Legally and politically important
Not cleared from scrutiny; further information requested; drawn to the attention of the Home Affairs Committee and the Committee for Exiting the European Union
(a) Proposal for a Regulation on new psychoactive substances (b) Proposal for a Directive amending Framework Decision 2004/757/JHA 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
(c) Proposal for a Regulation amending Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances
(a) Article 114 TFEU, ordinary legislative procedure, QMV; (b) Article 83(1) TFEU, ordinary legislative procedure, QMV; (c) Article 168(5) TFEU, ordinary legislative procedure, QMV
(a) (35324), 13857/13 + ADDs 1–2, COM(13) 619
(b) (35325), 13865/13 + ADDs 1–2, COM(13) 618
(c) (38033), 11520/16, COM(16) 547
11.1New psychoactive substances—often referred to as “legal highs”—present particular challenges for regulatory authorities across Europe. They constitute a rapidly growing market, are highly adaptable to changes in the regulatory framework and provoke differing views on the degree of risk they pose to health and society. Under existing EU rules set out in a 2005 Council Decision, EU-wide control measures and criminal penalties may be introduced for substances which pose unacceptable health and social risks, following a risk assessment prepared by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). These EU-wide measures do not prevent Member States from introducing or maintaining their own national controls.
11.2In 2013, the Commission proposed a revision of the EU legal framework to make it more responsive to the emergence of new psychoactive substances and to introduce a broader range of options for EU-wide market restrictions, but maintaining an outright ban and criminal sanctions for all high risk substances. Document (a)—the proposed Regulation—would repeal and replace the 2005 Council Decision and establish a new framework for EU-wide regulation of new psychoactive substances which present moderate or severe health, social and safety risks, whilst providing for the free circulation of those which present low, or no, risks. Document (b)—the proposed Directive—is the instrument through which Member States would implement criminal sanctions for the highest risk substances.
11.3The proposed Directive is a Title V (EU criminal law) measure. By contrast, the proposed Regulation cites an internal market legal base, largely on the strength of the Commission’s assertion that there is a significant legitimate trade in new psychoactive substances for commercial, medicinal or research purposes. The Government disputes this, describing the trade as “overwhelmingly illicit”. It considers that the Regulation (like the Directive) should cite a Title V criminal law legal base. It also argues that both proposals build on provisions of the 1990 Schengen Implementing Convention and are therefore subject to the UK’s Schengen opt-out Protocol. In January 2014, the then Coalition Government confirmed that it had “decided to opt out of both of the new psychoactive substances proposals under the Schengen Protocol” and that it had “informed the EU Council Secretariat of our position”.
11.4In the Committee’s earlier Reports (listed at the end of this chapter), our predecessors reviewed the proposed Regulation and Directive for compliance with the principle of subsidiarity and concluded that the regulatory framework proposed by the Commission would fetter Member State action to an unacceptable degree. The House of Commons debated and agreed a Reasoned Opinion on 11 November 2013. The previous Committee also sought further information from the Government on a number of issues, including the appropriate legal base for the proposed 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.
11.5Negotiations within the Council have continued at a slow pace. Earlier this year, the Government told us that the Dutch Presidency had called for “a strategic pause” so that it could hold bilateral talks with Member States to agree “a future approach”. The Government has now deposited a new proposal for a Regulation—document (c)—which focuses exclusively on the role of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in facilitating the exchange of information on newly emerging psychoactive substances, strengthening the early warning system, and preparing risk assessments. The Commission says it will consider withdrawing its more far-reaching proposal—document (a)—as part of its 2017 Work Programme. It makes clear that its latest proposal has to be read alongside its earlier proposed Directive, document (b), and that both instruments—documents (b) and (c)—are intended to replace the 2005 Council Decision. This Decision no longer applies to the UK following the previous Government’s “block opt-out” of a range of EU police and criminal justice measures adopted before the Lisbon Treaty took effect on 1 December 2009.
