Written answers

Wednesday, 26 July 2017

Department of Health

Medicinal Products Licensing

Photo of Niamh SmythNiamh Smyth (Cavan-Monaghan, Fianna Fail)
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812. To ask the Minister for Health if he will review the case of a person (details supplied); and if he will make a statement on the matter. [35455/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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Thank you for bringing this case to my attention, and if the patient's consultant requires further information following this reply I would invite him or her to contact my Department.

Cannabis is strictly controlled under the Misuse of Drugs Acts, 1977 to 2016 and the Regulations made thereunder.

The two most common active components found in cannabis oil are tetrahydrocannabinol (THC) and cannabidiol (CBD).

CBD is derived from cannabis. Since it is not psychoactive, it is not controlled under the Misuse of Drugs legislation. CBD oil is sometimes marketed as a nutritional or dietary supplement, however it should be noted that it is not authorised as a medicinal product in Ireland.

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

There are two pathways for medical practitioners to prescribe cannabis-based products for medical purposes: (i) through the Medicinal Cannabis Access Programme (which is currently being established); (ii) through the Ministerial licence application route.

(i)Medicinal Cannabis Access Programme:

In February I published the Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’ and undertook to establish an Access Programme for cannabis-based treatments, for patients under the care of a medical consultant, for certain medical conditions, including severe, refractory (treatment-resistant) epilepsy.

An expert reference group has been established to operationalise this access programme. This work is being progressed.

(ii)Ministerial licence application route

Pending implementation of the Cannabis Access Programme, and for medical conditions that are not included in the Cannabis Access Programme: under existing legislation it is open to me as Minister to consider granting a licence to an Irish registered medical practitioner, under the Misuse of Drugs Acts, for access to medical cannabis for named patients. 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, 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.

The main elements of an application submitted under the Misuse of Drugs legislation for a licence for cannabis for medicinal use must include:

- An outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate in their patient’s specific circumstances to prescribe a Schedule 1 drug.

- Details of the cannabis-based product which it is proposed to prescribe and administer to the patient.

- The source of the cannabis-based product.

- The arrangements for the ongoing monitoring and care of the patient once the cannabis-based treatment has commenced.

Ultimately it is the decision of the clinician, in consultation with their patient, or their patient's guardian, to prescribe or not prescribe a particular treatment for a patient under their care. The Minister for Health has no role in this clinical decision-making process.

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