Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

466. To ask the Minister for Health his views on the discrepancy in access to innovative oncology treatments for Irish cancer patients in the public health system, compared with patients with private health insurance; if he is aware of the extent of this discrepancy; and if he will make a statement on the matter. [23945/24]

Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

467. To ask the Minister for Health if his Department is monitoring the discrepancy in access to innovative oncology treatments for Irish cancer patients in the public health system, compared with patients with private health insurance; if he will request the HSE to commence tracking of this data as part of its role in assessing and reimbursing medicines for patients in the public health system; and if he will make a statement on the matter. [23946/24]

Duncan Smith (Dublin Fingal, Labour)
Link to this: Individually | In context | Oireachtas source

468. To ask the Minister for Health if he is aware of the impact of delays in access to innovative oncology treatments on disease progression; and if he will make a statement on the matter. [23947/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 466 to 468, inclusive, together.

The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 - 2023 provided almost €100 million of dedicated funding for new drugs. This enabled the HSE to approve 148 new drugs, 61 of which are for cancer. This brings the total spend on Cancer drugs in the last 3 years to over €600 million.

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 licensed 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 cannot add a medicine to the reimbursement list until an application is received from the company holding the market authorisation.

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 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. 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. 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.

As Minister for Health, I regulate the private health insurance market. This is a voluntary market, which is underpinned by certain principles, including minimum benefit, that are set out in law. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person. I do not have a role in the commercial decision-making of any private health insurer.

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, I am not in a position to direct any insurer to provide cover for any particular procedure or service or medicine, or direct how that cover is to be provided.