Science-Driven Policies: The Key to Better Outcomes

Sukhi Hayer: Hello and welcome to the 16th Open Science event with three PMI guests, two here in the studio and one online. A reminder that this is a prerecorded session and it will be available on the usual platforms LinkedIn®, YouTube, and the Open Science platform. We are of course discussing “Science-Driven Policies: The Key to Better Outcomes.” We're going to hear from our guests very shortly, but I'd like them to introduce themselves and see what they do on a day-to-day basis first. Yvonne, can you tell us what you do for PMI? 

Yvonne Khoo: Hi Sukhi. I'm a pharmacist with a doctorate in Pharmacology. At Philip Morris, I have the exciting role of communicating science updates on smoke-free products to a diverse range of audience. I believe in the power of honest and open communication and, hence, I look forward to engaging with you today.  

Claude Guiron: I'm Claude Guiron, I'm a Swede, and I work for Swedish Match in the Nordics. It's an affiliate of Philip Morris. I'm a cardiologist by training and have been with the company for 8 years. What I do on a day-to-day basis is basically scientific communication in the context of regulation to different audiences, like physicians, scientists, journalists, and of course, regulators. 

Agnieszka Wyszynska-Szulc: Hi Sukhi. My name is Agnieszka Szulc. I'm Polish. I have spent more than 20 years in Regulatory Affairs. In my current role at PMI, I lead our global efforts in regulatory and product policy development and evidence-based advocacy to support innovation towards better alternatives to smoking. And I'm really looking forward to having discussion with you today. 

Sukhi Hayer: And we look forward to having you here today. Thank you very much for joining us all. I just want to start off with you, Agnieszka. In terms of the title of this event, “Science-Driven Policies”, what do we mean by that?  

Agnieszka Wyszynska-Szulc: Let me start maybe with putting a bit more context to our discussion from the policy-making perspective. So, let's ask ourselves the question: what is the role of policy? In very simple terms, public policy is creating a structured and functional society that creates an environment that can address the challenges of this society and eventually improves the quality of life for the citizens. But, in order for regulation and policy to be effective, [they] need to be grounded in scientific research, evidence, data, and it also needs to adapt to the market realities and reflect the changing environment.  

So, if I put it in the context of tobacco industry, the current tobacco control policies are not working effectively anymore. There was a set of measures that were promoted for a long time. But these measures, whether regulatory or fiscal measures, they have reached their limits of having an effect.  

And if you look at the global numbers today, you still have 1 billion smokers globally. [It] is a huge number that has not meaningfully changed in decades and, based on the current trends, does not seem [likely] to change in the near future.  

Sukhi Hayer: What do you mean by regulations keeping up with market realities? What do you mean by that? 

Agnieszka Wyszynska-Szulc: Well, from my experience of engaging with policymakers, there is a big challenge to embrace innovation, to embrace new technologies. And there are a number of reasons for that, one of them being that these are new products. There is a lot of science behind them, but they are not very well understood by policymakers. And this is, obviously, the role for the scientists as well to chip in and explain: what is the science behind these products? What is their role? And how they can benefit public health policies? [The] second thing is very simple: existing tobacco regulation can be very slow in adapting to market realities. So, effectively, it's restricting [the] adoption of innovation. And, last but not least, and which is very common, the policymakers are very much used to the conventional type of tobacco control policies. It's very difficult for them to change the mindset and to shift from approaches that are very familiar to them.  

So, in this context, I think what is critical for us is to really start with the basics: to educate policymakers about the new products and specifically about the science behind them. And, here, when we talk about science, it is critical to also address the misconceptions about nicotine, because today the perception of many regulators is that, because smoke-free products contain nicotine, as cigarettes [do], they are equally harmful to cigarettes. And obviously this is then reflected in the policy making, which is not the right way. And obviously nicotine is addictive, not risk free, but it's not the primary cause of smoking-related diseases. And these are the basics of the science that needs to be explained to the regulators in order to start shaping the policies in the right way.  

Sukhi Hayer: And you're the one that has to explain that to regulators. So you talk about misconceptions of nicotine. What is that? What does that look like?  

Claude Guiron: I think for the last couple of years, the knowledge around the smoke-free products has increased. The number of publications has increased almost exponentially. And it's—I think we have to be fair—it's hard for regulators to keep up with everything that's happening. And I'm thinking about myself. When I worked as a cardiologist, I rarely thought about the importance of how nicotine was delivered to the body, because nicotine is so linked to cigarettes and cigarette smoking. So you don't really think about that. It's also very easy for the brain to make [these] sorts [of] errors, like—I mean—for sure cigarettes are harmful. Cigarettes contain nicotine. And it's easy to think that, because of that, nicotine must be very harmful. But that is actually not what science is telling us because, if you look at the evidence, of course nicotine is addictive, it's not risk free, but it's not what makes cigarettes so deadly. Instead, it is the combustion process in the cigarettes, the burning of tobacco that creates a mixture of chemicals, included carcinogens, including toxicants, which leads to cardiovascular disease, which leads to lung disease, which leads to cancer.  

