Cannabis for Medical Use – Information for patients and healthcare professionals.

Introduction

The following information is for healthcare professionals, patients and others who are interested in finding out more about cannabis for medical use. It will discuss current and proposed access to potential cannabis treatment and describe the legal and policy status of cannabis. It also describes the Minister for Health’s role in relation to access to cannabis for medical use, as provided for in the Misuse of Drugs Acts 1977-2016 and in line with expert clinical and scientific advice.

It is important to note that cannabis and cannabis-based products which do not have a marketing authorisation have not been subjected to the same rigorous safety, quality and efficacy standards that are in place for medicines, nor are the producers of such cannabis-based products subject to the same responsibilities as the marketing authorisation holders for authorised medicines.

This information refers only to cannabis for medical use. Other matters related to cannabis including recreational use, decriminalisation, non-medical research, manufacturing, growing/producing cannabis or any other cannabis-related matters should be considered separate and distinct from the information below.

Background and Policy Context to use of cannabis for medical purposes in Ireland

There is considerable public interest in the use of cannabis for medical purposes. While the medical potential of cannabis is clearly of interest and potentially promising, the quality of the evidence reported so far is limited.

A Health Products Regulatory Authority (HPRA) review in 2017 concluded that the available scientific evidence found, at best, a moderate benefit for cannabis in a small number of medical conditions.

In their report the HPRA recommended that if access to cannabis is to be permitted for medical purposes, that it should only be available as part of a structured and supervised clinical programme in a limited number of defined medical conditions.

Additionally, the HPRA specified that use of cannabis should only be considered where a patient with one of those conditions has failed to respond to approved and authorised existing treatments and where there is at least modest evidence that cannabis may be effective.

The HPRA report noted that all such patients should be under the direct supervision of an appropriately trained and experienced medical consultant.

Differences between the main active components of cannabis – THC and CBD

The two active components of cannabis that are of current medical interest are tetrahydrocannabinol (THC) and cannabidiol (CBD).

THC

THC is the main psychoactive constituent of cannabis. Under the Misuse of Drugs legislation, products containing THC are strictly controlled and possession is unlawful, except under Ministerial licence.

CBD

CBD is also derived from cannabis; however, as it is not psychoactive, it is not controlled under the Misuse of Drugs legislation. Therefore, products containing only CBD do not require a Ministerial licence for use.

Legal and policy position on access to cannabis for medical use

The Misuse of Drugs Acts 1977 to 2016, and enabling Regulations, set out the controls and restrictions that apply to cannabis in Ireland.

Under the Misuse of Drugs Regulations 2017, cannabis and products or preparations extracted from the cannabis plant which are psychoactive are listed in Schedule 1. This means that it is subject to the strictest level of control; however, under this legislation it is open to the Minister for Health to consider granting a licence to an Irish-registered medical practitioner for medical cannabis for a named patient. It is important to note that a licence cannot be granted in relation to the provision of cannabis for medical use to a patient in their own name.

The Chief Medical Officer has advised that the granting of a licence must be based on an appropriate application being submitted by an Irish-registered medical practitioner to the Minister for Health. The application must be endorsed by the patients’ medical consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the medical cannabis treatment over time.

Medical cannabis products that meet accepted quality standards have not, as yet, been made available by producers directly to the Irish marketplace. Until these products are available in Ireland, it will be a matter for the prescriber and their patient to source the prescribed medical cannabis-based product. It is understood that patients who have been prescribed such products have sourced it from the following Pharmacy in the Netherlands: Transvaal Pharmacy, Kempstraat 113, 2572 GC The Hague. Tel: 070-3469314.

This pharmacy is supplied with the active ingredients for their CBD and THC-based oils by BEDROCAN International, Postbus 2009 9640CA Veendam, the Netherlands, who are licenced by the Dutch Office of Medicinal Cannabis.

Neither the Minister, nor the Department of Health can make the clinical decision that medical cannabis would be appropriate for the treatment of an individual’s health. The safety and efficacy of cannabis in a large number of medical conditions has yet to be proven. Such products should only be considered for use, after consultation with an individual’s medical advisors and where conventional/existing, evidence-based treatments or therapies have proven unsuccessful or inappropriate for the patient.

It will always be the decision of the clinician, in consultation with their patient, to prescribe or not prescribe a particular treatment, including cannabis-based treatments, for a patient under their care. The Minister for Health has no role in this clinical decision-making process.