Change to the Misuse of Drugs Act 1971: control of tapentadol and amineptine.

Home Office circular 005/2011

Change to the Misuse of Drugs Act 1971: control of tapentadol and amineptine.

1.    This circular draws attention to the contents of the above Statutory Instruments (SIs), S.I. 2011/744, S.I. 2011/447 and S.I. 2011/448 which come into force on 28 March 2011.

2.    The Misuse of Drugs Act 1971 (Amendment ) Order 2011 classifies tapentadol and amineptine as controlled drugs under Schedule 2 to the Misuse of Drugs Act 1971.  These substances are subject to control as Class A and C drugs respectively under Parts I and III of that Schedule. This Order also clarifies the legislation on mephedrone by bringing mephedrone within the generic definition in paragraph 1(aa) Part 2 of Schedule 2 to the 1971 Act as amended. 

3.    The Misuse of Drugs (Designation) (Amendment) (England, Wales and Scotland) Order 2011 clarifies the legislation on mephedrone by bringing mephedrone within the generic definition in paragraph 1(q) of Part 1 of the Schedule to the Misuse of Drugs (Designation) Order 2001 (as amended).

4.    The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2011 (the '2011 Regulations') place tapentadol and amineptine in Schedule 2 to the Misuse of Drugs Regulations 2001 (as amended). The 2011 Regulations similarly clarify the legislation on mephedrone by bringing mephedrone within the generic definition in paragraph 1(m) of Schedule 1 to the Misuse of Drugs Regulations 2001 (as amended). The 2011 Regulations also insert a new paragraph 4B in the 2001 Regulations relating to the legislation on gamma-butyrolactone and 1,4-butanediol.

5.    The codes for recording offences by the police and the courts for statistical purposes within the Home Office Recorded Crime and Ministry of Justice Court Appearance Database (CAD) – which includes cautions – for tapentadol and amineptine are set out in Annex A and are the same for those used for the recording of offences for other Class A and C drugs.  

6.    The SIs together with explanatory memoranda can be found at http://www.legislation.gov.uk. They are also published by The Stationery Office. Telephone orders/General enquiries 0870 600 5522 or online at www.tso.co.uk/bookshop.  A copy of this circular can be found at: http://www.homeoffice.gov.uk/about-us/corporate-publications-strategy/home-office-circulars/circulars-2011/ .

Background

7.    The Misuse of Drugs Act 1971 ('the 1971 Act') controls drugs that are 'dangerous or otherwise harmful' under a 3-tier system of classification (A, B and C) which provides a framework within which maximum criminal penalties are set with reference to the harm a drug has or is capable of having when misused and the type of illegal activity undertaken in regard to that drug. The control and classification of tapentadol and amineptine is predicated on an assessment of their respective harms and in accordance with recommendations of the Advisory Council on the Misuse of Drugs.

8.    The Misuse of Drugs Regulations 2001 (as amended) (S.I. 2001/3998) regulate the availability of those controlled drugs that have a recognised and legitimate use, by placing them in one of 5 schedules to the Regulations.  The Schedule into which a drug is placed primarily dictates the extent to which it is lawful to import, export, produce, supply and administer and possess the drug and also imposes requirements around prescription writing, record keeping, labeling and safe custody.

Specific drugs

Tapentadol

9.    Tapentadol is a recently developed centrally-acting analgesic (painkiller), with effects similar to opioids like morphine, likely to be marketed in the UK in the near future. Tapentadol presents a risk of misuse, diversion from legitimate sources, addiction and potential medicinal misuse. The risks associated with an overdose of tapentadol are constriction of the pupils, vomiting, loss of consciousness, seizures, difficulty in breathing and a risk of serious complications likely to lead to death. Consistent with the UK’s legislative approach to other drugs with effects similar to that of tapentadol, the Misuse of Drugs Act 1971 (Amendment ) Order 2011 controls tapentadol as a Class A drug.

10.    Tapentadol is inserted into Schedule 2 to the Misuse of Drugs Regulations 2001 (as amended) due to its legitimate uses, with the effect that the requirements of Regulations 14, 15, 16, 18, 19, 20, 21, 23, 26, and 27 would apply to the drug. As a Schedule 2 drug, tapentadol will be available for possession, supply and manufacture for legitimate use, and for import and export under provisions set out in the1971 Act.

