TC Online First, published on February 24, 2015 as 10.1136/tobaccocontrol-2014-051919 Tob Control: first published as 10.1136/tobaccocontrol-2014-051919 on 24 February 2015. Downloaded from Research paper The revision of the 2014 European tobacco products directive: an analysis of the tobacco industry’s attempts to ‘break the health silo’ Silvy Peeters,1 Hélia Costa,2 David Stuckler,2,3 Martin McKee,3 Anna B Gilmore1 ▸ Additional material is ABSTRACT the size of graphic health warnings, a ban on charac- published online only. To view Background The 2014 European Union (EU) Tobacco terising flavours, restrictions on the size and shape please visit the journal online (http://dx.doi.org/10.1136/ Products Directive (TPD) was negotiated in a changed of cigarette packs, and the regulation of Electronic tobaccocontrol-2014-051919). policy context, following adoption of the EU’s ‘Smart Nicotine Delivery Systems (ENDS) (table 1), must 6 1 Regulation’ agenda, which transnational tobacco be transposed into national law by 2016. Department for Health, fi University of Bath, and companies (TTCs) anticipated would increase their While these changes represent signi cant public member of the UK Centre for influence on health policy, and the WHO Framework health advances, the final Directive is weaker than Tobacco and Alcohol Studies Convention on Tobacco Control (FCTC), which sought to initial drafts7 (table 1). The review process involved (UKCTAS), UK reduce it. This study aims to explore the scale and nature controversy, notably the forced resignation of 2Department of Sociology, of the TTCs' lobby against the EU TPD and evaluate how Health Commissioner John Dalli and claims of University of Oxford, Oxford, 8–12 UK these developments have affected their ability to exert tobacco industry interference, with the TPD 3Department of Public Health influence. described as ‘the most lobbied dossier in the and Policy, London School of Methods Analysis of 581 documents obtained through history of the EU institutions’.13 Although previous Hygiene & Tropical Medicine, freedom of information requests, 28 leaked Philip Morris research reveals transnational tobacco companies’ London, UK International (PMI) documents, 17 TTC documents from (TTCs) efforts to derail earlier EU tobacco regula- 214–16 Correspondence to the Legacy Library, web content via Google alerts and tion, the policy context has since changed in Silvy Peeters, Department for searches of the EU institutions' websites, plus four ways that may mitigate or exacerbate TTCs’ ability Health, University of Bath, stakeholder interviews. to influence EU legislation. On the one hand, Claverton Down, Bath BA2 7AY, UK; Results The lobby was massive. PMI alone employed FCTC Article 5.3 entered into force in 2005, [email protected] over 160 lobbyists. Strategies mainly used third parties. requiring that ‘in setting and implementing their Efforts to 'Push' (amend) or 'Delay' the proposal and public health policies with respect to tobacco copyright. Received 23 July 2014 block 'extreme policy options' were partially successful, control, parties shall act to protect these policies Accepted 16 December 2014 with plain packaging and point of sales display ban from commercial and other vested interests of the removed during the 3-year delay in the Commission. The tobacco industry’.17 Conversely, regulatory reforms Smart Regulation mechanism contributed to changes known in the EU as Better or Smart Regulation, and delays, facilitating meetings between TTC and shown to facilitate tobacco industry influ- representatives (including ex-Commission employees) and ence,18 19 were implemented in the mid-2000s.20 senior Commission staff. Contrary to Article 5.3, these Smart Regulation seeks to reduce regulatory http://tobaccocontrol.bmj.com/ meetings were not disclosed. burdens and enhance business competitiveness via Conclusions During the legislative process, Article 5.3 impact assessment (IA), which attempt to estimate was not consistently applied by non-health Directorates the costs and benefits of policies in monetary of the European Commission, while the tools of the terms, and stakeholder consultation in which those Smart Regulation appear to have facilitated TTC access affected by the policy are formally consulted early to, and influence on, the 2014 TPD. The use of third in the policy process. Worryingly, British American parties undermines Article 5.3. Tobacco (BAT), working with a large number of other corporations whose products are potentially damaging to health, was instrumental in promoting INTRODUCTION Smart Regulation, anticipating it would make it 21 Tobacco is Europe’s largest preventable cause of harder to enact public health legislation. In line on September 26, 2021 