Ireland: 16 patients now benefit from ministerial licensing system

Ireland's interest in medical cannabis began in 2016. Since 2017, the government has been looking to set up a medical cannabis access scheme for Irish patients. Until this is up and running, a temporary system allows patients to apply for a «ministerial license» issued by the Department of Health. 16 patients are currently benefiting from this scheme.

A medical cannabis program in the works

In November 2016, the Department of Health announced a review of cannabis policies to consider, among other things, authorizing its therapeutic use. Irish health authorities, Health Products Regulatory Authority (HPRA), were then tasked with assessing recent developments in the field and ruling on the appropriateness of this use. In February 2017, they published a report (Cannabis for Medicinal Use - A Scientific Review) which recommends allowing the therapeutic use of cannabis in some cases.

Following the publication of this report, the Ministry of Health set up a group of experts to advise the government on setting up a medical cannabis program. This is not yet operational, but the government is working on it. In the meantime, the ministerial licensing system guarantees access to medical cannabis for patients who need it.

Ministerial licenses

These licenses are available for the treatment of multiple sclerosis, epilepsy and the side effects of chemotherapy. A license has also been for a patient suffering from chronic pain. They are valid for three to six months and can be renewed. A total of 29 licenses have been granted for 16 patients.

Applications for ministerial licenses are made on a nominative basis and must be submitted by a doctor registered with the Medical Council and actively involved in the patient's treatment. He/she must provide :

• a description of the patient's current treatment and a justification for the change in treatment.
• the opinion of the consulting physician if the request is made by another healthcare professional.
• details of the composition of the product to be administered and its source.
• treatment details: dosage and follow-up conditions.

What kind of medical cannabis?

At present, only one cannabis-based medicine has been authorized in Ireland: Sativex, for the treatment of plasticity in multiple sclerosis. This was the subject of a centralized authorization procedure at European level (which is why it is also legal in France). Its prescription does not therefore require a ministerial license. Nor does Nabilone, which is classified as a schedule 2, it is not subject to the same restrictions as cannabis. Prescribing Dronabinol (a synthetic version of THC), on the other hand, requires a ministerial license.

Cannabis-derived products (oils, sprays, capsules, etc.) can be considered as treatment options, but as they are not pharmaceutical products authorized by the health authorities, they also require a ministerial license. Should they be prescribed, they must be produced by a specified laboratory to certain production standards, and their composition must be transparent. These products will be made more easily accessible through the future medical cannabis program.

The supply issue

The therapeutic use of cannabis is authorized in Ireland under the conditions we have described, but the production of medical cannabis is still illegal. The current problem with the Irish program is supply. For the time being, this is done through a Dutch pharmacy on presentation of a license, but the Minister for Health, Simon Harris, a reported is in discussion with other suppliers, as well as with its Danish and British counterparts.

«The drafting of secondary legislation to support the medical cannabis access program continues and will be finalized once an adequate supply system is established,» explained the Minister. This supply system will eventually involve local production. Details will be included in the final version of the Medical Cannabis Access Programme which the ministry is currently working on. Simon Harris has declared medical cannabis a priority for 2019.