MADES study: evaluation plan of the new tobacco product directive 2014/40/UE in Italy

Background The transposition of the New Tobacco Product Directive (TPD) 2014/40/UE in Italy entered into force in 2016. Main regulations were: Reporting obligations, ban of some ingredients and of some products with characterising flavours Pictorial warnings with Quitline number Sale ban of 10-cigarette packages Reporting obligations for new electronic-cigarettes (e-cigs); Advertising ban; child - and tamper - proof for refill containers. The transposition was an occasion to add new measures: Stricter enforcement of the sale ban to minors Smoking ban in cars with minors and pregnant women Smoking ban in outdoor areas of Pediatric and Gynecologic Departments Sale ban of e-cig and refill containers to minors Methods Presentation of the evaluation plan of the impact of the new TPD in Italy. Presentation of preliminary results for the year 2017. Results - The behavioural risk factor surveillance system PASSI, the ISTAT survey and the DOXA surveys on representative samples of Italians will allow us to study smoking and e-cigarette prevalence in adults; quitting attempts among smokers; the impact of pictorial warnings on smokers; second-hand smoke exposure in non-smokers; attitudes, perception, and behaviours of Italians after the coming into force of the new TPD; - The GYTS (Global Youth Tobacco Survey) will monitor smoking and e-cig prevalence, tobacco access and availability among Italian adolescents; - the National Institute of Health (ISS) will monitor the compliance with the smoking ban in cars, and the outdoor ban outside some Hospital Departments; - Temporal trend in Quitline calls will be studied. The impact of pictorial warnings will be also studied among smokers calling the Quitline, or attending Italian Smoking Cessation Centers; - The online transmission of ingredients of tobacco products from tobacco companies will be followed at the ISS. We will add preliminary results not yet produced. Conclusions The evaluation plan will allow to study all dimensions of the TPD impact