International, European and National Challenges
Edited by Lukasz Gruszczynski
This chapter introduces the theme of the book. In this context, it looks at the variety of approaches taken by regulators around the globe with respect to e-cigarettes, as well as at the science that stands behind specific regulatory choices. It also delimits the scope of the book and clarifies terminological nuances. Against this background, the chapter summarizes and critically assesses the findings of the individual authors relating to: (i) the factors that influence the particular paths taken in different jurisdictions; (ii) general features of an optimal regulatory model for e-cigarettes; and (iii) constraints imposed by international and European rules on regulators in this policy space. The chapter also offers some general observations as to the possible future directions of e-cigarette regulation.
The Framework Convention on Tobacco Control (FCTC) is an international treaty that sets global standards for national tobacco control measures. It is widely seen as a major achievement of the global community in the area of public health. However, the emergence of e-cigarettes poses serious conceptual challenges for the Parties as to their proper classification (and subsequent legal treatment) under the Convention. In this context, the chapter investigates whether and to what extent the FCTC disciplines apply to e-cigarettes and whether the mandate enjoyed by the FCTC Conference of the Parties (COP) is sufficiently broad to deal with these products. It concludes that due to the formulation of the relevant provisions, the complex nature of e-cigarettes, and the COP’s unwillingness to take a decisive stance on their status, the Convention regime currently has only a limited impact on the development of legal standards in this policy space.
Anna Pudło and Lukasz Gruszczynski
The market for e-cigarettes has recently been harmonized at the European Union (EU) level by the 2014 Tobacco Products Directive (TPD). To some, the TPD establishes a golden regulatory standard for the treatment of e-cigarettes - one which can be replicated in the future in other jurisdictions - while for others it is an example of an overprotective regulation that stifles innovation, which in the end may have a negative impact on public health protection. The aim of this chapter is twofold. First, it analyzes the legislative process that led to the adoption of the new EU regulatory framework for e-cigarettes, at the same time identifying the factors that have had an impact on its ultimate shape and presenting its main features. Second, the chapter assesses the legality of the relevant TPD provisions under applicable EU rules in light of the Pillbox 38 (UK) Ltd v Secretary of State for Health judgment.