John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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231. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

Patrick Costello (Dublin South Central, Green Party)
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232. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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Thank you for your question.

As indicated in Parliamentary Question No. 512 of 24 September 202 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;