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Peter Dator: Good day, everyone. I am Peter Dator and I will be the moderator and host of our workshop this morning. By profession, I am a lawyer. and the immediate past president of the Vapors of Philippines, which is the longest running consumer group in our country. I used to smoke a lot of cigarettes years ago until I discovered vaping. And to this day, I have quit smoking traditional cigarettes. Since then, it has been my advocacy together with like-minded vapors, doctors, scientific and policy experts to pass a reasonable NO which would regulate the products in the Philippines. Now, this particular workshop aims to share the experience of the Philippines in passing the vaporized nicotine and non-nicotine product slope. The main purpose of the law is to regulate the non-combustible nicotine products and introduce a harm reduction approach, stating that reducing the harm caused by smoking is one of the very main purposes of the law. And as with most countries, our Congress took its time to fully understand what this law is all about. Because this new category of products presented questions and caused a lot of debate, apprehension among the public. and the policymakers. Working with a couple of familiar faces here, Congress took its time to study the available science and listen to the perspective of the affected stakeholders, including the consumers and the public health community. Our panelists today, who are all anti-smoking advocates, will share their challenges and the learnings in working past this landmark legislation. The outcome of our document from this particular workshop The outcome of this particular panel is a paper highlighting the elements on ideal regulation, which keeps unintended consequences to a minimum, but at the same time, it allows adult smokers access to these problems and how it can be achieved in an age of fake news and misinformation. Let me just go through my notes and introduce our first panelist. Our first panelist today is Mayor Alfredo Garbin. He is a recently elected mayor of Legazpi City in the Philippines. He was a congressman in the Philippine House of Representatives from 2010 to 2013. and from 2016 to 2022. He successfully defended the VNNP Bill of the House Pledge of Debates, which led to its passage into law as the Philippines Vaporized Equitine and Non-Equitine Products Act of 2020. Mayor Garbin, would you like to share an opening statement?
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Alfredo Garbin: Thank you, Peter. Good morning everyone and to my co-panels here, good morning. This is an excellent platform for all of us, an opportunity to talk about the Vaporized Nicotine and Non-Nicotine Products Law and to share our experience with the rest of the international harm reduction community. In the Philippines, we want to keep up with the new technologies and trends, and this is the reason behind the passage of this law. Our existing laws were designed for cigarette smoking, and we needed a new law that's a better fit for these products. Right now, the law has been passed. The implementing rules have been issued, and we have seen the government agencies in charge. of the enforcing the law at work. And the government just needs to ensure that we are not overzealous and follow the letter in spirit of the law, which includes the transitory period of 18 months for the stakeholders to comply and given enough time to comply. I also call upon the industry to comply with the requirements of the law as soon as possible. Thank you.
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Peter Dator: Thank you very much, Mayor Gergwit. Our next guest for today is Undersecretary Sharon Garin of the Department of Energy. Prior to her joining the Department of Energy, Undersecretary Garin started her career with public service from the 15th to the 19th Congress as the representative of AAMVBIS OAPartinist, and was the first female deputy speaker from the province of the Indo. She is an author of the Vaporized Nicotine and Non-Nicotine Products Act 2022, defending it during the Second Reading in the House of Representatives, while at the same time serving as a member of the Bicameral Conference Committee on the Vape Bill. Under Secretary Garin, Good morning.
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Sharon Garin: Good morning, and thank you for this opportunity. Although in my more than a decade experience as a legislator, which I'm not anymore, I was recalling that this was one of the most dramatic or more stressful bills that we have had because the discussion was so rich in a sense that the scientists, the doctors had their own views, and among them, among themselves, they could not come to an agreement. Not only doctors, but also lawyers, legislators, and advocates. And in fact, there were also different types of products that wanted something different from the other stakeholders. But what happened in the 18th Congress was the alignment of the stars. That's what they always call it. that it was the right Congress, right Senate, right mentality of all the stakeholders that came together, along with the President, the Speaker, and the Senate President, and the agencies. It made it more substantial, the changes that we have made. So we are quite proud of the bill. It is very specific as to what we wanted to happen. In fact, we don't give too much leeway to the implementing agencies. But how come we made a bill or a law that we are so proud of? Because this was scientifically driven. We had consultations in all the stakeholders. We had lengthy discussion from all the industry players. So I think we arrived at a version that we hope that will deliver what we have wanted. We don't want more people, those non-smokers, to take up vaping or any kind of non-combustible. We don't want minors to pick up the habit, but we also wanted to give an alternative to those who are already smoking. I think this bill, the way it's written, hopefully it will achieve that objective. Thank you.
