EU Directive 2011/24 (the “2011 Directive”) provides for patients’ rights in cross-border healthcare within the European Union (“EU”) and European Economic Area (“EEA”). It was transposed into Irish law by virtue of the European Union (Application of Patients’ Rights in Cross-Border Healthcare) Regulations 2014 (the “2014 Regulations”) and later, the European Union (Application of Patients’ Rights in Cross-Border Healthcare) (Amendment) Regulations 2015 (the “2015 Regulations”). These EU and State laws impact upon the delivery of cross-border pharmaceutical services within the EU/EEA.
“The minimum elements that must be included on such electronic prescriptions in order to be recognised in another EEA Member State are as previously outlined for hardcopy prescriptions.”
Irish citizens who are entitled to avail of public health services in the Republic of Ireland (“ROI”) are generally entitled to access public and private healthcare services in other Member States in the EU or EEA, if they are a person who has a right to claim for reimbursement under the above-mentioned legislation. There are provisions in the legislation which entitle patients and recipients of healthcare services to be reimbursed for treatment obtained in Member States. Healthcare is deemed to include the prescription, dispensation and provision of medicinal products and medical devices and therefore, persons may be entitled to seek reimbursement for availing of (and paying for), those services whilst abroad.
The 2011 Directive sets out that patients should be able to access information on their rights and entitlements in the EU/EEA Member State, which is competent to grant the authorisation to receive the cross-border treatment outside the Member State of residence or the Member State where that individual is entitled to sickness benefits, known as the Member State of Affiliation. In particular, patients should be able to access information on their right to seek reimbursement of treatment costs and information on appeal procedures and redress, should their rights to cross-border healthcare be infringed. The information should clearly differentiate between the rights conferred on citizens under the 2011 Directive versus rights conferred on them by virtue of Regulation (EC) No 883/2004 (which relates to the coordination of social security systems). The 2011 Directive seeks to ensure that citizens who receive cross-border healthcare have the same rights they would have had in a comparable situation in the Member State of Affiliation.
Irish citizens who are entitled to recover costs of healthcare obtained in an EU/EEA State must recover costs from the HSE upon provision of evidence of treatment costs. The legislation provides for reimbursement of costs of prescriptions, dispensation and provision of medicinal products and medical devices where these are provided in the context of a health service.
The 2011 Directive considers the right to protection of personal data in the context of cross-border healthcare. The transfer of personal data regarding patients’ health is considered necessary for the continuity of cross-border healthcare, and personal data should be transferrable between Member States insofar as is necessary without compromising data protection rights.
Since Brexit, the Irish and British governments have sought to maintain prior healthcare arrangements under the Common Travel Area. Pursuant to the Trade and Cooperation Agreement brought into effect on 1 January 2021, residents of Ireland who reside in, work in or visit the UK have the right to access public health services in the UK. However, since 2021 Irish residents who access healthcare in the UK cannot benefit from the cross-border healthcare provisions under the 2011 Directive. Those persons will not be entitled to seek reimbursement under the legislation discussed here. However, where treatment in the UK was commenced or booked prior to 31 December 2020 or rescheduled to 2021 due to the COVID-19 pandemic, Irish citizens may apply for reimbursement per the provisions of the 2011 Directive.
The 2014 Regulations and the 2015 Regulations impose certain obligations on “healthcare professionals” who provide cross-border healthcare in ROI. This includes pharmacists.
Pharmacists are also required to provide patients with the information required to allow that patient make an informed decision on whether to avail of cross-border healthcare in ROI. Where patients seek to avail of, or do avail of healthcare in ROI, pharmacists are required to provide those patients with sufficient invoices and information on their prices, their professional liability insurance and authorisation/registration status. The definition of “healthcare” in the 2014 Regulations is non-exhaustive and includes health services provided to patients to assess, maintain or restore their state of health. Pharmacists are not obliged to furnish more extensive information to patients from other Member States, than that which is provided to the patients residing in ROI. With regard to professional indemnity insurance, the pharmacist providing the cross-border treatment within Ireland must have insurance appropriate to the nature and the extent of the risk for that treatment. The pharmacist must furnish evidence of such insurance to an authorised officer (appointed by the HSE) within 15 days, if requested to do so.
The legislation imposes obligations on the HSE and on pharmacists in relation to prescriptions that are issued in a cross-border healthcare context.
