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Wednesday, 18 Nov 2020

Written Answers Nos. 150-169

Garda Training

Questions (150)

Catherine Murphy

Question:

150. Deputy Catherine Murphy asked the Minister for Justice further to Parliamentary Question No. 174 of 24 September 2020, if the 323 members that have already been given access to the FCN app completed the training to date and if not, the date on which it is planned that online training can take place for the other 407 members. [37203/20]

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Written answers

The Deputy will appreciate that the Garda Commissioner is responsible for managing and controlling generally the administration and business of An Garda Síochána, and I, as Minister, have no direct role in the matter.

I have requested information from the Garda Commissioner in relation to this matter but it was unfortunately not possible to compile it in the time available.

I will write to the Deputy directly with the information requested, when it is available.

The following deferred reply was received under Standing Order 51.
SUBSTANTIVE ANSWER:
I refer to Parliamentary Question Number 150 for answer on 18 November 2020, in which you requested further to Parliamentary Question No. 174 of 24 September 2020, if the 323 members that have already been given access to the FCN app completed the training to date and if not, the date on which it is planned that online training can take place for the other 407 members.
You will recall that the information could not be obtained in the time available and I undertook to consult with An Garda Síochána and contact you again when the information was available.
You will appreciate that the Garda Commissioner is, by law, responsible for the management and administration of An Garda Síochána including arranging for the training of its members and civilian staff, and I, as Minister, have no direct role in the matter.
I am informed by Garda authorities, that the 323 members referred to in Parliamentary Question No. 174, dated 24 September 2020, have received training in respect of the FCN App.
With respect to the remaining members, given the decision of Government to move the entire Country to Level 5, all face-to-face meetings became unachievable and it was decided to sanction the download of the FCN App to the remainder of the Roads Policing Units remotely. All Members have been provided access to training material, and local Champions and the Active Mobility Team are available for support to these members. A formal online course, in respect of the FCN App, will be available by the end of 2020, and local familiarisation and demonstrations will recommence when safe and practical to do so.
I hope this information is of assistance.

Departmental Meetings

Questions (151)

Catherine Murphy

Question:

151. Deputy Catherine Murphy asked the Minister for Justice if she will provide a schedule of the engagements she and her predecessor have had with the Israeli Ministry of Public Security; and if she will provide details of the nature of the engagements and her plans to meet and or engage with the Israeli Ministry of Public Security. [37213/20]

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Written answers

I have consulted with officials in my Department and can confirm that neither I, nor my predecessor Minister Flanagan during his tenure in office in this Department, have had any meetings with representatives of the Israeli Ministry of Public Security.

Further, I can confirm that I have no plans to meet with any representatives of the Israeli Ministry of Public Security at present.

Garda Operations

Questions (152)

Catherine Murphy

Question:

152. Deputy Catherine Murphy asked the Minister for Justice if she has been briefed by the Garda Commissioner regarding the EU funded research project called ROXANNE. also known as Real time network, text, and speaker analytics for combating organised crime. [37214/20]

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Written answers

The Deputy will be aware that, under the Garda Síochána Act 2005, the Garda Commissioner is responsible for the management and administration of An Garda Síochána. As Minister, I have no role in these independent functions.

An Garda Síochána are responsive to the changing nature of crime, responding to evolving threats, increasing their capabilities and knowledge and working with partner agencies/police services to ensure organised crime and criminals do not impact on our society and people.

I have been briefed by the Commissioner on Project ROXANNE which is an EU-funded project targeting criminal networks.  The project is a collaboration between law enforcement, industry and academia to develop new tools to support investigations.  I understand the project is funded through the EU's Horizon 2020 initiative and is made up of 24 members from the private and public sectors. As with all EU projects, participants and partners must adhere to the highest ethical and research integrity principles.  As the Deputy will appreciate, the objective is to strengthen/enhance capacity to combat international and transnational serious and organised crime, in addition to combating threats against the security of the State.

