Fergus O'Dowd (Louth, Fine Gael)
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743. To ask the Minister for Health further to Parliamentary Question No. 1619 of 21 April 2021, if he will address further matters raised in correspondence (details supplied); and if he will make a statement on the matter. [23904/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives 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.

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

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

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). 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 a drug's clinical and cost effectiveness as a health intervention.

As Minister for Health, I have no role in individual decisions relating to either the authorisation or reimbursement of medicines.

Clinical trials on medicinal products for human use is a highly regulated activity, governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004 and amendments. The regulatory authority for clinical trials in Ireland is the Health Products Regulatory Authority (HPRA) and authorisation for the conduct of a clinical trial is solely for the HPRA to decide.

Questions regarding treatment plans and options specific to individual patients are a matter for each patient’s treating clinician.