Home > Dail Eireann debate. Written answer 392 - Medicinal products licensing [25288/17] [Medicinal cannabis].

[Oireachtas] Dail Eireann debate. Written answer 392 - Medicinal products licensing [25288/17] [Medicinal cannabis]. (30 May 2017)

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392. Deputy Fergus O'Dowd asked the Minister for Health the status and projected timeframe for the possible introduction of medical cannabis under the supervision of medical professionals; if he will make available information related to this area of interest; and if he will make a statement on the matter. [25288/17]


Minister for Health (Deputy Simon Harris): Cannabis is strictly controlled under the Misuse of Drugs Acts, 1977 to 2016 and the Regulations made thereunder.


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


In February I published the Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’. On foot of the conclusions from the HPRA’s report I announced my intention to establish an access programme for cannabis-based treatments, for patients under the care of a medical consultant, for the following medical conditions:    

- spasticity associated with multiple sclerosis resistant to all standard therapies and interventions;    

- intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes;   

- severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications.


An expert reference group has been established to develop the operational, clinical and practice guidelines for this access programme. Officials in the Department are also working on secondary legislation to underpin the access programme. This work will take a number of months to complete.


Under existing legislation it is open to me, as Minister, to consider granting a licence under the Misuse of Drugs Acts, for access to medical cannabis for named patients, where the proposed course of treatment has been endorsed by the patient’s Irish-based consultant who is responsible for the management of the patient, and who is prepared to monitor the effects of the treatment over time. One such licence has already been granted under this mechanism.


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, to prescribe or not prescribe a particular treatment for a patient under their care. I have no role in this clinical decision-making process.

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