Written Answers Nos. 738-752
738. Deputy Jackie Cahill asked the Minister for Health the reason St. Brigid's Hospital has not reverted its pre-Covid-19 status in the same manner as other facilities; and if he will make a statement on the matter. [28732/20]
View answer739. Deputy Jackie Cahill asked the Minister for Health when St. Brigid's Hospital will have its Covid-19 designation removed and begin resumption of normal operations at the hospital; and if he will make a statement on the matter. [28733/20]
View answerI propose to take Questions Nos. 738 and 739 together.
As these are service matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
740. Deputy Denis Naughten asked the Minister for Health the number of applications for a primary medical certificate that are now on hold as a result of the Supreme Court ruling of 18 June 2020; and if he will make a statement on the matter. [28735/20]
View answerThe Minister for Finance has responsibility for the Disabled Drivers and Disabled Passengers (Tax Concessions) Scheme which is operated by the Revenue Commissioners. To qualify for the Scheme, an applicant must be in possession of a Primary Medical Certificate.
The extent of the involvement of Health Service Executive (HSE) personnel in the Scheme relates to making a professional clinical determination as to whether an individual applicant meets the specified medical criteria. This determination is undertaken by Senior Medical Officers for the relevant HSE Community Health Organisation, on behalf of the Department of Finance and the Revenue Commissioners.
As the matter of assessment by a HSE Senior Medical Officer is a service matter, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.
742. Deputy Thomas Gould asked the Minister for Health the reason SouthDoc in Blackpool, Cork, is closed; and if a timeline can be given for the reopening of this facility. [28739/20]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
743. Deputy Carol Nolan asked the Minister for Health the number of patients whoreceived care post termination of pregnancy in maternity hospitals from January 2019 to date; the number of those who were for medical abortions provided by general practitioner or community, family planning or sexual health clinics; and if he will make a statement on the matter. [28741/20]
View answerAs this is a service issue, I have asked the Health Service Executive to reply to the Deputy as soon as possible.
744. Deputy Carol Nolan asked the Minister for Health if he will request the HSE to include data on all adverse outcomes specific to medication used in the provision of termination of pregnancy services in the annual national healthcare quality reporting system; and if he will make a statement on the matter. [28742/20]
View answerThe National Healthcare Quality Reporting System (NHQRS) aims to provide a mechanism through which data about the quality of Ireland's healthcare structures, processes and outcomes can be made publicly available so that this data may be compared against accepted standards or best practices. The reporting of performance and outcome indicators is designed to enable policy makers and service providers to improve the quality of health service provision. Indicators are presented to allow for comparisons between regions, nationally, internationally and over time.
The NHRQS annual report is published by the Department of Health. Five reports have been published to date and the reports have evolved over time, including additional indicators as datasets within the Irish health service mature and become available.
The NHQRS and its governance structure is based in the National Patient Safety Office (NPSO) in the Department for Health. In 2016, a multi-agency committee was re-established to provide oversight and advice on the strategic direction of the NHQRS; to agree the selected indicators in line with international trends and health policy in Ireland; to agree definitions and metadata for the indicators; and to prepare and present an annual report to the Minister for Health.
To safeguard the integrity and validity of the NHQRS, the committee agreed a procedure for the selection of new indicators for inclusion in the report. In addition, a transparent annual screening exercise facilitates consideration of those indicators to be retained or de-selected in future editions of the NHQRS. This exercise is designed to ensure the validity, timeliness and accuracy of indicator data and allow for the identification of gaps to ensure that the NHQRS reflects developments in our health system over time. In addition, each year all indicators are evaluated for the quality of the data available. This evaluation process is informed by HIQA's Guidance on a data quality framework for health and social care.
NHQRS indicators are generally high-level measurements relating to healthcare system performance, which can provide information on population health overall rather than on specific outcomes for individual patients. The NHQRS does not currently, as the Deputy noted, report on adverse outcomes specific to medication used in the provision of termination of pregnancy services. The inclusion of any new indicator is considered by the multi-agency committee using a standardised process which examines the evidence regarding international trends, health policy in Ireland and availability of robust data.
745. Deputy Éamon Ó Cuív asked the Minister for Health when CAR T-cell therapy will be available here; when he expects it will be approved for reimbursement; the arrangements that are currently being worked on in relation to facilities for the therapy; and if he will make a statement on the matter. [28766/20]
View answerThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
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 HSE advised that on 18 September 2018, it received an application for pricing and reimbursement of tisagenlecleucel (Kymriah®) for both its licensed indications:
- for the treatment of paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (pALL) that is refractory, in relapse post-transplant or in second or later relapse; and
- for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Following the NCPE’s completion of Rapid Reviews for both of these indications, on 22 October 2018, the HSE commissioned full HTAs for both indications.
On 27 August 2019, the NCPE’s HTA report for the pALL indication was received by the HSE The NCPE recommended that tisagenlecleucel not be reimbursed for pALL unless cost-effectiveness could be improved relative to existing treatments
On 20 September 2019, the NCPE HTA report for the DLBCL indication was received by the HSE. The NCPE recommended that Tisagenlecleucel not be reimbursed for DLBCL unless cost-effectiveness could be improved relative to existing treatments. The HSE has confirmed that it engaged in commercial negotiations concerning Tisagenlecleucel with the applicant.
The HSE also advised that it received an application on 6 September 2018 for the pricing and reimbursement of axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Following the NCPE’s completion of a Rapid Review with respect to this indication, on 22 October 2018, the HSE commissioned a full HTA.
