8 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
|
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
|
Document originated | (Both) 17 September 2013
|
Deposited in Parliament | (Both) 25 September 2013
|
Department | Home Office
|
Basis of consideration | EMs of 8 October 2013
|
Previous Committee Report | None
|
Discussion in Council | No date set
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Committee's assessment | Legally and politically important
|
Committee's decision | Not cleared; further information requested; recommended for a Floor of the House debate on the Reasoned Opinion before 13 November 2013
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Background
Existing control measures for new psychoactive
substances
8.1 Psychoactive substances affect the central nervous
system and functioning of the brain, inducing changes in mood,
perception and behaviour similar to those associated with the
consumption of illicit drugs. They are often referred to as "legal
highs" because they are marketed as licit alternatives to
controlled drugs. The market in these substances is highly adaptable,
responding rapidly to the imposition of new drug controls. Legal
highs are usually sold through specialised shops or over the internet.
Although their composition and effects are often unclear, they
can be toxic, addictive, damaging to health and carry longer-term
social risks (for example, because of the involvement of organised
crime groups).
8.2 In 1997, the Council established a mechanism
for Member States to exchange information, request a risk assessment
and introduce EU-wide control measures and criminal penalties
which Member States would implement through their domestic drugs
legislation.[19] The
mechanism was strengthened by a Council Decision adopted in 2005
("the 2005 Decision")[20]
and its scope extended to all new psychoactive substances not
already subject to international controls under United Nations
Conventions on narcotic drugs and psychotropic substances.[21]
8.3 The 2005 Decision provides for Europol and the
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
to produce a Joint Report on new psychoactive substances reported
by Member States via an Early Warning System. The Council (acting
by a simple majority of its members) may request a further assessment
which would focus, amongst other things, on the health and social
risks associated with the use of a new psychoactive substance,
as well as the degree of involvement of organised crime networks.
Following the risk assessment, the Commission or (if it chooses
not to act) one or more Member States, may propose the introduction
of EU-wide control measures. If endorsed by the Council (acting
by a qualified majority), a Council Decision would require Member
States to introduce control measures and criminal penalties, in
accordance with their national law, within 12 months. The 2005
Decision makes clear, however, that:
"Nothing in this Decision shall prevent a Member
State from maintaining or introducing on its territory any national
control measure it deems appropriate once a new psychoactive substance
has been identified by a Member State."[22]
8.4 The Commission published an assessment of the
2005 Decision in 2011[23]
which concluded that changes were needed for three reasons:
· the procedure for introducing control
measures only tackles one psychoactive substance at a time, making
it difficult to take action on drugs composed of several substances,
in a variety of combinations, and lengthening the time needed
to decide whether EU-wide control measures/criminal sanctions
are justified;
· the procedure is too reactive, lagging
behind developments in the market, as substances submitted to
control measures are rapidly replaced by new ones which have similar
effects as a result of small changes to their chemical composition;
and
· where EU control measures are justified,
the Decision only provides for criminal sanctions but, in those
cases where the public health implications are less clear-cut,
lighter risk management options might be beneficial.
8.5 The Commission set out a number of options for
revising the 2005 Decision which the Government described as "entirely
sensible" and in line with measures being taken domestically
to improve the UK's response to new psychoactive substances, such
as enhanced forensic monitoring of new substances, and the introduction
of temporary class drug orders and generic drugs legislation for
groups of chemically related substances.
8.6 Council Conclusions on new psychoactive substances
agreed in December 2011 invited the Commission to propose changes
to the 2005 Decision which should:
· seek to close gaps in the different types
of laws used by Member States (drug control, medicines, and consumer
protection legislation) to address new psychoactive substances;
· strengthen practical cooperation, the
exchange of information, research and risk assessment, and improve
monitoring of new psychoactive substances, with the EMCDDA as
the leading body;
· address groups of hazardous substances;
· encourage Member States to develop fast-track
procedures and impose temporary marketing restrictions for substances
raising immediate concerns, pending completion of a risk assessment;
and
· further streamline EU procedures and enhance
cooperation between forensic and toxicological institutes.
