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Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 23 July 2019

Tuesday, 23 July 2019

Ceisteanna (1775)

Fiona O'Loughlin

Ceist:

1775. Deputy Fiona O'Loughlin asked the Minister for Health the progress made on the granting of licences for medicinal cannabis; and if he will make a statement on the matter. [34019/19]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy may be aware, on 26th June I signed legislation which allows for the operation of the Medical Cannabis Access Programme (MCAP) on a pilot basis for five years.

This new legislation means that 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 to the Irish market.

Once suitable medical cannabis products are made available by suppliers, the Access Programme will make it possible for a medical consultant to prescribe, in line with the published clinical guidance, a listed cannabis-based product 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.

It should be noted that currently no medical cannabis products are available for use under the MCAP as it is expected that it will take some time for suppliers to arrange to have their products made available on the Irish market.

Up to date information relating to the MCAP, which includes a FAQ (Frequently Asked Questions) document, is available on the Department's website.  

Pending full operation of the MCAP, and for medical indications not included in 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. 

To date Ministerial licences have been issued in respect of twenty-five individual patients.

Question No. 1776 answered with Question No. 1767.
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