponsors engaging in non-compliant advertising.

The decision to abolish the CRP is a response to a number of streamlining assessments reported in the Expert Review of Medicines and Medical Devices Regulation delivered to the Government in 2015 and chaired by Emeritus Professor Lloyd Sansom AO (Sansom Review). The Sansom Review considered 103 submissions by individuals, industry bodies, health professionals and consumer groups and made recommendations for the removal of unnecessary and duplicative regulation in the advertising space, including the disbandment of the CRP.

Abolishing the Inefficiencies

The CRP is established by the current Therapeutic Goods Regulation 1990 (Cth) for the purpose of “receiv[ing] and consider[ing] complaints about advertisements and generic information. [1] Members of the CRP include government and industry stake holding bodies, as well as healthcare practitioners.

Although the CRP has some powers to consider, evaluate and make determinations in relation to advertisements for OTC and complementary medicines (including, for example, print, radio and television advertisements), this power extends only to a comparison of advertising claims against a product’s listed indications and not an assessment of the accuracy of the advertising claims or the product’s indications against the sponsor’s substantiating evidence. The latter must inevitably be conducted by the TGA.

In the course of advising our clients in countless advertising complaints before the CRP and TGA over the past several years, we provided extensive feedback and criticism to the TGA’s Advertising Compliance Unit about the systematic flaws, inefficiencies and duplication in the advertising complaints process. The CRP’s limited scope in the assessment of claims and evaluation of evidence and its inability to enforce sanctions is one of the main reasons why sponsors have often opted to ignore CRP determinations in favour of having the complaints referred to the TGA for consideration.  In effect, the CRP’s power have been neutered by an industry which has long been dissatisfied with the process.

We strongly endorse a centralised process for the handling of advertising complaints and welcome the Bill, which seeks to create a more streamlined and efficient system for the management of OTC and complementary medicine advertising by abolishing the CRP and alternatively vesting responsibility solely with the TGA.

Unfounded Criticisms

Despite the apparently overwhelming evidence and widespread support in favour of the Bill, an article in Pharma in Focus last week announced that the forum would be held on Wednesday 24 January to hear claims that the Bill would “lead to consumers being misled by baseless advertising claims.”

Quite frankly, it is sweeping statements of this kind are that misleading. Sceptics have suggested that removing the pre-approval process for OTC and complementary medicine advertisements will lead to the advertisement of dangerous products to the public in newspapers and on the television. The CEO of Complementary Medicines Australia (CMA), Carl Gibson, has described such declarations as “nonsense and disingenuous.” As Mr Gibson aptly acknowledged, the existing pre-approval process only applies in relation to specified forms of media advertising, that is:

“pre-approval is not required today for advertising on the internet, social media or subscription
television – and yet the sky hasn’t fallen in.”

Furthermore, all advertisements (whether subject to pre-approval or not) remain subject to the requirements of the Therapeutic Goods Advertising Code 2015 and the Australian Consumer Law in relation to false and misleading claims. As Mr Gibson explained, “claims that anyone can advertise anything is just plain wrong. Illegal products are still and remain illegal and cannot be advertised.”

CMA has expressed its support for the Bill, which will “introduce a broader range of sanctions and penalties including measures to enable effective action to be undertaken expeditiously if an advertisement breaches the requirements of the Act, Regulations or Advertising Code.” These additional enforcement measures empower the TGA to issue infringement notices, injunctions, substantiation notices and public warning notices to advertisers, as well as criminal and civil penalties. Mr Gibson described these changes as:

“giving the TGA Watchdog much needed teeth – which is supported by industry but disappointingly not
supported by Dr Harvey despite him campaigning for years on the issue.”

It is evident that the criticisms raised at the forum do not arise from the arguments canvassed in the Sansom Review, or the Government’s response. It is therefore apparent that the purpose of the forum was not for an objective analysis of the proposed changes or any potential reform alternatives.

A Hidden Agenda

The forum was conducted on Wednesday 24 January and followed a venue change to facilitate an expected large number of attendees. The forum was facilitated by consumer organisations Australian Consumers’ Association (Choice) and Access 2 (The Foundation for Effective Markets and Governance) campaigners, but did not include participation by the TGA, or any significant representation by OTC or complementary medicine sponsors, or other relevant industry stakeholders such as CMA. In fact, we were advised that there were only approximately 50 attendees on the day (in a 750-person capacity venue) and as such, the forum was anything but representative of the opinions or interests of the industry as a whole. [2]

In essence, the forum supplied a platform to individuals such as Dr Ken Harvey, a former member of the CRP and executive member of the sceptic organisation Friends of Science in Medicine.  Despite publicly acknowledging his conflicted position as an “anti-quackery” and “pro-science” campaigner, this did not seem to deter Dr Harvey from determining complaints that concerned complementary medicines. He also famously undermined the integrity of the advertising complaints process by being directly involved in Monash University’s “Whack-a-mole” campaign to purposely inundate the CRP with complaints (see here).

In addition to being a key spokesperson for the forum, Dr Harvey has been active in publicly conflating the Bill’s proposal to disband the CRP with “getting rid” of a system for complaints handling altogether, which is quite clearly not the case.  Further, given that Mr Gibson reported that it is currently taking approximately 125 days for the CRP to deal with a complaint from the date of receipt, it is difficult to see how Dr Harvey’s insistence on preserving the CRP is anything other than part of a self-serving agenda, rather than an appeal that is in the best interests of consumers.

Another individual who fronted the forum is Mr Allan Asher, the current Chairman of the CRP, who also used the forum to argue for the conservation of the CRP.  It would be difficult to ignore the obvious conflict of interest that Mr Asher’s attendance raised, but the bigger issue is the one-sidedness of the forum and the missed opportunity to convey a balanced viewpoint by presenting the counter-arguments.

Concluding remarks

By implementing the recommendations of three eminent experts set out in the Sansom Review, the Bill simply seeks to streamline advertising complaint mechanisms for OTC and complementary medicines. As such, the proposed reforms are undeniably aligned with the interests of the Government and the therapeutic goods industry. To the contrary, industry sceptics appear to be attempting to preserve something else altogether: an inefficient and flawed process, infected with bias, conflict and ideological agendas.

[1] Regulation 42S(a).

[2] This is the main reason why, as a matter of principle, we decided not to attend the forum.