8.7 The Council Conclusions also underlined the need
for new legislation to "respect the division of competences
between the EU and the Member States."[24]
CRIMINAL PENALTIES
8.8 A Framework Decision adopted by the Council in
2004 ("the 2004 Framework Decision") establishes minimum
rules on the definition of offences linked to trafficking in illicit
drugs and drug precursors and requires Member States to introduce
criminal penalties. It only applies to drugs covered by United
Nations Conventions on narcotic drugs and psychotropic substances,
not to new psychoactive substances.
THE UK'S 2014 BLOCK OPT-OUT DECISION
8.9 The 2005 Decision and 2004 Framework Decision
are "Third Pillar" measures, adopted by unanimity under
the procedures applicable to EU police and criminal justice measures
before the Lisbon Treaty entered into force in December 2009.
From 1 December 2014, all such measures will be subject to the
full jurisdiction of the Court of Justice unless the UK exercises
the right, conferred by the Lisbon Treaty, to opt out of them.
The Government has notified its intention to opt out, and to
rejoin a smaller number of measures which it considers are helpful
in combating serious and organised crime. The 2005 Council Decision
and 2004 Framework Decision are not included in the list of measures
which the Government proposes to rejoin. They will therefore
cease to apply to the UK from 1 December 2014, but the UK retains
the right to participate in any replacement measures.
EU COMPETENCE IN THE FIELD OF DRUGS POLICY
8.10 There is no specific EU competence for drugs
policy, but there are a number of provisions in the Treaty on
the Functioning of the European Union (TFEU) that provide a basis
for regulatory action. For example, harmonised rules to monitor
and control trade in drug precursors within the EU (chemical substances
with legitimate commercial uses that may be diverted into illicit
drug production) are based on Article 114 TFEU, an internal market
legal base, because their purpose is to prevent Member States
adopting divergent national measures that would disrupt the licit
trade in precursors and fragment the internal market.[25]
Article 114(3) TFEU includes a requirement that measure affecting
health, safety or consumer protection should "take as a base
a high level of protection, taking account in particular of any
new development based on scientific facts."
8.11 Whereas Article 114 TFEU provides for the approximation
of Member States' laws, Article 168 TFEU on public health precludes
harmonisation and envisages, instead, the adoption of incentive
measures to protect and improve human health, which may include
monitoring and early warning mechanisms to combat serious cross-border
threats to health.
8.12 Illicit drug trafficking is one of the areas
of crime listed in Article 83(1) TFEU on the grounds that it has
a cross-border dimension and may need to be tackled on a common
basis. Article 83(1) provides for the adoption of minimum rules
on the constituent elements of drug trafficking offences and on
criminal sanctions. Measures based on this Article are subject
to the UK's Title V (justice and home affairs) opt-in or, if they
build on elements of the Schengen acquis, the Schengen
opt-out. The net effect is the same in both cases, enabling the
UK to determine whether or not it wishes to participate in the
measure.
Document (a) the draft Regulation
8.13 The draft Regulation would repeal and replace
the 2005 Decision. Unlike the 2005 Decision, it cites an internal
market (Article 114 TFEU) legal base because, according to the
Commission, its objective is to ensure that "trade in new
psychoactive substances having industrial and commercial uses
is not hindered and that the functioning of this market is improved,
while the health and safety of individuals are protected from
harmful substances, which cause concern at the EU level."[26]
THE MAIN ELEMENTS OF THE DRAFT REGULATION
8.14 There are a number of similarities between the
draft Regulation and the 2005 Decision. It maintains the existing
mechanism for exchanging information on new psychoactive substances,
as well as the possibility to request a Joint Report (produced
by the European Monitoring Centre for Drugs and Drug Addiction
and Europol) on substances giving rise to concerns and to draw
up a risk assessment as the basis for EU-wide control measures.
