Early-warning system on new synthetic drugs

[Alfa]

Early-warning system on
new synthetic drugs
Guidance on implementation
Information on the EMCDDA can be found on its website
(http://www.emcdda.org).
A great deal of additional information on the European Union is available on the
Internet.
It can be accessed through the Europa server (http://europa.eu.int).
© European Monitoring Centre for Drugs and Drug Addiction, 2002
Reproduction is authorised provided the source is acknowledged.
The publication has been prepared by the European Monitoring Centre for Drugs
and Drug Addiction in the framework of the Phare project ‘Cooperation EMCDDA
– central and eastern European countries’.
Printed in Portugal
Contents
Introduction .................................................. .......... ................................. 5
A. Scope .................................................. .......... ................................. ..... 6
B. Actors .................................................. .......... ................................. ..... 9
C. Information exchange tools .................................................. .......... ... 11
D. Reporting and feedback .................................................. .......... ......... 16
E. Structure of national sources for the early-warning system ................. 17
F. Extended glossary .................................................. .......... ................... 20
Annexes
Checklist .................................................. .......... ........................... 32
Text of the Joint Action .................................................. .......... ...... 35

Introduction
Within the framework of the Joint Action of 16 June 1997, the Early-warning
System (EWS) aims to create a mechanism for the rapid exchange of information
on the production, traffic, use and risks of new synthetic drugs.
Taking into account the experience acquired by all actors involved since the
adoption of the Joint Action, some guidance is presented here to contribute
to improving the functioning of the EWS. This has been put together by
analysing the main elements of the system and identifying the developments
needed.
This document should be regarded as a practical booklet on how the EWS
functions and it will continue to be modified in the future in light of new
experience and additional knowledge. Within the framework of the
EMCDDA’s tasks of preparing for the enlargement process, it has been considered
useful to publish this booklet so as to help the candidate countries
to enhance their knowledge of the Joint Action, and especially on the challenges
of setting up an EWS on new synthetic drugs.
We would like to thank very much all the National Focal Points (NFPs) of the
EMCDDA’s Reitox network for their valuable contribution to this booklet.
Alain Wallon
Lena Westberg
EMCDDA Joint Action Coordination
Lisbon, 29 June 2001
5
A. Scope
Background
The scope of the Joint Action is set out in article 2.
This Joint Action concerns new synthetic drugs which are not currently listed
in any of the Schedules of the 1971 United Nations Convention on
Psychotropic Substances, and which pose a comparable serious threat to
public health as the substances listed in Schedules I or II thereto and which
have a limited therapeutic value. It relates to end-products, as distinct from
precursors. (JA article 2)
Explanation
Common definitions have been developed as elaborated below.
6
Definition
Synthetic drug A psychoactive substance that is manufactured
through a chemical process in
which the essential psychoactive constituents
are not derived from naturally
occurring substances.
New synthetic drug A synthetic drug which presents a new
phenomenon on the market either:
a) because it has been created as a new
molecule or compound; or
b) because of its new mode of use (for
psychotropic effects).
New synthetic drug within A synthetic drug which:
the scope of the Joint Action a) is not included within any Schedule of
the UN Convention on Psychotropic Substances;
and
b) has similar characteristics to substances
listed in Schedules I or II of the
above-mentioned Convention, meaning
that it poses a serious threat to public
7
health and that it has limited therapeutic
value.
Early-warning system (EWS) A system aiming to detect a significant risk
to public health and to inform the relevant
authorities and services as quickly as
possible.
EWS of the Joint Action An EWS to detect new synthetic drugs
which pose a serious threat to public health
and which are of limited therapeutic value.
The EWS should make it possible to provide
the authorities of the Member States with
rapid information about new substances
and their modes of consumption in order to
identify dangerous substances.
Pattern of use A broad concept defined operationally in
terms of:
• different drugs and combinations used;
• frequency/intensity of use;
•mode of administration;
• characteristics of main user groups;
• main settings of use;
• main effects/consequences reported.
Chemical precursors Chemical products used in the laboratory
fabrication of either synthetic or nonsynthetic
drugs. In the fabrication of a
synthetic drug only chemical compounds
are involved: precursors, reagents and additives.
For non-synthetic drugs, chemicals
are used at different stages in the transformation
of the raw natural substance into the
end product. Precursors themselves are
generally the result of combining and processing
various chemicals, called preprecursors,
and reagents.
Interagency cooperation The adoption of the Joint Action by the
Council of the European Union, has given
the EMCDDA a clear mandate to coordinate,
together with Europol, the collection
8
and exchange of information on new substances
as they appear on the market. A
cooperation system has been established
between, on the one hand, Europol for the
collection of law-enforcement information
through its Europol National Units (ENUs)
and, on the other hand, the EMCDDA,
through the National Focal Points (NFPs) of
the Reitox network, for the collection of
information on the social and health aspects.
Interagency cooperation
(cont.)
(See also Part F: Extended glossary)
B. Actors
Background
The role of each actor set is set out in article 3 of the Joint Action.
Each Member State shall ensure that its Europol National Unit and its representative
in the Reitox network provide information on the production,
traffic and use of new synthetic drugs to the Europol Drugs Unit (EDU) and
the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA),
taking into account the respective mandates of these two bodies. The EDU
and the EMCDDA shall collect the information received and communicate
this information in an appropriate manner immediately to each other and to
the Europol National Units and the representatives of the Reitox-network of
the Member States, to the Commission and the European Agency for the
Evaluation of Medicinal Products. (JA article 3)
Explanation
The role and interaction of the actors is explained in more detail below.
9
Member State As the Joint Action is a binding Council decision (1),
it is the responsibility of the national government/
administration to guarantee that its Europol National
Unit (ENU) and National Focal Point (NFP) have
in place the appropriate infrastructure and the
resources and capacity to obtain and provide the
information requested.
EMCDDA The Joint Action gives the EMCDDA the mandate to
ensure that the network remains operational so as to
be able to obtain the information required. As such,
the EMCDDA ensures the coordination of its network
in the collection and provision of information,
which is centralised, quality-checked and completed
(as far as possible) by the Centre. The EMCDDA
(1) The Joint Action on new synthetic drugs has the same legal value as the founding
regulation of the EMCDDA.
10
then reports this information to Europol for for finetuning
the information received, among others.
Subsequently, the EMCDDA reports back to the network,
as well as to the Commission and the European
