To help prepare those who create and/or place therapeutic goods ads for the end of mandatory pre-approvals, CHP Australia held a special briefing with the Therapeutic Goods Administration addressing advertisers’ obligations and liabilities.
Thank you to Gillian Mitchell and Nicole McLay from the Department of Health for taking the time to join us to share the regulator's perspective and expectations.
Throughout the webinar we received well over 100 questions from participants. Where appropriate, duplicate or substantially similar questions have been combined and will be answered as one.
Written responses provided by CHP Australia for the majority of participants' questions can be found below, along with a recording of the webinar presentations - click here for the accompanying slide deck.
Questions directed to the TGA have been forwarded to them. Responses will be posted alongside CHP Australia’s when received.
Topics addressed in this webinar include;
In response to the high level of stakeholder interest and engagement in our webinar, we aim to host additional information sessions in the coming months.
CHP: We have been working with our members to develop a series of FAQs on digital and social media. These are now being finalised and are nearly ready for publication. Two main themes; “control” (what is within the advertiser’s control and what is not?) and the “physical limitations” of the different platforms (how do you comply when you have limited control, limited space, limited time, limited characters?)
CHP: Similar to current arrangements. Mandatory pre-approval is not a guarantee either. Some pre-approved ads have been found in breach by the CRP. The AdCheck service will not be a guarantee, it will be a risk reduction and risk mitigation strategy. At the moment, the TGA’s complaints database contains nearly 3,000 cases. Of these there are 2 “medium” level complaints relating to pre-approved TV ads (which were dismissed against the TV station and – as far as I can tell - not pursued against the advertiser) and there are 4 “low” level complaints (from about 2800) in the database about pre-approved ads. Pre-approval is not a guarantee now and not a guarantee in the future. The AdCheck service will be a risk reduction and risk mitigation strategy as well as a demonstration of your attitude towards compliance.
CHP: We have designed the service with all the different stakeholders in mind, but we cannot insist that anyone require advertisers to use the service. If you want to take advantage of the publisher exceptions or if you cannot use the publisher exceptions, and you want to discharge your obligations under the Act, then you need to find some way of assuring yourself that the ad is compliant. This is one way you could do it. We have a mechanism for verifying the compliance numbers, so if an advertiser comes to you with an ad they want you to run, and they say that they ad was assessed by us, then you can verify with us whether a number was issued for that ad. We are not insisting that anyone use the service, but we have designed it to be as attractive as possible to all stakeholders.
CHP: After payment is received, the assessors will need 1-2 days for initial assessment. If there are compliance issues that need to be addressed, we estimate most can be resolved in 10 working days. Therefore, we recommend advertisers make accommodations for 10 working days in their schedules/planning. This turnaround time is about the same as the current mandatory service.
CHP: The service will be available to everyone.
CHP: We would normally provide assistance to members in relation to any complaints they received as part of the ordinary member service offering (whether AdCheck had been used or not). The assistance service provided as part of the AdCheck offering would be confined to ads that have been assessed by AdCheck.
CHP: No. The inclusion of the number will be voluntary. While the number will serve to demonstrate that the ad has been assessed, there may be situations where including a number is not practical (e.g. radio advertisements).
CHP: The first step is to see if the activity meets the definition of “advertising”. The notion of “causing” the advertising is a tool for capturing those who are involved in the advertising, but who might not obviously be the advertiser (e.g. someone who transmits the ad, but did not create it). This is about casting a wider net and trying to capture anyone who was involved with the ad or associated with it. Need to look at the ordinary definition, did you cause the advertising to take place, rather than were you technically the “advertiser”.
CHP: [post-meeting] Although the primary service will relate specifically to finalised ads, based on the feedback received, AdCheck will also offer advice on concepts, ideas and strategies at their early stages of development. Pricing to be quoted on an individual basis, depending on needs.
CHP: There are still some problems with the TGAC, that we think need addressing and we will be pursuing them with the TGA. We understand that there are also some minor changes with regard to health warnings anticipated and that there are other changes pending (but we don’t know the precise details at the moment).
