EU Tobacco Products Directive Revision

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In 2001, the European Union (EU) adopted directive 2001/37/EC, the Tobacco Products Directive (TPD), which regulates the manufacture, presentation and sale of tobacco products in the European Union (EU). A spokesperson for the European Parliament described the TPD as “the most lobbied dossier in the history of the EU institutions”.1

In April 2014, the European Union (EU) completed the first revision of the TPD. The revised 2014 TPD (2014/40/EU) repealed and replaced the 2001 TPD. It aimed to reduce the differences in approaches to tobacco regulation in the 28 EU Member States, laying down minimum rules for cigarettes, cigars, pipe tobacco, waterpipe, cigarillos (short and slim cigars), smokeless tobacco (snus), Roll-Your-Own tobacco (RYO), and E-cigarettes. It significantly improved on the original TPD provisions, for example including a ban on ‘characterising’ flavours and an increase of graphic health warnings from 30-40% to 65% on the front and back of the pack.

Article 28 of the 2014 TPD set out a timeline for a further review of the TPD to begin in May 2021. 2 The Commission is therefore obliged to review the implementation and impact of the TPD, and draft further amendments according to market developments in Next Generation Products, including Heated Tobacco Products. This review coincides with the launch of the European Beating Cancer Plan, which sets a target of reducing tobacco use in the EU to less than 5% by 2040, as well as a commitment to significantly strengthen tobacco control measures in the EU 3

Background to the TPD review

The idea of strengthening the TPD was first floated in 2007, and formalised in 2009 when the European Commission (‘the Commission’) began the TPD review. This was in response to new products that had entered the market but were not covered by the 2001 TPD (for example e-cigarettes), and new emerging scientific evidence including evidence that tar and nicotine levels on tobacco packs may mislead consumers into thinking that some tobacco products are less harmful than others.4 In addition, the EU and its member states had become signatories to the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) in 2005, which aims to reduce the harm from tobacco. Each signatory is legally obliged to implement the provisions in this Treaty.

The TPD review took over 5 years to complete, with the majority of this time taken up in the Commission. Image 1 illustrates the different stages of the European legislative process that the TPD passed through before being enacted.

Image 1. The ordinary legislative procedure of the 2014 EU Tobacco Products Directive, 2009-2014. Following a comprehensive impact assessment, the Commission (representing the EU civil service) drafts the legislative proposal and presents it jointly to the Parliament (representing EU citizens) and the Council (representing EU member states) for revision and adoption)5

During these five years several controversies hit the news, including an opaque lobbying scandal known as ‘Dalligate’ which saw Health Commissioner John Dalli forced to resign in October 2012 following a complaint by smokeless tobacco manufacturer Swedish Match, a professional burglary of the offices of Brussels-based NGOs lobbying on tobacco control, and repeated claims of tobacco industry interference across all three EU institutions (the Commission, Parliament and the Council).567 This led to major concerns about the processes, transparency and independence of EU policymaking and the influence of the tobacco industry in Brussels. 68

Concerns over industry interference in the EU have resurfaced in light of the 2021 TPD revision. Article 5.3 of the FCTC binds the Commission to take action to limit the influence of the tobacco industry in its policymaking processes. However, the Commission made limited changes to its practices in the period following the 2014 TPD revision. Tobacco Control advocates have called for stricter, and more proactive transparency practices to be adopted to prevent industry interference in the 2021 TPD revision process. 910

Tobacco industry’s response to the 2014 TPD

A study led by the University of Bath 5 examined the nature and size of the tobacco industry’s response to the 2014 TPD. Based on analysis of, among other things, 581 freedom of information (FOI) documents released by the Commission and 45 internal tobacco industry documents, the study demonstrated that the tobacco industry went to enormous effort and expense to amend and delay this legislation, and felt particularly threatened by the proposed introduction of Plain Packaging, a Point of Sale Display Ban, and an ingredients ban. For example, Philip Morris International (PMI) spent millions of euros on an elaborate lobbying campaign, involving more than 160 lobbyists. 5

Other tobacco companies were similarly politically active, with the overall tobacco industry’s response closely mirroring their efforts to undermine the 2001 TPD, albeit this time with an increased use of Third Party Techniques.

