Dáil Éireann Debate, Wednesday - 20 April 2016
305. Deputy Michael Moynihan asked the Minister for Health if he will consider allowing the use of cannabidiol 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. [7442/16]
Amharc ar fhreagraCannabidiol (CBD) oil 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 medicine is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements.
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 HPRA website. 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.
CBD is derived from cannabis which is a controlled drug. If a CBD oil product does not contain an ingredient which is a controlled substance, 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.
