John Lahart (Dublin South West, Fianna Fail)
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2085. To ask the Minister for Health his plans to improve Ireland’s performance on access to new medicines relative to other western European countries; and if he will make a statement on the matter. [19792/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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"League tables" comparing speed of reimbursement in Ireland with that of other countries are often misleading, as several countries have quite different and often less rigorous statutory assessment arrangements than Ireland. Furthermore, many of the newer products being licensed are falling well short of cost-effectiveness thresholds, with limited clinical benefits.

As the Deputy is aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give 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. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.

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.

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.

The process for assessing applications works very well where the new medicines have strong evidence of clinical effectiveness and are priced in a cost-effective manner. Delays in reimbursement decisions for new products may occur in cases where the evidence of clinical effectiveness is weak, and where prices are set well outside of cost effectiveness parameters.

The HSE strives to reach a decision in as timely a manner as possible. However, because these commitments are often multi-million-euro investments on an ongoing basis, it must ensure that the best possible price is achieved. This can lead to a protracted negotiation and deliberation process.

The Government wants new and innovative medicines to be available to our citizens as quickly as possible, but this can only be achieved if medicines are priced by the pharmaceutical industry in a viable and sustainable manner.

Ireland has been engaging over the past number of years with a number of voluntary EU forums. In June 2018, Ireland joined the Beneluxa Initiative on Pharmaceutical Policy. This Initiative is in line with the objective of working with other European countries to identify workable collaborative solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative which aims to assist member states' planning and allocation of resources with respect to new medicines.

As the Deputy will be aware, additional funding of €50m was provided for new medicines in Budget 2021. This funding will allow the HSE Executive Management Team (EMT) to approve new and innovative medicines which have been recommended by the HSE Drugs Group on the basis of efficacy and value for money in line with the 2013 Health Act.

As of 15 April, the HSE EMT had approved reimbursement of 22 new medicines or new uses of existing medicines in 2021. The HSE will continue assess any pricing and reimbursement applications received for new medicines, in line with the 2013 Act.