The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister I do not have any power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list. It is the sole responsibility of the company to make an application for reimbursement and the price sought for any product is purely at the discretion of the applicant.
However, upon receipt of an application for reimbursement, the HSE engages in a thorough assessment process to ensure that reimbursement decisions are made on objective, scientific and economic grounds, on the advice of expert bodies such as the National Centre for Pharmacoeconomics (NCPE).
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted negotiation process with a view to achieving the best value for the taxpayer in terms of the final negotiated price for the product in question.