Written Answers Nos. 787-802
787. Deputy Colm Burke asked the Minister for Health the number of applications for managed access protocols, MAPs, medicines that have been approved or rejected in the past 24 months; how Ireland compares with other EU member states regarding the rates of approval for medicines covered by MAPs; and if he will make a statement on the matter. [24384/23]
View answerAs the Health Service Executive (HSE) has statutory responsibility for the pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013, I have asked the HSE to respond to the Deputy directly, as soon as possible.
788. Deputy Colm Burke asked the Minister for Health the governance process for deciding on a managed access protocol for a new medicine; the criteria used to inform a managed access protocol; and if he will make a statement on the matter. [24385/23]
View answerAs the Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013, I have asked the HSE to respond to the Deputy directly, as soon as possible.
789. Deputy Colm Burke asked the Minister for Health the access criteria for managed access protocols, MAPs, across all medicines; if he has considered whether there is sufficient transparency of the MAP process for patients and clinicians, particularly with regards to the rejection of applications; if MAPs should be amended if they are found not to be accommodating to clinicians and patients; and if he will make a statement on the matter. [24386/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 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.
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 Medicines Management Programme (MAP) has Managed Access Protocols in place for a number of medicines as part of the reimbursement approval process. MAPs are used to identify patients or subgroups of patients who would most benefit from the specific treatment approved for reimbursement and for whom the clinical evidence of therapeutic benefit is strongest.
Given the HSE's statutory responsibility under the 2013 Act, I have also asked the HSE to respond to the Deputy directly in respect of the access criteria for managed access protocols across all medicines, as soon as possible.
790. Deputy Colm Burke asked the Minister for Health when he will publish the review of cardiac services in Ireland; and if he will make a statement on the matter. [24387/23]
View answerThe National Review of Specialist Cardiac Services (NRCS) commenced in January 2018 under the Chairmanship of Professor Phillip Nolan and a Steering Group formed from nominations of interested stakeholders representing medical, professional/technical staff, nursing and patient representatives.The aim of the NRCS is to recommend configuration for a national adult cardiac service to achieve optimal patient outcomes at population level with particular emphasis on the safety, quality and sustainability of the services that patients receive. This aligns with the Sláintecare reform programme. In terms of scope, the NRCS covers scheduled and unscheduled hospital-based services for the diagnosis and treatment of cardiac disease in adults.
The Review is complete, and the Report is being finalised. The Report will be sent to the Minister for his consideration.
791. Deputy Aengus Ó Snodaigh asked the Minister for Health to provide an update on the issue of nursing staff being removed from a health centre (details supplied); and to provide clarity as to whether nurses will be practicing from the centre or the Armagh Road Primary Care Centre. [24395/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
792. Deputy Paul Murphy asked the Minister for Health if he is aware of the call from Home and Community Care Ireland, HCCI, to ensure that the new home care tender 2023 is not delayed again; if he will fulfil the HCCI request for an urgent meeting with Minsters (details supplied); if the HSE will agree funding for a new rate on tender 2023 that reflects increased costs of care and that allows home care staff to receive a living wage, travel time and mileage costs; and if he will make a statement on the matter. [24422/23]
View answerThe 2018 Tender Framework for the provision of home support services was initially valid for the period 01 September 2018 to 31 December 2020. The HSE extended the framework by two 12-month extensions, to 31 December 2022. This was further extended by the HSE at the end of 2022, initially to the end of April 2023. The HSE has proposed a further extension of the contract arrangements to Friday 30th of June, to allow time to finalise tender arrangements.The process of developing the new tender is at an advanced stage. Officials in the Department of Health are engaging at a senior level with the HSE and the HSE has ongoing engagements with home care providers to progress the new tender. No final decisions on the tender content have been reached. As a strict communication protocol applies in all phases of the procurement process it is not possible to arrange a meeting while the process is ongoing.
