7 Regulation of new psychoactive substances
(a)
(35324)
13857/13
+ ADDs 1-2
COM(13) 619
(b)
(35325)
13865/13
+ ADDs 1-2
COM(13) 618
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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 13 January 2014
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Previous Committee Reports
| HC 83-xxiii (2013-14), chapter 11 (4 December 2013); HC 83-xviii (2013-14), chapter 8 (23 October 2013)
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Discussion in Council
| No date set
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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
7.1 Document (a) the draft Regulation
would establish a new framework for EU-wide regulation
of new psychoactive substances which present moderate or severe
health, social and safety risks and provide for the free circulation
of those which present low, or no, risks. Document (b)
the draft Directive is the instrument through which Member
States would implement criminal sanctions for the highest risk
substances. Our earlier Reports provide a detailed overview of
the Commission's proposals and the Government's position.[32]
7.2 We sought further information from
the Government on a number of issues, 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 (a 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.
7.3 We also considered that the Commission
had produced insufficient information to demonstrate that market
intervention on the scale envisaged in the draft Regulation, as
well as the limitations placed on Member States' freedom of action,
were justified. Our recommendation to send a Reasoned Opinion
to the Presidents of the EU institutions was debated and agreed
to in the House on 11 November 2013. It was one of only two Reasoned
Opinions issued by national Parliaments (the other by the House
of Lords), insufficient to meet the threshold required to trigger
a formal review of the proposal by the Commission.
7.4 The Minister for Crime Prevention
(Norman Baker) told us that the Government shared our subsidiarity
concerns, adding that "the net effect of the proposed Regulation
would be significantly to undermine the competence of Member States
to introduce domestic drug controls".[33]
He rejected the internal market legal base proposed by the Commission
for the draft Regulation, on the grounds that trade in new psychoactive
substances is "overwhelmingly illicit" and should therefore
be regulated as a criminal matter, with the EU's competence to
act based on the criminal law provisions contained in Title V
of Part Three of the Treaty on the Functioning of the European
Union (TFEU). He reiterated the Government's view that the draft
Regulation should be categorised both as a Title V measure and
as a Schengen-building measure, bringing the UK's Title V opt-in
and Schengen opt-out Protocols into play.
7.5 Given that the differing views of
the Commission and the Government on the correct legal base appeared
to stem largely from differing perceptions of the existence and
scale of the legitimate trade in new psychoactive substances,
we asked the Government to provide 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.
7.6 Whilst noting the Government's view
that the draft Regulation and draft Directive should both be considered
Schengen-building measures, we asked the Minister to address
the point we made in our earlier Report which noted that the provisions
of the 1990 Schengen Convention relied on by the Government
appear to be limited in scope to narcotic drugs and psychotropic
substances covered by three United Nations Conventions.[34]
By contrast, the Commission proposals are intended to regulate
new psychoactive substances that are not subject to international
control measures under these Conventions. In particular, we asked
the Minister whether this difference in scope took the draft Regulation
and draft Directive outside the framework established by the 1990
Schengen Convention, and 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.
The Minister's letter of 13 January 2014
7.7 The Minister (Norman Baker) provides
an update on recent discussions attended by officials which have
focused on the evidence base to justify EU action, the internal
market legal base proposed for the draft Regulation, and subsidiarity
concerns (including the impact on Member States' competence to
adopt domestic measures). He continues:
"My officials continued to
contest all three areas strongly and I am pleased to note that
the UK arguments on legal base and subsidiarity appear to be chiming
with a number of other countries."
7.8 The Minister reiterates the Government's
view that trade in new psychoactive substances is "overwhelmingly
illicit", adding that this view is informed by experts from
the Centre for Applied Science and Technology and the Advisory
Council on the Misuse of Drugs. He notes that the Home Office
also consults:
· other Government departments
and industry on new psychoactive substances that are being recommended
for temporary or permanent control measures, in addition to statutory
consultation of the Government's independent expert advisers on
drugs;
· the Department for Business,
Innovation and Skills in relation to legitimate industrial uses
of substances;
· the Medicines and Healthcare
Products Regulatory Agency in relation to legitimate medicinal
uses and/or use in production of medicines; and
· the PISTOIA Alliance, encompassing
life science companies, academic groups, informatics vendors,
and publishers, whose aims are to lower barriers to innovation
by improving the interoperability of research and development
business processes through pre-competitive collaboration.
