231. Deputy John Paul Phelan asked the Minister for Health that actions that are being immediately taken to ensure that a person (details supplied) can have access to their prescribed medication within the State; and if he will make a statement on the matter. [39276/24]

Dear Deputy Phelan,

Your query relates to the treatment of an individual patient. It would not be appropriate for me or my Department or to comment on the treatment of a patient, which would be a matter for the patient and their healthcare professional(s).

In relation to the availability of the medications which are referenced in ‘details supplied’, both of these medicinal products are not licensed in Ireland. This means that they have not been granted a marketing authorisation in Ireland by our medicines regulator, the Health Products Regulatory Authority (HPRA), or in Europe by the European Medicines Agency, and they would not be assessed by the HPRA for quality, safety or efficacy.

There is a mechanism in Ireland that allows for the supply of unauthorised medicines: the Exempt Medicinal Product (EMP) route. EMPs can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients.

If sourced in response to a bona fide unsolicited order as a licensed product from another market, these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country, carried out by the respective competent authority for medicines in that state.

The legislation underpinning EMPs is set out in Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended, and also in the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007, as amended. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription. Paragraph 2 of Schedule 1 of the Control of Placing on the Market regulations refers to a personal responsibility undertaken by the prescriber when prescribing an EMP.

The supply of EMPs in Ireland must be notified to the HPRA. The availability of this information is used for the purpose of allowing the HPRA to react very quickly to reports of quality defects received about medicines from other competent authorities and to identify whether the batch of concern has come to Ireland as an EMP. The HPRA then ensures that the necessary risk-mitigating actions, such as product recall actions, are undertaken in Ireland promptly to protect patients from the risks presented by such quality defects.

An exempt product may not be prescribed or supplied in situations where an authorised equivalent (i.e. same active substance(s), strength and dosage form) is available in Ireland.

As these two products are not regulated by the HPRA, they can not provide information on supplies or availability of these products.

I understand that shortages of medicines can cause a great deal of stress for patients and their healthcare professionals alike. Thusly, my Department would advise that patients, or their carers, who are concerned about their medicine(s) and their availability speak to their prescribing physician, who will be able to discuss alternatives for them.