The 'Dispatched' Podcast - Week in review

An important reminder about the impact of innovation and why it matters. What does it say about Australia and our life sciences policy frameworks that locally developed innovations are commercialised in other markets, but not here? Patients need access to the rights they are currently denied and the 'Abilene paradox'.

Transcript

Paul 0:08

Hello and welcome to the Dispatched Podcast Week in Review. I'm Paul Cross, delighted to be joined by my co-host, Felicity McNeil, PSM, Chair of Better Access Australia, amongst other things.

Felicity 0:19

Hi Felicity. Hi, Paul. How's your week?

Paul 0:22

Oh, it's been been okay. Yeah. Pretty good. Can't complain?

Felicity 0:28

Well, you can. Here's your 30 seconds. I think some people might have said this podcast is one big complaint, but anyway.

Paul 0:38

True, true. Well, there is a lot to complain about. Hey, I wanted to start with something we reported on today, which was uh information on people living with cystic fibrosis and the remarkable change uh that the innovative therapies have provided to this group. Just the statistical difference is now more adults living with cystic fibrosis than children. And uh which obviously reflects people living longer in that if you're born with cystic fibrosis in 2026, your life expectancy is is 70, which is basically very close to a normal life expectancy. I think often we take innovation for granted, but the transformation of uh these lives is quite remarkable.

Felicity 1:33

Yes, it does show you that uh when genuine change comes, it is transformative. I I think we've spoken in the past uh about the reflections of rheumatologists who said that biological DMID were another example of a transformation in a medicine that has in that that consequence also extended life. But particularly in rheumatology was an example of early disability, lack of uh capacity to work, hospitalization wheelchairs, and we're still arguing about access to it. I think the upside in uh cystic fibrosis and the risk is the exception proves the rule, that this is something that has been quickly recognised even by the HTA systems and being made available. And so instead of being the exception, it should be the rule. So what we're seeing here is a transformation in people's lives because of the capacity to intervene with the medicine, preventing deterioration. And that is not something that the system otherwise is doing. And so we should be celebrating what this means for the CF community and taking the lesson from that, saying, Imagine if we did this in every other disease state. I think the second thing that's very important, and having spoken to people at some of your conferences over the years, because you have access to this medicine does not mean that the fight is over. So for whether it's people with gene mutations that don't have access to the treatments yet, or whether it's the complexity of living with a chronic disease, I think sometimes people can be quite harsh on the cystic fibrosis community saying, look at everything you've got. And yet when you make something a chronic disease, a livable chronic disease, which is it's no longer what was perceived when you were a child as a death sentence, and I did lose my friend at 18 to cystic fibrosis, you then have to live with what it is to have a chronic disease. So all the arguments that are going on with um continuous glucose monitoring and the denial of access to cystic fibrosis patients and mitochondrial patients. I I don't like the way the system looks at them and said, but you know, you've already got so much already. No, they've got their life back and they've got most of their health back, but that's not a privilege. That's a bloody human right in this country.

Paul 4:11

Yeah, well, we're gonna talk about that, I think, a little bit around patient rights, but certainly on cystic fibrosis and the biological uh rheumatology or immunology products. There's always a sense of what have you done for me lately on innovation. And I like the work that Vertex has done with CF Australia just to say, well, let's just let's just pause for a moment and assess the impact of these therapies. And it's a quite a stunning development. There was a great event at Parliament House earlier in the year that CF Australia um hosted, and it was the patient's stories were just remarkable. And I thought it was a good a good piece of work and also a good opportunity just for us to reflect on the value, and I it's a terrible phrase. The value of innovation of innovation. So yeah, kudos, kudos to the organisations that put that report together and providing us with an opportunity just to reflect.