Agency for the Evaluation of Medicinal
Products (EMEA).
The NFP guarantees the functioning of its earlywarning
system network for rapid detection and collection
of information. The NFP sends the
information to the EMCDDA, at the same time taking
steps to validate it.
Europol has the same mandate as the EMCDDA to
ensure that its network for rapid detection and
exchange of information in the Member States
remains operational.
The ENU guarantees the functioning of its national
network of law-enforcement sources.
The European Commission receives the information
from the EMCDDA or Europol, and may contribute
with information on chemical precursors, in respect
of Council Regulation 3677/90 and Council Directive
92/109/EEC (see JA article 2).
The EMEA receives the information from the
EMCDDA or Europol, and may contribute with
information on the medicinal use and pharmacological
aspects of new synthetic drugs.
EMCDDA (cont.)
Reitox National
Focal Point (NFP)
Europol
Europol National
Unit (ENU)
European
Commission
European Agency
for the Evaluation
of Medicinal
Products (EMEA)
C. Information exchange tools
Levels
Two different levels of information exchange are distinguished in two separate
sub-articles (a and b) of article 3 of the Joint Action mandate:
• a first level for the early detection of a new substance (‘rapid
alert’) the aim of which is to initiate the mechanism of the Joint
Action, informing the other partners on the emergence of the
substance on the market. In this phase ‘rapid reaction’ is the
key concept; and
• a second level for the collection of as much relevant information
about this substance which aims to provide a more complete
picture at European level. At this level ‘to complete the
picture’ is the key concept.
Both these levels of information exchange require a proactive approach and
are important in preparing a basis for a decision of the authorities to carry
out the risk assessment of the substance.
Information
Three types of information are requested:
• information useful for the identification of the substance;
• information related to the use of the substance; and
• information on the consequences of this use.
When the substance is first detected, the information about its identification
(physical, chemical and street name) is very important to allow the other
partners to check whether it is also present on the market in their respective
countries. The information about use and consequences cannot be exhaustive
if the substance is new. The ‘rapid reaction’ phase requires only a first
indication on use and consequences.
During the second level of information gathering, focus should be placed
on providing complementary information on the substance’s identification
(production process) and on providing all relevant information on its use
and consequences.
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Level 1
Background
The Joint Action specifies the information required at level 1.
The information referred to in paragraph 1 shall include:
A chemical and physical description, including the name under which a
new synthetic drug is known,
• information on the frequency, circumstances and/or quantities
in which a new synthetic drug is encountered,
• a first indication of the possible risks associated with the new
synthetic drug, (JA article 3, 2)
Explanation
The requirements at level 1 of the information exchange are set out in more
detail below.
12
Information required
The chemical composition is the key element of
identification (scientific name). It is also important
to know whether samples on the market contain
the NSD only or if it is mixed with other substances.
In this case, information on the average
content and range of the NSD is needed.
The physical description of the different forms in
which the NSD is encountered will assist the visual
identification of the substance on the market. It
is therefore important to describe the form (pill,
powder, capsule), colour, shape, size, weight, logo
and other relevant markings.
The name(s) and synonyms under which the NSD
is known (street name) is also relevant and could
help to determine whether it was sold as itself or
as something else (e.g. paramethoxymethylamphetamine
or PMMA sold as ‘ecstasy’).
A chemical and
physical description,
including the name
under which a new
synthetic drug (NSD)
is known
13
This refers to the information available about the
circumstances in which the drug is encountered,
especially:
• number of occurrences (e.g., seizures,
deaths);
• quantities;
• dates and places where found; and
• circumstances of findings (e.g., rave parties).
Although knowledge of risks is generally limited at
this stage, preliminary information might include
immediate effects reported (symptoms, onset of
action, intoxication, adverse reactions, mixtures
with other drugs).
Information on the
frequency, circumstances
and/or quantities
in which a new
synthetic drug is
encountered
A first indication of
the possible risks
associated with the
new synthetic drug
Level 2
Background
For level 2, the Joint Action specifies the need for more detail.
And, (the information referred shall include), as far as possible:
• information on the chemical precursors,
• information on the mode and scope of the established or expected
use of the new synthetic drug as a psychotropic substance,
• information on other use of the new synthetic drug and the extent of
such use,
• further information on the risks of use of the new synthetic drug,
including the health and the social risks. (JA article 3,2)
Explanation
The requirements at level 2 of the information exchange are set out in more
detail below.
14
Information required
Relevant information on precursors used in and
needed for the production process, and, if
possible, information on the availability of the precursors
at national level (e.g. industrial use).
Information focused on the use of the NSD as a
psychotropic substance, and in particular:
• the type and patterns of use: to what extent
the user knows what drug he is taking or
whether the user believes it is something else
(e.g. ‘ecstasy’), the effects expected or
searched for by the user, the user’s purpose
(experimental, recreational, social), the route
of administration, combination with other
substances, knowledge and perceptions, etc.;
• information from local services (observed
effects, attitudes of users);
Information on the
chemical precursors
Information on the
mode and scope of
the established or
expected use of the
new synthetic drug
as a psychotropic
substance
15
• the types of users – age, gender, social
aspects, etc.; and
• the types of places – rave parties, discos,
bars, private.
Information on the use, other than psychotropic,
such as medical, nutritional, esthetical, performance,
industrial, etc. In particular the information
available on users, circumstances and the
extent of such use.
At this stage the information should be focused in
more detail on the reported effects, in particular:
• the immediate effects;
• the short-term effects (if available); and
• the medium-term effects (if available).
These effects could be presented in the various
relevant fields (physical, psychological, individual
behaviour, and social). Referring to the EMCDDA’s
risk-assessment guidelines could be useful for the
collection of this information.
Information on other
use of the new synthetic
drug and the
extent of such use
Further information
on the risks of use of
the new synthetic
drug, including the
health and the social
risks
D. Reporting and feedback
Background
The Joint Action outlines the procedure to be followed.
The EDU and the EMCDDA shall collect the information received and communicate
this information in an appropriate manner immediately to each
other and to the Europol National Units and the representatives of the
Reitox-network of the Member States, to the Commission and the European
Agency for the Evaluation of Medicinal Products. (JA article 3,1)
Explanation
16
Communication
Independently of the communication between