In order to examine the significant workforce challenges in the home-support and nursing home sectors in Ireland, Minister Butler established the cross-departmental Strategic Workforce Advisory Group in March 2022. Working closely with key stakeholders, the Advisory Group made 16 recommendations to address the challenges in frontline carer roles in the home support and long-term residential care sectors, including recommendations concerning the living wage and travel time. Progression of these particular recommendations are linked to the outcome of the Tender 2023 process.Minister Butler has endorsed the Advisory Group’s recommendations. Implementation of the recommendations will be overseen by a cross departmental Implementation Group, chaired by the Department of Health. The Department is engaging with recommendation owners to define an implementation plan. A detailed implementation plan will be published containing steps involved in delivering the recommendations in the coming months. It is envisaged that the implementation group will meet quarterly and publish progress reports thereafter.
793. Deputy Mary Lou McDonald asked the Minister for Health to set out the short-term measures in place to address the shortages of Ozempic; the reason for the ongoing shortages; the long-term solutions being put in place to prevent these shortages recurring in the future; and if he will make a statement on the matter. [24437/23]
View answer930. Deputy Cormac Devlin asked the Minister for Health if he will provide an update on the supply of a medication (details supplied); and if he will make a statement on the matter. [24991/23]
View answerI propose to take Questions Nos. 793 and 930 together.
Novo Nordisk, the marketing authorisation holder for Ozempic, has notified the Health Products Regulatory Authority (HPRA) of intermittent supply issues with Ozempic products due to increased global demand. The company anticipates that intermittent supply will continue throughout 2023. Similar supply constraints are being experienced in other EU countries.
Novo Nordisk has implemented monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients. The company has issued letters to relevant stakeholders, including healthcare professionals, to ensure they are aware of this supply issue and its management.
In one such communication to healthcare professionals (dated 24 March 2023), the company stated that Ozempic is only indicated for treating adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Any other use, including for weight management, represents off-label use and currently places the availability of Ozempic for the indicated population at risk. Reimbursement support from the HSE is available for the licensed indication and approved dosage only.
The Department of Health, along with relevant experts from the HSE, HPRA, Pharmaceutical Society of Ireland (PSI) and the Medical Council met recently to review supply issues relating to the GLP-1 agonist, Ozempic. In addition to continuation of efforts to work together during time of limited supply, the group agreed to issue a joint communication to the health system on this situation. This letter issued on 19th May.
794. Deputy Mary Lou McDonald asked the Minister for Health the measures being put in place to address the shortages of 241 medicines, including 13 which are on the World Health Organisation, WHO, critical list; and if he will make a statement on the matter. [24438/23]
View answerAt any given time, shortages of medicines can occur in any country. Increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months.
Ireland experienced some shortages of antibiotics earlier this year – as did most other European countries. The increase in shortage notifications from the pharmaceutical industry in the first quarter of the year was directly related to the increased demand due to the winter surge.
There has been reduction in notifications since this time, coinciding with a stabilisation in the supply, for example, with paediatric antibiotics. Shortages have not disappeared, but there are factors, such as the winter surge, that can put additional pressure on a health system and on medicine supply. It will take time for supply chains to stabilise following this period of excess demand.
In Ireland, whilst individual brands or strengths of a medication may be temporarily unavailable, for the vast majority of medicines supplied in Ireland, there are alternatives, such as different strengths, brands or similar classes, to ensure continuity of care.
Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The medicine shortage framework aims to prevent, where possible, and mitigate the impact of medicines shortages. The framework allows for shortages to be carefully managed by the HPRA in close collaboration with the Department, the HSE, industry and healthcare professionals. The HPRA maintains regular contact with the Department of Health regarding medicines shortages.
The HPRA publishes a list of medicines currently in short supply on its website, at www.hpra.ie, with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information to hand.
Regarding the WHO list of essential medicines, this is a general list aimed at, in the main, developing countries. For example, the list includes treatments for African trypanosomiasis, snake anti-venom and non-medicinal products, such as condoms. It is not a comprehensive list of medicines critical for Irish citizens.