Strategy in the Commission: Flooding consultation processes and targeting non-health Commissioners and their officials

Strategy in the Commission: Flooding consultation processes and targeting non-health Commissioners and their officials

The tobacco industry started actively opposing the TPD as early as 2009, aiming to block so-called “extreme policy options” such as plain packaging, Point of Sale Display Ban, and an ingredients ban at an early stage of the TPD decision-making procedure.11 Evidence shows that the stakeholder consultation process was an important entry point for the tobacco industry to influence and delay the TPD revision. For example, a public consultation held in late 201012 attracted 85,000+ submissions, with the Commission commenting that “no previous public consultation launched by the European Commission has ever registered such significant participation”.13 Despite only 2,320 submissions openly disclosing being linked to the tobacco industry, subsequent analysis of the responses showed that a large portion of submissions were attributed to tobacco industry-led mobilisation campaigns in Poland and Italy.13 Flooding the consultation subverts the democratic process, and the sheer volume of responses significantly delayed the TPD review process.

Other than (mis)using the formal stakeholder consultation processes, led by the Commission’s Directorate-General (DG) for health and consumers (DG SANCO), the tobacco industry also actively lobbied non-health Commissioners and other DGs.5 This was in an attempt to shift the policy debate away from health to economics, and to generate TPD opposition within the Commission. Key targets were DGs Enterprise, Trade, Internal Market, and Agriculture5, but evidence also shows that the highest echelons of the Commission (i.e. the Secretariat-General, the Legal Service, and President Barroso and his Cabinet) had repeated undisclosed contact with the tobacco industry during the TPD review.514 In contrast to DG SANCO’s practice of minuting meetings with the tobacco industry and publishing these minutes on their website, in line with FCTC 5.3, meetings between the tobacco industry and other (non-health) elements of the Commission were not routinely minuted, and none were publicly disclosed.5 This is in clear violation of article 5.3 of the FCTC.
Some of the contact between the Commission and the tobacco industry occurred via former EU politicians or civil servants that are now employed by the tobacco industry, so-called Revolving Doors. For example, Michel Petite used to be the Commission’s Head of Legal Service before becoming a consultant to PMI in his role at a Brussels-based law firm. In his role as PMI consultant, Petite had several exchanges (none minuted) with the Commission’s Legal Service about the TPD.14 As is shown below, the Legal Service played a role in some of the delays and dilutions to the TPD. Dalli has since claimed that the Legal Service only started raising concerns following Petite’s involvement.15

Strategy in Parliament: Curbing the influence of the Health Committee and targeting key MEPs in political parties and parliamentary non-health committees

Strategy in Parliament: Curbing the influence of the Health Committee and targeting key MEPs in political parties and parliamentary non-health committees

The tobacco industry strongly lobbied Members of European Parliament (MEPs). PMI lobbyists had individually approached over one third of MEPs (257 of 754) when the TPD proposal was still being drafted in the Commission.5 The lobbyists meticulously assessed each MEP’s position on TPD policy options and sensitivity to pro-tobacco arguments, and MEPs were often approached in their national constituencies where there were fewer staff to remind them of EU protocol. Third parties were employed to approach health-friendly MEPs, often hiding their tobacco industry links, and former MEPs were purposively recruited to approach MEPs on the basis of being “an old friend”.5 Tobacco-friendly MEPs were used to attempt to isolate influential MEPs within their own parties who did not support tobacco industry positions.

As in the Commission, the tobacco industry attempted to increase the prominence of market versus public health arguments in Parliament. First, it unsuccessfully attempted to push for the Internal Market Committee (IMCO) to be the co-lead parliamentary committee with the Health Committee (ENVI), which would normally preside over a file like the TPD. Second, it tried to generate opposition from the five appointed Parliamentary Committees of Opinion, in the TPD’s case the Committees of International Trade, Internal Market, Legal Services, Agriculture and Rural Development, and Industry Research and Energy. One of the key messages targeted by the tobacco industry and third parties at MEPs was the alleged ‘spill-over’ effect of the TPD on other sectors. Image 2 shows Christmas gifts sent to MEPs in December 2013, suggesting an overspill effect on the food and alcohol industries.

