Brendan Smith (Cavan-Monaghan, Fianna Fail)
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187. To ask the Minister for Health his proposals to licence and authorise the drug Ampligen; and if he will make a statement on the matter. [21797/16]

Simon Harris (Wicklow, Fine Gael)
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Ampligen is an experimental drug currently undergoing clinical development and has not been authorised to be placed on the market in Europe. Before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency (EMA). In the case of Ampligen, because of the biotechnology nature of the active substance involved, any application for a marketing authorisation must be made to the EMA. I have no information on whether or not such an application has been received by the EMA.

The Food and Drug Administration (FDA) is the regulatory authority for medicines in the US. I understand that the FDA has refused an application to make this product available in the US citing safety and efficacy concerns.