795. Deputy Mary Lou McDonald asked the Minister for Health to elaborate on the media comments made by his Department regarding the Government's consideration of the introduction of a serious shortage protocol, SSP; and if he will make a statement on the matter. [24439/23]
View answerIn other jurisdictions outside of Ireland Serious Shortages Protocols (SSP) are used to facilitate community pharmacists to supply either an alternative quantity, strength, pharmaceutical form, or medicine. Legislation in Ireland already allows for generic substitution (alterative strengths, quantity and forms) but does not allow for therapeutic substitution.
Shortages protocols are product specific and are only used in very limited situations. For example, in the UK every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and raise any potential safety concerns, and Ministerial authorisation is necessary to give effect to the protocol. Each SSP is time limited.
The Department of Health is scoping the introduction of a similar framework, a limited stock supply framework (LSS) in Ireland which will only be used in certain emergency situations such as shortages. This is the case in all other countries that have a protocol in place. Legislative amendments will be required.
There are risks associated for both the pharmacist and patient with substituting prescriptions and the Department will need to be satisfied that these risks are addressed which will impact the timeframe for implementation. An initial proposal on implementation of this policy option is complete and work to develop the governance, legal, training and patient safety aspects of this proposal will be completed this year. The Department will engage with key stakeholders as this policy is developed.
796. Deputy Louise O'Reilly asked the Minister for Health if he will provide information on the financial supports being made annually to support breastfeeding in hospitals; if he will provide information on the financial supports being made annually to support breastfeeding in the community; and if he will make a statement on the matter. [24496/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
797. Deputy Louise O'Reilly asked the Minister for Health if he will provide details of the HSE business case put forward in respect of breastfeeding supports, including but not limited to lactation consultants; and if he will make a statement on the matter. [24497/23]
View answerEncouraging mothers to breastfeed is a priority for the Department of Health. National health policy, including the Healthy Ireland Framework, the National Maternity Strategy, the Obesity Policy and Action Plan, and the National Cancer Strategy, emphasises the importance of supporting mothers who breastfeed, as well as taking action to increase breastfeeding rates in Ireland.
It is important that children get the best possible start in life, and this is something all Government partners have prioritised in the Programme for Government.
The HSE Breastfeeding in a Healthy Ireland Action Plan is the framework for progressing supports for breastfeeding in Ireland. Since its publication, the Department of Health has funded the HSE to establish the role of National Breastfeeding co-ordinator. The National Breastfeeding Implementation Group partner with the Department of Health and key divisions within the HSE to progress a range of actions.
Following detailed engagement between the Department of Health and the HSE to identify additional service needs, the Minister for Health, Stephen Donnelly, TD announced additional funding to the HSE of €1.58 million to fund 24 additional Lactation Consultants in May 2021, thereby providing support to every maternity unit in the country.
Currently 54 staff are in Infant feeding/lactation positions, with 35.5 working in maternity services and 18.5 in primary care. There are an additional four posts that are actively being recruited.
The HSE provide and fund voluntary breastfeeding organisations to provide community- based supports throughout the country. There are approximately 110 breastfeeding services available nationwide. The mychild.ie website is an online resource designed by practitioners within the HSE, which provides information to parents-to-be and parents of young children. The mychild.ie website covers pregnancy, labour and birth, babies and toddlers and provides material on every aspect of breastfeeding.
798. Deputy Pauline Tully asked the Minister for Health the number of Child and Adolescent Mental Health Services, CAMHS, mental health intellectual disability teams that are currently in operation; the staffing levels within CAMHS mental health intellectual disability teams; and if he will make a statement on the matter. [24499/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
799. Deputy Rose Conway-Walsh asked the Minister for Health if he will provide a list of all external assurance process reviews tendered for to date; the value of the contract; and the name of the successful company, in tabular form. [24508/23]
View answerIn 2021, Department of Public Expenditure, NDP Delivery and Reform (D/PENDPDR) Circular 25/2021 introduced the External Assurance Process (EAP) making it a mandatory requirement for Exchequer-funded projects with an estimated capital cost in excess of €100 million. The independent scrutiny processes for major capital projects was established to ensure appropriate project preparation, to further strengthen project management, and ultimately improve project outcomes.
