Written evidence submitted by Philip Morris Limited (ECG0073)

Executive Summary

1. Philip Morris Limited (“PML”) is the U.K. and Ireland subsidiary of Philip Morris International (“PMI”).
2. In 2016, PMI announced its ambition to replace cigarettes with smoke-free products that are scientifically proven to be much less harmful than cigarette smoking. Our goal is to switch all smokers who would otherwise continue using cigarettes to smoke free products. These include e-cigarettes and novel smokeless tobacco products (“NTPs”) such as heat-not-burn.
3. Smoke-free products have significant potential to be less harmful as the vast majority of toxicants associated with smoking related diseases are generated when tobacco is burned and produces smoke.[1]
4. In our ‘Introduction’ (paragraphs 8-14), we provide further background on PMI’s product portfolio, our smoke-free vision, and how we think our innovative technology can help the Government achieve its smoke-free target of reducing smoking to below 5% earlier than 2040 (the date forecast by Frontier Economics in recent research we commissioned).
5. We address the health implications of e-cigarettes at paragraphs 15-18, and regulation at paragraphs 19-23. We also submit evidence on heated tobacco at paragraphs 24-32, focusing on IQOS, our first heated tobacco product and Annex 1 contains data on IQOS that we submitted to the U.S. Food and Drug Administration (“FDA”) for our Modified Risk Tobacco Product (“MRTP”) application.
6. We would be pleased to provide oral evidence to the inquiry. In particular, as the U.K. and global leader in heated tobacco technology (the most popular NTP), we are uniquely positioned to provide the Committee with evidence in this area.
7. We ask the Committee to consider the following recommendations:
1. Support the principle of harm reduction and of smokers switching to e-cigarettes and any other smoke-free products.
2. Call on the Government to improve e-cigarette regulations (effective post-Brexit) to permit communication that informs consumers of the substantiated benefits of switching to specific products instead of smoking cigarettes.
3. Endorse the recent Advertising Standards Authority (“the ASA”) consultation proposal to remove the prohibition on ‘health claims’ in e-cigarette advertising, and welcome any further guidance on claim substantiation. 
4. Encourage more independent research into smoke-free products to validate manufacturers’ research, following the progressive step by PHE to review the evidence on heated tobacco.
5. Recognise the importance of having defined processes for substantiating, and communicating, accurate information about the risks of different smoke-free products, including heat-not-burn, relative to cigarettes – enabling smokers to make better informed choices.

