Seán Sherlock (Cork East, Labour)
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450. To ask the Minister for Health his position regarding indicative timelines for a medicine to complete the application/approval process which he committed to in February 2023; if these have been introduced as per his request to the HSE; and if he will make a statement on the matter. [28068/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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In February 2023 the Mazars Review was published 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. The recommendations contained in the Mazars report included improving the process, increasing transparency, providing easier access, and supporting value for money.

In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process. This is a recommendation of the working group established following the publication of the Mazars ‘Review of the Governance Arrangements and the Resources in place to support the HSE’s reimbursement and pricing decision-making process’ in February 2023.

Funding has been allocated for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system has been granted. This will enable them to conduct timely and efficient evaluations of medicines for reimbursement. It will also maximise the use of this substantial public investment to support access to more medicines for more people. This recruitment process has commenced and is ongoing. Funding has also been approved for an online tracker which will allow patients and industry to follow the progress of an application through the assessment process. This will enhance transparency for all stakeholders.

Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of medicines for reimbursement.

Seán Sherlock (Cork East, Labour)
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451. To ask the Minister for Health the reason no pathfinder programmes, such as the one recently announced for the RSV vaccine, have been implemented for cancer patients in need of newly licenced oncology medicines; and if he will make a statement on the matter. [28069/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2023 saw almost €100 million allocated for the reimbursement of new drugs, enabling the HSE to approve 148 new medicines. This included 61 oncology medicines.

Budget 2024 made €30 million available for new drugs. €20 million of this will be invested directly by the Government and a further €10 million will come from efficiencies to be identified by the HSE. Efficiencies were identified as a priority for 2024 by the Minister, with a joint HSE-Department of Health Taskforce established to address medicine expenditure.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the 2013 Act. 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.

In assessing the application, the HSE is required by statute to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.

In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process.

Funding has been allocated for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system has been granted. This will enable them to conduct timely and efficient evaluations of medicines for reimbursement. It will also maximise the use of this substantial public investment to support access to more medicines for more people. This recruitment process has commenced and is ongoing.

Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of cancer medicines for reimbursement.

Seán Sherlock (Cork East, Labour)
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452. To ask the Minister for Health the reason no pathfinder programmes, such as the one recently announced for the RSV vaccine, have been implemented for patients with rare diseases and in need of newly licenced orphan treatments; and if he will make a statement on the matter. [28070/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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On Rare Diseases Day 2023, I announced a plan to develop a revised National Rare Disease Plan, in line with the commitment in the Programme for Government.

Since then, a Rare Disease Policy unit has been established in my department. This unit liaises with the National Rare Disease Office in the HSE and relevant stakeholders.

A National Rare Disease Steering Group was established in December 2023, and it has met eight times since it first convened.

The Steering Group has been tasked with developing the new National Rare Disease Strategy and an associated Implementation Plan.

This Strategy will set out the vision for Rare Disease services in Ireland and the actions required to achieve this, while focusing on delivering positive change for people living with a rare disease in Ireland.

The New National Rare Disease Strategy is envisaged to be published in 2024, this will be dependent on the work of the Steering Group in the development of the Strategy.

Regarding orphan medicines, the State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2023 saw almost €100 million allocated for the reimbursement of new drugs, enabling the HSE to approve 148 new medicines. This included 39 orphan medicines.