Neale Richmond (Dublin Rathdown, Fine Gael)
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996. To ask the Minister for Health if his attention has been drawn to the fact that while the Medical Cannabis Access Programme allows for those who suffer from epilepsy to avail of the scheme, there is currently no product included on the programme which meets his Department’s clinical guidelines for the use of medical cannabis based products in epilepsy being a product with less than 2% THC; if he is taking steps to address this; and if he will make a statement on the matter. [52816/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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In the Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019 (S.I. 262/2019) a cannabis product or preparation that can be used in the Medical Cannabis Access Programme is defined as ‘specified controlled drugs’ and the definition outlines the specific requirements for those products.

A prospective supplier can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in the Regulations. As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017, a controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products.

Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA.

It is open to any supplier or producer to apply to the HPRA to have their products assessed for inclusion in the programme.