Felicity 5:21

Yeah, and I think it is nice to stop and smell the roses sometimes. And I just realised that given that they used the rose as their logo, that was not a deliberate pun. Um, but it is sometimes a good opportunity to to enjoy those moments. And like I said, as someone who's a patient advocate, I'd like to see the same access for other conditions, and I would like to see the the community understands what it is to live with chronic disease. And I think in cancer, we've seen a lot of that with uh the cancer community trying to say the more and more I I can get access to treatments, the more it's not a death sentence, it's a chronic disease for life sentence. And and how do we manage that? So the the statistics on chronic disease in in this country are quite extraordinary, and the the percentage of it in under 29s is huge and under 44, and the more we have these innovations that give people an opportunity to long and healthy life, the more chronic disease is is a challenge for us, and it's one that the system is shirking instead of running towards.

Paul 6:32

Well said. I wanted to talk about an interesting development for the Australian life sciences sector, and we wrote about it this week. Uh the Australian biotech sector has grown remarkably in recent years over the past decade. As you know, I've had a publishing relationship with Os Biotech for over a decade now. And so I've been had the privilege of proximity and there's still challenges in the sector, and I think the government's changes to the RD tax incentive and capital gains tax are pretty unwise. But it's interesting to see how companies are emerging commercially. So the the source of their innovation and their science is now starting to uh make it onto or into global markets. And Felix is obviously the very famous example as a company that's less than ten years old, has market capitalization now of over five billion dollars, I think. Uh the Australian government tried to do a job on it by funding unapproved and unapprovable versions of its product, just complete lunacy, and and they've made a complete hash of it in terms of the nuclear medicine market in Australia now.

Felicity 8:04

Just trying to remind everybody that the person that recommended that is now a vice-chancellor in charge of innovation at uh Meeting University. Yeah.

Paul 8:13

Interesting.

Felicity 8:14

Yes, happy to take it when it wasn't in her job description.

Paul 8:17

Yes. The other example I think I've used this week is neuron who who have the only globally approved product for Rhett syndrome. It's a rare and degenerative uh disorder, neurological disorder, and that affects females. Around five to six hundred in Australia, New Zealand. The product was discovered in Auckland by a New Zealand researcher. Then Urine acquired rights to it, uh, started developing it, an Australian company New, obviously, and signed a deal with Acadia, US-based, big US-based company Acadia, and Acadia have global commercialisation rights. And Uran gets a nice clip of the royalties on the way through. And the product in the US is you know approaching a billion dollars in annual sales, which is terrific. Uh, it's uh going through the approval process in Europe, and that's pending commercial launch because they got positive recommendation. I think it's approved in Israel. Uh, some non-EU countries have approved it as well. So this is a fantastic company. I think its market cap is over two and a half billion. Products not registered in Australia.

SPEAKER_01 9:35

No.

Paul 9:35

Uh, another product, Clinaville, who are making some pretty sophisticated uh cell therapies. Uh, they've recently announced they're go they're going to re-domicile to the US. Now, it actually makes a lot of sense for Australian life sciences companies to list on the US uh equities markets because of the accessibility of capital. It's a much, much better market for that. Uh so there's a lot of rationality in it, but I'm just I'm just I was actually emailing with Brennan Shaw about it, the former CEO of uh Medicines Australia, and uh I think he was the deputy CEO of FBA, which is or IFPMA, sorry, which is the International Pharma Associations. But we were just sort of contemplating you know, what does this all mean for for for the country when Australian discoveries are for perfectly commercial, rational commercial reasons, are not being commercialised in Australia.

Felicity 10:38

Yeah. Well, I think it it's it's the story. It's it's the like I said, it's highly rational. Business is highly rational. Um you're a small business, I'm a small business. We make very I mostly make very rational decisions. I think sometimes I volunteer times to be, but um we make rational decisions on the market and what we can and can't do. And when you look at the access process, there is no point listing a medicine on the going through the hurdle of the TJ R T G process unless you are going to make it available via the PBS or, you know, the MSAC, you know, national health reform agreements. And if you're a smart Australian company, my advice to them as someone who acts in this system would be if you if you go for ARTG here, the pressure on you to hand this medicine over for free is going to be astronomical, and the time frames that you're gonna have to go through before you actually get subsidy are not worth the worth your while. And so you create false hope. So uh we have seen, you know, uh Minister Butler put pressure on a company to provide access to a medicine for free while it's still going through ARTD and you know, heaven forbid if it ever gets through BBAC, etc. And so you've got to think with a business mind and say, well, don't do it. You know, maybe in five or ten years' time when you've made uh sufficient funds overseas that you can afford to go through the Australian process and have to hand this medicine over for free for five years till you get through. Sure, maybe. But that would be the rational advice I would give to one of these companies, which is Australia is a charity case. Um, sorry, Professor Barbara. It is a charity case, and if you go through this ARTG process, you will come under huge pressure to make it available under compassion or you know, pending something happening, and then you will go be ripped through a process that um, you know, as we've seen from from 2022 when or 2023 when Mark Butler said his MSAC process was killing in on you know inadvertently killing people, it still took him three years to get a recommendation enacted in one state. So why would you?

