September 24, 2018

On Friday (21st September) the government responded to the recommendations of the Advisory Council on the Misuse of Drugs (ACMD) about the scheduling of cannabis-derived medicinal products (CDMPs). 

The revised definition of CDMPs is that they
•       contain cannabis, cannabis resin, cannabinol or cannabinol derivatives
•       must be produced for medicinal use in humans
•       must be a product that is regulated as a medicinal product or an ingredient of a medicinal product

It is very encouraging to see such a swift response from the government, and indeed Minister Sajid Javid was quoted as saying ‘Agreeing this definition means specialist doctors will be able to prescribe them to patients most in need later this autumn’, meaning a very imminent change in policy regarding the use of CDMPs.

Generally, the government has accepted almost all of the recommendations from the ACMD.  The highlights of these accepted recommendations are that
•   CDMPs will be rescheduled from Schedule 1 to Schedule 2 and will need to comply with Schedule 2 drug regulations 
•       CDMPs will need to meet safety and quality standards, with clear content descriptions
•       Guidance and training will be developed for clinicians and pharmacists involved in their prescribing
•       Prescribing of CDMPs will only be by consultants or those performing clinical trials
•       Smoking is not an acceptable route of administration (although inhalation wasn’t specifically ruled out)
•       Outcomes from the use of CDMPs should be captured for research and safety purposes

It is clear from the government’s response that parallel and crucial work is being carried out by NICE, the MHRA, NHS England, the Royal College of Physicians and the British Paediatric Neurology Association to support and implement these recommendations.  The involvement of the British Paediatric Neurology Association suggests that particular consideration is being paid to the use of CDMPs in children with epilepsy.

There are some very optimistic take home messages from the government’s response. 

Firstly, the made a very swift and positive response to the ACMD, accepting and adding to almost all of their recommendations for progress.  

Secondly, the government letter suggests they will be flexible and monitor the area closely allowing for amendments of what is and is not considered a CDMP; ‘the Government is keen to not inadvertently exclude a product of medicinal value‘ and ‘As we learn more about the products and compounds it might become appropriate to reschedule particular products’.  

Thankfully, there did not appear to be any mention of the ACMD’s original recommendation that CDMPs should only be used as a medicine of last resort.  We hope this means that the government did not accept this suggestion.

From a researcher’s point of view, it is excellent to see that the national Institute for Health Research (NIHR) plans to publish a highlight notice to coincide with the rescheduling of CDMPs.  It is really important to also have similar calls for research from the research councils (BBSRC or MRC) to call for important preclinical research in this area.  Basic researchers will still have the same issues that some of the new drugs that we are researching will still be Schedule 1 (because they will not fall under the new definition of a CDMP), and this will restrict the early research we can out on novel cannabinoids and their ability to be of beneficial in novel disease areas.  It would be great to see the government implement a system that would allow scientists broader access to new products.

There are some potential issues at this stage that might be worth highlighting. Only allowing consultants to prescribe CDMPs will restrict access for those patients that are not under specialist care, for example those with pain, sleep or anxiety disorders. Perhaps, this initial and limited approach by the government is a stepping stone towards broader access and that the guidelines could be broadened as we gather more experience in this novel space.  A very large patient group who would like access to CDMPs is cancer patients, and it would be good to see some early involvement and representation of the relevant clinical or patient groups (like The Association of Cancer Physicians, Macmillan and the Teenage Cancer Trust). 

As yet, there has been no mention of what medical conditions a consultant can prescribe a CDMP, so the reality of what a difference these government changes will make on patients’ lives is yet to be seen.