Bernard Durkan (Kildare North, Fine Gael)
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1071. To ask the Minister for Health the amount and percentage of the amount spent on medicines by the State that related to generic medicines; his plans to increase the use of generics in Ireland; the saving achieved in generics in each of the past five years in tabular form; and if he will make a statement on the matter. [14958/22]

Bernard Durkan (Kildare North, Fine Gael)
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1074. To ask the Minister for Health the specific targets set out by his Department for increasing the use of generic medicines within the medicines market in Ireland; the extent to which Ireland compares to other European Union countries in the use of generic medicines; the estimated additional saving envisaged in 2022 by increased use of generic medicines; and if he will make a statement on the matter. [14961/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1071 and 1074 together.

The Health (Pricing and Supply of Medical Goods) Act 2013 permits community pharmacists to dispense generic medicines where a brand name medicine has been prescribed, provided they have been designated as interchangeable by the Health Products Regulatory Authority.

Reference pricing means a single reimbursement price, or reference price, for a group of interchangeable medicines. This is the maximum price that the HSE will pay community pharmacies for all medicines in this group, regardless of the individual medicines’ prices.

While my Department does not have specific targets in relation to the usage of generics in the health service, it is fully supportive of domestic policies that maximise efficiency in our medicines usage. The HSE is actively engaged in implementing measures to ensure improve cost-effectiveness in medicines usage, including those under the Acute Hospitals Drugs Management Programme (AHDMP), within the Primary Care Reimbursement Service (PCRS) and under the Medicines Management Programme (MMP) which seeks to enhance evidence-based and cost-effective prescribing in Ireland.

My Department does not collate data on medicine usage in other European Union member states.

I have referred this matter to the HSE for their attention and direct reply to the Deputy in relation to the statistical information sought.

Bernard Durkan (Kildare North, Fine Gael)
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1072. To ask the Minister for Health the amount and percentage of the amount spent on medicines by the State that related to biosimilar medicines; his plans to increase the use of biosimilar medicines in Ireland; the saving achieved in biosimilar medicines in each of the past five years in tabular form; and if he will make a statement on the matter. [14959/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I am pleased to inform the Deputy that the prescribing of Best Value Biologic (BvB) medicines is leading to significant savings for the health service, which is assisting us in facilitating access to new, innovative medicines for patients.

The HSE is actively engaged in implementing measures across a number of domains and under several initiatives, including the Acute Hospitals Drugs Management Programme, the HSE Medicines Management Programme (MMP), and within the Primary Care Reimbursement Service.

The HSE Medicines Management Programme published recommendations in May 2019 in relation to two high tech drugs, adalimumab and etanercept. That year, the HSE also introduced the Gainshare Initiative, which provides a financial incentive to public hospitals and clinics to pursue biosimilar treatment switching programmes. By January 2022, over 17,000 patients had switched to a best-value-biologic (BvB). In January 2022, the percentage value of Biosimilar drugs reimbursed to High Tech suppliers was over 54% of the available market. Associated annual savings in excess of €80 million have been achieved.

Further progress in this area must be carefully planned and implemented, with patient’s confidence and assurance at the forefront of any new initiatives and developments.

I have referred this matter to the HSE for their attention and direct reply to the Deputy in relation to the statistical information sought.

Bernard Durkan (Kildare North, Fine Gael)
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1073. To ask the Minister for Health the engagement that he or his officials undertook in 2021 with organisations (details supplied) as part of the process to agree two new framework agreements on pricing and supply of medicines 2021-2025; the measures within these agreements to help reduce the cost of medicines in Ireland; the estimated savings for the State over the lifetime of each agreement; and if he will make a statement on the matter. [14960/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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In December 2021, I announced two new Framework Agreements on Pricing and Supply of Medicines 2021-2025.

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 improving access to innovative new medicines for patients.

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

It is estimated that this will result in the State paying between €600 million and €700 million less for medicines than it would otherwise.

As a result of these Agreements with IPHA and MFI, the HSE will be in a much stronger position to meet the increasing demand for existing medicines and also to invest in new medicines over the next four years.

The €30m allocated in Budget 2022 will have a further significant impact on the availability of new and innovative medicines, including for the treatment of rare diseases. These new deals also provide greater certainty for industry over the next four years.

The new measures in the Agreement with IPHA include increased rebate contributions from on-patent medicines, closing loopholes in relation to hybrid medicines, and increased savings from off-patent medicines.

A parallel agreement was secured with MFI on behalf of the generic and biosimilar industry in Ireland. This four-year Agreement runs from 1st December 2021 to 30th November 2025 and, like the IPHA Agreement, provides for enhanced price cuts in the case of generic and biosimilar medicines. The provisions of this Agreement will complement the State’s overall efforts in managing the drugs budget, including supporting a competitive market in the off-patent space.

These Agreements followed extensive negotiations and engagement by the Department of Health, alongside partners in the Department of Public Expenditure and Reform and the HSE, with the two organisations concerned.