I propose to take Questions Nos. 540 to 542, inclusive, together.
As the Deputy will be aware, the Oireachtas put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013 which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The degree of clinical benefit and value for a given medicine may vary considerably between indications. The HSE therefore advises that the current pricing/reimbursement assessment process for new uses of currently reimbursed medicines derives significant value for the health service.
I am advised by the HSE and NCPE that a process of pre-approval enabling of reimbursement while further clinical evidence and data are collected on a given medicine is not recommended. The HSE and NCPE have indicated that such a process would be founded upon the assumption that the collected data would support a positive reimbursement recommendation, which is often not the case.
It is clear from an analysis of trends over the last few years that the overriding factor in the approval of medicines for reimbursement is the availability of Exchequer resources.
- In 2020 there was no dedicated funding allocated for new drugs and the HSE approved 11 new medicines / new uses of existing medicines in the area of cancer treatment. This represents 48% of all approvals that year. Such decisions had been pending with the HSE Executive Management Team (EMT) since 2019 until a dedicated funding stream for new medicines in 2021 was confirmed in Budget 2021.
- In 2021, the HSE was allocated €50 million for the reimbursement of new medicines and approved 26 new medicines / new uses of existing medicines in the area of cancer treatment. That represents 50% of approvals that year.
- Budget 2022 allocated €30 million to the HSE for the approval of new medicines. As of 15 February, the HSE has approved 10 new medicines / new uses of existing medicines in 2022.
In December 2021, I announced two new Framework Agreements on Pricing and Supply of Medicines.
The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in reducing the cost of medicines and improving access to innovative new medicines for patients for the years 2021 to 2025.