There are, however, important differences:
· a new psychoactive substance must be notified
by several Member States before any action is taken at
EU level (Article 6);
· the Commission, rather than the Council,
determines whether to commission a Joint Report (Article 6) and
request a risk assessment (Article 7);
· the risk assessment report is submitted
to the Commission, not the Council, and it is for the Commission
to determine the level of health, social and safety risks that
a new psychoactive substance presents (Article 7); and
· more rigorous deadlines are included to
reduce delays in producing a Joint Report and risk assessment,
and a broader range of stakeholders (including the European Chemicals
Agency and European Food Safety Authority) are to be consulted
(Articles 6 and 7).
8.15 Perhaps the most significant difference is
that the principle of free movement is placed at the core of the
draft Regulation. Article 3 provides that:
"New psychoactive substances and mixtures shall
move freely in the Union for commercial and industrial use, as
well as for scientific research and development purposes."
8.16 The principle of free movement may be displaced,
and market restrictions imposed, in the following circumstances:
· if a new psychoactive substance poses
"immediate risks to public health" as a result of reported
fatalities and severe health consequences "in several Member
States" related to the toxicity of the substance, an immediate,
temporary ban (valid for up to 12 months) must be imposed on the
marketing of the substance to consumers. The ban would be introduced
before the risk assessment has been completed (Article
9);
· in all other cases, market restrictions
would be based on the outcome of the risk assessment, with the
Commission determining the extent of health, social and safety
risks associated with a new psychoactive substance and the type
of restrictions that should apply (Article 10);
· if a new psychoactive substance presents
low health, social and safety risks, no market restrictions may
be introduced (Article 11);
· if a new psychoactive substance presents
moderate health, social and safety risks, a permanent ban on marketing
it to consumers must be imposed (Article 12); and
· if a new psychoactive substance presents
severe health, social and safety risks, a ban on its production,
manufacture and marketing (including importation to, or exportation
from, the EU) must be imposed without undue delay (Article 13).
8.17 The introduction of market restrictions would
be overseen by a Committee of Member State representatives under
the so-called "examination procedure".[27]
This procedure is intended to ensure that a draft implementing
act cannot be adopted by the Commission if it is not supported
by a qualified majority of Member State representatives.
8.18 Where Decisions introducing market restrictions
have been adopted by the Commission, the draft Regulation includes
safeguards to ensure that new psychoactive substances may still
be used for authorised purposes. These include their use as active
substances in human or veterinary medicinal products, or in other
products provided that they cannot be recovered or abused, and
their use for scientific research and development (Article 14).
All new psychoactive substances on which a Joint Report has been
produced will remain subject to monitoring by Europol and the
European Monitoring Centre for Drugs and Drug Addiction (Article
15) and an updated risk assessment may be requested by the Commission
in light of new information and evidence on the risks associated
with a particular substance (Article 16).
8.19 The draft Regulation requires Member States
to establish "effective, proportionate and dissuasive sanctions"
for any breach of market restrictions introduced by the Commission
(Article 17) and to ensure that an effective remedy is available
for those whose rights are affected by the implementation of any
such sanction (Article 18). It also requires Member States and
the Commission to support the development, sharing and dissemination
of information on new psychoactive substances and to facilitate
cooperation with the European Monitoring Centre for Drugs and
Drug Addiction, other relevant EU Agencies, and scientific and
research centres (Article 20).
8.20 Member States remain free to adopt "technical
regulations" on new psychoactive substances which are not
subject to EU-wide market restrictions, but these must be communicated
to the Commission under the procedures set out in Directive 98/34/EC.[28]
The purpose of the notification procedure is to enhance market
transparency and identify barriers to trade within the internal
market. The Directive includes provision for technical regulations
to be implemented immediately, without prior consultation, "for
urgent reasons, occasioned by serious and unforeseeable circumstances
relating to the protection of public health or safety [...] also
for public policy, notably the protection of minors."[29]
Even in cases where EU-wide market restrictions have been adopted,
there is scope to exceed them provided the procedures and safeguards
foreseen in Article 114(4) and (5) TFEU are respected.
