Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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1045. To ask the Minister for Health the status of the cannabis access programme for cannabis-based treatments for qualifying persons (details supplied); when it will be in place; and if legislation will be required or if it can be put in place in advance of legislation being enacted [36250/17]

Simon Harris (Wicklow, Fine Gael)
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In February 2017 I published the HPRA report ‘Cannabis for Medical Use - A Scientific Review’ and I committed to the implementation of a Cannabis for Medical Use Access Programme, in line with the HPRA’s report, which recommended the introduction of a monitored cannabis treatment programme for the 3 medical conditions:

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

- intractable nausea and vomiting associated with chemotherapy;

- severe, refractory (treatment-resistant) epilepsy.

An Expert Reference Group, chaired by Dr Mairín Ryan, Director of Health Technology Assessment at the Health Information and Quality Authority (HIQA) convened on 30 March to commence work on drafting guidelines.

The Expert group, which comprises representation from the areas of Oncology, Palliative care, Anaesthesiology, General Practice, Adult Neurology, Paediatric Neurology, Multiple Sclerosis, Psychiatry, Pharmacy, Patients, Ethics, Health Technology Assessment, the Health Products Regulatory Authority and the Department of Health, has been asked to develop operational and clinical guidance which sets out how a Cannabis Access programme can be implemented. This draft Clinical Guidance document on the Medical Use of Cannabis under the Access Programme is currently out for stakeholder consultation.

Work is continuing on aspects of the Access Programme such as: education requirements for healthcare professionals and patients in relation to the use of cannabis for medicinal purposes; establishment of a central registry through which the scheme can be monitored; requirements for monitoring mechanisms through which the scientific developments in this area can be monitored over time, clarification of the ethical implications that the Access Programme may have for patients, the general public, healthcare professionals or the health system; drafting of secondary legislation under the Misuse of Drugs Acts.

Work on the project and legislative amendments is progressing and will take a number of months to complete.

Cannabis is listed in Schedule 1 of the Misuse of Drugs Regulations 2017, which means that it is subject to the strictest level of control; however, under the Misuse of Drugs legislation it is open to the Minister for Health to consider granting a licence to an Irish-registered medical practitioner for access to medical cannabis for a named patient.

Under these existing arrangements, which will continue in parallel to the Cannabis Access Programme once it is established, medical practitioners wishing to prescribe cannabis-based products containing THC for medical purposes may apply via the Ministerial licence application route. The Chief Medical Officer has advised that the granting of such a licence 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 Minister for Health has no role in the clinical decision-making process.

A licence application endorsed by the patient’s medical consultant and submitted under the Misuse of Drugs Acts, 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 cannabis-based product;

- details of the cannabis-based product which it is proposed to prescribe and administer to the patient;

- the source of the cannabis-based product;

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

Where consultants require further information or clarification in relation to the licence application process, he or she should contact the Department of Health directly. 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. It is the decision of the medical practitioner to make an application to the Minister for Health for such a licence.