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Wednesday, 1 Feb 2023

Written Answers Nos. 242-261

Health Services Staff

Ceisteanna (242)

Christopher O'Sullivan

Ceist:

242. Deputy Christopher O'Sullivan asked the Minister for Health the number of lactation consultants that will be appointed in CHO4 in 2023; and if he will make a statement on the matter. [4977/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy, as soon as possible.

Health Services Staff

Ceisteanna (243)

Christopher O'Sullivan

Ceist:

243. Deputy Christopher O'Sullivan asked the Minister for Health the number of lactation consultants that will be appointed in Bandon, Kinsale, and Carrigaline networks of network 13 in 2023; and if he will make a statement on the matter. [4978/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy, as soon as possible.

Health Services Staff

Ceisteanna (244)

Christopher O'Sullivan

Ceist:

244. Deputy Christopher O'Sullivan asked the Minister for Health if the HSE will separate out the public health nurse role in order that public health nurses can have a choice between working with children and babies (child welfare clinics) or the elderly; and if he will make a statement on the matter. [4980/23]

Amharc ar fhreagra

Freagraí scríofa

A Registered Public Health Nurse ( PHN) is licensed under regulation to provide care in the community setting, supporting patient groups ranging from new-born to those who require end of life care.  The PHN role in Ireland encompasses health promotion, disease prevention, screening and nursing care. 

The issue of offering any group of staff a choice as to their preferred area to work in is a Human Resources /staff deployment matter inextricably linked to organising and managing the particular health service in question. Therefore, any such proposal would require careful consideration, including consideration of the potential impacts on both the service being provided currently and overall staffing deployment in the wider context.

As the specific issue raised by the Deputy refers to the operational responsibilities of the HSE, I have referred the matter to the HSE for its attention and direct response to him.

Health Services Staff

Ceisteanna (245)

Christopher O'Sullivan

Ceist:

245. Deputy Christopher O'Sullivan asked the Minister for Health if there will be any specialist posts created in community healthcare under the field of maternity care, including anti-natal education, anti-natal clinics, post-natal care and mother and babies, and so on; and if he will make a statement on the matter. [4981/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Medicinal Products

Ceisteanna (246, 247)

David Cullinane

Ceist:

246. Deputy David Cullinane asked the Minister for Health when he expects the ongoing medicine shortages problem to end; and if he will make a statement on the matter. [4991/23]

Amharc ar fhreagra

David Cullinane

Ceist:

247. Deputy David Cullinane asked the Minister for Health if he expects the medicine shortages problem and record levels of out-of-stock medicines to end after the winter flu season; and if he will make a statement on the matter. [4992/23]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 246 and 247 together.

Medicine shortages have become increasingly prevalent worldwide over the past decade. The causes of such shortages are multi-factorial, including shortages of raw materials, manufacturing difficulties, increased demand, product recalls due to potential quality defects, and industry consolidations. As such, medicine shortages can originate at any point in the supply chain, at any stage.

Medicine shortages and their prevention are not unique to Ireland. Similar increases in demand and medicines shortages have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland however, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every product.

The Health Products Regulatory Authority (HPRA) publishes a list of medicines currently in short supply on its website with the reason for the shortage and expected dates for the return of supply. This information is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.

The list of shortages (which is continuously updated) is publicly available and can be found here: www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages

The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The HPRA continues to work with all marketing authorisation holders to increase supply to the market. They also continue to offer regulatory flexibility where possible to suppliers. Through this close engagement the HPRA has secured additional stock of many products currently in short supply for the Irish market.

Question No. 247 answered with Question No. 246.

Medicinal Products

Ceisteanna (248)

David Cullinane

Ceist:

248. Deputy David Cullinane asked the Minister for Health if, given research showing medicine manufacturers in Ireland are getting paid up to four times as much for their products in the UK and seven other EU member states, he accepts that price is one of the factors contributing to the ongoing high level of medicine shortages. [4993/23]

Amharc ar fhreagra

Freagraí scríofa

Two new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years. 

Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020. 

The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland. 

There are a number of clauses set out in both agreements in detail, which provide clear pricing rules for applicant companies, that have been agreed between the State and main Pharmaceutical Industry representative groups in Ireland as appropriate and intended to provide a predictable environment for Marketing Authorisation Holders (MAHs) to supply their products (and prevent shortages). These are grossly summarised as:

The pricing application form for new medicines is based on a basket of 14 countries (13 EU Member States and the UK). Pricing is permitted to be no more than the average price based on the pricing in these 14 countries.