by guest. Protected death, claiming nearly 700 000 lives in the with BAT’s predictions, growing evidence suggests 19 21 22 23 24 European Union (EU) annually.1 Although the EU’s that Smart Regulation can and has public health legislative powers are limited,2 favoured corporate interests and might undermine 19 21 22 the launch of the 1985 ‘Europe Against Cancer’ efforts to implement public health policies. programme3 prompted a range of tobacco control We previously demonstrated, using quantitative measures,4 including the 2001 Tobacco Products content analysis, that successive drafts of the TPD Directive (TPD) (2001/37/EC) which regulates the shifted towards the tobacco industry’s preferred 7 manufacture, sale and presentation of tobacco pro- position. We explore how the tobacco industry ducts. In 2009, the European Commission (‘the engineered some of these policy changes. We To cite: Peeters S, Costa H, Commission’) began revising this Directive in light examine the nature and scale of TTCs’ efforts to Stuckler D, et al. Tob of new market and scientific developments and the influence the TPD revision, identifying key entry Control Published Online ’ First: [please include Day WHO s Framework Convention on Tobacco points used to access and shape the policy process. Month Year] doi:10.1136/ Control (FCTC).5 The process took over 5 years, We also examine whether Smart Regulation tobaccocontrol-2014- with the new Directive finally adopted in April enabled corporate influence on the TPD, as those 21 051919 2014. The Directive, which includes an increase in promoting it intended, and whether the Peeters S, et al. Tob Control 2015;0:1–10. doi:10.1136/tobaccocontrol-2014-051919 1 Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence. Research paper Tob Control: first published as 10.1136/tobaccocontrol-2014-051919 on 24 February 2015. Downloaded from Table 1 Textual changes to the 2014 TPD Trilogue agreement Council common Parliamentary health Parliamentary plenary (between commission, Commission proposal approach committee approved text approved text council and parliament) Key provisions 19/12/2012 21/06/2013 10/07/2013 8/10/2013 18/12/2013 Size and position of 75% front, back and 65% front, back and 75% front, back and top 65% front, back and top 65% front, back and top health warnings top top MS discretion MS discretion MS discretion MS discretion MS discretion Ban on Yes Yes Yes Yes, menthol 5 years derogation Yes, menthol 4 years ‘characterising derogation flavours’ Slim cigarette ban Yes No Yes No No Ban on 10 cigarette Yes Yes Yes Yes Yes pack Cross border Notification, mandatory Prohibit or notification Prohibit Prohibit Notification distance sales age verification MS discretion MS discretion Traceability and Track and trace to Track and trace to Track and trace to extend to the Track and trace to extend to the Track and trace system for the security features extend to the whole extend to the whole whole supply chain. No tobacco whole supply chain. No tobacco legal supply chain supply chain supply chain industry solutions industry solutions Snus sales ban Maintained Maintained Maintained Maintained Maintained ENDS regulation Medicines licence, Medicines licence, Medicines licence all No, only if they make health No, only if they make health depending on nicotine depending on nicotine claims claims concentration concentration MS, Member States. application of Article 5.3 is adequate to prevent TTC influence 2007 to 2014, were recorded in a timeline to map key develop- on EU tobacco control policymaking. ments, identify stakeholders and points of access to EU institu- tions, and time the Directive’s progress through the legislative METHODS process. We compared the time the 2014 TPD revision took in We analysed a wide variety of materials. First, we obtained each legislative stage, that is, in the Commission, then copyright. 2007–2014 reports, meeting minutes, and press releases from Parliament and Council, with the original 2001 TPD. the Commission (http://ec.europa.eu/health/tobacco/policy/ Semistructured interviews were undertaken with staff of the index_en.htm), Council of Ministers (http://www.consilium. most active Brussels-based tobacco control NGO, the Smoke europa.eu/homepage) and European Parliament (http://www. Free Partnership (SFP) and three Members of European europarl.europa.eu/news/en/news-room/) websites. Second, rele- Parliament (MEPs) (Twelve MEPs identified in the European vant web content (including press coverage, media releases and, Parliament’s TPD ‘procedural file’ as key players28 were invited blogs) was identified prospectively through Google alerts estab- for interview, but only three accepted). Staff of DG-SANCO, lished in 2011 on BAT, ‘Philip Morris International’