The EU Actions On New Drugs

The EU actions on new drugs
Dr. R. Sedefov, Vilnius, 20 May 2009
EMCDDA monitoring system: sources and output

Indicator-based Event-based Reitox EWS Europol EWS Evidence base Early-warning new drugs Risk assessment Public-health warning Description state of the drugs
Adapted from R. Kaiser at al., 2005
KE indicators Crime & supply
problem in Europe
Legal framework
Joint Action on new synthetic drugs (1997) Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances
The Early Warning System (EWS) Risk assessment Control measures
Council Decision 2005/387/JHA: a three-step process

Information exchange/Early-warning
A new psychoactive substance is detected in the EU Member States and described in a reporting form
Reitox focal points
EMCDDA
The European Commission
(Official Journal/ L 117, 20.05.2005) Europol national units Europol European Medicines Agency (EMEA)
Risk assessment
The Council of the EU may request a risk assessment, based on a EMCDDA Europol Joint report
EMCDDA extended Scientific Committee
Risk assessment report
Decision-making
At the initiative of the European Commission or a Member State based on the Risk assessment report
Council of the EU decides whether or not to submit the new psychoactive substance to control measures
Council Decision on control measures
Control measures and criminal penalties in the EU Member States
The search for the new ecstasy (1997-2004)
PIHKAL and TIHKAL Tablets > powders > capsules Risk assessments (1999 2004): MBDB, 4-MTA, PMMA, TMA-2, 2C-T-2, 2C-T-7, 2C-I By 2004 over 30 illicit phenethylamines identified in EU Tryptamines all hallucinogens
Recent developments legal highs

Phenethylamines/tryptamines now less common Wide diversity of new substances & research chemicals
Substituted piperazines party pills Substituted cathinones
Misused medicinal products Plant products Spice
Piperazines (2004-2007): BZP mCPP

By 2006, 1(3-chlorophenyl)piperazine (mCPP) found in 10% of ecstasy tablets in EU. More seizures, larger quantities than any other substance since 1997 2007: EMCDDA risk assessment on 1benzylpiperazine (BZP) leads to expected EU-wide control in 2009 Critical review of six piperazine derivatives by ECDD/WHO in 2009
Cathinones (2006-2008)
Over 20 illicit substances derived from cathinone (e.g. mephedrone, methylone, MDPV) Available from websites and smart shops Mostly CNS stimulants
Plant products herbal highs

Salvia divinorum (Mexican Sage) salvinorin A Mitragyna speciosa (Kratom) mitragynine Piper methysticum (Kava) kavalactones Argyreia nervosa (Hawaiian Baby Woodrose) lysergamide
The story of Spices

Herbal mixtures under the brand name Spice sold on the Internet and specialised shops since at least 2006 (2004). There are a number of Spice products an exotic incense blend which releases a rich aroma and not for human consumption. When smoked, Spice products have been reported by some users to have effects similar to those of cannabis. EMCDDA monitors Spice products as of the beginning of 2007. Extensive forensic investigations by some Member States: JWH018 (DE, AU, Dec 2008), CP 47,497 and homologues (DE, Jan 2009), HU-210 (US, 2009), added to the herbal mixture. Spice products are mainly an Internet phenomenon available on national websites in two-thirds of the EU Member States. Control measures: Austria, Germany, France, Luxembourg JWH-073 (DE, April 2009) Challenges
Why did it take such a long time to establish the psychoactive principles in Spice?
A number of factors may have contributed to this problem, among them: The content (design) of the Spice products. Conceptual problem reflecting the lack of consensus on how this type of product should be viewed. Legal sales of Spice products as a commodity via the Internet or in specialised shops, rather than clandestine production and illegal circulation as a drug did not generate seizures or criminality that might have prompted the interest and involvement of specialised law enforcement agencies. Thus the distribution and sale of these products took place in a grey zone where the potentially responsible institutions (law enforcement bodies, public health authorities, consumer protection agencies or the competent authorities for medicinal products) did not assume direct responsibility.
Purported product design

Some of the declared ingredients are said to produce cannabis-like effects:
Canavalia maritima (Baybean) Pedicularis densiflora (Indian Warrior) Leonotis leonurus (Lions Tail) Zornia latifolia (Maconha Brava) Leonurus sibiricus (Siberian Motherwort)
Some examples
Internet
There is an online market for herbal/legal highs on the Internet and it is expanding.
The Internet constitutes an important source of information on new products/new drug trends (triangulation with other data)
Retailers react towards new drug controls
Results: number of identified online shops selling legal alternatives to illegal drugs (n=115) (by country: domain name; contact address)
50 45 43; 37% 40 35 30 25 20 15 10 5 0 UK DE NL RO IE AU LV PL LT FR PT SI SE CZ IT HU SK 8; 7% 5; 4% 4; 3% 4;3% 3; 3% 3; 3% 2;2% 2; 2% 2; 2% 2;2% 1;1% 1;1% 1 1 17; 15% 16; 14%
N= 17 countries
AT
Around 45% of online retailers provide different language versions of their site
Results: Spice products* offered for sale