Paul 13:06

Yeah. Well, yeah, I I actually think it's a really important discussion. It's a national interest discussion. See these companies. NewRen has outsourced the commercial rights of this product to a US-based company, and naturally a US-based company has got investor funds, it's it can't look at behave like a charity, it's got to contemplate a return uh and it looks at all the markets and targets those that are investable, and Australia is not one.

SPEAKER_01 13:40

Nope.

Paul 13:41

So if local companies are not finding a pathway to reimburse access in Australia, we can't really blame multinationals for not bothering with us.

SPEAKER_01 13:51

Correct.

Paul 13:52

And we haven't quite got to that conversation yet. Obviously, Natasha's uh Robinson has got very close to it uh with her team at The Australian and has written about the GLP ones today. And and I I don't have any I don't have any particular objection to companies not launching in Australia. I have an objection to government policy frameworks that make it unviable. So naturally Australian policy has supported the development of TLIX and NewRen and all of these products with things like the RD tax incentive.

SPEAKER_01 14:33

Yeah.

Paul 14:35

And so and then and then they hit the virtual brick wall with these reimbursement frameworks. So there's obviously a a lack of policy coherence. And we saw that we saw that with Nevada's manufacturing that, briefly manufacturing their car T product in Melbourne, whilst they were getting done over by the HTA frameworks. And you kind of go, well, it seems to be a lack of coherence in Australian policy.

Felicity 15:01

And look, to be fair to the health system and industry system, they're not Robinson Crusoe. I mean, we can look at our our policy in solar, which is predominantly and electric vehicles, which is predominantly encouraging stuff coming in from China rather than actually making it available in Australia. We can look at our defence investment policies, we can look at our roads policies, we can look at everything, and that that disconnect is quite significant. And then we have these massive, you know, medical research future funds and various other funds to to invest in because we we want the best and the brightest in Australia, but we just want to keep funding them to research, not actually translate anything into a product. So it it isn't unusual. Um I know you you've talked lovingly in the past about your magic factor F, uh, which used to be a pricing issue. Uh look, and I've sat in the Department of Health during my time and when the MRFF was being discussed, and unlike, say, in Israel where you are given money to invest and you you pay it forward, you don't they don't want to clip. They just like once you've made your money, give it back to the next person. The department was actually sitting there saying, hang on, if we're going to put money into something that might lead to a commercial outcome, we want a discount when it comes into the the PBS or the MBS to it or you know some other part of the system. So we it's a really good example of how you know pay our and patch are a provider and we we see it as a tender and a transaction, not as investment.

Paul 16:29

What's this and it's just Marxist nonsense, right? So if if the government wants to wants a discount or some kind of return, well they should invest in the companies.

Felicity 16:38

But also, I I think the point I made at the time was okay, so if you want a discount for something that might have been had a clinical trial or process in Australia, then the counterfactual to that is then you have to accept that you need to pay more for something that was invested in by another country's government. I don't know, that sounds wow. I'm I might sound like President Trump right now. But my point was you you can't have it both ways.

Paul 17:03

Did they do they actually believe that nonsense?

Felicity 17:05

Oh, yeah, it was a very serious discussion. Yes.

Paul 17:08

Right. So they actually believe that because government supported somehow basic bench top research, so they put a few million million dollars into a project and then investors came along and put a billion dollars into realizing that product that somehow they should derive some financial benefit down the track. They actually believe that, do they?

