Mark Ward (Dublin Mid West, Sinn Fein)
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2353.To ask the Minister for Health if he is aware of investigations at EU level for a drug (details supplied); if there is any such investigation in Ireland; and if he will make a statement on the matter. [32672/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The European Medicines Agency’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is assessing a safety signal for medicines containing doxycycline and signs of suicidality. Ireland is involved in this assessment through the Health Product Regulatory Authority’s (HPRA) membership in the PRAC. The outcome of the evaluation is currently anticipated in November 2024.

It is important to understand that a safety signal does not directly mean that a medicine caused the reported adverse event. Other factors, such as existing illnesses or medicines, could also be responsible. The PRAC’s evaluation of safety signals involves a thorough review of all available evidence to determine if there is a causal relationship between the medicine and the reported adverse event. Evaluating safety signals is a routine part of pharmacovigilance and is essential for ensuring that regulatory authorities have the most current information on the medicine’s benefits and risks.

Robert Troy (Longford-Westmeath, Fianna Fail)
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2354.To ask the Minister for Health if consultations could take place with a healthcare provider (details supplied) to approve a new intravenous drug, vyepti containing eptinezumab, for chronic migraine sufferers. [32677/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Ireland has a voluntary private health insurance market which operates under the principles of community rating (including lifetime community rating), open enrolment, lifetime cover and minimum benefits. Insurers are required to offer a minimum level of cover in every insurance policy. Health insurance companies may exclude certain services and providers in their policies, provided they remain in compliance with the Minimum Benefit Regulations. Beyond Minimum Benefits regulations, the Minister has no role to play in the commercial decisions of any health insurer. The Minister for Health regulates the Private Health Insurance Market in Ireland. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person.

The Minister does not have a role in the commercial decision-making of any private health insurer including directing a company to approve a drug for use. Private Health Insurance companies operate as commercial entities in a competitive private health insurance market. Beyond prescribing under the Regulations the minimum level of coverage that health insurers must provide, the Minister is not in a position to direct any insurer to provide cover for any particular procedure or service, or direct how that cover is to be provided.