plus smokers in the world according to the World Health Organisation, and the organization estimates that there will still be over a billion smokers in 2025. While the best thing one can do is quit nicotine use altogether, Philip Morris International is working on smoke-free alternatives for those adult smokers who would otherwise continue smoking. Since 2008, Philip Morris International invested more than USD 7.2 billion into the science and research of developing smoke-free products, and employs more than 400 world-class scientists, engineers, and technicians to help them achieve that goal. Interview with Dr. Gizelle Baker, VP of Global Scientific Engagement at PMI, will discuss company's transformation journey aimed at becoming more than a cigarette company, and changing society while delivering a better, smoke-free future. Gizelle leads the Epidemiology and Biostatistics team which is responsible for the biostatistics, programming, data management, and epidemiology within the Product Assessment and Scientific Substantiation department at the PMI Science. Her department conducts clinical and post-market assessment programs. Do you believe cigarette sales will eventually be outlawed? Cigarettes are legally sold all over the world, even though smoking is harmful and causes serious diseases. The best thing is to never start, and for smokers to quit tobacco and nicotine use altogether. Governments, the public health community, doctors, and healthcare providers should therefore continue to encourage cessation and discourage initiation. But we must also consider that the vast majority of adult smokers, do not quit, and will continue smoking cigarettes. The WHO predicts there will still be more than 1 billion smokers by 2025, roughly the same number as today. In tobacco control, the traditional measures of smoking prevention and cessation initiatives could be complemented with scientifically substantiated smoke-free products, which are better alternatives for adult smokers who would otherwise continue to smoke. Smoke-free alternatives are a common-sense approach that could play an important role in reducing the number of people smoking cigarettes, which has the potential to improve public health. How is PMI transforming and preparing for a smoke-free future? PMI's aims to have smoke-free products account for 30 percent of our shipping volumes by 2025, which means approximately 40 million adult smokers switching to these products and no longer smoking cigarettes. We are making tremendous progress toward this goal and our vision of a smoke-free future. IQOS is already commercialized in more than 60 markets (including KSA), and to date more than 16.4 million adult smokers have adopted the product, with 11.7 million of them having completely moved away from cigarettes.[1] This transformation is happening within each country. We need researchers, healthcare professionals, policy experts, governments, the industry, and media to work together to ensure adult smokers have access to and accurate information about these new products so that smokers can make informed decisions about their health, relative to continued smoking. We need to find ways to encourage and incentivize innovation with the development and scientific assessment of smoke-free products. It will also be important to implement regulatory frameworks that recognize that not all tobacco products are the same, and can incentive adult smokers who would otherwise continue to smoke cigarettes to switch to products like these. This would maximize the number of adult smokers who switch to better alternatives, while at the same time minimize the number of non-smokers and youth who start using tobacco and nicotine containing products. How much is PMI investing in new technology to create alternatives to cigarettes? Since 2008, we have invested USD 7.2 billion in the research and development of our smoke-free products. In 2019, 71 percent of our commercial expenditure and 98 percent of our R&D expenditures were dedicated to our smoke-free products. These numbers are good indicators of our investment in and dedicated efforts to not only develop and market smoke-free products, but to help adult smokers move away from cigarettes as fast a possible. How does PMI ensure its new products are scientifically credible? PMI follows international standards such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Epidemiological Practices (GEP). Our assessment approach was inspired by long-standing practices of the pharmaceutical industry and the U.S. FDA guidances, including theirModified Risk Tobacco Products Application (MRTPA) draft guidance from 2012. Our scientific methods and results are shared openly and transparently in scientific conferences, peer-reviewed open-source journals – in fact over 365 peer-reviewed scientific publications and book chapters on smoke-free products have been published in the past 10 years. We encourage independent experts to assess our scientific results and are committed to sharing scientific data for independent verification by qualified third parties. Recently the US FDA authorized marketing of the IQOS system to be marketed in the U.S. as a Modified Risk Tobacco Product with reduced exposure claim. This decision demonstrates that the product is fundamentally different from cigarettes. The FDA review concluded that "scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body's exposure to harmful or potentially harmful chemicals."[2] What do you say to critics of vaping products who say that they encourage young people to take up smoking? PMI has been clear that youths, former and never users of nicotine-containing products, should not use any tobacco or nicotine products. Smoke-free products are intended for one audience: adult smokers who would otherwise continue to smoke cigarettes. Alongside parents, public health professionals, and regulators, we, as makers of tobacco and nicotine products must do our part to prevent youth access. PMI develops all our communications for adult smokers. We implement strict measures to limit youth exposure and access to our communications and products, complying with our "Good Conversion Practices", a set of rules that we have developed to govern the marketing and sales of our smoke-free products. Everyone involved in our commercialization activities – including employees and third parties acting on our behalf – must strictly follow our GCP without exception and regardless of country We are also clear that these products are not risk-free and they deliver nicotine, which is addictive. The best option is and always has been to not use any tobacco or nicotine-containing product. But for adult smokers who would otherwise continue to smoke, switching to these products is a better alternative than continuing to smoke cigarettes. Experts agree that nicotine is addictive and not risk-free. But—contrary to what many believe—nicotine is not the primary cause of smoking-related diseases. Smoke-related diseases are caused by chronic exposure to toxic constituents in the smoke that are emitted when tobacco is burned. This is why all our products are designed and based on the principle of eliminating burning to reduce these harmful constituents. Science-based smoke-free alternatives are offering a massive public health opportunity. Smokers deserve access to and accurate and non-misleading information about these products, so they can make informed decisions for their health. We support the monitoring of the marketing and uptake and use of these new products (especially among youth) so that swift actions can be taken to correct issues that may arise with unintended use. This is what is happening in the US, where the FDA while acknowledging the uncertainties with any new product, concluded that the "available data, while limited, also indicate that few non-tobacco users would be likely to choose to start using IQOS, including youth". Therefore, they defined as part of their marketing authorization of IQOS, a set of post-market surveillance and studies requirements that will allow them to monitor the impact of these orders on consumer perception, behavior, and health. Who is PMI targeting with its new products? Our smoke-free products are for adult smokers who would otherwise continue to smoke. They are not for non-smokers, or for smokers who want to quit tobacco and nicotine products altogether.They are better alternatives to cigarettes.
