Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

1043. To ask the Minister for Health if urgent approval can be granted for the medicines nivolumab (opdivo) and chemotherapy, authorised by the European Medicines Agency (EMA) since October 2021 for gastric cancer with a PD less than 1 and CPS of 7.5, and pembrolizumab, authorised since December 2023 by the EMA for gastric cancer with a PD less than 1 and CPS greater than or equal to 1, as currently, neither the HSE nor the NCCP have included these drugs for the treatment of cancer on their reimbursement scheme for a person (details supplied), though both his surgeon and oncologists have strongly recommended immunotherapy as the best and most viable course of treatment for him; and if he will make a statement on the matter. [44066/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Patrick Costello (Dublin South Central, Green Party)
Link to this: Individually | In context | Oireachtas source

1044. To ask the Minister for Health whether he was made aware of the withdrawal from the Irish market of a number of presentations of medications (palladone, MST, oxycontin and targin) which are predominantly used by patients with life-limiting illness, by a manufacturer (details supplied), on the basis that the supply of these medications are not commercially viable in light of Brexit and the Windsor Framework; and if so, the measures he is taking to ensure that undue hardship is not caused to patients, by continuing the supply of these medications through sourcing an alternative manufacturer or supplies to the Irish market, or by making the necessary changes to the import licence requirements overseen by the Health Products Regulatory Agency, in order that these essential medications can be imported into the country from other EU Member States. [44074/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Dear Deputy Costello,

In order to fully answer your questions, my Officials have engaged with the Health Products Regulatory Authority (HPRA), as medicines regulator. The HPRA have advised that with relation to a rationalisation of the Mundipharma Pharmaceuticals Limited product portfolio, their opinion is that the withdrawal of these products are neither Brexit or Windsor Framework related.

The HPRA maintains a list of withdrawn product authorisations. The decision to withdraw a product authorisation is one taken by the Marketing Authorisation Holder (MAH), in this case Mundipharma Pharmaceuticals Limited. The MAH is continuing to market alternative presentations of Palladone, MST, OxyContin and Targin in Ireland.

My Department would advise that if patients or their carers have concerns in relation to the availability of their medicines that they engage with their primary physician who can advise of alternative treatments for them, if required.