Sorca Clarke (Longford-Westmeath, Sinn Fein)
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220. To ask the Minister for Health the current status of ampligen for treatment of myalgic encephalomyelitis, ME; and the engagement he has had with the European Medicines Agency, EMA, on the issue of authorisation. [11745/23]

Sorca Clarke (Longford-Westmeath, Sinn Fein)
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221. To ask the Minister for Health the number of occasions, per year, that the drug ampligen has been applied for, denied access or approved via the exempt medicines scheme, in tabular form. [11749/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 220 and 221 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals. In order to submit a formal application the medicine must hold a marketing authorisation.

The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU.

Rintatolimod (Ampligen) was designated as an orphan medicine by the EMA for the treatment of Ebola virus disease on 24April 2015 and for pancreatic cancer on 19 February 2021.

To date the EMA has not granted a marketing authorisation for Rintatolimod (Ampligen®) for the treatment of pancreatic cancer, Ebola virus disease or myalgic encephalomyelitis (ME). As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.