Report from the Commission to the Council called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning Ketamine
Date: 2000-11-16
Institutions: European Commission
Subjects: health control, health policy, health risk, medicinal product, narcotic

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.11.2000
COM(2000) 737 final

REPORT FROM THE COMMISSION TO THE COUNCIL

called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning
Ketamine

REPORT FROM THE COMMISSION TO THE COUNCIL

called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning GHB

REPORT FROM THE COMMISSION TO THE COUNCIL

called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning
Ketamine

REPORT FROM THE COMMISSION TO THE COUNCIL

called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning GHB

1.

2.

3.

4.

Commission Report on Ketamine

On 17 October 2000, the European Commission received from the EMCDDA the
report of the risk assessment of ketamine (2-(2-chlorophenyl)-2-(methylamino)-
cyclohexanone). The risk assessment report was established following a meeting on
25-26 September 2000 of the Scientific Committee of the EMCDDA and experts
nominated by the Member States, representatives of the Commission, Europol and
the EMEA. The risk assessment was requested by the Horizontal Drugs Group in
April 2000,
in the framework of the Joint Action on New Synthetic Drugs of
16 June 1997.

Article 5 of the Joint Action states that following the establishment of the report
there can either be an initiative presented to the Council within a month to make the
new synthetic drug subject to measures of control, or “if the Commission deems it
not necessary to present an initiative … it shall present a report to the Council
explaining its views”.

Article 2 of the Joint Action states that the 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.”

The Commission has considered the conclusions of the report and notes the
following:

4.1. Ketamine was first synthesised in 1962 and patented in 1963.

4.2. Ketamine is used as an anaesthetic and analgesic and it has a unique
therapeutic value in veterinary practice and value also in human medicine.

4.3. Ketamine is used as a medicine in nearly all Member States and is subject to
the medicine legislation. It can legally be sold only to authorised people (eg
pharmacists).

4.4. Ketamine is also used in recreational settings. In illicit use, an important factor
of health risk is the lack of reliable indication of dose and the mixture with
other substances accompanying sales of ketamine at street level. In some
Member States, ketamine tablets are sold as ecstasy.

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4.5. Ketamine has been associated with four deaths in the EU since 1996, in none
of them ketamine was considered the main cause of death. There is a lack of
information about hospital emergencies.

4.6. The main effects of ketamine are anxiety, agitation, changes in perception and
the analgesic effects. In such condition, the user may be at risk of injury.
Ketamine is contraindicated in patients with significant ischaemic heart disease
and is to be avoided in those with a history of high blood pressure or
cerebrovascular disorders.

4.7. There is no evidence that ketamine causes an abstinence syndrome in human

beings.

4.8. The manufacturing process of ketamine is complicated. The precursors and
numerous solvents and reagents needed for the manufacture of ketamine are
difficult to obtain and the supply for illicit recreational use comes mostly from
diversion from licit market. Seizure data suggests mostly low levels of
availability of ketamine for illicit use.

5.

Basing itself solely on the risk assessment report on ketamine and the principle of
proportionality, the Commission concludes that it is not appropriate to present an
initiative to the Council to propose that ketamine be submitted to control measures at
the EU level, as provided for by Article 5(1) of the Joint Action on New Synthetic
Drugs. But the Commission will:

5.1. Suggest that possible improvements in the control of diversion be discussed
with the chemical and pharmaceutical industry, bearing in mind the importance
of ensuring the continued availability of ketamine for medical and veterinary
use.

5.2. Encourage EMCDDA and Europol

to continue monitoring the trends in
recreational ketamine use as part of the early warning system provided for by
the Joint Action.

5.3. Welcome proposals for

research on the effects of ketamine use to be

considered by the Fifth Framework Program for Research and Development.

5.4. Take into account the outcome of the risk assessment of ketamine when it
organises the assessment of the Joint Action on New Synthetic Drugs called for
in point 2.2.5 of the EU Action Plan on Drugs (2000-2004).

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1.

2.

3.

4.

