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Medicinal Products

Dáil Éireann Debate, Wednesday - 28 February 2024

Wednesday, 28 February 2024

Questions (136)

Pádraig O'Sullivan

Question:

136. Deputy Pádraig O'Sullivan asked the Minister for Health to outline the Governance arrangements in place by his Department to ensure schedule 1 of the framework agreement with the pharmaceutical industry is complied with by the HSE; and if he will make a statement on the matter. [9450/24]

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Written answers

Schedule 1 of the Framework Agreements on the Pricing and Supply of Medicines (FASPM) outlines the principles and processes for the assessment of new medicines in Ireland. The HSE has statutory responsibility for the assessment of new medicines is accordance with the Health (Pricing and Supply of Medical Goods) Act, 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

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 I 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. 

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

More detail on the measures to be implemented in 2024 are set out in the HSE’s National Service Plan (NSP). These include a commitment to deliver increased visibility on the steps / progress made by each individual medicine through the HSE assessment and approval processes. My Department will monitor the performance of the HSE in delivering the NSP through an established DoH-HSE performance engagement model.  The model provides for structured engagement at various levels within both organisations to identify service delivery challenges and agree and implement improvement actions.

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