Naturalisation Applications

Questions (153)

Bernard Durkan

Question:

153. Deputy Bernard J. Durkan asked the Minister for Justice the progress to date in the determination of an application for naturalisation in the case of a person (details supplied); when the application will be concluded; and if she will make a statement on the matter. [37220/20]

View answer

Written answers

An application for a Certificate of Naturalisation has been received from the person concerned and will be processed with a view to establishing whether the person meets the statutory conditions for the granting of naturalisation. Foremost among those conditions is that the person will have accumulated 60 months of reckonable residence in the State.

The granting of Irish citizenship through naturalisation is a privilege and an honour which confers certain rights and entitlements not only within the State but also at European Union level and it is important that appropriate procedures are in place to preserve the integrity of the process.

It is recognised that all applicants for citizenship would wish to have a decision on their application without delay. However, the nature of the naturalisation process is such that, for a broad range of reasons, some cases will take longer than others to process. In some instances, completing the necessary checks can take a considerable period of time.  In that context, it is important that an applicant ensures that his or her contact details, including their up to date address, is notified to the Citizenship Division of my Department's Immigration Service.

Queries in relation to the status of individual immigration cases may be made directly to my Department by e-mail using the Oireachtas Mail facility which has been specifically established for this purpose. This service enables up to date information on such cases to be obtained without the need to seek information by way of the Parliamentary Questions process. The Deputy may consider using the e-mail service except in cases where the response is, in the Deputy’s view, inadequate or too long awaited. 

Garda National Immigration Bureau

Questions (154)

Brian Leddin

Question:

154. Deputy Brian Leddin asked the Minister for Justice the number of registrations Henry Street Garda National Immigration Bureau office in Limerick city is processing each week; the wait time for appointments; the current backlog in registrations for the Limerick office; and if she will make a statement on the matter. [37226/20]

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Written answers

My Department registers persons residing in the Dublin area only. The Garda National Immigration Bureau (GNIB) processes all applications outside of Dublin through the Garda Station network.  However, in order to be of assistance to the Deputy, I have made enquiries with the Commissioner and have received the following update. 

The Henry Street Immigration Office is processing circa 375 - 400 registrations per 7 day week and the wait time for appointments is approximately 6 - 7 weeks. The backlog in registrations is estimated to be between 700 to 800.

Every effort is being made to address the backlog of registrants and a number of measures have been introduced to reduce the waiting time. The capacity of the Henry Street Immigration Office to process applicants has recently been increased with the addition of a third customer hatch. The opening hours have been extended with the Immigration Office now open for appointments from 7.30am straight through to 10.30pm.

Gambling Sector

Questions (155)

Louise O'Reilly

Question:

155. Deputy Louise O'Reilly asked the Minister for Justice if her Department will be bringing forward legislation to regulate the area of online gambling and gambling advertising given the lack of regulation combined with scale and nature of problem gambling which has been extenuated during the public health lockdowns. [37242/20]

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Written answers

The Programme for Government gives a clear commitment to establish a gambling regulator focused on public safety and well-being, covering gambling online and in person, and the powers to regulate advertising, gambling websites and apps.

Work is currently underway in my department on the development of the legislation to provide for the necessary modern licensing and regulatory provisions for the Irish gambling industry.  I hope to bring proposals in that regard to Government next year.

Given the size, complexity and technological development of the modern gambling industry and having regard to the current outdated and complex arrangements, it will be important that the regulator will be established on a strong footing and adequately resourced to carry out this important task.

Visa Applications

Questions (156)

Jennifer Carroll MacNeill

Question:

156. Deputy Jennifer Carroll MacNeill asked the Minister for Justice the timeline for an application for a visa by a person (details supplied) whose partner is an Irish national; when a decision will be made on the application; and if she will make a statement on the matter. [37268/20]

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Written answers

Based on the details provided by the Deputy, there is no record of an application, or a request, from the person concerned for permission to remain in the State since their last permission expired on 12 May 2019. If more information can be provided, my officials will be happy to re-examine the Deputy's request. 

The person concerned is advised to write to the Immigration Service of my Department and request to regularise their position in the State. When submitting their request, they should outline their current circumstances, the date of their arrival in the State. They should also enclose a copy of their passport, along with any documentation that they believe will support their case. The application should be submitted, via registered post, to Residence Division - Unit 2, Immigration Service, 13/14 Burgh Quay, Dublin 2, D02 XK70. 

