UK Government Releases Regulations Legalising Medical Cannabis
The UK government has announced regulations legalising cannabis-based medicines from 1 November 2018.
The Government have announced historic regulations rescheduling cannabis-based medical products and making them available on prescription from 1 November 2018.
The new regulations - the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018, or “the 2018 Regulations” - were laid before the House today in a written statement by Sajid Javid, Secretary of State for the Home Department, and will come into force on 1st November 2018.
The law change reflects advice given to the Government over a two-part review of cannabis-based medical products, undertaken by the Chief Medical Adviser and the Advisory Council of the Misuse of Drugs (ACMD) earlier this year.
The 2018 Regulations provide a definition of ‘cannabis-based product for medicinal use in humans’, as previously reported by Hanway Associates:
To constitute a ‘cannabis-based product for medicinal use in humans’, a product must satisfy three requirements:
1. It needs to be a preparation or product which contains cannabis, cannabis resin, cannabinol or a cannabinol derivative;
2. It is produced for medicinal use in humans and;
3. 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.
Products meeting this definition will be rescheduled from Schedule 1 to Schedule 2 of the 2001 Misuse of Drugs Regulations, and de-designated from the 2015 Misuse of Drugs Designation Order, allowing access through prescription without the need for a Home Office licence.
The statement also designates the three access routes for the order, supply and use of cannabis-based products for patients:
These are as follows:
1. 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;
2. An investigational medicinal product without marketing authorisation for use in a clinical trial or;
3. A medicinal product with a marketing authorisation.
These access routes bring cannabis products explicitly into the existing medicines framework, rather than creating a parallel system for their administration.
Products without full marketing authorisation - that is, currently all products other than Sativex - must be prescribed by a consultant, rather than a GP.
Once a product is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA), it will be available for prescription in the same way as other Schedule 2 drugs.
Products without full marketing authorisation, or unlicensed ‘specials’ as they are also known, can only be produced in the UK by a manufacturer licensed by the MHRA, or imported by a wholesaler dealer similarly licensed to do so. Products must also be produced according to Good Manufacturing Practice (GMP) standards.
The new law will continue to prohibit the smoking of cannabis in the UK, even by patients prescribed products for medical use. However, a Home Office briefing suggests that flower products will be available to patients.
The provisions announced will apply to England, Wales and Scotland, with the Department of Health in Northern Ireland announcing that they will also mirror the legislative amendments.
Until the changes come into force on 1 November, the Independent Expert Panel currently providing the Home Secretary with clinical advice on individual licence applications will remain in place. The Home Secretary’s statement also reaffirms that the government has no intention to legalise the recreational use of cannabis.
The Regulations do not address anything which was not already expected by those close to the process, nor do they contain any unpleasant surprises, from a patient access perspective.
As Hanway Associates has previously remarked, the regulations are restrictive in that only consultants will initially be able to prescribe cannabis-based medicines. However, we expect change is likely in October 2019, when the National Institute for Health and Care Excellence (NICE) guidelines are published and GPs will have been, to a greater or lesser extent, educated on how to prescribe these medicines.
Finally, in a huge win for patient access, the regulations do not limit the types of conditions that can be considered for treatment with cannabis-based medicines. Decisions for prescription will be made on a case-by-case basis, when it can be shown that a patient has an unmet special clinical need that cannot be met by existing licensed products.
Hanway Associates continues to monitor all developments relating to the regulation of and access to cannabis medicines in the UK closely. For more insights and advice on cannabis regulations in the United Kingdom and Europe, please get in touch firstname.lastname@example.org