Written Answers Nos. 737-756
737. Deputy Danny Healy-Rae asked the Minister for Health if there have been deaths recorded consequential to having received the Covid-19 vaccines; if so, the number; and if he will make a statement on the matter. [23877/21]
View answerI have referred this question to the relevant agency, the Health Products Regulatory Authority (HPRA), and have requested that they respond directly to the Deputy as soon as possible.
738. Deputy Danny Healy-Rae asked the Minister for Health if serious side effects or sickness have been recorded following receipt of the Covid-19 vaccines; if so, the number; and if he will make a statement on the matter. [23879/21]
View answerThe Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.
The HPRA follows up on reports of suspected adverse reactions received from healthcare professionals and members of the public through the voluntary reporting system, including any deaths notified following vaccination.
The latest safety update from the HPRA regarding COVID-19 vaccinations is available here:
https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/safety-update-covid-19-vaccines-overview-of-national-reporting-experience-22-april-2021&id=22720f26-9782-6eee-9b55-ff00008c97d0
739. Deputy James O'Connor asked the Minister for Health if he will report on a WHO recommendation (details supplied); and if he will make a statement on the matter. [23880/21]
View answerThe COVID-19 Vaccine Allocation Strategy sets out a provisional list of groups for vaccination. The Strategy was developed by the National Immunisation Advisory Committee (NIAC) and my Department, endorsed by the National Public Health Emergency Team (NPHET), and approved by Government on 8 December 2020.
On the 23rd of February, I announced an update to Ireland’s COVID-19 Vaccine Allocation Strategy. In comprising the initial Vaccine Allocation Strategy, the NIAC listed several conditions associated with increased risk of severe disease and death. In the intervening period, national and international evidence has become available which has enabled a more detailed analysis of underlying conditions that may increase the risk of developing severe disease or death. The NIAC has now been able to more comprehensively identify those medical conditions and to distinguish between those which place a person at very high or high risk of severe disease if they contract the virus. Medical conditions and the magnitude of the risk they pose will continue to be monitored and periodically reviewed.
On the 30th of March, the Government approved a further update to the COVID-19 Vaccination Allocation Strategy. Based on clinical, scientific and ethical frameworks produced by the National Immunisation Advisory Committee and my Department, following the vaccination of those most at risk, future groups will be vaccinated by age, in cohorts of 10 years (i.e., 64-55; 54-45, etc.).
The move to an age-based model better supports the programme objectives by:
- protecting those at highest risk of severe disease first, which benefits everyone most;
- facilitating planning and execution of the programme across the entire country;
- improving transparency and fairness.
Further details are available here: https://www.gov.ie/en/press-release/93f8f-minister-donnelly-announces-update-to-irelands-vaccination-prioritisation-list/
Vaccine registration for those aged 50 to 59 years has begun.
740. Deputy Danny Healy-Rae asked the Minister for Health the number of recorded Covid-19 deaths that are solely attributed to Covid-19 in which the person had no underlying illness; and if he will make a statement on the matter. [23881/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
741. Deputy Danny Healy-Rae asked the Minister for Health the number of the recorded Covid-19 deaths that already had an underlying health condition; and if he will make a statement on the matter. [23890/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
743. Deputy Fergus O'Dowd asked the Minister for Health further to Parliamentary Question No. 1619 of 21 April 2021, if he will address further matters raised in correspondence (details supplied); and if he will make a statement on the matter. [23904/21]
View answerAs the Deputy will be aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE if it wishes 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 NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.
As Minister for Health, I have no role in individual decisions relating to either the authorisation or reimbursement of medicines.
Clinical trials on medicinal products for human use is a highly regulated activity, governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004 and amendments. The regulatory authority for clinical trials in Ireland is the Health Products Regulatory Authority (HPRA) and authorisation for the conduct of a clinical trial is solely for the HPRA to decide.
Questions regarding treatment plans and options specific to individual patients are a matter for each patient’s treating clinician.
745. Deputy Colm Burke asked the Minister for Health the cost of the review by a company (details supplied) of governance structures in relation to the HSE drug reimbursement process; and if he will make a statement on the matter. [23981/21]
View answer746. Deputy Colm Burke asked the Minister for Health the specific date his Department plans to complete its consideration of a review by a company (details supplied) of the HSE drug reimbursement process; and if he will make a statement on the matter. [23982/21]
View answerI propose to take Questions Nos. 745 and 746 together.
Following a tender by the Office of Government Procurement, Mazars conducted a review of the governance structures around the HSE's drug reimbursement process. This report was submitted to my Department in January 2020. The total amount paid to Mazars for producing this report was €86,123.86 including VAT.
The review made recommendations in respect of the HSE’s systems, structures, processes, governance arrangements and use of specialist resources in respect of the drug reimbursement process.
The report was under consideration by officials earlier last year, however the focus of the Department of Health changed to the immediate public health considerations of the COVID-19 pandemic and the preservation of life. This meant that this work stream was temporarily suspended to reallocate resources to support essential services.
