11 Regulation of new psychoactive substances
| (a)
(35324)
13857/13
COM(13) 619
(b)
(35325)
13865/13
+ ADDs 1-2
COM(13) 618
|
Draft Regulation on new psychoactive substances
Draft Directive amending Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking as regards the definition of drug
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| Legal base | (a) Article 114 TFEU; co-decision; QMV
(b) Article 83(1) TFEU; co-decision; QMV
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| Department | Home Office
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| Basis of consideration
| Minister's letter of 11 November 2013
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| Previous Committee Report
| HC 83-xviii (2013-14), chapter 8 (23 October 2013)
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| Discussion in Council
| No date set |
| Committee's assessment
| Legally and politically important
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| Committee's decision
| Not cleared; further information requested
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Background and previous scrutiny
11.1 The purpose of document (a) — the draft
Regulation — is to establish the basis for EU-wide regulation
of new psychoactive substances which present moderate or severe
health, social and safety risks and to provide for the free circulation
of those which present low, or no, risks. It would repeal and
replace a 2005 Decision under which the Council may require Member
States to introduce control measures and criminal penalties for
new psychoactive substances assessed by Europol and the European
Monitoring Centre for Drugs and Drug Addiction as posing unacceptable
health and social risks. Whilst retaining many features of the
regulatory system set up by the 2005 Decision, including mechanisms
for the exchange of information and for common risk assessments,
the draft Regulation would introduce a broader range of options
for mandatory EU-wide marketing restrictions. These seek to distinguish
between low, moderate and high risk substances and to introduce
a more proportionate response, ranging from no market intervention
to restrictions on consumer sales and, in the most severe cases,
an outright ban accompanied by criminal sanctions. The draft
Directive — document (b) — is the instrument through
which Member States would implement criminal sanctions by amending
a 2004 Framework Decision specifying which types of illicit drugs
and drug precursors must be made subject to EU-wide controls and
criminal penalties.
11.2 The 2005 Decision (which the draft Regulation
would replace) and the 2004 Framework Decision (which the draft
Directive would amend) are both subject to the UK's 2014 block
opt-out of pre-Lisbon EU police and criminal justice measures.
The Government notified Parliament, in July 2013,[35]
that it does not propose to rejoin either measure, meaning that
they will cease to apply to the UK from 1 December 2014. Our
Nineteenth Report of 23 October 2013 provides a more detailed
overview of the Commission's proposals and the Government's position.
11.3 In his Explanatory Memoranda on the proposals,
the Minister for Immigration (Mr Mark Harper) raised a number
of significant concerns, particularly with regard to the legal
base for the draft Regulation and the application of the Schengen
Protocol which, if accepted by the Commission and other Member
States, would allow the UK to opt out of both proposals. Regrettably,
the Minister provided no assessment of the compliance of the draft
Regulation and draft Directive with the principle of subsidiarity,
a significant omission given the tight eight-week deadline available
to national Parliaments to produce a Reasoned Opinion. He did
suggest, however, that by limiting the autonomy of the UK to determine
what type of restrictions to apply to new psychoactive substances,
the draft Regulation was in breach of the principle of proportionality.
11.4 We asked the Minister to address a number of
issues which arose from his analysis of the Commission proposals,
notably:
· the appropriate legal
base for the draft Regulation, in light of the Government's view
that it is a justice and home affairs rather than an internal
market measure;
· whether it would be
legally possible for the UK to participate in the draft Directive,
given that its purpose is to amend an existing instrument (the
2004 Framework Decision) that will cease to apply to the UK from
1 December 2014;
· a more detailed justification
of the Government's reasons for considering that both proposals
are Schengen-building measures and subject to the Schengen Protocol,
as well as the views of other affected States (notably Denmark
and non-EU Schengen-associated countries);
· the absence of a Government
impact assessment or consultation with external stakeholders,
given that the Government appears to contest the evidence adduced
by the Commission to demonstrate legitimate commercial or research
uses for around one fifth of new psychoactive substances; and
· the Government's view
on the conferral of significant implementing powers on the Commission.
11.5 Whilst dissatisfied with the information made
available to Parliament in the Minister's Explanatory Memoranda,
and the absence of a subsidiarity assessment, we nevertheless
concluded that market intervention on the scale envisaged in the
draft Regulation, combined with the limitations placed on Member
States' freedom of action, was unwarranted. We were not convinced
that the Commission had produced sufficient evidence to demonstrate
that divergent national regulatory approaches had led to a disruption
of legitimate trade, or a displacement of the harmful effects
of new psychoactive substances from one Member State to another,
and recommended that the House send a Reasoned Opinion to the
Presidents of the EU institutions. Our draft Reasoned Opinion
was debated and agreed to in the House on 11 November 2013.
