5.1. Legal status
Ketamine is subject to control in five Member States: Belgium, France,
Greece, Ireland (to be scheduled in the Misuse of Drugs Act) and
Luxembourg. It is controlled through general medicines legislation in all
Member States. Due to the fact that ketamine preparations, as medical and
veterinary products, have marketing authorisation in most Member States
and have a recognised unique therapeutic value, the major concern appears
to be diversion from legitimate supply to the black market.
The complex routes of synthesis for illegal manufacturing of ketamine
reduce the potential impact on the illegal market for ketamine of targeted
measures to control ketamine precursors. Illegal production of ketamine is
unlikely to develop, due to these conditions. However, the implication of
organised crime in the production and supply of ketamine in tablet form,
with the possible health risks associated with sale of ketamine tablets with
ecstasy logos, represents a particular matter for concern.
5.2. Possible consequences of prohibition
The possible consequences of prohibition discussed at the meeting included
The EMEA highlighted the fact that changes in the conditions of marketing
authorisations for ketamine containing medicinal products proposed by
the meeting should be dealt with at national level or referred to the
Committee for Proprietary Medicinal Products (CPMP) and the Committee
on Veterinary Medicinal Products (CVMP).
Introducing penalties for use would be unlikely to deter use in groups
where illegal drugs are already well established.
Concern was expressed about the effects of prohibition and control measures
on informal information and harm-reduction networks.
One opinion was that control measures might draw unnecessary attention
to the drug, thus increasing its attractiveness to potential users.
In discussions on possible mechanisms of control, differences between
control of the bulk drug and of medicinal products containing ketamine
were mentioned. In this regard, there was strong support for the suggestion
that the chemical and pharmaceutical industry should be consulted about
suitable control measures.
The view that, as a common minimum approach, medicines legislation (4)
should be used as a control measure received strong support.
Another opinion expressed at the meeting was that, in addition to existing
medicines legislation, stronger control measures to deal with diversion,
trafficking and inadvertent exposure (i.e. through fake ‘ecstasy’ tablets)
were necessary. It was also felt that such measures are required to control
the import and export of ketamine.
The meeting noted the concern of the Federation of Veterinarians of
Europe that placing ketamine under the same stringent restrictions as opioids
could be detrimental to good veterinary medicine. It was noted that the
same concern could apply to the use of ketamine in human medicine.
(4) Legislation such as the EU regulation based upon Council Directive 65/65/EEC of 26 January 1965,
as amended by Directives 83/570/EEC, 87/21/EEC, 89/341/EEC and 93/39/EEC, as well as decisions
of the Court of Justice of the European Communities, especially Case C-112/89.