1.1 Date of introduction of Joint Action, purpose and scope
(Document I)

The Joint Action on new synthetic drugs was adopted by the European Council on 16 June
1997 in Amsterdam (O.J. no. L 167 of 25.06.1997).

The purpose of the Joint Action is the creation of a mechanism for rapid exchange of
information on new synthetic drugs and the assessment of their risks in order to permit the
application of the measures of control on psychotropic substances, applicable in the Member
States, equally to new synthetic drugs (Article 1). Common action can be taken only on the
basis of reliable information and the results of expert assessment of the risks caused by the
use of and the trafficking in new synthetic drugs and the implications of submitting such drugs
to control.

The scope of the Joint Action focuses on psycho-active substances (end-products, not
precursors) with limited therapeutic value, which are not currently listed in any of the
Schedules to the 1971 UN Convention on Psychotropic Substances and which pose
potentially comparable public-health risks as the substances listed in Schedules I or II of this
Convention (Article 2).

1.2 Notification of MBDB by the UK Presidency
(Document II)

The implementation of the Joint Action on new synthetic drugs started formally in January
1998. The EMCDDA and Europol had already begun testing a common reporting form to collect
and exchange information in the framework of the ‘early-warning system’ (Article 3).

On 27 February 1998, on behalf of all Member States, the United Kingdom Presidency of the
European Union formally referred a new synthetic drug N-methyl-1-(3,4-
methylenedioxyphenyl)-2-butanamine (or MBDB) to the EMCDDA for risk assessment under
Article 4. On 4 March 1998, the Horizontal Drugs Group of the Council of the European Union
requested all Member States to report any relevant information to Europol or the EMCDDA by
means of Article 3.

1.3 Exchange of information on MBDB (Article 3)

In the context of Article 3, the EMCDDA and Europol collected and exchanged a first set of
information about MBDB. This information was communicated to the Commission and to the
European Agency for the Evaluation of Medicinal Products (EMEA). On 15 May 1998, the
EMCDDA and Europol submitted a joint progress report to the Chairman of the Horizontal Drugs
Group of the Council and the Council Secretariat. The joint Report was presented by the
EMCDDA and Europol at the Horizontal Drugs Group meeting of 20 May 1998 (Document III).

1.4 Implementation of the risk assessment of MBDB (Article 4)

The risk assessment focuses on the evaluation of the possible risks, including the health and
social risks, caused by the use of, and traffic in, new synthetic drugs, and possible
consequences of prohibition. The risk assessment on MBDB has been carried out on the
basis of the information provided by the Member States, the Commission, the EMCDDA,
Europol and the EMEA.

The risks of MBDB were assessed by the special meeting convened by the EMCDDA under
the auspices of its Scientific Committee. This meeting was held at the EMCDDA in Lisbon on
9–10 November 1998, and chaired by Dr Desmond Corrigan, Chairperson of the Scientific
Committee. The Committee designated Dr Salme Ahlström, Vice-Chairperson of the Scientific
Committee, as the Rapporteur of the special meeting for risk assessment of MBDB.

According to Article 4, the participants in this special meeting are the following:

Members of the Scientific Committee of the EMCDDA.
Additional experts nominated by the Member States to participate in the special meeting for
risk assessment of MBDB.
Representatives of the Commission, Europol and the EMEA.

1.5 Report on the risk assessment of MBDB

Article 4.3 states: ‘On completion of the risk assessment, a report will be drawn upon the
findings. In the report all aspects shall be addressed. All opinions on these aspects shall be
reflected in the report.’

According to Article 5, the report will be forwarded to the Council: ‘The Council may, on the
basis of an initiative to be presented within a month from the date on which the report of the
results of the risk assessment pursuant to Article 4 (1) is established and acting in
accordance with Article K.3 (2) (b) of the Treaty, adopt unanimously a decision defining the
new synthetic drug or drugs which are to be made subject to necessary measures of
control’.

1.6 Documentation considered

Text of the Joint Action of 16 June 1997.
Formal referral of MBDB to the EMCDDA.
Joint EMCDDA–EDU Progress Report (20.05.98) – Chapter II: Preliminary information on
MBDB collected and exchanged under Article 3 of the Joint Action.
An Outline of Principles for Risk Assessment of New Synthetic Drugs (Guidelines)
ST/SCO/9/98 (rev. 1).
Technical Annexes A and B: The pharmacotoxicology and neuropsychology of MBDB,
Report to the EMCDDA. Doc. NO. ST/SCO/10/98.
Technical Annex D: Public health risks: epidemiological evidence, EMCDDA.
Technical Annex C: Sociological/criminological evidence, EMCDDA.
Europol contribution to the risk assessment on MBDB.
Existing legal provisions: MBDB, Legal Situation in the EU Member States, EMCDDA
background document.
National Risk Assessment Reports: France, the Netherlands, Germany.