The EU Actions on New Drugs

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The EU actions on new drugs

Dr. R. Sedefov, Vilnius, 20 May 2009



KE indicators

Crime & supply

Reitox EWS

Europol EWS

Adapted from R. Kaiser at al., 2005

Evidence base Early-warning new drugsRisk assessment

Public-health warning

Description state of the drugs

problem in Europe

EMCDDA monitoring system: sources and output

Indicator-based Event-based



Legal framework

• Joint Action on new synthetic drugs (1997)

• Council Decision 2005/387/JHA on the informationexchange, risk assessment and control of newpsychoactive substances

• The Early Warning System (EWS)• Risk assessment• Control measures



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

Information exchange/Early-warning

(Official Journal/ L 117, 20.05.2005)

A new psychoactivesubstance is detectedin the EU MemberStates and describedin a reporting form

EMCDDA

EuropolEuropean MedicinesAgency (EMEA)

The Council of the EU mayrequest a risk assessment,based on a EMCDDA–Europol Joint report

EMCDDA extendedScientific Committee

Risk assessment report

At the initiative of the

EuropeanCommission or aMember Statebased on the Riskassessment report

CouncilDecisionon controlmeasures

Reitox focal points

Europol national units

Risk assessment

Decision-making

Council of the EUdecides whether or notto submit the newpsychoactivesubstance to controlmeasures

Controlmeasures andcriminalpenalties in theEU MemberStates

The EuropeanCommission



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 m CPP

• By 2006, 1(3-chlorophenyl)piperazine ( m CPP) foundin 10% of ‘ecstasy’ tablets in EU. More seizures,

larger quantities than any other substance since 1997

• 2007: EMCDDA risk assessment on 1-

benzylpiperazine (BZP) leads to expected EU-widecontrol in 2009

• Critical review of six piperazine derivatives byECDD/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 theInternet and specialised shops since at least 2006 (2004).

• There are a number of ‘Spice’ products – an ‘exotic incense blendwhich releases a rich aroma’ and ‘not for human consumption’.

• When smoked, Spice products have been reported by someusers 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: JWH-

018 (DE, AU, Dec 2008), CP 47,497 and homologues (DE, Jan2009), HU-210 (US, 2009), added to the herbal mixture.

• Spice products are mainly an Internet phenomenon – available onnational 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 typeof product should be viewed.

• Legal sales of Spice products as a commodity via the Internet or inspecialised shops, rather than clandestine production and illegalcirculation as a drug did not generate seizures or criminality that mighthave prompted the interest and involvement of specialised lawenforcement agencies.

• Thus the distribution and sale of these products took place in a ‘greyzone’ where the potentially responsible institutions (law enforcementbodies, public health authorities, consumer protection agencies or thecompetent authorities for medicinal products) did not assume directresponsibility.



Purported product design

Some of the declared ingredients are said to produce cannabis-like effects:

Canavalia maritima (Baybean)

Pedicularis densiflora (Indian Warrior)

Leonotis leonurus (Lion‘s Tail)

Zornia latifolia (Maconha Brava)

Leonurus sibiricus (Siberian Motherwort)



Some examples



Internet

• There is an online market for herbal/legal highs on the Internetand it is expanding.

• The Internet constitutes an important source of information onnew 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)

Around 45% of online retailers provide different language versions of their site

1 1

43; 37%

17; 15% 16; 14%

8; 7%5; 4% 4; 3% 4;3% 3; 3% 3; 3% 2;2% 2; 2% 2; 2% 2;2% 1;1% 1;1%

0

5

10

15

20

25

30

35

40

45

50

UK DE NL RO IE AU LV PL LT FR PT SI SE CZ IT HU SK

N= 17 countries

AT



Results: Spice products* offered for sale

*Any spice product including Spice Gold, Spice Silver, Spice Diamond, SpiceArtic Synergy, Tropical Synergy

