The Minister for Health Simon Harris TD has signed legislation which will allow for the operation of the Medical Cannabis Access Programme.
The Programme will allow for access to cannabis-based products for medical use in line with the legislation.
The scheme will operate on a pilot basis for five years and will follow the principles laid out in the Health Products Regulatory Authority 2017 Review and the Clinical Guidelines finalised by the Expert Reference Group earlier this year.
Severe, refractory (treatment-resistant) epilepsy is one of three medical conditions where a consultant can prescribe a listed cannabis-based treatment. According to documentation released by the Department today, “all standard approved treatments have been exhausted for that patient”. The Clinical Guidelines however, specify that the patient must have “severe epilepsy where the severity and frequency of seizures are significantly impacting on quality of life and that has failed to respond to 5 or more standard antiepileptic treatments”.
It is important to note that currently no medical cannabis products are available in Ireland. It is therefore not possible to be prescribed a cannabis-based product at the moment.
However, the signing of the legislation means that commercial operators whose cannabis products meet the specified requirements set out in the legislation can now apply to supply these products to the Irish market. The HPRA will then assess these products for suitability for medical use. Only products approved by HPRA and included on “the schedule of specified controlled drugs” can be prescribed by consultants under the programme.
The criteria cannabis products must meet in order to be included on the schedule are set out in the legislation However, the legislation signed today is not yet (June 26th) available from www.irishstatutebook.ie.
Once the scheme is fully operational, patients will need to be enrolled in the Medical Cannabis Access Programme by their consultant. HSE will maintain a Register recording data on the utilisation of the programme.
Crucially, and as called-for by Epilepsy Ireland, the HSE will meet the cost of approved cannabis products under the Long-Term Illness Scheme, GMS (Medical Card) Scheme and the Drug Payment Scheme on a named-patient basis. Authorisation is subject to the patient having a qualifying medical condition, standard approved treatments have been exhausted and the prescription has been issued by a consultant. Note that enrolment on the Programme does not automatically mean approval for reimbursement.
Pharmacists will be able to dispense products as normal.
It is not known exactly when the Programme will be fully operational. However, the Minister has indicated that he expects access to begin in the autumn. In the meantime, consultants may still utilise the Ministerial licencing route to access medical cannabis products for their patients.
Information released today reinforces the important point that cannabis-based products are not authorised, licenced medical products and the same levels of efficacy data do not exist for them compared to standard epilepsy treatments. The Department adds that the State “will have no liability in respect of the use of such products... The use of a cannabis product for the purposes of the MCAP is a matter for the patient and their medical advisor”.
Epilepsy Ireland has previously outlined concerns regarding the evidence of efficacy and safety for medical cannabis products. While there are a number of anecdotal success stories, to date, good scientific evidence is limited to the use - in specific rare epilepsies - of Epidiolex, a CBD drug which has been licenced by the FDA in the US and is awaiting approval from the European Medicines Agency.
However, given the widespread interest in the possibilities offered by cannabis products and a largely unregulated marketplace, this legislation is to be welcomed. It will allow for a safer, more regulated environment for patients to access alternative last-line treatment options which will have met manufacturing and labelling criteria set by the HPRA. It will also enable valuable data collection to inform patients and medical professionals about the role that cannabis products may play in epilepsy treatment in the years to come. We also hope that the programme will enable full and open communication between patients and doctors, an important consideration in light of the potential interactions that can exist between cannabis products and epilepsy medications.
As ever, please talk to your doctor/ epilepsy nurse about any concerns relating to your medications, or if you are using/ considering using cannabis-based products.
We will continue to post updates on the scheme as more information becomes available.