ENU and Europol (Europol’s remit), the contacts
between the NFPs and the law-enforcement
sources are important.
Reporting forms and a feedback templates are
used.
Interactive communication tools for use between
the EMCDDA and the NFPs through the Reitox
website have been developed.
The Commission Focal Point receives the same
information as the other Focal Points.
The Commission also receives the EMCDDA/
Europol ‘Article 3 reporting form on NSD’ and the
EMCDDA/Europol Progress Report on NSD.
The EMEA receives the same information as the
Commission.
The NFP provides feedback to the partners in its
national network. These partners provide all relevant
information to the NFP (bottom-up and topdown).
Between ENU and
Europol
Between the
EMCDDA and NFPs
(feedback)
To the Commission
To the EMEA
Between the NFP
and its national
networks
E. Structure of national sources for the earlywarning
system
Background
The Joint Action outlines the respective responsibilities within the Member
States for providing the necessary information.
Each Member State shall ensure that its Europol National Unit and its representative
in the Reitox network provide information on the production, traf-
fic and use of new synthetic drugs to the Europol Drugs Unit (EDU) and the
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), taking
into account the respective mandates of these two bodies. (JA article 3)
Explanation
When considering an appropriate structure for national EWS sources, it is
useful to bear in mind the following questions:
• How does each Member State ensure that its Europol National
Unit and its Reitox National Focal Point obtain the information
requested?
• How is the information collection organised in each Member
State?
• How is this information analysed, cross-checked and validated?
The following key elements have been identified.
17
Key elements
• National coverage
• Coordination body
• Political support
• Data collection and feedback tools
• Validation system
Part of a general
national system to
monitor drug use
A suggested structure for these sources is illustrated opposite.
18
• Agreed criteria and procedures
• Regular meetings and support activities
• Support of health authorities for the EWS
• Partnership with relevant services
• Horizontal coordination and partnership
with the ENU and national law-enforcement
agencies
• Rapid access to seizures data
• Rapid access to forensic reports
• Access to information from prosecution
services
• Prevention units/low-threshold programmes
• Outreach/street workers
• On-site prevention programmes/pill-testing
interventions
• Qualitative researchers
• Rapid access to clinical data
• Networking sources (emergency wards, poison
units, non-forensic labs, GPs/medical
on-site interventions)
• Information map of laboratories
• Access to toxicological analysis
• Regular two-way information flows
• Access for laboratories to electronic
forum/databases
Part of a general
national system (cont.)
Health and social
sources
Law-enforcement
sources
Sources used to monitor
emerging trends
Linked to the clinical
network
Linked to the network
of forensic and toxicological
laboratories
(Please also refer to the Checklist on page 32.)
19
Suggested structure
Health and Treatment Outreach Law-enforcement Others
epidemiology sources sources sources
(Reporting) Forms in electronic version: real-time responses
Links with laboratories
National Focal Point (validation and notification)
Extended glossary
The purpose of the extended glossary is to explain in more depth procedures
and definitions of key terms and concepts from the perspective of the
EMCDDA.
1. A new synthetic drug
The scope of the Joint Action (article 2) considers synthetic drugs (2) which
are:
• not currently listed under any of the Schedules of the 1971 UN
Convention on Psychotropic Substances
These may, however, already be controlled by national legislation
in one or several EU Member States.
• posing a comparable serious threat to public health as the substances
listed in Schedules I or II of the Convention
In general, little sound knowledge is available about a new
substance appearing on the drug scene. Consequently, a comparison
with the effects of scheduled substances could turn out
to be difficult or impossible at a first stage. This explains the
importance given by the Joint Action mechanism to the collection
and exchange of information (article 3) and to the scientific
assessment of health and social risks (article 4).
• with limited therapeutic value
This criterion may exclude drugs with a well-recognised therapeutic
value, meaning that it has a current legitimate use and
that it cannot be replaced with another substance if this causes
important medical and commercial consequences. This particular
aspect has also to be assessed (article 3,2; article 4).
20
(2) Synthetic drugs cover a wide range of types/groups of substances. The date of
‘invention’ of each of these drugs is not an indication for whether the drug
should be considered as new in the framework of the Joint Action. For example,
MDMA was patented by Merck in Germany in 1912 and Shulgin’s list of
phenetylamines appeared in 1991.
2. The grey zone
Diverted medicines which have a recognised therapeutic value (e.g. ketamine)
are concerned by a number, but not all, criteria of the Joint Action
(article 2). These are non-scheduled synthetic drugs, appearing in similar
conditions of use as scheduled synthetic drugs and which may pose comparable
health problems to users. Diversion from legitimate supply and/or
the scale of trafficking are also important criteria.
The Joint Action only focuses on synthetic drugs which can be classified in
Schedules I and II of the 1971 UN Convention. This definition excludes de
facto from the procedure of article 5 all substances with a well-established
therapeutic value. However, the above-mentioned diverted medicines could
be taken into consideration by the responsible political bodies (Commission
and Council) in the course of the further development of the Joint Action
system.
3. An early-warning system
In general, early-warning systems are defined as information systems used
to obtain an early indication on possible risks (industry, environment,
health), with the main objective being to prevent the spread of negative consequences
through quick responses and preventive action.
Within the framework of the Joint Action, an early-warning system is a system
which proves its capacity to detect a new substance and, with a high
degree of probability, to identify this new synthetic drug within a short delay
from the moment it appears on the national market and/or in the territory
(transit flows). The capacity to do this is determined by the coverage and
sensitiveness of the national network and by its rapidity in collecting,
exchanging, centralising and validating the information for transmission to
the relevant partners.
Although this EWS should specifically respond to the need for rapid detection
and identification of a substance, it should also have the capacity to
‘complete the picture’ as is clearly indicated in the two separate sub-articles
(a and b) of article 3 of the Joint Action.
When further developed, this EWS may also be able to contribute to identifying
and monitoring emerging trends. However, a clear distinction should
be made and maintained between, on the one hand, the specific objectives,
information collection system and strict delivery procedures of the Joint
Action (EU Council decision) and, on the other hand, the collection and dispatching
of information on emerging trends. The latter is a complementary
21
project, which is not bound by a legal text such as the Joint Action and
which aims to cover all kinds of drugs and user groups.
4. A trend (emerging, stabilising, decreasing)
Definitions
Trend: Consistent changes in the same direction observed in successive
measures of a specified phenomenon over a given period of time.
Trend in drug use: A trend (as defined above) in the prevalence or pattern
of use of specified drugs.
