Regulatory approaches of

‘New Psychoactive Substances’

The case of Hungary

István Ujváry

i Kem BT

Budapest, Hungary

12th Annual meeting of the REITOX Early-Warning System network

EMCDDA, May 24–25 2012, Lisbon

New psychoactive substances recently controlled in Hungary as narcotic or psychotropic drug

mCPP

oripavine, BZP

4-MMC

4-FA, JWH-018, JWH-081, JWH-073, JWH-122, JWH-210, MDPV, 4-MEC, methylon

§ Schedule A) – narcotic drugs (120 are listed in Annex 1)

regardless of whether it is natural or synthetic;

§ Schedule B) – psychotropic substances (144 are listed in Annex 1)

regardless of whether it is natural or synthetic;

§ Schedule C) – new psychoactive substances (listed in Annex 1):

• individual compounds (43)

• group of chemical compounds (four main groups)

Introducing three Schedules – 2 April 2012 Annex 1 of Govermnent Decree 66/2012 (IV. 2.)

NEW generic definition

’New Psychoactive Substance’ (NPS) – Definition Act CLXXVI of 2011 (amendment to Act XCV of 2005 on medicines)

newly emerged on the European or domestic market

has no therapeutic value

alters mental state, behaviour or perception by affecting the CNS

poses a public health threat comparable to illicit drugs - Schedules A) & B)

(UN Conventions 1961 & 1971)

scheduled as an NPS (compound or compound group) by Government Decree

Schedule A narcotics

Schedule B psychotropics

Schedule C new psychoactives

compound group individual

duration permanent permanent* temporary#

production,

import, export,

transportation,

trade, commerce,

offer, supply

criminal offense criminal offense

acquisition,

possession criminal offense not criminalised

Prosecution relating to scheduled substances

Criminal Code § 282 applies for Schedules A) and B), while § 283/A applies for Schedule C) drugs

* Risk assessment not necessary; can be amended #

Risk assessment by National Addiction Centre within 12 months

(10) The risk assessment obligation under Article 15/C(2) of Gytv shall not be

applied to groups of chemical compounds in Schedule C) of Annex 1.

The group of chemical compounds shall stay on Schedule C) as long as

there are substances belonging to the group [that is qualify as ‘NPS’], or all

substances of the group are not included in another Schedule.

Temporary and permanent scheduling of NPSs Special consideration of chemical groups in Schedule C)

The 43 ‘New Psychoactive Substances’ listed individually will be evaluated

(risk assessment) by an expert panel of the National Addiction Centre of

Hungary within one year removal from the Schedule

permanent control (another Schedule)

Schedule C) – ‘New Psychoactive Substance’ groups Government Decree No. 66/2012 (IV. 2.)

Coverage: Substances satisfying the structural descriptions given for

a chemical family

exceptions: substances already listed in Schedule A) or B)

or specifically named (e.g., medicines)

Chemical families

1. synthetic cannabinoids (indolyl ketones)

2. cathinones (2-amino-1-phenylpropan-2-ones)

3. tryptamines (2-(1H-indol-3-yl)ethanamines)

4. phenethylamines (2-phenylethanamines)

such as

Examples of a generic definition in The United Kingdom Misuse of Drug Act 1971 (Amendment order, 2009)

Any compound structurally derived from 3-(1-naphthoyl)indole or 1H-indol-3-yl-

-(1-naphthyl)methane

by substitution at the nitrogen atom of the indole ring

by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)-

ethyl, whether or not further substituted in the indole ring to any extent

and

whether or not substituted in the naphthyl ring to any extent.

Description of a group of synthetic cannabinoids N

O

JWH-series

Auf Grund des § 3 des Neue-Psychoaktive-Substanzen-Gesetzes (NPSG), BGBl. I Nr.

146/2011, wird verordnet:

§ 1. (1) Als Neue Psychoaktive Substanzen im Sinne des § 3 NPSG gelten

1. die in Anlage I dieser Verordnung angeführten Substanzen,

2. alle Substanzen, die von den chemischen Definitionen in Anlage II umfasst sind.

(2) „Chemische Strukturen“ im Sinne der Anlage II sind Aldehyde, Alkane, Alkene,

Alkohole, Alkoxide, Alkyle, Alkylhalide, Alkyne, Amide, Amine, Benzyle, Carboxylate,

Ester, Ether, Halogenide, Isocyanate, Ketone, Nitrile, Nitroxide, Phenole, Phenyle,

Selenoalkyle, Selenoester, Selenole, Thioalkyle, Thiocyanate, Thioester, Thioketone,

Thiole, Thiophenole * sowie alle chemisch möglichen Ringverbindungen und Hetero-

Ringverbindungen

(3) Anlage III enthält zur Veranschaulichung Beispiele chemischer Strukturformeln in

Bezug auf die in der Anlage II erfassten Substanzen.

