Dáil Éireann Debate, Tuesday - 17 October 2023
483. Deputy Gino Kenny asked the Minister for Health if he will make funding available for a drug from Merck called sotatercept, this drug which has had positive results to treat pulmonary hypertension a condition that is progressive and incurable effecting heart and lungs. [44643/23]
Amharc ar fhreagra486. Deputy Fergus O'Dowd asked the Minister for Health to respond directly to concerns raised (details supplied); and if he will make a statement on the matter. [44651/23]
Amharc ar fhreagraI propose to take Questions Nos. 483 and 486 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.
To date, the EMA has not granted a marketing authorisation for sotatercept for the treatment of pulmonary hypertension. As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.