CHP: Yes. We will look at every form of advertisement directed to consumers, from point-of-sale materials, to websites, to TVCs, radio ads, print ads etc. If it meets the definition of advertisement under the Act and it is directed to consumers then we will look at it.
CHP: Nobody needs to use the service; it is not mandatory. The service is not meant to replace the in-house expertise. It is an arm’s length review of your materials. Someone outside your organisation providing an objective assessment of compliance. Also, it is a demonstration to others that you’ve gone through this compliance exercise. If you develop an ad and submit it to AdCheck and it is assessed as compliant without any change at all, this does not devalue the service or indicate that the AdCheck review was unnecessary. What is does show is that your internal processes and our assessment are aligned – which is a good thing on its own. But what you then have is something that you can show to others who you want to publish or broadcast your ad to demonstrate that it is compliant. What you also get is something you can use later on if someone does allege that the ad is in breach, you have something that you can produce to demonstrate that you tried to do the right thing by seeking a review.
CHP: Note that the formulation that is in the Act captures those who advertise and those who cause the advertising. If you can’t take advantage of the publisher exceptions, then you are on the hook the same as the advertiser.
CHP: The TGA has published a (non-exhaustive) list of those persons who might be said to have “caused” the advertising (https://www.tga.gov.au/sites/default/files/advertising-public.pdf (see pages 12 and 13 of 80)). Relevantly, this list includes:
CHP: A dedicated website has been set up (adcheck.com.au) which contains information about the process, the pricing and the services provided. Further information is scheduled to be added as it becomes available (e.g. the application forms, the terms and conditions etc). There will also be links to the site from the CHP Australia website.
CHP: If an ad is going to go live on 1 July, then you can still get it approved through the TGA mandatory process before then.
CHP: There will be ongoing training for the assessors to make sure they are kept up to date with the requirements. Like any other important stakeholder, we will have ongoing liaison with the TGA. What we will be doing as part of the piloting and soft launch of the service will be finalising our processes for escalation and for ensuring that the assessors provide consistent decision making. Communication between them and open discussions between them will be essential. We will also have escalation processes available if necessary. This will need to be one of the fundamental aspects of the service – no matter who picks up your application you have to be confident that the outcome will be the same. For the credibility of the service, we need to make sure that the decisions are consistent.
CHP: I would expect so.
CHP: Yes, in the same way that there is a concession at the moment for minor variations, we will keep that going forward. We want to keep the pricing structure and the process as close as possible to the current pricing and process.
CHP: Yes. The new service will apply to all ads directed to consumers no matter what medium is employed.
CHP: Yes, and there will also be fee discounts when the different elements of a campaign are bundled up and submitted together.
CHP: It will be similar. In both cases, the advertiser will be approaching an external expert to give them an arm’s length, objective, assessment of the advertising material’s compliance. In the end, it will just come down to the operation of the market to determine whether our service complements, or is superior to, any other offering and then which services people may want.
CHP: This will be a matter for those parties to resolve between themselves. We cannot compel anyone to use our service. We have tried to design a service that people will find desirable, useful, attractive. If you are approaching someone to publish an ad for you and they say they won’t touch your ad until you have it assessed by AdCheck, then there may be a number of reasons for them making such a request. Maybe, they have been penalised in the past. Maybe they think that this is the best way to meet the criteria for the publisher exceptions, or their other obligations, under the Act. It will have to be a matter for discussion. There is not much that we can do if someone is insisting that you use our service before they will publish your ad.
External parties can submit a request to CHP Australia to verify an AdCheck number and confirm that the specific ad was reviewed by AdCheck. They will NOT be told if an ad was NOT put through the service; and they will NOT be told if an ad was put through the service but didn’t receive an AdCheck number.
If your ad was reviewed by AdCheck and given an AdCheck number, CHP Australia will provide support to you relating to our rationale and justification for its original compliance. You can then share this with the TGA. As well, the TGA (like any other external party) can request AdCheck to verify the AdCheck number to confirm it was assessed by us. We will not share your submissions or their outcomes with the TGA (or any other party).