On 25 February 2020, The NCPE’s HTA report was received by the HSE. The NCPE recommended that axicabtagene ciloleucel not be reimbursed unless cost-effectiveness can be improved relative to existing treatments. Subsequently, the HSE engaged in commercial negotiations concerning axicabtagene ciloleucel with the applicant.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. In October 2020, these three indications are expected to be included on the agenda of the next HSE Drugs Group meeting.
The decision-making authority in the HSE is the HSE Executive Management Team (EMT). These three indications remain under consideration with the HSE, in line with the 2013 Health Act.
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. Both CAR-T therapies described above were licensed as medicines by the EU in 2018. Although licensed as medicines 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 which have been assessed and accredited from a quality control and a process management perspective. The designated site would not manufacture the CAR-T, which is a separate process that occurs off-site.
The NCCP have designated the National Stem Cell Transplantation (SCT) unit at St James’s Hospital (SJH) and the Haemopoetic Stem Cell Transplant (HSCT) unit at Children’s Health Ireland (CHI) Crumlin as the initial sites to develop/deliver this service for adult and paediatric patients on the island of Ireland.
The companies providing the licensed CAR-T products require hospitals to be technically ready to provide these products through an established CAR-T service. Each of the designated hospitals has completed a gap analysis, considering these technical readiness requirements and the service requirements and have identified areas where investment is required.
746. Deputy Jackie Cahill asked the Minister for Health the reason the State Claims Agency is opposing claims by those who allege they have developed narcolepsy as a result of a faulty batch of the swine flu vaccine in view of the fact that the claims are supported by medical proof; and if he will make a statement on the matter. [28772/20]
View answerThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. The management of cases taken by persons who allege they developed Narcolepsy and/or Cataplexy as a result of receiving the H1N1 vaccine, Pandemrix, is delegated to SCA and, as such, the Government has no role in determining how these cases are conducted. I understand that it is the Agency’s preference to resolve claims using mediation where possible.
Separately, an Expert Group was established by the Government in June 2018, chaired by Mr Justice Charles Meenan, to examine the law in relation to personal injuries arising in the healthcare context and to explore alternative mechanisms by which claims could be managed more effectively, particularly from the perspective of the person on whose behalf a claim has been made. A report from this Expert Group was received by the Minister for Health and the Minister for Justice earlier this year, and I am considering how best to act on this report - I intend to bring forward a number of reforms that are recommended.
747. Deputy Jackie Cahill asked the Minister for Health the reason the first narcolepsy case related to a claimed bad batch of the swine flu vaccine to go to trial was not settled before an estimated €10 million was spent on the case approximately three weeks after going to trial; and if he will make a statement on the matter. [28773/20]
View answerThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. The management of cases taken by persons who allege they developed Narcolepsy and/or Cataplexy as a result of receiving the H1N1 vaccine, Pandemrix, is delegated to SCA and, as such, the Government has no role in determining how these cases are conducted. I understand that it is the Agency’s preference to resolve claims using mediation where possible.
Separately, an Expert Group was established by the Government in June 2018, chaired by Mr Justice Charles Meenan, to examine the law in relation to personal injuries arising in the healthcare context and to explore alternative mechanisms by which claims could be managed more effectively, particularly from the perspective of the person on whose behalf a claim has been made. A report from this Expert Group was received by the Minister for Health and the Minister for Justice earlier this year, and I am considering how best to act on this report - I intend to bring forward a number of reforms that are recommended.
748. Deputy Jackie Cahill asked the Minister for Health the reason over 90 cases have been taken by individuals who claim they have developed narcolepsy as a result of a faulty batch of the swine flu vaccine are being taken to trial instead of mediation; and if he will make a statement on the matter. [28774/20]
View answerThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. The management of cases taken by persons who allege they developed Narcolepsy and/or Cataplexy as a result of receiving the H1N1 vaccine, Pandemrix, is delegated to SCA and, as such, the Government has no role in determining how these cases are conducted. I understand that it is the Agency’s preference to resolve claims using mediation where possible, and that that has been offered in these cases.
Separately, an Expert Group was established by the Government in June 2018, chaired by Mr Justice Charles Meenan, to examine the law in relation to personal injuries arising in the healthcare context and to explore alternative mechanisms by which claims could be managed more effectively, particularly from the perspective of the person on whose behalf a claim has been made. A report from this Expert Group was received by the Minister for Health and the Minister for Justice earlier this year, and I am considering how best to act on this report - I intend to bring forward a number of reforms that are recommended.
749. Deputy Peadar Tóibín asked the Minister for Health the terms of reference of the National Public Health Emergency Team. [28778/20]
View answerThe Deputy is advised that the Terms of Reference of the National Public Health Emergency Team (NPHET) have been published on the website of the Department of Health. A link to the relevant page is attached below for ease of reference:
www.gov.ie/en/collection/691330-national-public-health-emergency-team-covid-19-coronavirus/.
751. Deputy Catherine Murphy asked the Minister for Health the status of the distribution of PPE to dentists. [28780/20]
View answerI am aware of the difficulties that the current Covid-19 pandemic poses for the dental profession. My Department has worked with the Health Protection Surveillance Centre (HPSC) to provide guidance to allow for the resumption of the safe provision of routine care. My Department, in conjunction with the HSE, is examining the issue of the provision of PPE across all parts of the health service, including health service contractors.
The HPSC advises that regular PPE, which has always been used, is generally sufficient for routine dentistry. This is supported by the Dental Council which has indicated that dentists must take a case by case assessment when deciding if additional PPE is warranted.
752. Deputy Paul Murphy asked the Minister for Health if a provision can be made in relation to the case of persons (details supplied) [28786/20]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
