Bernard Durkan (Kildare North, Fine Gael)
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348. To ask the Minister for Health if he remains satisfied that reimbursement in respect of new and orphan drugs and other emergency drugs is sufficiently speedy and capable of meeting the demand; if he has identified any shortcomings in relation to same; when these will be addressed; and if he will make a statement on the matter. [61612/22]

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. 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 State is committed to providing timely access to new and innovative medicines to all patients. Budget 2021 allocated €50 million for the reimbursement of new drugs, enabling the HSE to approve fifty-two new medicines. This included twenty-seven oncology medicines and nineteen medicines for the treatment of rare diseases. 

Budget 2022 has allocated a further €30 million for the reimbursement of new medicines and as of 7 November the HSE has approved reimbursement for 47 new drugs, nine of which were orphan drugs. Further dedicated funding has also been announced for new drugs in Budget 2023.