377. Deputy Charlie McConalogue asked the Minister for Health the HSE's position regarding the promotion of vaping as a means to achieve the State's goal of becoming smoke free (details supplied); and if he will make a statement on the matter. [41513/17]

379. Deputy Charlie McConalogue asked the Minister for Health the reason vaping and vaping products are classified in the same category as cigarette and tobacco products; his plans to amend the way in which vaping is classified in order to remove some of the expense associated with the practice (details supplied); and if he will make a statement on the matter. [41528/17]

Minister of State at the Department of Health (Deputy Catherine Byrne): I propose to take Questions Nos. 377 and 379 together.

The EU Tobacco Products Directive 2014/14/EU introduced new rules for tobacco products and for nicotine-containing e-cigarettes and refill containers. The EU Commission indicated that as nicotine is an addictive and toxic substance, safety and quality requirements for nicotine-containing e-cigarettes were necessary. Reporting obligations were also included so that public authorities could monitor and learn more about these products.

As a member of the EU, Ireland was obliged to transpose the Directive into Irish law. The new rules were transposed by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016), came into effect on 20th May 2016. The European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) (Amendment) Regulations 2017 (S.I. No. 252 of 2017) amended the Principal Regulations and gave effect to a number of Commission Implementing Acts.

My Department, in pursuing the recommendations of Tobacco Free Ireland requested the Health Information and Quality Authority to carry out a health technology assessment (HTA) of the clinical and cost-effectiveness of pharmaceutical and non-pharmaceutical smoking cessation products and service.

The HTA found that pharmacological therapies are generally safe and well-tolerated in those for whom these treatments are medically indicated for use. It is important to note that no e-cigarette product is currently licensed as a medicinal product in Ireland. The safety of e-cigarettes is an evolving area of research; while potentially safer than smoking, evidence on long-term safety has yet to be established. The results of the HTA will inform the development of national clinical guidelines which are currently being developed by the Health Service Executive in conjunction with the National Clinical Effectiveness Committee.

My Department will continue to monitor the emerging research on these products, so as to inform decisions around any future additional regulation in this area.