Queries in relation to the status of individual immigration cases may be made directly to my Department by e-mail using the Oireachtas Mail facility which has been specifically established for this purpose. This service enables up to date information on such cases to be obtained without the need to seek information by way of the Parliamentary Questions process. The Deputy may consider using the e-mail service except in cases where the response is, in the Deputy’s view, inadequate or too long awaited.

International Protection

Questions (157)

Catherine Connolly

Question:

157. Deputy Catherine Connolly asked the Minister for Justice further to her public statement of the 21 October 2020 (details supplied), if she will confirm the changes are now in place; if she intends to bring forward new regulations in order to give effect to the changes announced; if so, when it expected that such regulations will be in place; and if she will make a statement on the matter. [37280/20]

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Written answers

The European Communities (Reception Conditions) Regulations 2018, transposing the EU (Recast) Reception Conditions Directive, came into effect from 30 June 2018. The Regulations include a provision on access to the labour market for eligible international protection applicants. Currently, any applicant who has not received a first instance decision within 9 months can make an application for a labour market access permission.

Following a review of Access to the Labour Market for Persons Seeking International Protection, led by my Department, and approval of the recommendations by Government, I announced on 21 October 2020, that a number of positive changes are being introduced. The waiting period for applying for a labour market permission is being reduced from 9 months to 6 months and the validity of the permission is being extended from 6 months to 12 months. I also announced that we will expand the access to the labour market to include those applicants who received a first instance recommendation before the European Communities (Reception Conditions) Regulations 2018 came into force, provided that they meet the criteria set out in the Regulations. The restriction preventing people accessing employment with public health employers, subject to them having the necessary qualifications, is also being removed.

These changes will need to be facilitated by an amending Statutory Instrument to the 2018 Regulations, which it is hoped to progress as soon as possible.

Citizenship Applications

Questions (158)

Marian Harkin

Question:

158. Deputy Marian Harkin asked the Minister for Justice the progress to date in the determination of an application for citizenship in the case of a person (details supplied); when correspondence will be issued to confirm receipt of the application; when the active passports will be returned to the applicant; and if she will make a statement on the matter. [37284/20]

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Written answers

The Citizenship Division of the Immigration Service of my Department is working very hard to maintain as prompt a service as possible during the restrictions imposed by the COVID-19 global pandemic. Unfortunately, as a result of these restrictions, significant delays are occurring in the issuing of acknowledgment receipts and the processing and return of documentation. 

If the person concerned sends their An Post tracking number that they received when posting their application to citizenshipinfo@justice.ie, the Citizenship Division will check the record and confirm if the application has been received.

The ability of staff to attend at the office continues to be impacted and the verification of passports cannot be performed remotely for data protection reasons. However, if the person concerned urgently requires their passport for emergency reasons such as medical reasons, they should email the Citizenship Division setting out the reasons and provide colour scanned copies of supporting documentation such as a letter from their medical consultant.

Queries in relation to the status of individual immigration cases may be made directly to my Department by e-mail using the Oireachtas Mail facility which has been specifically established for this purpose. This service enables up to date information on such cases to be obtained without the need to seek information by way of the Parliamentary Questions process. The Deputy may consider using the e-mail service except in cases where the response is, in the Deputy’s view, inadequate or too long awaited.

Garda Deployment

Questions (159)

Róisín Shortall

Question:

159. Deputy Róisín Shortall asked the Minister for Justice the number of gardaí allocated to each Garda station in the DMR by rank; the number in the community Garda service in each station in tabular form; and if she will make a statement on the matter. [37292/20]

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Written answers

The Deputy will be aware that the Garda Commissioner is by law responsible for the management of An Garda Síochána, including personnel matters and deployment of resources.  As Minister, I have no role in these matters.  I am assured, however, that Garda management keeps the distribution of resources under continual review in the context of crime trends and policing priorities, to ensure their optimum use.

The resources provided by Government to An Garda Síochána have reached unprecedented levels, with an allocation of €1.88 billion for 2020 and of €1.952 billion in Budget 2021.  This level of investment is enabling sustained, ongoing recruitment of Garda members and staff.  There are now approximately 14,600 Gardaí nationwide, supported by over 3,000 Garda staff.  Taken together, this number of Garda members and staff is delivering a significant growth in operational policing hours nationwide. 

