Documents considered by the Committee on 4 September 2013 - European Scrutiny Committee Contents

1 The manufacture, presentation and sale of tobacco and related products



COM(12) 788

+ ADDs 1-7

Draft Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products

Legal baseArticle 114 TFEU; co-decision; QMV
Basis of considerationMinister's letter of 31 July 2013
Previous Committee ReportsHC 83-viii (2013-14), chapter 5 (3 July 2013);

HC 83-vi (2013-14), chapter 1 (19 June 2013);

HC 83-v (2013-14), chapter 5 (12 June 2013);

HC 86-xxx (2012-13), chapter 3 (30 January 2013

Discussion in CouncilNo date set
Committee's assessmentLegally and politically important
Committee's decisionFor debate in European Committee C

Background and previous scrutiny

1.1 The draft Directive would replace the existing regulatory framework for tobacco products, which has been in force for more than a decade, and introduce a number of changes which are intended to take account of scientific, market and international developments, including the entry into force of the World Health Organisation Framework Convention on Tobacco Control in 2005. As with previous EU Directives, it is an internal market measure based on Article 114 of the Treaty on the Functioning of the European Union (TFEU) and (as required by that Article) takes as its base a high level of public health protection. A particular concern is to discourage tobacco consumption by young people. The Commission estimates that 70% of smokers start before the age of 18. The draft Directive was published in December 2012 and deposited for scrutiny early in 2013. Our Thirtieth Report of Session 2012-13, agreed on 30 January 2013, provides a detailed overview of the draft Directive.

1.2 In her Explanatory Memorandum, the Parliamentary Under-Secretary of State for Public Health (Anna Soubry) broadly welcomed the draft Directive and indicated that the then Irish Presidency was keen to secure a general approach within the Council by the end of June. She also indicated that many of the changes proposed by the Commission would require further detailed examination and highlighted, in particular, research being undertaken by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the regulation of non-tobacco nicotine-containing products ("NCPs"), such as e-cigarettes, as well as the Government's consultation on the possible introduction of standardised (or plain) packaging for tobacco products.

1.3 We expressed our disappointment that the Minister was unable to provide more information, particularly in light of the ambitious timetable set by the Presidency, and asked her to clarify the Government's position on those elements of the draft Directive introducing new or more stringent regulatory requirements.

1.4 The Minister responded on 3 June, apologising for the delay in providing the information we had requested and adding that it had taken some time to secure cross-Government clearance of the UK's negotiating position. She highlighted the UK's role as "a European and global leader in tobacco control" and expressed the Government's support for the proposed ban on additives and flavourings, the mandatory use of combined picture and text health warnings, and larger health warnings. She wrote again on 11 June to announce the outcome of the MHRA's research on NCPs and its endorsement of the Commission's proposal to regulate NCPs exceeding a particular dose threshold (in practice, most NCPs currently on the UK market) as medicines, not least because this would enable better long term monitoring of their safety and the imposition of controls on access and advertising where justified (for example, to protect children). The details are contained in our Fifth Report, agreed on 12 June.

1.5 The Minister wrote again on 17 June to confirm that the Council would be invited to agree a general approach on a Presidency compromise text at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 21 June and to request a scrutiny waiver. She indicated that the Government would seek further changes (specifically to Article 24) to enable Member States to maintain or introduce more stringent domestic tobacco control measures (especially plain packaging) if duly justified on public health grounds. She also reiterated the Government's preference for provisions on the tracking and tracing of tobacco products to be included in EU customs and excise legislation rather than in the draft Directive. However, her overall assessment of the Presidency compromise text was that it was "good for public health" and that UK support for it at the Health Council could be crucial in securing an acceptable agreement. Details of the Presidency compromise are described in our Sixth Report, agreed on 19 June.

1.6 We considered that too many important issues remained unresolved and that the outcome of the Council appeared too uncertain to warrant a scrutiny waiver, and asked the Minister to provide a full report on the Council. Her letter of 1 July confirmed that the Council had agreed a general approach and that UK support was "decisive" in forming a qualified majority. She indicated that UK support for the Presidency compromise text was "vitally important" and gave the following reasons for overriding our scrutiny reserve:

  • to secure improvements which were beneficial for the UK (for example, ensuring that the UK could maintain picture/text warnings on all smoked tobacco products, including cigars, and increasing flexibility for Member States to implement domestic public health policies, such as standardised packaging);
  • to ensure that the draft Directive was able to continue to progress; and
  • to prevent other Member States securing a general approach on a different compromise text that might have been less favourable for the UK.

