Duncan Smith (Dublin Fingal, Labour)
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322. To ask the Minister for Health the estimated amount in euros that has been saved by his Department from moving from branded to generic medications in each of the years 2019 to 2021 and to date in 2022; and if he will make a statement on the matter. [61496/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Duncan Smith (Dublin Fingal, Labour)
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323. To ask the Minister for Health the volume of packs of unlicensed medicines that are being brought into the market to alleviate medicine shortages; the estimated cost of these unlicensed medicines per annum; and if he will make a statement on the matter. [61497/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Duncan Smith (Dublin Fingal, Labour)
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324. To ask the Minister for Health the average time taken by the HSE to decide on applications for medications to be added to the reimbursement list; the average time taken to adjudicate on hardship cases where manufacturers are seeking price increases due to inflationary costs; and if he will make a statement on the matter. [61498/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Duncan Smith (Dublin Fingal, Labour)
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325. To ask the Minister for Health if he has plans to enhance the functionality of the reimbursement approval process to improve efficiency in decision-making and thereby secure additional sources of medicines, in particular generic medicines, onto the market, in the context of the increasing medicine supply shortages; and if he will make a statement on the matter. [61499/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Pricing and Supply of Medical Goods) Act 2013 provides a rigorous process for the assessment of new medicines for reimbursement. This allows taxpayers to be confident both that the right medicines are chosen, and that those medicines are approved at a price that can sustainably be afforded in a budget-limited health service. Economic assessment is valuable to stretch the funds granted to the HSE as far as possible, allowing them to provide a range of services as well as innovative medicines for all citizens. 

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.

The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE would not be able to approve or assess a drug until an application for reimbursement was received. 

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 €2.54bn by 2021.

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.

In respect of generic medicines, The Health (Pricing and Supply of Medical Goods) Act 2013 provides for Interchangeability/Substitution, informed by the HPRA list of interchangeable products for medicines with a generic equivalent.

Under the 2013 Act, pharmacists are obliged to offer the lowest cost product on the interchangeable list. The HPRA maintains a list of interchangeable products to enable substitution in this way.

Under the 2013 Act, the HSE sets a common reimbursement price for all medicines in any group of interchangeable products (internal reference pricing). This includes both generics and branded medicines.

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.

Duncan Smith (Dublin Fingal, Labour)
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326. To ask the Minister for Health the reason that some branded medicines have not been required to be reduced in price following the approval of a generic equivalent, as required by the 2021 industry agreements; and if he will make a statement on the matter. [61500/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Duncan Smith (Dublin Fingal, Labour)
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327. To ask the Minister for Health if a higher reimbursement price is granted to unlicensed medicines than the licensed version of the same medicine; and if he will make a statement on the matter. [61501/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.