Clare Daly (Dublin Fingal, Independent)
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1028. To ask the Minister for Health the way in which the process of compassionate exemption for access to medicinal cannabis operates; when the process is relevant, the persons eligible to apply; the criteria for access; and the number of successful applicants there are under the scheme [20177/17]

Simon Harris (Wicklow, Fine Gael)
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On 10 February I published the HPRA’s Report ‘Cannabis for Medicinal Use – A Scientific Review’ and announced the establishment of an access programme for cannabis-based treatments to be provided for patients under the care of a medical consultant for the following 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 Cannabis 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 Cannabis Access Programme.

This is being facilitated through an Expert Reference Group comprising representation from the areas of Oncology, Palliative care, Anaesthesiology, General Practice, Adult Neurology, Paediatric Neurology, Multiple Sclerosis, Psychiatry, Pharmacy, Patients, Ethics, Health Technology Assessment, and Health Products Regulator. The Reference Group has already commenced work on drafting guidelines, in line with National Standards for Clinical Practice Guidance Development, to facilitate the prescription and supply of medicinal cannabis to qualifying patients.

Officials in the Department are also working on secondary legislation to underpin the access programme. This work will take a number of months. In the meantime it remains open to me, as Minister, under the Misuse of Drugs Act, to consider granting a licence for access to medical cannabis for named patients, where this course of action has been endorsed by the patient’s consultant.

The main elements of an application for a licence for the Schedule 1 drug, cannabis 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 the decision on the appropriate course of treatment for any patient is a matter for the clinician treating the patient. To date one license has been granted.