My Department aims to complete its consideration of the report’s recommendations in the near future.
747. Deputy Colm Burke asked the Minister for Health the status of the National Rare Disease Plan; if incomplete or unfinished actions in the existing plan are being prioritised in the context of the update of the plan; and if he will make a statement on the matter. [23983/21]
View answerA National Rare Disease Plan for Ireland (2014 – 2018) was launched by the Minister for Health in July 2014. This is a generic policy framework for rare diseases. The scope of the plan is broad given that there are approximately 8,000 rare diseases affecting millions of EU citizens; and consequently, there can be a dearth of expertise and knowledge about some rare diseases, simply because they are so rare.
Many of the major recommendations of the plan have already been implemented including the establishment of a National Clinical Programme for Rare Diseases and a Rare Disease Office. Building on this progress to date, themes for inclusion in a roadmap for the coming period have been agreed with the Rare Disease Task Force, which comprises the main rare disease advocacy groups; Rare Disease Ireland, the Medical Research Charities Group (MRCP), and the Irish Platform for Patient Organisations, Science and Industry (IPPPOSI). The Rare Disease Plan is now firmly embedded in the work of the Rare Disease Office which is under the governance of the HSE, Office of the Chief Clinical Officer. This means that, from 01 September 2020, the NRDO became the main contact point and driver for national HSE rare disease projects and initiatives and the National Clinical Programme for Rare Diseases was wound down and any outstanding projects transferred to the NRDO.
I recently met with the HSE, The National Rare Disease Office and The Rare Disease Taskforce which comprises the main rare disease advocacy groups; Rare Disease Ireland (RDI), the Medical Research Charities Group (MRCP), and the Irish Platform for Patient Organisations, Science and Industry (IPPPOSI). A very fruitful discussion was held regarding priority areas for the future in order to build on the significant progress made to date in implementing the Rare Disease Plan. A number, of themes for inclusion in a roadmap for the coming period have been agreed.
748. Deputy Peadar Tóibín asked the Minister for Health the number of cases currently before the CervicalCheck Tribunal. [23984/21]
View answerThe CervicalCheck Tribunal was established on 27 October 2020 under the CervicalCheck Tribunal Act 2019. Establishment of the Tribunal was finalised with the appointment of the nominated members to the Tribunal with effect from 1 December 2020.
The Tribunal has indicated to my Department that it has received three claims as at close of business on 7 May 2021. No claims have yet been heard by the Tribunal; but it is anticipated that the Tribunal will be able to facilitate early hearing dates once all parties are ready.
The Tribunal is the most appropriate venue to hear and determine CervicalCheck claims. It has been specifically designed for that purpose. It is, of course, entirely up to eligible women as to whether or not they use it.
749. Deputy Peadar Tóibín asked the Minister for Health the number of legal proceedings initiated by persons that identify themselves as persons allegedly affected by the CervicalCheck scandal in each of the past five years and to date in 2021; the number of cases currently before the courts; the number of cases currently settled; and the number of cases which have not yet reached the courts. [23985/21]
View answerThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. I have been informed by the SCA that the information below has been extracted from the National Incident Management System (NIMS).
Criteria used
Overall Criteria
Claims received between 01/01/2016 to 06/05/2021 in relation to the Cervical Check issue
Question 2
- Proceedings are Issued and
- Claims have not yet Concluded
Question 3
- Claim is Concluded
Question 4
- Proceedings are not Issued and
- Claims have not yet Concluded
This is correct as of 06/05/2021.
Question 1: Cervical Cancer NSS claims created between 2016 & 2021
|
Claim Received Year |
Number of claims |
|
2016 |
2 |
|
2017 |
1 |
|
2018 |
86 |
|
2019 |
52 |
|
2020 |
95 |
|
2021 YTD |
51 |
|
Grand Total |
287 |
Table 1: Claims received between 2016 & 2021 to date under the Cervical Cancer NSS mass action
Question 2: Cases currently before the courts
The number of cases where legal proceedings have issued is 185.
Question 3: Cases currently settled
The number of cases currently concluded is 32 of which 25 were settled, 1 had a court award, 5 were intimated but not pursued and 1 was discontinued.
Question 4: Case which have not yet reached the courts
The number of claims received by the State Claims Agency where legal proceedings have not issued is 70.
750. Deputy Peadar Tóibín asked the Minister for Health the number of claims made and proceedings initiated against the HSE by persons or groups of persons whose loved ones died after contracting Covid-19 in HSE run nursing homes or community hospital settings. [23986/21]
View answerThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. The State Claims Agency has informed me that the information contained below was extracted from the National Incident Management System (NIMS) according to the below criteria:
- The explicit reference to “nursing homes” or “community setting” is interpreted as claims notified to the SCA which relate to incidents occurring within a nursing home or a community health organisation location/unit run by the HSE.
- Claims arising may relate to the death of a service user or staff member.