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Peter Dator: Thank you very much, Undersecretary Garin. Moving on, our third guest for today who is also joining us via Zoom is Dr. Rafael Arcastillo. He is a noted cardiologist who earned his medical degree from the University of Santo Tomas not so long ago in 1977. graduating with laude and meritissimus distinctions from 1993 to 1994. He was the president of the Philippine Heart Association and the Philippine College of Cardiology. He is a regular columnist of the Philippine Daily Empire. He is also a professor in cardiovascular medicine and is a member of several distinguished international organizations. Dr. Castillo,
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Rafael Castillo: Yes, thank you, Peter. And let me also thank the organizers of the event for this kind invitation to be a part of this panel. I think there can be no opinions about it. This is indeed a recently passed state law, is indeed a landmark law. It's well-thought of, well-prepared, well-discussed, and I think on paper it's an excellent law. What remains to be seen is how it is executed or implemented. Well, there's good reason to believe that once it's properly implemented, this can really curb the incidence of non-communicable diseases, particularly cardiovascular diseases, which is right up my alley. You know, we've been lamenting that the cardiovascular disease has been the number one killer in the Philippines and practically worldwide for the last 30 to 40 years. It hasn't really changed and tobacco smoking is still the leading or at least one of the leading risk factors that lead to most of these NCD deaths. So, I'm quite confident that with proper regulation and with this alternative, then we can ship a lot of conventional seabird smokers, ship them to what I describe as a problematic middle ground. It's not completely safe. There are still some residual risks that can be expected with e-cigarettes and vapes, but there's no question that definitely the harm is much, much less compared to traditional tobacco smoking. So we look forward to seeing a significant reduction in the prevalence of cigarette smoking in the Philippines. And I envision that in 12 years time, with this law regulating everything properly, that we can probably really reduce the prevalence of cigarette smoking to a bare minimum. And finally, we can put this problem to rest. Thank you.
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Peter Dator: Thank you very much, Dr. Castillo. I think all of us here in this particular group share the same hope. Next on our list is a person I've worked with closely for the last few years, is another pillar of high reduction in the Philippines, Dr. Lorenzo Mata, who is the current president of Wait for Good. It is a non-profit, non-stock organization. promoting harm reduction as a compassionate strategy to mitigate the damage and loss of tobacco secrets brought to the society. Dr. Matay is a recognized harm reduction expert in the Philippines, serving as a resource person, speaker in local and international harm reduction forums in the Philippine Senate and House of Representatives. Dr. Mata has significantly contributed to the crafting of the VNNP law. And Dr. Mata has been an occupational medical specialist for three and a half decades in both hospital and industrial settings. Dr. Mata?
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Lorenzo Mata: Yeah, good morning everyone. I don't think I need any further introduction because as attorney, Dator has already mentioned everything, but I would just like to express my gratitude to two of the pillars or the leader in the Congress who helped us put this into law and now we're enjoying the benefit of it. So as a doctor, as the good doctor I said mentioned ago, we're just waiting for its implementation and that everything will be in place and we think that this is going to be a bright prospect that will have health gains in the Philippines considerably in the future.
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Peter Dator: Thank you very much, Doctor. I'll first move on to ask a couple of questions based on what you have experienced and what you have done through this journey of passing the VNNP law. Let me start off with the good mayor from Ligaski, Mayor Alfredo Gervin. Mayor Gervin, what led you to file the bill that eventually became the VNNP law?
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Alfredo Garbin: Peter, thank you. First, we saw the need to regulate the same. And second, there was a momentum on the part of the Congress to regulate the said product. And as you all know, that was 10 years in the making. In fact, the earliest bill that was filed was way back 2013. And that was in the Senate. In the House of Representatives, the first bill that was filed relating to this beverage nicotine and non-nicotine products, the earliest was in 2014. My bill was filed in the 18th Congress. That was in 2018. There were three public hearings and seven technical working group hearings that was conducted. Aside from that, as you can see, speaking of momentum, there were 23 similar bills that were filed, and we all know that as between banning it or regulating it and treating it as consumer goods, then we choose the latter, regulating it, and that has become the result, and we have now the law, the vaporized nicotine and non-nicotine products.
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Peter Dator: I vividly remember those days, Mayor Gargit. There was a lot of congressional hearings. I've worked with Doc Mata. I've seen him in Congress, Senate. I remember vividly that the dedication which was being pursued by the World Health Organization was being, you know, championed by other groups and those are one of the rare the the types that you know I was awed by the way you explained things from a constitutional perspective. I remember because, if I remember correctly, you said that we cannot just adopt what others are saying because we must be able to pass a law that is applicable to the Philippines. Peter, I think I remember. Peter.
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Sharon Garin: Can I just ask why the bill was important? Because I'm no doctor, I do more of the economic side. If you don't regulate, the government does not have revenues. So in order for you to tax, it has to be regulated. So, it will also add to the budget of the government, and in fact, these collections on taxes, on the excise taxes, are earmarked towards, most of it is earmarked, I think, 75%. is earmarked towards health-related activities or programs. So it's a win-win situation, whether you're with the Department of Health or Department of Trade and Industry, because it will add to the budget of the Department of Health. But at the same time, we do also attain the responsibility or the obligation to tax all the products that are sold. So it's also the economic side.
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Alfredo Garbin: Peter. Thank you very much. Pierre, let me also ask... Yeah, let me also add to my previous statement that aside from the fact that there was a momentum on the part of the Congress to regulate the same by passing a law, previously that there was a resolution adopted by the entire Congress. That's the Resolution 125 that calls for the Department of Health to adopt a harm reduction measure. as part of the National Tobacco Control Strategy, and that was overwhelmingly approved by the entire Congress. Not only the trade and the health committee, but the entire lower house. So this was the history, which was, you know, under the circumstances of passing the vaporized nicotine and non-nicotine products. And we want to do the same in a sense that the House adopted a strategy wherein that is fit or suited to Philippine experience. An informed bill that will suit the smokers and having or giving them an alternative to, you know, a less harmful alternative to smokers.