I am informed by the Garda authorities that the total number of Gardaí stationed in the DMR as of 31 October 2020 is 3,924.

Table 1 attached shows the Garda Strength by grade in the DMR by division, district and station.

With regard to the number in the community Garda service in each station, I am advised by the Commissioner that not all of the information requested is readily available in the format requested, as Community Gardaí are assigned on a Garda Divisional basis. 

I am however informed that the table below shows the number of Community Gardaí by division as at 30 September 2020, the latest date for which figures are available.

DIVISION

Sept 2020

D.M.R.   EAST              

21

D.M.R.   NORTH             

17

D.M.R.   NORTH CENTRAL     

54

D.M.R.   SOUTH             

50

D.M.R.   SOUTH CENTRAL     

56

D.M.R.   WEST              

76

TOTAL

274

The Deputy may wish to know that detailed information in relation to Garda numbers is available on my Department’s website.  This information is updated every month with the latest data provided by An Garda Síochána, at the following link:

http://www.justice.ie/en/JELR/002_Garda_Numbers_by_Division_District_and_Station_2009_to_August_2020.xlsx/Files/002_Garda_Numbers_by_Division_District_and_Station_2009_to_August_2020.xlsx

Figures for Community Policing by Division can be found  on my Department's website at the following link:

 http://www.justice.ie/en/JELR/Pages/Community_Policing

Additional information on Garda staff, the Garda Workforce and other relevant statistics are available at the following link:

http://www.justice.ie/en/JELR/Pages/An_Garda_Siochana_facts_and_figures.

DMR Strength

Crime Data

Questions (160)

Róisín Shortall

Question:

160. Deputy Róisín Shortall asked the Minister for Justice the number of stolen bikes seized by An Garda Síochána in 2019 and to date in 2020; the number that were returned to owners by An Garda Síochána in the same period; and if she will make a statement on the matter. [37295/20]

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Written answers

The Deputy will appreciate that the Garda Commissioner is responsible for managing and controlling generally the administration and business of An Garda Síochána, and I, as Minister, have no direct role in the matter.

I have requested information from the Garda Commissioner in relation to this matter but it was unfortunately not possible to compile it in the time available.

I will write to the Deputy directly with the information requested, when it is available.

The following deferred reply was received under Standing Order 51
I refer to Parliamentary Question 160 which was for answer on 18 November 2020 where you asked for the number of stolen bikes seized by An Garda Síochána in 2019 up to the 18 November 2020; and the number that were returned to owners by An Garda Síochána in the same period. You will recall that the information could not be obtained in the time available and I undertook to consult with An Garda Síochána and contact you again when the information became available. The delay in responding is regretted.
As you will be aware that the Garda Commissioner is by law responsible for the management and administration of An Garda Síochána, including operational matters and recording of crimes.
The Criminal Justice (Theft and Fraud Offences) Act 2001 provides for offences of theft, the handling of stolen property and the possession of stolen property. The offence of theft provided for by this legislation would, based on the broad nature of the offence, includes the theft of bicycles. Maximum sentences of 10 years are provided for in the case of offences of theft and handling of stolen property; while maximum sentences of 5 years are provided for the offence of possession of stolen property.
The Garda Commissioner and his management team are responsible for putting in place targeted Garda operations to tackle bike theft.
Community Gardaí are also available to provide crime prevention advice to residents' groups in areas affected by thefts, and Garda members keep injured parties appraised as to the status of investigations at all times.
I am informed by the Garda authorities that a search of the PULSE database was conducted up to 27 November 2020 to identify pedal cycles which were seized, found or recovered by An Garda Síochána in 2019 and up to 26 November 2020. Not all of the pedal cycles recovered may have been stolen in the first instance. Similarly, even if the pedal cycle was originally stolen, that theft may not have been reported to the Garda Síochána. Additionally, a pedal cycle could be seized, found or recovered in a different year to that in which it was originally lost/stolen. Unless the serial number of the pedal cycle is available, it is very difficult to definitively match a particular bike to another incident.
I am informed by the Garda authorities that the tables included in the attached Appendix set out the number of pedal cycles recovered in 2019 and up to and including 26 November 2020; and the number of pedal cycles returned to their owners during the same period.
I trust this information is of assistance.
Appendix
Table 1: Pedal Cycles Recovered by Year