The Minister's letter of 11 November 2013
11.6 The Minister for Crime Prevention (Norman Baker)
fulfils the commitment he gave in his Explanatory Memorandum to
provide further information on the legal base for the draft Regulation
and the Government's subsidiarity assessment.
11.7 Turning first to subsidiarity, the Minister
describes the legal framework established by the EU Treaties for
assessing compliance with the subsidiarity principle, as set out
in Article 5(3) of the Treaty on European Union and Protocol (No.2)
on the application of the principles of subsidiarity and proportionality.
He observes:
"Whether any proposed
action cannot sufficiently be achieved by Member States and would
be better achieved by action at Union level must be informed,
in part, by an assessment of the merits of the proposed action.
This is particularly relevant where, as with the proposed NPS
[new psychoactive substances] measures, there may be a spectrum
of possible options for EU-level action, but not all EU action
will comply with the principle of subsidiarity. The role of national
parliaments under Protocol (No. 2) to the Treaties would be academic
if they were constrained to assess issues of subsidiarity with
no corresponding assessment of the parameters of the Union's proposed
action in the relevant area."
11.8 The Minister accepts that "some EU action
could be justified", adding:
"The development and
use of NPS is a fast moving area which transcends national borders.
There are clear benefits to sharing knowledge and expertise at
an EU level, providing the systems established to do so are swift
and responsive. To the extent that the proposed Regulation builds
on existing information sharing arrangements, I am satisfied that
it complies with the principle of subsidiarity."
11.9 The Minister considers, however, that the draft
Regulation goes beyond these legitimate areas of activity, noting:
"It mandates common
standards; it is a harmonisation measure. This appears to be
a consequence of the premise that there is a substantial licit
trade in NPS which underpins the draft Regulation. In our experience,
the trade in legitimate NPS is minimal at best. This in turn
has led to the draft Regulation citing a single market legal base
(Article 114 of the Treaty on the Functioning of the European
Union - TFEU), a matter to which I shall return shortly.
"Article 4 of the draft
Regulation provides that, 'insofar as the Union has not adopted
measures to subject a new psychoactive substance to market
restriction under this Regulation, Member States may adopt technical
regulations...' It is quite clear that Member States will no longer
be able to control NPS as a matter of national competence.
"This could have significant
implications for our domestic legal framework for controlling
drugs in at least two ways.
"First, we may be compelled
to declassify or downgrade the classification of existing controlled
drugs if the new EU classification system leads to a lower EU
classification. Because the new Regulation provides for a tiered
scheme of restrictions, it is entirely possible that the EU may
decide that a measure merits a moderate restriction, whereas
our own scientific evidence suggests that it requires a severe
restriction, with the ensuing categorisation under domestic drug
control legislation. In the event of such a conflict, the categorisation
under the Regulation would have to prevail.
"While Article 114 TFEU
contains two potential derogations for Member States, neither
preserves national competence. Article 114(4) provides that Member
States may apply for a derogation from a harmonisation measure
to maintain existing national provisions on the grounds of major
needs referred to in Article 36 TFEU.[36]
Article 114(5) provides that after the adoption of a harmonisation
measure, a Member State may apply to introduce national provisions
on certain narrow criteria relating to the protection of the environment
or the working environment, on the grounds of a problem specific
to that Member State. In either case, it is the Commission which
is to decide whether to permit the Member State so to derogate
from the measure.
"Secondly, we will be
compelled to comply with the requirements of Directive 98/34/EC
if we want to classify NPS outside the proposed EU system, which
would be a lengthy process. This is in contrast to the responsive
system we have under the Misuse of Drugs Act 1971, which allows
temporary bans to be imposed on emerging NPS pending a full assessment
by the Advisory Council on the Misuse of Drugs and a classification
decision by the Secretary of State.
"The net effect of the
proposed Regulation would be significantly to undermine the competence
of Member States to introduce domestic drug controls. Put simply,
we do not consider that such extensive Union action in this area
is appropriate. Member States should not be prohibited from unilaterally
introducing more stringent controls for NPS. It is not necessary
to remove that decision-making power from Member States and place
it at EU level. To adopt the language of the Treaty, such an
objective cannot 'be better achieved at Union level' when there
is no justification for that objective in the first place (Article
5(3), Treaty on European Union).
