Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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486. To ask the Minister for Health the extent of engagement that he has had with his Department officials on the Health (Pricing and Supply of Medical Goods) (Amendment) Private Members Bill 2021 that is due for Committee Stage; and if he will make a statement on the matter. [38268/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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In response to the Bill, the Department of Health, HSE and National Centre for Pharmacoeconomics had significant, detailed engagement on the current processes. It was concluded that the current Act does not present legal barriers for the approval of orphan drugs for reimbursement.

The 2013 Health Act does not include provision for a different ruleset when assessing orphan medicines. However, the criteria that apply to the evaluation process allow the HSE to have particular regard for the unique circumstances surrounding orphan drugs, such as small patient populations and clinical need.

I am therefore satisfied that the criteria contained in the 2013 Act are fit for purpose and do not discriminate against the assessment of orphan drugs.

The allocation of dedicated funding for new medicines has had a positive impact on the reimbursement of orphan drugs. The allocation of €50m for new medicines in 2021 enabled the HSE to approve 52 new medicines/expanded uses of existing medicines in 2021, 19 of which were for the treatment of rare diseases. Budget 2022 allocated a further €30 million for the approval of new drugs. The HSE has approved 36 new medicines/new uses of existing medicines to date in 2022. At 30 April 2022 three of these were for the treatment of rare diseases.