Introduction

8. PMI is a leading international tobacco company, and pioneer of NTPs including heat-not-burn and other smoke-free products. PML is also a major supplier of e-cigarettes, through the VIVID, NICOCIGS and MESH brands.
9. In 2016, we announced our ambition to replace cigarettes with smoke-free products. To facilitate this transformation, we have invested more than £2.5 billion in developing a portfolio of smoke-free products.
10. PMI’s smoke-free portfolio comprises four innovative technology platforms to satisfy the diverse tastes and preferences of adult smokers. We are happy to provide oral evidence on the R&D and scientific assessments of our portfolio:
1. Platform 1 – a heat-not-burn tobacco product that does not involve combustion. It is commercialised under the name IQOS, and is an electronic device using an innovative tobacco heating system designed to heat-not-burn a specially designed tobacco stick[2] to below 350oC (avoiding combustion). This creates a nicotine containing aerosol without fire, ash, or smoke. IQOS is available in more than 31 countries and was launched in the U.K. in 2016. Nearly four million consumers worldwide have switched to IQOS and stopped smoking, and a further 8,000 smokers switch every day.
2. Platform 2 – a heat-not-burn technology that uses a carbon tip heat-source. A proprietary design separates the tobacco from the carbon heat source and provides an effective and controlled temperature transfer to generate a nicotine-containing aerosol. It is at an earlier stage of development than Platform 1.
3. Platform 3 – still going through our research and development processes, this non-tobacco based product uses a weak base of nicotine that reacts with a weak organic acid to generate a respirable nicotine salt. 
4. Platform 4 – battery operated e-cigarettes that heat a nicotine solution to vaporise it and produce an aerosol for inhalation. This includes MESH our latest e-vapour technology that uses a stainless steel mesh to increase the surface area in contact with the solution and atomise it, improving the vaping experience. MESH is puff-activated, with auto temperature control (to avoid liquid burn) and low-liquid level detection to avoid ‘dry-puff’ which is associated with the formation of higher levels of toxicants. It is available online following a successful pilot in Birmingham.
11. The best way for the millions of men and women who smoke to reduce smoking-related health risks is to quit. Many try to quit but find it difficult, and there are still approximately eight million smokers in the U.K. By developing e-cigarettes and other smoke-free products that smokers can switch to instead of smoking, we believe that we can play our part helping the Government to realise its ambition of creating a smoke-free generation sooner than would otherwise happen.
12. PML recently commissioned research from Frontier Economics[3] to forecast when England might be smoke-free, based on the Government definition of “reducing smoking to below 5% of the adult population”.[4]  The report forecast that this would occur around 2040.
13. Frontier Economics noted that smoking rates in England fell twice as fast during 2012-2016 as between 1993-2011. It concluded that e-cigarettes made a “material contribution” and that, if the trend could be maintained, then England could be smoke-free by 2029. However, the report concluded that this was unlikely, in part due to the slowing growth in e-cigarette usage. There were 800,000 new vapers in 2013-14, this fell to 500,000 in 2014-15, 200,000 in 2015-16, and just 100,000 in 2016-17.[5]
14. Persuading more smokers to switch from cigarettes to smoke-free alternatives is one way to help the U.K. become smoke-free sooner. We believe that no single technology will appeal to all U.K. smokers, which is why we offer a portfolio of smoke-free alternatives. However product innovation should be combined with proportionate regulation which is critical to encouraging smokers to switch. We ask that policymakers maintain an open mind towards innovative and emerging technology that is scientifically substantiated to present less risk of harm than cigarettes, so that new products can emulate the success of e-cigarettes in reducing smoking prevalence.

E-cigarettes

Health

15. There is an established consensus in the U.K. that e-cigarettes are less risky than smoking. In 2015, Public Health England (“PHE”) concluded that e-cigarettes were around 95% less harmful than smoking.[6]  This was endorsed in 2016 by the Royal College of Physicians,[7] and PHE continues to review and update its evidence annually.
16. Our research also indicates that there is a significant reduction in harmful and potentially harmful chemicals and toxicity in the vapours of e-cigarettes versus cigarette smoke.[8],[9]
17. Further evidence continues to be published, including one of the first long-term clinical studies by Cancer Research U.K. This found that levels of cancer-causing chemicals and other toxins were substantially reduced in those who had completely switched to e-cigarettes compared to smokers.[10]  Similarly, there is little evidence that e-cigarettes increase smoking initiation (a ‘gateway’ effect). ASH’s 2017 survey of e-cigarette usage found that 97% of e-cigarette users are current or former smokers,[11] and that e-cigarettes are not a gateway to young people smoking.[12] 
18. Many smokers use e-cigarettes to help them quit smoking. In 2016, it was estimated that two million consumers in England had used them and completely stopped smoking.[13] It was also estimated that a further 470,000 were using them as an aid to stop smoking.[14]

Regulation

19. U.K. e-cigarette regulation derives principally from the Tobacco Products Directive (TPD).[15]  Regulatory differences among devolved nations remain comparatively minor and this should be maintained.
20. The e-cigarette provisions of the TPD were formulated in 2013-14, before much of the research on the relative risks of e-cigarettes was published. Following Brexit, the U.K. is now well-placed to reconsider the proportionality of these regulations that we believe can be improved to better reflect the risk profile of heat-not-burn and other smoke-free products relative to cigarettes (e.g. in product regulation, advertising and communication).
21. One regulatory measure unrelated to EU Law is the prohibition on ‘health claims’ in e-cigarette advertising. The ASA recently proposed removing this prohibition; we support such a reform.   Research by ASH has revealed growing public misunderstanding of the relative risks of e-cigarettes compared to smoking. In 2017, twice as many British adults (26%) erroneously thought e-cigarettes were more or equally harmful as those who correctly identified they were actually a lot less harmful (13%). This represents a reversal since 2013, when three times as many adults (21%) correctly understood that e-cigarettes were a lot less harmful, than those who thought they were equally or more harmful (7%).[16] 
22. Proportionate regulation should permit factual, truthful, non-misleading communications that inform consumers of the relative risks of different tobacco and nicotine-containing products. Such health-related information should be scientifically substantiated to help boost public confidence and encourage smokers to switch to products that are a better choice for their health. We would welcome the ASA providing any further guidance on how manufacturers and suppliers should substantiate a health claim.
23. We agree with the UK Committee of Advertising Practice (CAP)[17] that any substantiation should be product specific given the variation that exists between different e-cigarettes.[18] This will allow comparative risk claims to be made between e-cigarettes and cigarettes. 

