Written answers

Wednesday, 31 January 2018

Department of Health

Medicinal Products Availability

Photo of Fergus O'DowdFergus O'Dowd (Louth, Fine Gael)
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221. To ask the Minister for Health if a reply will issue to correspondence from a person (details supplied) in relation to THC; and if he will make a statement on the matter. [4815/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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In March, following the publication of the Health Products Regulatory Authority’s report ‘Cannabis for Medical Use – A Scientific Review’, I established an Expert Reference Group to advise on the development of a Cannabis for Medical Use Access Programme, for patients who are under the care of a medical consultant and have been diagnosed with the following medical conditions:

- spasticity associated with multiple sclerosis resistant to all standard therapies;

- intractable nausea and vomiting associated with cancer chemotherapy, despite the use of standard anti-emetic regimens;

- severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications.

The Access Programme is intended to facilitate access to cannabis-based products, that are not authorised as medicines but are of a standardised quality and meet an acceptable level of quality assurance. The Expert Group has drawn up clinical guidance for healthcare professionals treating patients through the Access Programme. Officials in the Department of Health are working on legislation to underpin the Access Programme. This work is well advanced but will take some further time to complete.

In the meantime, medical practitioners who wish to prescribe cannabis-based products containing THC may apply under the Misuse of Drugs Act for a licence to do so. 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.

To date four licences in respect of four individual patients have been granted.

Valid applications received by the Department are assessed and responded to without delay.

If the patient’s consultant requires further information or clarification in relation to the licence application process, he or she should contact the Department of Health directly.

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