Colm Burke (Cork North Central, Fine Gael)
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616. To ask the Minister for Health if consideration will be given to the creation of a national medicines reserve facility in Ireland specifically to help during a public health emergency, in particular taking into account the current risk of medicine shortages and supply disruptions and the way this negatively impacts on patient health; and if he will make a statement on the matter. [60596/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Irish medicine supply chain has a different wholesaling model to other jurisdictions and additional stocks of medicines are routinely built into the model of pharmaceutical procurement in Ireland. The benefits of this model have been realised both during the response to Covid-19 and in preparations for Brexit and provides for supply chain resilience during periods of logistics disruption.

Unfortunately, medicine shortages can occur as they 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. Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines 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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617. To ask the Minister for Health if his Department will engage with the largest group of suppliers of medicines to the HSE and patients directly (details supplied) to review pricing and procurement policies in order to protect patient access to high-quality affordable treatment and help to mitigate the risk of medicine shortages; and if he will make a statement on the matter. [60597/22]

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 Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), represent an important step in reducing the cost of medicines and facilitating access to innovative new medicines for patients. Medicines for Ireland 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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618. To ask the Minister for Health if consideration will be given to the putting in place of a mechanism within the framework agreements on Pricing and Supply of Medicines 2021-2025 (details supplied); and if he will make a statement on the matter. [60598/22]

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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619. To ask the Minister for Health if consideration will be given to the extension of the 0% VAT rate that currently applies to certain oral medicines to non-oral medicines, including injections, infusions, liniments, ointments and transdermal patches, which would be in line with the programme for Government commitment (details supplied); and if he will make a statement on the matter. [60599/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Tax Strategy Group Paper on Value Added Tax (VAT) published in July 2022 noted that Ireland could extend the zero VAT rate that currently applies to certain oral medicines to non-oral medicines also. Non-oral medicines include injections, infusions, liniments, ointments, and transdermal patches. The estimated cost of extending the zero VAT rate to all forms of non-oral medicines would be approximately €145 million per annum.

As announced in Budget 2023, the VAT rate for non-oral forms of Hormone Replacement Therapy (HRT) and non-oral forms of Nicotine Replacement Therapy (NRT) will be reduced to zero from 1 January 2023. This will reduce the cost of non-oral forms of HRT and NRT medicines for all those who need them.

The proposal to extend the zero VAT rate to all forms of non-oral medicines, or to additional sub-categories of non-oral medicines beyond those announced in Budget 2023, must be considered in the context of other competing health priorities and the available budget.

It is also important to note that the chief consideration for the Department of Health in making any such requests to the Minister for Finance is the benefit to public health.