Heat-not-burn

24. Smokers’ enthusiasm for trying e-cigarettes in the U.K. demonstrates the potential for heated tobacco. ASH’s survey of e-cigarette usage reveals that 60% of British smokers have tried e-cigarettes[19] but the majority who try them, reject them, and revert to smoking. Only 18% of British smokers still use e-cigarettes, and almost half still smoke as well (i.e. dual users).[20]
25. We believe that heated tobacco devices, like our product IQOS, can deliver a smoke-free alternative for the millions of adult smokers who would otherwise not stop smoking nor switch to e-cigarettes, including those who have tried e-cigarettes but not managed to use them to quit smoking completely. More than half of U.K. registered IQOS users have fully converted to the product, implying that IQOS can help reduce smoking rates.[21]
26. PMI has designed and implemented a rigorous scientific assessment program to confirm that switching completely to IQOS – while not risk free – does present less risk of harm than continued smoking. Our approach is inspired by the pharmaceutical industry and guidance from the US FDA, which has a separate marketing pathway for tobacco products that are formally approved as Modified Risk Tobacco Products (MRTPs). PMI submitted an MRTP application to the FDA for IQOS in December 2016 (the result of which is still pending). Further detail on PMI’s seven step scientific assessment program and the evidence package submitted to the FDA is included at Annex 1.

Japan: real-world evidence of the potential harm reduction benefits of IQOS

27. In Japan, the first market where IQOS was launched in 2014, we have real-world evidence that heated tobacco, coupled with greater flexibility to communicate with consumers, can encourage substantial switching of smokers:
1. Millions of Japanese smokers have switched to IQOS and 72% have permanently switched.[22]
2. National market share of IQOS versus all tobacco products reached 12.7% in Q2 of 2017. In certain areas it was even higher, for example 14.8% in Tokyo and 17.1% in Sendai.[23]
3. In Sendai, total market share of heat-not-burn (including IQOS) has grown rapidly. Since being launched in late 2014, market share for heat-not-burn is now around 29%.[24] 
4. Nearly all IQOS users (more than 98%) smoked cigarettes or used some other form of tobacco or nicotine-containing product before they used IQOS.[25] Only 1.9% of IQOS users started using tobacco products with IQOS.[26]
5. Those who do switch to IQOS are not using more tobacco. Clinical trials found those in the IQOS study used about the same number of HeatSticks per day as cigarettes smoked by those in the cigarette study. Post-market studies show similar results.[27]

Scientific substantiation

28. To earn consumer confidence, we recognise that our scientific work must be independently verified, and we are committed to sharing our data, methodologies and findings through scientific publications, presentations at scientific conferences, and on PMIScience.com. Independent validation of the science behind our product portfolio is already underway,[28] and we anticipate (and would welcome) further studies in 2018.
29. Government and independent scientific experts can perform a crucial role in ensuring smokers have access to factual and non-misleading information, and we particularly welcome government scrutiny of our science and products. Currently, the U.K.’s independent Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (“the COT”)[29] is reviewing our scientific assessment for IQOS, following a presentation by a number of our scientists to the Committee in May 2017.
30. PHE has also expanded the scope of its annual evidence review of e-cigarettes to include heated tobacco. Were PHE to conclude that any of these products are less harmful than smoking, then U.K. regulation should be updated to reflect this.
31. There is general acceptance that there is a continuum of risk for tobacco and nicotine-containing products, with tobacco-burning cigarettes posing the greatest risk.[30] Therefore, the assumption that all tobacco products are equally harmful is not accurate. We would welcome a formalised, proportionate regulatory process or at a minimum, the publication of transparent and objective criteria for substantiating health claims. We would also welcome a broader debate on regulatory measures to promote further switching.
32. We believe that heat-not-burn tobacco-based products with a scientifically substantiated reduced risk profile should be regulated differently to combustible tobacco products, so that smokers can be informed better of the relative risks. For example, we would like to include information about reduced risk products inside packs of our cigarette brands, to encourage our cigarette smokers to quit entirely or switch. This is currently unlawful under UK Standardised Packaging Regulations.