New trend: A trend in the use of drugs in a given population or community
which has not been observed before in that population or community
within a defined historical period.
System to monitor trends in drug use: A broad concept covering mechanisms
for the systematic collection of information that can detect and track
trends in the prevalence and patterns of drug use, independently of whether
the drugs are new or not, natural or synthetic. The coverage of different
information sources varies – as does the way in which data collection structures
are organised – but it is likely to include data from the EMCDDA’s five
key epidemiological indicators as well as from other less standardised
sources such as local monitoring systems, qualitative ‘leading edge’ indicators,
etc.
Context and objectives
As with all trends by definition, trends in drug use are not immediately
established as such, even if they are sometimes identified before they stabilise,
as was the case for ‘ecstasy’.
From the mid-seventies onwards, drug information systems have focused on
opiates and injectors and have not demonstrated the capacity to detect and
identify emerging trends in drug use, in particular among young users. Thus
it has been realised that, to be predicted, monitored and assessed at an early
stage, a new trend will require more sensitive information-collection methods,
closer to frontline drug use. Main methods used in this area are networking
qualitative researchers, screening youth media and Internet sites or
chat-rooms, launching short but targeted ethnographic studies among users,
introducing selected new questions in regular surveys, etc.
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5. The synergies and differences between the EWS of the Joint Action and
the existing systems for monitoring new and emerging trends
The functions of the EWS on NSD and of the Emerging Trends project are
different. The EWS of the Joint Action aims to detect a new substance, not
identify a potential trend. The rapid reaction mechanism of the Joint Action’s
EWS has been defined precisely to avoid the situation of the use of a new
synthetic drug developing as a trend.
To be sound-based and scientifically validated, the process of identifying an
emerging trend needs to track changes over a period of time in order to verify
their potential to develop and stabilise as a trend, and to predict further
evolution, if possible. Hard data are essential and sources need to be developed
and understood in the light of qualitative investigations. Even though
some information to be collected for the detection and tracking of a trend
could benefit from the capacity of the network put in place for the Joint
Action’s EWS, neither the tasks nor the outputs are the same.
On the other hand, qualitative information compiled for the purpose of
understanding emerging trends, especially in recreational settings where
synthetic drugs are commonly used, could provide useful insights into the
context within which new synthetic drugs are used.
In conclusion, the synergies between the EWS and the emerging trends systems
are:
• the sensitiveness of the system to monitor new trends can contribute
to detecting the use of new substances such as NSD;
• the focus of trend monitoring systems on users and on social
aspects could contribute to the EWS as regards information on
the context in which the NSD is used and the risks linked to it,
as well as on the effects reported by the users; and
• the information collected through the EWS gives, as far as possible,
a picture on the use of a NSD at European level.
6. A precursor
Precursors are chemical products used in the fabrication in laboratories of
synthetic or non-synthetic drugs. In the fabrication of a synthetic drug, only
chemical compounds are involved: precursors, reagents and additives. For
non-synthetic drugs, chemicals are used at the different stages in the transformation
of the raw substance into the end product. Precursors themselves
are generally the result of combining and processing various chemicals,
called pre-precursors, and reagents.
23
Reagents are chemicals used in the fabrication of synthetic drugs to stimulate
reaction in the different precursors, separately or together, during the
process of synthesising the end product.
Additives are compounds which are not used to stimulate a chemical reaction
between precursors in the synthesis process, but rather to facilitate this
reaction (e.g. dilution) or to filter a liquid solution, or to obtain the final
form, consistency, colour, etc. of the synthetic end product.
Impurities are non-desired effects of the fabrication process, at one or more
of its different stages (filtering, tableting and packaging). Along with other
elements, impurities may provide useful information to forensic laboratories
and other law-enforcement services for determining the profile of drugs for
intelligence purposes.
End product: after fabrication, the final compound to be consumed by drug
users, in its different possible forms (tablets, powder, liquid, pure or mixed
with other substances).
7. The availability of reference samples
Definitions (3)
Sample: In laboratory analysis, the equivalent to specimen; it is a representative
portion of whole material (e.g. a seizure of n units) to be tested.
Reference sample: Sample of a drug which serves as a reference for various
purposes, in particular in forensic science, for example to verify the presence
of the same drug in another sample.
Control sample: A reference sample used as a standard for verifying or
checking the findings of an experiment.
Pure standards: Samples of a pure substance, (whereas ‘reference samples’
may contain various components).
Certified samples: Reference samples in which one or more of the property
values has been certified by a technical procedure, accompanied by (or
traceable to) a certificate or other documentation that has been issued by a
certifying body.
Reference standards: A standard, generally of the highest quality available
at a given location, from which measurements at this location are derived.
24
(3) United Nations International Drug Control Programme (1995), ‘Glossary of
Terms for Quality Assurance and Good Laboratory Practices’, Vienna.
Context and objectives
The availability of reference samples is important for forensic and toxicology
laboratories when they want to identify a drug, especially in the case
where the drug is new and limited scientific literature on it is available to
them. The best and most cost-effective way of identifying a new drug is to
match the sample transmitted to the laboratory for analysis with a reference
sample, applying the same analytical methods to both samples.
A reference sample is also important as laboratories need to provide accurate
information not only on seizures of a particular drug in Member States,
but also on its presence in body fluids in accident, emergency and post
mortem cases. Such information is also a key element of the technical annexes
of the EMCDDA’s guidelines upon which the risk assessment is based.
The availability to laboratories of reference samples would also enhance the
process of building up a laboratory network for the purpose of the Joint
Action (see point 8 below).
At first glance, the issue of transmitting a sample of a non-controlled drug
could appear to be quite a simple one. However, this is not the case: a new
synthetic drug may be controlled in some Member States and not in others,
and legal conditions on this issue are currently not set up in most Member
States or at EU level.
Different, complementary approaches could be combined in order to tackle
this issue.
Political level
In its conclusions of the risk assessment of 4-MTA, the enlarged Scientific
Committee recommended that ‘when a new synthetic drug is notified for
risk assessment, arrangements be made for the provision of standard reference
material and associated analytical data to forensic and toxicology laboratories
within the European Union’.
This recommendation, supported by an explanatory memorandum from the