23

03

8

4

0

41 2

02 2 2 1 1 1 1

0

5

1015

20

25

30

35

40

45

50

UK DE NL RO IE AU LV PL LT FR PT SI SE CZ IT HU SK

Number of online shops Spice offered

55 out of 115 shop (47,8%)

14 countries out of 17 (82%)

AT



Costs (approximation)

Spice Gold (3 g) = 7 joints (1 joint 0,4 g);Typical price of Spice Gold sold over the internet7,5 Euros per g; 1 joint = 3 Euros

Herbal cannabis* = 1 joint (0,5 g); typical retail price inthe EU for herbal cannabis 2-14 Euros per g (4-10Euros 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 theusers seem to be a heterogeneous group mainly, generally teenagers andyoung people.

• They may include those wanting a legal alternative to illegal drugs

• Cannabis users wishing to avoid employment or other drug testingprocedures 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 controlpolicies:

• Conceptual: how to define which products are of interest;

• Practical and methodological: how to monitor the products sold, identify thesynthetic 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 meansthat control measures targeting individual chemicals can be easilycircumnavigated (consider generic approach to control ?).

Little knowledge about the pharmacology, toxicology and safetyprofile in humans, the type and amount of synthetic substancesadded may vary considerably and some compounds may be activein very small doses.



Challenges 2

Even if control legislation is adopted, the unavailability of analyticaldata and reference samples, as well as methodologies fortoxicological identification of metabolites in urine, are likely topose challenges to the effective implementation of controlmeasures

It remains unclear where and how the actual production of the

herbal mixtures, the synthetic cannabinoids and their addition to theherbal mixtures takes place.

The extent to which Spice products are used in Europe is unknownand 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 – herbalproducts will remain uncommon

• Cheap organic synthesis – chemical retailers

• Precursor chemicals should be commerciallyavailable 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 January2008 – UK

2. Ethylcathinone/Subcoca I (2-Ethylamino-1-phenylpropan-1-one) – 7 March 2008 –

Finland

3. Mephedrone/Subcoca II (2-Methylamino-1-p-tolylpropan-1-one) – 7 March 2008 – Finland

4. Kratom (Mitragynin/7 α-Hydroxy-7H-mitragynin/Paynanthein) – 19 March 2008 – Austria

5. 4-HO-MET (4-hydroxy-N-methyl-N-ethyltryptamin) – 4 June 2008 – Sweden

6. Kava (Piper methysticum) – 22 July 2008 – UK

7. Flephedrone (p-fluormethcathinone) – 30 September 2008 – Denmark



New substances notified in 2008 (cont.)

8. 3-Fluoromethcathinone – 20 October 2008 – UK

9. LSA ((8β)-9,10-didehydro-6-methyl-ergoline-8-carboxamide) – 29 October 2008 – Bulgaria

10. pFBT (3-pseudotropyl-4-fluorobenzoate) – 1 December 2008 – Finland, 22 December2008 – Denmark

11. MDPV (1-(3,4-methylenedioxyphenyl)-2-pyrrolidinyl-pentan-1-one) – 5 December 2008 – Finland

12. p-Fluoramphetamine (1-(4-fluorophenyl)propan-2-amine) – 5 December 2008 – Denmark

13. JWH-018 (Naphthalen-1-yl-(1-pentylindol-3-yl)methanon) – 19 December 2008 – Austria



New substances notified until April 2009

1. PPP (alpha-pyrrolidinopropiophenone) – 27 January 2009 – Denmark

2. 2- or 3-fluoroamfetamine – 27 January 2009 – Belgium

3. 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

5. JWH-073 (1-butyl-3-(1-naphthoyl)indol) – Netherlands – 27 February 2009

6. 4-AcO-MET (4-acetoxy-N-methyl-N-ethyltryptamine) – Finland – 24 April 2009



www.emcdda.europa.eu

The EU Actions on New Drugs

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