Michael Moynihan (Cork North West, Fianna Fail)
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53. To ask the Minister for Health if he will consider allowing the use of cannabidol oil to treat a person diagnosed with Dravet syndrome (details supplied), who otherwise faces the prospect of having to travel to the United States to access this treatment; and if he will make a statement on the matter. [29898/16]

Simon Harris (Wicklow, Fine Gael)
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Cannabidiol (CBD) is derived from cannabis. However, since it does not have psychoactive properties it is not controlled under the Misuse of Drugs Acts.

While I am aware that CBD oil is sometimes marketed as a nutritional or dietary supplement, it should be noted that it is not authorised as a medicinal product in Ireland. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA) or, in the case of certain medicinal products, the European Medicines Agency. A determination on an application for authorisation of a medicinal product is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements.

Where a medicinal product is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and in order to meet the special needs of a patient. Therefore, if a CBD oil preparation does not contain an ingredient which is a controlled substance, such as THC, it may be feasible to have that product imported and used in Ireland, in accordance with specific conditions, should a patient’s doctor be of the opinion that this is an appropriate treatment.

On the wider issue of medicinal cannabis, I am aware that cannabis has been legalised for medicinal use in certain countries. The Deputy will be aware that a Private Members’ Bill on this issue was recently published. My officials are considering the contents of this Bill