Scientific Committee, needs to be discussed at political level (Commission,
Council).
EWS level
Short-term practical solutions can be examined:
• firstly, the possibility for NFPs to inform the EMCDDA systematically
of the name, location and contact person of the laboratory(
ies) involved in the identification of a NSD following its
25
detection by seizure or another event. This information could
then be forwarded by the EMCDDA to the laboratory network
of the EWS at European level; and
• secondly, the organisation of permanent access to a library of
GC/MS chromatograms and other analytical documents, on
the basis of existing databases and other sources.
Further development is also required with regard to recording progress on
the availability of reference samples.
8. The laboratory network
The importance of links with forensic and toxicology laboratories for the
purpose of early detection and identification of a new synthetic drug has
been underlined as a key aspect of an EWS. The two levels of work in this
area should be distinguished.
National level
The setting up of a network of laboratories requires:
• mapping all the laboratories that could be involved, at any
stage, in the process of detecting/identifying a NSD;
• taking into account various information flows – from a laboratory
to the NFP and vice-versa, and between laboratories; and
• ensuring the maintenance of the information flow and the
motivation and effectiveness of the network, by: the quality
and relevance of the information dispatched to the laboratory
network; easy and selective access to this information
(electronic tools, links to databases, etc); and regular meetings
(specialised, local, national).
EU level
The EMCDDA is in charge of providing the national EWS and their partner
laboratories with:
• clear definitions of the scope of action, the role of each actor,
agreed criteria and procedures for reporting, and feedback etc.;
• quality control (validation); and
• information and feedback in line with agreed definitions,
criteria and procedures.
26
Future actions envisaged include:
• providing access to an online European inventory of NSD with
links to existing national databases;
• documentary support, when available (scientific references,
analytical papers, etc.);
• updating this guidance booklet taking into account new experience;
and
• organising meetings.
9. Step-by-step procedure for data collection and transmission (JA article 3)
Level 1
As indicated in Part C, the detection of a new synthetic drug implies a rapid
process of collection and transmission of the information.
Procedure for the transmission of information upon the first notification of
a new synthetic drug
Two situations can be distinguished when a NSD is detected:
Situation 1: Member States where the NSD is encountered
In each Member State where the first detection of a NSD occurs, the
information collected and rapidly sent to the EMCDDA should give
the necessary elements to enable other Member States to check
whether the drug is also present in their country (identification of the
drug):
• a precise physical description (for visual identification of the
product);
• the chemical composition;
• street name(s) when known;
• the event through which the new drug has been encountered
(e.g. seizure, forensic analysis of fluids, pill test);
• the service (or programme, if pill testing) which has detected
the drug;
• date and location of the event;
• quantities found; and
27
• other significant information if rapidly available (e.g. name of
the laboratory which has identified a NSD).
Situation 2: Member States where the NSD is not detected at the time
of its first notification in one (or more) other Member State(s)
In these countries, as soon as the first notification is received of a
NSD in (an)other Member State(s), the national EWS should:
• quickly disseminate the information from the EMCDDA to the
national EWS partners in order to enable them to identify the
substance;
• actively check this early-warning information with the national
EWS partners; and
• inform the EMCDDA about the results of the check-up as soon
as it is completed.
If the NSD is found through this process, the country enters in Situation
1 as described above.
Procedure for new information to be collected after the first notification
(both for Situations 1 and 2)
As soon as new information is collected which is liable to modify the pro-
file of the information already known, this information should be transmitted
without delay to the EMCDDA. Examples of such information are:
fatality, non-fatal acute intoxication, significant seizure (in terms of volume,
its particular location and/or circumstances), first findings from the forensic
analysis of samples.
The types of information that can be compiled in a short report are:
• data which are not liable to modify the profile of the information
already transmitted to and by the EMCDDA; and
• data which require a delay for reasons of quality check and
validation.
The rhythm of reporting depends on the importance (nature, amount, frequency)
of the information collected. The EMCDDA may always be consulted
in case of doubt. The EMCDDA itself may also ask for an update (e.g.
for the preparation of a Joint Progress Report with Europol).
28
Level 2
Part C lists the main items which require an information search in order to
obtain a more complete picture of the characteristics, mode, context, possible
scope and risks of use of a NSD.
This more in-depth data collection process should be followed up with a
combination of rapid reporting and the transmission of compiled information.
(In this situation the same procedure as the one followed after the first
notification applies.)
For both levels 1 and 2, the information should, as far as possible, be validated
by the NFPs as well as by the EMCDDA (see point 14 below).
10. Status of information
Two different types of information to be transmitted can be identified:
• information relevant to the scope of the Joint Action; and
• information not relevant to the scope of the Joint Action.
Consequently, two different statuses as regards the transmission of information
by the EMCDDA can be distinguished:
• for action; and
• for information.
Synthetic drugs that do not fall within the scope of the Joint Action may be
the subject of information (4) sent to the Reitox network because of risks or
harm arising from, for example:
• their marketing form and promotion;
• their higher dosage than the one commonly expected by users;
• their mix with another drug (not a new synthetic drug) or with a
dangerous additive (e.g. strychnine) which could pose a serious
health risk; and
• the number of acute incidents in a short period of time suggesting
a particular and unusual problem to be quickly identified.
29
(4) If a NFP or the EMCDDA decides to provide the Reitox network with information
on synthetic drugs not falling within the scope of the Joint Action, this cannot
be done as a Joint Action procedure. It means that there is no obligation for
any partner of the Joint Action’s EWS to reply, to use or to report such information
received from either the Centre or a NFP.
A NFP could also envisage providing such information to national partners
as well as to the EMCDDA when the necessity arises for a broader dissemination
for prevention purposes. The EMCDDA can then disseminate this
information according to a number of criteria:
• quality check of the information, including its origin
(official/non official);
• seriousness of an immediate or potential risk; and
• geographical dimension of a potential spread of the risk.
11. Cooperation between law-enforcement and health cultures
The collection and exchange of information between the EMCDDA and its
Reitox network, on the one side, and Europol and its network of ENUs on
the other, is based on the principles of specialisation and complementarity
with full respect for each agency’s mandate, work programme and core
tasks. The EMCDDA’s mandate for the collection and exchange of information,