Description of New Psychoactive Substances in Austria 468. Verordnung: Neue-Psychoaktive-Substanzen-Verordnung (30.12.2011)

*Note: Carbamates are missing ;-)

1. Those substances containing structural parts

1.1 indolyl naphthyl ketone ((1H-indol-3-yl)(naphthalene-1-yl)methanone,

(1H-indol-3-yl)(naphthalene-2-yl)methanone) or

1.2 indolyl phenyl ketone ((1H-indol-3-yl)(phenyl)methanone) or

1.3 benzyl indolyl ketone ((1-(1H-indol-3-yl)-2-phenylethanone) or

1.4 adamantyl indolyl ketone (indolyl(tricyclo[3.3.1.13,7]decane-1-yl)methanone or

indolyl(tricyclo[3.3.1.13,7]decane-2-yl)methanone)

in which the

1.1.1 nitrogen atom of the indole ring is substituted by

1.1.1.1 an alkyl, alkenyl or alkynyl group containing up to 7 carbon atoms or

1.1.1.2 a derivative of a group specified in 1.1.1 containing hydroxy, cyano, cycloalkyl,

cycloalkenyl, tetrahydropyranyl, morpholinyl, N-methylpirrolidinyl or

N-methylpiperidinyl group, or one or more halogen atom

1.1.2 carbon atom at position 2 of the indole ring

1.1.2.1 may contain a methyl or an ethyl group

1.1.3 naphthyl or phenyl group may be substituted

1.1.3.1 an alkyl group of 1–4 carbon atoms or

1.1.3.2 methoxy- or ethoxy group or

1.1.3.3 a halogen atom or an azido, dimethylamino, hydroxy, hydroxymethyl, nitro

or cyano group.

Example: 1. Indolyl Ketones text as in the Hungarian legislation

CnH2n+1, CnH2n-1 or CnH2n+1 (where n = 0–7),

and their OH, F, Cl, Br, I, CN, cycloalkyl,

tetrahydropyranyl, morpholinyl,

N-methylpyrrolidinyl or N-methylpiperidinyl

derivatives

H,

CnH2n+1 (where n = 1–4),

OCH3, OC2H5, F, Cl,

Br, I, N3, N(CH3)2, OH,

CH2OH or CN

H, CH3 or C2H5

N

O

Example: 1.1 indolyl naphthyl ketones graphical description (not in legislation)

Example: 2. Cathinones text as in Hungarian legislation

2. Those compounds containing a cathinone (2-amino-1-phenylpropane-1-one) structural

part – with the exception of bupropion –,

in which the

2.1 carbon atom at position 3 of the propane-1-one structural unit may contain

2.1.1 an alkyl group of up to 3 carbon atoms

2.2 phenyl group may contain one or – in any optional combination – more

2.2.1 halogen atom, or methyl, ethyl, methoxy or methylenedioxy group

2.3 nitrogen atom

2.3.1 may contain one or two alkyl group of 1–4 carbon atoms or

2.3.2 may contain a benzyl group or

2.3.3 is a member of a pyrrolidine or piperidine ring

Example: 2. Cathinones graphical description (not in legislation)

H,

CnH2n+1 (where n = 1–4), or

– if the other substituent is

hydrogen atom – CH2Ph

one or more

H, CH3, C2H5,

OCH3, F, Cl, Br, I.

and/or H, CH3, C2H5

or C3H7

H or CnH2n+1

(where n = 1–4) O

N

Exception:

bupropion

O

CH3

NClC(CH

3)3

H

CH2

O

O

Example: 3. phenethylamines text as in Hungarian legislation

4. Those compounds containing a phenethylamine (2-phenylethanamine) structural part

in which the

4.1 amino group may contain one or – in any optional combination – more

4.1.1 alkyl, alkenyl, cycloalkyl, haloalkyl, hydroxyalkyl, cyanoalkyl or methoxyalkyl

group of up to 4 carbon atoms, or

4.1.2 acetyl, hydroxy, methoxy, cyclopropylmethyl, benzyl, methoxybenzyl or

furylmethyl group.

4.2 amino group may be a member of an azetidine, pirrolidine or piperidine ring.

4.3 carbon atom at position 1 of the ethanamine structural part

4.3.1 may contain an alkyl group of up to 4 carbon atom

4.4 phenyl group may contain one or – in any optional combination – more

4.4.1 alkyl-, (cycloalkyl)alkyl, alkoxy, (cycloalkyl)alkoxy, (alkoxy)alkyl, alkylsulfanyl,

alkylamino or haloalkyl group of up to 5 carbon atoms, and

4.4.2 halogen atom, benzyl, benzyloxy, amino, cyano, trimethylene, methylenedioxy,

ethylenedioxy, ethyleneoxy, ethanediyloxy, ethyleneimine or ethanediylimino

group.

Example: 3. phenethylamines graphical description (not in legislation)

one or more

H, CnH2n+1 (where n = 1–4)

and its halogen, hydroxy,

methoxy or cyano

derivatives; or CnH2n-1

(where n = 3–4), OH, OCH3,

acetyl, benzyl or

methoxybenzyl, and

–(CH2)n– (where n = 4–6) H or CnH2n+1

(where n = 1–4)

one or more

H, CnH2n+1, CnH2n+1O,

CnH2n+1NH or CnH2n+1S

(where n = 1–5), NH2, F, Cl,

Br, I, CN, OCH2Ph, etc.;

or –(CH2)3–,

–CH2CH2O–, –OCH2O–,

–CH2CH2NH–,

–OCH2CH2O–, etc., fused

ring derivatives

N

O

O

OCH3

N

N

N

C H

H

H H

C=O

Cl

D

F Cl

Br

C

S P

N

CH

NH

O

NCH3

N

Thank you!