11.6The Minister for Vulnerability, Safeguarding and Countering Extremism (Sarah Newton) explains that the latest Commission proposal—document (c)—now cites a public health rather than an internal market legal base. The Government is “content with this approach” and intends to “work with EU partners to finalise negotiations”. She confirms that the proposed Regulation “does not engage” the UK’s Title V (justice and home affairs) opt-in Protocol or Schengen opt-out Protocol and that the Government’s earlier subsidiarity concerns have been resolved. In particular, the scope of the proposal is limited to the sharing and analysis of information on new psychoactive substances—important given the likelihood of cross-border trade in these substances—and would not constrain the UK’s ability to control drugs under the Misuse of Drugs Act 1971.
11.7In separate correspondence, the Home Secretary (Amber Rudd) makes clear that the UK will be bound by the proposed Regulation while it remains a member of the EU but says that “there is no prospect” of the UK participating in the proposed Directive—document (b)—and provides a copy of the latest draft. She indicates that there is “substantial support” within the Council for the revised package and anticipates that it may be possible to conclude negotiations within the Council, and with the European Parliament, by mid-2017.
11.8We have never been convinced that either the UK’s Title V (justice and home affairs) opt-in Protocol or Schengen opt-out Protocol applied to the Commission’s original proposal for a Regulation—document (a)—for the reasons set out in our earlier Reports. The revised Commission proposal—document (c)—puts the matter beyond any doubt. It is now clear—and the Government accepts—that neither Protocol applies, and that the Regulation (once adopted) will bind the UK while it remains a member of the EU. We note the Commission’s intention to withdraw its earlier proposal—document (a)—within the next six months. We ask the Government to notify us once the Commission has done so.
11.9The Home Secretary makes clear that the UK will not participate in, or be bound by, the proposed Directive. The previous Coalition Government purported to opt out of the proposal in January 2014 on the grounds that it was a Schengen-building measure. Does the Home Secretary consider that the proposed Directive, unlike the revised Regulation, remains a Schengen-building measure? If not, can she confirm that the proposed Directive is subject to the UK’s Title V opt-in Protocol and explain when the Government notified Parliament of its decision not to opt in? We also ask her to explain how the UK’s non-participation in the proposed Directive will be reflected in its recitals.
11.10The Home Secretary does not accept that the agreement reached in COREPER—the deliberative body on which each Member State is represented—in April to amend the legal base of the proposed Directive triggered afresh the three month deadline available to the UK to decide whether or not to opt into the amended Directive. She tells us that a fresh opt-in decision is only required if the Commission publishes “a formal proposal or a formally amended proposal” to reflect the changes agreed by the Council during the course of negotiations. We note that the Government’s view is at odds with the Council’s position that a new three month opt-in period starts to run from the date on which the European Parliament is notified of a change of legal base. It is also at odds with the Government’s expansive interpretation of the UK’s Title V opt-in Protocol and its stated commitment to “significantly strengthen Parliament’s oversight of EU justice and home affairs matters and make the Government more accountable for the decisions it makes in the EU”.
11.11Turning to the substance of the latest proposed Regulation, we note that it confers exclusive power on the Commission to request a risk assessment on one or more new psychoactive substances. Does the Government agree with this approach, or will it press for a similar power to be conferred on the Council?
11.12The Home Secretary tells us that “there will be no interface” between the Regulation and Directive, once adopted, and the UK’s Advisory Council on the Misuse of Drugs. Does she accept, nevertheless, that the information collected by the EMCDDA on new psychoactive substances and its in-depth risk assessment reports will be of considerable interest to the Advisory Council in making its own assessment of the harmful effects of these substances and the need for domestic control measures?
11.13Under its founding Regulation, third (non-EU) countries which share an interest in the EMCDDA’s objectives are able to participate in its work on the basis of a bilateral agreement concluded with the EU. If the UK were to seek to conclude such an agreement, it would be entitled to a non-voting representative on the EMCDDA’s Management Board, the body responsible for establishing the EMCDDA’s work programme. The previous Coalition Government’s Command Paper evaluating a range of EU police and criminal justice measures which were within the scope of the UK’s “block opt-out” made the following observation:
“The UK’s participation in time-sensitive EU-wide information about prevalence and harms of new substances enables us to influence EU and Member States’ legal responses, supporting enforcement and judicial cooperation in a drugs market that does not respect borders, especially with the role of the internet and use of internal transit countries.”
