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European Regulatory Science on Tobacco:Policy implementation to reduce lung diseases

Periodic Reporting for period 1 - EUREST-PLUS (European Regulatory Science on Tobacco:Policy implementation to reduce lung diseases)

Reporting period: 2016-01-01 to 2017-06-30

Smoking and other forms of tobacco consumption are considered the single most important cause of preventable morbidity and premature mortality worldwide. Smoking within the European Union (EU) is estimated to cause 650,000 deaths annually, half of which are among 35–69-year-olds. Tobacco-related morbidity is expected to have a significant impact on the provision of health care and pose an additional burden to economies within the Eurozone, many of which are already under significant economic constraints. Efforts to reduce the devastation of tobacco-related deaths and illness in the EU consist of its newly adopted binding legislation, the Tobacco Products Directive (TPD), and the ongoing implementation of the WHO Framework Convention on Tobacco Control (FCTC), the first-ever health treaty. These two instruments provide the EU Member States (MS) with the framework of actions that, if appropriately implemented, would greatly reduce tobacco use initiation, increase cessation efforts, and reduce demand for tobacco products. Within Europe and after substantial debate, the TPD was finally adopted by the Council and the European Parliament on 29 April 2014 with its Articles to be implemented by 22 May 2016. However between these two dates, and in order to make the revised TPD fully operational and to keep up with future trends in the tobacco sector, delegated and implementing powers are foreseen to amend or supplement the basic act and to give effect or 'shape the rules' laid down in the text of the TPD. The main objective of EUREST-PLUS is to monitor and evaluate the impact of TPD within the context of the WHO FCTC ratification at an EU level.
The EUREST-PLUS Project is a 36-month project that consists of an integrated sequence of seven work packages. All research performed in EUREST-PLUS will focus on the evaluation of populations exposed to tobacco products. The work performed for the period includes:

The project coordination (WP1) has established a clear and effective coordination and communication plan between partners, participating networks, important stakeholders and the EU. Among other specific objectives, it ensures and establishes high standards and quality criteria needed for the designated milestones and deliverables of each WP of the Project.

In WP2 a large multi-country cohort study has been initiated with the primary objective to evaluate the psychosocial and behavioural impact of the TPD, as well as other tobacco control measures of the FCTC. WP2 has finalised a Survey Questionnaire and Sampling Plan, a First Study Subject Approvals Package, the All Approvals Package and a Midterm Recruitment Report.

The primary task of WP4 is to conduct cross-sectional and longitudinal cross-country comparisons, examining differences and similarities between before the implementation of the EU TPD and longitudinal comparisons of any differences in changes after the implementation of the EU TPD. The Wave 1 and Wave 2 cross-sectional and longitudinal data will also be compared with (1) data collected from the 6 countries in the project (Germany, Greece, Hungary, Poland, Romania, and Spain), (2) data collected from other EU countries involved in the International Tobacco Control Policy Evaluation (ITC) Project (UK, France, Netherlands), and (3) data collected from selected non-EU counties from the ITC Project (e.g. Australia, Canada, Kenya, Thailand, United States, Uruguay, Zambia). WP4 has produced a Priority list and analytical plans of Wave 1 cross country analyses.

The overall objective of WP5 is to assess support for TPD implementation and FCTC policies across 28 EU MS in 2015 through a secondary analysis of the 2015-SETS. The survey was conducted in January 2015 in the 28 EU MS and included respondents aged ≥15 years. Nationally representative samples of persons aged ≥15 years old were selected through a multi-stage sampling design in each of the 28 EU MS. Interviews were conducted in people's homes and in the language of each country. A total sample size of approximately n=27,000 adults was obtained. Although the questionnaire design does slightly change over time, the main objectives have remained unchanged: mapping the current consumption of tobacco products, understanding the motivations behind smoking and the attitudes underlying smoking behavior, and identifying measures to reduce the number of Europeans who smoke. WP5 has produced a Final analysis plan of the 2015 SETS dataset.

WP6 evaluates the changes in e-cigarette products that will be attributable to the implementing Act of Art 20 of the TPD. Hence the aim of WP6 is to evaluate and re-evaluate the labelling/packaging practices, the technical design/safety features and chemical composition of e-cigarettes in 9 EU MS before the implementation of Art 20 of the TPD. To assess the potential changes we will identify the most common examples of e-cigarettes in the 9 EU MS participating in the EU-PLUS project (Greece, Germany, UK, France, Poland, Romania, Spain, Netherlands, Hungary), well before TPD Art 20 is implemented. WP6 has made a Report on the Pre-TPD status quo for e-cigarettes.

WP7 will work towards maximising the impact of the project by supporting the consultation with stakeholders and the dissemination of the project’s results. WP7 has launched and maintained the project website and prepared the consultation meetings with stakeholders.
EUREST-PLUS represents a significant advance beyond the state of art of tobacco control and regulation science in the EU. Although there exists one evidence-gathering system for tobacco use—the Special Eurobarometer on Tobacco Surveys—that system is focused on surveillance, not evaluation. The kinds of inferences that can be drawn through the SETS about the impact of tobacco control measures such as the TPD and the FCTC, especially among smokers, are limited mainly due to: 1) the sample sizes of smokers is very low in each country as it is based on population statistics (hence only 20-28% of respondents are smokers); 2) the design of the Eurobarometer Surveys is repeat cross- sectional, so that it is not possible to link individual changes in behaviour to changes in policy impact. EUREST-PLUS will take the current “best practice” that is implemented in the EU and maximize the evidence that can be obtained through this plethora of surveillance data collected within the SETS. Subsequent trend analyses using the Eurobarometer data indicate an additional departure from the status quo for European regulatory science on tobacco (WP5) as to date such repeated analyses have not been performed on EU data. In contrast, the proposed ITC Europe Surveys in the EUREST-PLUS Project (WP2, WP3, WP4) represent significant advances in European Tobacco Control.

Moreover, the strong integration of the transdisciplinary components of the EUREST-PLUS Project represent another advance beyond the current state of research in the EU. WP6, which will focus on measuring the parameters of product design of e-cigarettes before and after TPD implementation represents an advance in studies of e-cigarrettes. This will be the first time that changes in e-cigarette product evolution attributable to policies will be evaluated and also linked with population based indexes collected from WP2 and WP3. EUREST-PLUS thus represents a substantial advance beyond the state-of-the-art in the EU with respect to research on tobacco use and tobacco control policies and regulations.
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