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Home > Dail Eireann debate. Written Answer 149 - Medicinal products licensing [39974/17].

[Oireachtas] Dail Eireann debate. Written Answer 149 - Medicinal products licensing [39974/17]. (21 Sep 2017)


149. Deputy Clare Daly asked the Minister for Health if he will make medicinal cannabis available without first passing legislation to do so; if medicinal cannabis can, under current legislation, be prescribed via the compassionate access for medicines programme; and if he will make a statement on the matter. [39974/17]

 

Minister for Health (Deputy Simon Harris):  Currently medical practitioners who wish to prescribe cannabis-based products containing THC may apply to me, as 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.

 

Ultimately it is the decision of the clinician, in consultation with their patient, to prescribe or not prescribe a particular treatment for a patient under their care. As Minister for Health I have no role in this clinical decision-making process.

Where consultants require information or clarification in relation to the licence application process, he or she should contact my Department directly.

 

In February, I published the Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’. On foot of the HPRA’s conclusions I announced that I would establish a cannabis for medical use access programme, for patients under the care of a consultant, for the following medical conditions:

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

 

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

 

- severe, refractory (treatment-resistant) epilepsy.

 

An expert group, chaired by Dr Mairín Ryan from HIQA was established in March to develop the operational, clinical and practice guidelines for this access programme.

 

The Expert Group conducted a targeted consultation on the draft guidelines and is due to finalise these guidelines shortly. Officials in my Department are working on secondary legislation to underpin the programme and on the logistics of sourcing suitable cannabis-based product supplies for the Irish market place. This work will take a number of months to complete but the Access Programme will be operational later this year.

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