Colm Burke (Cork North Central, Fine Gael)
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125. To ask the Minister for Health the action his Department is taking to help mitigate against the increasing risk to the supply of off-patent medicines nationwide due to rising inflationary, energy and transport costs; and if he will make a statement on the matter. [61151/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Two new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years.

Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020.

The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in reducing the cost of medicines and facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland.

Specifically, the new deals will deliver:

- Improved access for patients to new and innovative medicines

- Reductions in the cost of existing medicines

- An easing of financial pressure on the health services into the future

Under the terms of the agreement, there is scope for the Department of Health, the HSE, and industry to continue to maintain their engagement throughout the lifetime of the agreement on all matters pertaining to the agreement.

On the question of medicine shortages, unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

Medicine shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicine shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health.

Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

Colm Burke (Cork North Central, Fine Gael)
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126. To ask the Minister for Health if the Health Products Regulatory Authority, HPRA, has expressed concern to him, his Department or the HSE regarding the number of current medicine shortages listed on the HPRA website; and if he will make a statement on the matter. [61152/22]

Colm Burke (Cork North Central, Fine Gael)
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127. To ask the Minister for Health his plans, if any, to reduce the number of medicines in short supply nationwide; and if he will make a statement on the matter. [61153/22]

Colm Burke (Cork North Central, Fine Gael)
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128. To ask the Minister for Health the actions taken by him and the Department to mitigate against future medicine shortages; and if he will make a statement on the matter. [61154/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 126, 127 and 128 together.

Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

Medicine shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicine shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health.

Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

In many instances a shortage of a particular medicine is effectively addressed to ensure continuity of care for a patient including through the substitution for a generic version (in the case of a branded medicine short supply) or a generic version from a different manufacturer (in the case of a generic medicine in short supply). Under the Health (Pricing and Supply of Medical Goods) Act 2013 medicines which are deemed to be interchangeable can be directly substituted for one another by a pharmacist.

Where an interchangeable product is not available in Ireland, a pharmacist, in consultation with the prescriber, can source a medicine containing the same active ingredient in order to ensure that continuity of patient care is maintained, wherever possible. Such medicines may be sourced in another European Member State, or by a specialist wholesaler in a third country, and are known as exempt medicinal products (EMPs). EMPs have not been granted a marketing authorisation in Ireland by the HPRA but are sourced in response to a bona fide unsolicited order in order to fulfil the special needs of a patient. These medicines will however have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in another EU Member State or third country by the respective competent authority for medicines.

In other instances, where a medicine shortage occurs due to a more global issue affecting multiple countries, a patient may be directed to return to their clinician to consider prescribing an alternative medicine for the treatment of their condition.

The HSE maintains a reimbursement list of medicines that are provided under the General Medical Services (GMS) scheme or the Drugs Payment Scheme (DPS). These products are approved for the schemes by the HSE. In some cases, an alternative product sourced to maintain continuity of care in the event of a medicine shortage may be more expensive than the original medicine prescribed and will not ordinarily be included in the reimbursement list.

However, GMS medical card holders can apply to the local HSE health office to have these costs covered under the discretionary hardship arrangements. Under the DPS an individual or family will pay no more than €80 each calendar month for approved prescribed medicines. In certain cases, the cost of EMPs can be included in the total costs of medicines up to the threshold of €80. Patients are advised to consult with their pharmacist or clinician, who can make an application under the discretionary hardship arrangements on their behalf or to have the product covered by the relevant scheme.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.