Twenty-seventh Report of Session 2013-14 - European Scrutiny Committee Contents


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

(34587)

18068/12

+ ADDs 1-7

COM(12) 788

Draft Directive 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
DepartmentHealth
Basis of considerationMinister's letter of 9 December 2013
Previous Committee ReportsHC 83-xxxiii (2013-14), chapter 1 (4 December 2013);

HC 83-xx (2013-14), chapter 1 (6 November 2013);

HC 83-xiii (2013-14), chapter 1 (4 September 2013);

HC 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 decisionRecommended for debate in European Committee C (decision reported on 4 September 2013)

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. Our earlier Reports provide a detailed overview of the draft Directive and its scrutiny history.[1]

1.2  At our meeting on 4 September 2013, we recommended the draft Directive for debate in European Committee C. At the time, the European Parliament was expected to approve a negotiating mandate for trilogue discussions at its plenary session in September. In the event, the plenary vote was postponed until October. The Parliamentary Under-Secretary for Public Health (Jane Ellison) wrote to us shortly afterwards setting out the European Parliament's position on key aspects of the draft Directive. Our Twenty-second Report, agreed on 6 November, provides further details. The Minister subsequently confirmed that the debate would take place on 16 December and briefly described the main issues being discussed in trilogue negotiations. She alluded to the efforts being made to reach an acceptable compromise on non-tobacco nicotine-containing products (such as e-cigarettes) on which the Council and European Parliament have staked out different positions, but added that she was unable to provide any detail on possible compromises at this stage "due to the sensitive nature of the negotiations". She promised to write again after trilogue discussions on 3 December to inform us of any further provisional compromises reached by the parties and indicated that negotiations were expected to conclude by the end of the year, with formal approval of the outcome anticipated in the new year.

1.3  Whilst recognising the sensitivity of the negotiating process, we considered it imperative that Parliament should have further information on the scope of the compromises being considered and some indication of how the continuing and significant differences in approach towards the regulation of e-cigarettes would be bridged in advance of the debate on 16 December.

The Minister's letter of 9 December 2013

1.4  The Minister (Jane Ellison) tells us that trilogue negotiations are progressing "in a positive direction" and that the Government is making headway towards securing its goal of a proportionate outcome that meets the UK's public health objectives. She indicates that a provisional agreement has been reached on the removal of misleading tar, nicotine and carbon monoxide yields on cigarette packets and on more stringent reporting requirements for characterising flavours (such as menthol). On the latter, she adds:

"While both the Council and EP agree that characterising flavours should be banned, the two texts take different approaches to achieve this objective, including the EP wanting a five-year transition for menthol flavour while the General Approach text envisages a 3 year transition for all flavours which have a certain market share. The UK supports the General Approach text but a compromise will have to be reached and discussions about the length and application of the transition periods are continuing in Trilogue. The most important thing is that characterising flavours will be prohibited."

1.5  The Minister reiterates the Government's position that non-tobacco Nicotine-Containing Products (NCPs) should be regulated as medicines and expresses disappointment that the European Parliament (EP) has advocated a different regulatory approach. She continues:

"We have continued to push for the regulation of NCPs as medicines during the Trilogue negotiations. However, it is very important to the EP that NCPs that do not make a medicinal claim should not be regulated as medicines and the EP has reaffirmed this position in recent Trilogue negotiations. We are working with other Member States to establish whether Council is ready to move away from the General Approach text to achieve a compromise.

"Specifically, we are carefully considering if it would be possible to secure a proportionate compromise with the European Parliament whereby e-cigarettes are regulated so that they are not appealing to children and this emerging market is monitored and we are also seeking a final text whereby Member States will be able to set an age of sale for e-cigarettes. This possible compromise is still being discussed in Trilogue.

"At this time, it is too early to speculate on the outcome of negotiations but it is possible that an alternative to medicines regulation for those NCPs that do not make a medicinal claim with a number of safeguards built in may result."

1.6  The Minister refers to earlier correspondence concerning Article 24, which determines the amount of flexibility Member States will have to maintain or introduce more stringent national tobacco control measures, and notes:

"Both the [Council] General Approach and the EP texts move in the right direction in this regard, as compared to the Commission's starting proposal. Both texts introduce some flexibility but in different ways. The General Approach text envisages Member State flexibility with regard to introducing more stringent rules in relation to additives and standardisation of packaging, where it is justified and proportionate in line with the Treaty. By contrast, the domestic flexibility envisaged in the EP text in relation to areas covered by the Directive is broader in scope. However, the EP text retains the power for the Commission to approve or reject such domestic measures, which was removed in the General Approach text.

"The final text of Article 24 is now even more relevant given the Government's announcement in November to take regulation-making powers to introduce standardised packaging. An independent review of the evidence for the public health benefits of standardised packaging is also underway. The Government will make a final decision on this policy once it has received the report of the review."

1.7  The Minister indicates that the Government continues to support the version of Article 24 contained in the Council's General Approach. She undertakes to write again when she has further information on compromises provisionally agreed with the European Parliament, including on Article 18 on non-tobacco Nicotine-Containing Products.

Conclusion

1.8  We thank the Minister for writing to us in advance of the debate in European Committee C with further information on the progress of trilogue negotiations. We note that negotiations are only likely to be concluded if the Council and European Parliament are able to reach a compromise on Article 18, on the regulation of non-tobacco Nicotine-Containing Products (NCPs), and on the scope for more stringent domestic tobacco control measures under Article 24. The Minister does not state in terms whether the UK would be willing to abandon the recommendation made by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to regulate non-tobacco Nicotine-Containing Products as medicines; nor does she set out the minimum safeguards the Government would seek to ensure appropriate and proportionate regulation of these products. We trust that she will be in a position to do so in the forthcoming debate.

1.9  We wish to make clear that we expect Parliament to be informed of any substantial amendments to the Commission's original proposal which emerge from the trilogue negotiations by means of a Supplementary Explanatory Memorandum accompanied by a new depositable text. This text will be subject to the usual scrutiny procedures, including our scrutiny reserve, and we expect Parliament to have sufficient time to consider and if necessary, debate it before it is formally agreed by the Council.



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Prepared 23 December 2013