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Peter Dator: Thank you. Go ahead, Dr. Castillo.
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Rafael Castillo: Yes, I would just like to add to the economic aspect that's highlighted by former representative Bakirin. We're quite confident that with the regulation and taxation of vape products, BNNPs, then it will really yield to a positive bottom line. It's not like the former excise taxes for cigarette tobacco, for cigarettes, what we call the sin taxes. Although the government was collecting something like $130 billion in additional taxes from excise taxes, But the government was spending more than $200 billion, something like $210 billion, to treat the complications of those who smoke. So, the bottom line is still negative. So, hopefully, with the BNNP low, we can expect a more positive bottom line. So more revenues, but less government expense to feed the complications caused by this alternative tobacco products.
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Peter Dator: Just a very quick comment, Dr. Castillo. It's very refreshing to hear a doctor always scientifically connecting it to economics. Send away, counter anyone who's interested in that. I'll go back to Mayor Gerbin. Just a follow-up question. Mayor, I know that you know the bill inside and out. If you are given a chance just to touch on the three main features of the VNN VBL. What would you highlight, May?
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Alfredo Garbin: I think first, the BNNP law recognizes a category of products that provide nicotine without combustion. So, this is the number one key element of the law. The second, it restricts the use of this product in public places. There must be a designated vaping area. And I think the third element is to keep it from minors, and at the same time, also to limit the product statements. That any statement that will be used should be true and scientifically substantiated. I think these were the three elements of the B and below.
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Peter Dator: That's great. Those are the main things that I would also agree, Mayor Derbin. And it's a good thing that you mentioned about minors. This is the one thing I remember vividly with then Congresswoman Garin. Undersecretary of Quick question for you. I understand that when we were doing the debates, discussions in Congress, the biggest concern of the public is that issue of youth uptake because it was a big deal with media before, the news about the vaping epidemic. in the United States, how do you think this particular law will protect the Filipino youth under Secret Act?
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Sharon Garin: Well, first of all, there was a huge debate whether it should be 18 or 21 or any other age, but we adopted a similar restriction as to the traditional cigarettes, which is 18 years old. And when you buy, there are provisions that require that there should be age verification, whether when you sell online and even more restrictions when you deliver from an online sale. and also in the brick and mortar stores. One that probably would attract minors is the flavors, so we addressed that. You cannot put attractive names attracting minors, like bubblegum or candy flavored. So it was restricted to a very... We don't restrict the flavors. It's the name, the description that is controlled, so you can put a very vanilla name to it, but not too fancy. So that would avoid it from getting children to think that, oh, it's bubblegum flavored, something that they should try. The next one would be the point of sale. it has to be at least 100 meters away from any schools or any places where minors are. So, in fact, there was a huge debate on malls that are next to schools because they're less than 100 meters away, but the law states that it should be at least 100 meters. And we also designated the areas where you can use or sell And one is the advertising. Other than just the health warnings, which have to be at least 20% of the packaging, the advertising, the companies cannot sponsor. No names on T-shirts or bags. They cannot, they are not allowed to have ads not only celebrities or sports celebrities or any cartoon character, but also social media influencers. We are trying to adapt it to the current technology that's available. So half of the bill actually addresses the risk of uptake of minors. So that's, I think, one strength of the law that we have in the Philippines.
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Peter Dator: Undersecretary, I totally agree with what you mentioned. I agree that there are enough what you call provisions in the law geared particularly towards the protection of the minds. Before I move forward and ask questions to our doctors here, I just have one question for you, Undersecretary Atom. Another issue that I remember that divided the health community during that time about the way and peace, is how the flavors, is how to regulate the flavors. Some sectors say that flavors should be banned or simply be limited to tobacco or menthol. The same conception that they had with respect to traditional cigarettes. and that this should be allowed only for adults, as you mentioned earlier. How did the Philippine Congress decide on that particular issue, if you remember, Madam Anderson?
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Sharon Garin: Yes, you have to remember what's the objective. The objective is not for minors to consume or to start the habit, and the second would be for those who are already smokers to adopt a less harmful habit. So if you remove flavors, that might affect the second part, which is the adults that are already smokers that have more options when they want to go for a less harmful product. So, the stance was, let's not attract minors by avoiding the ads or the attractiveness of the flavor to minors. Hence, we removed, it's prohibited to put packaging that is attractive to minors, even cartoon characters you cannot put, or even any character that might be attractive to minors. And the second part is to keep the flavors so that those who opt to change to a healthier option have more options and we'll be more attracted to adapt it. So we kept the flavors, but the packaging or the way you describe it, the descriptive part, it should not be appealable to minors. That's how we balance the... Mind you, it was not easy to formulate this, but I think all the stakeholders are quite satisfied with this option.
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Peter Dator: I remember back that because there were pictures being shown, certain shops near a popular chain here in our country and certain flavors that, you know, supposedly are to attract and I saw how you and Mayor Darbin fought to have fair regulations for not all staple foods.
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Sharon Garin: If you remember correctly, we even had that phase where we tried to define what flavors should be allowed. We started listing from mango, strawberry, and And then until we arrived at tea, coffee flavored, but then it became arbitrary because you don't know which one should be included and which one should not be included. So I think this type of formulation is better for everyone.
