Medical Cannabis Access Programme
In November 2016, the Minister for Health announced a review of policy on cannabis for medical purposes and requested the HPRA’s views on recent developments in the use of cannabis for medical purposes including products available, research, indications and evidence of effectiveness, an overview of the different regulatory regimes in place in countries which allow cannabis to be used for medical purposes and legislative changes that would be required to allow use of cannabis for medical purposes in Ireland.
The HPRA established a Working Group of relevant experts to assist with its review. The experts included consultant neurologists, a consultant in palliative medicine, a consultant psychiatrist specialising in addiction, a consultant anaesthetist/pain specialist, and a palliative care pharmacist as well as patient representatives.
The HPRA’s subsequent report ‘Cannabis for Medicinal Use – A Scientific Review’, published in February 2017, recommended that if access to cannabis is to be permitted for medical purposes, that its use should only be initiated as part of a structured process of formal on-going clinical evaluation in a limited number of clearly defined medical conditions which have failed to respond to all other previous treatments, and where there is at least modest evidence that cannabis may be effective.
The report noted that all such patients should be under the direct supervision of an appropriately trained and experienced medical consultant. The specified medical conditions (medical indications) are:
- 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.
The HPRA report further recommended the introduction of a monitored cannabis treatment programme and advised that such a programme is necessary, both to maximise the safe and effective use of cannabis as a medical therapy for an individual patient, and to minimise the potential negative impact of wider access on society. It is planned that the programme should run for a period of five years, with a centralised data collection point and regular reports to the Department of Health. This information will provide data on the medical use of cannabis and the supply needs in Ireland.
On foot of the conclusions from the HPRA’s report, the Minister established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme. The Expert Reference Group is 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 Assessments and the Health Products Regulatory Authority.
The Expert Group was asked to advise on the development of operational, clinical and practice guidelines for healthcare professionals treating patients through an Access Programme. An important aspect of the work of the Group was to engage with representative bodies, clinicians, patients, and pharmacists, all of whom are integral to the production of clinical and operational guides for an Access Programme. The Group also conducted a targeted consultation on the draft form of the clinical guide, which has been finalised and is available here.
Expert stakeholder engagement is being undertaken to set the quality standards to be applied to medical cannabis products that will be permitted for use under the Access Programme. This will help to ensure that many of the quality controls expected for other medicines can be applied to medical cannabis.
The Access Programme is not yet operational, as further work is required in relation to certain elements, in particular the availability of appropriate quality-approved medical cannabis products for patients. This is a critical aspect in establishing the access programme. The Department is working intensively on finding solutions to the supply of appropriate products for Irish patients.
In the meantime, prescribing of cannabis for medical treatment by medical consultants, for their individual patients is being facilitated via the Ministerial licence application route