232. Deputy Patrick Costello asked the Minister for Health further to Parliamentary Question No. 512 of 24 September 2024, the Irish legislation which states that pharmacists in Ireland are not authorised to supply unlicensed medicines from a prescription that is written by a registered practitioner practising in another EEA Member State. [39280/24]

Thank you for your question.

As indicated in Parliamentary Question No. 512 of 24 September 2024 Directive 2011/24/EU on patients’ rights in cross-border healthcare sets out the conditions under which a patient may travel to another EU country to receive medical care and reimbursement, and also covers the prescription and delivery of medications and medical devices. The provisions of this Directive are transposed nationally in respect of the dispensing of prescriptions nationally in the Medicinal Products (Prescription and Control of Supply) Regulations 2003 as amended, and the provisions of Regulation 7(1A) (inserted by the 2014 Amendment (No.2) Regulations and amended by 2020 Amendment (No. 6) Regulations) refer.

Medicines placed on the Irish market must be authorised by the HPRA or, in the case of centrally authorised products, by the European Commission. Medicines are categorised in accordance with the requirements specified in Directive 2001/83/EC and nationally by the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended. This is a permissive rather than restrictive authorisation system.

In line with Directive 2011/24/EU, pharmacists in Ireland are authorised to dispense from a prescription that is issued by a registered practitioner practising in another European Economic Area (EEA) Member State provided certain conditions are met.

Article 11 of the 2011/24/EU Directive notes that “If a medicinal product is authorised to be marketed on their territory, in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in compliance with their national legislation in force…”

In line with Article 5 of Directive 2001/83/EC, Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No.540 of 2007) (as amended) includes an exemption for the supply of an unauthorised medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients, on his direct personal responsibility in order to fulfil the a special need of this patient. Such products are defined as ‘exempt’ medicinal products and are also known as ‘unauthorised’ or ‘unlicensed’ medicinal products.

In these regulations ‘practitioner’ means a registered dentist, a registered medical practitioner, a registered nurse prescriber or a registered midwife prescriber;

• ‘registered dentist’ means a person registered in the register established under the Dentists Act 1985 (No. 9 of 1985);

• ‘registered medical practitioner’ means a person registered in the register established under the Medical Practitioners Act 1978 (No. 4 of 1978);

• ‘registered nurse prescriber’ means a person registered in the nurse prescribers division of the register of nurses and midwives;

Pharmacists operate and practice under a statutory framework of legislative and governance controls with the best interest of the patient being the inherent primary principle. The dispensing of any prescription to a patient includes considering the legislative framework, the guiding principles of any supporting guidance issued and the application of the Code of Conduct for pharmacists. It is worth noting that in supplying any medication a pharmacist has an obligation to assess any prescription presented and dispense in the patient’s best interest which may include, to refuse, for ethical reasons, to dispense a product that was prescribed in another Member State (where the pharmacist would have the right to refuse to dispense, had the prescription been issued in the Member State of affiliation), and the legislation and the guidelines in place do not affect this.

This will assure the application of competence and expertise in making an informed decision regarding the safety and appropriateness of supplying a particular medicine to a patient, based on an authorising prescription, issued either nationally or in another EEA member state.