2019

*2020

Pedal Cycles seized/found/recovered

2,503

2,594

* Data for 2020 is for incidents recorded to 26 November 2020 only.
The Property and Exhibit Management System (PEMS) is used to track all property and exhibits in Garda possession. This is a separate database to PULSE and contains additional information in respect of the current status of property, including where same is no longer in Garda possession and has been returned to the owner. The table below provides details of the number of the pedal cycles in each year which had a status of returned to owner (based on the pedal cycle records above from PULSE).
Table 2: Pedal Cycles Returned to Owners by Year

2019

*2020

Pedal Cycles Returned to Owners

154

111

* Data for 2020 is for incidents recorded to 26 November 2020 only.
Additional Information
Information on the number of pedal cycles seized or found or recovered is based upon operational data from the PULSE system on 27 November 2020 and is liable to change. Additional information on the current property status was taken from the PEMS database which is also operational and liable to change.

Departmental Reports

Questions (161)

Róisín Shortall

Question:

161. Deputy Róisín Shortall asked the Minister for Justice if a copy of the report will be provided which it is understood issued in February 2019 from a cross-agency meeting, comprising the Department of Transport, An Garda Síochána and the Office of the Attorney General and which aimed to identify specific solutions to deal with the misuse of scramblers and quad bikes; and if she will make a statement on the matter. [37297/20]

View answer

Written answers

My Department, alongside colleagues in the Department of Transport and An Garda Síochána, is acutely aware of the severe difficulties and dangers the misuse of scramblers and quad bikes causes in the communities it impacts and my officials have been working to find solutions to this complex issue.

Insofar as your reference to a report issued by the cross-agency grouping is concerned, the then Minister referenced a report in the House on 13 February 2019. This reference was to the legal advice sought from the Attorney General in the aftermath of the initial meeting of this grouping which was received the prior November. As you will appreciate, legal advices received from the Attorney General are not generally published.

The cross-agency group most recently met in September 2020. The group agreed that the Department of Transport - which has primary responsibility for road traffic legislation – would explore the feasibility of developing new legislative provisions in road traffic legislation, following on from the suggestions of An Garda Síochána, without causing unintended consequences for existing law. 

The Programme for Government contains a commitment to "enhance powers available to An Garda Síochána to limit the use of scramblers and quads by those engaged in anti-social behaviour and enact legislation to add to those powers if needed."

It was also agreed at the September meeting that my Department would consider and develop actions in order to increase awareness of the dangers of these vehicles jointly with affected communities, community groups and other stakeholders, and explore how best to engage with young persons who are drawn to this behaviour. My Department is examining options in this area, with due regard to social distancing requirements.

Irish Naturalisation and Immigration Service

Questions (162)

Martin Kenny

Question:

162. Deputy Martin Kenny asked the Minister for Justice if her attention has been drawn to the fact that the INIS registration offices in Dublin and regionally are currently closed for first-time registration (details supplied); the reason immigration registration offices are closed and are not deemed to be an essential public service; and if she will make a statement on the matter. [37327/20]

View answer

Written answers

On 18 September 2020, I announced that all immigration and international protection permissions to reside in the State that were due to expire between 20 September 2020 and 20 January 2021 were automatically renewed to the 20 January 2021. The renewal of a permission is on the same basis as the existing permission and the same conditions attach.  This has ensured that people do not fall out of permission and remain legally resident in the State during this time.

The Registration Office in Burgh Quay closed to the public on 22 October 2020 following the introduction of Level 5 restrictions under the Government’s Framework for Living with Covid-19. The decision was taken in line with public health guidelines, for the safety of our customers and staff. First-time registrations require the taking of fingerprints and therefore cannot be done online. The Office will reopen as soon as Level 5 restrictions are lifted and appointments will be available to people living in the Dublin area who are required to register for the first time.

