David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

403. To ask the Minister for Health the number of medicine pricing applications submitted to the primary care reimbursement service of the HSE to date in 2024, in tabular form; the submission date of each application; and if he will make a statement on the matter. [30413/24]

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

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

404. To ask the Minister for Health the number of medicine pricing applications in total currently under consideration by the primary care reimbursement service of the HSE, in tabular form; the submission date of each application; and if he will make a statement on the matter. [30414/24]

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

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

405. To ask the Minister for Health the number of medicine pricing applications submitted to the primary care reimbursement service of the HSE in 2023, in tabular form; the submission date of each application; the status of each application; and if he will make a statement on the matter. [30415/24]

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

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

406. To ask the Minister for Health if, given the ongoing issue of medicine shortages, he has concerns as to the period of time it is taking from application to outcome for medicine pricing applications to be adjudicated; if he is giving consideration to making operational and/or resourcing enhancements to reduce the waiting time duration; and if he will make a statement on the matter. [30416/24]

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

The shortage of some medicines are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues.

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. 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 medicines for reimbursement.

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.