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This publication is available at https://www.gov.uk/government/publications/circular-0062013-scheduling-of-sativex/circular-0062013-scheduling-of-sativex
This circular draws attention to the contents of the above Statutory Instruments (SIs), S.I. 2013/624 and SI 2013/625 which came into force at 00:01 on 10 April 2013.
The Misuse of Drugs (Amendment No. 2) (England, Wales and Scotland) Regulations 2013 amend the Misuse of Drugs Regulations 2001 (the 2001 Regulations) (S.I. 2001/3998) by placing “Sativex”, as defined, under Part 1 of Schedule 4 to the 2001 Regulations. The SI also places specific record keeping requirements on persons authorised by or under the Misuse of Drugs Act 1971(the 1971 Act) to possess or destroy “Sativex”.
The Misuse of Drugs (Designation) (Amendment No. 2) (England, Wales and Scotland) Order 2013 amends the Misuse of Drugs (Designation) Order 2001 (the 2001 Order) by placing “Sativex”, as defined, under Part 2 of the Schedule to the 2001 Order with the effect that “Sativex” is now excepted from section 7(4) of the 1971 Act, essentially because “Sativex” has a recognised medicinal or legitimate use.
The SIs together with an explanatory memorandum can be found at www.http://www.legislation.gov.uk. They are also published by The Stationery Office. Telephone orders/general enquiries 0870 600 5522 or online at The Stationery Office.
0.1 Legislative Background
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 Misuse of Drugs Regulations 2001 (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.
The Misuse of Drugs (Designation) Order 2001 designates drugs listed in Schedule 1 to the 2001 Regulations as drugs to which section 7(4) of the 1971 Act applies. Drugs designated under the 2001 Order (listed in the Schedule) have no legitimate or medicinal use and can only be imported, exported, produced, supplied, etc under licence issued by the Home Secretary.
SIs 2013/624 and 2013/625 are made under sections 7, 10, 22 and 31 of the 1971 Act. The Act received Royal Assent on 27 May 1971. Section 31(3) of the Act provides that the Secretary of State may not make regulations under the Act except after consultation with the Advisory Council on the Misuse of Drugs (ACMD). The scheduling of “Sativex” is predicated on an assessment of its harms and in accordance with recommendations of the ACMD.
0.2 Policy Context
“Sativex” is the first cannabis-based medicine (oral spray) recognised in the UK to have medicinal properties. The production of the cannabis used in the manufacture of “Sativex” is carried out under a Home Office licence for ‘research or other special purpose’.
Pending marketing authorisation, in 2006 the Home Office issued a licence to enable doctors, at their own risk to privately prescribe, pharmacists to possess and dispense, and named patients who have been prescribed “Sativex” to possess the drug under a clinical trial (clinical trials have ended). The Medicines Healthcare Regulatory products Agency (MHRA) issued a marketing authorisation (MA) for “Sativex”, specifically as add-on treatment for symptom improvement in patients with spasticity due to multiple sclerosis in June 2010. Doctors can also prescribe “Sativex” for other indications outside of the marketing authorisation at their own risk.
Following the grant of MA the ACMD, at the request of the Home Office, considered the need for the continued availability of “Sativex” to be governed by the regulatory framework on all medicines that are also controlled drugs – the 2001 Regulations – rather than under the extant Home Office licence. The ACMD recommended that “Sativex” should be placed in Part I of Schedule 4 to the 2001 Regulations. The SIs implement the ACMD’s advice, and when in force will ensure that availability of “Sativex” for use in healthcare is governed by the 2001 Regulations. The extant Home Office licence will be revoked at the same time as the SIs come into force.
0.3 Specific Amendments
“Sativex” is placed in Schedule 4 Part I of the 2001 Regulations with recording requirements applicable to possession and destruction.
S.I. 2013/625 excepts “Sativex”, as defined, from the definition of cannabis in Schedule 1 to the 2001 Regulations and places “Sativex” in Part I of Schedule 4 to the 2001 Regulations. The effect is that “Sativex”, as defined, is distinguished from cannabis in its raw form which continues to remain a Class B and Schedule 1 controlled drug under UK legislation.
The SI also places specific requirements on persons authorised by or under the 1971 Act to possess “Sativex” in compliance with requirements under Article 34(b) of the 1961 UN Convention on Narcotic Drugs. Records made for the possession and destruction of “Sativex” must be kept for a minimum of two years. Patients who have been prescribed “Sativex”, patient representatives, and other persons listed in new regulation 22(6) of the 2001 Regulations, are specifically excluded from the record keeping requirement applicable to “Sativex”.
“Sativex” is placed in Part 2 of the Schedule to the 2001 Order
S.I. 2013/624 places “Sativex”, as defined, in Part 2 of the Schedule to the 2001 Order with the effect that the designation provisions under Section 7(4) of the 1971 Act no longer applies. This has the result that a Home Office licence “for research or other special purpose” is no longer required for the possession, supply etc of “Sativex”. A Home Office licence “for research or other special purpose” is still required for cannabis in its raw form.
0.4 Offences relating to “Sativex”
“Sativex” remains a Class B drug under the 1971 Act. Class B drug offences – possession, supply, possession with intent to supply etc – apply to “Sativex”. A person can lawfully possess “Sativex” under a prescription issued by a qualified healthcare professional. However, the resupply of prescribed medication (except to a person lawfully entitled to possess the drug) amounts to unlawful supply of a controlled substance.
Additionally, a person who fails to disclose information that they have already been prescribed “Sativex”, including where another person makes a false declaration or statement on their behalf, in order to obtain further supplies from another qualified healthcare professional does not have authority to possess the drugs obtained as a result of the failure to disclose or false statement. The possession of “Sativex” under these circumstances is unlawful. Drug offence codes relating to “Sativex” are provided in Annex A.
0.5 Application to England, Wales and Scotland
The changes to the Misuse of Drugs Regulations 2001 described in this circular apply to England, Wales and Scotland. The contact for changes relating to Northern Ireland is:
Seamus Camplisson Health Protection Branch Department of Health, Social Services and Public Health 22 Castle Buildings, Stormont Belfast BT4 3SQ Email – Seamus.Camplisson@dhsspsni.gsi.gov.uk
Any enquiries about the contents of this circular should be directed to; Des Niimoi Drugs and Alcohol Unit Home Office 4th Floor Fry Building NE 2 Marsham Street London SW1P 4DF
Yours faithfully, Des Niimoi Drugs and Alcohol Unit Home Office
1. Annex A
1.1 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:
92/22 - Production of or being concerned in the production of “Sativex” - Class B 92/42 - Supplying or offering to supply or being concerned in supplying or offering to supply “Sativex” - Class B 92/62 - Possession of “Sativex” - Class B 92/82 - Possession of “Sativex” with intent to supply - Class B 93/22 - Permitting premises to be used for unlawful purposes - “Sativex” - Class B
Offences under s. 19(a) and 19(b) of the Criminal Justice (International Co-operation) Act 1990 will fall under the appropriate sub-classification code for Class B drugs. Codes 77/54 and 77/57 refer.
Importation and exportation offences under s. 50(2), (3) & (5), s. 68 (2) & (4) and s. 170 (1), (2), (3) & (4) of the Customs and Excise Management Act 1979 will fall under the appropriate sub-classification code for Class B drugs. Codes 92/04 and 92/07 refer.