Registrations outside of the Dublin area are processed by the Garda National Immigration Bureau (GNIB) through the Garda Station network. Further information, and the contact details of each registration office outside Dublin, is available from https://www.garda.ie/en/about-us/our-departments/office-of-corporate-communications/news-media/reopening-of-registration-offices.html.

Veterinary Inspection Service

Questions (163)

Thomas Pringle

Question:

163. Deputy Thomas Pringle asked the Minister for Health the reason small abattoirs are required to have veterinary inspectors present during operation; when this was introduced; the reason it is necessary; the differences made for small independent producers and the large meat processors; and if he will make a statement on the matter. [37196/20]

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Written answers

All slaughterhouses are required to have official veterinarians present to examine animals before slaughter (ante-mortem) to ensure they are fit for slaughter for human consumption and that animal health and welfare legislation is complied with, including requirements for traceability. Slaughterhouses are also required to have official veterinarians present to examine the carcases of slaughtered animals post-mortem to check for evidence of disease and traces of illegal substances, to verify compliance with hygiene requirements and to stamp the carcases with a health mark to verify that they are suitable for human consumption. These checks are fundamental to maintaining the safety of the supply of meat and to protect public health.  Policy concerning animal health and welfare rests with the Department of Agriculture, Food and the Marine (DAFM).

Meat inspection by official veterinarians has been legislated for at European level since 1964 (Directive 64/432/EEC) and in Ireland for the smaller slaughterhouses since 1988 (Abattoirs Act 1988). The current legal framework for meat inspection is Regulation (EU) 2017/625 and implementing legislation (Regulations (EU) 2019/624 and 2019/627), as given effect to by the European Union (Food and Food Hygiene) Regulations 2020 (S.I. No. 22 of 2020).

In Ireland, large slaughterhouses are supervised by the Department of Agriculture, Food and the Marine and smaller ones by the Local Authorities – in each case the official food controls take place under a service contract between the respective official agency and the Food Safety Authority of Ireland. 

The Regulations governing hygiene requirements in slaughterhouses, for which DAFM has policy responsibility, apply to large and small slaughterhouses, though there is scope for some flexibility for small producers in Regulation (EU) 853/2004 on the hygiene of foods of animal origin provided that the appropriate high standards of hygiene are achieved. In line with this flexibility, the smaller local authority-supervised slaughterhouses tend not to have a permanent veterinary attendance during slaughter, whereas the larger DAFM-supervised slaughterhouses tend to have a permanent veterinary presence.

Mental Health Services

Questions (164)

Neasa Hourigan

Question:

164. Deputy Neasa Hourigan asked the Minister for Health when a full recommencement of services at the community mental health centre in Mullingar, County Westmeath will take place; when all staff will be re-deployed to their original positions; and if he will make a statement on the matter. [37122/20]

View answer

Written answers

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

Medicinal Products

Questions (165, 189)

Neasa Hourigan

Question:

165. Deputy Neasa Hourigan asked the Minister for Health when the HSE management team is expected to make a final decision on the reimbursement of Dupilumab for the treatment of atopic eczema; and if he will make a statement on the matter. [37144/20]

View answer

Róisín Shortall

Question:

189. Deputy Róisín Shortall asked the Minister for Health the status of the application for reimbursement of the drug Dupilumab to treat severe atopic eczema; and if he will make a statement on the matter. [37265/20]

View answer

Written answers

I propose to take Questions Nos. 165 and 189 together.

The 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.

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 NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions.

The HSE has advised that it has received pricing and reimbursement applications for two indications of Dupilumab (Dupixent®):

- For the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

- For the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.

The HSE received an application for pricing / reimbursement of Dupilumab in November 2017 from the manufacturer for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.  The HSE commissioned a full HTA on 29 November 2017 as per agreed processes.  This assessment was completed on 12 December 2019 with the NCPE recommending that Dupilumab be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments.

Subsequently, the HSE received an application for the pricing/reimbursement of Dupilumab on 13 December 2019 for the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.

The HSE commissioned the rapid review process on the 17 December 2019. Following receipt of a rapid review dossier, the NCPE advised the HSE on the 17 January 2020 that a HTA was not recommended and that Dupilumab not be considered for reimbursement for this indication at the submitted price.

