Decision of the European Commission following the EMCDDA's risk assessment of ketamine.
REPORT FROM THE COMMISSION TO THE COUNCIL called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning Ketamine
1. 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.
2. 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".
3. 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."
4. 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.
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).