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Stronger control measures for the synthetic drug BZP

Outline of the Community (European Union) legislation about Stronger control measures for the synthetic drug BZP

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Combating drugs

Stronger control measures for the synthetic drug BZP

Document or Iniciative

Council Decision 2008/206/JHA of 3 March 2008 on defining 1-benzylpiperazine (BZP) as a new psychoactive substance which is to be made subject to control measures and criminal provisions.

Summary

BZP (1-Benzylpiperazine) is a new psychoactive substance that acts as a stimulant on the central nervous system. It a purely recreational drug, with no established or recognised medical value, which is sold over the Internet and at ‘herbalists’ and ‘smart shops’.

The risks associated with the ingestion of this substance are still little known. That is why the Commission asked the Council – on the basis of a joint European Monitoring Centre for Drugs and Drug Addiction EMCDDA / Europol report – to measure its health and social risks via a risk assessment based on Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of new psychoactive substances.

The BZP risk assessment exercise produced the following results: 13 Member States and Norway have reported seizures of BZP in quantities from 1 to 64 900 tablets. There is no evidence of an organised crime link.

BZP is a psychoactive substance. The risks associated with its use may include:

increased heart rate;
raised blood pressure;
restlessness and hyperactivity.

It may also have secondary effects, in the ‘down’ phase, that can last for up to 24 hours after the drug was taken. These can include:

vomiting and nausea;
headache and stomach ache;
loss of appetite;
anxiety and insomnia;
mood swings and irritability;
strange thoughts;
confusion;
palpitations and trembling.

The effects of using BZP are still largely unproven. Although clinical reports tend to establish a link between BZP and seizures, this conclusion is based on a very small number of cases, in which moreover the BZP was detected in post mortem specimens and its role in the death could not be determined since other factors were involved.

The risk assessment report reveals the lack of conclusive scientific proof establishing the global risks of this new substance. To be on the safe side, however, given that it does represent a health risk, it would be wise to make it subject to control and to take appropriate measures.

Final provisions

The Member States are required to make BZP subject to the control measures and criminal penalties provided under their national laws in accordance with the obligations imposed by the 1971 United Nations Convention on psychotropic substances.

Background

A number of initiatives have already been taken. The EMCDDA risk assessment concluded that the use of BZP can result in health problems whose long-term effects are still unknown. Based on this finding, the Commission wants to have BZP made subject to control measures, as provided by the UN Convention on psychotropic substances. This proposal also takes account of the data that have been collected as a result of the new psychoactive substances risk assessment procedure.

Council Decision 2005/387/JHA of 10 May 2005 provides for a three-step procedure for placing this type of substance under control. The first step is to draw up a report collating all available information on BZP. This assessment was carried out by the EMCDDA and Europol before being submitted to the Council on 22 February 2007. The Council responded by asking for a more extensive study of the risks associated with BZP, to be conducted by:

the extended scientific committee of the EMCDDA;
the Commission;
Europol;
the European Medicines Agency (EMEA).

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Decision 2008/206/JHA	8.3.2008	–	OJ L 63 of 7.3.2008

Related Acts

Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances [Official Journal L 127 of 20.5.2005].

'Drug prevention and information' programme

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‘Drug prevention and information’ programme

Outline of the Community (European Union) legislation about ‘Drug prevention and information’ programme

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Combating drugs

‘Drug prevention and information’ programme (2007-2013)

Document or Iniciative

Decision 1150/2007/EC of the European Parliament and of the Council of 25 September establishing for the period 2007-2013 the specific programme ‘Drug prevention and information’ as part of the General Programme ‘Fundamental Rights and Justice’.

Summary

The death rate from drug addiction in Europe is very high. It is essential to measure the immediate and long-term consequences of drug use on health and social and psychological development, and the equality of the chances of the individuals concerned.

The ‘Drug prevention and information’ programme set up by the European Union has three objectives. Specifically to:

prevent and reduce drug use, drug addiction and the associated inherent risks;
improve information about drug use;
support the implementation of the EU Drugs Strategy.

To this end, the programme supports transnational actions aimed at:

creating multi-disciplinary networks;
ensuring the expansion of the knowledge base, as well as the exchange of information and good practices;
raising awareness of the health and social problems caused by drug use;
preventing drug use.

Scope

The actions financed by this programme are:

the actions implemented by the Commission (research, surveys, conferences, campaigns, public events, analysis, Internet sites, etc.);
transnational projects of European interest presented by Member States or by candidate countries for membership of the EU;
the activities of non-governmental organisations and other bodies pursuing aims of general European interest.