So, now, if we look at what authorities are saying—and this, I don't think this is widely known around nicotine itself, because most people don’t think about nicotine itself outside the context of cigarettes—but what authorities are saying on nicotine itself (authorities like the U.S. FDA, like the National Health Service in the U.K.): they are very clear that nicotine has quite low risks for healthy adults. And what do they base that on? Well, first of all, we have studies, long-term epidemiology studies on nicotine replacement therapy and on snus with high levels of nicotine, which don't show a connection between nicotine and smoking-related diseases. So, to be very clear, these authorities say that you don't get cancer from nicotine, you don't get cardiovascular disease from nicotine, you don't get lung disease from nicotine. So now, when I look at what kind of questions I get in my daily work, of course, as a cardiologist, but I think also in the general debate, I think a lot of discussions are going around cardiovascular disease and nicotine. And there are a lot of misconceptions here and a lot of misinformation in this field. And I think that's because the relationship between cardiovascular disease and nicotine is somewhat complex. Because, on one hand, you can see that nicotine increases the blood pressure, the heart rate at rest. But, on the other hand, we have long-term studies as I mentioned on nicotine replacement therapy but also on snus with high nicotine levels, which don't show a relationship between nicotine use and cardiovascular disease. So now what makes it even more complex is the fact that if you have cardiovascular disease and use nicotine, you have an increased risk of fatal outcomes. So, as a clinician explaining this to other people, I tend to think in this way: even if this substance doesn't give you the disease, once you have the disease, you take away some of that reserve capacity in the body—in a body that's already stressed from the underlying disease—and then you have increased risks. So that's why nicotine should not be used by people who have cardiovascular disease.  

Sukhi Hayer: And with you Yvonne—just to bring you in here—when you go out and talk to stakeholders, for example, or scientists, etc., what are you finding in your part of the world?  

Yvonne Khoo: I think, Sukhi, I can start by sharing with you what I see when I walk on the streets in New Zealand. I see posters from the Ministry of Health telling their people that vaping is less harmful than smoking. And this has got to do with, back in 2018, when the New Zealand government noticed an increasing uptake of vapes among smokers and hence chose to regulate vaping as a consumer product. By choosing to regulate, what the government can do is to control product quality while at the same time deter unintended underage use of vaping. And today the number is very telling: the smoking prevalence in New Zealand is now going very near to its smoke-free goal of 5% or less. 

However, when I walk in the streets in Australia I see a very different approach. The Australian government would put up a poster with a scary image of someone on [a] hospital bed, on respiratory support, with the message that vaping is harmful to your health. If you're a smoker in Australia today, you either need a doctor's prescription or [to] see a pharmacist to get your vape. But here's the reality: over 90% of vapers in Australia obtain their vapes from illegal channels. This booming illegal trade has opened up to high gang fights and that has led to arson attacks on tobacconists in Australia, as we can see widely reported in the news. So both countries, neighbouring each other, take a very different approach in regulating smoke-free products. And what we see today is [that] in the last 5 years the prevalence of smoking in New Zealand has decreased twice as fast when compared [with] Australia. So I think the evidence is very telling [of] how different approaches can lead to different outcomes. 

Agnieszka Wyszynska-Szulc: I'm really very happy that Yvonne brought these two examples, because from the policy-making perspective they are really very interesting cases, because both countries began their journey from the same starting point. They were at the forefront of tobacco control policies globally, very restrictively treating cigarettes with a very high taxation, with restrictions, such as plain packaging, etc., while not allowing smoke-free products. But then, as Yvonne mentioned, [the] New Zealand government started reflecting on what has been achieved so far and they concluded that they cannot reach the target of 5% smoking rates because the effectiveness of the measures was not there anymore. Hence, they decided to change. They listened to the scientists. They listened to the stakeholders [and] to the public health community who brought to them also the evidence behind smoke-free products. And this is when they decided to change the approach to the policy to regulate—legalize—smoke-free products and put them on the market so that smokers can switch, obviously with all the necessary safeguards to prevent the use by underage persons. So, you see with these two examples how the different approach to policy can drive completely different outcomes.  

Sukhi Hayer: And, Claude, in Europe, are there similar examples—two contrasting examples like that, or contrasting governments? 

