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 base | Article 114 TFEU; co-decision; QMV
|
| Department | Health |
| Basis of consideration | Minister's letter of 9 December 2013
|
| Previous Committee Reports | HC 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 Council | No date set
|
| Committee's assessment | Legally and politically important
|
| Committee's decision | Recommended 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.
1 See headnote. Back
| 