For the External Assurance Process, D/PENDPDR established a single lot, multi-supplier framework from which funding Departments can source the independent reviewers to conduct the reviews.
In March 2023, the Minister for Public Expenditure, National Development Plan (NDP) Delivery and Reform informed Government of changes to the capital appraisal guidelines as part of package of significant actions aimed at enhancing delivery of the NDP. Among other things, this increased the thresholds for the classification of major projects at which full Public Spending Code (PSC) scrutiny is required and reduced the number of steps for proposals to travel through before approval to proceed.
The EAP remains a requirement for major projects in excess of €200 million, at Decision Gate 1 - Approval in Principle of the updated PSC, prior to seeking Government consent following the approval of the Approving Authority.
Two EAP reviews have been tendered to date by the Department of Health (details below):
|
Contract Title |
External Assurance and Review Process for proposed Elective Care Centre's in Cork and Galway* |
|
Contractor Name |
Archus |
|
Value of contract (excl VAT)(This is the overall value of the contract including any costs associated with the option to extend the contract) |
€113,286 |
|
Date contract awarded |
27/06/2022 |
*a combined tender process was held for both individual projects
|
Contract Title |
Consultancy to review the business case documentation for the relocation of the National Maternity Hospital (NMH) to the St Vincent’s University Hospital (SVUH) campus at Elm Park |
|
Contractor Name |
PricewaterhouseCoopers |
|
Value of contract (excl VAT)(This is the overall value of the contract including any costs associated with the option to extend the contract) |
€79,950 |
|
Date contract awarded |
22/06/2022 |
800. Deputy Neasa Hourigan asked the Minister for Health if he will set out in tabular form the number of full-time posts and the number of part-time posts currently funded and staffed for non-clinical data management across genetic and rare disease services in the HSE. [24531/23]
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.
801. Deputy Neasa Hourigan asked the Minister for Health if he will outline the current dedicated funding to support clinical leads in European Reference Networks on Rare Diseases in their engagement with European partners in the provision of services (outside of research funds, given the network is not a research network); and if he will make a statement on the matter. [24532/23]
View answerEuropean Reference Networks (ERNs) are virtual networks involving healthcare providers across Europe established in line with Article 12 of EC Directive 2011/24/EU (Cross-Border Care Directive). They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources.
Ireland has membership to 18 European Reference Networks (ERNs) on Rare Diseases out of 24. These ERNs include representation from five academic hospitals and three universities and is coordinated by the National Rare Diseases Office. This represents a significant achievement by the health service, to drive innovation, training and clinical research for highly specialised care. Through the European Reference Networks, the National Rare Diseases Office is leading out on the development of optimal care pathways across a range of rare diseases.
The Minister for Health has recently announced a plan to develop a revised National Rare Disease Plan, in line with the commitment in the Programme for Government. Initial work for the new plan has begun, and due consideration is being given to the required funding.
Last year the HSE was nominated as the National Competent Authority in an EU Joint Action of European Reference Networks for Rare Diseases, which enables greater coordination and sharing of best practices in key areas such as genetic testing.
The government has also substantially increased funding for new innovative medicines for rare diseases, investing €100 million over the last three Budgets. During this time, more than 100 new medicines have been approved, including 39 orphan medicines to treat rare diseases.
In 2023, the government has committed €2.7 million to support the implementation of the National Strategy for Accelerating Genetics and Genomics Medicine in Ireland. The Department has also progressed Irish entry into Horizon Europe Partnerships on Rare Disease and Personalised Medicine.
Participation in ERNs and Horizon Europe Partnerships ensure greater coordination and sharing of best practices in key areas such as genetic testing with European partners.
802. Deputy Neasa Hourigan asked the Minister for Health the total amount spent by the HSE on legal fees in each of the years 2019, 2020, 2021 and 2022 involving the defence of Grievance and or Dignity At Work cases or advice on such cases taken by HSE employees against HSE managers; and if he will make a statement on the matter. [24533/23]
View answerI have asked the HSE to respond directly to the Deputy on this matter.