Felicity 17:27

Yeah, it it was like, you know, that God help us that you know, I I I think maybe they'd looked at you know how you would banks and pay out dividends. I think they thought it was kind of like that, but instead of getting a dividend, we we we we get a discount when it comes here. You know, if you if you wanted to if you're looking at these issues and the support and the biotechs and things, sure, you you'd like a a nation preference, which is sort of saying, you know, if you've developed all of that in Australia, we'd love for you to be as part of all the money we invest, be in the top five of the countries that you bring that to market for, and this is our deal with it. Like we we will support it. Um, you know, if you if you're talking about all these unicorns and HTA reviews, isn't it saying if something is developed in Australia or supported in Australia, you get priority of access to the ARTG and PBAC and MBS and MSAC processes. So rather than actually being about the discount, don't we make it about, hey, if you're local, bring it here.

Paul 18:24

Yeah, and that that that's going to come up against trade agreement rules around national treatment. But if they literally believe that, they're they're they're dumber than a bag of doorknobs, basically. If they if they actually believe that, because of course the evidence suggests the opposite, is where things are developed and made in Australia, government tends to pay more. Look at the fluvax, for example. Look at the blood supply. So Australia actually tends to pay more. It's just so, so, so asinine for someone to say, because we invested a few million dollars in this, that somehow gives us a privileged position over the billions invested by actual shareholders in supporting the development of a product. And of course, the logical extension is what do we do for all the failures? So the MRF, the vast bulk of what the MRFF or the NH and MRC supports in terms of research just hits dead end. It doesn't go anywhere.

Felicity 19:17

No.

Paul 19:17

And so how do we recoup that? So anyway, it's it's that's just if that's the level of conversation you kind of go, yeah, we're in more trouble than I thought.

Felicity 19:29

But hopefully it's moved on.

Paul 19:31

Yeah, you would hope so, but but I I doubt it has, it's probably um gone backwards. Look, the other thing that I really wanted to focus on was the story, which got an interesting response about the Abilene paradox.

Felicity 19:49

Yeah, okay.

Paul 19:50

When everyone knows it's a dumb idea, but no one wants to say it. So the paradox was uh developed in the 1970s, and it's based on a a group of people sitting at home in Abilene, I think Abilene, Texas, and someone suggests they go to dinner and they all agree because they assume everyone else wants to do it as well. But as it turns out, none of them wanted to go for dinner. And I and and I thought I thought of those 75 patient organizations who signed up to the HTA review, and it doesn't it doesn't really make any sense to me as to why anyone would sign up to a review when they don't know what the outcome is, uh, particularly because we're in that sort of Delphi survey weirdness. It also strikes me as odd that you'd advocate for something the government has basically already agreed to.

Felicity 20:37

Yeah, I I think you made a sage point in talking to some patient groups this week. I said, be careful because that's kind of already the concept of sticking you in the process somewhere a bit more has already been agreed to. That's what you're gonna get. That it's already a no-brainer. And if you ask for anything more, it's like, well, we we gave you what you wanted. Um I think a lot of groups decided that they they still need to have visibility. I think it's an important issue when there are groups that are dominating the conversation within the department and within the minister's office and have that easier access. Let's be clear, there's a handful of patient organizations that have a highly privileged access position into uh the Technology Assessment and Access Division in the Minister's Office, and the others write letters and seek access and get an uh a bulk letter response from something that's not even signed by an individual. So you can see people wanting to be attached to something to remember. I'm still here. I think some of it was that. Um when I've been talking to people about why uh better access is going bold or going home, is that we believe that that's actually We we don't want that to begin with, but we we wouldn't sign it because we we don't want it. That second of all, we don't believe it solves the problem and we are curious as to how a minister tells us no, that patients being an important part of the system, that the PBAC and the PBS having to recognise that it's for patients, that him issuing an annual statement of his expectations of the system is weird that um the denial of patients' rights to appeal is somehow um something he should defend, that yeah, it's perfectly okay to to leave people disenfranchised uh in our health system, whether or not they have that lovely little green card. So I I think it was a really good point because it does make people uncomfortable because they do realise that we fall into patterns of is it something we can do? Well, something's better than nothing, and I'll agree because everyone else is agreeing, and those that do challenge basically get told to be quiet. So again, something is better than nothing, and that's not always the case. But um, I did also think of my family dinners and went, wow, that's how we always end up with yep. Well, we all just separate and go to four different rooms and go, yeah, I went out doing this, but yeah.