11.14What assessment has the Home Secretary made of the costs and benefits of continuing UK participation in the EMCDDA post-Brexit? We ask her to share the Government’s assessment with us and to indicate whether she believes that it would be in the UK’s interest to establish a formal working relationship with the EMCDDA.
11.15Pending further information, we are holding these documents under scrutiny. We draw the latest developments to the attention of the Home Affairs Committee. We consider that the Committee for Exiting the European Union also has an interest in any post-Brexit relationship with the EMCDDA which the Government may be contemplating.
(a) Proposal for a Regulation on new psychoactive substances: (35324), + ADDs 1–2, COM(13) 619; (b) Proposal for a 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: (35325), + ADDs 1–2, COM(13) 618; (c) Proposal for a Regulation amending Regulation (EC) No. 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances: (38033), , COM(16) 547.
11.16Psychoactive substances—often referred to as “legal highs”—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. Whilst their composition and effects are often unclear, they can be toxic, addictive, damaging to health and carry longer-term social risks, not least because of the involvement of organised crime groups in their distribution.
11.17The changes proposed by the Commission in 2013 to the EU regulatory framework reflected its view that current EU rules on new psychoactive substances are inadequate on the grounds that: they are too reactive, following rather than anticipating developments in the market; lack the flexibility to respond quickly to changes in the chemical composition of new psychoactive substances; and only provide for criminal sanctions, even though lighter risk management options might be beneficial in some cases. The Commission also highlighted the risk that divergent national approaches to new psychoactive substances might impede their legitimate use (for example, for commercial, industrial or scientific research and development purposes) or divert trade in harmful substances from one Member State to another, thereby fragmenting the internal market.
11.18The Commission’s insistence on an internal market legal base (Article 114 of the Treaty on the Functioning of the European Union) for its original proposed Regulation—document (a)—has proved to be a major sticking point in negotiations. Earlier this year the Government told us that the then Dutch Presidency had called for “a strategic pause” and was holding bilateral talks with Member States to agree a way forward. It said there was a “broad consensus” that any EU-wide criminal controls should be contained within a Directive citing a Title V (justice and home affairs) legal base but added that there was “no consensus yet on the form of sanctions needed to restrict the supply of new psychoactive substances”.
11.19Our earlier Reports listed at the end of this chapter provide a detailed overview of the proposed legislation, the Government’s position, and the twists and turns in the negotiations. When we last considered the proposals in May, we expressed our concern at the apparent inconsistencies in the Government’s position on the application of the UK’s Title V (justice and home affairs) opt-in and Schengen opt-out Protocols, noting:
“We are unlikely to clear the proposals from scrutiny until a satisfactory outcome on the legal base has been achieved within the Council and the Government is able to tell us which of the UK’s Title V opt-in or Schengen opt-out Protocols apply and how this will be reflected in the recitals to the draft Regulation and the draft Directive.”
11.20We asked the Government to provide a further update once the Dutch Presidency had concluded its bilateral talks with Member States and resumed negotiations, as well as a copy of any revised text produced by the outgoing or incoming Presidency.
11.21The Commission’s latest proposal reflects an agreement reached in April by COREPER—the deliberative body on which each Member State is represented—to advance negotiations on the basis of a compromise approach put forward by the then Dutch Presidency in a discussion paper. The agreement is based on two elements: changes to the Directive proposed in 2013 concerning the definition of new psychoactive substances and the procedures for criminalising harmful substances; and an invitation to the Commission to present a new proposal amending the 2006 Regulation establishing the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). The Council’s record of the COREPER meeting notes that the changes to the proposed Directive—document (b)—would include an amendment of the legal base so that it would cite Article 83 TFEU rather than Article 83(1) TFEU as originally proposed by the Commission. Moreover:
“This decision triggers the start of the 3 months’ opt-in deadline for the Member States concerned by Protocol 21 […].”