THE JUSTIFICATION FOR EU ACTION
8.21 The Commission considers that there is a clear
need for EU action for the following reasons:
· decision-making procedures under the 2005
Decision are too slow and reactive to deal with the rapid emergence
of new psychoactive substances in recent years and the number
of notifications made by Member States (which have tripled from
24 in 2009 to 73 in 2012);
· 80% of new psychoactive substances are
reported by more than one Member State, demonstrating that there
is a significant cross-border dimension;
· approximately one fifth of notified new
psychoactive substances are used for legitimate purposes in industry,
research, or as active substances in medicines; and
· divergent national approaches to new psychoactive
substances can impede their legitimate use, divert trade in harmful
substances from one Member State to another, and fragment the
internal market.
8.22 The Commission suggests that the draft Regulation
would increase legal certainty for economic operators and improve
the functioning of the internal market whilst at the same time
introducing a swifter, graduated and proportionate response to
new psychoactive substances that takes into account the degree
of health, social and safety risks associated with their consumption.
It adds:
"Member States individually cannot solve the
problem, since substances withdrawn from the market in one country
can still be sold in neighbouring countries or over the internet,
which renders national action ineffective. EU-level action would
also have the benefit of alerting Member States to harmful substances
that have emerged in other countries, helping them anticipate
and address potential health threats."[30]
8.23 In terms of subsidiarity, the Commission considers
that action at EU level is necessary to ensure that new psychoactive
substances causing EU-wide concern can be withdrawn from the market
quickly in all Member States without disrupting legitimate trade.
It would also add value by improving the exchange of information
between Member States, pooling scientific resources and analytical
capacities and producing the evidence needed to develop the most
effective responses. EU-level decisions restricting the availability
of new psychoactive substances would enhance legal certainty,
remove obstacles to legitimate trade, reduce the likelihood of
unilateral Member State action and improve consumer protection
across the EU. The Commission adds that Member States would "continue
being responsible for addressing those substances that are a problem
at local or national level."[31]
Document (b) the draft Directive amending
Framework Decision 2004/757/JHA
8.24 The purpose of the draft Directive is to extend
the scope of the 2004 Framework Decision to include new psychoactive
substances which present severe health, social and safety risks
and are subject to permanent market restriction under Article
13 of the draft Regulation. The amendment is intended to ensure
that the production and manufacture of all such substances, or
the act of making them available on the market, is made a criminal
offence in all Member States, and that the same criminal law provisions
that currently apply to narcotic drugs and psychotropic substances
under United Nations Conventions also apply to new psychoactive
substances. An Annex to the draft Directive contains a list of
substances which are already subject to EU-wide control measures
and criminal penalties under the 2005 Decision.
8.25 As the legal base for the draft Directive is
Article 83(1) TFEU, the UK's Title V opt-in applies.
The Government's view
DOCUMENT (A) THE DRAFT REGULATION
8.26 The Minister for Immigration (Mr Mark Harper)
recognises that new psychoactive substances present "a significant
challenge", adding that "early identification and sharing
of information is key to our understanding and response."
He suggests that a further strengthening of the existing information
exchange mechanism would "continue to complement the UK's
own drugs early warnings systems which inform our public health
messaging, legislation and enforcement responses."[32]
8.27 However, the Minister questions the Commission's
choice of legal base for the draft Regulation and suggests that
the proposal should cite a Title V (justice and home affairs)
legal base. He notes that the 2005 Council Decision which it
would replace is a justice and home affairs measure and continues:
"Save for the graduated categorisation system
proposed in the new measure, its operative provisions are very
similar to Council Decision 2005/387/JHA. While the new measure
is expressed in many places to harmonise the single market, it
is clear that its main purpose is to control access to NPS [new
psychoactive substances], mostly in a substantially similar manner
to Council Decision 2005/387/JHA. The explanatory memorandum
prepared by the Commission focuses on the risks to health and
society arising from the misuse of NPS. The mischief at which
the instrument is aimed is not barriers to trade arising from
the internal market; it is the need for a coordinated, EU-wide
approach to tackling emerging NPS.