7.9 Given this extensive consultation,
the Minister suggests that a formal public consultation at this
stage would be unlikely to add value to existing information sources
and expertise.
7.10 Turning to the evidence base for
the legitimate use of new psychoactive substances set out in the
Commission's Impact Assessment, the Minister explains:
"What has become clearer over
time is that the European Commission has used a broad definition
of 'legitimate use' to include new psychoactive substances with
medicinal use, plants and herbs and scientific research. We,
and others, strongly contest this. Medicines, whether or not
they have a psychoactive effect, are dealt with in a separate
EU regime and [the] draft Regulation expressly excludes medicinal
new psychoactive substances from the scope of the proposed internal
market control mechanisms. The Commission's justification for
taking invasive single market measures is essentially made by
reference to the trade in medicinal use of new psychoactive substances
which is a separate market expressly excluded from the scope of
the control mechanism which lies at the heart of the draft Regulation.
We are also not convinced of the need to include plants and
herbs, nor scientific research, in the theoretical market the
Regulation purports to protect."
7.11 The Minister indicates that there
is "growing doubt from a sizeable number of Member States
about the estimated legitimate market" and that five or six
Member States also have concerns about the internal market legal
base for the draft Regulation. He says that the Government is
"actively building alliances with these countries" and
continues:
"Some Member States have suggested
that a public health legal base under Article 168 of the Treaties
of the European Union (TFEU) would be appropriate, while others
agree with us that the measure should cite Article 83(1) TFEU.
Others are content with Article 114. We, with others, are pushing
for a written opinion from the Council Legal Service. We will
be encouraging the Greek Presidency to resolve these issues in
the forthcoming meetings."
7.12 The Minister amplifies the Government's
reasons for considering that the draft Regulation and draft Directive
are Schengen-building measures. He contends that Article 71 of
the 1990 Schengen Implementing Convention is the source of the
underlying Schengen obligation for the draft Directive, as is
Article 76 of the Convention for the draft Regulation, and adds:
"It is our view that Article
71 of the Convention Implementing the Schengen Agreement incorporates
the procedures and law enforcement standards of the UN Conventions,
while not limiting the scope of measures building on Article 71
to the substances listed in those Conventions.
"Article 76 of the Schengen
Convention is not anchored to the UN Conventions. Within its
scope is the licit trade in psychoactive substances. To the extent
that there is a licit trade in new psychoactive substances, we
consider the proposed measures to build on this aspect of the
acquis."
7.13 The Minister concedes that the
UK is so far alone in considering the draft Regulation and draft
Directive to be Schengen-building measures, but suggests:
"That is hardly surprising
given the present lack of certainty on the legal base and uncertainty
surrounding the scope and evidence base for the Regulation. We
will of course continue to focus on the Title V nature of the
measure on which we share common ground with a number of Member
States."
7.14 He notes that the issue is "academic"
as far as the draft Directive is concerned, since it cites a Title
V legal base and is subject to the UK's Title V opt-in Protocol.
He refutes the suggestion, made in our earlier Report[35]
that, the Government has sought unilaterally to determine the
scope of the Title V opt-in and Schengen opt-out Protocols, but
adds:
"It must be true that those
Protocols reflect the particular conferral of competence in Schengen
and Title V matters by the United Kingdom on the Union. Therefore,
Union measures which involve the exercise of competence in areas
covered by those Protocols engage those Protocols, regardless
of whether the Union measure in question expressly recognises
that engagement."