Claude Guiron: I think, I believe we really have a diverse picture in Europe. As a Swede, I was really surprised a couple of weeks ago when I saw a WHO report which said that Europe still has the highest smoking prevalence in the world; and that is despite all the regulatory measures, all the excise measures, being implemented in Europe. Because when I walk on the streets of Stockholm, you rarely see any smokers. And it is really a diverse picture because Europe, as a region, is set to miss the goal of a 30% reduction in smokers by 2025. But there are exceptions, and some of these exceptions are for example Norway, Iceland, and my home country Sweden, who have been far more successful. So, in Sweden, for the last two decades, smoking rates have declined very, very rapidly, and last year in 2024 daily smoking was at 5.4%—very, very close to the WHO target of 5%—and that is despite Sweden not having implemented very extensive regulatory measures. So for example, we don't have plain packaging in Sweden, we don't have point-of-sale display bans for cigarettes in Sweden, and we have—in a European perspective—quite low excises and prices of cigarettes. But the main difference between Sweden and the rest of the EU is that oral products have been allowed for a very, very long time, initially in the form of snus (an oral form of tobacco) and, for the last decade, in the form of nicotine pouches. And consumers in Sweden, they have embraced these new products—it's really been a consumer-driven movement to move away from cigarettes—and consumers understand that these products are less harmful than cigarettes. Then the authorities have reinforced this movement by having differentiated excises for cigarettes compared with smoke-free products. So, the exercises for cigarettes are far higher than they are for smoke-free products.  

Agnieszka Wyszynska-Szulc: And if I may jump, I think this is a very good example [of] how the policy can shape the behavior of consumers. So you subject the most harmful product to the most restrictive measures—I mean cigarettes here—and then you differentiate these regulations for smoke-free products so that you drive the consumer, so you basically tell them what is better for them if they don't quit smoking.  

Claude Guiron: Yeah. And I think you asked about whether there are other examples in Europe where it's going the other way? I think there's plenty of examples. The most striking one I think is France because, if you look at France, smoking rates have not declined as much as in Sweden for the last 20 years and, for the last 5 years, very, very little. And France is currently in a smoking rate of 23%. And that's despite France having implemented a lot of measures. In France, they have plain packaging and they have very high excises on cigarettes. Cigarette prices are much, much higher than in Sweden. 

Agnieszka Wyszynska-Szulc: Indeed. And also the regulatory environment for smoke-free products is not very permissive. And there is a now pending proposal from the French Ministry of Health to actually ban nicotine pouches, the same pouches which are bringing so much effect in Sweden. And if you look at the outcomes of this policy, well, there is a huge illicit trade today in cigarettes, [and] so a huge part of the market is uncontrollable. The government is losing revenues and obviously you cannot control who is using these products, including the access to these products of youth.  

Claude Guiron: To me, I think it's really strange. If you have 23%+ smokers, why are you discussing so much around the smoke-free products? Because the real problem is smoking in France. 

Sukhi Hayer: But you can understand why governments are trying to reduce tobacco prevalence [or] nicotine prevalence in society, because that's part of their healthcare policy essentially. Yvonne, from where you sit, what are you seeing in terms of the governments there? Are they more trying to ban rather than have this sort of balanced approach that you talk about? 

Yvonne Khoo: Well, Sukhi, I wish I could bring Claude over to my country and have Claude go to my Ministry of Health and talk to my policymakers. Look, I've been in the shoes of a regulator before. And to any regulator, when you present a new technology, a new product category, the immediate reaction is to dismiss any value by choosing to ban this new product. In the case of smoke-free products, well, regulators often think along the line [of] “Well, I don't want a new generation of smokers.” Well, I think regulators must choose to trade a balance between regulating risk and potential of what new product categories can bring. The problem today is that we have 1 billion smokers. There are millions of lives at risk from the harms of smoking and we know that smokers want to switch to less harmful products, away from the harms of cigarette smoking. So good policy making calls for achieving a good balance between acknowledging the risks and also allowing regulated access to the intended group of the population, in order to have mass switching away from smoking.  

Sukhi Hayer: It's interesting you mentioned generation ban, because that has been touted in a few countries, one in the U.K. for example. So, in terms of generation ban, I think what—it seems—the policymakers are trying to do is make sure that don't get into the hands of young people, youth. And that has become an issue, hasn't it, with vaping?

Agnieszka Wyszynska-Szulc: Look, if we focus on youth vaping, indeed, I think we need to put the facts straight. So these products—[neither] smoke-free products nor any tobacco or nicotine-containing product—should be used by underage persons. So, obviously, here, the regulators have a role to play to put the necessary safeguards in place. And that can be the minimum age for selling these products, that can be rules for how these products are marketed, what kind of flavors are allowed in these products, how these products are presented. So, basically, the regulation needs to, on one hand, find this balance to maximize the benefits of smoke-free products for adult smokers so that they are encouraged to switch, but at the same time mitigate the risk that these products will end up in the hands of the kids. So that is very clear.  