The HSE engaged in commercial negotiations with the company in February 2020 regarding both the adult and adolescent populations.

The final HTA report concerning Dupilumab was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations, and the patient group submission received during the HTA process. The HSE Drugs Group considered all the evidence and gave a recommendation to the HSE EMT not to support reimbursement of Dupilumab for the treatment of moderate-to-severe atopic dermatitis in both adults and adolescents 12 years and older who are candidates for systemic therapy.

The HSE has confirmed that the applicant company was issued with notice of the proposed decision of the HSE EMT not to support reimbursement on 21 August 2020.  On 18 September 2020, the applicant company submitted representations with respect to this application.

The HSE reviewed these representations, as is required in such circumstances under the 2013 Act, and has engaged in a meeting in November 2020 with the applicant company to discuss the submission. The HSE advises that Dupilumab will be included on the agenda for the December HSE Drugs Group meeting at which the two applications and the submitted representations will be reconsidered.

Dupilumab remains under consideration with the HSE and a final decision will be made in line with the 2013 Health Act.

Hospital Appointments Status

Questions (166)

Maurice Quinlivan

Question:

166. Deputy Maurice Quinlivan asked the Minister for Health the length of time a person (details supplied) will have to wait for a hospital appointment; and if he will make a statement on the matter. [37150/20]

View answer

Written answers

It is recognised that waiting times for scheduled appointments and procedures have been impacted as a direct result of the COVID-19 pandemic.

In response to the Covid-19 pandemic the HSE had to take measures to defer most scheduled care activity in March, April, and May of this year. This was to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work. This decision was in line with the advice issued by the National Public Health Emergency Team (NPHET) in accordance with the advice of the World Health Organisation.

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 HSE continues to optimise productivity through alternative work practices such the use of alternative settings including private hospitals, community facilities and alternative outpatient settings.

Under 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.

The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures.  It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.

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.

Health Services Provision

Questions (167)

Michael Lowry

Question:

167. Deputy Michael Lowry asked the Minister for Health if funding will be provided to establish a renal dialysis unit in one of current health care facilities in County Tipperary; and if he will make a statement on the matter. [37167/20]

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Written answers

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

Brexit Issues

Questions (168)

Cormac Devlin

Question:

168. Deputy Cormac Devlin asked the Minister for Health his views on whether Brexit will have a positive impact on any policy area or sector under the remit of his Department; and if the details of same will be provided. [37180/20]

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Written answers

In line with cross Government planning, the Department of Health, in conjunction with the HSE, the HPRA and other health agencies, is continuing to work on a comprehensive and coordinated set of preparations to ensure the health sector is ready for Brexit.

While responding to Brexit has been a significant challenge for the health sector over recent years, certain no-deal Brexit contingency planning structures were helpful in providing a basis for my Department's response to the COVID 19 pandemic.

My Department will continue to work between now and the end of the transition period to ensure continuity of access to health services as far as possible and the maintenance of public health post-Brexit.

Covid-19 Pandemic

Questions (169)

Richard O'Donoghue

Question:

169. Deputy Richard O'Donoghue asked the Minister for Health the position regarding the EU deal for 300 million Covid-19 vaccine doses; if he will report on the dose supply; and if he will make a statement on the matter. [37200/20]

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Written answers

Ireland is currently involved in an EU Procurement Exercise being operated by the European Commission on behalf of member states to procure a portfolio of suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19. BioNTech/Pfizer is one of the vaccine suppliers that the Commission has negotiated with. 

On 11 November, the European Commission approved an Advance Purchase Agreement (APA) with a pharmaceutical company, BioNTech-Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to purchase up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Ireland will be entitled to a pro rata share of these. The EU has also concluded APAs with AstraZeneca, Sanofi-Pasteur and Janssen (Johnson and Johnson). 

While a number of media reports have pointed to the potential for a high degree of efficacy in relation to some of these vaccines, no vaccine for COVID-19 has yet been approved for use and usage of any vaccine is condition on their receipt of market authorisation from the European Medicines Agency.

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