Tuesday, 19 February 2013

Questions (670)

Shane Ross

Question:

670. Deputy Shane Ross asked the Minister for Health if he will engage with the relevant authorities to assess the potential benefits of Ampligen to M.E patients; if he will work to ensure that Ampligen is made available to M.E patients here; and if he will make a statement on the matter. [8174/13]

View answer

Written answers (Question to Health)

Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) 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 legal and regulatory requirements. In the case of Ampligen, because of the biotechnology nature of the active substance involved, any application for Ampligen to be made available to European patients has to be made to the EMA. I have no information on whether or not such an application has been received by the EMA.

The current position therefore is that Ampligen has not been authorised to be placed on the market in Europe.