Image 2. Gifts sent to MEPs by tobacco companies in the lead up to Christmas 2013, suggesting the measures in the TPD will set a precedence for other business sectors

Strategy on national level: creating blocking minorities

PMI also considered national level influence another key element to subverting the TPD.5 When the Commission began drafting the TPD proposal, national level lobbying started via the TPD Regulatory Committee, a committee which met twice a year to discuss the TPD review’s progress, and consisted of the Ministries of Health of all EU Member States and DG SANCO. For example, Dutch FOI documents reveal that PMI cultivated an amicable relationship with the Dutch Department of Health. In March 2010 PMI hosted health officials at PMI’s Dutch factory.16) In an email to the Health Department a few months earlier, PMI criticised the quality of the RAND’s TPD’s impact assessment and the short stakeholder consultation period given, asking the Department to critically review RAND’s report and challenge the period of consultation with DG SANCO.17 It’s unclear if the Health Department followed PMI’s suggestion, but email correspondence reveals that the Department promised to incorporate PMI’s input into the Dutch Government’s response to the RAND report where appropriate.18

Two other national level entry points for the tobacco industry to influence the TPD were the National Parliaments and the Council of Ministers. The national parliaments have the power to scrutinise a Commission’s legislative proposal to ensure it meets the EU’s subsidiarity principle. Although unsuccessful, PMI planned to encourage sufficient negative opinions from national parliaments to trigger a so-called ‘yellow card system’, which means the Commission would have to redraft the proposal.

The tobacco industry also tried to exert influence through the Council of Ministers, the EU’s co-legislator alongside the European Parliament. On 21 June 2013 the Council voted on the Commission’s TPD proposal. Western European Member States were in favour of stricter tobacco regulations, whilst Central and Eastern Member States expressed concern with the TPD’s impact on tobacco industry jobs.19 This is consistent with PMI’s document which shows that the company sought to mobilise a blocking minority in the Council by framing the debate around employment.20
One of the Member States voicing concern was Poland, which criticised the TPD’s impact assessment for given too much weight to the health impacts of the proposal, and not enough to the impact on the tobacco industry and the competitiveness of the European tobacco industry in international markets.21 Polish media had revealed a few months earlier how the tobacco industry had actively lobbied the Polish Prime Minister in December 2012 to oppose the TPD. 22

Ultimately the Council reached a compromise agreement that slightly diluted the Commission’s proposal. Bulgaria, Czech Republic, Poland and Romania did not agree, but the opposition of these Member States was not enough to block the agreement.23

How successful was the tobacco industry’s interference in the 2014 TPD revision?

The tobacco industry’s attempts to amend and delay the TPD were successful on both counts, however, the Directive, albeit somewhat weakened, was ultimately successfully enacted.

Delays

The TPD was delayed by three years, which nearly jeopardised its adoption altogether, as the proposal had to be adopted before the Parliamentary elections in May 2014. First through the hijacking of the public consultation. Second, through intervention by the Secretary-General, the Head of the Legal Service, and the President and his Cabinet, the Commission’s Inter-service Consultation (ISC), an internal consultation with DGs affected by the proposal and a crucial element of the legislative process, was delayed three times:5

  • First, the ISC was postponed in July 2012 because the Secretary-General and Head of the Legal Service claimed that there were substantial issues in the impact assessment that needed further attention, and that there were also alleged concerns with the proposal’s legal basis.
  • Second, the ISC was postponed in September 2012 by the Secretary-General and the Head of Barroso’s Cabinet because the Commission apparently sought to avoid controversy ahead of the European Council meeting in October.
Email dated 23 September 2012 from the Secretary-General to DG-SANCO’s Director-General, requesting that the ISC be delayed until after the October European Council

In Parliament, the vote in the plenary was delayed by a month amidst rumours of industry interference. Following the vote in the Health Committee on 10 July 2013, the plenary was scheduled to vote on 10 September 2013. Less than a week before the vote was due, the European People’s Party (EPP), the largest political party in the European Parliament and one that PMI heavily relied on for support, requested a delay of the vote, supported by two other political groups. Different justifications for this delay were given; MEPs were supposedly not given enough time to read the ENVI report, the revised TPD allegedly did not sufficiently take into account other Parliamentary Committees’ opinions, and German MEPs were up for federal elections on 22 September 2012 and therefore many would be absent for the vote.242526The TPD’s rapporteur, Linda McAvan MEP, strongly condemned the delay, arguing that “All the proper procedures for the vote had been respected and the timetable has been in place since January so the move is disappointing”.27 The postponed vote took place on 8 October 2013, when McAvan was given the mandate to progress the TPD and start negotiations with the Council.

