medicinal cannabis products
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David Hardstaff of BCL’s Cannabis Law & Regulatory team considers the Achievement of the UK’s legalisation of medicinal cannabis Goods

The results are in — The UK’s Advisory Council on the Misuse of Drugs (ACMD) released its assessment on the impact of the rescheduling of cannabis-based products for medicinal usage (CBPMs) in people in November 2020. As individual organisations and groups digest the Council’s findings, I consider the key points to take away from the report.

In the UK, cannabis, until relatively recently, was treated mainly as a recreational drug, with evidence of risk to health through misuse. In response to increasing public pressure and a growing body of evidence regarding the effectiveness of cannabis-based medications, in 2018, CBPMs were rescheduled into Schedule 2 of the Misuse of Drugs Regulations 2001, which makes them available for prescription in certain restricted conditions. As with all medications, CBPMs might be licensed, through receiving marketing authorisation in the Medicines & Healthcare products Regulatory Agency, or unlicensed and provided with respect to a prescription by a specialist medical practitioner.

Accessibility to CBPMs remains closely regulated, so much that critics have contended the vast majority of UK patients cannot benefit from medications widely available in other countries. This has resulted in a fierce debate regarding not only the efficacy and safety of CBPMs, but also the political, economic, and societal factors underpinning the role of cannabis in 21st century Britain.

While there has been much disagreement and reporting in relation to patient access, the ACMD report concentrates on the available statistics in trying to assess the impact of the rescheduling of CBPMs.

The Council’s decisions

The report concludes :

• The impact of the rescheduling of CBPMs has been slow, which there hasn’t been sufficient time to reach a conclusive comprehension of the changes. It was exacerbated by the COVID-19 pandemic, which has impacted data collection.

• Only three licensed CBPMs are now accessible in the United Kingdom and approved by the National Institute for Health and Care Excellence. Around 800 patients a year received a licensed CBPM out of 2017–2019, with evidence of an increase in prescriptions at the four to six months after November 2019.

• More starkly, it is believed that no more than four patients are prescribed unlicensed CBPMs throughout the NHS. The number of patients independently prescribed juvenile CBPMs is supposed to be much higher, however, the information is uncertain.

• the purchase price of unlicensed CBPMs has been high compared to licensed medications. Even though the marketplace is still in its infancy, the report notes that there is minimal interest from manufacturers of unlicensed CBPMs to apply for marketing authorisation.

• Instances of adverse drug reaction reporting associated with CBPMs have improved since the rescheduling of CBPMsnonetheless, this growth was from extremely restricted levels of reporting in 2017. The report concludes that it is just too soon to draw conclusions concerning the security of the products in the limited data available.

• As for its illicit use of cannabis, it is too soon to say if the rescheduling of CBPMs has any impact. There’s minimal evidence of this diversion of CBPMs into the illicit market.

Recommendations and reactions

  • The ACMD ought to be commissioned to run a further assessment over the subsequent two years;
  • The availability of a CBPM patient registry ought to be recognised as necessary for prospective assessment of the impact of the rescheduling of CBPMs;
  • That research ought to be commissioned to assess the impact of the rescheduling of CBPMs on public knowledge of, and attitudes towards, cannabis and CBPMs, and to research security, quality and efficacy of CBPMs and;
  • That government departments should conduct a full review of international approaches to laws which facilitates the medicinal usage of cannabis-based medicines.

Reactions to the report are generally positive. Science-led charity, Drug Science, in its response to the report, supported the ACMD’s conclusion that the growth of a CBPM patient registry is necessary, describing this as”a critical step in allowing for a careful evaluation of the scope and pattern of prescription of CBPMs, and their advantages and risks.”

Drug Science was in the forefront of calls for broader and more effective set of information relating to the use of CBPMs. Its 2020 initiative, Project TWENTY21, was started with the ambition of collecting data from up to 20,000 medicinal cannabis patients over a two-year interval. Project TWENTY21 represents a good example of the possible gains to be made through greater cooperation between government departments and the private sector.

Running themes and lessons

The ACMD’s recommendation that government departments should examine global approaches is also particularly welcome. There’s long been a perception of reluctance on the part of government departments and agencies to recognise evidence from other, often similar, authorities. This is not an approach the ACMD has taken, citing global evidence supporting the therapeutic use of CBPMs as part of its assessment.

The report also suggests that there is emerging evidence of a divergence between medications available to NHS patients and those seeking treatment independently. So far, only a couple of all NHS patients have received prescriptions for juvenile CBPMs, whereas the number of personal prescriptions is supposed to be in the hundreds, or even thousands (the information is incomplete). This disparity suggests there are likely to be many patients with a real need who cannot access treatment through the NHS, and unable to afford the high prices of private prescriptions. Patients across the board have been further impacted as a consequence of the pandemic, which resulted in the NHS temporarily suspending the processing of personal prescriptions of unlicensed CBPMs.

If there are any central themes to be taken in the report, it is that more research is needed and that government departments, agencies, and the private sector need to do more to record, share, and apply available data. The institution of a CBPM patient registry will certainly be a step in the ideal direction. Whether it’s going to be as extensive as other endeavors in its scope remains to be seen. It seems improbable that evidence from individuals who have turned to the illicit market to self-medicate will be included, which could be a wasted opportunity to gather invaluable information.

Physicians, the Government, Big Pharma, and anybody with an interest in this innovative and exciting field of medicine, will hopefully have the Council’s next review to look forward to in two years’ time. Sadly, the pandemic may in the meantime continue to hinder efforts to estimate the true impact of CBPMs. Hopefully, by the time the Council reports back again the picture will be clearer, which makes way for renewed optimism around cannabis-based medicines.

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