The pricing of non-patented medicines (i.e., generic, biosimilar or hybrid medicine marketed in Ireland) is based on the originator medicine at a specific time point.

Under the terms of the agreement, there is scope for the Department of Health, the HSE, and industry to continue to maintain their engagement throughout the lifetime of the agreement on all matters pertaining to the agreement.

In the interests of continuity of supply, where it becomes uneconomic for a Supplier to supply a particular medicine under the terms of the Agreements, direct representations may be made by the Supplier to the HSE for variation of any term of the Agreement, in relation to that medicine, including its price terms. Where representations are made by the Supplier to the HSE, the HSE shall have the final decision on whether to vary the terms of the Agreement in any case, but will consult with the Supplier before reaching its decision. The HSE expects a robust submission of evidence to support any claim, from any Supplier, in the event that they wish to set out to the Executive an inability to meet pricing terms set out in said Agreements.

As of January 2023, there are 9 applications from 6 separate manufacturers/suppliers currently under review by the HSE, for a pricing increase request related to a claim of increased cost of goods making continuity of supply to the Irish market and Irish patients unsustainable.

In the case of such pricing increase requests the time taken to adjudicate on these is highly variable (on a case-by-case basis) and dependent on a number of factors, that the HSE is required to consider including the number of alternative suppliers for that medicine, the potential alternative therapeutic options, the clinical need for the product, the potential budget impact, and European pricing.

The HSE also takes an active role at the time of notification, in engaging with manufacturers/suppliers intending to discontinue priority medicines due to the lack of commercial viability of those products. In many of the cases where this arises as a scenario, the commercial decision relates to global discontinuations and is outside of the control of the HSE i.e., cannot be addressed through pricing increases at a national level.

The Agreements are the product of extensive collaboration between the State, HSE, and Industry. They remain current and appropriate for their purpose since their signing in December 2021.

Medicinal Products

Ceisteanna (249)

David Cullinane

Ceist:

249. Deputy David Cullinane asked the Minister for Health if, in light of comments from the executive director of the European Medicines Agency stating that the very low price of generic medicines threatens the sustainability of supply of medicines, he will now move to initiate a full review of the 2019 medicines pricing agreements. [4994/23]

Amharc ar fhreagra

Freagraí scríofa

Medicine supply issues and their prevention are not unique to Ireland. Similar increases in demand and medicines supply issues have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every single product.

Management of medicine supply issues necessitates a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. To that end, at the request of the Department of Health, the Health Products Regulatory Authority (HPRA) has assumed a coordinating function in Ireland’s response to managing medicine shortages when they occur.

The HPRA publishes a list of medicines currently in short supply on its website 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 the HPRA has to hand, including removal from the list when a shortage has been resolved. Of those medicines listed as in short supply at the end of January, the most common reasons provided to the HPRA were manufacturing delays and unexpected increases in demand.

Two new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years.

Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020.

The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland.

There are a number of clauses set out in both agreements in detail, which provide clear pricing rules for applicant companies, that have been agreed between the State and main Pharmaceutical Industry representative groups in Ireland as appropriate and intended to provide a predictable environment for Marketing Authorisation Holders (MAHs) to supply their products (and prevent shortages). These are grossly summarised as:

The pricing application form for new medicines is based on a basket of 14 countries (13 EU Member States and the UK). Pricing is permitted to be no more than the average price based on the pricing in these 14 countries.

The pricing of non-patented medicines (i.e., generic, biosimilar or hybrid medicine marketed in Ireland) is based on the originator medicine at a specific time point.

Under the terms of the agreement, there is scope for the Department of Health, the HSE, and industry to continue to maintain their engagement throughout the lifetime of the agreement on all matters pertaining to the agreement.

In the interests of continuity of supply, where it becomes uneconomic for a Supplier to supply a particular medicine under the terms of the Agreements, direct representations may be made by the Supplier to the HSE for variation of any term of the Agreement, in relation to that medicine, including its price terms. Where representations are made by the Supplier to the HSE, the HSE shall have the final decision on whether to vary the terms of the Agreement in any case, but will consult with the Supplier before reaching its decision. The HSE expects a robust submission of evidence to support any claim, from any Supplier, in the event that they wish to set out to the Executive an inability to meet pricing terms set out in said Agreements.

As of January 2023, there are 9 applications from 6 separate manufacturers/suppliers currently under review by the HSE, for a pricing increase request related to a claim of increased cost of goods, making continuity of supply to the Irish market and Irish patients unsustainable.