7.15 The Minister agrees with us that
the conferral of significant implementing powers on the Commission
represents an important shift in decision making powers from the
Council (under the current regulatory framework) to the Commission
and says that the Government has voiced its concern at the reduction
in the influence of Member States. He continues:
"In practice what it means
is that it would be the Commission, rather than the Council, which
would decide when to request a joint report and risk assessment
to be produced on a new psychoactive substance. At that point
Member States would have influence through qualified majority
voting on agreeing whether a substance should be the subject of
a joint report, but this is only after a Commission proposal.
Member States could not make a proposal themselves and this process
will also impact on the decisions around adoption of control measures."
7.16 Finally, the Minister explains
that the Government has decided to "opt out" of the
draft Regulation and the draft Directive, basing its opt-out on
the Schengen Protocol, adding:
"This is largely based on the
arguments set out in the House's Subsidiarity Reasoned Opinions.
We do not think the proposals comply with the principle of subsidiarity
and we want the UK to retain competence on regulating new psychoactive
substances."
7.17 The UK will nonetheless continue
to play an active part in negotiations, and seek to:
"shape the current proposals
in such a way as to achieve the most favourable outcome for the
UK, particularly in our ability to respond quickly to public health
risks posed by new psychoactive substances as they emerge on the
market."
7.18 The Minister underlines the global
challenge presented by the emergence of new psychoactive substances
and says that the Government's opt-out decision will not in any
way lessen its commitment to addressing the issue.
Conclusion
7.19 As we have stated previously,
we consider 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, to be crucial in
determining the "centre of gravity" of the draft Regulation
and its classification as either an internal market or criminal
law measure. We thank the Minister for clarifying the various
sources of information and expertise utilised by the Home Office
to estimate the extent of legitimate trade, and note that some
other Member States share the Government's concerns regarding
the strength of the Commission's Impact Assessment. We look forward
to hearing how this matter is resolved during the Greek Presidency.
7.20 The Minister tells us that the
Government has decided to opt out of the draft Regulation and
draft Directive in reliance on the opt-out rights conferred on
the UK under the Schengen Protocol.[36]
This decision is difficult to reconcile with the Minister's statement
that:
"at present we are the
only Member State to consider the measures to be Schengen building"
and:
"we will of course continue
to focus on the Title V nature of the measure [the draft Regulation]
on which we share common ground with a number of other Member
States."
7.21 As the Minister indicates, consideration
of the Schengen origins of the draft Directive is "academic"
as the Government's decision not to opt in (however described)
means that the UK will not participate in its adoption or be bound
by it. The same cannot be said for the draft Regulation. We
have consistently held that the UK cannot rely on its Title V
opt-in Protocol in relation to a measure which does not cite a
Title V legal base. It must also follow that the UK cannot rely
on its Schengen opt-out Protocol in relation to a proposal which
does not state that it is a Schengen-building measure or which
is not accepted as such by other Member States.
7.22 We note that, under the terms
of the Schengen Protocol, once the Government has formally notified
the Council of its decision to opt out, the usual decision making
procedures must be suspended until the Council has decided whether,
and to what extent, the UK should remain bound by the existing
regulatory framework for new psychoactive substances (set out
in a 2005 Council Decision). We ask the Minister to report back
to us on whether and how these provisions of the Schengen Protocol
are being applied, given that no other Member State so far accepts
that the Schengen Protocol is in play. We also ask him whether
the Government considers it to be desirable and/or feasible for
the UK to remain bound by the 2005 Decision without also participating
in the draft Regulation.
7.23 We welcome the Government's
intention to continue to play an active role in negotiations on
the draft Regulation, not least because the UK will be legally
bound by the outcome of negotiations unless doubts as to the application
of the Title V opt-in or Schengen opt-out Protocols are resolved.
We therefore ask the Minister to continue to provide progress
reports on the negotiations, as well as the additional information
we have requested in this chapter. Meanwhile, the proposals remain
under scrutiny.
32 See headnote. Back
33
Reported in HC 83-xxiii (2013-14), chapter 11 (4 December 2013). Back
34
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
35
See HC 83-xxiii (2013-14), chapter 11 (4 December 2013). Back
36
See also the Minister's Written Ministerial Statement, HC Deb,
13 January 2014, col.22WS. Back
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