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Medicinal Products

Dáil Éireann Debate, Tuesday - 24 May 2022

Tuesday, 24 May 2022

Ceisteanna (593)

David Cullinane

Ceist:

593. Deputy David Cullinane asked the Minister for Health if he will advise on a matter raised in correspondence (details supplied) in relation to a licence for a product ; and if he will make a statement on the matter. [25742/22]

Amharc ar fhreagra

Freagraí scríofa

In Ireland, clinicians have two routes for access to medical cannabis-based products for their patients.   

The Medical Cannabis Access programme (MCAP)  

This is a 5-year pilot programme restricted to prescribing of cannabis-based products by medical consultants, for patients with certain medical conditions who have exhausted all other available medical treatment options. Those conditions are:  

- Spasticity associated with multiple sclerosis  

- Intractable nausea and vomiting associated with chemotherapy  

- Severe, refractory (treatment-resistant) epilepsy.  

For more information relating to the MCAP, including FAQs, please see the Department of Health’s website at the following link.  

www.gov.ie/en/publication/90ece9-medical-cannabis-access-programme/.

The purpose of the programme is to facilitate access to acceptable cannabis-based products for medical use that are of a standardised quality and which meet the requirements outlined in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended).

In the Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019 (S.I. 262/2019) a cannabis product or preparation that can be used in the Medical Cannabis Access Programme is defined as ‘specified controlled drugs’ and the definition outlines the specific requirements for those products.

On the 19th July 2021, the Minister for Health announced that the MCAP was now open for medical consultants to make an application for themselves and their patients to be registered for the programme.  

The operation of the Medical Cannabis Access Programme is the responsibility of the HSE, and any queries in relation to applications should be addressed to the HSE at the email address below:  

Pharmacy.response@hse.ie.

Ministerial Licence under Section 14 of the Misuse of Drugs Acts 1977-2016:

Doctors may continue to utilise the Ministerial licensing route to prescribe cannabis-based products for their patients, should they wish to do so. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, either by a consultant or by a GP which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time. This information can be found at the following links:

www.gov.ie/en/publication/1a5c4e-applying-to-the-minister-for-health-for-a-medical-cannabis-licence/.

www.gov.ie/en/publication/e35cb4-ministerial-licence-application-process/.

It is important to note that the medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process.

If the treating clinician wishes to prescribe cannabis-based products for the patient they may contact the Controlled Drugs Unit of the Department of Health at controlled_drugs@health.gov.ie for advice.

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