11.22The new Regulation proposed by the Commission is intended to enhance mechanisms for monitoring the emergence of new psychoactive substances, assessing the risks they present, and reducing the availability of those that are of concern to the EU because of their cross-border effects. It would:
11.23The Commission anticipates that the risk assessment will provide the evidence base needed to determine whether or not EU-wide criminal sanctions for a new psychoactive substance are justified, based on the procedures set out in the proposed Directive, document (b).
11.24The Commission’s latest proposal differs from the version it put forward in 2013—document (a)—in the following respects:
11.25The Commission emphasises that its latest proposal and the Directive it proposed in 2013 should be “read in conjunction” and are “designed to replace” the existing mechanisms for information exchange, early warning and risk assessment set out in the 2005 Council Decision. It considers that “there is a clear need for EU action” as “Member States alone cannot reduce the problems caused by the spread of harmful new psychoactive substances”, adding:
“Uncoordinated national action in this area can produce adverse knock-on effects, for instance displacement of harmful substances from one Member State to another. Criminal groups may exploit this situation.
“Consequently, EU-level action is necessary to ensure that potentially harmful new psychoactive substances, which cause EU-wide concern, can be identified, assessed and, if they pose risks, incriminated in all Member States.”
11.26The EMCDDA is funded from the EU budget. Given “the massive growth” in new psychoactive substances, the Commission envisages that an extra €776,000 will be needed in the period 2017–20 to enable the EMCDDA to manage the information exchange and early warning mechanism and to meet the tighter deadlines for producing reports and risk assessments.
11.27The Minister (Sarah Newton) makes clear that the UK’s participation in negotiations on the Commission’s revised proposal for a Regulation will not be affected by the outcome of the referendum on the UK’s membership of the EU:
“On 23 June, the EU referendum took place and the people of the UK voted to leave the EU. Until exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. During this period the Government will continue to negotiate, implement and apply EU legislation.”
11.28She explains that new psychoactive substances are “drugs which are generally not controlled under the Misuse of Drugs Act 1971 but which can pose a similar risk to public health”. These substances have proliferated in Member States in recent years—100 new substances were reported to the EU’s existing Early Warning System in 2015, bringing the total being monitored to more than 560:
“The UK’s primary legislative response to these substances is the Psychoactive Substances Act 2016, which contains a range of criminal and civil sanctions for the production, supply, import and export of psychoactive substances which are not exempted.”
11.29The Minister notes that the current system for risk assessing and controlling new psychoactive substances at EU level is “slow and struggles to keep pace with the fast moving market in new psychoactive substances”. The latest Regulation proposed by the Commission is intended to “speed up the process by which a substance is controlled at EU level”. A “key difference” between this proposal and the earlier version published in 2013 is the change in legal base from Article 114 TFEU (concerning the internal market) to Article 168 TFEU (public health). The Minister observes:
“This is in response to concerns from the UK and a majority of Member States that the use of Article 114 would unduly restrict Member States’ competence to control drugs according to national circumstances. This is because Article 114 is used to adopt harmonising measures which, to remove barriers to trade in the internal market, could require all Member States [to] adopt the same level of control on a drug. The Government also argued that Article 114 is inappropriate for measures regarding new psychoactive substances as the vast majority of them do not have a legitimate use.
“A further difference between the two draft Regulations is that the original draft contained Articles relating to the process for applying EU-wide controls on a drug. These Articles have been removed from the new draft, which focuses on information exchange and risk assessment. Articles regarding EU-wide controls are now included in the draft Directive which accompanies the draft Regulation […]. The Commission will consider withdrawal of the original draft Regulation in preparing its Work Programme for 2017.”
