concerning
Annex: Reasoned Opinion of the House of Commons
Submitted to the Presidents of the European Parliament,
the Council and the Commission, pursuant to Article 6 of Protocol
(No 2) on the Application of the Principles of Subsidiarity and
Proportionality.
a Draft Regulation of the European Parliament
and of the Council on new psychoactive substances and a draft
Directive of the European Parliament and of the Council amending
Council 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[43]
TREATY FRAMEWORK FOR APPRAISING COMPLIANCE WITH SUBSIDIARITY
1. In previous Reasoned Opinions, the House of Commons
has set out what it considers to be the correct context in which
national parliaments should assess a proposal's compliance with
subsidiarity. The House of Commons continues to rely on that
context without restating it.
PROPOSED LEGISLATION
PURPOSE
2. The draft Regulation has a dual purpose: to reduce
obstacles to legitimate trade in new psychoactive substances whilst
also ensuring that appropriate and proportionate EU-wide restrictions
are imposed on substances presenting moderate or severe health,
social or safety risks. The draft Regulation seeks to achieve
this dual purpose by:
· establishing the free movement of new
psychoactive substances for commercial and industrial use, or
scientific research and development purposes, as a core principle;
· strengthening the existing mechanism for
exchanging information on new psychoactive substances, drawing
on the expertise of Europol and the European Monitoring Centre
for Drugs and Drug Addiction (EMCDDA) to produce a Joint Report
on substances notified by several Member States, and providing
for a swifter risk assessment procedure;
· proposing a more graduated approach to
the regulation of new psychoactive substances which seeks to distinguish
between low, moderate and high risk substances and to introduce
a more proportionate response at EU level, ranging from no market
intervention to restrictions on consumer sales and, in the most
severe cases, an outright ban accompanied by criminal sanctions;
· providing for the introduction of a temporary
ban on consumer sales, prior to a risk assessment, if there is
evidence to suggest that a new psychoactive substance poses immediate
risks to public health in several Member States;
· ensuring that, where market restrictions
have been introduced, new psychoactive substances may still be
used for authorised purposes, for example, as active substances
in medicinal or veterinary products or for scientific research
and development;
· strengthening the monitoring of new psychoactive
substances by Europol and the EMCDDA and promoting cooperation
in research and analysis.
3. The draft Directive which accompanies the draft
Regulation would amend a 2004 Framework Decision establishing
minimum rules on the definition of offences linked to trafficking
in illicit drugs and requiring Member States to introduce "minimum
maximum" criminal penalties. The amendment is intended to
ensure 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 which have
been assessed under the draft Regulation as presenting severe
health, social and safety risks.
OPERATION
4. The draft Regulation is based on Article 114 TFEU
— an internal market legal base — because the Commission
says that 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."[44]
The draft Regulation would repeal and replace the existing regulatory
framework for new psychoactive substances set out in Council Decision
2005/387/JHA. The 2005 Decision focuses exclusively on control
measures which warrant the imposition of EU-wide criminal penalties
and cites a justice and home affairs legal base.
5. The draft Regulation empowers the Commission (or
Europol and the EMCDDA) to commission a Joint Report on a new
psychoactive substance that gives rise to concerns across the
EU. It authorises the Commission to determine whether a risk
assessment is needed and whether, pending its completion, a temporary
restriction on consumer sales is warranted because a substance
poses immediate risks to public health. The Commission also determines
the level of health, social and safety risks that a new psychoactive
substance presents and the type of market restrictions to impose.
In reaching a decision, the Commission acts under the supervision
of a Committee of Member State representatives.[45]
6. The draft Directive is based on Article 83(1)
TFEU which provides for the approximation of Member States' criminal
laws and sanctions in cases where there is a clear cross-border
dimension or a special need to take common action. It is the
instrument through which Member States would be required to implement
criminal sanctions following a decision by the Commission to impose
a permanent market restriction on new psychoactive substances
posing severe health, social and safety risks under Article 13
of the draft Regulation.
