Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I am taking this on behalf of the Minister, Deputy Harris. I apologise to the Deputy that the Minister could not be here. Before I read the statement, I commend the Deputy on his resilience in bringing this topic to the floor of the House over the past year. People can now access medical cannabis but it has to be prescribed.

On 26 June the Minister signed legislation, which allows for the operation of the MCAP on a pilot basis for five years. This new legislation means that commercial medical cannabis suppliers whose cannabis products meet the specified requirements set out in the legislation and 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 via an Irish-based authorised wholesaler.

Once suitable medical cannabis products are made available by suppliers, the access programme will make it possible for a medical consultant to prescribe, in line with the published clinical guidance, a listed cannabis-based product 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; and severe, refractory, treatment-resistant, epilepsy. Cannabis products will only be listed in the Schedule to the legislation once they have been accepted as meeting the criteria for such products to be added to Schedule 1 of the regulations underpinning the access programme. Based on the information provided by applicants, two cannabis-based products have been deemed by the Health Products Regulatory Authority, HPRA, to have met the applicable criteria set out in the legislation. These two products are Aurora high CBD oil drops from Aurora Cannabis Enterprises and CannEpil from MGC Pharmaceuticals. The Minister has accepted the HPRA's advice and the products have been added to Schedule 1 of the legislation. As these products will be subject to international export licensing requirements, which are outside the control of the Department of Health, they are not expected to be available in Ireland for a further period. It will be the decision of the treating medical consultant, in consultation with his or her patient, to prescribe a cannabis-based treatment for a patient under his or her care.

Pending full operation of the access programme, doctors may continue to apply through the ministerial licensing route for a licence to prescribe medical cannabis for an individual patient under their care. Sixty-six licences have now been granted in respect of 31 individual patients.

Departmental officials and the HSE will meet next week to finalise plans for the MCAP patient register and reimbursement procedures. In the interim, the HSE has advised that for an application to be considered for reimbursement approval, prescribers must submit a valid medical prescription for the prescribed cannabis product, provide a copy of the ministerial licence, and the patient must have sourced and positively responded to the cannabis-based product. If approval is given, the primary care reimbursement service, PCRS, when authorised to proceed, will make the necessary arrangements to cover the costs involved for the patient.

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