The TGA might appear somewhat confused over how to manage the promotion by brand of some PBS-listed medicines because having said the "advertising rules do not apply" the regulator is now applying those rules to argue they do not apply.
The Targeted Therapies Alliance recently released resources as part of its government-funded initiative to deliver around $55 million in savings from the reduced use of biologic disease-modifying anti-rheumatic drugs (bDMARDs).
The resources were released via a media release and remain freely available on a publicly accessible website.
The three resources promote by medicine and even brand name the use of thiopurines for Crohn’s disease and ulcerative colitis, a range of non-bDMARD treatments for ulcerative colitis and low-dose methotrexate for Crohn’s disease.
They do not even mention PBS-listed bDMARDs as an option.
The initial response
In its initial response to questions about the legality of these resources, given they selectively and publicly promote some PBS-listed medicines by brand, the TGA said it believes the campaign would have minimal impact on the general public, the audience would understand its intent and that "therefore the advertising rules do not apply."
The subsequent response
In a subsequent response to questions about how it determines 'impact on the general public', a spokesperson for the TGA actually applied the advertising rules as the basis for this assessment.
"Information is available on the TGA website https://www.tga.gov.au/book-page/part-1-preliminary which outlines considerations regarding the impact advertisements may have on a reasonable person to whom the advertisement is directed.
"Where an advertisement is freely available in the public domain, as opposed to, for example, in a particular publication directed to a particular audience, some consideration must be given to the impact for the general public, notwithstanding that impact may be considered insignificant," said the spokesperson.
The Targeted Therapies Alliance distributed the resources via media release.
The media release and the resources, which are advertising by brand a small number of PBS-listed medicines, remain "freely available in the public domain" on the NPS MedicineWise website.
The TGA spokesperson then further confused the issue by saying the advertising of prescription medicines must be authorised.
They said, "The ‘authorisations’ you refer to are authorising the use, in advertisements for therapeutic goods, of representations which refer to serious diseases or conditions. Even where a registered medicine is advertised to consumers with its approved indication, if that indication refers to a serious disease such as ‘arthritis’, that reference cannot be advertised to consumers without prior authorisation by the TGA."
Another subsequent response
Asked for further clarity, the spokesperson said the TGA "does not consider the resources published by the Targeted Therapies Alliance as advertising. The previously provided link to the Therapeutic Goods Advertising Code guidance (Advertising to the public: Part 1 - Preliminary | Therapeutic Goods Administration (TGA)) outlines considerations regarding the impact advertisements may have on a reasonable person to whom the advertisement is directed."
Having said the "advertising rules do not apply," the regulator is now applying those rules to argue they do not apply.
The 'reasonable person' test in the Code guidance does not contemplate whether or not something is advertising. It considers how a 'reasonable' person would understand an advertisement's claims and uses this as the basis for assessing its compliance with the Code.
In other words, this 'reasonable person' test applies where the regulator recognises the resource as advertising.
How does the regulator define advertising?
According to the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG), which is published on the TGA website, promotional material is a form of advertising.
"Information that is purely factual and balanced and is disseminated for the appropriate use of the goods (for example, consumer medicine information, instructions for use) is unlikely to be considered promotional," it says.
People might question why the regulator does not use this as the basis for its non-action on the resources published by the Targeted Therapies Alliance?
Yet it would be difficult to use this as a defence given it also says, "...if information you release intends (from the end viewer's point of view) to directly or indirectly promote the use or supply of a therapeutic good then we would likely consider it to be advertising and it must meet legislative requirements as set out in Act and the Code."
Clearly, the Targeted Therapies Alliance is promoting - advertising - certain therapeutic goods.
Are there any other similar examples?
This is not a new issue because the TGA has previously dealt with organisations advertising certain PBS-listed medicines on websites.
In June last year, the regulator fined two pharmacists a total of $244,440 for advertising some prescription medicines on public websites.
"Under the Act, representations concerning a serious form of a disease, condition, ailment or defect are restricted representations. The use of restricted representations in advertisements for therapeutic goods is unlawful without the express permission of the TGA," it said in announcing the fines.
How does the impact of this website advertising differ from or exceed that of the Targeted Therapies Alliance? In its 2019-20 annual report, NPS MedicineWise reported 18 million visits to its website in that single year. It is an organisation that heavily promotes its activities and internet presence through traditional and social media.
The Therapeutic Goods Advertising Code (No. 2) 2018 says it all
The advertising of medicines in Australia is regulated by the TGA under the Therapeutic Goods Act 1989 and Therapeutic Goods Advertising Code 2018 (Code).
The Code might be described as the operational framework for the regulation of the advertising of medicines in Australia.
In its response to questions, the TGA has referred to the Code - the advertising rules - to essentially make the 'reasonable person' case on the resources published by the Targeted Therapies Alliance. They seem to be arguing against taking action on the resources because a reasonable person would know whether or not they are the intended audience.
As previously stated, the 'reasonable person' test applies to advertising. The regulator can not apply this test, as described in the Code, unless it accepts the resources are advertising. As such, this advertising of prescription medicines must be authorised or cease.
The TGA's approach to the Targeted Therapies Alliance also appears somewhat inconsistent with its previous strong action against unlawful advertising.
In addition, according to the Code, "Only once the target audience for an advertisement is identified can an assessment be made as to the likely 'reasonable consumer' in that audience, how that person is likely to interpret the advertisement and how they are likely to be impacted by it."
Who is the target audience for the Targeted Therapies Alliance and their resources on inflammatory bowel disease?
The TGA said, "Taken as a whole the fact that non-bDMARDs are a first-line treatment is quite clear."
The resources do not delineate between forms of the disease or line of therapy and fail to even mention PBS-listed bDMARDs as a treatment option, so how would someone living with severe inflammatory bowel disease know the resources are not intended for them?
This scenario is essentially anticipated in the Code.
It says, "For example, an advertisement that states a particular therapeutic good is (only) for the relief of pain associated with mild arthritis but uses images of a person that is debilitated with pain from arthritis is likely to leave the viewer with the 'takeout message' that the product may provide pain relief for serious forms of arthritis."
Presumably, the TGA has used this example because it would take action against this kind of advertising on the basis it is misleading and a risk to patient safety.
The Targeted Therapies Alliance has issued advertisements and essentially state some brands of PBS-listed medicine are effective for treating inflammatory bowel disease. However, the advertisements do not state they are for mild to moderate forms of the disease or even list all the treatment options meaning a viewer living with a severe form of inflammatory bowel disease could be left with the 'takeout message' the listed treatments are appropriate for them.
The regulator could almost use this as a case study in the next iteration of the Therapeutic Goods Advertising Code.