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Peter Dator: I agree, Madam Undersecretary. Dr. Castillo, so very quick, one short. As I understand that you're one of the pillars of tobacco control in the Philippines, we were a staunch supporter of the Tobacco Excise Act's law, which passed during the time of the late President Toyoyaki. During that time, there was still no vape products in the Philippines. How bad is the problem of cigarette smokers in our country? And what actually made you decide to move to support a tobacco army?
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Rafael Castillo: Yes, well, I wish I could say that it's so far so good for the tobacco control in the Philippines, but it's not really as good as we'd like it to be. Although, admittedly, there has been some decline in the prevalence of smoking, something like 29.5% in 2009. to 18.5% in 2021, that means it's declining at a very slow rate, slow pace, something like 1.5% a year. Or in terms of actual number of smokers, quitting cigarette smoking, that's around 150,000. So although there has been some decline, like you said, it's not good enough. It's not fast enough. Meanwhile, we still have thousands upon thousands. It's estimated that close to 100,000 adult Filipinos are dying every year because of smoking-related complications. In 2021, for example, because that's the latest data we have available, about 880,000 Filipinos died. Well, of course, part of that is our COVID deaths. But even if you discount COVID deaths, which in that year was something like 35,000, that means that we still have more than 800,000 deaths. 70% of which can be attributed to non-communicable diseases, and we know that cigarette smoking is the leading cause for non-communicable disease. Practically one out of five non-communicable disease deaths can be linked to smoking-related complications like heart attack, stroke, chronic obstructive pulmonary disease, and cancers. So, you know, it's something that has to be addressed more properly. Like Albert Einstein said, if you keep on doing the same thing over and over again and you expect to get different results, then, you know, there must be something wrong with you. So, with this problem, it's really mandated that we try new measures novel alternatives aside from the ones which we've been using like nicotine replacement therapy, you know, behavioral counseling, you know, even tried acupuncture and hypnotherapy in some patients, but Well, it didn't really work as well as we expected them to. The quit rate was less than 20%, even well-supported clinics. And so that means that the majority of patients remain smokers, and I call many of them as recalcitrant smokers. You know, they come to us and they tell us, doctor, I swear, I definitely really want to quit, but I just couldn't help it. You know, the spirit is willing, but the flesh is weak. And we used to have a very stern policy in our clinic regarding smokers or constituent smokers who failed to quit. You know, we don't give them appointments anymore after six months. You know, we give them all the support within six months, and they still are not able to quit. Then we cautiously refer them to water clinics who might be more successful in making them quit. But we soon realized, especially during the pandemic, Some of them develop COVID and, you know, smokers develop COVID, a worse outcome. So we realized that this might not be the right thing to do. This is not really treating our smokers properly. So that's when we reconsidered our view regarding alternative tobacco products like the BNNPs, alkylated tobacco products. and e-cigarettes. And we also conducted several studies on it on our own because we don't want to just rely on hand-me-down data. We wanted to really prove, you know, we wanted to find out whether, you know, we're making the right recommendation for our patients. And we were convinced that, you know, all of the data that we need more long-term and large population data. Well, with all current available data, you know, there's good reason to believe that definitely it's much less harmful. I'm not saying safer, Peter. I'm not saying it's safer. It's less harmful than conventional cigarettes. So I think we want to say really lives of smokers, you know, cut down the debts attributable to smokers, then I think we should consider this alternative solution.
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Peter Dator: Thank you very much for that insight, Dr. Castillo. Now we move to Dr. Mata real quick so that we can see the comparison between tobacco reduction and a high reduction from the perspective of the vaporized liquid and non-vaporized liquid and vaporized non-liquid products. So, Dr. Mata, there were some sectors that said that the VNNPs should be banned, or at the very least, they should be regulated and taxed the same way as cigarettes. I understand that you support the more progressive position which is to regulate and tax debt differently compared to cigarettes. I know this because we talked about this numerous times. Now let me ask you, why do you say that or why is it that that's your position?
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Lorenzo Mata: Thank you, Peter. Well, cigarette and BNPs are different if you look at the risk to the user. Of course, in an ideal world, no one should ever start to smoke. But reality check in the Philippines, our country in particular, Over millions of Filipinos still smoke, and most of them do not want to quit. So these are the people you want the products to be available to them. Why is there a difference in regulation and taxation? If you don't have that, you will not be able to encourage these people to shift from smoking to vape to be in peace. Now, if you have the same regulation, for example, or taxation, say, same health warning, same restrictions on public use, same price, same tax, then the smoker will always think that they're the same, they have no difference. So our intention here is for them to be motivated to shift to be NNPs, okay? Now, I'm not alone, Wolf, in saying this. If you look or read the report in the 2016 report by the Royal College of Physicians in London called Nicotine Without Smoke, they recommend the promotion of all this nicotine, e-cigarette, that's how they term it. So they promote the They recommend the promotion of e-cigarette as a substitute to smoking. In so doing, but this should be done in the context of a regulatory framework designed to discourage uptake by the youth and the never-spokers. That was the intention of the law. You can just imagine if you offer something as an alternative and it is more expensive, less easily accessible, you prohibit innovation, then you are causing more harm because you perpetuate smoking. you actually are in the process depending or promoting the most dangerous product in the market, which is cigarette. Now, for me, the best approach still, I would like to emphasize this, that the best approach still is to stop smoking altogether. This is the gold standard and our main thrust as an advocacy group, the Quit for Good. Unfortunately, not all people are able to quit or are successful in quitting or even want to quit. So, having said that, Having said that, I think it's time that we should recognize the effectivity of vapor products and heated tobacco products as a risk reduction product against smoking. We always have to take that in mind that When we stop smoking, there's no more problem. There's no more problem. Everything is already done. But then a lot of people cannot do that. Even no matter what we do, with a quitting rate of 4%, it offers a very slim chance of having to get out of the deadliest product in the market today.
