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Home > Dail Eireann debate. Written answer 449 - Medicinal products regulation [23142/17] [Parkinson's, Cannabis].

[Oireachtas] Dail Eireann debate. Written answer 449 - Medicinal products regulation [23142/17] [Parkinson's, Cannabis]. (16 May 2017)

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449. Deputy Frank O'Rourke asked the Minister for Health if consideration is being given to the inclusion of Parkinson's disease as one of the medical conditions for which cannabis for medicinal use could be approved on the list of medical conditions which is being compiled by the Health Products Regulatory Authority; and if he will make a statement on the matter. [23142/17]


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.   

The HPRA Report did not recommend the inclusion of Parkinson’s disease in the access programme. This position will be kept under review, and if better clinical evidence becomes available in future, the inclusion of such conditions can be reconsidered.

(ii)   Ministerial licence application route   It is the decision of a clinician to prescribe a particular treatment, including cannabis for medicinal purposes, for a patient under their care. As Minister for Health I have no role in the clinical decision-making process.   Under the existing arrangements the role of a Minister for Health comes into play when an application for a licence to prescribe medicinal cannabis has been received by the Department of Health from a clinician. In such cases it is open to me to consider granting a licence under the Misuse of Drugs Acts, for access to medical cannabis for that named patient, where the proposed course of treatment has been endorsed by the patient’s consultant who is responsible for the management of that 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.

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