Very briefly on your point [of] generation sales ban[s]—but I think it requires a separate discussion. I mean this proposal, first of all, is not tested. Secondly, it's not addressing the problem of today's smokers. So it misses the point that we have still, as Yvonne said, 1 billion smokers globally and we need to find immediately solutions to address this problem. And if I think of other countries in other regions, actually among these 1 billion smokers, you have smokers in countries, such as India, Turkey, Brazil, just to give a few examples. And these are the countries that explicitly ban smoke-free products. So, basically, they deny the access to smoke-free better alternatives to cigarettes to adult smokers. Instead, they, in a way, encourage the trade in cigarettes and perpetuate smoking. So you see how diverse the regulatory landscape [is] today and what kind of different approaches are taken and how much effort needs to be put there to clarify the science and clarify the benefits of smoke-free products.  

Sukhi Hayer: I think that's a question for you. When you do go to these regulators who have very strict policies on tobacco control, how do you introduce science to the conversation if they have little understanding of it? 
 
Agnieszka Wyszynska-Szulc: Look, I think there is a role for scientific community, definitely, because obviously we talk to the government, but they are often more likely to listen to independent stakeholders. And here the scientific voice is extremely important. So I would encourage all the scientific community, medical community, to speak up and to engage with the regulators to have a meaningful science-based discussion and present what kind of benefits smoke-free products offer today to decline smoking rates.  

Sukhi Hayer: And as scientists, you're having these discussions with all that knowledge. How are you guys getting on with these governments and stakeholders?  

Claude Guiron: But I think when we meet with the governments, we're always meeting them with our Philip Morris hat on. And, of course, the tobacco industry has a history, so that will affect how they listen to us. So I think that's why it's so important that independent scientists are involved in the debate. I think a lot of people I meet, they share our views when we meet in closed room or even if we meet at scientific meetings, but to bridge that to a scientific debate on regulation—I don't think most scientists are used to that, because they're not used to do[ing] that.  

Sukhi Hayer: And Yvonne, you know, with scientists it's very difficult to get consensus sometimes. Are you finding that there? 

Yvonne Khoo: Of course, Sukhi, I hear Agnieszka when she says that scientists need to be educated about the science behind these smoke-free products. And I've had personal experience. When I talk to a fellow pharmacist, I often get a response that “no way will I carry vape in my pharmacy.” So this shows you how strong their emotion can be against a new innovation without understanding what’s the science behind it. And I've also read that, in Australia, less than 1% of medical doctors registered themselves as licensed prescribers for vapes. So this shows you there is much work to be done to make the scientific and the healthcare practitioners community sit up, take notice of the building evidence in smoke-free products, and let's work together in allowing a regulated access to our smokers who want to switch to less harmful alternatives.  

Sukhi Hayer: OK, so I'm going to make your lives very easy now. I'm going to give you this magic wand. And, with this magic wand, you can do whatever you wish—within the context of this conversation, obviously. In the next few years, what would you like to see with it, Agnieszka?  

Agnieszka Wyszynska-Szulc: So from the policy point of view, I would like to see more policymakers putting adult smokers at the core of policy making and designing regulation in a way to maximize the benefits of smoke-free products for adult smokers. And second wish, if I can have, is to make scientists more vocal [to] promote the science, promote the evidence that exists today, such as the case of snus in Sweden and the long-term evidence which already is there that demonstrates that smoke-free products can bring public health benefit. 

Claude Guiron: For me, as well, to get more scientists engaged in the debate, and not just in the scientific debate scientist-to-scientist, but also in the scientific debate more general in community, because I think their scientific voices are needed if we should get a scientific regulation, scientific-based regulation. Then second, I would like to see authorities giving information to smokers that there are better smoke-free alternatives out there if they're not willing to quit cigarettes.  

Sukhi Hayer: And Yvonne, this magically appeared in your hand, and it seems that everyone's getting two wishes with this wand. So what are your two wishes? 

Yvonne Khoo: Well, if I have a magic wand, I'd like to see a reduction in 1 billion smokers to at least half of them in the next 10 years. But, in order to do that, what I will consciously do is to have conversations with my fellow healthcare practitioners to help them overcome their strong emotions against smoke-free products. I will call for them to read the science, to acknowledge the evidence, and work together towards providing and educating our society towards better, less harmful alternatives away from smoking. So I think, in this instance, scientists have a very important role to play here.  

Sukhi Hayer: OK, thank you very much. And with my magic wand, we'll bring this session to a close. Thank you each and everyone of you for joining us, and thank you for watching today. That's the 16th Open Science event for you.