"Our own experience suggests that there is a
very small legitimate trade in NPS, namely commercial and industrial
use. For that reason, at this stage, we would question the basis
of the Commission's assessment that NPS should be tackled by way
of controls on the internal market pursuant to Article 114 TFEU.
Our preliminary view is that there are good arguments that if
the trade of NPS ought to be regulated at EU level, it should
be pursuant to a measure under Title V TFEU, given the lack of
evidence of legitimate NPS usage."[33]
8.28 The Minister says that he will write with further
details on the Government's position on the legal base. However,
even if the Government maintains its preliminary view that a Title
V legal base should be cited, the Minister suggests that the UK's
Title V (justice and home affairs) opt-in Protocol would not apply
because the draft Regulation is a Schengen measure, building on
Article 76 of the 1990 Schengen Implementing Convention. Article
76 provides that Schengen States 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." These measures should also apply to "substances
frequently used in the manufacture of narcotic drugs and psychotropic
substances."
8.29 EU measures which build on elements of the Schengen
acquis in which the UK participates are subject to the
Schengen Protocol, which takes precedence over the UK's Title
V opt-in Protocol.[34]
Under the terms of the Schengen Protocol, the UK is deemed to
participate in a proposal building on a Schengen measure by which
the UK already is already bound (in this case, Article 76 of the
1990 Convention), but has the right to opt out. If the UK wishes
to opt out, it must notify the Council in writing within three
months.
8.30 The Minister notes that the draft Regulation
does not state that it is a Schengen-building measure, but that
the UK intends to assert that it is and that the UK's Schengen
opt-out applies. The Minister sets out the factors which are
likely to be relevant in determining whether or not to participate
in the draft Regulation:
· the introduction of a swifter process
for assessing the risk of substances that cause EU-wide concern
and for withdrawing from the market those that pose "severe"
or "moderate" risks;
· the difficulty of "scientifically
defining the thresholds between high, moderate and low" health,
social and safety risks, and the implications of determining that
a particular new psychoactive substance is low risk and does not
warrant EU-wide action the Minister adds that the UK's
Advisory Council on the Misuse of Drugs undertakes its own risk
assessment of new psychoactive substances;
· the potential to enhance effective law
enforcement and judicial cooperation in tackling "a fast-paced
market, cross-border activity and the role of the internet"
through swifter EU-wide action the Minister notes that
the UK has already banned the majority of new psychoactive substances
currently subject to EU-wide control measures; and
· the effectiveness of the calibrated approach
set out in the draft Regulation, which envisages administrative
and criminal sanctions, depending on the nature and extent of
the market restriction imposed the Minister adds that
there will be associated enforcement (including forensic) costs.[35]
8.31 Turning to the justification for EU action,
the Minister notes that drug policy is "predominantly a competency
of Member States" but that collective EU action "can
be necessary to complement national approaches."[36]
He does not express a view on the compliance of the draft Regulation
with the principle of subsidiarity, adding that he will write
with further information shortly. However, he considers that
the proposal breaches the principle of proportionality to the
extent that it "fetters the UK from adopting more stringent
measures to control NPS." He continues:
"In our view, it is vital for the UK, guided
as necessary by EU expertise in NPS but not bound by it, to have
a final say when deciding whether to exceed any minimum standards
mandated by the EU. Where the UK proposes to take action unilaterally,
it should not have to comply with Directive 98/34/EC. Whereas
Council Decision 2005/387/JHA imposed minimum standards across
the EU, this measure seeks to impose common standards across the
EU. We do not consider the potential derogations contained in
Article 114(4) or (5) of the TFEU to preserve sufficient autonomy
for the UK in this challenging area. This level of EU control
exceeds that which is required for the objectives of the Treaties
to be achieved and therefore does not appear to comply with the
principle of proportionality."[37]
8.32 Whilst acknowledging that the draft Regulation
would not adversely affect fundamental aspects of the UK legal
system, the Minister notes that it would be directly applicable
in the UK (unless a UK Title V opt-in or Schengen opt-out applies)
and would, as a result:
"direct the UK Government and the UK Parliament
on future legislative steps to take to limit or control the availability
of NPS. At present, the drug control framework in the UK is made
under the Misuse of Drugs Act 1971 and statutory instruments made
thereunder and is a responsibility of the Home Secretary. This
EU Regulation would place some limits and constraints on the Home
Secretary's and the UK Parliament's freedom of action in this
field."[38]
8.33 The Minister's Explanatory Memorandum indicates
that the Government has no plans to undertake an impact assessment
on the draft Regulation and makes no reference to consulting external
stakeholders.
