John Brady (Wicklow, Sinn Fein)
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2814. To ask the Minister for Health the number of persons on the waiting list for ophthalmology in County Wicklow; the average waiting time for appointment in tabular form; and if he will make a statement on the matter. [39239/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services.

Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.

Thomas Gould (Cork North Central, Sinn Fein)
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2815. To ask the Minister for Health the timeline for the implementation of CAR-T therapy here. [39240/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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CAR-T is a novel treatment for patients with cancer. It is a patient-specific, individualised cell therapy that consists of genetically modifying the patient’s own T lymphocytes. Two CAR-T therapies were licensed as medicines by the EU in 2018 and a further one was licensed in late 2020.

Although licensed as a medicine by the EMA, there are technical processes required to support the use of CAR-T therapy which are more multifaceted than standard drug administration. These involve a complex supply chain, laboratory accreditation and other specific supports to be in place in addition to the drug reimbursement approval. As a result, CAR-T can only be carried out at designated, accredited centres that have been assessed and accredited from a quality control and a process management perspective. The administration of CAR-T must occur in hospitals with the appropriate infrastructure and trained staff.

In preparation for a CAR-T service in Ireland the NCCP has:

- formally designated the National Stem Cell Transplantation unit at St James’s Hospital (SJH) and the Haematopoietic Stem Cell Transplant Unit in Children's Health Ireland at Crumlin as the initial sites to deliver this service for adult and paediatric patients on the island of Ireland;

- supported SJH and CHI at Crumlin in progressing the technical/service readiness elements required;

- agreed a service specification and a patient pathway for adult and paediatric patients whereby all patients to be considered for CAR-T must be discussed at the appropriate multidisciplinary team (MDT) meeting in the designated CAR-T centre. This agreed pathway will ensure that there is a clear clinical governance structure in place for these services; and

- agreed the basis of a national CAR-T Review Group whose role will be to consider all patients who have been referred for discussion at the designated CAR-T centre MDT meeting and to prioritise patients for treatment based on assessment of information regarding patient fitness, disease severity and available capacity.

Service planning discussions are ongoing involving the NCCP, service providers and pharmaceutical companies to move forward on a CAR-T service in Ireland. It is hoped that the service will be operational for both adult and paediatric patients by end 2021.

Violet-Anne Wynne (Clare, Sinn Fein)
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2817. To ask the Minister for Health if he will provide a progress update for the public inquiry into the historical licensing and use of the anti-epileptic drug sodium valproate epilimf in Ireland announced in November 2020; and if he will make a statement on the matter. [39242/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Details of the proposed inquiry into the historical licensing and use of sodium valproate in Ireland are currently being considered by officials within the Department of Health.