(The Secretary of State for the
Home Department): Today, the Government is laying
the Misuse of Drugs (Amendments) (Cannabis and Licence Fees)
(England, Wales and Scotland) Regulations 2018 (“the 2018
Regulations”) in the House. These regulations reschedule
cannabis-based products for medicinal use and will come into
force on 1 November 2018.
On 19 June, I announced a two-part review to look at the
scheduling of cannabis-related medicinal products under the
Misuse of Drugs Regulations 2001 (the 2001 Regulations). I have
been clear that my intention was always to ensure that patients
have access to the most appropriate course of medical treatment.
I stressed the importance of acting swiftly to ensure that where
medically appropriate, these products could be available to be
prescribed to patients. I have been clear that this should be
achieved at the earliest opportunity whilst ensuring that the
appropriate safeguards were in place to minimise the risks of
misuse and diversion.
Building on the expert advice we have received, first from the
Chief Medical Adviser to the UK Government and then the Advisory
Council on the Misuse of Drugs (ACMD), the regulations we have
laid today give effect to my commitments. I outline in this
statement, the main features of our approach.
The 2018 Regulations introduce a definition of ‘cannabis-based
product for medicinal use in humans’. Only products meeting this
definition will be rescheduled to Schedule 2 to the 2001
Regulations and de-designated from the 2015 Designation Order.
Any product which does not satisfy this definition will remain a
Schedule 1 drug and only be available under a Home Office
licence.
To constitute a ‘cannabis-based product for medicinal use in
humans’, a product must satisfy three requirements:
- It needs to be a preparation or product which contains
cannabis, cannabis resin, cannabinol or a cannabinol derivative;
- It is produced for medicinal use in humans and;
- Is a medicinal product, or a substance or preparation for use
as an ingredient of, or in the production of an ingredient of, a
medicinal product
Whilst the evidence base further develops and clinical expertise
builds, the Government believes it is important that access to
these products is strictly controlled so as to prevent unintended
misuse, harm and diversion. The 2001 Regulations therefore only
allow three access routes for the order, supply and use of these
products by patients. These are as follows:.
- A special medicinal product for use in accordance with a
prescription or direction of a doctor (who has made the decision
to prescribe) on the Specialist Register of the General Medical
Council;
- An investigational medicinal product without marketing
authorisation for use in a clinical trial or;
- A medicinal product with a marketing authorisation.
This brings these products explicitly into the existing medicines
framework. There are well-established mechanisms for the supply
of unlicensed medicines to patients with exceptional needs.
Unlicensed medicines of this sort are known as “specials” and can
only be manufactured in or imported into the UK by a manufacturer
or wholesale dealer that has a licence from the MHRA to do so and
are expected to meet standards of good manufacturing practice
(GMP).
The decision to prescribe is only restricted to a doctor on the
Specialist Register of the General Medical Council where the
cannabis-based product is an unlicensed ‘special’ medicinal
product for use by a specific patient. Once a product is licensed
by the MHRA, it will be available for prescription in the same
way as any other Schedule 2 drug.
I have been consistently clear that I have no intention of
legalising the recreational use of cannabis. To take account of
the particular risk of misuse of cannabis by smoking and the
operational impacts on enforcement agencies, the 2018 Regulations
continue to prohibit smoking of cannabis, including of
cannabis-based products for medicinal use in humans.
Until recently, licences for Schedule 1 drugs were generally
issued for research purposes. As we have seen in recent cases,
there may be exceptional circumstances which would require a
Schedule 1 licence to be issued for medicinal or treatment
purposes. In the exceptional event that an individual will need
to be issued a Schedule 1 licence for treatment, the 2018
Regulations will ensure that the Secretary of State can determine
that no fee should be paid in that case.
Until the changes come into force on 1 November 2018, the
Independent Expert Panel, set up to provide me with clinical
advice on individual licence applications, will remain in place
to consider any application received before then.
These provisions will apply to England, Wales and Scotland. My
officials continue to engage closely with the Department for
Health in Northern Ireland, which intends to mirror these
legislative amendments.
These regulations are not an end in themselves. The ACMD will be
conducting a long-term review of cannabis and the National
Institute for Health and Care Excellence (NICE) has been
commissioned to provide advice for clinicians by October next
year. The Government will monitor the impact of the policy
closely as the evidence-base develops and review when the ACMD
provides its final advice.
Further explanation of the legislative changes is set out in the
Explanatory Memorandum to the regulations.