DOCUMENT (B) THE DRAFT DIRECTIVE
8.34 The Minister notes that most harmful new psychoactive
substances identified as being of concern at EU level under the
2005 Decision were already subject to control measures and criminal
penalties under the Misuse of Drugs Act 1971. The UK has notified
its intention to opt out of the 2004 Framework Decision, which
the draft Directive would amend, as part of its 2014 block opt-out,
and the Government does not propose to seek to rejoin it. The
Minister adds that "participation in any future NPS measure
will need to be considered in light of the decision to opt out
of the original measure."[39]
8.35 The Minister suggests that the draft Directive,
like the accompanying draft Regulation, is a Schengen measure
that builds on Article 71 of the 1990 Schengen Implementing Convention.
Article 71 requires Schengen States to take "all necessary
measures to prevent and punish the illicit trafficking in narcotic
drugs and psychotropic substances", including administrative
and penal sanctions, in accordance with United Nations Conventions.[40]
The Government intends to assert that its right to opt out of
the proposal under the Schengen Protocol applies.
8.36 The Minister expresses no view on the compliance
of the draft Directive with the principle of subsidiarity and
says he will write with further information shortly.
Conclusion
Questions for the Government
8.37 The Minister's Explanatory Memoranda on these
proposals raise many questions and provide few answers at this
stage. This is disappointing given that the Government has already
decided to opt out of the 2005 Decision (which the draft Regulation
will replace) and the 2004 Framework Decision (which the draft
Directive will amend) with effect from 1 December 2014 and might
therefore be expected to have a clearer appreciation of the risks
and benefits of EU action on new psychoactive substances and the
introduction of EU-wide criminal offences and penalties.
8.38 Turning first to the draft Directive, we
do not see how it would be legally possible for the UK to participate
in an instrument in this case, the draft Directive
which would amend a measure (the 2004 Framework Decision) which
will cease to bind the UK from 1 December 2014. Whilst we understand
that there are potential timing issues, if the draft Directive
and Regulation are adopted and/or enter into force before 1 December
2014, we ask the Government whether it agrees with our understanding
of the basic legal position.
8.39 We note that the Government considers that
the draft Directive and draft Regulation are Schengen-building
measures and that the UK's Schengen opt-out applies to both, regardless
of the legal base cited. The Minister's Explanatory Memoranda
refer to Articles 71 and 76 of the 1990 Schengen Implementing
Convention as the source of the underlying Schengen obligations.
We understand that these Articles are limited in scope to narcotic
drugs and psychotropic substances covered by existing United Nations
Conventions and so do not extend to new psychoactive substances.
We ask the Government whether it shares our understanding of
the scope of these Articles and to amplify its reasons for considering
that the Commission's proposals (which concern new psychoactive
substances that are not subject to international control
under the relevant UN Conventions) are Schengen-building measures.