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Peter Dator: Thank you very much, Dr. Marca. Just a very quick follow-up, very shortly. Your face has been there always in the hearings, worked with this together with our panelists here. What do you think pushed Congress to pass the BNP law, Dr. Armat?
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Lorenzo Mata: Well, this Congress, represented by these two brilliant legislators beside me, this Congress is listening to the people, okay? But how can they not? We have over one million vapors in the Philippines. And according to the latest Philippine Gats survey, 19.5% of Filipinos are current tobacco users. They're current tobacco users. And that is one out of five Filipinos. I have been the doctor for over 40 years and I know how difficult it is for smokers to have no less harmful alternative and they just get stuck on the deadliest product in the market. So I think This is an acknowledgement by the government that there's really a need for them to come up with an alternative to smoking that is less harmful to the smokers. Now, having attended or having been invited to the public hearings in both houses of Congress, I brought a lot of I shared a lot of scientific studies and actually furnished them copies of both studies coming from the Philippines and abroad. And I bet you this Congress that passed the law is really a Congress supporting a science-based public health policy.
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Peter Dator: Thank you, Dr. Mata. And I will go back to the phrase that our good Madam Secretary said earlier, that it was an alignment of mistakes. And just to ask Dr. Castillo on the other hand, I read somewhere that you have looked into the science behind these vaporized nicotine and non-nicotine products, and that you have published papers on the subject. If you could give us maybe one or two main takeaways from that research, what would that be, Dr. Gustin?
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Rafael Castillo: Yes, Peter, let me say that probably I was one of the late stars which aligned with the universe with regards to the Big Low because we really wanted to make sure that we were making the right recommendation. And I must make a confession here. Initially, I had some misgivings about particularly electronic cigarettes and vaping solutions because we're well aware that there was quite a big scare in regards to acute lung injury caused by electronic cigarettes, so-called EVLI, electronic vaping, acute lung injury. So, initially, we We were really against Everly, but you know, like they said, we should not throw the baby with the bath water. Let's try to find out what's really wrong, and if we can eliminate that, and if the product is still effective in achieving what we want to achieve, then we should still consider it. And so, okay, so we did a lot of reviews. Our group, not only myself, but actually our group conducted a lot of reviews. We published commentaries and reviews initially, and then subsequently we completed two meta-analyses which were published in international journals and also presented in international conferences. So the first meta-analysis was on the level of of biomarkers of exposure of heated tobacco products compared to conventional cigarettes. We know very well that with tobacco combustion, around 6,000 chemicals and ultrafine particles are released, close to 100 of which are considered by the FDA as toxic and potentially harmful, and around 80 of which are suspected to be carcinogens. So, we selected some of these and very consistently, and there's no question about it. Like you said, it's very clear, you know, that we conducted statistical analysis and that the percentage that it can just be due to a chance occurrence is something like one in a hundred thousand or one in a million. And so that means that it's a true effect that that the use of this alternative tobacco products, particularly heated tobacco products, can reduce the level of these harmful chemicals by something like 70 to 95 percent. And we know very well that carcinogens causing cancer, it's actually dose dependent. Exposure to carcinogen does not necessarily make us develop cancer, but if the level is quite high, then the risk of cancer increases. So that means if you can reduce the level of carcinogens by as much as 95%, it stands to reason that we're really substantially reducing the risk of developing cancer. Well, again, we're not saying it's completely safe. There's still some incremental risk, but it's significantly reduced. The second meta-analysis that we conducted is on evaluating the cardiovascular parameters between those who smoke conventional cigarettes and those who smoke heated tobacco products. And the parameters that were favorably affected or impacted by e-tobacco products are heart rate. Those who smoked HDBs had slower heart rate compared to those who smoked cigarettes. Is this significant? We believe it is, because heart rate is a very important risk factor. The faster the heart rate, the more the oxygen consumption of the heart, and the higher the risk to develop heart attack. It's a heart rate that's underrated as a risk factor. We always look at the blood pressure, but we rarely look at the heart rate. But a fast heart rate is just as significant a risk factor as an elevated blood pressure. So if we can reduce that by shifting our chronic cigarette smokers to this alternative tobacco products, then it can be potentially reducing the risk. Other beneficial effects that we observed were that there's an elevation of HDL, high-density lipoprotein. It's a good cholesterol. Not all cholesterols are bad, so it's a good cholesterol. It's cardio protective. It protects the heart from blood clots, from malfunction, from mandibular dysfunction. And so if you have a high level of HDL, that's good. You want a high level of HDL, the good cholesterol, and a low level of LDL on the bad cholesterol. So shifting to HDP may potentially increase the HDL, which is a favorable effect. And the last favorable effect we observed was the improvement or enhancement of co-mediated dilatation. It's a surrogate of endothelial or the function of the arteries. And if you have good endothelial function, that circulation is maintained. Again, the risk of developing a heart attack, stroke, and other cardiovascular events. is significantly reduced. So after having conducted all these studies ourselves, where we were convinced that all the more data are needed from where we stand right now, like I said, There can be no two opinions about it that definitely it's less harmful. The use of BNNPs is less harmful and what can be considered as a pragmatic middle ground to which we should bring our current adult cigarette smokers to. Thank you.
