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8 April 2019
A change in the law
In 2018 the law changed so that products containing Cannabis, can now be prescribed (in certain circumstances) for medicinal use.
This followed mounting public and media pressure to change the law. There have been several high profile cases involving children in the UK suffering from Epilepsy, who supporters argued would benefit from being prescribed Cannabis based medicinal products.
The law was changed by the creation of a new regulation called the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 (‘the 2018 Regulations’). This made changes to the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’). Both the 2001 and 2018 Regulations were made under powers conferred on the Secretary of State under the Misuse of Drugs Act 1971. The 2018 Regulations allow for the wider lawful use of cannabis-based products for medicinal use in humans in England, Wales and Scotland.
Under the 2001 Regulations, controlled drugs are placed in one of five schedules, corresponding to their therapeutic usefulness and potential for misuse. Each schedule specifies the requirements governing activities such as import, export, production, supply, possession, prescribing, and record keeping which apply to them.
Before the law change Cannabis was located in Schedule 1. Cannabis for medicinal purposes has now been moved into Schedule 2.
Schedule 1 – These drugs are the most tightly controlled. They are deemed to have no therapeutic benefit, and a Home Office licence is generally required for their production, possession or supply. Any drugs in this schedule handled by a pharmacy must be recorded on a controlled drug register.
Schedule 2 – These drugs are considered to hold therapeutic benefit and can be prescribed by doctors. They are subject to strict record keeping and storage requirements.
The 2018 Regulations came into force on 1st November 2018.
The regulationsalso defined ‘Cannabis-based product for medicinal use in humans’:
- a preparation or other product, which is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative;
- 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.
In Northern Ireland the rescheduling of Cannabis is a devolved issue, so it is not covered by the above 2018 regulations. However similar regulations, specific to Northern Ireland have been passed; and came into force on 1st November 2018.
Evidence that led to changes in the law
UK Government reports
This change in legislation followed reports commissioned by the UK Government, from the Chief Medical Officer and the UK Advisory Council on the Misuse of Drugs (ACMD).
The Chief Medical Officer’s report (PDF, 699KB) concluded that there is now conclusive evidence of the therapeutic benefit of Cannabis-based medicinal products for certain medical conditions, and reasonable evidence of therapeutic benefit in a number of other medical conditions.
As Schedule 1 drugs by definition have little or no therapeutic potential, it is therefore now clear that from a scientific point of view keeping Cannabis based medicinal products in Schedule 1 is very difficult to defend. Moreover, I believe that it would not make sense to move Cannabis and its derivatives out of Schedule 1 whilst leaving synthetic cannabinoids, which the evidence suggests have potentially greater therapeutic benefit and less potential for harm, in Schedule 1. I therefore recommend that the whole class of Cannabis based medicinal products be moved out of Schedule 1.’
The ACMD report (PDF, 388KB) regarding Medicinal Cannabis concluded;
- Cannabis-derived medicinal products of the appropriate medicinal standard should not be subjected to Schedule 1 requirements.
- Clinical trials to establish the effectiveness and safety of Cannabis-derived medicinal products are urgently required.
The report recommended;
- a clear definition of a Cannabis-derived medicinal product is established so that only products meeting this definition be moved into Schedule 2 pending further ACMD advice.
- the Home Office, Department of Health and Social Care (DHSC), and Medicines and Healthcare Products Regulatory Agency (MHRA), should develop additional frameworks and clinical guidance for ‘checks and balances’ to maintain safe prescribing of Cannabis-derived medicinal products.
- at present, synthetic cannabinoids should remain in Schedule 1 pending the ‘longer term’ review by the ACMD.
The UK Government response (PDF, 319KB) stated;
‘the Government decided to act with pace and reschedule Cannabis based products for medicinal use, within the current legal framework, as quickly as it could.’
The Government decided not to move synthetic cannabinoids to Schedule 2; in line with ACMD guidance.
The ACMD have been asked to produce a long term review on Cannabis derived medicinal products to;
- assess whether a more refined listing of Cannabis and Cannabis related products under the Schedules to the 2001 Regulations should take place,
- advise on any potential mitigation for harms and risks of diversion of rescheduling to a different schedule to the 2001 Regulations.
Response from stakeholders
The Multiple Sclerosis (MS) Society have been actively involved in the debate over Cannabis for medicinal use. They published their position statement supporting the use of medicinal Cannabis to manage MS symptoms. They also produced a report in 2017 on MS and Cannabis, which included findings from their 2014 MS symptom management survey on cannabis based drugs. After the change in law they published an article which set out their view on the legislative changes and current regulations.
Epilepsy Action believes that the current guidance is too restrictive. They outline their concerns about difficulty in accessing Cannabis based medicine and are ‘working in Parliament to raise [their] concerns’.
Deputy chief executive Simon Wigglesworth said:
Today’s change in the law should open the door for some children and adults with severe epilepsy to access potentially life-changing treatment.
While this change is an important step forward, the guidance we have seen so far on how it will work in practice seems extremely restrictive.
It suggests that cannabis-based medicines will only be an option for a very limited number of people with epilepsy – children with Dravet or Lennox Gastaut syndromes. Though this is welcome, there are children and adults with other complex and treatment-resistant epilepsy syndromes who could potentially also benefit.