Paul 23:16

I just you know, and I'm not I'm not denigrating or criticizing, I'm I'm qu I'm questioning because to me it's part of the institutional problem is that this is what patients think they need to do.

SPEAKER_01 23:26

Yes.

Paul 23:26

It's a bit like the well, we all need to basically adjust our input to the HTA framework so that so that you know we that they will accommodate our view. But in order for them to accommodate our view, we have to accommodate their way of thinking. And I just think that's completely arse about. And I also wrote about the complete absence of rights, and you've been on this for a very long time, and I'm completely 100% in support of you, is that patients have no right in this process. And what what's the evidence of no rights? Well, the act is evidence of no rights, but also the evidence of no rights is patients meeting to talk about how we have to modify our input to these processes to make sure that it's relatable to the HTO framework. And I I I have a I have a real problem, I have a definite problem with that. And I also know that a lot of these patient groups know that it's rubbish, but there is a reluctance to speak out because of the fear of exclusion, which is a very real issue in this system, is that it is in some ways punitive, and at its worst, it's when some external organizations or non-government organizations are punitive against their peers. I d I I don't like that. So I suppose that Abilene Paradox is the is an apt example, it's probably the phrase of the week in many ways, because I I do think there needs to be greater courage about speaking out. And look, that letter, as well intentioned as it is, will be used as a prop. Uh I hate to make the comparison, and I actually took it out of the story. Uh yeah, it's a Neville Chamberlain piece of piece of our time coming back from from Munich, and uh it's going to be waved around for years to come. I gave you what you want, so what are you complaining about? That's going to be the reality because everyone knows that this is this process is the most busted of busted flushes, and there needs to be an honest conversation about it. And I think there was an opportunity just for a bit of cautious reflection, but also communicating publicly on this, and to the minister, knowing that it's failed, it's in perfectly acceptable to say to the minister, we have not got anything out of this that matched your word and your descriptions of it three or four years ago.

Felicity 25:46

Yeah. And look, I understand why people are doing this and a few things. First of all, you talk about, you know, we all have to work out how we can put information in for these expert advisory committees to better understand the the consumer or the patient experience, which is always funny when you consider they're the independent not experts, and they're so expert at HT and everything else, they're just really dumb as all heck about actually understanding the impact on a patient or what it's like to live in the real world. So that that's always curious to me. But the thing that really hit home to me is the the controlling influences. And so talking to some patient groups about, and this is a call out to Minister Butler and his office, your increasing setting. I get DNDIS is a big issue right now, and I get age care is a big issue right now. But the continuing not bothering to return calls, not bothering to respond to correspondence, not bothering to meet, you know, unless you actually jump up and down and you get your stuff in the paper, they don't give two hoots. And that's not how he started, but that is how it is these days. And so one of the reasons you find patient groups going something's better than nothing, or these guys have a big banner, and I know they get to go to these things all the time, and they're at Parliament House all the time, and they get to talk to the department all the time, is that I've got to hitch my wagon to something because the minister just ignores me. The department just ignores me. I'm serious, like you get letters which are not even signed, and you don't even know where they've come from. There's not even a generic mailbox.

Paul 27:17

That's appalling if letters aren't even been signed by the book.

Felicity 27:19

Oh, yeah. It's it's it's quite common. The second thing I, or third thing, I want to highlight is that this part, health in particular, but this part of the health system, this is not my experience in any other area of social services. So as you know, we work in disability, aged care, and um general uh support services and social care, so centre link, all that stuff. Groups don't treat each other like this. No people don't work like this. The system gives money to these groups to expect them to agitate, to question, to focus. It is not it is inclusive, not divisive. And it you know, I I I look forward to it. I've got to do some stuff in in aged care and social services disability. And that gives me energy because the people you work with are so collegiate and the system is so open and listening, and yet you don't get this in here. And I I think that is that's again one of the reasons why I say to people, why am I wanting legislative change? Because the stewardship isn't there. So if you will only do something because it's in the law, and I I heard Professor Wilson as the former chair say on many of occasions at your conferences, the law says he has to do this. Well, fine, then change the law. It's it's actually not what it says exactly. But if you if that's how you're all gonna operate, then I'm gonna change the damn law and teach you to think about a patient and what the PBS really stands for, once again.