1.7 The Minister indicated that further compromises were needed to secure agreement. In particular, the size of the combined picture and text warnings for smoked tobacco products was reduced from 75% of the outer front and back surfaces of packaging in the Commission's original proposal to 65% in the Presidency general approach. However, the Government succeeded in obtaining further changes to Article 24 to protect its ability to introduce plain packaging, should it (or a future Government) choose to do so. Our Eighth Report of 3 July sets out further details.

1.8 We reiterated our concern that the Government's inability to clarify its position on some key elements of the draft Directive (such as the provisions on packaging and product description and the regulation of NCPs) left insufficient time for Parliament to consider the implications for UK policies in these areas and invited the Minister to explain in person the reasons for deciding to override scrutiny. A transcript of the Minister's oral evidence is available on our Committee website.[1]

The Minister's letter of 31 July 2013

1.9 The Minister (Anna Soubry) provides further information on two issues raised during the evidence session. First, the Minister told us that UK support for the Presidency compromise text was "absolutely critical" in securing a general approach. We asked her whether the outcome would have been different if the UK had abstained:

"As I set out in my letter to the Committee of 1 July 2013, four Member States — Bulgaria, Czech Republic, Poland and Romania — were unable to offer their support, which meant that the UK's support was decisive in forming a qualified majority.

"My understanding of likely Member State voting intentions on the morning of the meeting was that, without the UK's support, it was possible that agreement would have been reached on a different version of the proposal that would have watered down the important public health measures in the proposal, perhaps even removing some of the tobacco control measures we currently have in place, and would not have been in keeping with our agreed negotiating position. For example, by supporting a General Approach, the UK secured the flexibility in the current Council compromise text to apply picture warnings to all smoked tobacco (including cigars), and also not to apply a ban on cross border distance sales.

"Most importantly, the fact that the UK offered its support for a General Approach meant that we could secure freedom for Member States to take forward domestic public health policies in certain key areas in the current Council compromise text. As set out in earlier correspondence to the Committee, and as I reiterated during my oral evidence, securing these flexibilities for Member States has been my priority, hence my decision to offer the UK's support. I should be clear that this is not just about retaining flexibility for the current or any future UK Government to go further than the Directive in the area of standardised packaging but also retaining similar flexibilities in some other areas within scope of the Directive, for example on additives.

"I would also wish to emphasise the UK's position of leadership around the world on tobacco control. I felt it very important to be seen to be supporting the progress of the proposed Directive, of which the Government is broadly supportive. The use of tobacco remains one of the biggest public health challenges that we have. Given our reputation for leadership in this area, I was very concerned about what the longer-term consequences for effective tobacco control across Europe in the future would have been, had the UK not taken a supportive approach at EPSCO."

1.10 The second issue concerns the delay in responding to the Committee's first Report of 30 January, for which the Minister offers her apologies and adds:

"The Government agreed its position on almost all of the provisions in the proposal on 23 May 2013. I subsequently wrote to the Committee on 3 June 2013, on all aspects of the proposal other than packaging and nicotine-containing product (NCP) provisions, on 11 June 2013, on NCPs, and on 17 June 2013, requesting a scrutiny waiver. I acknowledge that those letters arrived with the Committee in the days and weeks leading up to the EPSCO meeting, which is regrettable, but without an agreed Government position on the Directive, it was not possible for me to write any earlier with any great clarity.

"I understand that throughout the period from January to June 2013, Department of Health officials were in very regular contact with the Committee clerks, explaining the delay in securing cross-Government clearance, providing updates on progress and discussing handling. The Department's officials agreed with the Committee clerks that, on balance, it may be preferable to await cross-Government clearance before I wrote to you again. At the oral evidence session, the Committee made it clear that it would have preferred me to provide more frequent updates on progress in relation to the Government's position on the Directive. With hindsight, I can see that this may have been preferable, even when there was little progress to report and I am happy to commit to writing earlier in the future."

1.11 The Minister indicates that she wishes to make two corrections to the transcript of the oral evidence session held with the Committee. The first concerns the regulation of non-tobacco nicotine-containing products, such as e-cigarettes, which the Minister suggested had "fallen out" of the draft Directive. She requests the addition of the following footnote to the corrected transcript:

"In fact, Article 18 of the proposal for a revised Tobacco Products Directive which addresses nicotine-containing products remains in the General Approach compromise Council text. The text foresees all but the very lowest dose nicotine-containing products (NCPs) being regulated as medicines and appropriate health warnings for the low dose NCPs under the medicines threshold."

