Brendan Griffin (Kerry, Fine Gael)
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888. To ask the Minister for Health the breakdown of the additional €30 million for new medicines announced as part of Budget 2022; the amount that will be made available for the approval of non-oncological rare disease and gene therapies; and if he will make a statement on the matter. [52327/21]

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, 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 non-oncological rare disease and gene therapies, 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.

Brendan Griffin (Kerry, Fine Gael)
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889. To ask the Minister for Health further to Parliamentary Questions Nos. 575 and 578 of 12 October 2021, the number of the 15 rare disease new medicines approvals resulting from the €50 million for new medicines announced as part of budget 2021 that were for the treatment of non-oncological rare diseases; and if he will make a statement on the matter. [52331/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Brendan Griffin (Kerry, Fine Gael)
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890. To ask the Minister for Health further to Parliamentary Questions Nos. 586, 587 and 588 of 12 October 2021, the specific themes that have been agreed for inclusion as part of the update of the National Rare Diseases Plan; and if he will make a statement on the matter. [52332/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Many of the major recommendations of the National Rare Disease Plan have already been implemented. In late 2020, the National Clinical Programme for Rare Diseases was operationalised and incorporated into the National Rare Disease Office, who has become the main contact point and driver for national HSE rare disease projects and initiatives. The work of the NRDO is overseen and governed by HSE Acute Operations under the governance of the Office of the Chief Clinical Officer, where the National Rare Disease Plan is firmly embedded.

Building on the significant progress to date, a number of themes for inclusion in a roadmap for the coming period have been agreed with the Rare Disease Task Force, which comprises the main rare disease advocacy groups; Rare Disease Ireland, the Medical Research Charities Group (MRCP), and the Irish Platform for Patient Organisations, Science and Industry (IPPPOSI). Those themes identified for future progress, include: Patient Awareness; European Reference Networks; Research & Registries; Access to Services; Access to Medicines; Diagnosis; Education & Training and Legislation & Policy.