Written Answers Nos. 594-606
595. Deputy Cathal Crowe asked the Minister for Health if he will outline the timeline for the implementation of the European Reference Networks standards for ensuring data from all health settings is captured with regard to rare disease, i.e., community healthcare up to hospital settings. [2495/24]
View answerAs the matter raised is a service delivery matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
596. Deputy Róisín Shortall asked the Minister for Health if his Department or any of the other relevant bodies will issue a formal authoritative request to a representative body to issue a notification to its members regarding the recall of products (details supplied); the reason this has not been done; and if he will make a statement on the matter. [2515/24]
View answerI am informed that the Food Safety Authority of Ireland (FSAI) published an alert of the recall of two Nutramigen products on the afternoon of Tuesday, 2nd January. On the same afternoon, FSAI informed the National Health Protection Office of its intention to issue this food alert relating to possible contamination by Cronobacter sakazakii of these two powdered infant formula products.
The FSAI alert was updated on Thursday, 4th January with further information. Both the original and updated alerts were published on the FSAI website, through social media platforms and notified to those consumers who have subscribed to receive food alerts from FSAI. The alerts also received coverage in local and national print media.
Nutramigen is a hypoallergenic powdered infant formula for small infants classed as “Food for Special Medical Purposes”. It is given on medical advice but is not a Prescription Only Medicine (POM), so it was possible for the general public to purchase this product in pharmacies.
I am informed that the FSAI called an Incident Management Team (IMT) meeting on Thursday, 4th January, with the National Health Protection Office (NHPO). At this meeting the issue of communications was thoroughly explored. Following consideration, it was decided not to issue a public alert from the HSE.
Immediately following the IMT meeting, the NHPO carefully considered alerting GPs. However, following discussion between HPSC and the Irish College of General Practitioners (ICGP), the NHPO found it was apparent that a high degree of penetration of the alert message to the professionals with greatest contact with parents of children likely to be taking this infant formula had been achieved. The NHPO concluded that a general GP alert would have been unlikely to have been an effective, or efficient way to rapidly mitigate risk, when there were more appropriate and rapid risk communication routes available, especially as the recall was rapidly issued by the FSAI.
597. Deputy Michael Healy-Rae asked the Minister for Health the status of funding for a person (details supplied); and if he will make a statement on the matter. [2537/24]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday, 6 October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE
598. Deputy Jim O'Callaghan asked the Minister for Health whether the former Baggot Street Hospital could be used as a State owned nursing home for elderly people in the vicinity; and if he will make a statement on the matter. [2544/24]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday, 6 October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE
599. Deputy Michael Healy-Rae asked the Minister for Health to provide an update on the case of a person (details supplied); and if he will make a statement on the matter. [2549/24]
View answerI wish to advise the Deputy that this is a matter for the Department of Education.
600. Deputy Niall Collins asked the Minister for Health if there are plans to approve skyclarys (omaveloxolone) for Friedreich's ataxia; and if he will make a statement on the matter. [2552/24]
View answerOn 14 December 2023, the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Skyclarys 50mg Capsules, intended for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. The Applicant for this medicinal product is Reata Ireland Limited.
The active substance of Skyclarys is omaveloxolone. Omaveloxolone activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway which is involved in the cellular response to oxidative stress. The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown, but as Nrf2 activity is reduced in patients with Friedreich's ataxia, Nrf2 activators may be involved.
The benefit of Skyclarys is an improvement in the mFARS (modified FA rating scale) score measuring disease progression, as compared with a placebo control in a randomised clinical trial. The most common side effects are increased ALT and AST, decreased weight and appetite, nausea, vomiting, diarrhoea, headache, fatigue, oropharyngeal and back pain, muscle spasms, and influenza.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available on the EMA’s website after the marketing authorisation has been granted by the European Commission. This normally occurs within 2-3 months after a positive CHMP opinion.
It is not known at present if the company has applied for pricing and reimbursement in Ireland or if / when they plan to launch this medicine in Ireland.
601. Deputy Michael Healy-Rae asked the Minister for Health if a commitment will be given by the HSE for the key requirements that were committed to within the SIA report to be fully and immediately funded for services (details supplied); and if he will make a statement on the matter. [2590/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday, 6 October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
602. Deputy Pearse Doherty asked the Minister for Health if a person (details supplied) in County Donegal can be allocated a GP; and if he will make a statement on the matter. [2592/24]
View answerGPs are private practitioners, most of whom hold a GMS contract with the HSE for the provision of medical services without charge to medical card and GP visit card holders.
