Shane Cassells (Meath West, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

419. To ask the Minister for Health the process for a person to receive access to a medical product (details supplied); and if he will make a statement on the matter. [22543/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Cannabis is strictly controlled under the Misuse of Drugs Acts 1977 to 2016, and the Regulations and Orders made thereunder.

The two most common active components found in cannabis oil are tetrahydrocannabinol (THC) and cannabidiol (CBD).

- THC is the principal psychoactive constituent of cannabis. Under the Misuse of Drugs legislation products containing THC are strictly controlled and possession is unlawful except under licence.

- CBD is derived from cannabis. However, since it is not psychoactive it is not controlled under the Misuse of Drugs legislation, and does not require a Ministerial Licence.

Access to Medical Cannabis via the Ministerial Licence Route

- Currently medical practitioners who wish to prescribe cannabis products containing THC may apply to the Minister for Health, for a licence under the Misuse of Drugs Act.

- The Chief Medical Officer has advised that the granting of such a licence must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

How to apply for a Ministerial licence

A medical cannabis licence application submitted to the Minister for Health, in line with the Misuse of Drugs Acts, must include:

- An outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate in their patient’s specific circumstances to prescribe cannabis.

- Details of the cannabis product which it is proposed to prescribe and administer to the patient.

- The source of the cannabis product.

- The arrangements for the ongoing monitoring and care of the patient once the cannabis-based treatment has commenced.

The application must be submitted either by the patient’s medical consultant, or by their General Practitioner (GP). Applications from the patient's GP must include written endorsement for the proposed cannabis treatment for the individual patient by the patient's consultant.

The decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process.

Consultants or GPs requiring further information or clarification in relation to the licence application process are advised to contact the Department of Health directly. Valid applications received are assessed without delay.

A patient who is eligible under the Long Term Illness Scheme has automatic access to all of the products on the core list of products for that condition. This list is published on the HSE website. Medical cannabis is not listed as one of the approved products currently. Where a patient seeks reimbursement of a product outside the core list, there is an individual reimbursement application process.

The patient's treating clinician should complete the individual reimbursement request application form and return it to the HSE Primary Care Reimbursement Service (PCRS). Where such an application is approved, the HSE will then determine how the patient may be assisted, where they hold a Ministerial License.