Medical cannabis is a rapidly developing area in the life sciences and healthcare sector in Ireland. In June 2019, regulations were introduced establishing the Medical Cannabis Access Programme (the "Access Programme").
The Regulations permit the importation, prescription and supply of certain cannabis products for a five year period under a pilot scheme. The initial phase involves the assessment of products for suitability for medical use. Importantly, it is intended that the HSE will reimburse approved products through the existing schemes.
Since our last update, available here, two medicinal cannabis products have been approved by the Minister for Health for use under the Access Programme:
a. Aurora High CBD Oil Drops, manufactured by Aurora Cannabis Inc.; and
b. CannEpil, manufactured by MGC Pharmaceuticals.
Companies who wish to have their cannabis-based product considered by the Minister for Health for inclusion in Schedule 1 of the Regulations must apply to the Health Products Regulatory Authority (the "HPRA"). The HPRA will only consider finished products, which require no further processing or manipulation for inclusion in the Access Programme. In order to apply for inclusion in the Access Programme, the product must satisfy the following criteria:
a. it does not have a marketing authorisation as issued by the HPRA under the national procedure;
b. it is permitted to be sold or supplied for medical purposes by the relevant public or state body of a Member State other than Ireland;
c. it is currently supplied to patients in the other Member State in which it is already available;
d. it is packaged and labelled in English and in line with the HPRA's guidance on labelling and packaging;
e. it is produced from dried, ground or powdered flower of Cannabis;
f. it contains not more than 230mg of tetrahydrocannabinol ("THC") per gram and not more than 5 grams per product pack;
g. it is in the form of an oil-based solution, suspension or capsule; and
h. it contains not more than 30mg of THC per ml in each unit dose and not more than 60ml per total volume.
Cannabis products which are approved for use under the Programme will be subject to importation, storage and distribution licensing requirements. Products which have already been granted a marketing authorisation by the HPRA using the national procedure are not eligible for inclusion under the Access Programme.