1.12 The second correction concerns the position of the Lithuanian Presidency and its willingness to take forward negotiations on the draft Directive if the Irish Presidency had failed in its attempt to secure a general approach. The Minister explains:

"We can never be absolutely certain of the voting intentions of other Member States and another very possible scenario at EPSCO was that, without the UK's support, a General Approach would not have been reached at all. The Committee asked me what I thought was likely to happen to the Directive had that been the case. While this would not have immediately killed off the Directive, which I believe will bring important public health benefits to the UK, it would almost certainly have represented a serious set-back. It would have re-opened the debate across all aspects of the Directive, possibly bringing back into debate provisions which were not in the interest of the UK. It would also have made it very unlikely that the revised Directive would have been adopted by Council and the European Parliament within the terms of the current European Parliament and the European Commission.

"I am sorry that I did not accurately reflect the position of the Lithuanian Presidency on the Directive in my evidence and I would be grateful if a footnote, using the following wording, could be included in the corrected transcript at an appropriate place:

'During my evidence, I may have given the impression that the Lithuanian Presidency was not planning to prioritise the Directive. I have learned that the Lithuanians are keen to maintain the excellent progress on the Directive in Council made by the Irish. The point I was wanting to make about the importance of agreeing a General Approach was that I considered this to be vital so that the Lithuanians could pick up a version of the Directive in Council that had broad agreement from all Member States rather than one that could be completely re-opened which may have jeopardised the future of the Directive.'"

1.13 The Minister concludes:

"I will ensure that the UK Government will continue to seek to prevent a watering down of the Directive, an important public health measure, in the second half of 2013. I will write again to the Committee later in the summer setting out the Government's views on the recent vote in the European Parliament's ENVI Committee, ahead of the vote in Plenary in the European Parliament and the trilogue process in the autumn."


1.14 We note that the general approach agreed at the EPSCO Council on 21 June was based on an expression of Member States' voting intentions rather than the outcome of a vote. We accept, on that basis, that the Irish Presidency would have been two votes short of the threshold of 255 votes required to secure a qualified majority, had the Government indicated that it intended to abstain, and that UK support was therefore decisive in reaching an agreement on the Presidency compromise text.[2]

1.15 As the Minister herself acknowledges, "we can never be absolutely certain of the voting intentions of other Member States", and it would be fruitless for us to speculate on what might have happened if the UK had abstained. The Minister suggests that re-opening the debate on all elements of the draft Directive would have represented a step backwards, but it is also possible that more prolonged debate and public scrutiny might, for example, have prevented the reduction in the size of health warnings from 75% in the Commission's original proposal to 65% in the Council's general approach. In any case, we consider the Minister's suggestion, in her oral evidence, that the draft Directive would have "fallen" or been "lost for a very long time" to have been somewhat rash. We welcome the correction she has made to reflect the position more accurately. We also note the correction she has made to her oral evidence on the status of non-tobacco nicotine containing products (NCPs) in the draft Directive.

1.16 The Minister alludes in her letter (and in her oral evidence) to the delay in securing cross-Government clearance for the UK's negotiating position on the draft Directive. We are in no doubt that this delay has significantly impeded our ability to scrutinise the Government's approach to the draft Directive and is the reason why we were unwilling to lift our scrutiny reserve. Whilst we accept the Minister's apology for the delay, and her undertaking to write sooner in the future, we also wish to underline the need for Government to engage with the substantive issues at a much earlier stage in the scrutiny process. Sending us a holding response which does not address the concerns we have raised is unlikely to advance our consideration of important legislative proposals.

1.17 In light of the agreement reached by the Council, we are recommending the draft Directive for debate in European Committee C. Before the debate takes place, we ask the Minister to provide a summary of the key changes sought by the European Parliament, and the Government's position on them.[3] We think that the debate should consider how effective the draft Directive is likely to be in discouraging tobacco consumption by young people, tackling illicit trade (through the inclusion of new provisions on the tracking and tracing of tobacco products across the supply chain) and ensuring appropriate regulation of the rapidly expanding e-cigarette market.

1   See Back

2   The qualified majority threshold has been raised to 260 votes following the accession of Croatia to the EU on 1 July 2013. Back

3   We understand that the September plenary session of the European Parliament will vote on the amendments which various Parliamentary Committees have proposed to the draft Directive. Back

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Prepared 23 September 2013