set out in its founding regulation, strictly excludes any data related to
an identified or identifiable individual or to groups of individuals. The scope
of the information requested from the EMCDDA and the NFPs and their
national health and social partners for the purpose of the Joint Action is not
related to or seeking intelligence data or other information exploitable as
such. Cooperation between health and law-enforcement cultures is focused
and limited to identifying new synthetic substances and the collection of
data on their associated effects and potential risks. The fact that the
EMCDDA and Europol are accountable to their respective mandatory bodies
and to the relevant EU Institutions ensures that these obligations and
rules are strictly respected.
12. Prevention
The Joint Action in fine aims to prevent the spread of the use and trafficking
of potentially dangerous new substances within the context of its political
orientation to decide whether or not control measures should be taken on
new synthetic drugs in the shortest delay possible after they appear on the
market.
The information on the health and social risks of synthetic drugs gathered
through the early-warning mechanism, but which falls outside the scope of
the Joint Action, may be of great value to health services and prevention networks
as well as to current or potential users, with a view to preventing serious
or fatal intoxications. Therefore, it is the EMCDDA’s responsibility to
30
transmit to the NFPs all relevant information when it deems that the information
at its disposal could serve this purpose. It is the responsibility of
national authorities to decide whether or not to use such information for the
purpose of preventive action at local or national level.
13. The use of electronic tools for the exchange of information
A key word emerging from the Joint Action is rapidity. Electronic tools offer
a range of possibilities to transmit and exchange information ‘in real time’.
These tools can facilitate the distinction between the different levels of information,
the status of the information and, moreover, can enhance the
cooperation between all actors involved in the EWS.
Taking into account the fact that some NFPs have already implemented specialised
EWS databases, an important development in the functioning of the
EWS could be to organise a website. In doing so, the national partners in
the EWS network could rapidly provide and have access to information
respecting an agreed common definition of the status of each data type.
14. Validation of the information (cross-checking/quality assurance)
Information received by the NFP from national or local partners of the
national EWS should be sent to the EMCDDA, and at the same time steps
taken to validate it.
The EMCDDA checks the information received from a NFP before its transmission
to the Reitox network.
In both cases, the quality check involves:
• identifying the primary source and/or secondary source of the
information;
• quoting date and place when/where the information was
issued, if available;
• assessing the reliability and quality of the information (ranking
from scientific peer-reviewed publication, official or authorised
sources to unconfirmed rumour); and
• assigning a status to the information (see point 10 above)
before transmission.
31
Checklist on the functioning of a national earlywarning
system on new synthetic drugs
1. Capacity for the early detection of a NSD
Sensitiveness
Is the sensitiveness of the national EWS considered by the Reitox NFP to be
sufficient to ensure that a new substance can be detected at an early stage
in the country and that the relevant preliminary information can subsequently
be collected and rapidly transmitted to the EMCDDA?
National coverage
How is this coverage organised? For example, is the coverage based upon
the selection of a limited number of cities, districts, locally-based entities or
‘spots’, and/or field workers? Are they adequate, in terms of their location
and respective capacity, to ensure that the web-like structure of the system
can capture significant signals on the appearance of a new synthetic drug
at an early stage and can report on this matter quickly?
Coordination body
Does the national EWS dispose of a well-identified coordination unit, with
corresponding political support, which can act as the central point for information
flows (collection, exchange and feedback), and which can also
ensure and enhance an effective partnership between the Reitox channel
and the law-enforcement side (national agencies and local police)? Check
whether the law-enforcement information is directly channelled through the
Europol National Unit or through other channels.
Information collection and transmission
Are data collection and analysis carried out on an ongoing basis (and not
sporadically) and sent regularly to the EMCDDA, using the agreed instruments
and mechanisms?
Development of the EWS network
Does the NFP regularly organise national meetings with the key partners of
its EWS and does the NFP provide detailed information on the outputs to the
EMCDDA?
32
Validation panels
How is the process organised for assessing the quality of the information
collected from different sources, and how is this information validated in
terms of its relevance for the purpose of the Joint Action’s EWS?
Levels of mobilisation of the network
Does the EWS have selective criteria for the dissemination of information
inside and outside the national network? Are there different levels of mobilisation
of the network, e.g. alert messages, requests for collecting and/or disseminating
specific information to local partners (informants, selected or all
potential users in a setting, the whole EWS network, national health authorities)?
What procedure is followed in the case of an alert message?
Sources of information
Which sources of information are used, for example, for:
• collecting data on availability and on prices of a NSD at user
level?
• collecting information on patterns of use of a NSD and the
relationship with other drug use patterns; on the characteristics
of users and users groups and of the related settings; on the
perceptions of users (expected effects, perceived effects) and of
local services (observed effects, attitudes of users)?
• collecting information on the combination of the new synthetic
drug with other licit or illicit drugs?
Level/rapidity of access
What is the level/rapidity of access to relevant services for obtaining information
on the circumstances of an event (acute intoxication, local seizure,
arrest, etc.) which has been reported to involve the use, possession, small
or major trafficking of a new synthetic drug?
33
2. Main functions of an EWS
Is the effectiveness of the information flows (two-way, selective, rapid)
ensured?
Is national coverage ensured?
Is the validation and rapid transmission of the relevant information to the
EMCDDA ensured?
Is the maintenance of the network’s response capacity provisioned for? Does
it ensure that partners receive added value from their participation at
national and EU levels (e.g. forums of exchange, electronic tools, access to
database, targeted feedback, training and other supporting activities, etc.)?
Is there quick access to hard data on the frequency/quantities encountered
from cases detected by law-enforcement services and forensic laboratories?
Is there access to information at user level through primary sources (outreach
workers, pill-testing and/or other on-site prevention teams, lowthreshold
units, etc.)?
Is there access to clinical data through established links with secondary
sources (poison units, hospital emergency wards, non-forensic laboratories,
etc)?
Is there access to additional information on circumstances of the cases
detected (local police, judicial system, etc.)?
34
Text of the Joint Action
97/396/JHA: Joint Action of 16 June 1997 adopted by the Council
on the basis of Article K.3 of the Treaty on European Union,
concerning the information exchange, risk assessment and the