SUBSIDIARITY
7. The Commission considers that there is a clear
need for EU action for the following reasons:
· decision-making procedures under Council
Decision 2005/387/JHA are too slow and reactive to deal with the
rapid emergence of new psychoactive substances in recent years
and the increase in 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. 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."[46]
9. In its Impact Assessment accompanying the draft
Regulation and Directive, the Commission sets out the two limbs
of the subsidiarity test: the necessity test and the EU added
value test.[47] 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 suggests that EU action 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."[48]
ASPECTS OF THE DRAFT REGULATION AND DIRECTIVE WHICH
DO NOT COMPLY WITH THE PRINCIPLE OF SUBSIDIARITY
I) FAILURE TO COMPLY WITH ESSENTIAL PROCEDURAL REQUIREMENTS
10. By virtue of Article 5 of Protocol (No 2) "any
draft legislative act should contain a detailed statement making
it possible to appraise compliance with the principles of subsidiarity
and proportionality". The requirement for the detailed statement
to be within the draft legislative act implies that it should
be contained in the Commission's explanatory memorandum, which
forms part of the draft legislative act and which, importantly,
is translated into all official languages of the EU. The fact
that it is translated into all official languages of the EU allows
the detailed statement to be appraised for compliance with subsidiarity
(and proportionality) in all the national parliaments of Member
States of the EU, in conformity with Article 5 of Protocol (No
2). This is to be contrasted with the Commission's impact assessment,
which is not contained within a draft legislative act, and which
is not translated into all the official languages of the EU.
11. The presumption in the Treaty on European Union[49]
is that decisions should be taken as closely as possible to the
EU citizen. A departure from this presumption should not be taken
for granted but justified with sufficient detail and clarity that
EU citizens and their elected representatives can understand the
qualitative and quantitative reasons leading to a conclusion that
"a Union objective can be better achieved at union level",
as required by Article 5 of Protocol (No 2). The onus rests on
the EU institution which proposes the legislation to satisfy these
requirements.
12. For the reasons given below, we do not consider
that the Commission has provided sufficient qualitative and quantitative
substantiation in the explanatory memorandum of the necessity
for action at EU level. This omission, the House of Commons submits,
is a failure on behalf of the Commission to comply with essential
procedural requirements in Article 5 of Protocol (No 2).
II) FAILURE TO COMPLY WITH THE PRINCIPLE OF SUBSIDIARITY
13. We recognise that there is considerable potential
for cross-border trade in new psychoactive substances and a 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. However, we consider that
the draft Regulation and Directive fetter Member State action
to an unacceptable degree.
14. 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.[50] 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. The existing regulatory framework, set out
in Council Decision 2005/387/JHA, recognises the legitimacy of
different regulatory approaches at national level and expressly
provides that the introduction of EU control measures shall not
"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."[51]
15. There is little analysis in the Commission's
explanatory memorandum and Impact Assessment of the scope for
Member States to act unilaterally, under Article 114(4) and (5)
TFEU, 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 under the draft Regulation and Directive than
exists under Decision 2005/387/JHA. 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 proposed measures or the imposition of additional constraints
on Member States' freedom of action. The first limb of the subsidiarity
test — that the proposed action cannot be sufficiently achieved
by Member States — is not, therefore, met.
CONCLUSION
16. For these reasons the House of Commons considers
these proposals do not comply with the principle of subsidiarity.
43 Council documents 13857/13 and 13865/13; COM(13)
619 and COM(13) 618. Back
44
See p. 8 of the Commission's explanatory memorandum accompanying
the draft Regulation. Back
45
See Articles 9, 12 and 13 of the draft Regulation. Decisions
made under these Articles are subject to the examination procedure
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
46
See p. 4 of ADD 1, Impact Assessment. Back
47
See pp. 44-5 of ADD 1. Back
48
See p. 45 of ADD 1. Back
49 Article
5. Back
50
See pp. 18-22 of ADD 1. Back
51
Article 9(3) of Council Decision 2005/387/JHA. Back
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