Government's second review recommends rescheduling cannabis
The second part of the government-commissioned review into whether cannabis should be rescheduled has also recommended Schedule 2 status — advice that the home secretary, Sajid Javid, previously said he would follow.
Medicinal cannabis should be rescheduled, the Advisory Council on the Misuse of Drugs has advised the Home Office; however, it has warned that ‘checks and balances’ should be put in place to ‘avoid harms to patients and others’.
The advisory body’s — the second of a two-part review commissioned by the government — found “there is now evidence of medicinal benefit for some cannabis-derived products in certain medical conditions for some patients”.
The ACMD recommended that clinicians in the UK should have the option to prescribe cannabis-derived medicinal products that meet the requirements for medicinal standards in patients with certain medical conditions.
“It is therefore appropriate for these medications to not be subjected to the requirements of Schedule 1 of the Misuse of Drugs Regulations (MDR) 2001”, the ACMD said.
The home secretary, Sajid Javid, has previously said that if both parts of the review recommended rescheduling, he would follow that advice.
The ACMD review also recommended that the Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) “promptly develop a clear definition of a cannabis-derived medicinal product”.
In addition to the provisions of Schedule 2 of the MDR, the ACMD recommended that the DHSC, MHRA and home office should develop additional frameworks and clinical guidance for ‘checks and balances’ to maintain safe prescribing of cannabis-derived medicinal products.
The findings stressed that understanding of the potential therapeutic uses of cannabis-derived products “is still developing”, and that “carefully conducted clinical trials are needed to establish the effectiveness of these products and to understand the short- and long-term safety of using them”.
The National Pharmacy Association welcomed the ACMD’s report, but said: “It is important that the DHSC and the MHRA determine appropriate definitions and medicinal standards for use of cannabis in treating specific medical conditions.
“Guidelines for ensuring clear checks and balances for prescribing and supply would ensure patient safety from use of cannabis-derived medicinal products, and control legitimate use.”
The ACMD’s recommendations are in line with findings of the chief medical officer, Dame Sally Savies, who led review. Davies said in her report: “There is clear evidence from highly respected and trusted research institutions that some cannabis-based medicinal products have therapeutic benefits for some medical conditions.”
Davies’s report stated that “using other forms, such as grown or street cannabis, as a medicine for therapeutic benefit is potentially dangerous”. The ACMD agreed that “raw cannabis (including cannabis-based preparations) of unknown composition should not be given the status of medication”.
Earlier this year, Billy Caldwell, a 12-year-old boy who has severe epilepsy, was granted an exceptional licence by the home office to be treated with medicinal cannabis oil bought by his mother in Canada. The oil, which contains tetrahydrocannabinol — a substance which is illegal in the UK — had previously been confiscated.
His case led to Javid announcing the two-part review to consider the therapeutic evidence of cannabis and cannabis-related products, and whether medicinal cannabis should be rescheduled.
If the review identified that there were significant medical benefits “then we do intend to reschedule”, Javid told the House of Commons in a speech on 19 June 2018.
ACMD has been tasked with giving a full review on the rescheduling of cannabis-based products by July 2019.
Citation: The Salvadore DOI: 10.1211/PJ.2018.20205212
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