(This note is not part of the Regulations)
These Regulations amend the Misuse of Drugs Regulations 2001 (S.I. 2001/3998) (the “2001 Regulations”) and the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (S.I. 2015/704) (“the 2015 Order”) to allow the wider use of cannabis-based products for medicinal use in humans, essentially for medical purposes. They also amend the Misuse of Drugs (Licence Fees) Regulations 2010 (S.I. 2010/2497) (the “2010 Regulations”) to provide for waiver of licence fees under those Regulations.
Section 7(3) of the Misuse of Drugs Act 1971 (c. 38) (the 1971 Act) requires regulations to be made to allow the use for certain purposes, including medical use, of the drugs which are subject to control under that Act. Section 7(4)(b) of the 1971 Act provides, however, that designated controlled drugs will be exempt from this easement and so cannot lawfully be prescribed, administered, produced, compounded or supplied except under licence or other authority issued by the Secretary of State. The designations in question are in the 2015 Order and include cannabis, cannabis resin, cannabinol and cannabinol derivatives not being dronabinol or its stereoisomers. Regulation 9 varies the 2015 Order to exclude cannabis-based products for medicinal use in humans, and some related products, from the relevant designations.
The 2001 Regulations are correspondingly amended to permit legitimate access. The Schedule to the 2001 Regulations in which a controlled drug is placed affects the extent to which the drug can be lawfully imported, exported, produced, supplied or possessed. Regulation 3 inserts the definition of a cannabis-based product for medicinal use in humans into the 2001 Regulations. Regulations 6 and 7(b) transfer these products from Schedule 1 to Schedule 2 to permit, subject to controls, those activities that are effectively prohibited by designation under the 2015 Order. The rescheduling also applies (as a consequence of existing provisions of Schedule 2) to related products such as stereoisomeric forms, salts and esters of cannabis-based products for medicinal use in humans where these related products are also produced for medicinal use in humans (by regulation 7(c)). A synthetic version of a constituent of cannabis, dronabinol, was already listed in Schedule 2, and a new definition is inserted to ensure its position is unchanged (regulation 3(c) and 9(4)).
Additional controls, beyond those generally provided for in relation to drugs specified in Schedule 2 to the 2001 Regulations, are imposed for cannabis-based products for medicinal use in humans. Regulation 4 inserts new regulation 16A to specify requirements for the order and supply of these products for the purpose of administration (whether to humans or animals) and their use. The order (by prescription, direction or otherwise) must be for: a special medicinal product (an existing category of medicines without marketing authorisations) for use in accordance with the prescription or direction of a specialist medical practitioner; an investigational medicinal product for use in a clinical trial in humans; or, a medicinal product with a marketing authorisation. Supply, by administration or for the purpose of administration, must be pursuant to such an order. Additionally, a person is restricted from self-administration of a cannabis-based product for medicinal use in humans by way of smoking other than for research purposes. An exception is, however, created for order and supply of such products for administration to animals for research purposes.
Regulation 8 amends the 2010 Regulations, which prescribe the fee payable where a licence is issued to engage in various activities in relation to controlled drugs, to provide that no fee is payable where the Secretary of State determines that the fee should be waived.
A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk. Copies may be obtained from the Home Office at 2 Marsham Street, London, SW1P 4DF.