The actions developed under this programme are open to public or private bodies, active in terms of preventing, or providing information, on drug use.

The programme is targeted at all groups implicated in drug use, but most particularly at ‘at risk groups’ such as young people, women, vulnerable groups and people living in socially disadvantaged areas.

Other targeted groups include educational staff, parents, teachers, social workers, local and national authorities, medical and paramedical personnel, judicial staff, law enforcement and penitentiary authorities, non-governmental organisations, trade unions and religious communities.

Financing

The programme has a budget for 2007-2013 of EUR 21.35 million. Grants are awarded by the Commission following calls for proposals, taking into account:

the conformity of the proposed action with the annual work programme;
the consistency of the expected results with the programme objectives;
the sum asked for and whether it is appropriate to the expected results;
the geographical and social impact of the action and its likely effect on the public;
citizen involvement in the organisation of the bodies concerned.

Context

The EU has launched a number of initiatives in its fight against drugs. In addition to the EU Drugs Strategy for the period 2005-2012, an Action Plan was adopted in order to translate the strategy into concrete actions.

The ‘Drug prevention and information’ programme forms part of the general programme ‘Fundamental Rights and Justice’ 2007-2013 aimed at promoting freedom, security and justice in the EU. The latter also includes the Criminal Justice, Civil Justice, and Fundamental Rights and Citizenship specific programmes, and the Daphne III programme on combating violence.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 1150/2007/EC	23.10.2007	–	OJ L 257, 3.10.2007

Related Acts

Report on the interim evaluation of the specific Programme ‘Drug prevention and information’ for the period 2007-2013 [COM(2011) 246 final – Not published in the Official Journal].

The evaluation of the programme shows that it has recorded good results during the first three years of implementation and that several objectives have been achieved. The Commission regrets, however, the insufficient budget it has at its disposal and which prevents the programme from having a real effect at European level. It therefore proposes to increase the financial resources of the programme, and also to prioritise projects with a European dimension, to simplify the administrative procedures and to improve the dissemination of the results obtained.

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

European Monitoring Centre for Drugs and Drug Addiction

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European Monitoring Centre for Drugs and Drug Addiction

Outline of the Community (European Union) legislation about European Monitoring Centre for Drugs and Drug Addiction

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The institutions bodies and agencies of the union

European Monitoring Centre for Drugs and Drug Addiction

Document or Iniciative

Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast).

Summary

Council Regulation (EEC) No 302/93 on the establishment of a European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) had to be recast to keep abreast of new developments in the European Union (EU). The regulation also needed updating so as to extend the centre’s role to the investigation of new trends in drug use, especially poly-drug use, where illicit drugs are taken in combination with legal drugs or medication.

Role and activities

The role of EMCDDA is to process and produce statistical, documentary and technical information on drugs and drug addiction, and thereby provide the EU and its countries with an overall view of the European drugs situation when they take measures or devise activities in their respective spheres of responsibility. The centre may not go beyond this overall information brief and must not collect personal data.

This recast regulation strengthens the centre’s role. It extends the centre’s collection, registration and analysis work to also cover data on emerging trends in drug use. The regulation underlines the importance of exchanging information on best practices developed in EU countries.

The priority areas of EMCDDA activities consist of:

monitoring the state of the drugs problem and emerging trends, in particular those involving poly-drug use;
monitoring the solutions applied to drug-related problems, providing information on best practices in EU countries and facilitating the exchange of such practices among them;
maintaining a rapid information system and assessing the risks of new psychoactive substances;
developing tools and instruments to help the Commission and EU countries to monitor and evaluate their respective policies on drugs.

The organisation and working methods of EMCDDA are defined in such a way as to ensure the objectivity of the results sought, i.e. the comparability of sources and methods concerning information on drugs. Its activities in this framework can be summarised as follows:

collection and analysis of existing data;
improvement of data-comparison methods;
dissemination of data;
cooperation with European and international organisations and non-EU countries;
dissemination of information on new developments and trends.

The centre is assisted by a scientific committee.

The centre also has at its disposal the European Information Network on Drugs and Drug Addiction (Reitox). The network consists of one focal point for each EU country and for each country that has concluded an agreement on participation in EMCDDA, as well as of a focal point for the Commission.

The centre must take account of activities already carried out by other agencies, e.g. the European Police Office (Europol).

Legal and organisational status

The centre has legal personality. Any actions brought against it fall under the jurisdiction of the Court of Justice of the European Union (EJC). The centre’s headquarters are in Lisbon, Portugal.