control of new synthetic drugs
Official Journal L 167, 25/06/1997, pp. 1–3
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, in particular Article K.3 (2)
(b) thereof,
Having regard to the initiative of the Netherlands,
NOTING that the Dublin European Council welcomed the progress report
on drugs on 13 and 14 December 1996 and endorsed the action proposed
in that report, including the proposal to tackle the problem of synthetic
drugs at three levels, namely, through legislation, practical cooperation
against production and trafficking and international cooperation,
REFERRING to the Joint Action 96/750/JHA of 17 December 1996, adopted
by the Council on the basis of Article K.3 of the Treaty on the European
Union, concerning the approximation of the laws and practices of the
Member States of the European Union to combat drug addiction and to prevent
and combat illegal drug trafficking (1),
REFERRING in particular to Article 5 of the said Joint Action, which provides
that the Member States shall endeavour to draft convergent legislation
to the extent necessary to make up legal ground or fill legal vacuums as
regards synthetic drugs. In particular they shall promote the establishment
of a rapid information system to enable such drugs to be identified as
substances liable to be prohibited as soon as they appear anywhere in a
Member State,
CONSIDERING that the particular dangers inherent in the development of
synthetic drugs require rapid action by the Member States,
CONSIDERING that when new synthetic drugs are not brought within the
scope of criminal law in all Member States, problems may arise in the international
cooperation between the judicial authorities and law enforcement
35
(1) OJ No L 342, 31.12.1996, p. 6.
agencies of the Member States owing to the fact that the offence or offences
in question are not punishable under the laws of both the requesting and the
requested State,
CONSIDERING that from an inventory drawn up since the adoption of the
said Joint Action it can be concluded that new synthetic drugs have
appeared within the Member States,
CONSIDERING that common action can be taken only on the basis of reliable
information on the emergence of new synthetic drugs and the results
of expert assessment of the risks caused by the use of the new synthetic
drugs and implications of submitting such drugs under control,
CONSIDERING that it is therefore necessary to set up a common mechanism
permitting expeditious action, in taking necessary measures or introducing
controls on new synthetic drugs, on the basis of a rapid exchange of
information on new synthetic drugs emerging in the Member States and the
common assessment of the risks thereof,
WITHOUT PREJUDICE to the powers of the European Community,
HAS ADOPTED THIS JOINT ACTION:
Article 1: Purpose
This Joint Action aims at 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.
This mechanism will be jointly implemented in accordance with the procedures
established hereunder.
Article 2: Scope
This Joint Action concerns new synthetic drugs which are not currently listed
in any of the Schedules to the 1971 United Nations Convention on
Psychotropic Substances, and which pose a comparable serious threat to
public health as the substances listed in Schedules I or II thereto and which
have a limited therapeutic value. It relates to end-products, as distinct from
precursors in respect of which Council Regulation (EEC) No 3677/90 of 13
December 1990 laying down measures to be taken to discourage the diversion
of certain substances to the illicit manufacture of narcotic drugs and
psychotropic substances (2) and Council Directive 92/109/EEC of 14
36
(2) OJ No L 357, 20.12.1990, p. 1. Regulation as last amended by Commission
Regulation (EEC) No 3769/92 (OJ No L 383, 29.12.1992, p.17).
December 1992 on the manufacture and the placing on the market of
certain substances used in the illicit manufacture of narcotic drugs and
psychotropic substances (3) provide for a Community regime.
Article 3: Exchange of information
1. Each Member State shall ensure that its Europol National Unit and its representative
in the Reitox network provide information on the production,
traffic and use of new synthetic drugs to the Europol Drugs Unit (EDU) of
the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA),
taking into account the respective mandates of these two bodies. The EDU
and and the EMCDDA shall collect the information received and the communicate
this information in an appropriate manner immediately to each
other and to the Europol National Units and the representatives of the
Reitox-network of the Member States, to the Commission and the European
Agency for the Evaluation of Medicinal Products.
2. The information referred to in paragraph 1 shall include:
(a) – a chemical and physical description, including the name under which
a new synthetic drug is known,
– information on the frequency, circumstances and/or quantities in which
a new synthetic drug is encountered,
– a first indication of the possible risks associated with the new synthetic
drug, and, as far as possible:
(b) – information on the chemical precursors,
– information on the mode and scope of the established or expected use
of the new synthetic drug as a psychotropic substance,
– information on other use of the new synthetic drug and the extent of
such use,
– further information on the risks of use of the new synthetic drug, including
the health and the social risks.
Article 4: Risk assessment
1. At the request of one of the Member States or the Commission, the
EMCDDA shall convene a special meeting under the auspices of the Scientific
Committee extended with experts nominated by the Member States and
37
(3) OJ No L 370, 19.12.1992, p. 76. Directive as amended by Directive 93/46/EEC
(OJ No L 159, 1.7.1993, p. 134).
to which representatives of the Commission, the EDU and the European
Agency for the Evaluation of Medicinal Products shall be invited.
This committee shall assess 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.
2. The risk assessment shall be carried out on the basis of information provided
by the Member States, the Commission, the EMCDDA, the EDU of
the European Agency for the Evaluation of Medicinal Products and taking
into account all factors which, according to the 1971 United Nations
Convention on Psychotropic Substances, would warrant the placing of a
substance under international control.
3. On completion of the risk assessment, a report will be drawn up on the
findings. In the report all aspects shall be addressed. All opinions on these
aspects shall be reflected in the report.
Article 5: Procedure for bringing specific new synthetic drugs under control
1. 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.
If the Commission deems it not necessary to present an initiative to have the
new synthetic drug or drugs submitted to control measures, it shall present
a report to the Council explaining its views.
The Member States undertake, in accordance with the decision taken by the
Council, within such delay as that decision may specify, to take the necessary
measures in accordance with their national law to submit these new
synthetic drugs to control measures and criminal penalties as provided
under their legislation complying with their obligations under the 1971
United Nations Convention on Psychotropic Substances with respect to substances
listed in Schedules I or II thereto.
2. Nothing in this Joint Action shall prevent a Member State from maintaining
or introducing on its territory any national control measure it deems appropriate
once a new synthetic drug has been identified by a Member State.
3. The Presidency shall each year submit a report to the Council on the
implementation of the decisions adopted by the Council on the basis of
paragraph 1.
38
Article 6: Publication and entry into force
This Joint Action shall be published in the Official Journal.
It shall enter into force on the day of its publication.
Done at Luxembourg, 16 June 1997.
For the Council
The President
H. VAN MIERLO
39

