Background to the 2014 Tobacco Products Directive

Since the 1980s, there have been legislative initiatives in the EU to curb tobacco use. The main laws governing tobacco control in the EU are the Directives on Tobacco Products, on Tobacco Advertising and on Tobacco Tax. In addition, as the EU is a Party to the FCTC, it has an obligation to comply with this international treaty. The term ‘tobacco control measures’ in this article refers exclusively to the measures under the competence of the TPD unless otherwise specified.

The 2014 TPD, Directive 2014/40/EU, was formally adopted in April 2014 and entered into force on 20 May 2016 across all 28 EU MS.1 Key measures include:

• Mandatory combined pictorial and text warnings covering 65% of all cigarette packets and placed at the top of the packet (Articles 8–10).

• Prohibition on all characterising flavours (including menthol, though menthol has a derogation until 2020) (Article 7).

• Standard cigarette packet sizing (minimum 20 cigarettes and prohibition of lipstick-sized packaging) (Article 14).

• E-cigarette regulation (including age restriction, customer information and more uniform nicotine delivery) (Article 20).

• Comprehensive tracking and tracing measures (Article 15).

• Explicit right of individual EU MS to adopt additional measures such as standardised packaging (Article 24).

This replaces the original TPD, adopted in 2001 prior to the ratification of the WHO FCTC. Though the 2001 Directive introduced several key measures including a ban on misleading descriptors such as ‘light’ and ‘mild’ and mandatory ingredient disclosure, by 2009 it required a revision to bring it into line with scientific and international developments that had materialised over the previous decade.2

It is important to note that, while the TPD introduces significant advances, many EU countries still lag behind in several key areas such as comprehensive smoke-free provisions. This was highlighted by a group of non-governmental organisations (NGOs) in a report on the EU role at FCTC COP4, which criticises the low priority and resources that the EU, national governments and European civil society alike give to tobacco control and their non-adherence to Article 5.3.3 Since 2009, while some countries made progress especially on enacting smoke-free laws, discrepancies remain in the overall importance of tobacco control within national policies.

This study describes how various advocacy tools were applied during the 5-year TPD campaign, drawing out lessons learnt that might be applied elsewhere in the following areas: the importance of a strong coalition and a united public health voice; understanding the legal base and the policy processes, and identifying political champions; prioritising activities to match limited resources; using FCTC Article 5.3 effectively to rebut industry tactics and applying strategies that will have the best impact on national legislation.

The importance of a strong coalition and united NGO voice

The tobacco control community's campaign for the TPD was mainly led by the SFP, a Brussels-based partnership of Action on Smoking and Health (ASH (UK)), Cancer Research UK and the European Heart Network (EHN), and until 2013, the European Respiratory Society (ERS), in partnership with the Association of European Cancer Leagues (ECL) and the European Public Health Alliance (EPHA). SFP was established in 2006 and led EU level civil society contributions at FCTC negotiations, especially on Article 5.3 (tobacco industry interference), as well as EU level measures such as tax and smoke-free policies.4

SFP provided strategy, leadership, policy analysis and relationship management to a large group of highly committed and engaged NGOs across 28 different European countries. In developing a shared set of priorities in 2009, before the revision began, and the subsequent cooperation on joint actions and sharing of intelligence and resources, the EU tobacco control community was able to optimally use its limited resources. SFP designed messages for dissemination by public health organisations, which enabled the tobacco control community to have a much larger impact, especially in the context of the multilayered approach of EU policymaking at national and EU levels. It was able to reach out, through national tobacco control and public health organisations, to policymakers across all EU MS as well as EU policymakers within the three institutions (Commission, Council and Parliament). SFP was able to build and develop its strong coalition through continuous engagement with partners and policymakers through workshops, briefings, national meetings, media activities, etc.

The importance of understanding policy processes

The EU policy environment is complex: under the standard decision-making procedure (the Ordinary Legislative Procedure), a legislative proposal is submitted by the EC to the European Parliament (EP) and the Council of the EU for consideration. The EP (751 Members of the EP (MEPs)) and the Council of the EU (28 national governments) as joint and equal decision-makers discuss the proposal separately and adopt institutional positions, which are subsequently deliberated by the two institutions with the EC acting as broker. There are numerous points of influence within the three institutions and advocacy campaigns must adjust to the different actors and different stages to be successful. As a result, those with procedural know-how tend to be more successful in influencing EU policymaking; it is not enough to simply provide scientific evidence to policymakers.

Indeed, while the tobacco industry fails to have credibility on scientific information, it uses legal and procedural challenges to hinder the adoption of tobacco control policies.5 In the initial adoption of the 2001 TPD, the tobacco industry was shown to have interfered at all levels of policymaking within the three EU institutions to block, weaken or delay its adoption.6 Echoing this strategy in the recent TPD revision, leaked internal Philip Morris International (PMI) documents confirmed that their ultimate goal was to delay the policy process, a goal only achievable through a clear understanding of how the EU works.7 For example, during the public consultation of the TPD organised by the EC in 2010,8 a record-breaking 85 513 responses were submitted, of which 64% originated in Italy and Poland, and 57% were duplicates and ‘form’ responses through petition campaigns organised by the tobacco industry,9 ,10 a fact that was publicised by SFP.