TPD measures weakened

Intervention by the Secretariat-General and Legal Service led both to the removal of the two provisions that the tobacco industry was most concerned about – Plain Packaging and a Point of Sale Display Ban.

Email dated 7 September 2012 from DG-SANCO’s Director-General to the Secretary-General and Director-General of the Legal Service, confirming changes made to the TPD text

The Commission’s proposal was subsequently slightly diluted in Parliament and Council. This is consistent with the findings of a study led by the University of Oxford who undertook a quantitative text analysis and documented that the TPD’s provisions shifted significantly towards the tobacco industry’s position while it was going through the legislative process.28

Impact of ‘Dalligate’

The evidence presented in the Bath study5 suggests that the ‘Dalligate’ affair changed the political landscape and backfired on the tobacco industry. Serious questions began to be raised by NGOs and the media about the transparency of EU policy making and the influence of the tobacco industry in the Commission. Previously amenable DGs became, at least temporarily, less inclined to engage with the tobacco industry. In Parliament, Dalli’s departure and exposure of tobacco industry interference had resulted in rare, all-party support to move the TPD forward. The European People’s Party decided not to nominate a candidate for TPD rapporteur (which is the MEP who leads on the proposal and oversees its progress). Instead, Linda McAvan from the Social-Democrats was appointed rapporteur, a choice PMI described as ‘hostile’.29. Equally, PMI’s plan to have IMCO assigned as co-lead committee did not succeed. As one MEP recalled “we guessed that the next tactic would be that they shouldn’t give proposal to the environment committee ENVI…, but it was really a nonstarter…it would have been another scandal…they shot themselves in the foot with that”.5

Legal Challenges

The TPD was challenged in the European Court of Justice (ECJ) by several parties.

Issues of Concern: Better Regulation and FCTC 5.3

The evidence of strong tobacco industry interference in the TPD review raises two major policy concerns:5

Better Regulation agenda does not necessarily serve public health interests

In case of the 2014 TPD revision, Better Regulation facilitated tobacco industry access to Commission staff, allowed the tobacco industry to frame their arguments and overwhelm the review process by mobilising an enormous response to the consultations, and delaying the TPD’s progress. Thus Better Regulation fails to take into account the ability of powerful corporate actors to dominate this policy process. This is consistent with previously raised concerns that Better Regulation favours corporate over public interests, economic over health considerations, and can be used to delay and prevent public health legislation.30 This is particularly pertinent considering evidence that British American Tobacco (BAT), with other companies producing products damaging to health, were instrumental in pushing the Better Regulation agenda in the 1990s, anticipating that it would make it more difficult to pass public health legislation.31

FCTC widely misunderstood and mis-implemented

FCTC Article 5.3, which requires that ‘in setting and implementing their public health policies with respect to tobacco control, parties shall act to protect these policies from commercial and other vested interests of the tobacco industry’, was unable to prevent tobacco industry influence on the TPD. While the Commission’s department responsible for health, DG SANCO, complied with 5.3, other parts of the Commission and some MEPs did not. For example, interventions by the highest echelons of the Commission to dilute and delay the TPD followed repeated and undisclosed contact between Commission officials and the tobacco industry, in contravention of Article 5.3. The staff involved did not suffer any consequences, while Article 5.3. was cited as a reason for Dalli’s dismissal, showing a misinterpretation and min-implementation of the Article.

Relevant Links

  • To read the full 2014 TPD text, click here.
  • Myth-busting briefing on the arguments used by the tobacco industry and its allies to influence the TPD, prepared by the Smoke Free Partnership

Related TobaccoTactics Resources

References

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  2. The European Parliament and the Council of the European Union, Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacturer, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC, Official Journal of the European Union, Brussels, accessed March 2021
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  4. European Commission, Commission Staff Working Document Impact Assessment. Brussels 19 December 2012, accessed March 2021
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