England’s medical cannabis market has barely gotten off the ground since launching about 19 months ago, with a two-tier system in which few patients access products through legal channels while most resort to illicit suppliers.
The number of “unlicensed” medical cannabis prescriptions issued in England continued to be negligible as of February 2020, Marijuana Business Daily has learned. Such products did not go through successful clinical trials to be granted a license to be marketed, but they can still be prescribed.
England’s National Health Service (NHS) has reimbursed patients on only a couple of dozen occasions for such products, also known as U-CBMPs, the National Health Service Business Services Authority told MJBizDaily in response to a Freedom of Information Act request.
The data – which covers November 2018 through February 2020 – relates only to prescriptions in England “in primary-care settings” and excludes the rest of the United Kingdom.
Because hospital prescriptions of U-CBMPs are not included in the data, the total number of NHS prescriptions could be slightly higher.
In the case of private health care – prescriptions that patients pay out of pocket – U-CBMPs were prescribed 313 times.
Only prescriptions that were “prescribed and submitted to NHSBSA” are included, meaning the data does not account for prescriptions issued but not redeemed. (That could happen, for instance, if patients realize they could not afford the cost after the prescription was issued.)
Private prescriptions are submitted to England’s NHSBSA only for reporting and monitoring purposes, but they are not reimbursed.
Unlike “licensed” medicines, U-CBMPs do not have marketing authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) – typically because they have not successfully undergone clinical trials to prove their safety, quality and efficacy.
Why so rare?
In the United Kingdom, only Epidiolex, nabilone and Sativex are considered licensed cannabis-based medicines.
All other cannabis-based medicines are unlicensed and often referred to as “specials.”
“Prescribing an unlicensed product should be considered third and only if an individual patient has exceptional clinical needs that cannot be met by a licensed or off-label medicine,” according to a Q&A on the NHS England website.
Unlicensed medicines may be prescribed only to meet the “special needs” of an individual patient when no suitable licensed alternatives are available.
Andy Yates, pharmacy lead at the U.K. Center for Medicinal Cannabis (CMC), told MJBizDaily that “whilst ‘specials’ medicines will always need to be prescribed appropriately and cautiously, our own data at the CMC shows that over 2% of the adult U.K. population are self-prescribing a cannabis medicine from black-market sources.”
“These low numbers of prescriptions can therefore only represent a fraction of those in need of cannabis medicine,” he added.
Considering that the NHS is covering only a handful of U-CBMPs prescriptions per month, companies hoping to capitalize on sales of such products in Britain must find ways to boost private prescriptions if they do not generate the necessary evidence through clinical trials to “license” the medicines.
“This highlights the disparity involved with cannabis medicine – with those that can afford it obtaining it legally, leaving others less well-off exposed to breaking the law to obtain their medicine,” Yates said.
Recent guidelines from England’s National Institute for Health and Care Excellence (NICE) recommended NHS coverage of licensed medicines Epidiolex, nabilone and Sativex for certain conditions.
Because they’re only rarely covered by insurance, unlicensed medical cannabis products remain at a competitive disadvantage to licensed medicines.
A recent report by the U.K.’s Conservative Drug Policy Reform Group identified the following obstacles to accessing unlicensed cannabis-based products:
- Limited evidence on quality, safety and efficacy.
- Limited medical education.
- High costs.
- Unreliable supply.
Import rules eased
The United Kingdom eased import restrictions for medical cannabis in March, which, in theory, could improve access.
Licensed wholesalers of medical marijuana are now able to import larger quantities of cannabis-based products and hold supplies for future distribution.
Before the change was made, the government acknowledged that burdensome regulations applied by the U.K. and exporting nations caused international shipments to take up to two months to reach British patients.
The new regulation allows up to 25 individual doses to be imported, or a quantity not exceeding that required for 25 courses of treatment of no more than three months.
Ben Langley, CEO of London-based medical cannabis importer and distributor Grow Pharma, told MJBizDaily that the recently eased import rules were necessary.
“It is now easier and cheaper to import cannabis medicines into the U.K., which has, in turn, reduced costs for patients.
“While patient numbers are still slow to increase, this shows that the private sector and government are both making progress in removing barriers to access.”
The U.K.’s full guidelines on importing medical cannabis are available here.
Alfredo Pascual can be reached at email@example.com