As the Deputy is aware, the HSE has statutory responsibility for medicine pricing and reimbursement decisions in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 which specifies the criteria for decisions on the reimbursement of medicines.
As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines and Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual. Therefore, it would be inappropriate for me to meet with Mr Holmes, although I have great sympathy for his situation.
In Ireland, the majority of patients access medicines through the publicly funded Community Drug Schemes.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must apply to have the new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
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).
Pembrolizumab (Keytruda) has been granted marketing authorisation in Ireland and the EU for a number of indications and is included on the HSE reimbursement list for some of those indications.
Furthermore, Pembrolizumab (Keytruda) is being assessed by the HSE, using the criteria in the 2013 Act, for a number of other indications for which it has received marketing authorisation.
There are no other indications for pembrolizumab approved in the European Union at this time.
Clinical trials for various immunotherapies, including pembrolizumab (Keytruda), are ongoing globally for a range of other possible indications, which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received.
In relation to your suggestion regarding VAT exemptions to medicinal products, I wish to advise you that changes to taxation policy are a matter for the Minister for Finance and Public Expenditure and Reform.