Minister for Health, Stephen Donnelly TD, has today announced provision for the delivery and funding of the Medicinal Cannabis Access Programme.
Speaking today Minister Donnelly said: “The Budget in October 2020 saw an extra €4billion added to the Health Budget. This increase is indicative of how determined we in Government are to fund an expansion of, and improvements in, our health and social care services.
“One of the improvements in our Health Services that will benefit from this extra funding is the Medicinal Cannabis Access Programme which has been added to the HSE Service Plan for 2021.
“The purpose of this Programme is to facilitate compassionate access to cannabis for medical reasons, where conventional treatment has failed. It follows the clear pathway laid out by the Health Products Regulatory Authority in their expert report ‘Cannabis for Medical Use – A Scientific Review’.
“Ultimately it will be the decision of the medical consultant, in consultation with their patient, to prescribe a particular treatment, including a cannabis-based treatment, for a patient under their care. It is important to state that there are no plans to legalise cannabis in this country.”
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.
Legislation underpinning the Medicinal Cannabis Access Programme was enacted in June 2019. The first stage of the Programme was to have potential suppliers apply to the HPRA (Health Products Regulatory Authority) to have their cannabis-based products assessed for suitability for medical use. Currently four products have been assessed as acceptable by the HPRA. Further products are currently being assessed and if assessed as acceptable, will be added to the schedule of products for inclusion in the Programme.
The HSE will establish and maintain an electronic register for the Medical Cannabis Access Programme to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the programme, as well as prescribed / supplied medical cannabis products.
Pending the commencement of the Access Programme clinicians and their patients have been availing of a licence under the Misuse of Drugs Acts 1977-2016 in order to prescribe and administer cannabis-based products. The commencement of the Access Programme will not affect these patients.
Notes to the Editor
Further information on the Medical Cannabis Access Programme:
Suppliers / Importers: A prospective supplier can apply to the 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.
The offences and penalties for unauthorised supply and possession of controlled substances remain unchanged.
It is important to note that where a cannabis product is a specified controlled drug legally permitted for medical use, in connection with the Medicinal Cannabis Access Programme, this does not signify any endorsement whatsoever of the safety, quality or efficacy of the specified controlled drug for the indication prescribed and the Minister for Health will have no liability in respect of the use of such products by a person issued with a prescription by their clinician under this Regulation. The use of a cannabis product for the purposes of the Medicinal Cannabis Access Programme is a matter for the patient and their medical advisor.