The Conservative Drug Policy Reform Group

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Call for Evidence: Part B of the UK Review of Medicinal Cannabis

Frederick Blunt

This call for evidence seeks stakeholder views on the regulation of the manufacture, importation, distribution, supply, prescription and use of cannabis-based medicines and products for medicinal use in the UK. The provisional closing date is 5pm on Friday 07 August 2020.

Background

On November 1, 2018, an amendment to the Misuse of Drugs Regulations 2001 laid by the UK Home Office defined ‘cannabis-based products for medicinal use in humans’ (CBPM) and rescheduled them from Schedule 1 to Schedule 2. This amendment allowed for the use of CBPM for medicinal and clinical research purposes without a Schedule 1 domestic licence. CBPM can since be prescribed by specialist medical practitioners as unlicensed medicines for patients with a special clinical need, and CBPM that are registered as Investigational Medicinal Products can be used in clinical trials under Schedule 2 controls.

The Conservative Drug Policy Reform Group (CDPRG) has conducted a review of access to cannabis-based products for medicinal reasons in the first year following the change in law, titled The UK Review of Medicinal Cannabis: The Needs of a Nation. Part A of this review “The Current Landscape” was published on April 23, 2020, and is available for download here. It covers seven routes of access by which UK citizens presently gain access to a range of cannabis-based products to treat symptoms of health conditions, outlining the distinct operational characteristics, rates of access, and challenges associated with each route.

There is a wide range of cannabis-based products in the UK, distinct in terms of form, contents, use, purpose, clinical evidence, quality, and legal control. Part A of the review assesses the impact of the 2018 rescheduling on the availability and use of unlicensed CBPM, but also evaluates both lawful and unlawful routes of access to a range of other cannabis-based products, from licensed cannabis-based medicines (CBM) to completely unregulated products distributed on the illicit market. The emphasis throughout is on individuals accessing products for the treatment of symptoms of health conditions, rather than recreationally-motivated use.

The CDPRG is now calling for evidence from stakeholders and interested parties to inform Part B of this review (The Road Ahead), which will evaluate a range of legal and regulatory options that might be considered for implementation in the UK to meet the unique challenges identified in Part A. We welcome all perspectives.

Policy Goals

The legal and regulatory models evaluated in Part B will be evaluated on the following three policy goals:

Safe access: What impact could this policy choice have on the development of safe and affordable access to cannabis-based medicinal products where clinically appropriate and cost-effective?

Evidence generation: What impact could this policy choice have on the development of a robust evidence base on the safety, quality and efficacy of cannabis-based medicinal products?

Risk minimisation: What impact could this policy choice have on actual and potential harms to individuals, wider society, and public health?

Call for evidence

To inform Part B of our report, we are calling for written evidence submissions in response to the questions outlined below. The call is open to any and all groups and individuals: as an evidence-based organisation CDPRG recognises all perspectives in regard to the control of cannabis-based products and we encourage all parties to participate regardless of your views.

Please submit your answers to any or all of the following questions and provide justification for your answers. If you would like to submit any additional evidence that you think is relevant to our inquiry, please attach it as a separate word document (see: 4. How to submit).

Key questions

1. Other than the three policy goals identified in (2) above, what primary objectives do you think should be prioritised by policymakers?

2. Which Government department do you think is best suited to be responsible for cannabis policies?

3. Does the current regulatory framework for the manufacture, importation, distribution, supply, prescription and use of licensed CBM (e.g. Sativex) and unlicensed CBPM (e.g. Bedrocan products):

  • Provide safe and affordable access where clinically appropriate?

  • Contribute to the development of the evidence base on product safety, quality, efficacy and/or effectiveness?effectively minimise risks and harms to individuals and to society?

  • Otherwise meet the needs of policymakers, regulators, prescribers, patients, producers and/or other industry stakeholders?

4. If you think current policy on cannabis-based medicines and products for medicinal use does not satisfactorily achieve any of the above, what policy changes do you think should be considered to improve outcomes?

5. Does the current regulatory framework for the manufacture, importation, distribution, supply, and use of non-medicinal, non-controlled cannabis-based products (e.g. CBD oils, hemp oils, hemp fibres): provide safe and affordable access to consumer products?

  • Contribute to the development of the evidence base on potential health harms and benefits of consumer products, particularly of non-medicinal CBD supplements?

  • Effectively minimise risks and harms to individuals and to society?

  • Otherwise meet the needs of policymakers, regulators, producers, suppliers and/or consumers?

6. If you think current policy on non-medicinal, non-controlled cannabis-based products does not satisfactorily achieve any of the above, what policy changes do you think should be considered to improve outcomes?

7. In your view, should unlicensed CBPM be subject to different regulatory controls than other medicinal products?

8. In particular: As compared to other medicinal products, should a lower or otherwise different standard of evidence be required of cannabis-based products for: market authorisation in the UK; evaluation of cost-effectiveness; or prescribing decisions?

9. What legal and regulatory controls do you think there should be in respect to the cultivation of small numbers of cannabis plants for personal use by individuals or the designated carers of individuals who:

  • Have a medically-recognised health condition for which there may be plausible therapeutic benefit from the use of cannabis-based products;

  • Are not able to access licensed CMB or unlicensed CBPM through NHS care;

  • Are not able to access licensed CMB or unlicensed CBPM through private healthcare, for financial or other reasons;

  • Are not selling or otherwise supplying products to other people; and are taking sufficient measures to prevent theft of products and accidental access by children?

10. What legal and regulatory controls do you think there should be in respect to the possession of small amounts of cannabis for personal use by individuals or the designated carers of individuals who:

  • Meet the criteria of a-e, as above;

  • Have bought or otherwise accessed products through the illicit market?

How to respond

To respond to this call for evidence, please email amber.moore@cdprg.co.uk with your responses attached as a word document (.doc, .docx, .odt).

Please name the document with your answers in the following format:

CDPRG_PartB_Response_Lastname_Organisation.doc

If you are submitting any additional evidence that you think is relevant to our inquiry but which does not specifically answer the questions above, please name the document(s) in the following format: CDPRG_PartB_Additional_Lastname_Organisation.doc

Due to the current coronavirus, we are not accepting postal submissions. The closing date for evidence is 5pm on Friday 07 August 2020. About you In your response please state whether you are replying on behalf of an organisation or as a member of the public. If you are replying on behalf of an organisation, please state the name of the organisation and your position.

Confidentiality and data protection information Information provided in responses to this call for evidence may be subject to release to the public or other parties. The CDPRG may publish the content of your response in the body of the forthcoming report and/or in attached evidence dossiers but will not publish your private contact details.