433. Deputy Paul Donnelly asked the Minister for Health the reason naloxone, a lifesaving medication, is only available on prescription and if he has any plans to make it available over the counter to help save lives. [11470/24]

Minister for Health: While Naloxone is a prescription required drug various measures have been put in place to ensure that as many people as are required have access to naloxone administration courses.

Currently the supply and administration of medicinal products in emergencies is done by persons engaged or employed by organisatons listed with the Health Products Regulatory Authority. The person supplying and administering the medicinal product must have been issued with a certificate stating that he or she has satisfactorily completed a course of training, approved by the Pre-Hospital Emergency Care Council (PHECC), the HSE or another body nominated by the Minister for that purpose, in the use of the specific medicinal product, relating to the administration of the medicinal product.

A legislative amendment was made in 2023, by Statutory Instrument 238/2023 Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2023 in order to give the HSE the same authority as PHECC to approve training courses and produce clinical practice guidelines.

Under the current Medicinal Products (Prescription Control of Supply) Regulations 2003 (SI 540/2003) it is permitted that naloxone may be used without prescription under certain conditions by individuals who belong to listed organisations registered with the HPRA and who have undergone a training course approved by either the Pre-Hospital Emergency Care Council (PHECC) subject to PHECC Clinical Practice Guidelines or the HSE subject to HSE Clinical Practice Guidelines.

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692. Deputy Duncan Smith asked the Minister for Health if there are plans to expand access to Naxolone, which is used to prevent drug overdoses, in line with the UK and Northern Ireland, whereby it is available without prescription via drug treatment services such as an NHS body, a local authority or a public health agency; and if he will make a statement on the matter. [10276/24] 

Stephen Donnelly, Minister for Health: While Naloxone is a prescription required drug various measures have been put in place to ensure that as many people as are required have access to naloxone administration courses.

Currently the supply and administration of medicinal products in emergencies is done by persons engaged or employed by organisatons listed with the Health Products Regulatory Authority. The person supplying and administering the medicinal product must have been issued with a certificate stating that he or she has satisfactorily completed a course of training, approved by the Pre-Hospital Emergency Care Council (PHECC), the HSE or another body nominated by the Minister for that purpose, in the use of the specific medicinal product, relating to the administration of the medicinal product. 

A legislative amendment was made in 2023, by Statutory Instrument 238/2023 Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2023 in order to give the HSE the same authority as PHECC to approve training courses and produce clinical practice guidelines. 

Under the current Medicinal Products (Prescription Control of Supply) Regulations 2003 (SI 540/2003) it is permitted that naloxone may be used without prescription under certain conditions by individuals who belong to listed organisations registered with the HPRA and who have undergone a training course approved by either the Pre-Hospital Emergency Care Council (PHECC) subject to PHECC Clinical Practice Guidelines or the HSE subject to HSE Clinical Practice Guidelines.