In the case of such pricing increase requests the time taken to adjudicate on these is highly variable (on a case-by-case basis) and dependent on a number of factors, that the HSE is required to consider including the number of alternative suppliers for that medicine, the potential alternative therapeutic options, the clinical need for the product, the potential budget impact, and European pricing.

The HSE also takes an active role at the time of notification, in engaging with manufacturers/suppliers intending to discontinue priority medicines due to the lack of commercial viability of those products. In many of the cases where this arises as a scenario, the commercial decision relates to global discontinuations and is outside of the control of the HSE i.e., cannot be addressed through pricing increases at a national level.

The Agreements are the product of extensive collaboration between the State, HSE, and Industry. They remain current and appropriate for their purpose since their signing in December 2021.

Medicinal Products

Ceisteanna (250)

David Cullinane

Ceist:

250. Deputy David Cullinane asked the Minister for Health if, further to a public statement by his Departmental spokesperson indicating that the HSE completed a comprehensive review of the published HPRA shortages list on 16 January 2023, he will publish this review in full. [4995/23]

Amharc ar fhreagra

Freagraí scríofa

Of the shortages listed on the Health Products Regulatory Authority (HPRA) website on that date, there was no evidence that framework agreements / pricing matters were notified as cause of the shortage. 

Of the 208 notified shortages, the cause were noted as follows:

Manufacturing delay

88

Unexpected Increase in Demand

63

Quality or Regulatory Issue

32

API unavailability

16

Shipping delay

5

Distribution Issue

3

Awaiting Information

1

Grand Total

208

Additionally, across the notified shortages on HPRA website on that date, in 80 cases the relevant company has confirmed “multiple countries affected”.

Medicinal Products

Ceisteanna (251)

David Cullinane

Ceist:

251. Deputy David Cullinane asked the Minister for Health the annual spend under the health vote on ingredient cost elements, excluding fees, of exempt medicinal products in each of the years 2020 to 2022. [4996/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Mental Health Services

Ceisteanna (252)

Fergus O'Dowd

Ceist:

252. Deputy Fergus O'Dowd asked the Minister for Health the total number of staff working in all CAMHS services in County Louth, by name and location of service, total number of staff employed, and the number of vacant posts, in each of the years 2020 to 2022 and to date in 2023 in tabular form covering south Louth and east Meath as of 1 December 2022; and if he will make a statement on the matter. [4997/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Health Services Staff

Ceisteanna (253)

Matt Carthy

Ceist:

253. Deputy Matt Carthy asked the Minister for Health the estimated full year cost of recruiting additional ten whole-time equivalent midwives for the maternity unit at Cavan General Hospital; and if he will make a statement on the matter. [5022/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Health Services Staff

Ceisteanna (254)

Matt Carthy

Ceist:

254. Deputy Matt Carthy asked the Minister for Health the number of whole-time equivalent vacancies by job title currently in the oncology day unit at Cavan General Hospital; when these vacancies will be filled, in tabular form; and if he will make a statement on the matter. [5023/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

Health Services Staff

Ceisteanna (255)

Matt Carthy

Ceist:

255. Deputy Matt Carthy asked the Minister for Health the number of staff who are needed to reach full staffing levels in each of the children's disability network teams in CHO1; the number of staff who are currently in place in each of the children's disability network teams in CHO1; and if he will make a statement on the matter. [5024/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Waiting Lists

Ceisteanna (256)

Sorca Clarke

Ceist:

256. Deputy Sorca Clarke asked the Minister for Health if his attention has been drawn to the purported 552-week waiting list for children awaiting tonsilitis assessment and surgery; and if he will make a statement on the matter. [5047/23]

Amharc ar fhreagra

Freagraí scríofa

It is recognised that waiting times for many scheduled appointments and procedures were too long before and have been made worse by the Covid-19 pandemic. While significant work continues to positively impact on waiting times and improve pathways to elective care, acute hospitals are still impacted by operational challenges arising from the pandemic and the current pressures on Emergency Departments.

The Health Service Executive (HSE) has confirmed to the Department that patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols. 

The Department of Health continues to work with the HSE and the National Treatment Purchase Fund (NTPF) to identify ways to improve access to care, including through increased use of private hospitals, funding weekend and evening work in public hospitals, funding “see and treat” services, providing virtual clinics, and increasing capacity in the public hospital system. 

