Written Answers Nos. 715-731
715. Deputy Thomas Pringle asked the Minister for Health when he will introduce the safe access zone legislation in order that women availing of legal services can do so in peace; and if he will make a statement on the matter. [29664/23]
View answerI am committed to ensuring that anyone seeking a termination of pregnancy can access services in safety and with privacy & dignity. To this end I secured cabinet approval to legislate for the designation of safe access zones around healthcare premises to safeguard access to termination of pregnancy services on the 27 July 2022.
Since that time, officials from my Department have worked with the Office of the Attorney General, and other relevant stakeholders, to draft the text of the bill. This legislation is currently being finalised and will be progressed through the Houses in the coming weeks.
717. Deputy Róisín Shortall asked the Minister for Health if his attention has been brought to a campaign by an organisation (details supplied) calling for a national strategy for haemochromatosis to be developed in Ireland; his views on same; if he will commit to developing a national strategy; and if he will make a statement on the matter. [29690/23]
View answerHereditary Haemochromatosis (HH) is a common autosomal recessive disease resulting in over absorption of iron from the gastrointestinal tract. Over time, excess iron accumulates in cells of organs including the liver, pancreas and heart causing damage. Research into the condition by the HSE found that 1 in 83 people are genetically predisposed to develop HH in this country.
I am aware of the advocacy work of the Irish Haemochromatosis Association in this area and I am in favour of a cohesive, multifaceted approach to the treatment of this disease utilising different areas of our health service in order to provide the required treatment patients need.
During my appearance before the Joint Committee on Health on 26 April this year, it was requested that a contact person be appointed for engagement with patient groups on Hereditary Haemochromatosis. In response, HSE Chief Clinical Officer, Dr Colm Henry, agreed to meet with Haemochromatosis Patient representatives on these issues.
The HSE has previously undertaken two Model of Care reviews on Hereditary Haemochromatosis and Therapeutic Phlebotomy for Patients with Hereditary Haemochromatosis. The diagnosis, treatment and management of patients living with HH is guided by these reviews as well as the Irish College of General Practitioners’ (ICGP) ‘Hereditary Haemochromatosis- Diagnosis and Management from a GP Perspective’ guidance document.
The ICGP has been very active regarding the diagnosis and treatment of HH for many years. In addition to producing its own guidance document for the disease, HH is also specifically referenced in the Curriculum for GP training (2020). The upcoming appointment of 9 new Advanced Nurse Practitioners for the liver services nationally is also expected to help with the diagnosis and management of HH patients.
The treatment for the management of HH is regular venesections, which involves the patient having their blood taken and monitoring of bloods. The Department of Health and HSE agree that such services should be provided at the lowest level of complexity that is clinically and operationally feasible. Venesections are typically performed via a wide variety of services in Ireland including GPs, nurse-led clinics within hospitals, in outpatient departments, via private services, or at an IBTS facility.
In May 2019, agreement was reached with the IMO on a major package of GP contractual reforms and service developments which will benefit patients and GPs. As part of this agreement, and since the beginning of 2020, GPs are paid by the HSE to provide venesection for GMS patients, those who hold a medical card or GP visit card, with haemochromatosis. GMS patients with this condition can now be managed locally by their GP and may no longer have to attend hospitals for therapeutic phlebotomy.
I am aware that for many patients, treatment is still provided in hospital as an out-patient or day case. The Health (Amendment) Act 2023, which came into effect on 17 April 2023, removes the acute public in-patient charge of €80 per day for people, benefiting HH patients who attend hospital for their treatment.
The Irish Blood Transfusion Service accepts HH patients who are eligible to donate blood at their fixed and mobile donation clinics nationwide. Patients can attend, free of charge, a maximum of four times a year with a minimum of ninety days between phlebotomies. Eligible patients continue to have their condition managed by their GP, including the monitoring of ferritin levels.
Early diagnosis and subsequent management of HH is essential to prevent organ damage and normalise life expectancy. The current model of care in Ireland recommends that genetic testing should only be performed in those with a raised transferring saturation or if there is a family history of the disease. Any decisions about changes to our national screening programmes, or the introduction of new programmes, such as screening for HH, will be made on the advice of our National Screening Advisory Committee (NSAC).
The NSAC is an independent, expert committee that makes recommendations to the Minister and the Department of Health on population screening in Ireland. The Committee's Annual Call 2022 for proposals for new screening programmes or changes to our existing programmes, received a total of 19 submissions, which included a submission on Genetic/Hereditary Haemochromatosis.
This proposal, along with proposals relating to several other conditions, is currently under consideration by NSAC. The Committee has published its Work Programme on its website, setting out the status of proposals currently being considered.