Reputation Comments on this post:

	very interesting and hopefully a light on the horizon
	Great information for those interested and who understand it

[dr ACE]

you got to be really bored to read all that lol (no offense alfa)

[hardcoreharmreducer]

The European strategie to go after mdma procussers and cut of supply for producers is a bad thing for the health of users. And certainly if there's no possibillity's to test your stuff.

The occurring of mcpp in the summer of 2005 is possibly a side-effect of the euro-police focus on mdma precursors and therefore shortage in the xtc production market. The police will say ‘aha our approach works ‘, but producers just find other chemicals for other kinds of drugs (like now mcpp).

The occurring of new chemical drugs is a sign that the policy focus on drug precursors fails and not that it’s working (sortage in mdma precursors).

Moreover: it’s a dangerous policy for public health because producers start experimenting under un-controlled circumstances again. Governments gave synthetic drug production to organised crime and this guy's’ll throw on the market whatever they produce.

grtz
stijn

[Alfa]

Originally Posted by dr ACE

you got to be really bored to read all that lol (no offense alfa)

On the contrary. Yes, it is a lot of text. But it sheds light on how the EU makes new synthetic drugs illegal. So in my view, this is more interesting info than how new drugs are made. And I find the latter most interesting info.

[imyourlittlebare]

I just dont understand..... it seems like the more synthetic the drug gets, the more side effects or health risks one may have. Like LSD. Hallucinogenic, but relativaly safe. To keep things short it went to ketamine for people, then salvia (which seems safe but pharmacology is much different) and a resurfacing of usage of anti-cholinergics, anti-histamines, cough-syrups and other drugs that scream im safe. I dont know, its the same with opiates. It used to be smoking opium. Now theres stuff 1000 times stronger than morphine in a microgram used in elephants? common now.

Great article alfa! Im glad someone enjoys reading journal articles and various reports on Narcotics and such

[razorweb]

yes swim agrees as well that the police and govenments will be responsible for more deaths trying to stop xtc production simply by forcing production of more chemicals
unknown and untested. Hence all the garbage in pills nowadays. hence why people get DXM and piperazines in so called mdma rolls