EMCDDA is headed by a director, who is responsible for the centre’s daily management. The management board, which is assisted by an executive committee, adopts the centre’s:

three-year work programmes;
annual work programmes (under the three-year work programmes);
annual activity reports.

EMCDDA is also open to non-EU countries that attach the same importance as the EU and its countries to the issue of drugs. The regulation specifies the status of members representing these countries on the management board.

The centre is to gradually achieve its aims, in light of the objectives laid down in the three-year and annual work programmes and with due regard to the resources available. Every six years the Commission will conduct an external evaluation that must also cover the Reitox network.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1920/2006	16.1.2007	–	OJ L 376, 27.12.2006

Information exchange, risk assessment and control of new psychoactive substances

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Information exchange, risk assessment and control of new psychoactive substances

Outline of the Community (European Union) legislation about Information exchange, risk assessment and control of new psychoactive substances

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Combating drugs

Information exchange, risk assessment and control of new psychoactive substances

Document or Iniciative

Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances.

Summary

The decision establishes a mechanism for a rapid exchange of information on new psychoactive substances. It repeals Joint Action 97/396/JHA, which concerned only new synthetic drugs. The Commission’s evaluation of the joint action of 1997, provided for by the European Action Plan to Combat Drugs (2000-04), showed that it should be strengthened and given a new direction.

The decision takes note of the information on the suspected adverse reactions to be notified under the pharmacovigilance system established by Title IX of Directive 2001/83/CE. It also provides for an assessment of the risks which these new psychoactive substances contain, so that supervisory measures may be applied.

It applies to substances not currently listed in any of the schedules to the 1961 United Nations Single Convention on Narcotic Drugs, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof, and the 1971 United Nations Convention on Psychotropic Substances, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof.

Each European Union (EU) country shall ensure that its Europol National Unit and its representative in the European Information Network on Drugs and Drug Addiction (Reitox) provide information on the manufacture, traffic and use of new psychoactive substances and of preparations containing new psychoactive substances.

Europol and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) collect the information received from EU countries through a reporting form and communicate this information immediately to each other and to the Europol national units, the EU countries’ representatives in the Reitox network, the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA).

If necessary, in light of the information supplied by EU countries, Europol and the EMCDDA may submit a joint report containing, among other things, information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance, a first indication of the risks associated with the new psychoactive substance, including the health and social risks, and the characteristics of users, the date of notification of the new psychoactive substance to the EMCDDA or to Europol, etc.

The EMEA informs Europol and the EMCDDA whether in the EU or in any EU country:

the new psychoactive substance has obtained a marketing authorisation;
the substance is the subject of an application for a marketing authorisation;
a marketing authorisation that had been granted in respect of the new psychoactive substance has been suspended.

The Council, taking into account the advice of Europol and the EMCDDA, may request an assessment of the health and social risks caused by the use of, the manufacture of, and traffic in, a new psychoactive substance, the involvement of organised crime and the possible consequences of control measures.

The risk assessment report includes the physical and chemical description of the new psychoactive substance, the health and social risks associated with the new psychoactive substance and the chemical precursors that are used for the manufacture of the substance, etc.

No risk assessment is carried out on a new psychoactive substance in the absence of a Europol/EMCDDA joint report or where the new psychoactive substance concerned is at an advanced stage of assessment within the United Nations system, namely once the WHO expert committee on drug dependence has published its critical review together with a written recommendation. No assessment is carried out if the new psychoactive substance is used to manufacture a medicinal product that is the subject of an authorisation or an authorisation request. There is no assessment either if the new psychoactive substance is used to manufacture a medicinal product for which a marketing authorisation has been suspended.

Within six weeks from the date on which it received the risk assessment report, the Commission will present to the Council an initiative to have the new psychoactive substance subjected to control measures. If the Commission deems that it is not necessary to undertake this initiative, it may be presented to the Council by one or more EU countries.

If the Council decides to submit a new psychoactive substance to control measures, EU countries will endeavour to take the necessary measures to submit the new psychotropic drug to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances and the 1961 United Nations Single Convention on Narcotic Drugs.

The EMCDDA and Europol report annually to the European Parliament, the Council and the Commission on the efficacy and achievements of the system created by this decision.

EU countries and the EMEA ensure an appropriate exchange of information between the mechanism set up by means of this decision and the pharmacovigilance systems as defined and established under Title VII of Directive 2001/82/EC and Title IX of Directive 2001/83/EC.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 2005/387/JHA	10.5.2005	–	OJ L 127, 20.5.2005