"Also, to the extent
that Member States are permitted to introduce national measures,
either through the Article 114 TFEU derogations or the process
contained in Article 4 of the draft Regulation, the mechanisms
for doing so are cumbersome and ill-suited to the speed required
to deal with NPS. Given the manufacture of NPS for illicit use
seeks to exploit the chemical differences in different psychoactive
substances with the aim of evading the controls on existing substances,
it is necessary for Member States to have the ability to respond
to this emerging threat at pace. We cannot see how this aspect
of the proposed system satisfies the requirement that action 'be
better achieved at Union level.'
"Finally, the draft
Regulation assumes that Member States will, and indeed, should,
have a reactive classification system, whereby particular substances
are classified after they have been released to the illicit market.
It should be open to Member States to introduce other control
systems, such as proactive classification systems, which
impose prohibitions based on the psychoactive effect of any substance,
rather than by reference to their precise chemical composition.
I am aware that the Republic of Ireland deploys such an approach:
see the Criminal Justice (Psychoactive Substances) Act 2010.
"We are not satisfied,
therefore, that the draft Regulation in its current form complies
with the principle of subsidiarity."
11.10 On the question of the legal base for the draft
Regulation, the Minister observes that:
"Assessment of the legal
base for an EU measure must rest on objective factors that are
amenable to judicial review, including the aim and content of
the measure.
"Our concerns in relation
to the citation of an Article 114 TFEU legal base for the measure
have their foundation in the overwhelmingly illicit nature
of the trade in NPS. Many of the features of the NPS Regulation
which do not comply with the principle of subsidiarity may be
traced back to the unnecessary citation of an Article 114 legal
base.
"The Commission relies
heavily on the underlying assumption that there is a significant
market for NPS in commercial and industrial use, and for scientific
research and development. By contrast, the UK's experience suggests
the NPS trade is not 'legitimate', with very few exceptions for
commercial and industrial purposes.
"Our view, therefore,
is that the aim and content of this measure relate to matters
which fall within Title V TFEU, in particular Article 83(1): offences
relating to NPS are 'particularly serious crime with a cross-border
dimension resulting from the nature or impact of such offences'.
In addition, it is accepted that there may be a 'special need
to combat them on a common basis'. The second paragraph of Article
83(1) states that the areas of crime to which Article 83(1) applies
may apply include 'illicit drug trafficking'. Indeed, the draft
Regulation recognises the proximity of the 'trade' in NPS to organised
crime, the illicit drugs market and the need to draw on the experience
of Europol: see Articles 6(2)(e), 6(3), 10(2)(b), 11(b), 12(1)(b),
and 13(1)(c).[37]
"The draft Directive
(which properly cites a Title V legal base) requires Member States
to adopt criminal penalties for NPS which have been found to present
severe risks and have been subjected to a permanent market restriction.
In the experience of the UK, most if not all NPS will have to
be so classified. Taken with the Directive, the primary effect
of the Regulation, therefore, will be to subject new NPS to mandatory
criminal classification. In our view, this reveals that the true
aim and content of the draft Regulation relate to Title V matters.
"We also consider this
to be a Schengen-building measure, as drafted. Article 76 of
the Schengen Convention (in which the UK participates: see Council
Decision 2000/365/EC, Article 1(a)(i)), provides that the Contracting
Parties shall:
'where necessary, and in
accordance with their medical, ethical and practical usage, adopt
appropriate measures for the control of narcotic drugs and psychotropic
substances which in the territory of one or more Contracting Parties
are subject to more rigorous controls than in their own territory,
so as not to jeopardise the effectiveness of such controls.'
"The legal base for
Article 76 was Article 95 EC, which is now Article 114 TFEU.
It was clearly aimed at single market measures regulating the
licit trade of certain substances where there is potential for
illicit use. While we do not accept that there is a substantial
licit trade in NPS, if there was such a trade, it would clearly
fall within Article 76 of the Schengen Agreement.
"Should the Commission
revise its view that there is a substantial licit trade in NPS,
it is our view that any revisions to the draft Regulation would
be likely to take it within the terms of Article 71 of the Schengen
Agreement in any event. Article 71 contains equivalent provision
governing measures relating to the illicit trade in narcotics
and psychotropic substances.
