Today, the Government are 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 while 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.
While the evidence base further develops and clinical expertise builds, the Government believe 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”. They 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.