8.40 The Government's assertion that the draft
Directive and draft Regulation are Schengen-building measures
will have important implications for Denmark and for other non-EU
States Iceland, Norway, Switzerland and Liechtenstein
associated with the application and development of the
Schengen acquis. We ask the Government whether it has
consulted with these States and whether they consider that the
Commission proposals are a development of the Schengen acquis.
8.41 With regard to the draft Regulation, the
Government's reservations about the Article 114 TFEU (internal
market) legal base appear to be based on a difference of view
with the Commission on the scale of legitimate trade in new psychoactive
substances. It is all the more surprising, given this difference
of view, that the Government does not propose to carry out its
own impact assessment or consult external stakeholders. We ask
the Minister to explain why.
8.42 We note that the Government has not contested
the use of an internal market legal base to regulate internal
trade in drug precursors, or sought to assert that its Schengen
opt-out applies.[41]
We therefore also ask the Minister to explain why the Government
considers that trade in drug precursors and new psychoactive substances
should be regulated differently, and why Article 76 of the 1990
Schengen Implementing Convention is not also applicable to the
trade in drug precursors, given that it expressly refers to "substances
frequently used in the manufacture of narcotic drugs and psychotropic
substances."
8.43 The Minister suggests that the draft Regulation
should cite a Title V legal base. We ask him, accordingly, to
identify which provisions of the draft Regulation establish specific
obligations in the justice and home affairs field and which Title
V Treaty Articles he considers should be cited as the legal base.
8.44 The Minister makes no reference to the conferral
of significant implementing powers on the Commission, even though
this is an important point of distinction with the 2005 Decision
which vests political control in the Council. We ask the Minister
whether he considers the conferral of implementing powers to be
appropriate and proportionate.
8.45 We have consistently maintained that a unilateral
assertion by the UK that its Title V (justice and home affairs)
opt-in or Schengen opt-out applies undermines legal certainty.
Whilst we recognise that the application of the Schengen Protocol
is often less clear-cut than the UK's Title V opt-in, given that
it is not dependent on the citation of a Title V legal base, we
would nevertheless expect the Schengen origins of EU proposals
to be set out in the recitals, not least as a means of clarifying
their application to Denmark and non-EU Schengen associated countries.
In the absence of any such recitals in the draft Regulation and
Directive, we do not consider that it would be appropriate to
recommend a Schengen opt-out debate, but we will wish to debate
both proposals once the Government has clarified is position on
the issues we have raised.
SUBSIDIARITY CONCERNS
8.46 It is particularly disappointing that the
Government has been unable to provide an assessment of the subsidiarity
implications of the draft Regulation and Directive. It is unreasonable
to expect Parliament to come to an informed view on compliance
with the subsidiarity principle within the timeframe required
for a Reasoned Opinion under Protocol No. 2 to the EU Treaties
without the benefit of an analysis by the Government.
8.47 Our preliminary view, however, is that the
Commission has not demonstrated a sufficient justification for
the scale of action proposed in the draft Regulation. Given the
potential for cross-border trade in new psychoactive substances
and the risk that divergent national approaches might displace
the health and social harms associated with their use from one
Member State to another, or hinder legitimate trade, we can see
some advantage in harmonised EU rules. We nevertheless consider
that the draft Regulation and Directive fetter Member State action
to an unacceptable degree.
8.48 The Commission acknowledges in its Impact
Assessment that trade in new psychoactive substances for legitimate
purposes is difficult to quantify as no comprehensive market information
is available.[42]
Given this uncertainty, as well as the known risks associated
with their recreational use, we do not consider that new psychoactive
substances should necessarily be treated in the same way as other
tradable commodities within the internal market. Divergent national
rules cited by the Commission as an obstacle to legitimate trade,
in our view, often reflect differing cultural and societal attitudes
towards the regulation of drugs and psychoactive substances and
are an important component of national strategies to manage and
control drug use.
