Clare Daly (Dublin Fingal, Independent)
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766. To ask the Minister for Health the steps he will take to reduce the lead-in time for reimbursement of a new medicine by the HSE in order to ensure speedy access to new and effective treatments through a fair and sustainable system for persons who need them. [15476/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.

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 NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

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 ongoing basis. This can lead to a protracted deliberation process.

When the decision is taken not to reimburse a medicine, there is an extension in this timeline. This is due to the requirement of the HSE to issue a “notice of proposal”, and to allow 28 days for manufacturers to make representations to reconsider their decision. The HSE must then consider those representations and make a formal decision.

I am keen to engage with Industry and to explore ways in which new medicines might be more easily introduced in Ireland. However, any innovative approaches that may be tabled must be compatible with the statutory provisions which are in place and must also recognise the fundamental pricing/funding issues in the context of finite Exchequer resources.