Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I have no role in the process of individual reimbursement decisions under the 2013 Health Act.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

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).

While the 2013 Health Act does not include provision for a different ruleset when assessing orphan drugs, the HSE seeks as far as possible to take into account issues such as the small patient numbers and the nature of the condition to be treated when evaluating these medicines. The criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs and rare diseases.

There has been a number of key changes in the HSE assessment process of medicines within the confines of the 2013 Health Act. These have included changes to the HSE Drugs Group, whose membership has been expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.

In June 2018, the HSE Leadership appointed a Technology Review Committee for Rare Diseases (RDTRC) which is responsible for:

1) reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases including orphan drugs, or expanded indications for existing products for rare diseases and making recommendations as to the implementation of the relevant recommendations from the National Rare Diseases Plan 2011-2018; and

2) providing contributions to the development of clinical guidelines for relevant Orphan Medicinal Products (OMPs) and supporting the implementation of guidelines in conjunction with the National Drugs Management Programme Office where applicable. The Committee’s recommendations for reimbursement of OMPs are not intended to replace any part of the existing medicines appraisal or reimbursement process but rather complement it.