Minister for Health Simon Harris has signed legislation which will allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years.
The Programme will facilitate access to cannabis-based products for medical use in line with legislation.
The signing of the legislation underpinning the Access Programme allows for commencement of the operation of the Access Programme, for first stage of which is for potential suppliers to apply to have their medical cannabis products assessed for suitability for medical use.
Currently no medical cannabis products are available in Ireland, however, this legislation now means that commercial operators whose cannabis products meet the specified requirements set out in the legislation and which have been listed in Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations will be able to supply these products to the Irish market.
Once suitable medical cannabis products are made available by suppliers, the Access Programme will make it possible for a medical consultant to prescribe a listed cannabis-based treatment for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:
- spasticity associated with multiple sclerosis;
- intractable nausea and vomiting associated with chemotherapy;
- severe, refractory (treatment-resistant) epilepsy.
In thanking the Expert Reference Group, chaired by Dr Máirín Ryan, Deputy Chief Executive of HIQA, which drafted the detailed Clinical Guidelines for the Access Programme, Minister Simon Harris commented that “the important work carried out by the Expert Reference Group in producing these clear and concise clinical guidelines, informed the development, direction and ultimate delivery of the Access Programme.”
Work on the establishment of Programme began in March 2017, on foot of the conclusions from the Health Products Regulatory Authority’s (HPRA) expert report Cannabis for Medical Use – A Scientific Review, which was prepared at the request of the Minister for Health. The Minister for Health extends his sincere thanks to Dr Lorraine Nolan and the staff of the HPRA and to the Expert Working Group for providing the foundation block for the development of this Programme and for assisting in making the Access Programme a reality for patients.
Further information on the Medical Cannabis Access Programme:
- Suppliers / Importers: A prospective supplier can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in this new piece of legislation (see also below under ‘Additional Information – Guidance for Suppliers/Importers’). As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017, a controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products.
- Patients with a specified medical condition should see their medical consultant for advice. It is important to understand that it will only be possible for specialist consultants to prescribe a specified controlled drug (medical cannabis products) under the Access Programme, once suppliers make these products available on the Irish market.
- Prescribers (medical consultants on the specialist register) will be able to prescribe cannabis for medical use to patients as set out in the legislation. It is important to understand that it will only be possible for specialist consultants to prescribe a specified controlled drug (medical cannabis products) under the Access Programme, once suppliers make these products available on the Irish market. Prescribers should also refer to the clinical guidelines prepared by the Expert Reference Group, available on the Department of Health Website.
- Pharmacists will be able to dispense Cannabis for Medical Use to patients as set out in the legislation, on foot of a valid prescription, once suppliers make the specified controlled drugs available on the Irish market. Pharmacists should also refer to the Clinical Guidelines prepared by the Expert Reference Group, available on the Department of Health website.