11.30The Minister reiterates the Government’s opposition to an internal market (Article 114) legal base:
“The UK, together with other Member States, helped the Commission to identify a more appropriate legal base. The new draft Regulation uses an Article 168 (public health) legal base, and would involve amendments to the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (the Centre). The Government is content with this approach, and we will work with EU partners to finalise negotiations on the basis of the Commission’s new draft.”
11.31The Minister expects negotiations to proceed more quickly now that the principal obstacle to reaching an agreement—the choice of legal base—has been resolved. She confirms that the proposed Regulation does not engage the UK’s Title V (justice and home affairs) opt-in; nor does the UK’s Schengen opt-out apply as the provisions in the Commission’s original 2013 proposal placing restrictions on trade in certain new psychoactive substances have been removed. The Minister considers that the proposed Regulation no longer raises subsidiarity concerns since it “concerns measures to share and analyse information on new psychoactive substances, which is appropriate given the cross-border nature of this trade”. Nor would it constrain the UK’s ability to control drugs under the Misuse of Drugs Act 1971. She notes that negotiations on the related proposal for a Directive—document (b)—are continuing.
11.32Turning to the substance of the Commission’s latest proposal, the Minister believes that the shorter time limits for producing an initial report and risk assessment will ensure a swifter process for controlling harmful new substances at EU level and “should help to restrict their supply to the UK”. The proposed Regulation would also enable the EMCDDA to carry out a combined risk assessment on substances which have a similar chemical structure, “sav[ing] time and resources by allowing several substances which are likely to have similar harmful effects to be considered together”.
11.33The Minister considers that the extra resources for the EMCDDA proposed by the Commission are “appropriate and proportionate to the resource requirements of the Centre” and says they would be funded by means of “a re-allocation of existing Commission budgets”, without requiring additional contributions from Member States. She adds that the EMCDDA has made “significant financial savings in recent years” and that “imposing additional tasks without matching resources would risk impairing its ability to fulfil the other aspects of its mandate”.
11.34The Home Secretary (Amber Rudd) provides an update on negotiations on the proposed Directive—document (b). Although put forward as part of a package with the Commission’s latest proposal for a Regulation—document (c)—she explains that it is possible for the UK to participate only in the Regulation, not the Directive. She encloses a copy of the latest text of the proposed Directive, noting that it would enable new psychoactive substances identified as harmful following a risk assessment to be subject to criminal controls in all participating Member States. The Home Secretary makes clear that “there is no prospect of the UK participating” in the proposal, adding:
“Our position is that decisions regarding the control of drugs should be taken by Parliament.”
11.35The Home Secretary confirms that the UK will be bound by the proposed Regulation, once adopted, as neither the UK’s Title V opt-in nor Schengen opt-out Protocols apply. She continues:
“I do not consider the UK’s participation in the Regulation to be problematic as the revised draft Regulation now focuses only on information sharing and risk assessment, which are processes the UK already contributes to. The Regulation will not affect the UK’s competence to control drugs domestically under the Misuse of Drugs Act 1971, and will not affect the operation of the Psychoactive Substances Act 2016.”
11.36The Home Secretary notes that the change in legal base from Article 114 TFEU (on the internal market) to Article 168 TFEU (public health) in the Commission’s revised Regulation has removed the main obstacle to reaching an agreement. She adds:
“There is substantial support for the current draft proposals within the Council. The European Parliament has said it is willing to work on the basis of the current proposals, rather than the original proposals that it approved in 2014. I expect that discussions in Council will conclude by the end of the Slovakian Presidency or early in the Maltese Presidency, with trilogue negotiations concluding by mid-2017. Clearly this is only an estimate.”
11.37Commenting on the Commission’s explanatory memorandum accompanying its revised proposal for a Regulation which indicated that a decision taken by COREPER in April triggered the three month opt-in deadline applicable to EU justice and home affairs proposals under the UK’s Title V opt-in Protocol, the Home Secretary explains:
“This meeting approved the approach recommended by the Netherlands Presidency to ask the Commission to present a new draft Regulation which does not have an internal market base, but which amends the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (a public health legal base). The UK does not accept that this meeting triggered a Justice and Home Affairs opt-in decision. No new text was presented by the Commission for consideration and there were no formal amendments by the Commission to existing texts. The Government considers that texts amended by the Council during negotiations do not re-trigger the UK’s opt-in. It is only triggered when the Commission publish a formally proposal or a formally amended proposal.”
