Paul Kehoe (Wexford, Fine Gael)
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1249. To ask the Minister for Health if he will outline specific measures planned to address the gap in access to newly approved cancer drugs by the European Medicines Agency between private and public patients; and if he will consider fast-tracking reimbursement timelines for these drugs to ensure equal access for all patients, regardless of insurance status; and if he will make a statement on the matter. [45124/24]

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.

In assessing an application to reimburse a medicine, 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. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

In February 2023 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 included improving the process, increasing transparency, providing easier access, and supporting value for money.

In 2024, there was significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process. This is a recommendation of the working group which I established following the publication of the Mazars Review in February 2023, with funding allocated for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement. The hiring process is ongoing and nearing completion.

Ireland has a voluntary private health insurance market which operates under the principles of community rating (including lifetime community rating), open enrolment, lifetime cover and minimum benefits. Insurers are required to offer a minimum level of cover in every insurance policy. Health insurance companies may exclude or include certain services and providers in their policies, provided they remain in compliance with the Minimum Benefit Regulations. Beyond Minimum Benefits regulations, the Minister has no role to play in the commercial decisions of any health insurer. The Minister for Health regulates the Private Health Insurance Market in Ireland. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person.

Private Health Insurance companies operate as commercial entities in a competitive private health insurance market. Beyond prescribing under the Regulations the minimum level of coverage that health insurers must provide, the Minister is not in a position to direct any insurer to provide cover for any particular procedure or service, or direct how that cover is to be provided.