Peter Burke (Longford-Westmeath, Fine Gael)
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264. To ask the Minister for Health if Ireland can now reassess its position with regard to supplying Ampligen for patients suffering from myalgic encephalomyelitis, ME, due to the distribution of Ampligen by countries in Europe (details supplied) under the early access programme; and if he will make a statement on the matter. [5111/17]

Simon Harris (Wicklow, Fine Gael)
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Rintatolimod (brand name Ampligen) is an experimental medicine in development for the treatment of a variety of chronic diseases and viral disorders, including Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (ME).

The medicine is not currently authorised by the European Medicines Agency for the treatment of ME in the European Union. Should the medicine receive marketing authorisation in Ireland, it would then be open to the marketing authorisation holder to make the medicine available for prescribing, and to apply to the HSE to have the product reimbursed under the community drugs schemes.

The Health Products Regulatory Authority has advised that is not aware of an early access programme for this medicine in Ireland.

Where a medicine is unauthorised the possible routes by which patients can access such medicines in Ireland are through the ‘exempt medicines scheme’ or participation in an authorised clinical trial.

With regard to the ‘exempt medicines scheme’, Irish law provides that a registered medical practitioner can prescribe medicines which are not authorised in Ireland for the treatment of a patient under his/her personal responsibility and in order to meet the special needs of that patient.

There are no authorised clinical trials with rintatolimod in Ireland.