Billy Kelleher (Cork North Central, Fianna Fail)
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428. To ask the Minister for Health if he is investigating the use of Cannabidiol, CBD, for the possible treatment of Dravet syndrome (details supplied); and if he will make a statement on the matter. [6605/16]

Leo Varadkar (Dublin West, Fine Gael)
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Products for which medicinal claims are made, or which contain certain substances likely to have pharmacological actions on the body are considered as medicinal products. There are no authorised medicinal products in Ireland containing CBD licensed for the treatment of Dravet syndrome or any other form of epilepsy.

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 (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements.

Before a medicinal product can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective, and also that the quality of the product is sufficient. The publicly accessible EU Clinical Trials Register of trials being conducted in the EU and European Economic Area currently lists 6 trials authorised investigating CBD in various forms of epilepsy. There are currently no clinical trials using CBD taking place in Ireland.