Amineptine

11.    Amineptine is a powerful and fast acting antidepressant, misuse of which has been reported mainly in Asia and Europe. The Commission on Narcotic Drugs, on the recommendation of the World Health Organisation, has included amineptine in Schedule II of the Convention on Psychotropic Substances of 1971. Amineptine has the potential both for dependence and misuse, predominantly in patients with a previous history of substance misuse. The withdrawal symptoms include anxiety, psychomotor agitation and insomnia. Consistent with the UK’s legislative approach to other drugs with effects similar to that of amineptine, the Misuse of Drugs Act 1971 (Amendment) Order 2011 controls amineptine as a Class C drug.

12.    Amineptine is inserted into Schedule 2 to the Misuse of Drugs Regulations 2001 (as amended) due to its legitimate uses, with the effect that the requirements of Regulations 14, 15, 16, 18, 19, 20, 21, 23, 26, and 27 would apply to the drug.

Mephedrone

13.    Mephedrone and other related cathinone derivatives were controlled under the Misuse of Drugs Act 1971 (Amendment) Order 2010 with effect from 16th April 2010. When Mephedrone was controlled at that time, the policy intention was to make it clear that the substance was controlled by specifying this on the face of the legislation (SI 2010/1207, SI 2010/1143 and SI 2010/1144). SIs 2011/744, 2011/447 and 2011/448 now clarify the legislation on mephedrone, bringing mephedrone under the generic definition used to control other cathinones under the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001 (as amended) and the Misuse of Drugs (Designation) Order 2001 (as amended). The classification of mephedrone is not affected by this clarification. Mephedrone remains a Class B drug under the Misuse of Drugs Act 1971 (as amended) and a Schedule 1 drug under the Misuse of Drugs Regulations 2001 (as amended).

Gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD)

14.    GBL and 1,4-BD were brought under the control of the 1971 Act in 2009 (SI 2009/3209). GBL and 1,4-BD were not placed in any schedule to the 2001 Regulations (as amended) as a result of their wide use in industry with offences relating to both drugs limited to supply with the knowledge or belief that the drugs will be ingested. The meaning of GBL and 1,4-BD given in Regulation 4B  included “stereoisomeric” forms of both drugs. Both drugs do not have any “stereoisomeric” forms. The new paragraph 4B substituted by the SI 2011/448 removes “stereoisomeric” forms in the meaning of both drugs and includes ethers or esters, or both an ether and an ester of 1,4-butanediol . This clarifying amendment does not affect the classification or offences relating to both drugs under the 1971 Act.

Yours faithfully,

Des Niimoi
Drug strategy unit
Home Office
 

Annex A

OFFENCE RECORDING CODES

The codes for recording offences by the police and the courts for statistical purposes within the Home Office Recorded Crime and Ministry of Justice Court Appearance Database (CAD) – which includes cautions - are as follows:

Tapentadol
This is to be placed under existing codes relating to “Other Class A” drugs as follows;

•  092/19- Production of or being concerned in production of a controlled drug – Class A
•  092/39 -  Supplying or offering to supply or being concerned in supplying or offering to supply a controlled drug – Class A
•  092/59 - Possession of a controlled drug – Class A
•  092/79 - Possession of a controlled drug with intent to supply – Class A
•  093/19 - Permitting premises to be used for unlawful purposes – Class A

Amineptine
This is to be placed under existing codes relating to “Other Class C” drugs as follows;

•  092/28 - Production of or being concerned in production of a controlled drug – Class C - other
•  092/48 -  Supplying or offering to supply or being concerned in supplying or offering to supply a controlled drug – Class C - other
•  092/68 - Possession of a controlled drug – Class C - other
•  092/88 - Possession of a controlled drug with intent to supply – Class C - other
•  093/28 - Permitting premises to be used for unlawful purposes – Class C - other

Offences under S19(a) and 19(b) of the Criminal Justice (International Co-operation) Act 1990 will fall under the appropriate sub-classification code for either Class A or C drugs.  Codes 77/54, 77/55, 77/57 and 77/58 refer.
 
Importation and Exportation offences under SS50(20, 930 & (50 and SS. 68(2) & (4)) of the Customs and Excise Management Act 1979 will fall under the appropriate sub-classification code for either Class A or C drugs.  Codes 92/04, 92/05, 92/07 and 92/08 refer.

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