Commission Report on GHB

On 17 October 2000, the European Commission received from the EMCDDA the
report of the risk assessment of GHB (gammahydroxybutyrat). The risk assessment
report was established following a meeting on 25-26 September 2000 of the
Scientific Committee of the EMCDDA and experts nominated by the Member States,
representatives of the Commission, Europol and the EMEA. The risk assessment was
requested by the Horizontal Drugs Group in April 2000, in the framework of the
Joint Action on New Synthetic Drugs of 16 June 1997.

Article 5 of the Joint Action states that following the establishment of the report
there can either be an initiative presented to the Council within a month to make the
new synthetic drug subject to measures of control, or “if the Commission deems it
not necessary to present an initiative … it shall present a report to the Council
explaining its views”.

Article 2 of the Joint Action states that the 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.”

The Commission has considered the conclusions of the report and notes the
following:

4.1. GHB has been used therapeutically in anaesthesia since the early 1960's, later
in the treatment of alcohol withdrawal and in long term sedation. It is being
investigated for the treatment of narcolepsy associated cataplexy. Products
containing GHB have a marketing authorisation in four Member States.

4.2.

In recent years GHB has been used recreationally. When used for such
purposes, the effects of GHB are much closer to those produced by alcohol,
cannabis and benzodiazepines (Schedule IV of the 1971 UN Convention) than
they are to MDMA (Schedule I of the 1971 UN Convention) and other
stimulant drugs.

4.3. There have been some media and police reports of GHB use in drug assisted

sexual assaults, but the extent of this involvement is unclear.

4.4.

Illicit use of GHB poses risks to health, given the narrow dose margin between
the desired and the serious adverse effects. These risks increase when GHB is
combined with other substances particularly alcohol. GHB has been associated
with 11 deaths in the EU between September 1995 and January 2000. Deaths
involving solely GHB appear to be rare. At least 200 non-fatal cases of GHB
overdose have been admitted to hospital
in the EU and Norway. No
information is available on the health consequences for the general population.

4.5. Throughout the EU GHB is subject to the medicines legislation. It can only be
legally sold to authorised people. In addition, six Member States have controls
on GHB under their legislation on illicit drugs.

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4.6. The 32nd WHO Expert Committee on Drug Dependence recommended to the
UN Commission on Narcotic Drugs (CND) that GHB be listed in Schedule IV
of the 1971 UN Convention on Psychotropic Substances.

4.7. There is no information on large-scale production, trafficking and distribution
of GHB, and seizures in the EU are very small when compared to seizures of
regular synthetic drugs such as amphetamine, MDMA and MDA.

4.8. GHB can be relatively easily produced from one of two precursors: GBL
(Gamma Butyrolactone) or 1,4 butanediol. Neither is included in the list of
chemical precursors in the UN Convention of 1988. GBL is included in the
Voluntary Monitoring List under
legislation, but
1,4 butanediol is not.

the EC Precursors

4.9. Biological samples can apparently contain levels of GHB in circumstances

where there is no evidence of GHB consumption.

5.

Basing itself solely on the risk assessment report on GHB and the principle of
proportionality, the Commission concludes that it is not appropriate to present an
initiative to the Council to propose that GHB be submitted to control measures at the
EU level, as provided for by Article 5(1) of the Joint Action on New Synthetic
Drugs. But the Commission will:

5.1. Encourage the EMCDDA and Europol

to continue monitoring trends in
recreational use of GHB as part of the early warning system provided for in the
Joint Action, and to inform the Horizontal Drugs Group should they find new
elements, particularly evidence of a threat to public health;

5.2. Pass the report on the risk assessment of GHB to the “Drug Precursors”
Committee
and
Directive 92/109/EEC, and ask the Committee whether or not 1,4 Butanediol
should be included in the Voluntary Monitoring List;

of Regulation 3677/90

under Article 10

set

up

5.3. Welcome research proposals on GHB, in particular with a view to establish
guidance for best practice in handling and analysis of biological samples
containing GHB, under the 5th Framework Programme for Research; and

5.4. Take into account

the outcome of the risk assessment of GHB when it
organises the assessment of the Joint Action on New Synthetic Drugs called for
in point 2.2.5 of the EU Action Plan on Drugs (2000-2004).

5