11.38Finally, the Home Secretary explains that there will be “no interface” between the Commission proposals and the UK’s Advisory Council on the Misuse of Drugs:
“The Advisory Council is a statutory expert body that advises the Government on the situation with respect to drugs which are being, or appear to them likely to be, misused and of which the misuse is having, or appears to them capable of having, harmful effects sufficient to constitute a social problem. One of its key functions is to advise on the control of drugs under the Misuse of Drugs Act 1971. This function will not be affected since the UK will not participate in the draft Directive, which concerns domestic controls. The Advisory Council will also not be affected by the draft Regulation, since it does not supply information to inform the EU’s information gathering and risk assessment on substances. This work is done by the UK Focal Point, based in Public Health England.”
Third Report HC 71-ii (2016-17), (9 March 2016); Thirty-seventh Report HC 219-xxxv (2014–15), (18 March 2015); Second Report HC 219-ii (2014–15), (11 June 2014); First Report HC 219-i (2014–15), (4 June 2014); Forty-fourth Report HC 83-xxxix (2013–14), (26 March 2014); Thirty-first Report HC 83-xxviii (2013–14), (22 January 2014); Twenty-sixth Report HC 83-xxiii (2013–14), (4 December 2013); Nineteenth Report HC 83-xviii (2013–14), (23 October 2013.(25 May 2016); Twenty-fifth Report HC 342-xxiv (2015–16),
49 See on the information exchange, risk assessment and control of new psychoactive substances.
50 See of 13 January 2014 from the then Minister for Crime Prevention (Norman Baker) to the Chair of the European Scrutiny Committee and his of the same date (HC Deb, col. 22WS).
51 See the of 10 February 2016 from the then Minister for Preventing Abuse, Exploitation and Crime (Karen Bradley) to the Chair of the European Scrutiny Committee.
52 Document (a)—the Commission’s first proposal for a Regulation—is listed in of the Commission’s recently published Work Programme for 2017 as one of a number of pending legislative proposals it intends to withdraw within the next six months.
53 See para 16 of the Minister’s Explanatory Memorandum.
54 See the Council’s of the COREPER meeting held on 6 April 2016.
55 See the of 20 January 2011 on enhancing Parliamentary scrutiny of EU business by the former Minister for Europe (Mr David Lidington).
56 See Article 21 of on the European Monitoring Centre for Drugs and Drug Addiction.
57 See p,51, para 110 of published in July 2013.
58 See the of 10 February 2016 from the then Minister for Preventing Abuse, Exploitation and Crime (Karen Bradley) to the Chair of the European Scrutiny Committee.
59 See the of 14 April 2016 from the then Minister for Preventing Abuse, Exploitation and Crime (Karen Bradley) to the Chair of the European Scrutiny Committee.
60 See our Thirty-seventh Report HC 219-xxxv (2014–15), (18 March 2015).
61 See the Council’s of the COREPER meeting held on 6 April 2016.
62 See p.4 of the Commission’s explanatory memorandum accompanying the proposed Regulation.
63 See para 13 of the Minister’s Explanatory Memorandum.
64 See para 3 of the Minister’s Explanatory Memorandum.
65 See para 4 of the Minister’s Explanatory Memorandum.
66 See para 17 of the Minister’s Explanatory Memorandum.
67 See paras 1–2 of the Minister’s Explanatory Memorandum.
68 See para 16 of the Minister’s Explanatory Memorandum.
69 See para 12 of the Minister’s Explanatory Memorandum.
70 See para 17 of the Minister’s Explanatory Memorandum.
71 See para 18 of the Minister’s Explanatory Memorandum.
72 See paras 21–2 of the Minister’s Explanatory Memorandum.
21 November 2016