It will be down to the regulatory bodies, clinicians and commissioners to ensure that patients with a clear clinical need can access these medicines in a timely and safe manner
Current prescribing guidance
The National Institute for Clinical Excellence (NICE) is developing guidance on Cannabis-based products for medicinal use.
It’s expected that draft guidance will be published for consultation in July and August 2019, and the final guidance will be published in October 2019.
In the interim the British Paediatric Neurology Association (BPNA) has been asked by NHS England, and on behalf of the devolved nations, to develop interim clinical guidance (PDF, 245KB) for clinicians in the use and prescription of Cannabis-based products for medicinal use in children and young people with Epilepsy.
The Association of British Neurologists has also produced interim guidelines (PDF, 179KB) on the use of Cannabis-based products in adult neurology.
The Royal College of Physicians and the Royal College of Radiologists, in liaison with the Faculty of Pain Medicine of the Royal College of Anaesthetists have developed recommendations on cannabis-based products for medicinal use. This covers the use of Cannabis based products for treating chemotherapy induced nausea and vomiting, and pain.
NHS England gives general guidance (relevant in Wales) on the prescription of controlled drugs as medicine.
Cannabis based medicinal products can only be prescribed by doctors on the General Medical Council Specialist Register.
Where does Wales fit in?
Are any powers relating to Cannabis devolved to Wales?
In Wales, health and health services are generally devolved areas. However, in Schedule 7A of Government of Wales Act 2006 (‘GOWA 2006’), both:
- misuse of and dealing in drugs or psychoactive substances;
- and medicinal products, including manufacture and authorisation for use;
are reserved matters. So in these areas, the Assembly does not have powers to make legislative changes.
The explanatory notes to the Wales Act 2017 (that amended GOWA 2006), further confirm that the legal framework concerning the misuse or dealing in drugs and psychoactive substances is reserved to the UK Government.
This means that the Welsh Assembly and Welsh Government do not have the power to change the law regarding Medicinal Cannabis. It also means that any further change to the legal position regarding Medicinal Cannabis in Wales will require changes to be made by Westminster.
Medicinal Cannabis related business in the Senedd
The legalisation of Cannabis for medicinal use, was debated in Plenary at the Welsh Assembly on 17th January 2018.
On the 14th of December 2018 David Rees AM asked the Welsh Government whether they would be assessing the UK Government guidelines and recommendations on Cannabis prescription. The Minister for Health and Social Care Answered;
‘As the guidelines were developed and issued by professional bodies with considerable expertise in this area, such as the British Paediatric Neurology Association and the Association of British Neurologists, no assessment has been undertaken. We do not intend to issue any separate guidelines. The guidance has been endorsed by the Chief Medical Officer of each UK nation’.
Sativex was the first Cannabis-based medicine recognised in the UK as having medicinal properties. In June 2010, the Medicines Healthcare Regulatory products Agency (MHRA) issued a marketing authorisation (licence) for Sativex, specifically as add-on treatment for symptom improvement in multiple sclerosis patients with spasticity.
Sativex remains a controlled drug under the Misuse of Drugs legislation (Schedule 4). Neither control of drugs nor licensing of medicines are devolved matters. However, in July 2014 Wales became the first part of the UK to make Sativex available to NHS patients following a positiverecommendation by the All Wales Medicines Strategy Group (AWMSG), which provides advice to the Welsh Government on the clinical and cost-effectiveness of licensed medicines.
Delta-9-tetrahydrocannabinol/cannabidiol(Sativex®) is recommended as an option for use within NHS Wales as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
In England the position is different, NICE clinical guidance published in October 2014 recommends (recommendation 1.5.23) that Sativex should not be offered to treat spasticity in people with MS because it is not a cost effective treatment. The Scottish Medicines Consortium also do not recommend Sativex.
While a NICE recommendation would often supersede the advice of AWMSG, the above negative recommendation is set out in a condition-wide clinical guideline rather than a single drug appraisal. As such, this does not affect the status of AWMSG’s advice in Wales.
However NICE checked the guidance in October 2018 and are proposing an update to the recommendations on MS diagnosis, symptom management and rehabilitation. It highlights that there is new cost-effectiveness evidence which indicates that Sativex may be cost effective.
The UK parliament are currently conducting an inquiry into medicinal cannabis, as part of a wider inquiry into the impact of drugs policy on public health. The inquiry has taken written evidence and has started to take oral evidence. On 19 March 2019 witnesses, including the CMO for England, the Medical Cannabis Clinicians’ Society, Royal College of Psychiatrists and Association of British Neurologists gave evidence to the UK Parliament Select Committee.
The Inquiry seeks to answer a number of questions to inform drugs policy; including;
- How suitable are the current procedures for enabling the use of medicinal cannabis in appropriate cases?
- Do practitioners have the knowledge and products available to them to confidently prescribe medicinal cannabis?
- Is the current prescribing guidance fit for purpose?
- What can we learn from other countries?
- Have recent changes in the scheduling and availability of Cannabis derived medicinal products, and media attention around this, affected public opinion and behaviours in the UK?
Article by Holly Kings, Senedd Research, National Assembly for Wales
Senedd Research acknowledges the parliamentary fellowship provided to Holly Kings by the British Biosciences Research Council, which enabled this blog post to be completed.