Dáil Éireann Debate, Wednesday - 20 April 2016
300. Deputy Clare Daly asked the Minister for Health if he has had consultations with the Health Service Executive regarding the possible funding of a drug, eculizumab, for a person (details supplied); the outcome of those consultations, if they have taken place. [7428/16]
View answer335. Deputy Finian McGrath asked the Minister for Health his views on correspondence (details supplied) regarding Degos disease; and if he will make a statement on the matter. [7577/16]
View answerI propose to take Questions Nos. 300 and 335 together.
Eculizumab is an ultra-orphan medicine licensed for the treatment of paroxysmal nocturnal haemaglobinurea (PNH) and atypical haemolytic uraemic syndrome (aHUS). Eculizumab is reimbursable for the treatment of these two conditions, for which the European Medicines Agency has completed assessments in relation to safety and efficacy.
The drug is not licensed for the treatment of Degos disease by either the European Medicines Agency or the U.S. Food and Drug Administration.
It is not in the Minister for Health's power to sanction the unlicensed use of any drug or medicine. Decisions on the use of unlicensed medicines for an individual patient are a matter for the prescribing clinician and the treating hospital. Under the HSE Governance Act 2013, I am barred from making any directions in respect of an individual patient.
