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Home > Dail Eireann debate. Written answer 191 - medicinal products licensing [22212/17] [Cannabis].

[Oireachtas] Dail Eireann debate. Written answer 191 - medicinal products licensing [22212/17] [Cannabis]. (10 May 2017)


191. Deputy Michael Moynihan asked the Minister for Health Information Simon Harris the position regarding the provision of cannabis for medicinal use here; and if he will make a statement on the matter. [22212/17]

 

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: (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’. 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.

 

A critical focus of the Department’s work in setting-up the access programme has been engagement with clinicians, patients and pharmacists who will be central to the drawing up of guidelines on the safe use of cannabis for those patients who will be prescribed cannabis-based treatments through the access programme. 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.

 

(ii) Ministerial licence application route

 

  Under existing arrangements 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 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. The Minister for Health has no role in this clinical decision-making process.

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