50 45 40 35 30 25 20 15 10 5 0 0 UK DE NL RO IE AU LV PL LT FR PT SI SE CZ IT HU SK 3 8 4 0 4 1 2 2 2 2 1 1 1 1 23
55 out of 115 shop (47,8%) 14 countries out of 17 (82%)
AT Number of online shops
Spice offered
*Any spice product including Spice Gold, Spice Silver, Spice Diamond, Spice
Artic Synergy, Tropical Synergy
Costs (approximation)
Spice Gold (3 g) = 7 joints (1 joint 0,4 g); Typical price of Spice Gold sold over the internet 7,5 Euros per g; 1 joint = 3 Euros
Herbal cannabis* = 1 joint (0,5 g); typical retail price in the EU for herbal cannabis 2-14 Euros per g (4-10 Euros majority of countries) (EMCDDA, 2008); 1 joint = 4 Euros (8 Euros per 1g)
Sources: Lycaeum.org, Erowid, EMCDDA Annual Report 2008
User groups
The extent to which Spice products are used in Europe is unknown and the users seem to be a heterogeneous group mainly, generally teenagers and young people. They may include those wanting a legal alternative to illegal drugs Cannabis users wishing to avoid employment or other drug testing procedures aimed at detecting illicit drug use The prison setting might be an important issue for this latter point Persons interested in using biogenic drugs Sensation seekers (psychonauts) Experimental drug users attracted by the media coverage
Challenges 1
Herbal highs pose a range of difficult questions for drug control policies:
Conceptual: how to define which products are of interest; Practical and methodological: how to monitor the products sold, identify the synthetic compounds that they may contain and assess their health risks.
Any substance could be added to any herbal mixture, the sheer number of potentially psychoactive synthetic cannabinoids means that control measures targeting individual chemicals can be easily circumnavigated (consider generic approach to control ?). Little knowledge about the pharmacology, toxicology and safety profile in humans, the type and amount of synthetic substances added may vary considerably and some compounds may be active in very small doses.
Challenges 2
Even if control legislation is adopted, the unavailability of analytical data and reference samples, as well as methodologies for toxicological identification of metabolites in urine, are likely to pose challenges to the effective implementation of control measures It remains unclear where and how the actual production of the herbal mixtures, the synthetic cannabinoids and their addition to the herbal mixtures takes place. The extent to which Spice products are used in Europe is unknown and the users seem to be a heterogeneous group. Is there a wider, specific demand for any of these particular substances?
The future
Synthetic drugs will continue to dominate herbal products will remain uncommon Cheap organic synthesis chemical retailers Precursor chemicals should be commercially available or readily synthesised and not controlled Internet as a main vehicle
New substances notified in 2008

1. bk-MBDB (2-methylamino-1-(3,4-methylenedioxyphenyl)butan-1-one) 29 January 2008 UK Ethylcathinone/Subcoca I (2-Ethylamino-1-phenylpropan-1-one) 7 March 2008 Finland Mephedrone/Subcoca II (2-Methylamino-1-p-tolylpropan-1-one) 7 March 2008 Finland Kratom (Mitragynin/7-Hydroxy-7H-mitragynin/Paynanthein) 19 March 2008 Austria 4-HO-MET (4-hydroxy-N-methyl-N-ethyltryptamin) 4 June 2008 Sweden Kava (Piper methysticum) 22 July 2008 UK Flephedrone (p-fluormethcathinone) 30 September 2008 Denmark
2.
3.
4. 5. 6. 7.
New substances notified in 2008 (cont.)

8. 9. 3-Fluoromethcathinone 20 October 2008 UK LSA ((8)-9,10-didehydro-6-methyl-ergoline-8-carboxamide) 29 October 2008 Bulgaria pFBT (3-pseudotropyl-4-fluorobenzoate) 1 December 2008 Finland, 22 December 2008 Denmark MDPV (1-(3,4-methylenedioxyphenyl)-2-pyrrolidinyl-pentan-1-one) 5 December 2008 Finland p-Fluoramphetamine (1-(4-fluorophenyl)propan-2-amine) 5 December 2008 Denmark JWH-018 (Naphthalen-1-yl-(1-pentylindol-3-yl)methanon) 19 December 2008 Austria
10.
11.
12.
13.
New substances notified until April 2009

1. 2. 3. PPP (alpha-pyrrolidinopropiophenone) 27 January 2009 Denmark 2- or 3-fluoroamfetamine 27 January 2009 Belgium 2-DPMP (2-benzhydrylpiperidine) 02 February 2009 Finland
4.
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol) 05 February 2009 France JWH-073 (1-butyl-3-(1-naphthoyl)indol) Netherlands 27 February 2009 4-AcO-MET (4-acetoxy-N-methyl-N-ethyltryptamine) Finland 24 April 2009
5. 6.
www.emcdda.europa.eu

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The EU actions on new drugs

Dr. R. Sedefov, Vilnius, 20 May 2009

EMCDDA monitoring system: sources and output

KE indicators Crime & supply

Council Decision 2005/387/JHA: a three-step process

Reitox focal points

The European Commission

EMCDDA extended Scientific Committee

Risk assessment report

Council Decision on control measures

Control measures and criminal penalties in the EU Member States

The search for the new ecstasy (1997-2004)

Recent developments legal highs

Misused medicinal products Plant products Spice

Piperazines (2004-2007): BZP mCPP

Plant products herbal highs

The story of Spices

Purported product design

Retailers react towards new drug controls

Results: Spice products* offered for sale

55 out of 115 shop (47,8%) 14 countries out of 17 (82%)

AT Number of online shops

Artic Synergy, Tropical Synergy

Sources: Lycaeum.org, Erowid, EMCDDA Annual Report 2008

New substances notified in 2008

New substances notified in 2008 (cont.)

New substances notified until April 2009

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