Any screening programme undertaken for Haemochromatosis would involve a public awareness campaign for the purposes of providing information regarding the symptoms of haemochromatosis, this would be an essential component of such a programme.
718. Deputy Fergus O'Dowd asked the Minister for Health further to Parliamentary Question No. 1312 of 13 June 2023 and as per original question, if he will answer the question on whether "this clear neglect of a vulnerable adult was referred to the gardaí by any the services involved."; and if he will make a statement on the matter. [29698/23]
View answerI have not been made aware of any referral of the nature referred to by the Deputy.
I and my Department take the regulation of the quality of care provided in healthcare and social care contexts, and safeguarding against the risk of abuse of vulnerable adults, very seriously. In the health and social care sector various structures and processes, including legislative and policy measures, are available to regulate care services and to protect against abuse and ensure prompt action.
721. Deputy Paul Kehoe asked the Minister for Health what his plans are for a disused building that could be potentially made available for homeless/family/refugee housing (details supplied); and if he will make a statement on the matter. [29714/23]
View answerAs the Health Service Executive is responsible for the management of the public healthcare property estate, I have asked the HSE to respond directly to you in relation to this matter.
722. Deputy Neasa Hourigan asked the Minister for Health if he will provide an update on the application for pricing and reimbursement of (details supplied); and if he will make a statement on the matter. [29728/23]
View answerThe Health Service Executive (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.
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). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.
In terms of the specific details of the application for pricing and reimbursement of Voretigene neparvovec (Luxturna®):
The HSE received an application for pricing / reimbursement of Voretigene neparvovec (Luxturna®) on the 23rd of September 2019 from Novartis for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
• The first step in the process is the submission of a Rapid Review dossier. The HSE commissioned the Rapid Review process on the 24th of September 2019. The NCPE Rapid Review assessment report was received by the HSE on the 23rd of October 2019. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was required for this medicine.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 29th of October 2019 as per agreed processes.
• The NCPE Health Technology Assessment report (www.ncpe.ie/wp-content/uploads/2019/10/Technical-Summary-document-voretigene-neparvovec-Luxturna.pdf) was received by the HSE on the 18th of September 2020. The NCPE recommended that Voretigene neparvovec (Luxturna®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU engaged in commercial negotiations with Novartis in November 2020 and June 2022 regarding their application for Voretigene neparvovec (Luxturna®).
• 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 February 2021 the Drugs Group requested Patient and Clinician Engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE Executive Management Team regarding reimbursement of Voretigene neparvovec (Luxturna®). The Drugs Group specifically requested a prescribing guideline for Voretigene neparvovec (Luxturna®) to inform their deliberations. The prescribing guideline was received on the 19th May 2022. The totality of clinical and economic evidence for Voretigene neparvovec was then comprehensively and extensively reviewed by the Drugs Group at the July 2022 meeting. The Group unanimously recommended in favour of hospital pricing approval of Voretigene neparvovec subject to the establishment of a HSE managed access programme. www.hse.ie/eng/about/who/cpu/drugs-group-minutes/hse-drugs-group-minutes-july-2022.pdf
• The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE EMT supported hospital pricing approval of Voretigene Neparvovec (Luxturna®) for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallellic RPE65 mutations and who have sufficient viable retinal cells, subject to a managed access programme being implemented.
• As a condition of reimbursement, an individual patient approval system will be put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access programme. The processes necessary to implement this required managed access programme (MAP) are currently being developed by the HSE.
The HSE cannot comment on the specific timeline for the HSE approval to be formalised while processes that involve a number of stakeholders and certain service development requirements to implement the managed access programme are ongoing.
724. Deputy Niall Collins asked the Minister for Health if his Department can provide any form of funding, one-off or recurring, to an organisation (details supplied); and if he will make a statement on the matter. [29777/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
725. Deputy Fergus O'Dowd asked the Minister for Health the number of facilities that have closed and ceased operations, by name and location, since the payments were awarded, of the recent TAPS payments of nearly €150 million distributed to nursing homes throughout the country to help manage the response to Covid-19, in tabular form; if any nursing homes voluntarily returned monies to his Department for any reason; and if he will make a statement on the matter. [29782/23]
View answerAs these are operational matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
727. Deputy Neasa Hourigan asked the Minister for Health the number of public representatives who applied to HSE management for consent to make political videos on the grounds of HSE health settings in CHO4 for the years 2020, 2021 and 2022; the names of the HSE representatives who monitored the making of those political videos, as per the HSE communications policy; if applicable, the number of public representatives who made such political videos on HSE grounds without consent and who were later contacted by HSE management in relation to this; and if he will make a statement on the matter. [29790/23]
View answerAs this is a operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
728. Deputy Michael Healy-Rae asked the Minister for Health if SouthDoc services will remain unchanged in the Kerry area (details supplied); and if he will make a statement on the matter. [29813/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
729. Deputy Steven Matthews asked the Minister for Health the position regarding a review of the community ophthalmic services medical treatment scheme; if he will request this process to be expedited in view of ongoing concerns related to reimbursement from medical professionals in this sector; and if he will make a statement on the matter. [29814/23]
View answerThe Community Ophthalmic Services Medical Treatment Scheme (COSMTS) was established in 2004 as a pilot project in response to an identified need. The Scheme engages four practices across seven locations to provide medical and minor surgical care to patients outside of the acute care setting. This allows hospitals and eye clinics to focus on treating more complex conditions. The treatments and the current fees payable under the Scheme were agreed in 2013.
