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For Written Answer on : 15/11/2022
Question Number(s): 564 Question Reference(s): 56513/22
Department: Health
Asked by: David Stanton T.D.


To ask the Minister for Health if a medication (details supplied) is covered under the drug payment scheme; if so, the current dosage allowable under the scheme; and if he will make a statement on the matter.

(Details Supplied) Primolut-Nor 5mg


The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.  Reimbursement for medicines under the community drugs schemes is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority (HPRA).

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. I, as the Minister for Health, have no role in these decisions.

The HSE have advised that Primolut N (norethisterone) 5mg was recently discontinued in Ireland and is no longer licensed with the HPRA. However, this product will remain on the reimbursement list until the expiry date of the last batch of this product which was notified from the manufacturer to the HSE has been reached. The expiry date for this current batch is September 2023, whereupon this product will then be withdrawn from the reimbursement list.

The HSE have further advised that there is currently a licensed therapeutic alternative available on the Reimbursement list. The HSE also notes that some patients have been approved on an individual basis for reimbursement of Primolut N (norethisterone) 5mg where licensed products have been exhausted. However, licensed products should always be considered in the first instance.

The medical decision to prescribe or not prescribe any treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. I, as the Minister for Health, have no role in this clinical decision-making process.

Finally, Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.