Dáil Éireann Debate, Tuesday - 13 June 2023
1226. Deputy Cian O'Callaghan asked the Minister for Health the reason the eye-drop medication, muro, has been removed from the medical card scheme; if he plans to reinstate its coverage in the scheme; and if he will make a statement on the matter. [27991/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The HSE advise that Sodium Chloride Hypertonic (Muro®) is not licensed with the HPRA in Ireland. However, Sodium Chloride Hypertonic (Muro®) (ULM) Eye Drops 5% 15ml is listed as an Exempt Medicinal Product (EMP) under the community drug schemes due to the unmet clinical need. This exemption enables practitioners to prescribe a medicine as an EMP under that practitioner’s direct responsibility, in order to fulfil the special needs of that specific patient.
Under the community drug schemes, EMPs must be Consultant initiated. However, the HSE will accept a GP prescription where the dispensing Pharmacist is satisfied that the product has been Consultant initiated. The relevant HSE circular regarding this exceptional arrangement is available at: www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-12-23-emps.pdf.