"It is also important
for the draft Regulation to be categorised as a Schengen-building
and Title V measure because doing so recognises the delineation
of competences between the United Kingdom and the EU under Protocols
19 and 21 to the Treaties. The UK has conferred competence on
the EU in these areas in accordance with the framework contained
in those Protocols."
11.11 The Minister concludes by summing up the Government's
position in the following terms:
"My concerns relating
to subsidiarity and legal base are therefore linked to the incorrect
premise on which the draft Regulation is based. I firmly believe
that EU-level action is not required to harmonise EU-wide controls
for NPS, and that any attempt to introduce controls at an EU level
should be based on an accurate evidence-base and realistic assumptions."
Conclusion
11.12 We thank the Minister for the thoughtful
and compelling case he advances to demonstrate that the draft
Regulation does not comply with the principle of subsidiarity.
Whilst we endorse his analysis, we very much regret that it was
not made available to Parliament in advance of the Reasoned Opinion
debate on 11 November. As we stated in our Nineteenth Report,
it is unacceptable to expect Parliament to come to an informed
view on compliance with the subsidiarity principle within the
tight timeframe required for a Reasoned Opinion under Protocol
No. 2 to the EU Treaties without the benefit of a preliminary
assessment by the Government.
11.13 We note the Minister's view that Article
83(1) TFEU should replace Article 114 TFEU as the legal base for
the draft Regulation. We note also that the differing views of
the Commission and the Government on the correct legal base stem
largely from differing perceptions of the existence and scale
of the legitimate trade in new psychoactive substances. An accurate
assessment of the licit market for new psychoactive substances,
as well as the extent of cross-border trade in these substances
and any displacement effect resulting from different national
regulatory approaches will, in our view, be crucial in determining
the "centre of gravity" of the draft Regulation and
its classification as either an internal market or criminal law
measure. As our earlier Report indicated, we think that there
would be some value in undertaking a stakeholder consultation
and producing an impact assessment to provide a clearer evidence
base for the Government's assertion that trade in new psychoactive
substances is "overwhelmingly illicit." We would also
welcome some indication of the views of other Member States on
the strength of the Commission's Impact Assessment and its analysis
of the legitimate uses of new psychoactive substances.
11.14 The Minister helpfully explains why he considers
that the draft Regulation and draft Directive are Schengen-building
measures subject to the provisions of the Schengen Protocol.
However, our earlier Report noted that the provisions of the 1990
Schengen Convention to which he refers appear to be limited in
scope to narcotic drugs and psychotropic substances covered by
three United Nations Conventions.[38]
By contrast, the Commission proposals are intended to regulate
new psychoactive substances that are not subject to international
control measures under these Conventions. We ask him whether
this difference in scope takes the draft Regulation and draft
Directive outside the framework established by the 1990 Schengen
Convention. We also ask him whether it would be possible, by
means of an amending draft Directive, to re-categorise the 2004
Framework Decision as a Schengen-building measure, given that
the recitals to the Framework Decision give no indication of its
Schengen origins.
11.15 We note the importance the Minister attaches
to the categorisation of the draft Regulation as both a Schengen-building
and Title V (justice and home affairs) measure "because doing
so recognises the delineation of competences between the United
Kingdom and the EU under Protocols 19 and 21 to the Treaties."
We would add, however, that these Protocols were agreed by all
Member States and that their scope cannot be unilaterally determined
by the UK. We are particularly interested to hear whether other
Member States, as well as non-EU States (Iceland, Norway, Switzerland
and Liechtenstein) associated with the application and development
of the Schengen acquis, share the Government's position
on the Schengen origins of the draft Regulation and draft Directive.
11.16 We look forward to receiving the Minister's
response to the questions we have raised in this Report and our
Nineteenth Report. Meanwhile, the proposals remain under scrutiny.
35 See Command Paper 8671 published in July 2013. Back
36
These are: public morality, public policy or public security;
the protection of human, animal or plant health and life; the
protection of national treasures; and the protection of industrial
and commercial property. Back
37
The correct reference is to Article 13(1)(b) of the draft Regulation. Back
38
These are the Single Convention on Narcotic Drugs 1961 (as amended
by the 1972 Protocol); the Convention on Psychotropic Substances
1971; and the United Nations Convention against Illicit Traffic
in Narcotic Drugs and Psychotropic Substances 1988. Back
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