The number of claims against the HSE, notified to the SCA, which relate to the death of a family member/dependent as a result of contracting Covid-19 in a Nursing Home or Community Healthcare location/unit is 5.
751. Deputy Cathal Crowe asked the Minister for Health if he and his officials will give consideration to a proposal (details supplied) to ensure the provision of eye clinic liaison officers in eye clinics outside of the Dublin area. [23989/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
752. Deputy Mark Ward asked the Minister for Health if consideration has been given to not counting fully vaccinated wedding guests in the 25 guest limit which is due to be introduced in June 2021; and if he will make a statement on the matter. [23990/21]
View answer753. Deputy Claire Kerrane asked the Minister for Health if consideration has been given to exempting persons that have been fully vaccinated from the 25 guest limit for weddings and six guest limit for after celebrations. [23997/21]
View answerI propose to take Questions Nos. 752 and 753 together.
There has been considerable progress in reducing infection levels since the peak of the wave of infection in late 2020/early 2021 because of the widespread commitment and adherence by the public to the public health measures in place. While there is still a high level of infection nationally, the situation is considered reasonably stable and significant progress is being made in relation to the roll-out of our vaccination programme.
In recognition of the improving situation, the Government announced a roadmap on the 29 April for the gradual lifting of some restrictions over the next two months, with a particular focus on allowing more outdoor activities. A range of measures will be eased in May, with a further easing of measures in June subject to the epidemiological situation at the time.
The announcement include the following changes to the measures applying to weddings: as of May 10, there can be an increase in the number of guests attending wedding services to 50 which brings this figure in line with the numbers permitted at religious services.
This increase to 50 guests relates to the service (both religious or civil) only. The number of guests attending a wedding celebration or reception should remain at 6 guests for indoor gatherings and 15 guests for outdoor gatherings. From 7 June, subject to the epidemiological situation at the time, it is envisaged that the numbers of guests attending a wedding celebration or reception will increase to 25.
The “vaccine bonus/dividend” provisions currently in place are guided by public health advice and are specifically focused on social visits to private homes to alleviate the impacts of social isolation. From 10 May, those that are fully vaccinated may visit with other fully vaccinated people, providing there is no more than 3 households present and those that are fully vaccinated may visit with unvaccinated people from a single household, provided that they are not at risk of severe illness and there is no more than 3 households present.
It is important to note that while there is now scope to ease a range of public health measures, this approach must continue to be cautious, gradual and on a phased basis, with sufficient time between any easing of measures to assess the impact. This will be critical to ensuring the protection of the gains of recent months, the protection of those most vulnerable, and the protection of health and social care, education, and childcare services.
Significant progress has been made on suppressing the virus over recent months due to the huge effort of people across the country. By working together, we have saved lives and limited the impact of the disease on society in Ireland. We all must continue to do everything possible to continue to avoid the virus spreading and to support the safe reopening of activities over the coming months.
754. Deputy Paul Kehoe asked the Minister for Health the reason the daily Covid-19 figures by county have not been available at weekends; if there are plans to resume supplying this information; and if he will make a statement on the matter. [24003/21]
View answerUnder Infectious Diseases (Amendment) Regulations 2020, all medical practitioners are required to notify the Medical Officer of Health (MOH)/Director of Public Health (DPH) of certain diseases including Covid-19. Cases are then reported on a daily basis to the Department of Health by the Health Protection Surveillance Centre (HPSC).
Daily county numbers in the press release are flagged as being provisional as the national Computerised Infectious Disease Reporting System (CIDR) is a dynamic system and case details are continually being validated and updated.
In particular, cases may need additional validation in relation to the county of residence and you will see on a daily basis small differences between the daily county case numbers in the press release and those published on the COVID-19 data hub the following day.
In recent weeks it was agreed with the HPSC to discontinue the inclusion of the provisional daily county numbers for cases notified up to midnight the previous day in the press release at weekends.
While the provisional daily county numbers up to midnight the previous day are no longer included in the daily press release at weekends, the daily confirmed case counts up to midnight the day prior to this continue to be published on the COVID-19 data hub every day. This data is published at the same time as the daily press release. The additional time lag allows further validation of the case detail including details of county of residence. This data is also made available through the COVID-19 app every day.
A full series of the data is made available as open data.
This consists of the cumulative totals for each county for each day and is published in a number of formats (including CSV).
Further information:
Daily cumulative county confirmed case totals can be downloaded from the following link.
https://data.gov.ie/dataset/covid19countystatisticshpscireland1
755. Deputy Paul Kehoe asked the Minister for Health when a directive will be issued to all hospital groups nationwide to allow birthing partners attend maternity appointments of all kinds given the current level of vaccination against Covid-19; and if he will make a statement on the matter. [24005/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
756. Deputy David Cullinane asked the Minister for Health further to Parliamentary Question No. 2092 of 21 April 2021, his plans to appoint a specific reproductive immunologist; and if he will make a statement on the matter. [24009/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
