Speakers: Senator Anne Ruston, Prof Anthony Lawler, Speaker 34, Senator Ellie Whiteaker, Unknown Speaker

Transcript

Senator Anne Ruston

>> Thank you very much. Um uh so uh Professor Lawler um I noted on the uh 28th of September um there was a um a guidance issued by the TGA um which says which was determining when news is subject to the therapeutic goods advertising rules. Um and in there I'll just read it for the interest of Hansard. Under the act any statement pictorial representation or design that is intended whether directly or indirectly to promote the use or supply of a therapeutic good is likely to be considered advertising. Um, in a news and media context, content can be considered advertising where assessed objectively as a whole, it appears to be designed or calculated to draw public attention to public attention to, not to uh, and to promote the supply and use of identified goods. And this may be the case even where the content is created for editorial, educational or public interest purposes if it goes beyond informing the public and is it presented in a way that promotes the use or supply of a therapeutic good. So um and the purpose of the guidance was to help journalists and news organizations distinguish between news reporting and advertising of therapeutic goods. Um so I'm keen to understand um was this guidance developed in response to any particular >> Thanks Senator for the question. Chris

Speaker 34

Bedford, first assistant secretary regulatory practice and support division. Uh the the guidance wasn't uh in response to any specific announcement.

Senator Anne Ruston

>> Okay. So it was not intended to um to target news reports about the availability of drugs in the private market you know obviously and particularly those that are not listed on the PBS.

Prof Anthony Lawler

>> No senator. So so I think I think so there are a couple of specific questions out there I think that are slightly different. There was not a specific therapeutic good that prompted it but uh the um the driver for it was very much that there have been increasing frequency of uh advertising of therapeutic goods those that are both on and off the the therapeutic goods register. Uh we see this particularly in the case of online advertising but also in mainstream media. uh we see it confluent with the increase in access to online Delhi health converter vertically integrated models. Our function uh at the TGA uh particularly in our safeguarding uh of therapeutic goods advertising is not related to whether medicines are on the PBS or not. They are related to the nature of and the extent of the risk that they present to the public if they are advertised directly or indirectly.

Senator Anne Ruston

um your direction seems to be very clearly speaking to um media >> as opposed to advertising. Um it talks about news stories, editorial content, um journalists and news organizations. This is not talking traditionally in relation to advertising um people. This is talking about people who provide news. So, it's sort of just I'm keen to understand the logic behind why it's written like this because immediately on the surface of this, this just looked like censorship to me. Um, that if a news outlet determines that a story about a particular pharmaceutical product is newsworthy enough for them to how does the TGA then go about deciding if that breaches some sort of advertising rules? I mean, what what's the legal advice that sits behind your belief that what you've put here is appropriate under the three acts that you are talking about here. Um because this is not talking about advertising. This is talking about media reports. And I'm sort of interested to understand how how is it that you as the TGA or your acts determine what is newsworthy and what's not newsworthy.

Prof Anthony Lawler

>> So I'll ask Mr. Bedford to to add add to to my response, but I I would just make a couple of observations. Firstly, u part of the driver is that the distinction between media and news reporting and advertising is not potentially not as as hardline as as we might um we might like. And um in informal conversations with media outlets, particularly when we're talking about some of the medicines uh or other therapeutic goods that we're talking there's actually there there actually was on occasion informal requests for guidance around whether this actually constitutes advertising under the act. So this was in part um to provide this this is not just to provide um a compliance tool. It was also to provide guidance and support uh and and education and information for for um media outlets. Um the second thing is uh I would say that this is not the only element of our approach to addressing risks to the public presented by advertising. This is just one of a number of things and and we frequently engage in in public education exercises around what advertising means beyond that. And there are um a number of instances in which we've actually taken action uh on the advertising of therapeutic goods and that can range anywhere from education warning letters up to potentially civil and criminal penalties in terms of the perhaps that what went into developing it and the legal backing. I'll ask Mr. Bedford to to

Speaker 34

>> Yeah, thanks uh Professor Lawler. Like I think the other bit of context is last financial year we had about 300 inquiries um asking about advertising um and promotion of therapeutic goods. So there was a significant amount of interest in making sure our guidance um was improved and we always

Senator Anne Ruston

>> from whom

Speaker 34

>> uh from all different outlets uh and different people. I don't need to take it on notice if you wanted a list of the 300.

