Tuesday, 17 December 2019

Questions (413)

Bobby Aylward

Question:

413. Deputy Bobby Aylward asked the Minister for Health the position regarding an application mechanism for a person who suffers from severe epilepsy and is seeking access to medicinal cannabis oil to treat the illness; the position regarding a mechanism being made available by which a person can apply for medicinal cannabis oil on the medical card or long term illness scheme; and if he will make a statement on the matter. [53026/19]

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Written answers (Question to Health)

On 26th June I signed legislation which will allow for the operation of the Medical Cannabis Access Programme (MCAP) on a pilot basis for five years.

The signing of the legislation underpinning the MCAP allows for commencement of the operation of the access programme, the first stage of which is that potential suppliers may now apply to have their cannabis products assessed for suitability for medical use.

Commercial medical cannabis suppliers whose cannabis products meet the specified requirements set out in the legislation, and which 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 into Ireland. Two cannabis-based products have been deemed to have met the applicable criteria set out in the legislation and 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.

Once suitable medical cannabis products are made available by suppliers, the MCAP will make it possible for a medical consultant to prescribe a listed cannabis-based treatment 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;

- severe, refractory (treatment-resistant) epilepsy.

The Department of Health will make this information available on their website.

Pending full operation of the MCAP, doctors may continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients, should they wish to do so. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes 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. 

Clinicians may submit an application on behalf of their patients to the HSE for reimbursement approval if the patient has a valid medical prescription for medical cannabis for one of the above medical conditions and have sourced a cannabis-based product which has been prescribed under a Ministerial license.

The HSE has advised that in the previous situations where it considered reimbursement support appropriate, the following steps were completed:

- The patient’s consultant is satisfied that all therapeutic options have been exhausted and is prepared to accept the responsibility for monitoring the patient’s response to the cannabis product.

- A prescriber applies to the Minister for a Ministerial license and this is granted.

- The consultant completes an Individual Reimbursement Form, setting out the therapeutic benefit for the patient. It is important that this is completed in sufficient detail for therapeutic benefit to be demonstrated.

- The Individual Reimbursement Form is considered by the Medicines Management Programme (MMP).

- On review of the documentation, the MMP makes a recommendation for or against reimbursement support for the patient to the HSE, under the patient's eligibility, and informs the Primary Care Reimbursement Service (PCRS) of that recommendation.

If approval is given, the PCRS, when authorised to proceed, will make the necessary arrangements to cover the costs involved for the patient.