Written answers

Wednesday, 22 January 2025

Department of Health

Medicinal Products

Photo of Carol NolanCarol Nolan (Offaly, Independent)
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1333. To ask the Minister for Health if concerns regarding the lack of supply for a certain medicine (details supplied) will be addressed; and if he will make a statement on the matter. [46362/24]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Evorel 25 micrograms/24 hours transdermal patch does not have a marketing authorisation in Ireland, via the Health Products Regulatory Authority (HPRA), or in Europe, via the European Medicines Agency (EMA), therefore making it an unlicensed medicinal product (ULM), otherwise known as an exempt medicinal product (EMP). 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.

This is likely the route by which your constituent received Evorel 25 mcg transdermal patches.

What is an Exempt Medicinal Product:

There is a mechanism in Ireland that allows for the supply of unauthorised medicines: the Exempt Medicinal Product 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.

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.

As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. 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.

Reimbursement of Exempt Medicinal Products:

Your constituent also raised queries as to why they were charged for Evorel 25mcg separately to the Drugs Payment Scheme.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for indications which have been granted market authorisation by the EMA or the HPRA. In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). I, as Minister for Health, have no role in these decisions.

Decision making power will remain with the HSE for HRT items on the reimbursement list in accordance with the 2013 Act for the HRT initiative.

The HSE further advise that an application for 25mcg estradiol patches can be made on an exceptional basis under Discretionary Hardship Arrangements for medical card holders and via DPS exceptional arrangements. All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient. Patients can discuss this option with their healthcare professional.

Shortage of Evorel 50mcg:

As our medicines regulator, the HPRA, does not licence Evorel 25mcg, they do not have visibility of expected future supplies. However, the HPRA is aware of a shortage of Evorel 50 micrograms per 24 hours transdermal patches, which is a licensed product in Ireland (by the HPRA).

This shortage is reported as due to an unexpected increase in demand in Ireland, from information provided by Theramex Ireland Limited, the company responsible for supplying Evorel 50mcg. This shortage is expected to be resolved on 15th February 2025.

Ireland has a multi-stakeholder Medicines Shortages Framework in place, operated by the HPRA on behalf of the Department of Health. The framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages as they arise. Stakeholders in this framework include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.

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