Where a GMS patient, a person that holds a medical card or GP visit card, experiences difficulty in finding a GP to accept them as a patient, the person concerned having unsuccessfully applied to at least three GPs in the area (or fewer if there are fewer GPs in the area) can apply to the HSE National Medical Card Unit which has the power to assign a GMS patient to a GP's GMS patient list, in accordance with the GMS contract.
Furthermore, GMS patients who are assigned to a GP's GMS panel and wish to change their GMS GP can do so via the “Change of GP form” available from the HSE website. The GMS scheme operates under a choice of doctor principle, meaning that patients who hold a medical or GP visit card have the freedom to choose their GP, or move from one GP to another, provided the new GP is willing to accept the patient to their panel, and that the GP concerned holds a GMS contract.
People who do not hold a medical card or GP visit card access GP services on a private basis and can make enquiries directly to any GP practice they wish to register with. As private practitioners, it is a matter for each individual GP to decide whether to accept additional private patients. Neither my department nor the HSE have any role in assigning patients who do not hold a medical card or a GP visit card to a GP's patient list.
603. Deputy Pearse Doherty asked the Minister for Health if he is aware that the only child and adolescent counselling service in Donegal is to close in March; if he is aware of how important this facility is for young people in Donegal; if his Department will make up the shortfall in funding; and if he will make a statement on the matter. [2593/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday, 6 October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
604. Deputy Michael Healy-Rae asked the Minister for Health the status of an appointment for a person (details supplied); and if he will make a statement on the matter. [2594/24]
View answerUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
605. Deputy Pa Daly asked the Minister for Health if repairs will be expedited on hearing aids for a person (details supplied) given the circumstances; and if he will make a statement on the matter. [2602/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
606. Deputy Marc Ó Cathasaigh asked the Minister for Health the level of collaboration between his Department and the HSE to streamline the process whereby aids and appliances provided through HSE resource allocation groups for children with disabilities in order to avoid and remove barriers as outlined in the case of a child (details supplied), to ensure they have timely access to mobility aids to optimise their and their family’s independence; and if he will make a statement on the matter. [2611/24]
View answerThe Health Service Executive (HSE) provides a wide range of medical and surgical aids and appliances, free of charge to eligible persons following assessment by a relevant health professional. These are provided through community services known as Community Funded Schemes and play a key role in assisting and supporting people to maintain everyday functioning, and to remain living in their homes and local community.Each Community Health Organisation (CHO) operates processes for the allocation of funding for medical and surgical aids and appliances. Each application within a CHO is assessed by the local Resource Allocation Group and a determination is made regarding approval based on clinical priority and the funding availability within local budgets.
At times, due to the demand for resources exceeding the available capacity, waiting lists may apply for some categories of items provided through the medical and surgical aids and appliances budget in a particular CHO. Waiting times also vary depending on the priority rating which is made by healthcare professionals based on clinical risk. Priority is given to clients with the greatest level of clinical need.
The effects of Brexit, global supply chains issues, and the rise in energy costs have unfortunately further impacted the sourcing of some aids and appliances. However, CHOs do undertake a range of initiatives to ensure optimum use of resources, for example, through the efficient recycling of stock items such as wheelchairs and walking aids. CHOs endeavour to provide medical and surgical aids and appliances in accordance with clinical priorities and subject to budgetary and supply constraints.
Following engagement with the Department, the HSE have outlined that no child should wait more than 3 weeks for approval of funding for an Aid or Appliance, upon receipt of a relevant healthcare prescription. This includes replacement appliances where there is an on-going need for the growing child, or appliance deterioration. The only delay children should experience is manufacturer timeline from order to delivery, ensuring a consistent and equitable service. CHOs are currently working to implement this change and dedicated funding has been allocated to support it.
The HSE’s National Service Improvement Programme for the Community Funded Schemes has been working on the development of standard operating procedures and guidelines with the aim of ensuring value for money, equity of access, and a management system that ensures compliance with those guidelines. The scale of this Programme is enormous given that many thousands of items are provided from community-based services across the country.
In respect of the aids and appliances stream, the category lists are completed, category specific information for prescribers is complete and the contracts for items under aids and appliances are in place. The lists and associated prescribing information have been communicated to CHOs and local health care workers. This should improve the equity of access to appropriate aids and appliances, following assessment, for all eligible persons, but especially for children with disabilities who need them.
In regard to the service matter raised, I have asked the HSE to respond to the Deputy directly, as soon as possible.
