Bernard Durkan (Kildare North, Fine Gael)
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238. To ask the Minister for Health the current or proposed regime governing new or orphan drugs; the number of such drugs under review or examination at the moment; the number to be approved in the course of the next year; the extent to which reimbursement will be in line with demand; and if he will make a statement on the matter. [59756/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Pricing and Supply of Medical Goods) Act 2013 gives full statutory powers to the HSE to assess and make decisions on the reimbursement of all medicines taking account of a range of objective factors, clinical benefits, cost effectiveness and expert opinion as appropriate. 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 HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The role of the Drugs Group is to make a recommendation to the HSE Executive Management Team (EMT) in relation to each individual application having considered the criteria under the Health (Pricing and Supply of Medical Goods) Act 2013. 

The Drugs Group considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, any inputs provided by the Rare Disease Technology Review Committee and any other pertinent information in advance of providing its recommendation to the HSE EMT.

As the decision-making authority within the HSE, the HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. 

While the 2013 Health Act does not include provision for a different ruleset when assessing orphan medicines, the criteria that apply to the evaluation process allow the HSE to take account of evidence of the benefits associated with each given medicine. The budget allocation of €30m funding for new medicines in Budget 2022 will provide for the reimbursement of both orphan and non-orphan medicines. 

The number of orphan drugs currently under assessment is an operational issue. I have therefore referred this matter to the HSE for their attention and direct reply to the Deputy.