8.49 There is little analysis in the Commission's
Impact Assessment of the scope for Member States to act unilaterally,
under Article 114(4) and (5), when faced with evidence of social
or health harms which exceed the level of risk identified by the
Commission when implementing market restrictions, but it seems
clear that there would be far less flexibility than exists under
the 2005 Decision. We do not consider that the Commission has
produced sufficient evidence of disruption to legitimate trade,
or displacement of the harmful effects of new psychoactive substances,
to warrant market intervention on the scale envisaged in the draft
Regulation or the imposition of additional constraints on Member
States' freedom of action.
8.50 We also question whether the draft Regulation
is proportionate and consider that it exceeds the scope for EU
action set out in Conclusions on new psychoactive substances agreed
by the Council in 2011. We note, with some concern, that the
Commission rather than the Council is empowered to determine when
to request a Joint Report and risk assessment on a new psychoactive
substance, and to decide which type of market restrictions to
apply. This is a significant departure from the 2005 Decision,
under which political control rests with the Council. We assume
that the intention is to accelerate the decision making process
but, for the reasons set out above, we consider that there are
sound reasons for Ministers, represented in the Council and accountable
to their national Parliaments, to decide what level of restrictions
are justified.
8.51 We conclude that the draft Regulation and
Directive do not comply with the principle of subsidiarity and
recommend that the House send the Reasoned Opinion annexed to
this report to the Presidents of the Commission, Council and European
Parliament following a debate on the Floor of the House.
19 Joint Action 97/396/JHA, OJ No. L 167, 25.06.1997. Back
20
Council Decision 2005/387/JHA, OJ No. L 127, 20.05.2005. Back
21
The United nations Single Convention on Narcotic Drugs 1961 and
the United Nations Convention on Psychotropic Substances 1971.
Back
22
Article 9(3) of the 2005 Decision. Back
23
Council document 13074/11, (33045), HC 428-xxxv (2010-12), chapter
22 (7 September 2011). Back
24
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/jha/126879.pdf
Back
25
See Council document 14514/12 (34286); see HC86-xvi (2012-13),
chapter 9 (24 October 2012) and HC 86-xx (2012-13), chapter 26
(21 November 2012). Back
26
See p. 8 of the Commission's explanatory memorandum accompanying
the draft Regulation. Back
27
The examination procedure is set out in Article 5 of Regulation
(EU) No 182/2011 laying down the rules and general principles
concerning mechanisms for control by Member States of the Commission's
exercise of implementing powers. Back
28
Directive 98/34/EC establishes a procedure for the provision of
information on technical standards and regulations. Back
29
Article 9(7) of Directive 98/34/EC. Back
30
See p. 4 of ADD 1, Impact Assessment. Back
31
See p.45 of ADD 1, Impact Assessment. Back
32
See paragraph 21 of the Minister's Explanatory Memorandum. Back
33
See paragraphs 22-23 of the Minister's Explanatory Memorandum.
Back
34
See Article 7 of Protocol No. 21 to the EU Treaties (the UK's
opt-in Protocol). Back
35
See paragraph 25 of the Minister's Explanatory Memorandum. Back
36
See paragraph 18 of the Minister's Explanatory Memorandum. Back
37
See paragraph 20 of the Minister's Explanatory Memorandum. Back
38
See paragraph 14 of the Minister's Explanatory Memorandum. Back
39
See paragraph 21 of the Minister's Explanatory Memorandum. Back
40
These are the Single Convention on Narcotic Drugs 1961, the Convention
on Psychotropic Substances 1971, and the Convention against Illicit
Traffic in Narcotic Drugs and Psychotropic Substances 1988. Back
41
See Council document 14514/15; (34286); HC 86-xvi (2012-13), chapter
9 (24 October 2012) and HC 86-xx (2012-13), chapter 26 (21 November
2012). Back
42
See pp. 18-22 of the Commission's Impact Assessment (ADD 1).
Back
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