Comprehensively understanding the policy process also meant that SFP could make best use of its resources. Unlike the tobacco industry, of which PMI alone had 161 lobbyists working on the TPD and spent €5.25 million in 2013,11 SFP only had the equivalent of two full-time members of staff.12 In the extensive decision-making process of the EP, the EC's draft proposal was submitted to six different parliamentary committees for consideration in December 2012. While the tobacco industry was able to send large numbers of lobbyists to influence all six of these,13 SFP focused on the Environment, Public Health and Food Safety (ENVI) Committee, which had the legislative lead, and was where SFP would be most likely to secure cross-party support. Encouragingly, the vote in July 2013 reflected the public health position and ENVI adopted a report that supported the majority of the tobacco control community's recommendations. However, the power of the tobacco industry was reflected in the votes of the other committees that were less supportive of stronger public health measures; for example, all except ENVI supported the exemption of menthol from the ban on characterising flavours.14 Understanding the policymaking process, therefore, can help to navigate procedural complexity, counter tobacco industry activity and compensate for limited resources by allowing the tobacco control community to act strategically, focusing on critical moments and actors. In this context, identifying influential individuals who supported the public health position and ensuring they were well-briefed at all key stages were crucial.

The importance of using FCTC Article 5.3 to counter industry interference

A key reason behind the success in securing a positive TPD was the use of FCTC Article 5.3. As parties to the WHO FCTC, all MS and the EU are obliged to limit interactions with the tobacco industry to those strictly necessary due to the internationally acknowledged ‘fundamental and irreconcilable conflict between the tobacco industry's interest and public health policy interests.’15

Tobacco industry interference in previous EU policymaking procedures is well documented,16–18 particularly in regard to the adoption process of the 2001 TPD.6 Adding to the tobacco industry's advantage of procedural knowledge and vast resources, the EU policymaking environment is also more amenable to industry interests due to a series of regulatory reforms, known as Better Regulation, adopted in the early 2000s.5 According to the EC, Better Regulation aims to design ‘EU policies and laws so that they achieve their objectives at minimum cost’.19 However, research has shown that Better Regulation marks a significant shift in the way policies are developed and is being manipulated by corporate interests, so that ‘policies that act in business' interest are more likely to succeed than policies required to protect population health’.5 Moreover, tobacco documents obtained in recent years through US litigation and information requests to the EC have revealed how the tobacco and other industries successfully influenced the debate towards the introduction of Better Regulation to the effect that the impact assessment phase would favour their corporate interests and place less value on the health impact.6 This research was promoted at a meeting in the EP by SFP.

Similar interference proved a recurrent theme during the 2014 TPD revision.20 ,21 The draft legislation had already been delayed by 18 months as a result of a record-breaking consultation process totalling over 85 000 responses.9 Then with the resignation of EU Health Commissioner, John Dalli, in October 2012 following allegations of bribe solicitation linked to Swedish Match, a Swedish tobacco manufacturer, the entire TPD revision was placed in jeopardy as the incident threatened to delay the release of the legislative proposal further.22 This would have resulted in additional pressure being placed on the small window of legislative opportunity available before the impending May 2014 EP elections and EC reshuffle in the ensuing autumn. The 2001 TPD had taken 18 months to negotiate between the EP and the then only 15-MS strong Council, and there was no reason to believe it would take less time on this occasion.

The EC initially announced that the legislative proposal would not be released to the decision-makers until a new Commissioner was appointed.23 Using FCTC Article 5.3 and its Guidelines as justification, SFP successfully challenged this decision by producing a briefing to MEPs asking them to hold the EC to account for the immediate appointment of a new Health Commissioner and the release of the legislative proposal (SFP document provided to MEPs, October 2012, not published). As a result, the legislative proposal was released ahead of schedule on 19 December 2012.24

Interest in FCTC Article 5.3 flared again at a critical juncture of the negotiations, weeks before the EP plenary vote, when the difference between the public health and tobacco industry lobbies was compounded publicly by the leak of internal PMI documents, detailing their influence and reach into the EU institutions. SFP enacted a comprehensive media strategy to expose the lobbying strategy, power and networking of the tobacco industry including their close connections to third-party groups and the extensive meetings held with MEPs by the acknowledged 161 PMI lobbyists. The story received coverage in a number of national and EU publications, generating support from additional policymakers, and resulting in MEPs being called to account by their national media.25–27

As these examples show, FCTC Article 5.3 is a powerful tool against industry interference and is particularly useful for reminding policymakers that they are accountable. The NGO community should be ready to exploit to its fullest advantage any infringements that come to light, and where possible, actively fund and promote research into industry activities.

The importance of understanding legislative impact

Engagement in EU-level tobacco control policy is essential as this is the cornerstone of important national tobacco control policies in EU MS. In the case of the 2001 TPD, the Directive acted as a legislative ‘floor’ for MS. They were permitted to introduce additional or stronger measures as long as the national legislation conformed to the basic measures set out at EU level. However, while some did adopt stronger measures, many MS implemented the minimum measures to comply with the Directive. For example, by 2012, only 10 MS had introduced pictorial warnings, and of those, just 3 MS had performed so before 2010.28

The new Directive was expected to set the standard of EU tobacco control policy over at least the following 10–15 years. The adoption of a poor new Directive, or failure to adopt a revised Directive altogether, would subsequently have had long-term implications for European tobacco control. Failure to adopt a revised TPD would have tacitly permitted some MS to continue doing the minimum to comply with the 2001 TPD as well as failing to acknowledge the developments in tobacco regulation within the FCTC, to which all EU MS and the EU itself are Parties.

Securing the adoption of Article 24 of the 2014 TPD was crucial as it allows EU MS to adopt complementary measures, particularly those concerning the introduction of standardised packaging. Article 24 explicitly states that MS are permitted to introduce additional measures beyond those in the Directive where justified on public health grounds. Its omission or negative amendment would likely have prevented, or at least slowed, the advent of standardised packaging in the EU.

Therefore, scrutiny, analysis and briefing to key decision-makers by tobacco control advocates is essential including at the drafting stage of legislation.