December 2017

Annex 1

PMI’s 7 Step Scientific Assessment Program[31]

PMI’s scientific assessment of IQOS is extensive.  It includes 17 non-clinical and 8 clinical studies, as well as pre-market and post-market studies.

In conducting these studies, we followed international quality standards such as ISO, Good Laboratory Practices and Good Clinical Practices and used validated analytical methods.  Finally, all of PMI’s clinical studies are registered on ClinicalTrial.gov.

Over the past decade, we published over 30 peer reviewed publications describing our IQOS assessment studies and over 150 publications describing the approaches and methods we used.

1. Product-design controls

Processes and related data established that IQOS heats the tobacco at a controlled temperature below those needed to burn.

2. Aerosol chemistry

Scientific analysis confirmed that levels of chemicals classified by the International Agency for Research on Cancer (IARC) as Group 1 Carcinogens were reduced on average by more than 95% compared to a standard research cigarette, and levels of harmful and potential harmful chemicals (“HPHCs”) identified by the US FDA as carcinogens, respiratory and cardiovascular toxicants were over 90% lower, on average, than those in cigarette smoke.[32] 

3. Standard toxicological assessment

This step determines whether reduced formation of HPHCs leads to reduced toxicity in laboratory models. Three in vitro assays compare the toxicity and mutagenicity of the aerosol with cigarette smoke, and two inhalation toxicity in vivo studies have found reduced exposure to HPHCs.

4. Systems toxicology

Systems toxicology relies on experimental technologies and advanced computational sciences to determine whether reduced toxicity leads to reduced risk of disease in laboratory models. Four studies in vitro and a further study in a laboratory model were undertaken.

5. Clinical studies

Clinical studies are at the core of PMI’s scientific assessment, which included two types of studies:

1. Pharmacokinetic/ pharmacodynamics (PK/PD); and
2. Reduced exposure studies - two conducted over the course of five days in confinement, and two conducted over the course of 90 days (five days in confinement, 85 days ambulatory).

PMI is also conducting a 6 + 6 month exposure response study.

The PK/PD studies found a similar profile of nicotine uptake and maximum nicotine concentration between IQOS and a reference cigarette and assessed subjective measures of product satisfaction, such as craving reduction.  These studies indicated that IQOS delivers nicotine in a way that satisfies smokers.

The four reduced exposure clinical studies measured 16 biomarkers of exposure to selected HPHCs.  These studies showed that switching to IQOS achieves 95% of the reductions in exposure achieved by smoking abstinence.[33]

6. Pre-market consumer perception and behaviour studies

PMI conducted nine Perception and Behaviour and Assessment studies in the U.S. with over 10,000 participants to assess risk perception, comprehension and intention to use IQOS among different adult groups, including adult smokers, young adult never smokers, adult former smokers and adult never smokers.

Pre-market testing has shown that IQOS is not attractive to adult non-smokers as evidenced by the low intention to use the product among adult former smokers and adults that have never smoked. The data showed a low level of interest from former smokers, and only 1% of never-smokers were interested in IQOS.[34]

7. Post-market assessments. 

PMI has developed, and will conduct post market assessment studies which may vary by market. These could include safety surveillance, cross sectional surveys (one time observational studies of a population sample) and cohort studies (monitoring recruited participants over a defined period) to allow for collection of safety data, prevalence of use over time, including initiation and cessation, use patterns and to evaluate the biomarkers of exposure and effect.