If your ad was reviewed by AdCheck and given an AdCheck number, it will come in a specific font type. It is recommended that you maintain this font when inserting into your ad but is not compulsory.
If your ad was reviewed by AdCheck and given an AdCheck number, CHP Australia will provide support to you relating to our rationale and justification for its original compliance. Mandatory pre-approval is not a guarantee of compliance. The new AdCheck service will not be a guarantee of compliance either. The AdCheck service is intended to provide benefits for all stakeholders, but as far as sponsors go, the new service is intended to act as a risk reduction and risk mitigation strategy as well as a demonstration of your attitude towards compliance.
We have modelled a number of potential scenarios. The volume of advertising submitted for review could go down (because it is no longer mandatory) or it could go up (because it will be available for all media and because it has been designed to provide benefits for all stakeholders). Publishers and broadcasters will still be responsible for compliance where they have “caused” the advertising and the AdCheck service is intended to assist them in discharging their obligations. Publishers and broadcasters must ensure that the ads are compliant, it will be up to them to decide what mechanism(s) they will employ.
No. AdCheck will review advertisements of any type or form for therapeutic goods directed at consumers. This includes all forms of ads including those previously subject to mandatory pre-approvals AND those that weren’t including websites, social media, in store materials, etc.
CHP Australia’s AdCheck service will determine if the ad is compliant with the version of the TGAC that is in force at the time it is assessed. It is the responsibility of the applicant to monitor any regulatory changes (e.g. TGAC revisions, TGA decisions etc) that may impact the continued compliance of the ad to the TGAC.
Yes. AdCheck will review advertisements of any type or form for therapeutic goods directed at consumers. This includes all forms of ads including those previously subject to mandatory pre-approvals AND those that weren’t including websites, social media, in store materials, etc. Given websites vary greatly in terms of quantity of pages and content, AdCheck will provide a specific quote for each website request.
Yes. Anyone involved in the creation and/or placement of ads of any type for therapeutic goods ads that are directed to consumers. This may include product sponsors, agencies, broadcaster, publishers, legal representatives, etc. It is open to both members and non-members of CHP Australia. Members receive a 10% discount.
Each separate advertisement will need to be assessed and will receive its own AdCheck number if it is deemed to be compliant.
AdCheck is an independent service provided by CHP Australia and can be accessed through the CHP website at adcheck.com.au The assessment of the ad will be commenced upon payment.
Every therapeutic goods advertisement directed to consumers has to comply with the TGAC (even those which only include the pack shot and the price). The AdCheck service will be available for all advertising directed to consumers.
Testimonials for therapeutic goods are permitted but they must comply with the requirements of the TGAC. The AdCheck service will be available for advertising that includes testimonials.
Every therapeutic goods advertisement directed to consumers has to comply with the TGAC (even those on social media). The AdCheck service will be available for all advertising directed to consumers.
The current TGAC is already in place and must be complied with. TGA guidance on the Code is published on the TGA’s website.
Responsibility for compliance lies with the advertiser and anyone who causes the advertising. Whether a sponsor is responsible for compliance will therefore depend on their role (if any) in the advertisement.
From 1 July 2020 the mandatory pre-approval requirement will end and we will be offering the AdCheck service in its place. The new service will not be mandatory, and nobody will ‘be forced’ to use it. Because the AdCheck service is intended to provide benefits for all stakeholders we anticipate that advertisers and those who cause advertising will use the new service because they want to rather than because they ‘have to’.
Every therapeutic goods advertisement directed to consumers has to comply with the TGAC (even those on social media). The AdCheck service will be available for all advertising directed to consumers. We have been working with our members to develop a series of FAQs on digital and social media advertising. These are now being finalised and are nearly ready for publication. Two main themes will be covered; “control” (what is within the advertiser’s control and what is not?) and the “physical limitations” of the different platforms (how do you comply when you have limited control, limited space, limited time, limited characters?)