The NTPF has advised my Department that ENT outpatient data only provides the number of patients waiting by specialty and does not provide a breakdown of the number of patients awaiting a consultation relating to a tonsillectomy. If the Deputy is aware of an individual patient waiting for the length of time noted in her PQ she might contact the HSE directly.

The 2022 Waiting List Action Plan set targets to reduce both the number of people waiting for care and the length of time they are waiting. Positive progress was made in 2022 in relation to both targets, despite negative impacts throughout the year on scheduled care from continued COVID-19 surges, emergency department pressures and other operational factors, including staff hiring. In 2022, there were c.1.56m patients removed from the Waiting list and c.1.53m patients added to the waiting list – a net reduction of c.30k (4%). Long waiters were significantly reduced in 2022: the number of patients exceeding the 18-month maximum wait time target for new outpatient (OPD) appointments target decreased by c.59.0k (38.5%) and the number of patients exceeding the 12-month maximum wait time target for in-patient day case (IPDC) procedures and GI Scopes has decreased by c3.8k (22.6%) and c.3.5k (86.5%) respectively.

Through the 2022 Plan, €350m funding was allocated to the HSE and the NTPF to provide additional public and private activity to reduce the waiting list backlogs that were exacerbated during the Pandemic, but also as the first stage of an ambitious multi annual approach, to lay the foundations for important reforms that will deliver sustained reductions in waiting lists.

For 2023, funding of €443 million is being allocated to tackle Waiting Lists, some €360m of which is targeted at acute hospital waiting lists. The plan to utilise this part of the funding is being developed by the Department of Health in conjunction with the HSE and NTPF. This will include details of new capacity planned for 2023 as well as important reforms that will improve capacity in the public hospital system.

Residential Institutions

Ceisteanna (257)

Catherine Connolly

Ceist:

257. Deputy Catherine Connolly asked the Minister for Health further to section 43 of the Residential Institutions Statutory Fund Act 2012; the amount paid into the special account maintained by the Minister for Health to be used as contributions towards the costs of the National Children's Hospital to date in 2023; and if he will make a statement on the matter. [5050/23]

Amharc ar fhreagra

Freagraí scríofa

Section 43 of the Residential Institutions Statutory Fund Act 2012 (No. 35 of 2012) provides for a special account to be established in the name of the Minister for Health for the purposes of making contributions towards building, furnishing, and equipping a new ‘National Paediatric Hospital’. The acceptance of moneys and placing it in the special account is within the remit of the Minister for Education and Skills, with the consent of the Minister for Public Expenditure and Reform.

This special account is held with the Central Bank, operates under terms and conditions of the Minister for Public Expenditure and Reform, and is subject to audit by the Comptroller and Auditor General.

No contribution has been made to this special account to date in 2023.

Question No. 258 answered with Question No. 197.

Hospital Facilities

Ceisteanna (259)

Peadar Tóibín

Ceist:

259. Deputy Peadar Tóibín asked the Minister for Health if his attention has been drawn to a rodent infestation in University Hospital Galway; and if he will make a statement on the matter. [5068/23]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

Health Services

Ceisteanna (260)

David Cullinane

Ceist:

260. Deputy David Cullinane asked the Minister for Health the awards made following a tender process to management consultancy firms, by firm, by his Department and aegis bodies, excluding the Health Service Executive, in each of the years 2013 to 2022, inclusive, in tabular form; the purpose and a brief description of the awards; the value of the awards and the total amounts paid; the timeline or timeframe of the contracts; and the desired or completed output. [5070/23]

Amharc ar fhreagra

Freagraí scríofa

The information requested by the Deputy is not immediately available, a full response is being collated and will be forwarded to the Deputy as soon as possible.

Details for other bodies under the aegis of my Department are operational matters for the bodies concerned and the Deputy should contact the relevant Director/CEO/Registrar directly.

Health Services

Ceisteanna (261)

David Cullinane

Ceist:

261. Deputy David Cullinane asked the Minister for Health the awards made without a tender process to management consultancy firms, by firm, by his Department and aegis bodies, excluding the Health Service Executive, in each of the years 2013 to 2022, inclusive, in tabular form; the purpose and a brief description of the awards; the value of the awards and the total amounts paid; the timeline or timeframe of the contracts; and the desired or completed output. [5071/23]

Amharc ar fhreagra

Freagraí scríofa

The information requested by the Deputy is not immediately available, a full response is being collated and will be forwarded to the Deputy as soon as possible.

Details for other bodies under the aegis of my Department are operational matters for the bodies concerned and the Deputy should contact the relevant Director/CEO/Registrar directly.

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