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. The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision. As Minister for Health, it would be inappropriate for me to comment on individual cases.
Pembrolizumab 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 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.
As the Deputy will be aware, the Government decision of 11 May 2018 put in place a package of support measures for the women and families affected by the issues related to CervicalCheck. Those measures included medicines which might not be approved for reimbursement including Pembrolizumab, once they are prescribed by the treating clinician. The establishment of such a comprehensive support package reflected the impact of the lack of disclosure of the result of clinical audit and the ensuing controversy on individual women and their families.
In January 2019, after careful consideration of the situation which had arisen in respect of patients with cervical cancer who were not encompassed by the terms of the support package agreed by Government for those affected by the CervicalCheck clinical audit non-disclosure issue, it was agreed that the HSE would put in place arrangements to facilitate access to Pembrolizumab for cervical cancer patients on a case-by-case basis in public hospitals when a treating clinician determined this to be in the patient’s best interests. As Minister, I have of course no role in relation to how doctors manage the care of individual patients. All prescribing decisions are entirely a matter for the treating clinician, in line with patient safety protocols and the Medical Council Guide to Professional Conduct and Ethics. This arrangement applies to cervical cancer patients only.
Clinical trials for various immunotherapies, including Pembrolizumab, 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 request to exempt Pembro from 23% VAT, this is a matter for my colleague, the Minister for Finance. I will arrange to send the Minister for Finance a copy of my response to this question.