Dáil Éireann Debate, Wednesday - 6 April 2016
480. Deputy Robert Troy asked the Minister for Health further to Parliamentary Question No. 377 of 22 March 2016, why he has not been actively supporting St. James's Hospital and its appeal for the use of a pharmaceutical company under the compassionate drug access scheme for the treatment of a person (details supplied). [5676/16]
Amharc ar fhreagra481. Deputy Robert Troy asked the Minister for Health if the drug Soliris will be available under the E112 scheme, as it appears the drug has been sanctioned to treat a person (details supplied) in Spain. [5677/16]
Amharc ar fhreagraI propose to take Questions Nos. 480 and 481 together.
As previously advised, Eculizumab (Soliris®) 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 my power as Minister for Health 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.
The HSE administers the Treatment Abroad Scheme (TAS), or E112 Scheme, for persons entitled to treatment in another EU/EEA member state or Switzerland under EU Regulation 883/04, as set out in EU Regulation 987/09, and in accordance with Department of Health Guidelines. A patient may only be referred to the TAS in cases where a treatment is a proven form of medical treatment.
