Press Release

Minister Harris announces ‘pivotal step’ on Medicinal Cannabis Access Programme – Prescribers, Patients and Pharmacists to draw up guidance for the safe use of cannabis-based treatments for qualifying patients

Following the Minister for Health’s publication of the Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’ on 10 February and his announcement that he will establish a Cannabis Access Programme for cannabis-based treatments for qualifying patients, Minister Simon Harris today announces a pivotal step in the progress towards operationalising this initiative.

The HPRA review concluded that a cannabis access programme could include access to cannabis-based therapies for the treatment of patients with:
• Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;
• Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;
• Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

As noted by the HPRA in their review, there is an absence of scientific data demonstrating the effectiveness of cannabis products and the safety of cannabis as a medical treatment is not well characterised. Given these concerns, it is particularly important that the planned Cannabis Access Programmes draws on the expertise of medical specialists who are responsible for the management of the patient groups listed above. Consequently, 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.

The Expert Reference Group will be chaired by Dr Mairín Ryan, Director of Health Technology Assessment at the Health Information and Quality Authority (HIQA). The group 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, Health Products Regulator. The Reference Group will convene tomorrow (30 March 2017) to commence 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. The group will have regard to the HPRA report and other international scientific evidence in developing operational guidelines for the implementation of the access programme through which the optimal use of cannabis for medicinal purposes in Ireland can be implemented. It is expected the guidelines will focus on the clinical criteria for patient access; forms of medicinal cannabis that will be permitted for use; prescribing and dispensing requirements for doctors and pharmacists; education requirements for healthcare professionals and patients and ethical implications of such a scheme.

“It has been reported in recent weeks that there is a legal barrier preventing access to cannabis-based treatments and that a change in the law is required to allow patients to access cannabis treatment. In fact there is no legal barrier. It remains open to me, as Minister for Health, to consider granting a licence under the Misuse of Drugs Acts, where the proposed course of treatment has been endorsed by a consultant. A licence has been granted for a named patient under this provision.

Ultimately the decision on the appropriate course of treatment for any patient is a matter for the clinician treating the patient. It would be wholly inappropriate for a Minister for Health to seek to instruct or influence any doctor to prescribe a particular treatment.

Note to Editors

The Expert Reference Group will include a community pharmacist, patient representatives and a medical ethicist. In addition, it will include representatives from the following professional organisations:

The Royal College of Physicians of Ireland (Neurology, Palliative Care, Oncology)
The College of Psychiatrists of Ireland
The College of Anaesthetists of Ireland
The Irish College of General Practitioners
The Pharmaceutical Society of Ireland
The Health Products Regulatory Authority
The Health Information and Quality Authority (Health Technology Assessment Unit)