Patrick Costello (Dublin South Central, Green Party)
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512. To ask the Minister for Health further to Parliamentary Question No. 254 of 23 May 2024, if he is aware that recent guidance from an organisation (detailed supplied) has led to valid EEA prescriptions being rejected; how this aligns with Directive 2011/24/EU paragraph 36 and Article 11 paragraph 1; and if he will make a statement on the matter. [37767/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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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. As was noted in Parliamentary Question No. 254 of 23 May 2024, there are no plans at this time to legislate to prohibit the dispensing of EEA prescriptions in the Republic of Ireland.

In order to support, and in response to queries from healthcare professionals on the dispensing of EEA prescriptions, officials in my department explored the available options to enhance safety standards around online EEA prescriptions. As part of this, the PSI, the Pharmacy Regulator, produced guidelines on ) . These guidelines facilitate practitioners in assuring the safe delivery of service to patients presenting a prescription issued in another EU state and are premised on the legislative provisions in place including the Directive and national legislation. The legislation and the guidelines in place do not affect a pharmacist’s 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).

In line with the Directive, 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. ) 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...”

Medicines placed on the Irish market must be authorised by the HPRA or, in the case of centrally authorised products, by the European Commission. There is provision for ) , also known as exempt medicinal products, which are not nationally authorised by the HPRA or centrally authorised by the European Commission to be supplied by pharmacists in certain circumstances. These medicines, under Article 5 of Directive 2001/83/EC, may be supplied where a registered doctor or dentist has prescribed the product for an individual patient under his or her direct responsibility. This is in order to fulfil the special needs of those patients. These medicines fall outside the scope of Directive 2011/24/EU. 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.

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.

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 a prescription, issued either nationally or in another EEA member state.