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Peter Dator: Thank you very much for those insights, Dr. Castillo. Now, I may go back to our co-authors of the BNNP bills. I hope that the good mayor and the good undersecretary could answer the same question. What were the main challenges as co-authors did you face when you sponsored the PAPE bill during your time in Congress?
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Sharon Garin: Everybody thought that they knew better than the other. But the challenge was, it was really a long debate. And the challenge was trying to find a balance of the health concerns, the economic concerns, and also the advocacy of different groups. I've been thinking about that. Well, of course, the challenge was we were attacked in the social media because of our stance in this issue as politicians. But I think it was the challenge of finding the balance between the scientific findings as well as the economic and all that. I would like to veer away a little bit from the question, if you don't mind, Peter. What I found challenging was not I always thought that we should have separated the vaping as against the non-combustible nicotine products because the technologies are different. Probably the harm or the findings scientifically are different. The way it should be regulated, I thought it should have been different, the way it's taxed also. That's a challenge because my idea was not entertained. But I always thought that it could have been a better regulation if you treat, for example, electronic cigarettes differently from vapes. Now, they're treated the same way in the law. Even tax-wise, it could be treated differently because, for example, an ICOS, for example, has a certain technology to it, but on the vape side, there's also the risk of tamper proof that the miners can mix or do their own backyard production. So those are issues that I would have wanted to be addressed. But since it's only one law, then it has the same standards for both products. So those are challenges that for me, because I had my own ideas that were not entertained. Having said that, I'm still happy with the law though. Thank you. Thank you, Peter.
00:53:59 --> 00:55:31
Alfredo Garbin: Well, Peter, one of the challenges as an author of the vaporized nicotine and non-nicotine product is how to receive and interpret those submissions of experts because, you know, they are quite opposing to each other. At the end of the day, you have to deal with a practical approach. The vaporized nicotine and non-nicotine products are here to stay, and that's the reality that we have to face. And there's also the challenge on the agencies of the government. We're in the FDA, the Food and Drug Administration of the Philippines, Department of Trade and Industry would like to have this sole jurisdiction over the regulation, but we come up with a practical approach that if there is a therapeutic or medicinal claim, then it should go to the jurisdiction of the Food and Drug Administration. But treated only as consumer goods, without any claims. The regulation is to pass the quality standard and that belongs to the jurisdiction of the Department of Trade and Industry. So these are the, I think, the most contentious provisions of the law. And the good thing is the Senate and the House agreed to that effect.
00:55:35 --> 00:57:18
Peter Dator: Those are great points, Ma'am, Sir. And I remember vividly how we were going back and forth, debating on these different aspects. And up to this day, I am still awed by your practicality and your sense of level-headedness and really listening to all the stakeholders, because it was really tough trying to find that balance, as you mentioned. And I also agreed that through it. you were able to come up with that middle ground, which I think can be seen with the product standards that you mentioned there. I remember that there's specific standards that must be met. And one provision I also remember is that there will be continuous research that we may be able to adapt our regulations accordingly should new science be discovered. And with that, personally, I'm really thankful that you fought with us in addition to the stakeholders. Again, to the two congressmen and congresswomen during that time, it's a very quick question again. Going back, I remember that Congress voted on the big bill in the House of Representatives. It was 192 in favor and 34 voting against it, with about four abstaining. While in the Senate, 19 voted in favor, two voted no, while two abstained. Why do you think Congress voted overwhelmingly in favor of
00:57:21 --> 00:59:25
Sharon Garin: it's regulation is better than not regulating. Not only on the health side or the economic side, but also on the trade. You don't want the illicit to dominate the market. Now, if it's illicit, you don't have control on the regulation of the product standards. You don't have revenues on whatever they're importing. or on the excise taxes. So I think in that sense, in the general sense, I think the legislators at that time saw the advantage of having it regulated rather than just ignoring it and not having a law and letting any type of product that they can buy from online be bought by anybody. even 15-year-old or 12-year-old kids. So with proper regulation, I think we have achieved a certain decorum among the stakeholders as well as the users. Well, our big gratitude to all the stakeholders, especially the doctors, because although it was quite overwhelming for us, because not all legislators are doctors, to get all the scientific findings that they have from all over the world and all over the country. But I think it made the bill or the debate very rich and fruitful. Hence, we came up with, I think, a very fair and a good regulation. The only part that we have yet to see is we can improve on the implementation. I do believe they're doing very well, but just to attain more than what our current objectives are, I think we can still do more on the implementation. Thank you.
