Mary Lou McDonald (Dublin Central, Sinn Fein)
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1714. To ask the Minister for Health if his attention has been drawn to the fact that sub-clause 7.2.2 of the 2021 IPHA Framework Agreement which requires off-patent brands to 40% of the ex-factory price of that medicine is not consistently applied; and if he will make a statement on the matter. [2330/23]

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.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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1715. To ask the Minister for Health when a decision will be made by the Health Service Executive’s corporate pharmaceutical unit regarding a reimbursement application submitted fourteen months ago by a company (details supplied) for a commonly-used generic antibiotic, nitrofurantoin, prescribed for urinary tract infections. [2331/23]

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.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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1716. To ask the Minister for Health the reason that the 2021 IPHA Framework Agreement does not include a dedicated reimbursement mechanism for older commonly-used generic drugs for which the pricing framework is not applicable due to the significant number of years since the drugs’ patent has expired. [2332/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, the Oireachtas put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013 which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

Section 21(2) of the 2013 Act sets out the factors that the HSE must take into account when setting the relevant reimbursement prices proposed by the supplier of a medicine, which are as follows:

(a) the equivalent relevant prices (if practically available) of each item in all other Member States where the item is marketed, (b) the relevant prices of therapeutically similar listed items, (c) the potential therapeutic benefits in each case, (d) the budget impact of each item, (e) the ability of suppliers to meet demand, (f) the resources available to the Executive, and, (g) any agreement on pricing in place with industry

The HSE has also agreed and set out standard processes with industry in relation to the assessment of pricing and reimbursement applications for medicines. In that context, the 2021-2025 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 IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland.

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 term of the agreement.

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.

As part of a pricing and reimbursement application for generic and biosimilar medicines, there are already dedicated reimbursement mechanisms in the agreements. Reimbursement is automatically approved, provided the pricing is in line with the generic and biosimilar (and hybrid) pricing framework/agreements. The pricing of such medicines is linked to the price of the originator or patented medicine.

As part of a pricing and reimbursement application for a new chemical entity, the manufacturer submits a price application form (PAF) for a medicine it wishes the HSE to include on its reimbursement list / for hospital pricing approval. Under the IPHA agreement, the price included in the PAF must be no more than the average price based on 14 nominated states. The states include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom (UK). This is referred to as external reference pricing (ERP) whereby the price in a ‘basket’ of reference countries is used to derive an acceptable price for the originator or patented medicine.

Under the terms of the 2021 IPHA Framework Agreements, there is scope for the Department of Health, the HSE, and industry to continue to maintain their engagement throughout the lifetime of the agreements on all matters pertaining to the agreements.