The Health Service Executive (HSE) have advised that a detailed evaluation of the current operation of the COSMTS will need to be carried out before it is extended further. This review remains a priority for my Department in 2023.
To date, my officials have engaged with the HSE to determine how such an evaluative review would best be conducted. My Department continues to pursue this issue with the HSE. The most recent meeting between my officials and their HSE counterparts was yesterday, the 19th of June.
731. Deputy Holly Cairns asked the Minister for Health if he will provide details on how and when public funding for IVF treatment will be distributed; when funding for treatment through the public hospital system will be made available; and if he will make a statement on the matter. [29840/23]
View answerAs the Deputy will be aware, a commitment to “introduce a publicly funded model of care for fertility treatment” is included in the Programme for Government. The Model of Care for Fertility was developed by the Department of Health in conjunction with the HSE’s National Women & Infants Health Programme (NWIHP) in order to ensure that fertility-related issues are addressed through the public health system at the lowest level of clinical intervention necessary. This Model of Care comprises three stages, starting in primary care (i.e., GPs) and extending into secondary care (i.e., Regional Fertility Hubs) and then, where necessary, tertiary care (i.e., IVF (in-vitro fertilisation), ICSI (intra-cytoplasmic sperm injection) and other advanced assisted human reproduction (AHR) treatments), with patients being referred onwards through structured pathways.
Phase One of the roll-out of the Model of Care has involved the establishment, at secondary care level, of Regional Fertility Hubs within maternity networks, in order to facilitate the management of a significant proportion of patients presenting with fertility-related issues at this level of intervention. Patients are referred by their GPs to their local Regional Fertility Hub, which provides a range of treatments and interventions for both males and females, including: relevant blood tests, semen analysis, assessment of tubal patency, hysteroscopy, laparoscopy, fertility-related surgeries, ovulation induction and follicle tracking.
There are currently five out of six Regional Fertility Hubs in service and the completion of Phase One of the roll-out of the Model of Care, envisaged for later this year, will result in fully operational Regional Fertility Hubs at six locations across the country.
Phase Two of the roll-out of the Model of Care will see the introduction of tertiary fertility services, including IVF, provided through the public health system. In this regard, funding was secured in Budget 2023 to support access to advanced AHR treatments, including, crucially, to allow the commencement of Phase Two of the roll-out of the Model of Care.
This investment will facilitate the first steps to be taken towards the provision of a complete publicly-provided fertility service, which is the ultimate objective of Government. In particular, it will allow the historic development of the first National Advanced AHR Centre, delivering IVF and ICSI through a wholly public clinic and is scheduled to open in 2024. Subject to the provision of additional funding in future, it is envisaged that additional National Advanced AHR Centres will be developed and become operational on a phased basis elsewhere in the country.
The 2023 allocation is also being utilised to support the Regional Fertility Hubs in order to expand the scope of services by introducing the provision of IUI (intrauterine insemination), which can, for certain cohorts of patients, be a potentially effective, yet less complex and less intrusive, type of AHR treatment.
Separately, as an interim measure, I have instructed that some funding be made available to support access to advanced AHR treatment via private providers from September 2023.
My officials, in conjunction with NWIHP, are continuing to actively prepare for the operationalisation of both the publicly- and privately- provided service, including finalising access criteria and determining how the interim funding for private treatments will be provided to individual eligible patients. The design and scope of this final phase of the Model of Care for Fertility have not yet been finalised, but I am hopeful to be in a position to provide more specific details shortly.
My Department and the Government is fully committed, through the full implementation of the Model of Care for Fertility, to ensuring that patients always receive care at the appropriate level of clinical intervention and then those requiring, and eligible for, advanced AHR treatment such as IVF will be able to access same through the public health system. The underlying aim of the policy to provide a model of funding for AHR, within the broader new AHR regulatory framework, is to improve accessibility to AHR treatments, while at the same time embedding safe and appropriate clinical practice and ensuring the cost-effective use of public resources.