00:59:27 --> 01:01:04
Alfredo Garbin: Peter, earlier I talked about how Congress had almost 10 years to debate and deliberate on this bill. And I think the overwhelming votes from the House of Representatives and in the Senate reflects how the Senate and the House receive those evidence, scientific proof, and at the same time, the submission of local and international experts, including the submission of our experts here, Dr. Mata and Dr. Castillo, And as I've said earlier, also, you know, the practical approach in doing it. Undersecretary Green said that between regulation and non-regulation, then we chose the former. And therefore, there's so many patterns also and models that we are based into. And if you look at the choices, whether we treat this as medicine, or do we treat this as, or we ban it, or treat this as consumer goods that will pass into product standards, that the practical approach is really is to, you know, choose the latter. And that reflects the vote of the entire Congress, an overwhelming vote to adopt and approve the vaporized nicotine and non-nicotine products.
01:01:04 --> 01:01:07
Peter Dator: Go ahead, Dr. Estudillo.
01:01:07 --> 01:02:21
Rafael Castillo: Yeah, Mayor Carbine and the other secretary, I don't know, but it might have been one of the causes for the tipping point, you know, because I talked to several congressmen and a few senators, and they told me that they know, you know, they have family members or friends shifted from cigarette smoking to the use of these alternative tobacco products, and they had dramatic improvement in their well-being, you know. Some of them were chronic lumbers, they had COPD and they felt a lot better, they had more energy. So somehow this might have helped convince these legislators that these products can be a good alternative that can offer benefits to a lot of smokers. So it took some time, but I think, you know, that the base of gate smokers reached a certain point, a threshold, that, you know, by themselves, they made a strong argument for the support of this alternative tobacco products.
01:02:24 --> 01:07:37
Peter Dator: In the interest of time, I'd like to thank all the panelists, but we still have a few things to tackle. But before I forget and before we move forward, I'd really like to thank everybody for sharing your insights and your experiences as we pass through the law and all the hurdles that we have to overcome. At this point on, I'd like to ask the team to at least share to the stream the outcome of our discussion. I'll go through it quickly to summarize and then we'll ask those in the audience to, you know, if they have any questions, they have the panel in front of them to answer those questions. All right. Let me just go through it real quick. The few things that, you know, I did, as you can see earlier, I was writing scribbling things down to really try to capture most, if not all, of the salient points that you mentioned. So let me just go through it real quick. As the past immediate president of the U.S. speech, a staunch advocate for Filipino consumers, the takeaway, these are my takeaways. One, smoking kits. That's again, cigarettes should be subject to the strictest regulations. After a thorough review of the scientific evidence, the premise for this law is that nicotine products that do not involve burning are less harmful than cigarettes and other tobacco products that aren't burned. Now, as mentioned earlier by Yusik Garin, the first step to regulation, or I'm sorry, and my notes here is that it was one of the highlights of the burger bid, that the first step to regulation is category recognition. Regulations should recognize the distinct category of products that provide nicotine-without-burgering-as-consumer goods. Well, this should include vaporized nicotine and non-nicotine products, or VNNPs, which include vapor products and heated tobacco products, as well as noble tobacco products like snus and we call that nicotine pouches. And this was the point that was raised by Yusek Agarin earlier. The intended users of these products are adult smokers. These products should not be sold for marketed tobaccos. If you look at the law, there are very heavy penalties that are imposed to those violations of sales and marketing restrictions. VNNPs in noble tobacco products should be regulated and taxed differently from cigarettes in order to encourage adult smokers to move to these products. Adult smokers should have access to correct and scientifically backed information about VNNPs. In addition, Pharmaceutical or therapeutic claims about nicotine products should only be made. This was mentioned earlier. if it is approved by the appropriate regulator or the appropriate agencies, like the FDA. VNNPs, as mentioned by Wisset Garin earlier, should have health warnings that are different from what are required for cigarettes packaging, and this should be in line with their risk profile. Public use restrictions for VNNPs should be different from cigarettes. In the Philippines, for example, vaping is generally banned indoors. If an establishment wants to allow vaping indoors, that establishment needs to convert that space to a designated vaping area so that minors will not be allowed. Smoking is also banned in designated vaping areas. And then flavors should be restricted in a way that balances, I like this word, balances access by allowed vapers to their preferred flavors and the need to restrict their appeal to buyers. In the Philippines, flavor descriptors that appeal to buyers are prohibited. Finally, a law on paper is only A law on paper is only as good as how it is implemented, as mentioned numerous times earlier. Enforcement is the key. The law should empower the regulators to recon, plan, cease noncompliance, and initiate progress. Regulators should also have the authority to take down noncompliant retail websites and similar online platforms or applications. With that being said, I open the floor for any questions from the audience that Adult Mata might be able to shed light on.