The HSE is obliged to provide patients with certain information as to what ought to be included in prescriptions issued in ROI which are to be dispensed in another EU/EEA State and prescriptions issued in a Member State to be dispensed in ROI. Directive 2012/52/EU on laying down measures to facilitate the recognition of medical prescriptions issued in another Member State has been transposed in Ireland by the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 (SI 504/2014). These Regulations set out the minimum elements that must be included on a prescription in order for it to be legally recognised in another EEA Member State. The prescription should be in ink or permanent and unalterable electronic form and be signed and dated by the person issuing the prescription with his or her usual signature, either in handwriting or by There is specific information which should be included on the prescription including:
In ROI only electronic prescriptions emailed from doctors within the State to pharmacies within the State via the national electronic prescription transfer system are permitted. The Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (S.I. No. 98 of 2020) defines the national electronic prescription transfer system as “a system providing for the transfer of prescriptions, in permanent and unalterable form, by electronic means approved, on behalf of the Health Service Executive, by the head of the Primary Care Reimbursement Service (PCRS) and the Chief Information Officer”. The approved systems are the HSE’s Healthmail System and the High Tech Hub. To be legally valid a prescription sent through the national electronic prescription transfer system must be:
In relation to electronic prescriptions written in another EEA Member State the PSI have produced Guidance on Dispensing Prescriptions Issued in Another EEA Member State. This guidance notes the following:
“there is no domestically approved electronic prescribing system to receive and dispense e-prescriptions issued in another EEA Member State.
It is worth noting that ePrescription services are being introduced across the EU but are not currently available in all countries.”
It then goes on to state that an electronic prescription issued in another EEA Member State:
“must be traceable back to a prescriber so there is a clear and documented record linking the prescription to the prescriber who issued it”.
They provide the example of either a paper copy of the prescription or direct email from the prescriber in an EEA Member State to the pharmacy being acceptable in terms of facilitating the required check on the authenticity of the prescription. Furthermore, they note that
“a prescription presented on a patient’s phone/electronic device would not be considered appropriate as it is not traceable back to the prescriber, making it difficult to confirm its legitimacy or authenticity.”
The minimum elements that must be included on such electronic prescriptions in order to be recognised in another EEA Member State are as previously outlined for hardcopy prescriptions.
In the case of both hardcopy and electronic prescriptions it is important that steps are taken to verify the authenticity of the prescription to ensure it is issued by a registered practitioner/qualified healthcare professional in an EEA country. It is important that you only dispense prescriptions where you can verify the registration status and authorisation of the prescriber. The Europa website of the European Commission has a section on Regulated Professions which include a Regulated Professions Database* that provides lists of regulated professions in the EU member states, EEA countries, the UK and Switzerland together with their Competent Authorities.
It may be the case that some drugs/products that are prescribed may not be available in another Member State. Prescriptions which issue outside the EU/EEA are not valid in ROI. Emergency supplies of medicine to patients who present a pharmacist within ROI with a prescription issued outside the EU/EEA is prohibited. If this situation arises, pharmacists should explain this to the patient and refer them to an appropriate practitioner. However, if a patient has obtained a prescription from a medical practitioner, dentist or nurse registered in the United Kingdom, they may have that prescription dispensed in ROI, provided it has the requisite information on the face of the prescription as would be required for prescriptions issued by practitioners practising in the EU/EEA.
There is a limitation on prescriptions issued from UK-located practitioners where the prescription issues via means of telehealth/online services, which is not permitted. This means that prescriptions which originate from an online/telehealth service where the prescribing practitioner is located in the UK, are not valid in Ireland. The pharmacist is responsible for screening prescriptions in those circumstances, and this can be done by discussing with the patient, for example, the means in which the consultation took place with the practitioner, or identifying the contact details/address of the prescriber.
For context, telehealth covers situations where healthcare services are delivered to patients by providers who are separated from the patient — for example, services provided via a remote consultation. The same cross-border healthcare criteria apply in the context of telehealth services as apply in circumstances where the patient seeks in-person treatment in the EU/EEA. The HSE has distinguished between inpatient healthcare and day-case healthcare in the context of telehealth and has described the circumstances in which patients eligible to avail of cross-border telehealth may apply for reimbursement. That is, where eligible persons undergo inpatient care abroad, they may seek reimbursement for costs of the healthcare only if the outpatient appointment is in person. They are not eligible to seek reimbursement where the outpatient appointment is conducted by means of telehealth. However, in circumstances where the patient is undergoing day-case healthcare, they are entitled to seek reimbursement for the cost of treatment where the outpatient appointment is conducted by means of telemedicine.
It is important that healthcare professionals, including pharmacists, adhere to the provisions of these Regulations. Non-compliance with the obligations imposed by these Regulations can result in criminal liability. Persons who are found guilty of an offence under the Regulations may be liable on summary conviction (either a Class A fine, up to three months imprisonment or both), or on conviction on indictment (either a fine not exceeding €300,000, up to one year imprisonment or both), in respect of each offence. However, criminal liability is not the end of the matter. Pursuant to the Pharmacy Act 2007, complaints may be made to the Council of the Pharmaceutical Society of Ireland about registered pharmacists. These complaints may be made on the grounds of, for example, convictions for indictable offences or professional misconduct in respect of the pharmacist. Such complaints are considered by the Preliminary Proceedings Committee and may be referred for an inquiry.
* ec.europa.eu/growth/tools-databases/regprof/professions accessed June 2025
Matthew Austin
Partner, Commercial and Business, Hayes Solicitors LLP
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