John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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595. To ask the Minister for Health if he intends to support the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 to provide for a dedicated pathway for the reimbursement of orphan medicinal products; and if he will make a statement on the matter. [52097/23]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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597. To ask the Minister for Health if he will report on the next steps of a working group (details supplied); and if he will make a statement on the matter. [52099/23]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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598. To ask the Minister for Health his views on whether legislative change is required to improve Ireland's reimbursement system for orphan medicinal products. [52100/23]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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599. To ask the Minister for Health if he supports interim access reimbursement models which allow early access to rare and ultra-rare disease medicines, as utilised in Scotland; and if he will make a statement on the matter. [52101/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 595, 597, 598 and 599 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible.

The HSE robustly assesses applications for pricing and reimbursement to make sure it can stretch available resources as far as possible and to deliver best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

In February, I published the Mazars Review which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. The Report found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms. I fully support the recommendations contained in the Mazars report around improving the process, increasing transparency, providing easier access, and supporting value for money.

An implementation group has been established between my Department and the HSE to consider and progress the various recommendations contained in the Report. The membership of the Group includes representatives of the Drugs Group, the HSE, the NCPE, and the Department of Health. The Working Group has met frequently since its establishment, to consider the involvement of patients, industry, and clinicians, in each stage of the reimbursement process.

Targeted stakeholder consultation commenced on the 31st of May and concluded on the 20th of June. The insights gained from stakeholders have been considered by the Group as it continues its work on progressing the various recommendations of the Review. The Group’s work is now nearing completion and a report on this will be submitted to me in the coming months.

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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596. To ask the Minister for Health his views on an indicator survey (details supplied) showing Irish patients are waiting an average of 877 days to access EMA-approved orphan medicinal products; and if he will make a statement on the matter. [52098/23]

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. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.

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.

When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.

The principal factors in determining the speed of reimbursement are the price at which a manufacturer applies for the reimbursement of a product and the outcome of the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.

In terms of the time taken from application to a decision on reimbursement, the HSE advise that the biggest impediments to achieving the 180-day timeline is often the failure of companies to provide sufficient evidence to support the efficacy of some medicines, and the need for the HSE to get involved in protracted negotiations in seeking to achieve better prices for the State.

The pricing and reimbursement of medicines is a national competence. Different pharmaceutical reimbursement systems are currently in place across the EU. As Member States operate different systems, a direct comparison of the reimbursement of products is not possible.