Gino Kenny (Dublin Mid West, People Before Profit Alliance)
Link to this: Individually | In context | Oireachtas source

421. To ask the Minister for Health to clarify the availability of the anti-epilepsy drug Epidiolex here; the arrangements for facilitating access by children with Dravet syndrome and Lennox-Gastaut syndrome; and if he will intervene to improve access. [17166/16]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Epidiolex is an investigational medicinal product currently undergoing clinical trials in a number of EU Member States. I have no authority to compel pharmaceutical companies to conduct such trials in Ireland.

Under European and Irish legislation, before a medicine can be placed on the market the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA), or in the case of certain medicines, the European Medicines Agency. To my knowledge, no application for a marketing authorisation for Epidiolex for the treatment of Dravet Syndrome or Lennox-Gastaut Syndrome has been submitted.

Where a medicine 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. The process for this is described in the ‘Guide to the Notification System for Exempt Medicinal Products’ which is available on the website of the HPRA, which administers the scheme. For this notification scheme, there are a number of specialist wholesalers which deal with the importation of ‘exempt medicines’ into Ireland, via pharmacies and subject to a prescription.

The HPRA is aware that Epidiolex has been prescribed and imported into Ireland under the exempt medicinal product route in response to a bona fide order from a registered medical practitioner.