01:07:41 --> 01:13:44
Lorenzo Mata: Yeah, thanks first of all for the interesting insights. My name is Stefan von Deiden and I would like to go into two points of your presentations. First of all, what a position did you have to face while setting up that regulation? That would be interesting because tobacco harm reduction is not free of conflict, at least the idea, and in that regard, was there, and if so, to what extent an impact by WHO and the regional office responsible for you? That would be the first thing. And the second, do you have any idea or what is your position? Is the regulation now in place, something that you expect the Philippines to put forward as a kind of benchmark, for example, at COP10 by the end of the year. Okay, can you please repeat the first part of the question? The challenges? Are you talking about the challenges? First part was the challenges and opposition you faced while setting up the regulation. Were there interest groups? What about NGOs saying, okay, we don't follow you on the way to put tobacco harm reduction as a kind of guideline for setting up this regulation? Okay, so I'll talk on my behalf as one of the defenders on the medical side of the issue. Okay, for me, the biggest challenge that I was faced is there's a lot of fake news and misinformation coming from the anti-vape law advocates, okay? So we have to contend with that. You can imagine they took advantage of the value situation in the U.S. at the time. So we have to overcome that great concern that they presented in the discussions. And you know very well that they are not telling it in the right context, that they just say it as it is caused by vaping, but they did not make the clarification, or they did not intentionally make the clarification, that it is due to the illicit application and inclusion of a contaminant, the tetrahydrocannabinol. and the tocopherol acetate, the vitamin E acetate, which was the cause of the injury. not the e-cigarette per se. So, these alarmist claims made by them, okay, would reverberate to all the users of, or probably spokers, and they will think that, you know, you can imagine e-cigarette is even more dangerous than smoking because the injury is more immediate than smoking. smoking, the injuries will be coming over time, 20, 30 years from now. And here, the e-cigarette is causing injuries almost immediately. causing lung injuries, which is, that's a very sensationalist claim, which is very irresponsible for even the people in the medical fields who are saying this. And another thing is, there's also that claim about the popcorn lung. If you remember the popcorn lung, it's due to diacetyl compound or the element that is included. Actually, the origin of the popcorn lung is that it came from a group of workers in a popcorn factory. They developed bronchiolitis obliterans. That is the medical term for the popcorn lung. So they just made it popcorn lung, so it's more like a layman term coming from the popcorn employees of that company. But the yacetyl compound has been banned since 2006 in Europe and 2016 in the US. So even after that time, they still keep on harping about the diacetyl being present in the e-cigarette. But why are we not discussing this, like, how much diacetyl is found in the cigarette, in the vape, no? How much diacetyl is present in the cigarette as against the vape? It's 104 times present, the diacetyl in the cigarette. So it's still, it is more, it's a destructive product, cigarettes. Now even the CDC, U.S. CDC, encourages those who are vaping not to switch, to go back to smoking, okay? And they advise those who are already vaped not to smoke. become dual smokers or go back to smoking. So if that is not an indication that they're saying that vaping is more beneficial than smoking, I don't know what is. So I hope that answers your question on my part as a medical doctor. I guess my fellow panelists can have their own challenges that they can share with you.
01:13:44 --> 01:16:22
Sharon Garin: Many. The challenge, because we are legislators, elected officials back then, so one huge challenge was the public response. It's not basically the organic response, it's more of the campaign of one side against the other. So we were getting all the crossfire among all the different, because there are health advocates, there's economic advocates, and it was, it could have been. affected our political career, let's say, in that sense. And when you do laws like this, which are very controversial, in fact very novel, it's new technology, Normally we rely on the experts, and we did that, but many of the experts have different opinions also. So we also studied all the international jurisdictions as well as the opinions of research from different countries in international organizations. Again, in that aspect, depending on which country and which institution, they had different opinions. The next step would have been to consult the different government agencies that should be experts on this. And the same thing was happening. The Food and Drug Administration had a different opinion as against the Department of Trade and Industry. And different, also the Department of Agriculture, because there's also agriculture side on the tobacco products. And the Bureau, the Department of Finance also had a different opinion. So it was challenging in the sense that we had to make the judgment call. As legislators, we are not the experts in the field, but we had to assess and weigh in the different opinions. So that was quite overwhelming for many. But in the end, I think if, the legislators just listen and study. I think they can come up with a bill that will be applicable to, our law might not be the perfect law in your country, but you have to find good balance that would be appropriate for that country.
01:16:24 --> 01:18:11
Alfredo Garbin: Yeah. We have a question. Let me just add to that. While we were debating and deliberating the BNNP law in Congress, the vape industry in the Philippines keep growing and growing without regulations. There were illicit traders who sell their products substandard, even sell to minors just to gain profit and without any remorse of doing all those that, you know, can inflict harm to the public. And that's prompted us to, you know, file and eventually approve this bill that has become into law. It was 10 years in the making. And the challenge just really is, you know, how to deal with all those submissions of the experts. And even the quarrel from amongst the agencies of the Philippine government on who will take jurisdiction of this product. So, the good thing is, after 10 years of heated debates in the plenary, we come up with a solution and it's now a Philippine law that will cater suited for Filipinos in order to, you know, give the public, the Filipino public, an option to an alternative, a less harmful alternative to smoking, and this is the vaporized nicotine and non-nicotine product law.
01:18:13 --> 01:18:52
Peter Dator: Well, thank you very much. Just to quickly answer the second question before we wrap up. On the second question, the corporates of parties is not being handled by our Congress. In fact, it is being handled by our DFA, DTI, and the Department of Health. Again, I would like to thank our participants and panelists for today, Mayor Alfredo Garbin, Undersecretary Sharon Garin, Dr. Rafael Castillo, and Dr. Lorenzo Mata. I hope we had more time, but it is what it is. Thank you very much for your participation.
01:18:57 --> 01:19:09
Sharon Garin: Peter, Peter, there's a few more that have been raising their hands, but I think we can answer the questions after we close this.