Paul 28:49

Yeah, I and people say to me all the time, yeah, but the government's not gonna do that. Well, they're certainly not gonna do it if you don't argue for it. But government changes law all the time. Every time the parliament sits and it sits for five months a year, very short winter recess this year, they're changing laws. Often badly, but they're often changing law. So there's no reason why this part of the act, which has been in place since the late 1980s, can't be changed, can't be revisited, particularly as you know, I describe it as the original sin. The complete genesis was a was a a deep disdain for patience. So I look, I understand why they did it, but I but I I think it's one of those situations, and and it's a bit like um it becomes an echo chamber, but I I always say, you know, and you you would know this being a Victorian and and from Melbourne, is that Melbourne is a very it's it's a very it's different to other cities in Australia, and it's different in a way that uh often, particularly in the AFL culture, what looks perfectly reasonable and sensible from within that culture looks completely weird from the outside. And it is weird, yeah, it looks completely weird from the outside, but when you're in it, and uh I I I confess to being one of those people, certainly when it comes to AFL, being an insider for many years, I suppose, that's you can't see it, you can't see it, and then when you step outside it, you kind of go, Oh, that's weird. And this is a classic example of that. So when a group when patient groups get together and talk about how we have to create an evidence basis that it's acceptable for our HTA institution, it's perfectly reasonable, but from the outside looking in, it is madness, it is complete madness. You should not be doing that, you're accepting the premise and appalling premise, and I think with the there's a real argument to push back. And you and I both know as being on every side of a change in policy, in order to get minor change, you have to argue for massive change because governments are incredibly good at backsliding, they're incredibly good at squeezing the juice out of the lemon. And the HTA review, so much you do a PhD on it as a case study in how governments manage down change. Expectations started very high, and they've just squeezed the life out of the process, doing it brilliantly in that Sir Humphrey way. And so, yeah, I think there's a there's an opportunity to be a little bit a lot more ambitious.

Felicity 31:37

I I agree, and it's I've been watching on Netflix uh Pan M 103.

Paul 31:43

Oh, about Lockerbie. Uh yeah.

Felicity 31:46

And there's there's the two sciences the the Lockerbie one, which is as Colin first about the the families, and then Pan M 103 is about uh the investigation and the process. But one of the things that is quite transformative in that is how I I encourage everyone in the system to watch it because it's about how a system starts. This is how we do an investigation, this we do it, and then one person saying, You're forgetting the families, you're forgetting the families, you're forgetting the families, and finally how the families manage to to change the processes, the actions, most of the security changes we have are because of the families, not because of the investigative model and how that all worked. So it's I guess it's a good series, but when I was watching it, for me it was like this is actually what is happening in our uh HTA systems right now. So um it's a it's a fun way to draw a parallel.

Paul 32:39

Alrighty. Short one this week.

Felicity 32:42

Yeah, because you've got appointments.

Paul 32:44

I've got a very important appointment under the looking at golf course fairway and talking about Japanese toilets. It's a it's a it's a it's a long story. It's a long story. It's a long story. Uh, one thing I did want to mention is Chris Bowen's travel. 350,000 on travel he spent in the last year.

Felicity 33:07

Does that include paying for carbon offset?

Paul 33:09

So he could be the first person ever to qualify for lifetime platinum. Yeah. Which is as if when you do the maths, you realize you've got to live to about 150, even if you fly a lot like we do. That that that's uh it's just unbelievable the amount of travel.

Felicity 33:29

I know. Has he not heard of Zoom?

Paul 33:32

That's right. That's right. That's right. All right, Felicity. Thank you very much, and thanks everyone for listening and uh keep the feedback coming.