Senator Anne Ruston

>> No, no. I'm just interested the type of people. So, you're saying you got inquiries with the inquiries from news outlets? Was it inquiry from um consumers? Was inquiry from drug companies? Was it in colleagues? Who was

Speaker 34

it from? from from news outlets, from pharmaceutical companies, from sometimesarmacies, a whole range of different um people that may uh be selling, promoting um uh reporting on different therapeutic

Prof Anthony Lawler

goods. Another example, if I may, Senator, is a number of health care professionals who are interested and engaged in education around what the best treatment options might be in heart disease or skin disease or or a number of other things and want to be really clear around to talk whether talking about a specific product or a specific medicine actually constitute advertising. We're I know it may seem easy for me to say this, but we're absolutely not in the business of of of censorship of of of free speech, but we need to be recognizing that there is a significant power imbalance, particularly when um people are hearing about information that's not appropriately contextualized in a clinical sense or when people are hearing information such as testimonials or advertising from health professionals. And it's not um it's not always easy for members of the public to be able to make a judgment around whether something is a balanced claim. And so this is about providing guidance. And you'll see there that we don't say this does or this doesn't. It says this may constitute advertising because we believe and we think that we are most appropriately approaching this by taking each case on its merits.

Senator Anne Ruston

>> But this guidance from from what I've just read out appears to be specifically about news reports. I mean, I I don't know that I would ever have heard a situation where news media would ever ask if their stories were advertising because I don't believe any of them ever thought they would be. Um, and neither they should be. So, and and media outlets also have very strong guidelines under which that they have to operate within their own jurisdictions around, you know, the ethics of what they're allowed to do. So, this seemed more like an issue of the TGA's interpretation. but this was about media outlets and media reporting. It wasn't around TGA's interpretation. I mean, I I accept what you've said about what you do, but it sort of seems somewhat in conflict with >> what's actually written in this

Prof Anthony Lawler

determination. I I guess what I'd say in response, Senator, is I I I I I take your comment that you've that you've not seen statements in media outlets or or from media that would be easily confused with advertising.

Senator Anne Ruston

>> No, no, that's not what I said.

Prof Anthony Lawler

>> Oh, sorry. That's what I took. I'm sorry.

Senator Anne Ruston

>> No, no, that's what I'm saying. I I was just saying that I don't believe that news media would believe that when they provide news stories that they are advertising. I I can't imagine a news media outlet picking up the phone and saying, "I'm gonna write a story about, you know, a particular drug. I won't say it just in case I'm in breach of, you know, saying a drug name." Um, they're not going to ring you up and say to you, you know, is this is this advertising news outlets write stories because they believe they're newsworthy.

Speaker 34

>> Yeah. Uh, Senator, there's even a current case before the courts that involves a news outlet. um that has published a story that led to a class of medications. So like the thing to understand is that um

Senator Anne Ruston

>> so can you explain to me what the process of that that particular you're saying there's there's currently

Speaker 34

which I can't go into further detail because of

Senator Anne Ruston

>> how did it come about to [clears throat] be before the courts. Was it something that is

Speaker 34

>> the TGA has action?

Senator Anne Ruston

>> You've taken action. >> Is that a recent case?

Prof Anthony Lawler

>> But I think it's safe to say it predated the the release of this guy. This one

Senator Anne Ruston

>> pre by a long way or just a minute or just you know a reasonably short period

Speaker 34

>> I I need to take the date on notice unless um Miss Cellers uh has the information in front of her. But like I think the important thing to understand is that any online contact that directly or indirectly promotes the use or supply of a therapeutic good may be considered advertising. um which goes to articles in newspapers too. Social media and others is much more >> proliferate at the moment.

Prof Anthony Lawler

>> So if I if I might add just just a couple of sorry um Senator as I mentioned this is this is just one element. We also have guidelines on on um advertising on social media. We have guidance for advertising by health professionals. So so this is not a targeted issue for media. But but the other thing I would say is there are there is significant um there are significant instances where we firstly we are contacted just to clarify whether whether this might be skirting advertising. The other thing though is if we're not being contacted and we do see coverage of where media outlets have been advertising and if I I'm hopefully I'm not misinterpreting you again, but but instances in which um media aren't going to ring us up because they're on a good story and they're going to be advertising. That's actually

Senator Anne Ruston

>> you keep using the word advertising. being on a good story and telling a good story because the yarn they believe is newsworthy and it happens to relate to a particular medicine >> that is I mean you're say you're calling this advertising the media outlet who just say it's a newsworthy yarn that they want to tell the story about. Now, I I'm just keen to understand how your act and and maybe this is something to take on notice because I am really concerned about what this is and I I'm happy to take it offline with you because I think this is a real overreach on your part in relation to your reaching into the jurisdiction of the media to be able to write a yarn about something that they think is newsworthy and in the public interest. And I'm not quite sure how that all works, but um I think there [clears throat] is a very significant difference between um you know advertising a product and and a story. You seem to be confusing the two because you're talking about a new story that's advertising.

Senator Ellie Whiteaker

>> What we will do um given it seems like we're going around in circles here. Um perhaps

Senator Anne Ruston

>> Well, that's your interpretation.

Senator Ellie Whiteaker

the officials could perhaps take on notice some further detail to your answer and then we can whether it's a private briefing for the committee or or or some further discussions about this topic tomorrow even.

Senator Anne Ruston

>> Um are you back tomorrow?

Senator Ellie Whiteaker

>> Yes. >> Uh I will pass the call to Senator Blair.